| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
|
|
|
|||||||
|
|||||||||
Letters and Responses |
 | Evaluating the Signature Form of CIT in Light of mCIT |
|---|
In contrast, the present study3 used approximately half that time (1.5 hours of clinic-based training per week over 10 weeks, for a total of 15 contact hours). However, mCIT as used here had far more restraint of the less-affected upper limb (5 hours/day in the home for 5 days for each of 10 weeks, or a total of 250 limb-restricted hours) compared with EXCITE (9 hours per day over 14 days, or 126 hours of limb-restricted hours).
Thus, the fundamental clinical research question might be: what specific self-training is undertaken in the home environment that leads to these documented improvements in the Motor Activity Log (MAL)?6,7 (The MAL is an outcome measure of real-world usage of the impaired upper-extremity that is common to EXCITE,4 the present study,3 and CIT from several laboratories.8–14) This consideration is important, because the improvements seen in the present study and most other papers written by Page and colleagues on this subject far exceed what have been seen by other investigators. Because the baseline scores are not provided here, readers can only deduce from the change scores that mean Amount of Use or Quality of Movement MAL scores must have eclipsed a 3/5, which is indicative of independent use of the impaired upper extremity that is in excess of those scores reported by most, if not all, other investigators. Provision of the home-based training program that the Page lab uses would be of immense value to those in the neurorehabilitation community who are interested in using any form of CIT. This phase of their mCIT occupies 94.3% of the treatment time (250 home-based hours/250 home-based hours + 15 clinic hours). Clearly, there are important elements that foster a unique sequencing of tasks coupled with monitoring of task dosing and patient adherence.
Parenthetically, although presumably the 30-task version of the original MAL was used as an outcome measure in the current study, recent data suggest that the patient Amount of Use portion of the MAL does not have reliability and should be used with caution.15 This observation is in distinct contrast to a chronologically earlier reference cited in the present work regarding the reliability and validity of the Amount of Use and Quality of Movement scales of the MAL.16
Revisiting Limitations in the Delivery of "Signature" CIT
There is little question that the signature form of CIT is intensive. The extent to which such concentrated effort is perceived by patients or therapists as disinterest or impracticality has been cited by Page and colleagues through results published in 2002 from a questionnaire administered in the Northeast United States.17 Although EXCITE has not performed a local, regional, or national survey, we did provide an exit interview among EXCITE participants. Twenty-four months after enrollment, 73 participants from 5 EXCITE locations were asked to rate the helpfulness of the training intensity in achieving results, using a 7-point scale (1=not helpful and 7=very helpful). A mean response of 6.21±1.07 was reported. Informal discussion with physical therapists and occupational therapists conducted at lectures and workshops throughout the United States has resulted in an overwhelming consensus that the limiting factor is not disinterest or time, but concern for adequate reimbursement relative to the time required to deliver the treatment.
As further evidence for the impracticality of the signature CIT approach, Page and colleagues1,3,18 frequently cite the following excerpt from our case study19: "the patient...grew tired of wearing the mitt and had difficulty with full adherence.... ‘cheating’ with the uninvolved hand was a frequent temptation."3(p334) However, the last portion of the passage—"but she responded well to verbal encouragement and gentle reminders to use the limb appropriately"19(p851)—is not included in the cited text. This latter part of the passage lends valuable insight into the role of therapists and caregivers in supporting the patient during challenging tasks. Furthermore, even in the presence of potential nonadherence, the patient did remarkably well. Unfortunately, taken out of context, the full impact of the discussion point is lost.
Mitt wearing adherence is an important concern and frequently is used to support the use of a modified version of CIT. However, it is important to note that mCIT as described by Page et al actually demands more mitt wearing time (250 hours versus approximately 126 hours in the EXCITE trial). From our extensive experience in treating or overseeing the administration of interventions, we have rarely seen patients who are totally satisfied with the nature of an intervention or with the extent of their progress or who have not strayed from full adherence, regardless of impairment severity or functional limitation, including patients exposed to modifications of CIT. With these concerns in mind, perhaps a more prudent and scientifically valid approach to clarification—if not resolution of differences between the concentrated version of CIT and mCIT as defined in this study—would be a well-controlled comparison.
The Alternative Treatment: Proprioceptive Neuromuscular Facilitation (PNF) Techniques and Functional Tasks
Approximately 80% of the treatment time for the alternative intervention was devoted to PNF techniques, with the remainder of the time centered on "functional tasks" and stretching of upper-extremity joints. Indeed, our fairly extensive review of the literature (Physiotherapy Evidence Database [PEDro], available at www.pedro.fhs.usyd.edu.au and accessed March 3, 2008) confirms the observations deduced from the source reference in the present article20 that the evidence supporting favorable outcomes using PNF techniques is weak. The selection of an alternative therapy that included specific elements of upper-extremity training—such as strengthening and repetitive task practice (for which literature supporting functional improvement following stroke has emerged21–24) with the intent to equilibrate the amount of practice targeting manipulation of the environment comparable to that which is embodied in mCIT—may have offered clearer evidence supporting the unique attributes of mCIT. The indication by Page et al that comparison interventions in their future studies will include these considerations is encouraging.
Other Queries
In the present study, efforts were made to ensure that participating clinicians were unaware of study hypotheses. In designating interventional roles for clinicians in many of our past studies, we have never made an attempt to disguise the study hypotheses for 2 reasons. First, we feel that clinicians’ knowledge about the intent of a study is important for fostering proactive involvement, and, second, we are certain that their inherent intellect and training would allow them to easily deduce the hypotheses anyway. This reality is particularly relevant in the present study, given that various forms of CIT are well-publicized, and, in this case, the intervention is being overseen by someone known to have been investigating it for several years. The neurorehabilitation research community would be well-served if the present investigators could inform us about how they succeeded in ensuring that participating clinicians never became aware of study hypotheses.
