Relative and absolute test-retest reliabilities of biomechanical risk factors for knee osteoarthritis progression: benchmarks for meaningful change.

OBJECTIVE: Biomechanical factors are important treatment targets in knee osteoarthritis. The knee adduction (KAM) and flexion (KFM) moments, quadriceps strength and power, load frequency, and body mass index (BMI) all have the potential to affect knee articular cartilage integrity by modulating forces across the joint. To identify clinically meaningful change, however, these measurements must be reliable and sensitive to change. This study estimated relative and absolute test-retest reliabilities over long periods of biomechanical risk factors for knee osteoarthritis progression. METHOD: Data from a longitudinal, observational study were analyzed for knee osteoarthritis patients with data at baseline, 6-month and 24-month follow-ups. Gait kinematics and kinetics, quadriceps strength and power, daily load frequency and BMI were collected. Relative and absolute test-retest reliabilities of these measures were estimated using intraclass correlation coefficients (ICCs) and standard errors of measurement (SEMs), respectively. Minimal detectable change at the 95% confidence level (MDC95) was also calculated. RESULTS: Data from 46 participants [36 women; age 61.0 (6.6) years] were included. Good-to-excellent relative reliabilities (ICC ≥ 0.80) indicated that KAM peak and impulse, quadriceps strength and power, and BMI had a strong ability to discriminate amongst participants. Absolute reliabilities were high for quadriceps strength and BMI, which demonstrated reasonable within-participant variability (SEMs ≤ 11% of the mean). The MDC95 values supported use of clinical interventions effective in reducing BMI and KAM, and increasing quadriceps strength. CONCLUSION: These data are useful in interpreting findings from interventional or longitudinal investigations by determining whether observed changes are beyond measurement error and interpretable as true change.

Reliability and measurement error of the Osteoarthritis Research Society International (OARSI) recommended performance-based tests of physical function in people with hip and knee osteoarthritis.

OBJECTIVE: To estimate the reliability and measurement error of performance-based tests of physical function recommended by the Osteoarthritis Research Society International (OARSI) in people with hip and/or knee osteoarthritis (OA). DESIGN: Prospective repeated measures between independent raters within a session and within-rater over a week interval. Relative reliability was estimated for 51 people with hip and/or knee OA (mean age 64.5 years, standard deviation (SD) 6.21 years; 47% females; 36 (70%) primary knee OA) on the 30s Chair Stand Test (30sCST), 40m Fast-Paced Walk Test (40mFPWT), 11-Stair Climb Test (11-step SCT), Timed Up and Go (TUG), Six-Minute Walk Test (6MWT), 10m Fast-Paced Walk Test (10mFPWT) and 20s Stair Climb Test (20sSCT) using intra-class correlation coefficients (ICC). Absolute reliability was calculated using standard error of measurement (SEM) and minimal detectable change (MDC). RESULTS: Measurement error was acceptable (SEM < 10%) for all tests. Between-rater reliability was: optimal (ICC > 0.9, lower 1-sided 95% CI > 0.7) for the 40mFPWT, 6MWT and 10mFPWT; sufficient (ICC >0.8, lower 1-sided 95% CI > 0.7) for 30sCST, 20sSCT; unacceptable (lower 1-side 95% CI < 0.7) for 11-step SCT and TUG. Within-rater reliability was optimal for 40mFPWT, and 6MWT; sufficient for 30sCST and 10mFPWT and unacceptable for 11-step SCT, TUG and 20sSCT. CONCLUSIONS: The 30sCST, 40mFPWT, 6MWT and 10mFPWT, demonstrated, at minimum, acceptable levels of both between and within-rater reliability and measurement error. All tests demonstrated sufficiently small measurement error indicating they are adequate for measuring change over time in individuals with knee/hip OA.

The incident tibiofemoral osteoarthritis with rapid progression phenotype: development and validation of a prognostic prediction rule.

