Assessing Outcomes And The Future

REPORTING STANDARDS FOR LIMB LOSS RESEARCH

To improve the quality of documentation, reporting and research, the conference group strongly suggests adopting reporting standards for the assessment of outcomes. Addendum #3 has been created as a template for future conferences, to begin to standardize the reporting of treatment options and outcomes. This will allow better understanding of the variations in treatment and how they ultimately affect the outcome. Much work needs to be done with regard to etiology of the problems resulting in amputation and comorbidities that may have contributed to the amputation. Current systems of classification used to simplify this complex issue (traumatic, diabetic, etc.) are inadequate. For example a "diabetic" amputation may be due to infection, minor trauma, poor circulatory status, chronic ulceration or other comorbidity, so simply calling it a diabetic amputation is incomplete.

Systemic complications such as death, myocardial infarction, deep venous thrombosis, pneumonia, stroke, and urinary infection should be tracked and reported. The traditional time frame for considering these to be perioperative complications is 30 days from time of surgery.

Wound healing should be recorded by documenting the type of wound healing, as recommended above. While recording the time of healing as number of days to healing can be documented as secondary information, the investigators must also document how that was determined and acknowledge the limitations of this measurement.

Contralateral limb status and the occurrence of ulcers, wounds, infections, and amputations in the contralateral limb should be documented.

Emotional outcomes such as depression or post-traumatic stress disorder should be documented using standardized and previously validated measurement tools.

Pre- and postamputation functional status should be documented using reliable and valid functional measure instruments. Functional outcome instruments can be divided into two categories: subjective or self-report assessment methods and the more objective performance-based assessment. With the self-report instrument, the patient, family member, or clinician is asked to complete a questionnaire or similar type survey and a test score or descriptive profile is generated. The use of self-rating instruments has been shown to be more accurate and less biased than informant-ratings, or the report given by a caregiver, both for individual activities of daily living and overall functional capacity. ¹ There are currently a fair number of subjective assessment instruments designed specifically for the amputee, as well as existing instruments that were designed for general patient populations that are now being applied to amputees.

Performance-based assessment tools, which are the more clinically based objective assessment tools, provide information concerning ambulatory ability by way of task performance or professional judgment by the clinician. The advantage of this type of assessment is that specific tasks must be demonstrated and the quality of the performance may be graded.

Within the two categories of functional outcome instruments there are several specific tools that may be employed by clinicians. Each instrument has advantages and disadvantages, depending on the information being sought by the clinician. There appears to be no consensus regarding the selection of measurement tools used with lower limb amputees among different rehabilitation centers. ² Often a combination of assessment tools is required to obtain the appropriate information of an individual amputee or a comprehensive picture of a particular group of amputees. As a result, it is important that clinicians, as well as clinical investigators, understand the appropriateness of the information a specific functional outcomes instrument yields.

Preamputation (whenever possible) and postamputation functional status must be documented using standardized general outcome tools, such as the Short Form 36 (SF-36), the Musculoskeletal Functional Assessment (MFA), or the Sickness Impact Profile (SIP).

Age-specific outcome tools, such as the American Academy of Orthopedic Surgeons/Pediatric Orthopedic Society of North America (AAOS/POSNA) Pediatric Questionnaire, the Child Health Questionnaire (CHQ), Functional Disability Inventory- Child Version (FDI-Child), Functional Independence Measure for Children (WeeFIM), Functional Status Questionnaire- General (for Children), and the Gross Motor Function Measure (GMFM) should also be used, realizing that with time these tools will continue to improve and provide essential information. ^3-8

Tools specific to amputation and prosthetics, such as the AMP (Amputee Mobility Predictor) or the PEQ (Prosthetic Evaluation Questionnaire), should also be used because the SF-36 and other nonspecific tools may not be sensitive enough to identify differences and changes specific to limb loss.

RESEARCH RECOMMENDATIONS

The conference group discussed a wide range of important lower limb amputation and postoperative management research needs. In addition to the recommendations throughout the prior text, the top priorities are postoperative management and dressing strategies, emotional care, therapeutic intervention, edema control, and pain issues.

POSTOPERATIVE MANAGEMENT AND DRESSING STRATEGIES

Standardization of the strategies for postoperative management of lower limb amputations and comparative randomized studies is critical. Although examination of all five major categories is needed, a well-done study with at least three randomized treatment groups would be an important addition to the literature. The three groups of highest interest are soft dressings, traditional thigh-level IPOP made from casting material with foot attachment, and a prefabricated postoperative device designed as a prosthetic system.

EMOTIONAL CARE

There is a need for improved understanding regarding emotional issues and adjustment during the entire postoperative period (and preoperative period in nonemergent situations). There is an identified need for studies on the impact of social support, self-management, and professional mental health treatment on these conditions, as well as the role of postoperative prosthetic systems and their effects on emotional care.

THERAPEUTIC INTERVENTION

A study of the impact of exercise and structured therapy training programs on ultimate outcome could change the role of therapy in treatment of the lower extremity amputee. Research must address the functional benefits of evidencebased rehabilitation.

EDEMA CONTROL

Research is necessary to understand postoperative edema and the limb volume changes that occur during the time of recovery. Defining these issues could optimize the timing of transition to a definitive prosthesis and could optimize the length of time that the definitive prosthesis continues to fit. Different strategies for managing postoperative edema in the immediate postacute hospital stage, including IPOP, prefabricated devices, or the early use of elastomeric liners, should be examined. During the intermediate recovery stage, strategies should be used that incorporate volume control. Such strategies include the use of padding, liners, adjustable sockets, temporary sockets, or ambulatory check sockets.

PAIN ISSUES

Improved documentation and understanding of all types of treatments (physical, behavioral, and pharmacologic) for acute and chronic pain conditions after limb loss to enhance long-term outcome and treatment are needed.

Correspondence to: Gary Berke, MS, CP, 801 Brewster Avenue, Suite 270, Redwood City, CA 94063; e-mail: gberke@pacbell.net .

References:

Dorevitch M, Cossar R, Bailey F, et al. The accuracy of self and informant rating of physical functional capacity in the elderly. J Clin Epidemiol 1992;43:791-798.
Deathe B, Miller WC, Speechley M. The status of outcome measurement in amputee rehabilitation in Canada. Arch Phys Med Rehabil 2002;83:912-918.
Daltroy L, Liang MH, Fossel AH, Goldberg MJ. The POSNA pediatric musculoskeletal functional health questionnaire: report on reliability, validity, and sensitivity to change. Pediatric Outcomes Instrument Development Group. Pediatric Orthopaedic Society of North America. J Pediatr Orthop 1998;18(5):561-571.
Landgraf JM, Maunseil E, Nixon Speechley K, et al. Child Health Questionnaire (CHQ). Qual Life Res 1998;7:433-445.
Lewis CC, Pantel RH, Kleckhofer GM. Functional Status Questionnaire-General (for Children). Med Care 1989;27: S54-S65.
Ottenbacher KJ, Taylor ET, Msall ME, et al. The stability and equivalence reliability of the functional independence measure for children (WeeFIM). Dev Med Child Neurol 1996;38(10): 907-916.
Russell DJ, Rosenbaum PL, Cadman DT, et al. Gross motor function measure. Dev Med Child Neurol 1989;31(3):341-352.
Walker LS, Green JW. Functional Disability Inventory-Child Version (FDI-Child). J Ped Psychol 1991;16:39-58.