Knee Surg Sports Traumatol Arthrosc DOI 10.1007/s00167-015-3588-6
KNEE
Anterior cruciate ligament reconstruction–rehabilitation research methodological quality: a systematic review with world region comparisons Artur Proniewicz1 · Paul Mazzone1 · John Nyland1,2 · Jeff Wera1 · Justin Givens1
Received: 6 November 2014 / Accepted: 20 March 2015 © European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2015
Abstract Purpose A systematic review and world region comparison of combined ACL reconstruction–rehabilitation studies was performed. Methods Studies that combined ACL surgical-rehabilitative management published between January 1990 and June 2014 were evaluated. The combined terms “rehabilitation” and “anterior cruciate ligament reconstruction” or “ACL reconstruction” were used to search the CINAHL Plus, Cochrane Library, MEDLINE, PEDro, and PubMed databases. A total of 5920 studies were initially identified. Inclusion criteria reduced this total to 299 studies that underwent abstract review. Following this, 155 studies underwent full text review and 109 met all inclusion criteria for Modified Coleman Methodology Score (MCMS) evaluation. Results Overall, MCMS were 74.0 ± 17 (mean ± standard deviation). Europe had slightly greater MCMS than North America (P = 0.041). Specific MCMS components that displayed significant world region differences included use of an independent investigator (Europe > North America and Asia; P = 0.047), including a patient-completed
written assessment (Europe > North America and Asia; P = 0.009), allowing the patient to complete the assessment without medical, surgical, or rehabilitation personnel intervention (Europe > North America and Asia; P = 0.009), and use of well-described subject selection or inclusion criteria (Europe > North America and Asia; P = 0.004). Tegner Activity Scale (P = 0.042) and VAS-Pain Scale (P = 0.007) use was greater in Europe compared with other world regions. Primary rehabilitation theme frequency was comparable between world regions (n.s.). Conclusion Regional research methodological quality differences were observed. Europe displayed a slightly greater MCMS for combined ACL reconstruction–rehabilitation studies. With this information, research groups can design better team-based approaches to ensure that study findings provide sufficient significance to foster meaningful patient care improvements. Level of evidence Systematic review, Level III. Keywords Systematic review · ACL · Rehabilitation · Surgical reconstruction · Research methodology
Introduction Electronic supplementary material The online version of this article (doi:10.1007/s00167-015-3588-6) contains supplementary material, which is available to authorized users. * John Nyland [email protected] 1
Division of Sports Medicine, Department of Orthopaedic Surgery, University of Louisville, 550 S. Jackson Street, 1st Floor, ACB, Louisville, KY 40202, USA
2
Athletic Training Program, Kosair Charities College of Health and Natural Sciences, Spalding University, 901 South 4th Street, Louisville, KY 40203‑2188, USA
There is a strong relationship between ACL surgical reconstruction, the ensuing rehabilitation experienced by the patient, and eventual treatment outcome [11]. While surgical innovations have evolved dramatically since the early days of ACL reconstruction [2], rehabilitation interventions have advanced more slowly, especially regarding the development of evidence-based criteria supporting whether or not a patient is ready to safely return back to unrestricted sports participation [5, 6]. Even less understood is the methodological quality of the research used to
13
acquire this evidence. The Modified Coleman Methodology Score (MCMS) criteria [7] has been previously used as a component of ACL reconstruction research focusing on graft type [3], bone–patellar tendon–bone graft defect closure [4], hamstring tendon regeneration post-harvest [8], surgical management following partial ACL injury [9], the influence of gender on knee laxity following ACL reconstruction with either a hamstring or a bone–patellar tendon–bone autograft [10], and the efficacy of retaining the ACL remnant during reconstruction [12]. Recently, Wera et al. [14] identified world region differences for International Knee Documentation Committee Knee Survey use following ACL reconstruction; however, this study did not require the combination of ACL reconstruction and rehabilitation as a study inclusion criteria factor. Based on these previous reports, the purpose of this systematic review of studies that combined both ACL reconstruction surgery and rehabilitation was to evaluate world region research methodological quality differences. Information such as this will help clinicians and researchers design more effective team-based approaches to better ensure that study findings provide sufficient significance to foster meaningful patient care improvements.
