Jane Scott

Graphic representation of pain.

&NA; Of the different types of visual analogue and graphic rating scales tested in a series of experiments, only two were satisfactory: these were the visual analogue scale and the graphic rating scales used horizontally with the words spread out along the whole length of the line. Other types of scale used gave distributions of results which were not uniform. Unusual distribution of results occurred when patients selected a position adjacent either to descriptive terms or preferred numbers. In some experiments, the distribution of results was determined by the nature of the experiment. Alternation of the ends of a scale did not affect the results. The behaviour of the graphic rating scale was different in patients accustomed to completing it and in those not so accustomed. The results of pain severity measured by these methods showed a very good correlation with pain severity measured by the simple descriptive pain scale. Changes in visual analogue scores also correlated well with changes in simple descriptive pain scores. The visual analogue and graphic rating scales were more sensitive than the traditional simple descriptive pain scale. Most patients could readily use visual analogue and graphic rating scales despite having no previous experience. The failure rate was slightly lower with the graphic rating method. Use of these scales is the best available method for measuring pain or pain relief.

Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations

UNLABELLED Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents. Consensus was refined by consultation with the international pediatric pain community through announcement of our recommendations on the Pediatric Pain List and inviting and incorporating comments from external sources. There was consensus that investigators conducting pediatric acute pain clinical trials should consider assessing outcomes in pain intensity; global judgment of satisfaction with treatment; symptoms and adverse events; physical recovery; emotional response; and economic factors. There was also agreement that investigators conducting pediatric clinical trials in chronic and recurrent pain should consider assessing outcomes in pain intensity; physical functioning; emotional functioning; role functioning; symptoms and adverse events; global judgment of satisfaction with treatment; sleep; and economic factors. Specific measures or measurement strategies were recommended for different age groups for each domain. PERSPECTIVE Based on systematic review and consensus of experts, core domains and measures for clinical trials to treat pain in children and adolescents were defined. This will assist in comparison and pooling of data and promote evidence-based treatment, encourage complete reporting of outcomes, simplify the review of proposals and manuscripts, and facilitate clinicians making informed decisions regarding treatment.

Developing patient-reported outcome measures for pain clinical trials : IMMPACT recommendations

a University of Washington, Seattle, WA 98195, USA b University of Rochester School of Medicine and Dentistry, Rochester, NY, USA c United States Food and Drug Administration, Rockville, MD, USA d Northwestern University, Chicago, IL, USA e Johnson and Johnson, Raritan, NY, USA f AstraZeneca, Wilmington, DE, USA g University of California San Diego, La Jolla, CA, USA h Merck and Company, Blue Bell, PA, USA i University of Texas, M.D. Anderson Cancer Center, USA j American Chronic Pain Association, Rocklin, CA, USA k Allergan, Inc, Irvine, CA, USA l National Institute of Dental and Craniofacial Research, Bethesda, MD, USA m University of Pennsylvania, Philadelphia, PA, USA n Johns Hopkins University, Baltimore, MD, USA o University Health Network and University of Toronto, Toronto, Canada p Novartis Pharmaceuticals, East Hanover, NJ, USA q VA Connecticut Healthcare System, West Haven, CT, USA r Yale University, New Haven, CT, USA s Celgene Corporation, Warren, NJ, USA t Pfizer Global Research and Development, Ann Arbor, MI, USA u Dalhousie University, Halifax, Nova Scotia, Canada v London Regional Cancer Centre, London, Ont., Canada

Patient-reported outcomes in randomized clinical trials: Development of ISOQOL reporting standards

PurposeTo develop expert consensus on a suite of reporting standards for HRQL outcomes of RCTs.MethodsA Task Force of The International Society of Quality of Life Research (ISOQOL) undertook a systematic review of the literature to identify candidate reporting standards for HRQL in RCTs. Subsequently, a web-based survey was circulated to the ISOQOL membership. Respondents were asked to rate candidate standards on a 4-point Likert scale based on their perceived value in reporting studies in which HRQL was a study outcome (primary or secondary). Results were synthesized into draft reporting guidelines, which were further reviewed by the membership to inform the final guidance.ResultsForty-six existing candidate standards for reporting HRQL results in RCTs were synthesized to produce a 40 item survey that was completed electronically by 161 respondents. The majority of respondents rated all 40 items to be either ‘essential’ or ‘desirable’ when HRQL was a primary RCT outcome. Ratings changed when HRQL was a secondary study outcome. Feedback on the survey findings resulted in the Task Force generalizing the guidance to include patient-reported outcomes (PROs). The final guidance, which recommends standards for use in reporting PROs generally, and more specifically, for PROs identified as primary study outcomes, was approved by the ISOQOL Board of Directors.ConclusionsISOQOL has developed a suite of recommended standards for reporting PRO results of RCTs. Improved reporting of PROs will enable accurate interpretation of evidence to inform patient choice, aid clinical decision making, and inform health policy.

An articular index for the assessment of osteoarthritis.

An articular index was devised for the sequential assessment of patients with osteoarthritis (OA). Forty-eight joint units, chosen to reflect the characteristic pattern of the disease, were scored for tenderness on pressure or movement on a 4-point scale. Four observers examined patients to assess inter- and intraobserver error. The index was highly reproducible both within and between observers; intraobserver error was, however, significantly smaller. In a double-blind, cross-over trial the index was sufficiently sensitive to detect a statistically significant difference between the responses of patients with OA to an anti-inflammatory agent and to a simple analgesic. It is likely to be a useful addition to current methods of measurement in osteoarthritis.

