Outcome Measure Recommendations From the Spinal Cord Injury EDGE Task Force

Best practice in the use of outcome measures (OMs) is critical to the field of rehabilitation. Standardized and effective OM use allows evaluation of which interventions are effective and helps clinicians objectively evaluate patient progress.1 Although the use of standardized OMs has increased,1,2 barriers continue to limit their implementation in practice,1,3,4 with more than 50% of physical therapists in one study reporting that they do not regularly use standardized OMs.1 Barriers to clinicians' OM use include: limited time to complete and analyze OMs1,3,4; limited clinician knowledge about OMs3,4; and lack of clinician time, knowledge, and resources to access up-to-date information about OMs.3,4 The American Physical Therapy Association (APTA) has implemented several initiatives to minimize these barriers and facilitate best practice related to OMs. The Neurology Section developed a regional course addressing OM use in people with neurologic diagnoses titled “Neurologic Practice Essentials: A Functional Toolbox,” which has now been modified and transitioned to an online format. The Section on Research developed the Evaluation Database to Guide Effectiveness (EDGE) Task Force in 2006 to advance best practice for use of OMs.5 The Neurology Section, in coordination with the EDGE Task Force, has organized task forces to make recommendations on the use of OMs in neurologic populations. Individuals can use these recommendations to more effectively and objectively develop a plan of care and report patient progress, as well as strengthen their clinical reasoning to continually improve patient care. To date, EDGE recommendations regarding OMs are available for the following patient populations: stroke, multiple sclerosis (MS), spinal cord injury (SCI), traumatic brain injury, Parkinson disease, and vestibular disorders. The EDGE task forces are disseminating their summaries of evidence and recommendations in partnership with the Rehabilitation Measures Database (RMD), a database developed to help clinicians and researchers use OMs effectively to assess patient outcomes. These resources facilitate use of OMs and alleviate barriers that clinicians face in utilizing and implementing OMs in practice, such as lack of time, knowledge, and resources.1,3,4 The purpose of this article is to report the process, results, and impact of the recommendations from the Spinal Cord Injury EDGE Task Force (SCITF). This report includes: (1) the SCITF's evaluation of the psychometric properties and clinical utility of a battery of OMs for individuals with SCI; (2) SCITF recommendations for the use of these OMs in clinical, research, and education settings; and (3) the dissemination of these recommendations. A modified Delphi process,6–8 described below, was used to reach consensus on recommendations for OMs and occurred over a 3-step consensus process (Figure) adapted from the methods of the MS and Stroke EDGE task forces.9,10 In October 2011, the Neurology Section of APTA recruited volunteers for the SCITF, and interested volunteers submitted applications. Neurology Section leadership selected the SCITF chairperson and members (Tab. 1) based on each applicant's evidence of working knowledge of OM psychometrics, ability to read and interpret literature, experience working with common clinical measures in people with SCI, and ability and willingness to complete the tasks involved in the SCITF proceedings (eg, Combined Sections Meeting [CSM] attendance, writing summaries of the research literature, ongoing communication). Schematic of Spinal Cord Injury Evaluation Database to Guide Effectiveness (EDGE) Task Force process. RMD=Rehabilitation Measures Database. Spinal Cord Injury Evaluation Database to Guide Effectiveness (EDGE) Task Force Membersa ABPTS=American Board of Physical Therapy Specialties, Y=yes, N=no. Spinal Cord Injury Evaluation Database to Guide Effectiveness (EDGE) Task Force Membersa ABPTS=American Board of Physical Therapy Specialties, Y=yes, N=no. The initial meeting of the SCITF occurred in Chicago, Illinois, at the APTA CSM. The goals of this meeting were to determine: (1) the process the SCITF would use for consensus, (2) which measures the SCITF would review, (3) appropriate subgroups to consider within SCI when developing recommendations, and (4) which rating scale would be used to evaluate the OMs. Unanimously, the SCITF agreed that consensus for decision making would be achieved when a minimum of 80% agreement among members was met. The chairperson compiled a master list of OMs that represented all domains of the International Classification of Functioning, Disability and Health11 (ICF) used in people with SCI from which the SCITF would select the most appropriate OMs to evaluate. Resources used to develop this master list included: literature on SCI, systematic reviews, resources from the Spinal Cord Injury Rehabilitation Evidence (SCIRE) Project