Materials and methods This systematic review evaluated studies that combined ACL reconstruction surgical and rehabilitation management published between January 1990 and June 2014 following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria (http:// www.prisma-statement.org/). The initial literature search combined the terms “rehabilitation” with “anterior cruciate ligament reconstruction” or “ACL reconstruction”. The following databases were searched by the primary investigator: CINAHL Plus, the Cochrane Library, MEDLINE, PEDro, and PubMed. A total of 5920 citations were initially identified. After applying study inclusion criteria that limited reviewed studies to either randomized controlled trials or patient cohort clinical studies with full English language text available, a total of 299 studies underwent further abstract review. A detailed appraisal of the rationale used to exclude certain studies from further review is presented in Fig. 1. A total of 109 studies underwent research methodological quality scoring using the MCMS criteria [7] (Appendix I in Supplementary Material). Reliability [13] and validity [1, 7, 14] have been previously demonstrated for these criteria. Wera et al. [14] reported that ACL reconstruction surgical studies with higher evidence levels displayed superior MCMS supporting the validity of these criteria for this patient group. Scoring was initially performed by the primary investigator (AP) and two
13
Knee Surg Sports Traumatol Arthrosc
co-authors (PM, JG). If unanimous agreement was not attained, a second review was performed with two additional co-authors (JW, JN). Multiple factors contributed to a given study displaying a higher MCMS (maximum of 100 points). This includes having a larger number of study subjects, a longer follow-up period, use of only one surgical procedure per reported outcome, use of a randomized controlled study design, presenting adequate surgical procedure details such as bone tunnel placement, drilling and graft fixation methods, presenting adequate description of post-surgical rehabilitation including primary criteria for program advancement to sport-specific training and return to unrestricted sports participation, clearly stating the outcome measures that were used, the timing of their administration, using outcome measurement criteria with good reliability and sensitivity, subject recruitment rather than extracting data from surgeon’s files, use of an investigator independent of the knee surgeon, use of a valid written survey in which subjects were allowed sufficient time to complete it independently with minimal investigator assistance, clear description of an unbiased subject selection process, subject recruitment rate of >80 % of eligible subjects, and adequate accounting for eligible subjects not included in the study sample [5]. Studies were also categorized and compared by world region (North America, Europe, Asia, and Australia–New Zealand). Systematic review and metaanalysis studies are deemed exempt by the University of Louisville Medical Institutional Review Board.
Statistical methods Demographic statistical analysis was performed for all study variables. World region comparisons of MCMS were performed using a one-way ANOVA and a Tukey HSD post hoc test to delineate the specific location of statistically significant differences. World region comparisons of individual component scoring were made using Chisquare or Fisher’s exact tests. Chi-square tests were used to determine world region differences for MCMS quartiles (high ≥ 75th percentile, moderate
KNEE
Anterior cruciate ligament reconstruction–rehabilitation research methodological quality: a systematic review with world region comparisons Artur Proniewicz1 · Paul Mazzone1 · John Nyland1,2 · Jeff Wera1 · Justin Givens1
Received: 6 November 2014 / Accepted: 20 March 2015 © European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2015
Abstract Purpose A systematic review and world region comparison of combined ACL reconstruction–rehabilitation studies was performed. Methods Studies that combined ACL surgical-rehabilitative management published between January 1990 and June 2014 were evaluated. The combined terms “rehabilitation” and “anterior cruciate ligament reconstruction” or “ACL reconstruction” were used to search the CINAHL Plus, Cochrane Library, MEDLINE, PEDro, and PubMed databases. A total of 5920 studies were initially identified. Inclusion criteria reduced this total to 299 studies that underwent abstract review. Following this, 155 studies underwent full text review and 109 met all inclusion criteria for Modified Coleman Methodology Score (MCMS) evaluation. Results Overall, MCMS were 74.0 ± 17 (mean ± standard deviation). Europe had slightly greater MCMS than North America (P = 0.041). Specific MCMS components that displayed significant world region differences included use of an independent investigator (Europe > North America and Asia; P = 0.047), including a patient-completed
written assessment (Europe > North America and Asia; P = 0.009), allowing the patient to complete the assessment without medical, surgical, or rehabilitation personnel intervention (Europe > North America and Asia; P = 0.009), and use of well-described subject selection or inclusion criteria (Europe > North America and Asia; P = 0.004). Tegner Activity Scale (P = 0.042) and VAS-Pain Scale (P = 0.007) use was greater in Europe compared with other world regions. Primary rehabilitation theme frequency was comparable between world regions (n.s.). Conclusion Regional research methodological quality differences were observed. Europe displayed a slightly greater MCMS for combined ACL reconstruction–rehabilitation studies. With this information, research groups can design better team-based approaches to ensure that study findings provide sufficient significance to foster meaningful patient care improvements. Level of evidence Systematic review, Level III. Keywords Systematic review · ACL · Rehabilitation · Surgical reconstruction · Research methodology