OBJECTIVES: No clinical prediction rules were found for estimating the likelihood of developing incident radiographic tibiofemoral osteoarthritis (OA) with rapid progression. Such a tool would enhance prognostic capability for clinicians and researchers. DESIGN: We used two longitudinal datasets to independently derive (Multicenter Osteoarthritis Study) and validate (Osteoarthritis Initiative) a prognostic clinical prediction rule for estimating the probability of incident rapidly progressing radiographic knee OA in the following 4-5 years. Eligible subjects had at least one knee with a Kellgren and Lawrence (K&L) graded tibiofemoral joint of 0 or 1. Several potential risk factors were examined including obesity, age, knee alignment, frequent knee symptoms, contralateral knee OA and knee injury history. Multiple logistic regression was used to identify significant predictors and area under the receiver operating characteristic curve (AUC) was used to assess discrimination. RESULTS: A total of 1690 subjects participated in the derivation and 2422 subjects participated in the validation of the clinical prediction rule. The multivariable model displayed good discrimination with AUC of 0.79 in the derivation dataset and 0.81 in the validation dataset. CONCLUSIONS: Persons with contralateral knee OA, a baseline index knee OA grade of 1, higher body mass index (BMI) and higher baseline Western Ontario and McMaster Universities arthritis index total scores were more likely to develop K&L grade of 3 or 4 within 5 years. Frequent knee symptoms at baseline were not a significant predictor. The prediction rule and nomogram can assist clinicians in estimating the probability of rapidly progressing radiographic knee OA and the nomogram can assist researchers conducting epidemiologic studies and clinical trials.

Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments.

BACKGROUND: Choosing an adequate measurement instrument depends on the proposed use of the instrument, the concept to be measured, the measurement properties (e.g. internal consistency, reproducibility, content and construct validity, responsiveness, and interpretability), the requirements, the burden for subjects, and costs of the available instruments. As far as measurement properties are concerned, there are no sufficiently specific standards for the evaluation of measurement properties of instruments to measure health status, and also no explicit criteria for what constitutes good measurement properties. In this paper we describe the protocol for the COSMIN study, the objective of which is to develop a checklist that contains COnsensus-based Standards for the selection of health Measurement INstruments, including explicit criteria for satisfying these standards. We will focus on evaluative health related patient-reported outcomes (HR-PROs), i.e. patient-reported health measurement instruments used in a longitudinal design as an outcome measure, excluding health care related PROs, such as satisfaction with care or adherence. The COSMIN standards will be made available in the form of an easily applicable checklist. METHOD: An international Delphi study will be performed to reach consensus on which and how measurement properties should be assessed, and on criteria for good measurement properties. Two sources of input will be used for the Delphi study: (1) a systematic review of properties, standards and criteria of measurement properties found in systematic reviews of measurement instruments, and (2) an additional literature search of methodological articles presenting a comprehensive checklist of standards and criteria. The Delphi study will consist of four (written) Delphi rounds, with approximately 30 expert panel members with different backgrounds in clinical medicine, biostatistics, psychology, and epidemiology. The final checklist will subsequently be field-tested by assessing the inter-rater reproducibility of the checklist. DISCUSSION: Since the study will mainly be anonymous, problems that are commonly encountered in face-to-face group meetings, such as the dominance of certain persons in the communication process, will be avoided. By performing a Delphi study and involving many experts, the likelihood that the checklist will have sufficient credibility to be accepted and implemented will increase.

Analysis of a phosphorylcholine-based polymer coating on a coronary stent pre- and post-implantation.

There has been a move towards surface treatments for metallic coronary stents in an effort to improve their compatibility within the body and to provide a vehicle for the delivery of therapeutics. The Biodiv Ysio range of stents is characterised by a biocompatible coating comprised of a crosslinked phosphorylcholine (PC)-based polymer. In addition to a review of some of the data collected to support safety and efficacy of this device, this paper also describes a number of techniques that have been employed to both visualise and quantify the coating on the stent. Explantation of both coated and uncoated stents from porcine coronary arteries revealed that both coated and uncoated stents were >90% endothelialised after 5 days. Typical histological analysis of stented vessel sections after 4 and 12 weeks implantation showed the presence of cell types characteristic of the inflammatory response associated with the trauma caused by stent placement, with no evidence for any additional coating-related adverse inflammatory sequelae. Finally, it was demonstrated by AFM and SEM that both the thickness and force required to remove the coating were essentially unchanged after 6 months implantation. Thus, both the long-term stability and relative biological inertness of the coating has been confirmed in vivo, supporting its use as a vehicle for local drug delivery.

Synthesis and characterisation of phosphorylcholine-based polymers useful for coating blood filtration devices.