and Spinal Cord Outcomes Partnership Endeavor (SCOPE), recommendations from the education consensus report from APTA, SCI Special Interest Group recommendations, RMD, and SCITF recommendations.12–25 Relevant literature was obtained via a PubMed search using the term “spinal cord injury” paired with each of the following key words: “OMs,” “clinical measures,” “assessment tool,” “measurement,” and “ICF,” including articles found through the “similar articles” feature of the PubMed search engine. In this initial meeting, the SCITF eliminated OMs that were not prevalent in the literature, lacked applicability to the SCI population, measured constructs not treated routinely or directly with physical therapy (eg, depression, anxiety, cognition, sexual function, incontinence), or were constructs secondary to SCI (eg, integumentary measures for measurement of pressure ulcers). The group discussed every proposed OM, and appropriate literature was evaluated before making a decision on a case-by-case basis through at least 80% group consensus. Next, the SCITF decided how to rate each OM in step 3 of our process. The SCITF elected to use an adaptation of the 4-point rating scale used by the MS and Stroke EDGE groups, as shown in Table 2.9,10 This scale incorporates an evaluation of the psychometrics of an OM (including reliability, validity, and available data to guide interpretation) and clinical utility of the OM. Examples of data to guide interpretation include: sensitivity to change, minimal detectable change, minimal clinically important difference, and floor and ceiling effects. These items are of importance clinically, as they assist clinicians in goal setting and evaluating how patients are responding to intervention. The score of 2 was modified from “Unable to Recommend” to “Reasonable to Use, but Limited Study in Target Group.” This change in wording clarified that clinicians may appropriately elect to use an OM that has been validated in a related patient population when there is no OM available that has been validated in the SCI population. Because psychometric data may not be generalizable between different patient populations, it is recommended to use OMs and psychometric data (eg, validity, reliability, minimal detectable change, minimal clinically important difference) in patient populations that are similar to those in which they have been studied whenever possible.26 Therefore, an OM had to have psychometric data specific to individuals with SCI in order to receive a rating of “Recommended” or “Highly Recommended.” In addition, “Highly Recommended” measures had excellent reliability and validity and data to guide interpretation, as well as excellent clinical utility (Tab. 2). The SCITF utilized the criteria defined on RMD, compiled from multiple sources,27–29 to assist in establishing whether reliability and validity were deemed excellent, good, or poor.25 For example, validity correlation coefficients above .6 were considered excellent.25 Spinal Cord Injury Evaluation Database to Guide Effectiveness (EDGE) Task Force Outcome Measure Rating Scale Spinal cord injury. A neurologic population that has some impairment similarities to the target group would be most helpful, but other groups, such as older adults with balance impairment, also could meet this criterion. Spinal Cord Injury Evaluation Database to Guide Effectiveness (EDGE) Task Force Outcome Measure Rating Scale Spinal cord injury. A neurologic population that has some impairment similarities to the target group would be most helpful, but other groups, such as older adults with balance impairment, also could meet this criterion. The SCITF rated each OM in a total of 8 categories: 5 related to clinical use of OMs, 2 related to entry-level physical therapy education, and 1 related to the OM's use in intervention research. The categories related to clinical use included the following subgroups of people with SCI: (1) motor complete (American Spinal Injury Association Impairment Scale [AIS] A or B), (2) motor incomplete (AIS C or D), (3) chronic SCI (>6 months postinjury), (4) subacute SCI (3–6 months postinjury), and (5) acute SCI (0–3 months postinjury). Each OM was rated in these 5 categories using the 4-point scale described above. The SCITF also considered rating the OMs based on other categories, including tetraplegia versus paraplegia and levels of care. Through discussion, the SCITF reached a unanimous decision that levels of acuity and AIS classification best described the spectrum of people with SCI and resulted in a clear delineation of one group from another, allowing the assignment of a rating in each Each OM was also rated or in the following categories related to education and (1) entry-level physical to the OM, (2) entry-level physical to the OM, and (3) use of the OM in intervention research based on available psychometric data and the of other OMs the The SCITF an for each OM, the the of the OM, the the constructs recommendations and in each of