IMMUNOSTIMULANT THERAPY WITH LEVAMISOLE FOR RHEUMATOID ARTHRITIS

In a controlled study involving thirty-four patients levamisole was shown to be as effective as D-penicillamine and more effective than placebo in the treatment of rheumatoid arthritis. Its action was slow and was accompanied by a reduction in erythrocyte sedimentation-rate, rheumatoid factor, and technetium index. These properties indicate that it has a specific action like that of D-penicillamine. Stimulation of cell-mediated immunity was evident in patients treated with levamisole, and there was a correlation between such changes and pain relief. Animal models confirmed the absence of anti-inflammatory effect and provided some evidence of enhancement of cell-mediated immunity and macrophage stimulation.

ASCPRO Recommendations for the Assessment of Fatigue as an Outcome in Clinical Trials

CONTEXT Development of pharmacological and behavioral interventions for cancer-related fatigue (CRF) requires adequate measures of this symptom. A guidance document from the Food and Drug Administration offers criteria for the formulation and evaluation of patient-reported outcome measures used in clinical trials to support drug or device labeling claims. METHODS An independent working group, ASCPRO (Assessing Symptoms of Cancer Using Patient-Reported Outcomes), has begun developing recommendations for the measurement of symptoms in oncology clinical trials. The recommendations of the Fatigue Task Force for measurement of CRF are presented here. RESULTS There was consensus that CRF could be measured effectively in clinical trials as the sensation of fatigue or tiredness, impact of fatigue/tiredness on usual functioning, or as both sensation and impact. The ASCPRO Fatigue Task Force constructed a definition and conceptual model to guide the measurement of CRF. ASCPRO recommendations do not endorse a specific fatigue measure but clarify how to evaluate and implement fatigue assessments in clinical studies. The selection of a CRF measure should be tailored to the goals of the research. Measurement issues related to various research environments were also discussed. CONCLUSIONS There exist in the literature good measures of CRF for clinical trials, with strong evidence of clarity and comprehensibility to patients, content and construct validity, reliability, and sensitivity to change in conditions in which one would expect them to change (assay sensitivity), and sufficient evidence to establish guides for interpreting changes in scores. Direction for future research is discussed.

Patients' Experiences With Cancer-Related Fatigue: A Review and Synthesis of Qualitative Research

PURPOSE/OBJECTIVES To systematically review published qualitative reports of descriptions of fatigue by patients with cancer and how cancer-related fatigue (CF) affects their lives. DATA SOURCES MEDLINE®, CANCERLIT®, Cochrane Database of Systematic Reviews, and the Cumulative Index to Nursing and Allied Health Literature. DATA SYNTHESIS Two researchers conducted independent reviews of 667 patient quotes found in 154 articles published from 1996-2009 to identify concepts and language used to describe CF. CONCLUSIONS CF is more intense than the tiredness patients recalled from before diagnosis or treatment. Published patient quotes fail to adjudicate whether CF should be approached as a single symptom or a more complex symptom cluster. IMPLICATIONS FOR NURSING Systematic study of patients with different cancer types and stages is needed to identify effective, valid, and reliable self-reported assessments of CF for clinical practice and trials.

Psychometric Evaluation of the Diabetes Symptom Checklist-Revised (DSC-R)-A Measure of Symptom Distress

OBJECTIVE To assess the psychometric validity, reliability, responsiveness, and minimal important differences of the Diabetes Symptoms Checklist-Revised (DSC-R), a widely used patient-reported outcome measure of diabetes symptom distress. RESEARCH DESIGN AND METHODS Psychometric validity of the DSC-R was assessed using blinded data from a large-scale trial of approximately 4000 type 2 diabetes patients. Confirmatory factorial analysis (CFA) and multitrait analysis were used to examine the construct validity of the structure of DSC-R. DSC-R internal consistency, discriminative validity, and responsiveness were also assessed. Distribution and anchor-based methods were used to estimate minimal important differences for DSC-R domains. RESULTS Mean age of the sample was 56 years, 42% were female, 88% were Caucasian. Patients had a mean body mass index (BMI) of 32.2 and mean glucose-fasting level of 151.7 md/dl. CFA and multitrait analysis indicated that the scoring of the DSC-R has acceptable construct validity. Item-scale correlations ranged from 0.44 to 0.78. Cronbachs alpha coefficients ranged from 0.69 to 0.87. At baseline, DSC-R scores were higher among patients with higher BMI scores (P < 0.0001), supporting the discriminative validity of the DSC-R. Minimal important difference estimates ranged from 0.39 to 0.60 points when using distribution methods and from 0.00 to 0.33 when estimated using anchor-based methods. CONCLUSIONS The DSC-R demonstrated excellent psychometric properties when tested in a large-scale diabetes clinical trial. Responsiveness and test-retest reliability of the DSC-R warrant further evaluation.

Clinical response to therapy with thymopoietin pentapeptide (TP-5) in rheumatoid arthritis

The effect of thymopoietin pentapeptide (TP-5) was evaluated in patients with rheumatoid arthritis (RA). Ninety-two patients were divided into 3 groups, namely, placebo, TP-5 intramuscularly (IM) 1 mg, TP-5 intravenously (IV) 50 mg, and were evaluated for 6 measures of disease activity at the beginning of the study and at 3 and 6 months. No difference was observed between the placebo group and the group treated with TP-5 IM 1 mg. However, in the group treated with TP-5 IV 50 mg a statistically significant improvement of all parameters except the ESR was observed.