Copolymers of 2-methacryloyloxyethylphosphorylcholine (MPC) and lauryl methacrylate (LMA) of molar ratios MPC: LMAX where x = 1, 2 or 4, have been synthesised by two different free-radical polymerisation techniques. The solubility characteristics of the resulting materials were investigated in a variety of water: alcohol solvent mixtures and found to be influenced not only by the molar ratio of MPC: LMA, but also the method of synthesis. A window of solubility was observed for certain copolymers and the alcohol used in the solvent mixture was also found to have a profound influence on the solubility profile of the polymers. These materials were soluble in a wider range of aqueous methanol mixtures compared to aqueous mixtures of higher aliphatic alcohols, such as ethanol or isopropyl alcohol, which was rationalised in terms of the affinity of the phosphorylcholine headgroup for the various alcohols relative to water. 1H nuclear magnetic resonance spectroscopy was used to further examine the solution properties of the copolymers in various solvents. The copolymer MPC: LMA2 was coated onto a variety of substrates from both alcohol-only and water: alcohol solvent systems and the surface properties of the films compared by static and dynamic contact angle, atomic force microscopy (AFM) and attenuated internal reflectance Fourier transform infrared spectroscopy (ATR-IR). The coating formed from the water: alcohol solvent was found to be hydrophilic in nature, possessing spontaneous wettability, whereas films formed from alcohol-only solvents were hydrophobic, and only on conditioning with water were more wettable surfaces attained. This phenomenon was applied in the coating of leukocyte filtration material, where the aqueous-based systems demonstrated lower critical wetting surface tension (CWST) and shorter wetting times relative to both uncoated filters and those coated from alcohol-only systems. The haemocompatibility of the coated filters was equivalent for both coating solvent systems. employed, and far superior when compared to the uncoated control.

Crosslinkable coatings from phosphorylcholine-based polymers.

2-Methacryloyloxyethyl phosphorylcholine (MPC) was synthesised and then used in the preparation of crosslinked polymer membranes with lauryl methacrylate, hydroxypropyl methacrylate and trimethoxysilylpropyl methacrylate (crosslinker) comonomers. Some physical aspects of the membrane properties were evaluated in order to establish the basis for the synthesis of a series of post-crosslinkable polymers. These materials were made by copolymerisation of the constituent monomers via a free radical method, and characterised using NMR, FT-IR, viscometry and elemental analysis. The optimum crosslink density and conditions required for curing coatings of these polymers were investigated using atomic force microscopy (AFM) and showed the inclusion of 5 mol% silyl crosslinking agent to be ideal. A nanoindentation technique was employed to determine if the coating developed elasticity upon crosslinking. The biological properties of the coatings were evaluated using a variety of protein adsorption assays and blood contacting experiments, and an enzyme immunoassay was developed to detect E. coli in order to assess the level of bacterial adhesion to these biomaterials. Polymers of this type were shown to be very useful as coating materials for improving the biocompatibility of, or reducing the levels of adherent bacteria to medical devices.

A novel phosphorylcholine-coated contact lens for extended wear use.

The preparation and characterisation of a new phosphorylcholine (PC)-coated silicone hydrogel contact lens for use in extended wear is described. The Michael-type addition of amines to acrylates forms the basis of the synthesis of a novel silicone-based macromer with hydrophilic functionality. It is demonstrated that this macromer can be combined with other silicone-based monomers, hydrophilic monomers and crosslinker to produce a contact lenses formulation. Examples of lenses with water contents of 33% and 46% are illustrated and their properties compared to other commercially available lenses. Materials with comparatively low modulus (<0.3 MPa) and adequate tear strength (>2-4MPa) with excellent elongation to break (>200%) can be obtained using this technology. In addition to the mechanical aspects. both the oxygen and solute permeabilities of the material can be controlled by the hydrophilic: hydrophobic monomer balance in the formulation. to obtain materials with attributes suitable for extended wear use. The PC coating is achieved by means of an in-mould coating (IMC) technique that produces a uniform and stable surface as determined by staining and XPS. The coating imparts both improved lens wettability (advancing contact angle of approximately 50 with virtually no hysteresis) and lower protein adsorption relative to the uncoated lens.

Measurement properties of the RM-18. A modified version of the Roland-Morris Disability Scale.