SCI, and The SCITF's EDGE was adapted from that used by the MS and Stroke EDGE with the change to the SCI EDGE of the of the psychometrics would be and an available at and described A between the and the EDGE task forces was with the SCITF, which the SCITF and the to to and information more effectively and The is an online database developed by the for Rehabilitation Outcomes Research at the Rehabilitation of The summaries and has a with an of and an of in of the SCITF process, a of each OM was or to the to this the EDGE task forces and developed summaries of OMs. these summaries would be for a more and up-to-date The EDGE and were developed as a of to be used The EDGE the and the the information and evidence for the the chairperson the SCITF members of and the list of OMs by In for to step each was an of OMs based on and consensus from the task The of the modified Delphi process occurred over a through Each of decided which would the on each of their OMs. The purpose of the was to complete an EDGE for an OM and (1) a of an with the of SCI information or (2) of a one not The a literature search for research, which was by members the of a literature The literature was and to the and EDGE the was to the secondary for review, discussion, and agreement on the of the the EDGE and the was this time, the SCITF had to and among The of the modified Delphi process was group consensus and occurred over 2 months to an 80% agreement for consensus, of the 8 members of the SCITF had to on each The chairperson compiled all EDGE and all summaries for each OM and a online The SCITF members were whether they agreed or with the EDGE rating for each of the 8 categories related to acuity of injury and AIS in each OM, using the EDGE and summaries as evidence for the an or was to a in the The chairperson and an SCITF the of the Each that not at least 80% consensus was in to the rating scale was and to consider each SCITF The SCITF members also on categories that initial consensus. 2 SCITF members and the EDGE and The of the and were to the SCITF and were via and consensus on was The SCITF all for consensus. In order to these summaries to a the were on the Neurology Section and summaries of OMs with to the EDGE were on of for each of these was as evidence of the dissemination of the information in the SCITF summaries and recommendations. A of the SCI EDGE process is represented in the In the initial meeting, the master list of OMs was to a list of and 1 with of and The SCITF that this list of OMs available at represented a list of measures that represented constructs by physical therapists within all categories of the were measures in the and in the and in the Each had a of measures within group The SCITF also that recommendations could be in the time In step 3 of measures at least agreement all categories of on of the initial the of step measures were a rating of “Recommended” or “Highly Recommended” in incomplete and complete SCI OMs were a rating of “Recommended” or “Highly Recommended” in at least 2 of the 3 OMs were as important for entry-level education, with the that be to of these OMs and to the OMs. OMs were recommended as appropriate to use in research and In the and of the of the measures for or a rating than a 2 in In the constructs included function, and 1 of balance measures Scale and 2 of measures the of and the and of and “Recommended” For The 1 “Recommended” rating and “Reasonable to Use, but Limited Study in Target and the other 2 measures in this Recommended” The SCITF also a lack of “Recommended” or “Highly Recommended” OMs for people with acute The acute SCI had a total of “Highly Recommended” OMs and “Recommended” OMs in with the chronic SCI which had a total of “Highly Recommended” OMs and “Recommended” OMs. The SCITF found a of OMs for of and The following constructs had multiple measures that could be recommended or recommended at least 3 of 5 categories: 5 of 8 OMs, 2 of OMs, and 3 of 3 OMs. of measures a “Recommended” and 1 of measures a “Highly Recommended” Each OM with the domains and the all 8 categories are in the of the SCITF's recommendations was through of at the in dissemination of these is ongoing through online resources and The EDGE and summaries of recommendations were on the Neurology and these have been In months the SCI EDGE an of for a total of this The SCITF recommendations and to summaries were to the in and of it is not to how SCITF were on the several of the measures for SCI (eg, also are used different the measures on were all or by the The SCITF for the measures and a from to These measures a rating of “Recommended” or “Highly Recommended” in at least 3 of 5 categories: (1) (2) (3) International for Classification of Spinal Cord Injury (4) for Spinal Cord Injury (5) Spinal Cord Measure and Spinal Cord Injury Functional The for these OMs a total of in to a total of in and in In addition, the SCITF measures to the such is the which in to in These that the is an effective dissemination for the The by the