Capturing the patient's view of change as a clinical outcome measure.

Palo Alto Medical Clinic, CA, USA.
JAMA The Journal of the American Medical Association (Impact Factor: 35.29). 282(12):1157-62.
Source: PubMed


Measurement of change in patients' health status is central to both clinical trials and clinical practice. Trials commonly use serial measurements by the patients at 2 points in time while clinicians use the patient's retrospective assessment of change made at 1 point in time. How well these measures correlate is not known.
To compare the 2 methods in measurement of changes in pain and disability.
Longitudinal survey of patients starting new therapy for chronic arthritis in 1994 and 1995. Surveys were completed at baseline (before intervention) and at 6 weeks and 4 months.
Community health education program and university medical and orthopedic services.
A total of 202 patients undertaking self-management education (n = 140), therapy with prednisone or methotrexate (n = 34), or arthroplasty of the knee or hip (n = 28).
Concordance between serial (visual analog scale for pain and Health Assessment Questionnaire for disability) and retrospective (7-point Likert scale) measures, sensitivities of these measures, and their correlation with patients' satisfaction with the change (7-point Likert scale).
When change was small (education group), serial measures correlated poorly with retrospective assessments (eg, r=0.13-0.21 at 6 weeks). With greater change, correlations improved (eg, r = 0.45-0.71 at 6 weeks). Average agreement between all pairs of assessments was 29%. Significant lack of concordance was confirmed in all 12 comparisons by McNemar tests (P = .02 to <.001) and by t tests (P = .03 to <.001). Retrospective measures were more sensitive to change than serial measures and correlated more strongly with patients' satisfaction with change.
The 2 methods for measuring health status change did not give concordant results. Including patient retrospective assessments in clinical trials might increase the comprehensiveness of information gained and its accord with clinical practice.