STUDY DESIGN: This investigation had two components: one was an item analysis that examined data obtained at the initial patient assessment, and the second was a validation study that used a pretest-posttest design. OBJECTIVES: The authors' goal, in this study, was to determine whether a shorter version of the Roland-Morris Questionnaire could be developed with measurement properties equal to or better than the original 24-item questionnaire. SUMMARY OF BACKGROUND DATA: The measurement properties of the Roland-Morris Questionnaire have been shown to be better than or equal to competing measures. A number of studies have reported modified versions of the Roland-Morris without providing the measurement properties of the modified tool. METHODS: The item analysis investigated endorsement frequency, interitem correlations, item-corrected item total correlations, and coefficient alpha with various combinations of items deleted. The validation study examined reliability, concurrent validity, and longitudinal validity (sensitivity to change). The analyses included comparisons with the Oswestry and Jan van Breeman Pain Questionnaires. RESULTS: The item analysis suggested than six items could be detected from the Roland-Morris Questionnaire. The validation study demonstrated that the shorter version, named the RM-18, has measurement properties that are equal to those of the longer version. CONCLUSIONS: The RM-18 can be used as an outcome measure in clinical trials or as a tool to aid in decision making concerning individual patients. In either case, its measurement properties are equal to those of the 24-item Roland-Morris Questionnaire.

Development and initial validation of the back pain functional scale.

STUDY DESIGN: A prospective repeated-measures design was applied. OBJECTIVES: To examine the measurement properties of the Back Pain Functional Scale (BPFS) and the Roland-Morris Questionnaire (RMQ) and to formulate hypotheses and sample size estimates for a subsequent comparison study. SUMMARY OF BACKGROUND DATA: Although there are numerous functional status measures for patients with low back pain, most have been conceived of and validated with a group rather than an individual patient as the unit of interest. Also, little has been done to formally compare-this includes the generation of a priori hypotheses, followed by statistical hypotheses testing-the many competing measures. METHODS: Subjects were 77 patients with low back pain who were referred by physicians to 10 outpatient physical therapy clinics located in Canada and the United States. The questionnaires were administered at patients' initial visits, within 48 hours of the initial visit, and at 1-, 2-, and 3-week follow-up visits. Reliability, cross-sectional validity, and longitudinal validity (sensitivity to change) coefficients were calculated. RESULTS: Test-retest reliability estimates of 0.81 and 0. 88 were obtained for the RMQ and BPFS, respectively. The measures demonstrated similar levels of cross-sectional validity. Correlations of 0.56 and 0.65 were noted between a prognostic rating of change and the RMQ and BPFS, respectively. The RMQ demonstrated a ceiling effect. Approximately 180 patients are needed for a subsequent head-to-head comparison study of the measures. CONCLUSIONS: The BPFS appears to have sound measurement properties, and a formal head-to-head comparison study with the RMQ is warranted.

Efficiency analysis of two written short-answer student evaluation formats.

The purpose of this study was to compare the efficiency of two written short-answer student evaluation formats. Efficiency was defined in this study as reliability per unit of examination time. Twenty second-year physical therapy students enrolled in the soft tissue injuries portion of the orthopedic course completed a 12-item quiz consisting of two formats (diagnosis and response set) with six parallel content items per format. The outcome measures of interest were 1) students' score, 2) amount of time required to complete each item, and 3) amount of time required by the faculty members to grade each item. The results indicated that a greater reliability per unit of examination time was achieved for the diagnosis format than for the response set format and that the diagnosis format could be graded more rapidly and with a higher level of interrater agreement than the response set format. Students' grades on the diagnosis format items tended to be higher (although not statistically significant) than the grades on the response set format items, suggesting that when a criterion-referenced system is used, the minimal acceptable baseline score should be raised when using the diagnosis format. Further study is required to evaluate the validity of the diagnosis format.

Use of the standard error as a reliability index of interest: an applied example using elbow flexor strength data.

The intraclass correlation coefficient (ICC) and the standard error of measurement (SEM) are two reliability coefficients that are reported frequently. Both measures are related; however, they define distinctly different properties. The magnitude of the ICC defines a measure's ability to discriminate among subjects, and the SEM quantifies error in the same units as the original measurement. Most of the statistical methodology addressing reliability presented in the physical therapy literature (eg, point and interval estimations, sample size calculations) focuses on the ICC. Using actual elbow flexor make and break strength measurements, this article illustrates a method for estimating a confidence interval for the SEM, shows how an a priori specification of confidence interval width can be used to estimate sample size, and provides several approaches for comparing error variances (and square root of the error variance, or the SEM).

The prevalence of low back pain in adults: a methodological review of the literature.