Similarly, patients recruited into the present study apparently "were not informed of the group in which the greatest changes were anticipated."3(p339) I am hard-pressed to understand how prospective patient subjects would not form an opinion regarding which groups would be expected to show the greatest changes. Given the inquiry processes of patients and their caregivers, and given the easy access to contemporary information retrieval resources, clinical researchers might be able to learn from Page and colleagues how to avoid participant exposure to such readily available knowledge from which obvious expectations would arise prior to randomization.
mCIT: A Reimbursable Procedure/Protocol?
Perhaps the most contentious issue raised in this paper is the claim that mCIT is a reimbursable procedure or protocol. The concern here is not one of semantics but of legality. The Centers for Medicaid and Medicare Services (CMS) are quite clear in their operational definitions of current procedural terminology (CPT) codes.25 Neither mCIT nor CIT is a reimbursable procedure, as there is not yet a specified code identified for either approach. Currently, therapists or physicians undertaking the training and performing the billing often utilize CPT codes such as 97535 (self-care/home management), 97110 (therapeutic exercise), 97112 (neuromuscular reeducation), and 97530 (therapeutic activities to improve functional performance). It is important to note that each of these CPT codes is defined for a specific intervention in an effort to appropriately document therapeutic treatment. A more accurate construct for the billing might be expressed, for example, as "reimbursement for mCIT as a therapeutic exercise under CPT 97110.... for a specified number of deliverable time intervals."
Continuing to identify mCIT as simply "reimbursable using existing CPT codes"3(p339) without also noting the lack of a specific mCIT code is confusing and misleading to both clinicians and policy makers and perpetuates a misuse of CPT codes.
In this context and as noted previously, the distributed practice embedded within mCIT represents a departure from the more "signature" form of CIMT first described by Taub et al26 and does represent an avenue of research that may be essential to better understand dosing while serving to meet immediate needs of the current health care environment. However, the long-term effects of molding our research questions to such a restrictive system ultimately may do more harm than good. In the immediate sense, reimbursement with the delivery of mCIT is very encouraging, yet the importance of knowing that there is no current CPT code for CIT cannot be underestimated. The listing of medical service codes and procedures describing therapeutic services provides a uniform language that serves as a consistent and reliable means of nationwide health care communication among clinicians, patients, and third parties.27 Not only is this information used by public and private health insurance programs, it is used for administrative management purposes, such as claims processing, medical care guidelines, and medical education and research comparisons. Current code descriptions do not adequately describe the intensity or the content of this intervention. Thus, development of a true CPT code for CIT, with all its justifiably documented models of delivery, is critical for future documentation of utilization and process evaluation of CIT within clinical practice.
Continuing to settle for billing of this intervention through imprecise descriptors only serves to narrow a future vision of neurorehabilitation based on true evidence-based practice and undermines legitimate efforts to place extensive research data in a proper context.28 Thus, an assertive, proactive approach to foster change in reimbursement policies demands that evidence drive the system.
One of the most critical components to provide a foundation to garner health care change is the consistent utilization of standardized outcome measures. In July 2007, Medicare's first performance-based bonus system was implemented.28 Support has been provided from Congress, CMS, and the Medicare Payment Advisory Commission (MedPAC) to establish policies that reward providers for efficient use of resources and create incentives to increase quality of care. In short, this "pay for performance" trend is thought to link payment to quality of care by health care practitioners. This was limited in 2007 to fall-risk screening in physical therapy, but policy makers are interested in future implantation of pay-for-performance programs in Medicaid and third-party payer service, and clinicians should be forward-planning in their practice structures.29 The extent to which comprehensively documented effectiveness studies in the area of upper-extremity task practice in neurorehabilitation embraces this forward planning should be beyond dispute.
Future Studies: The Horse-Cart Conundrum
There are several modifications of the signature CIT application, each with its own unique form of distributed practice and training elements. There is little question that monitoring dosing is an important consideration and one that has been under-appreciated in many neurorehabilitation studies.30 However, before a phase III clinical trial can be undertaken, it seems reasonable to first compare various forms of mCIT—as discussed by Page31—to determine if one form of modification is superior to another, controlling for patient attributes and dosing. With respect to the latter variable, recent analyses from the EXCITE trial would suggest that with the application of the signature form of CIT, there is no succinct relationship between intensity of training and outcome among participants who showed statistical and clinically meaningful improvements.32 Thus, there is a need for determining those factors leading to an optimal form of distributed practice with CIT before embarking on a larger scale exploration. At that time, hitching the cart to the horse would make sense.
SL Wolf, PT, PhD, FAPTA, FAHA, is Professor, Departments of Rehabilitation Medicine and Medicine, and Associate Professor, Department of Cell Biology, Emory University School of Medicine, Center for Rehabilitation Medicine; Professor, Health and Elder Care, Nell Hodgson Woodruff School of Nursing at Emory University; Senior Research Scientist, Atlanta VA Rehab R&D Center
Footnotes
Acknowledgments: I thank Sarah Blanton, PT, DPT, for invaluable discussion and input, and Paul Hansen and Kathleen Zettergren for their correspondence regarding PNF studies in response to a NeuroPT list serve posting.
This letter was posted as a Rapid Response on March 26, 2008, at www.ptjournal.org.
References
CiteULike 
Complore 
Connotea 
Del.icio.us 
Digg 
Reddit 
Technorati What's this?
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| HOME | HELP | FEEDBACK | SUBSCRIPTIONS | ARCHIVE | SEARCH | TABLE OF CONTENTS |