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Available from: Kate R Lorig, Oct 03, 2015
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    • "CGIC was assessed at treatment sessions 2 and 3 and final office visit. The PGIC is 7-item scale, similar to the CGIC, in which the subject assesses the change in his/her health status since the start of study treatment and provides insight into value of treatment to the subject [17]. PGIC was assessed at each office visit and phone interview except at baseline/visit 1. "
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    ABSTRACT: The Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE; NCT00836017) is a prospective, observational, multicenter, real-world registry designed to assess the safety, effectiveness, and treatment utilization following multiple treatments of onabotulinumtoxinA. Subjects were naïve to botulinum toxin, new to practice, or had not received toxin in ≥16weeks if in a clinical trial. Dosages and treatment intervals varied due to the real-world design. Descriptive and inferential statistics evaluated changes over 3 treatments. 1046 subjects enrolled. Subjects were 74.4% female, 63.5% toxin-naïve, mean age 58.0±14.7years. The mean dose over 2481 treatment sessions was 189.8±87.1U, with average treatment intervals of 14.6 and 15.1weeks. The mean Toronto Western Spasmodic Torticollis Rating Scale Total score in subjects who completed all assessments (n=479) decreased from 39.2 at baseline to 27.1 at final visit (P<.0001). A high percentage of physicians reported improvement in Clinician Global Impression of Change after initial assessment; this significantly increased at final assessment (n=479, 91.2% vs 95.0%; P<.0001). Similarly, a high percentage of subjects reported improvement in Patient Global Impression of Change after initial assessment, which significantly increased at final assessment (n=470, 83.0% vs 91.7%; P<.0001). Significant reductions in all Cervical Dystonia Impact Profile-58 scores were observed (n=407). Overall, 26.2% of subjects reported adverse events, including muscular weakness (7.0%) and dysphagia (6.4%). Results indicate robust improvement in clinical ratings and excellent tolerability following onabotulinumtoxinA treatment of CD. Copyright © 2014 Elsevier B.V. All rights reserved.
    Journal of the Neurological Sciences 12/2014; 349(1-2). DOI:10.1016/j.jns.2014.12.030 · 2.47 Impact Factor
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    • "Change (Follow-up, 2 weeks and 3 months): The Patients Global Impression of Change (PGIC) is a patient rated instrument which measures changes over time on a seven-points scale. Score range is from 1 (very much worse) to 7 (very much improved) [33-35]. "
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    ABSTRACT: Background The presence of nerve damage plays a key role in the development and prognosis of chronic pain states. Assessment of the presence and severity of a neuropathic pain component (NePC) is key in diagnosing chronic pain patients. Low back pain (LBP) and neck and shoulder pain (NSP) are highly prevalent and clinically important medical and societal problems in which a NePC is frequently present. The more severe the NePC, the worse the course of the pain, its prognosis and the results of treatment. Reliable and standardised diagnosis of the NePC remains difficult to achieve. Standardized and validated screening tools may help to reliably identify the NePC in individual chronic pain patients. The aim of this study is to validate the Dutch language versions of the PainDETECT Questionnaire (PDQ-Dlv) and the ‘Douleur Neuropathique 4 Questions’ (DN4-Dlv) for use in primary and specialist medical care settings to screen for a NePC in patients with chronic pain due to (1) LBP, (2) NSP or (3) known peripheral nerve damage (PND). Methods/design The study design is cross-sectional to assess the validity of the PDQ-Dlv and the DN4-Dlv with 2 weeks follow-up for test-retest reliability and 3 months follow-up for monitoring and prognosis. 438 patients with chronic pain due to (1) LBP, (2) NSP or (3) PND. will be included in this study. Based on the IASP definition of neuropathic pain, two physicians will independently assess whether the patient has a NEPC or not. This result will be compared with the outcome of the PDQ-Dlv & DN4-Dlv, the grading system for neuropathic pain, bed side examination and quantitative sensory testing. This study will further collect data regarding prevalence of NePC, general health status, mental health status, functioning, pain attribution and quality of life. Discussion The rationale for this study is to provide detailed information on the clinimetric quality of the PDQ-Dlv and DN4-Dlv in Dutch speaking countries. Our innovative multi-factorial approach should help achieve more reliable diagnosis and quantification of a NePC in patients with chronic pain. Trial registration The Netherlands National Trial Register (NTR3030).
    BMC Neurology 05/2014; 14(1):94. DOI:10.1186/1471-2377-14-94 · 2.04 Impact Factor
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    • "One week after the first treatment, data from the NRS (neck), NRS (arm), Patient Global Impression of Change (PGIC) scale [17], and the BQN were collected from the patient via a short telephone interview. Similarly, these same data were collected at 1 month and 3 months after the start of treatment via telephone interviews. "
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    ABSTRACT: Background Neck pain is a common complaint in patients presenting for chiropractic treatment. The few studies on predictors for improvement in patients while undergoing treatment identify duration of symptoms, neck stiffness and number of previous episodes as the strong predictor variables. The purpose of this study is to continue the research for predictors of a positive outcome in neck pain patients undergoing chiropractic treatment. Methods Acute (< 4 weeks) (n = 274) and chronic (> 3 months) (n = 255) neck pain patients with no chiropractic or manual therapy in the prior 3 months were included. Patients completed the numerical pain rating scale (NRS) and Bournemouth questionnaire (BQ) at baseline prior to treatment. At 1 week, 1 month and 3 months after start of treatment the NRS and BQ were completed along with the Patient Global Impression of Change (PGIC) scale. Demographic information was provided by the clinician. Improvement at each of the follow up points was categorized using the PGIC. Multivariate regression analyses were done to determine significant independent predictors of improvement. Results Baseline mean neck pain and total disability scores were significantly (p < 0.001and p < 0.008 respectively) higher in acute patients. Both groups reported significant improvement at all data collection time points, but was significantly larger for acute patients. The PGIC score at 1 week (OR = 3.35, 95% CI = 1.13-9.92) and the baseline to 1 month BQ total change score (OR = 1.07, 95% CI = 1.03-1.11) were identified as independent predictors of improvement at 3 months for acute patients. Chronic patients who reported improvement on the PGIC at 1 month were more likely to be improved at 3 months (OR = 6.04, 95% CI = 2.76-13.69). The presence of cervical radiculopathy or dizziness was not predictive of a negative outcome in these patients. Conclusions The most consistent predictor of clinically relevant improvement at both 1 and 3 months after the start of chiropractic treatment for both acute and chronic patients is if they report improvement early in the course of treatment. The co-existence of either radiculopathy or dizziness however do not imply poorer prognosis in these patients.
    Chiropractic and Manual Therapies 08/2012; 20(1):27. DOI:10.1186/2045-709X-20-27
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