The prevalence of low back pain (LBP) has been reported in the literature for different populations. Methodological differences among studies and lack of methodological rigor have made it difficult to draw conclusions from these studies. A systematic review was done for adult community prevalence studies of LBP published from 1981 to 1998. The technique of capture-recapture was performed to estimate the completeness of the search strategy used. Established guidelines and a methodological scoring system were used to critically appraise the studies. Thirteen studies were deemed methodologically acceptable. Differences in the duration of LBP used in the studies appeared to affect the prevalence rates reported and explain much of the variation seen. It was estimated that the point prevalence rate in North America is 5.6%. Further studies using superior methods are needed, however, before this estimate can be used with confidence to make health care policies and decisions relating to physical therapy.

Interpreting validity indexes for diagnostic tests: an illustration using the Berg balance test.

Physical therapists routinely make diagnostic and prognostic decisions in the course of patient care. The purpose of this clinical perspective is to illustrate what we believe is the optimal method for interpreting the results of studies that describe the diagnostic or prognostic accuracy of examination procedures. To illustrate our points, we chose the Berg Balance Test as an exemplar measure. We combined the data from 2 previously published research reports designed to determine the validity of the Berg Balance Test for predicting risk of falls among elderly people. We calculated the most common validity indexes, including sensitivity, specificity, predictive values, and likelihood ratios for the combined data. Clinical scenarios were used to demonstrate how we believe these validity indexes should be used to guide clinical decisions. We believe therapists should use validity indexes to decrease the uncertainty associated with diagnostic and prognostic decisions. More studies of the accuracy of diagnostic and prognostic tests used by physical therapists are urgently needed.

Use of generic versus region-specific functional status measures on patients with cervical spine disorders.

BACKGROUND AND PURPOSE: Few data exist to support the use of functional status measures on patients with disorders of the cervical spine. This study was designed to compare the construct validity and sensitivity to change of the Neck Disability Index (NDI) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). SUBJECTS AND METHODS: Patients (N = 146) with a variety of disorders of the cervical spine completed the NDI and the SF-36 prior to treatment. Following discharge from treatment, 69 of these patients completed a second NDI and SF-36. RESULTS: There was evidence for the construct validity and sensitivity to change of the NDI and the physical and mental component scores of the SF-36. The ability of the NDI and SF-36 to detect change varied, depending on the construct tested. The SF-36 was superior in some instances, and the NDI was superior in other instances. The NDI appears to measure both mental and physical health-related factors. CONCLUSION AND DISCUSSION: There appears to be substantial overlap between the 2 measures. The use of both measures, therefore, is probably not necessary. [Riddle DL, Stratford PW. Use of generic versus region-specific functional measures on patients with cervical spine disorders.

Interrater reliability of lumbar accessory motion mobility testing.

BACKGROUND AND PURPOSE: This study examined the interrater agreement, or reliability, of accessory motion mobility testing of the lumbar spine in patients with low back pain. SUBJECTS: Subjects were 18 patients with low back pain referred to the physical therapy outpatient department of a university teaching hospital. METHODS: Six orthopedic physical therapists evaluated the posterior-anterior (P-A) accessory motion mobility at each of six levels, L-1 to the sacral base, on each subject. The mobility was recorded on a nine-point scale, and reproduction of pain was noted. The physical therapists noted any level at which mobility or pain findings were of significance to treat. To evaluate agreement on the identification of spinal levels, therapists were asked to identify one spinous process, which was arbitrarily marked on each subject. Kappa analyses and intraclass correlation coefficients (ICCs) were calculated to evaluate agreement on the level of the marked segment and the mobility at that level, respectively. RESULTS: The ICC for determination of the marked level was R(2,1) = .69 (95% confidence interval = .53-.82). The ICC for mobility findings at the marked level was R(2,1) = .25 (95% confidence interval = 0-.44). A secondary Kappa analysis to determine agreement on treatment decision making demonstrated similarly low levels of agreement. CONCLUSION AND DISCUSSION: There is poor interrater agreement on determination of the segmental level of a marked spinous process. There is poor interrater reliability of P-A accessory mobility testing in the absence of corroborating clinical data. Caution should be exercised when physical therapists make clinical decisions related to the evaluation of motion at a specific spinal level using P-A accessory motion testing.

Grading written essays: a reliability study.