SCITF a for and to information about OMs in people with recommendations for which OMs to as well as evidence that has been from the literature, barriers such as lack of time, knowledge, and are dissemination of this information is critical to the between practice and best practice in this The between the SCITF and the resulted in and of this information to a and the SCITF's to the resulted in more people this information than were the Neurology Section In addition, the and of use of information in the was (1) summaries to the database via the SCITF, (2) of summaries by the SCITF, and (3) the of recommendations and for each OM the on the and the Neurology Section has been for the Neurology Section, the RMD, and the of this of the SCITF a of were constructs that the SCITF were for measurement in SCI, but that not have OMs “Recommended” or “Highly Recommended” all In the and these constructs included and In the these constructs included function, and the that these constructs are important in the SCI they had limited data that would recommendations. it is to information about and how it the and rehabilitation. the lack of reliability and validity of data on measures related to including and in the SCI population, researchers consider the use of methods of measurement in the as clinicians and time In the of “Highly Recommended” or “Recommended” as in the of clinicians can select a based on information that the SCITF has Measures a rating of Recommended” of 1) can be For of OMs that a score of 2 related to in patients with SCI, the specific of each in this be with patient and clinical decision The SCITF summaries and of each OM. For example, the Scale on the of the Scale may be used to and the Spinal Cord for may be used to Individuals with SCI are at an for and have levels of which can be through The SCITF 2 measures the of or the and the Physical for Spinal Cord Injury Although the lacked data on reliability and validity, it was recommended as to use as a to when more is This is a of how clinical decision making the use of the SCITF recommendations. A score of 2 on the SCI EDGE recommendations not that the OM be the clinician which would be the best available in the of measures with In this the is the best available for an OM of function, but clinicians with as they interpret the of the included lack of validity of the in and the of the to among individuals with SCI have levels of physical In this the on the SCI EDGE and information in the summaries important in OM The SCITF process a in an of measurement for individuals with SCI and the importance of clinical decision making when an OM. balance is a to following in individuals with motor incomplete Therefore, balance is an important for physical therapists to in this population. were OMs for balance that had psychometrics available in the SCI population to for a “Recommended” or “Highly Recommended” The is one that has been studied in this population to balance and multiple “Recommended” it has been found to have a ceiling in individuals with AIS These individuals continue to be in function, and it would be to have a to help these and change in this of the is that it not balance The and the Functional have been validated in related populations, but not The Spinal Cord Injury Functional is an that incorporates balance and related tasks that a “Recommended” rating in 2 the of chronic SCI has data The more balance and that would be to this population, but has not been studied in In to these for balance the SCITF process in measurement of The Functional was the of balance and rating of “Reasonable to Use, but Limited Study in Target of 2). the SCI EDGE process a in the of OMs for the measurement of balance in measures specific to SCI are of that of and is a in individuals with more for of the and in SCI the for measures more The and are 2 that clinicians and researchers are other measures that may be in the SCI population, but evidence is and the SCITF was to those For example, the use of the Research in the SCI intervention research literature, the SCITF found no psychometric properties in people with Therefore, this could not receive a score than use in the would be for research to on measures such as the to that clinicians and researchers can and of in individuals with with and to more are important for individuals with Although the a “Recommended” rating in one it is the best of available it the data to a This more validated OMs for people with The SCITF also found OMs that could be recommended for people with acute SCI (0–3 months postinjury). The SCITF found that this was to lack of research in these measures in acute In addition, there were 2 constructs with recommended OMs for chronic SCI that had in the acute SCI of and of may be to assess in people with acute SCI are people with SCI are to the in the acute of their and it is important that of be in this a recommended OM for this the ability to and improve of in the acute SCI is is critical for measurement in a