Introduction Electronic supplementary material The online version of this article (doi:10.1007/s00167-015-3588-6) contains supplementary material, which is available to authorized users. * John Nyland [email protected] 1
Division of Sports Medicine, Department of Orthopaedic Surgery, University of Louisville, 550 S. Jackson Street, 1st Floor, ACB, Louisville, KY 40202, USA
2
Athletic Training Program, Kosair Charities College of Health and Natural Sciences, Spalding University, 901 South 4th Street, Louisville, KY 40203‑2188, USA
There is a strong relationship between ACL surgical reconstruction, the ensuing rehabilitation experienced by the patient, and eventual treatment outcome [11]. While surgical innovations have evolved dramatically since the early days of ACL reconstruction [2], rehabilitation interventions have advanced more slowly, especially regarding the development of evidence-based criteria supporting whether or not a patient is ready to safely return back to unrestricted sports participation [5, 6]. Even less understood is the methodological quality of the research used to
13
acquire this evidence. The Modified Coleman Methodology Score (MCMS) criteria [7] has been previously used as a component of ACL reconstruction research focusing on graft type [3], bone–patellar tendon–bone graft defect closure [4], hamstring tendon regeneration post-harvest [8], surgical management following partial ACL injury [9], the influence of gender on knee laxity following ACL reconstruction with either a hamstring or a bone–patellar tendon–bone autograft [10], and the efficacy of retaining the ACL remnant during reconstruction [12]. Recently, Wera et al. [14] identified world region differences for International Knee Documentation Committee Knee Survey use following ACL reconstruction; however, this study did not require the combination of ACL reconstruction and rehabilitation as a study inclusion criteria factor. Based on these previous reports, the purpose of this systematic review of studies that combined both ACL reconstruction surgery and rehabilitation was to evaluate world region research methodological quality differences. Information such as this will help clinicians and researchers design more effective team-based approaches to better ensure that study findings provide sufficient significance to foster meaningful patient care improvements.
Materials and methods This systematic review evaluated studies that combined ACL reconstruction surgical and rehabilitation management published between January 1990 and June 2014 following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria (http:// www.prisma-statement.org/). The initial literature search combined the terms “rehabilitation” with “anterior cruciate ligament reconstruction” or “ACL reconstruction”. The following databases were searched by the primary investigator: CINAHL Plus, the Cochrane Library, MEDLINE, PEDro, and PubMed. A total of 5920 citations were initially identified. After applying study inclusion criteria that limited reviewed studies to either randomized controlled trials or patient cohort clinical studies with full English language text available, a total of 299 studies underwent further abstract review. A detailed appraisal of the rationale used to exclude certain studies from further review is presented in Fig. 1. A total of 109 studies underwent research methodological quality scoring using the MCMS criteria [7] (Appendix I in Supplementary Material). Reliability [13] and validity [1, 7, 14] have been previously demonstrated for these criteria. Wera et al. [14] reported that ACL reconstruction surgical studies with higher evidence levels displayed superior MCMS supporting the validity of these criteria for this patient group. Scoring was initially performed by the primary investigator (AP) and two
13
Knee Surg Sports Traumatol Arthrosc
co-authors (PM, JG). If unanimous agreement was not attained, a second review was performed with two additional co-authors (JW, JN). Multiple factors contributed to a given study displaying a higher MCMS (maximum of 100 points). This includes having a larger number of study subjects, a longer follow-up period, use of only one surgical procedure per reported outcome, use of a randomized controlled study design, presenting adequate surgical procedure details such as bone tunnel placement, drilling and graft fixation methods, presenting adequate description of post-surgical rehabilitation including primary criteria for program advancement to sport-specific training and return to unrestricted sports participation, clearly stating the outcome measures that were used, the timing of their administration, using outcome measurement criteria with good reliability and sensitivity, subject recruitment rather than extracting data from surgeon’s files, use of an investigator independent of the knee surgeon, use of a valid written survey in which subjects were allowed sufficient time to complete it independently with minimal investigator assistance, clear description of an unbiased subject selection process, subject recruitment rate of >80 % of eligible subjects, and adequate accounting for eligible subjects not included in the study sample [5]. Studies were also categorized and compared by world region (North America, Europe, Asia, and Australia–New Zealand). Systematic review and metaanalysis studies are deemed exempt by the University of Louisville Medical Institutional Review Board.
Statistical methods Demographic statistical analysis was performed for all study variables. World region comparisons of MCMS were performed using a one-way ANOVA and a Tukey HSD post hoc test to delineate the specific location of statistically significant differences. World region comparisons of individual component scoring were made using Chisquare or Fisher’s exact tests. Chi-square tests were used to determine world region differences for MCMS quartiles (high ≥ 75th percentile, moderate