The purpose of this study was to examine the interrater reliability of grades obtained by physical therapy and occupational therapy tutors in rating their students' term papers. This study was carried out in two phases. In phase 1, four student essay papers (two physical therapy students' papers and two occupational therapy students' papers) with grades that had been assigned from the previous year's course were randomly selected from a bank of papers. These papers were independently rated by three course planners (who were responsible for planning, coordinating, and tutoring in the course), and agreement as to the assignment of grades for each paper was established. In phase 2, the same students' essays were rated independently by eight course tutors. To test for differences among students' written essay papers and for differences among the raters in the subcategories of discipline (physical therapy versus occupational therapy) and level of expertise (novice versus experienced) in grading essays, a three-way analysis of variance was performed. An intraclass correlation coefficient (ICC) was calculated for interrater reliability. Although there were no statistically significant differences among the tutors with regard to their discipline and expertise, the reliability analysis produced an ICC of .79. Strategies to enhance the reliability of grading essays are discussed.

Health status measures: strategies and analytic methods for assessing change scores.

Over the last 15 years, numerous self-report health status measures have appeared in the literature. An important parallel development has been the development of numerous strategies for assessing change in health status over time. The purpose of this article is to summarize and critique the more common design and analytic strategies for assessing the meaningfulness of change over time. Five commonly reported designs are presented, critiqued, and depicted using examples from the literature. Methods for analyzing results are reviewed and illustrated using two data sets. Insights into comparing competing health status measures are provided. In summary, the article suggests that some designs and analytic strategies are more adept than others at assessing change and that these methods should be considered when planning sensitivity-to-change studies.

Sensitivity to change of the Roland-Morris Back Pain Questionnaire: part 2.

BACKGROUND AND PURPOSE: One purpose of this study was to determine whether the Roland-Morris Back Pain Questionnaire (RMQ) could be used to detect clinically meaningful change in individual patients. The construct that served as the basis for this study was that RMQ change scores should be greater for patients meeting their treatment goals than for patients who did not meet their goals. The second purpose of the study was to determine whether sensitivity to change (STC) varies depending on the magnitude of the initial RMQ score. SUBJECTS AND METHODS: Of the 143 patients with low back pain who completed the study, 104 patients achieved their goals and 39 patients did not achieve their goals. Receiver operating characteristic (ROC) curve analysis and likelihood ratios were used to determine the RMQ change scores that best classify patients as having met or not met their goals. RESULTS: The area under the ROC curve for the entire RMQ scale was 0.68, while the curve areas for smaller RMQ intervals varied from 0.80 to 0.97. CONCLUSION AND DISCUSSION: The STC for the entire RMQ scale was poor for the construct examined in this study. The likelihood ratios for smaller RMQ intervals support the construct validity of the RMQ for assessing change in disability. Initial RMQ score magnitudes must be taken into account to improve the rate of making correct predictions about whether meaningful change in disability will occur following treatment.

Comparison of two outcome measures for infants with cerebral palsy and infants with motor delays.

BACKGROUND AND PURPOSE: The purpose of this study was to compare the Gross Motor Function Measure (GMFM) and the Peabody Developmental Gross Motor Scale (PDMS-GM) as measures of change in infants with cerebr-al palsy (CP) and infants with motor delays. We hypothesized that mean change scores would be greater for the GMFM than for the PDMS-GM. SUBJECTS AND METHODS: Subjects were 42 infants with a mean adjusted age of 13.9 months (SD=6.1, range=4.2-24.2). Twenty-four infants had CP, and 18 infants had motor delays. The GMFM and the PDMS-GM were administered to the infants 3 times over a 6-month period. Raw scores were standardized for data analysis. Data were analyzed using a 3-factor repeated-measures analysis of variance. RESULTS: For the 6-month period, mean PDMS-GM age-equivalent scores increased 3.8 months and mean scaled scores increased 35 points for infants with motor delays compared with increased scores of 1.8 months and 13 points for infants with CP. Mean GMFM scores increased by 12.2% for infants with rmotor delays and by 4.2% for infants with CP. The diagnosis X time interaction was significant. Infants with motor delays had a greater change in motor development compared with the infants with CP. The hypothesis that the GMFM is more responsive to change than the PDMS-GM was not supported. CONCLUSION AND DISCUSSION: The findings suggest that the GMFM and the PDMS-GM are comparable in measuring change in infants with CP or motor delays. Implications for selection and use of either measure are discussed.