SCI, including the acute Although there were 2 measures that could be recommended in the chronic SCI there were in the acute SCI These 2 critical of measurement that research and in order to advance SCI rehabilitation. also were constructs that were well represented by the list of the SCITF's “Recommended” and “Highly Recommended” In the and of the had 3 “Recommended” and “Highly Recommended” the International for Classification of Spinal Cord Injury and The and were a a rating of “Highly Recommended” by of the rating have excellent reliability, validity, and data to guide is an important to ability for people with and and as measured by the are in for the of Therefore, excellent measures in this that data to guide interpretation are In the and had multiple “Recommended” and “Highly Recommended” The Functional Measure and the have a of psychometric data and a rating of “Recommended” in all was well with 5 measures that included reliability and validity and data to guide and The of these measures allows of to be as and used with with and In there are multiple “Recommended” and “Highly Recommended” OMs for the the SCITF can assist in which OMs to use based on and specific of these constructs that they to In the all measures that achieved a “Recommended” or “Highly Recommended” rating in at least 3 of the 5 categories were domains of of function, and and These measures had psychometric data available in the chronic SCI population. In the acute SCI population, one of these measures could be recommended based on the available research 2 of these measures could be recommended for use in the subacute SCI population. Therefore, of the OMs are most appropriate to be used in the chronic SCI population. In addition, limited psychometric data were available for change in these Therefore, the of OMs available with a “Recommended” rating is there are in their clinical on available research, these measures are to the in people with chronic when using to or it is how change is to or change and whether these measures the of that our patients make in rehabilitation. The experience of SCITF members was that these measures are not used in clinical practice, and these may at least of the for is that clinicians are with these measures or how to The EDGE process has to the knowledge related to measures by clinicians with information about measures to use with their Although more research is to guide how to interpret change in these the of is an important to in The SCITF's recommendations also were developed to guide researchers in appropriate OMs for in the of SCI rehabilitation. a limited of OMs for research help (1) the of research results, (2) improve the ability to among and (3) improve of research to the by making it more for clinicians to of interventions they with is in the The SCITF a list of recommended OMs for use in research to improve all of these were based on the psychometric data available for the OM and the of other OMs the with for clinical For the was recommended for research a score of 2 in of 5 Although the of psychometric data available for the was limited rating to a score of 2 in of 5 this was the best available to this which the most appropriate to for research. A to this process for consensus is that it not a systematic or to a the SCITF literature of each OM and utilized specific criteria in order to group members and decision making the modified Delphi process. use of the modified Delphi process for of of the literature in making recommendations clinical utility of a that more time to or has a for are related to ongoing implementation of these recommendations. more research on OMs is The information compiled by the SCITF was as of is not a in to the information from all of the EDGE the Neurology Section is to a to EDGE there is a to the in order to more EDGE for different diagnoses more recommendations, the of information may for For clinical recommendations, a total of OMs were including OMs that were specific to For entry-level education, the SCITF an to be in recommended OMs. there are OMs that were recommended for to to and an OMs for entry-level Although most of these OMs are not specific to SCI can be in multiple the of OMs to be in entry-level education is when all of the EDGE For clinicians and a through all EDGE group recommendations may be a for clinical Therefore, the of recommendations for OM use in a neurologic population may be appropriate in order to facilitate and effective the practice to this are in through the EDGE Task The SCITF SCI OMs and recommendations for use in clinical practice using a 4-point scale that was based on of psychometric properties and clinical recommendations were for entry-level education and research. The recommendations by the SCITF can clinical practice, research, and of entry-level education by an to for OMs that are clinically and for individuals with SCI; and help guide intervention. can use these recommendations to make clinical that are by effective measurement to patient care.