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Biomedical subjects

N Bellamy

Publications and source records attributed to N Bellamy.

At least 55 records · Page 3Linked to original sources
PubMed2000

Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis.

OBJECTIVE: To determine the minimal perceptible clinical improvement (MPCI) in patients with osteoarthritis (OA) with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire, and patient and investigator global assessment of disease status in randomized clinical trials for treatment of OA. METHODS: Subjects with OA of the knee or hip were randomized to receive either rofecoxib 12.5 or 25 mg once daily, ibuprofen 800 mg 3 times daily, or placebo for 6 weeks. The WOMAC and global assessments were completed at baseline and Weeks 2, 4, and 6. A patient global assessment of response to therapy (0 to 4 scale) was used to "anchor" the WOMAC scores. MPCI was defined as the difference in mean change from baseline in WOMAC (100 mm normalized visual analog scale, VAS) between patients with 0 = "None" global response to therapy and patients with 1 = "Poor" global response to therapy. RESULTS: MPCI was determined to be 9.7, 9.3, and 10.0 mm for the WOMAC pain, physical function and stiffness subscales, respectively, and 11.1 mm for WOMAC question 1: Pain walking on a flat surface. The MPCI for the investigator was 0.4 with investigator assessment of disease status reported on a 0 to 4 Likert scale. Of note, the estimated MPCI for the WOMAC and investigator globals were similar irrespective of treatment, sex, age, or geographic region. CONCLUSION: In this analysis, mean changes of roughly 9 to 12 mm (100 mm normalized VAS) on WOMAC scales were perceptible changes to patients with hip and knee OA. A mean decrease of 0.4 in global disease status (0 to 4 Likert scale) as assessed by the investigator corresponded to the patients' MPCI. Understanding the minimal perceptible differences may permit a better assessment of the clinical relevance of therapeutic interventions in OA.

Adult↗
PubMed1999

Comparison of the responsiveness and relative effect size of the western Ontario and McMaster Universities Osteoarthritis Index and the short-form Medical Outcomes Study Survey in a randomized, clinical trial of osteoarthritis patients.

OBJECTIVE: This study compares the responsiveness and relative effect sizes of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) with the Medical Outcomes Study Short Form Health Survey (SF-36) in a randomized clinical trial for treatment of osteoarthritis (OA). METHODS: Patients with OA of the knee or hip were randomized to receive either placebo or 2,400 mg/day of ibuprofen for 28 days. Patients completed the WOMAC and SF-36 at baseline and days 7, 14, and 28 of the trial. RESULTS: Patients receiving ibuprofen showed significant improvement in WOMAC pain, physical functioning, and the total score, while improvement was detected only for bodily pain on the SF-36. The WOMAC detected significant differences between ibuprofen and placebo for pain and physical functioning, whereas the SF-36 detected differences for the bodily pain subscale. CONCLUSION: These results suggest the WOMAC has greater power to detect treatment differences than the SF-36, with respect to pain and physical functioning, in OA clinical trials.

Activities of Daily Living↗
PubMed1999

The lack of associations between rheumatoid arthritis and both nulliparity and infertility.

OBJECTIVES: Rheumatoid arthritis (RA) is an autoimmune disease that occurs more commonly in women and frequently onsets in women of childbearing age. Pregnancy often causes disease remission, with a subsequent flare postpartum. Nulliparity may be a risk factor for RA, but the literature does not consistently report this finding. There may be a production of antibodies in women with RA that could lead to infertility, and subsequent nulliparity, but this has not been proved. We wanted to determine whether there was a relationship between nulliparity, infertility, oral contraceptive use, and adverse pregnancy outcome in women with newly diagnosed RA. METHODS: Through a case control study, using a mailed questionnaire, we compared the fertility and pregnancy outcome histories of 34 women between the ages of 19 and 44 years with recent-onset RA with 68 healthy controls matched for age and marital status. The response rate was 97%. A review of the literature also was performed to study the associations between RA and infertility and nulliparity, using Medline searching key references. RESULTS: We found no association between infertility and the onset of RA. Seventy-one percent of women with RA and 68% of controls had been pregnant. There was a trend toward increased nulliparity in these patients, but the result was not statistically significant (odds ratio [OR], 1.4; P<.6). There were no differences in the number of children (2.6 v. 2.7; P<.6) and parity outcomes in the two groups. Age at first pregnancy was younger in the women with RA (22.6 v. 25.5 years; P<.008), but the education level was higher in the controls (P<.0001), which may explain these differences. Oral contraceptive use was lower in the RA women, but more RA women had long-term use (greater than or equal to 5 years), and neither result was statistically significant. Literature review shows that at best, there are weak negative associations between current estrogen use and RA, and no association with nulliparity and infertility. CONCLUSIONS: It appears that infertility, the number of pregnancies, and pregnancy outcome are not strongly associated with the risk of developing RA in women of childbearing age. However, in this study there may have been selection biases in the women with RA and the controls that differentially could have affected their reproductive outcomes. Thus, a true association could have been missed. Most other published studies find no association between nulliparity and RA.

Adolescent↗
PubMed1999

Clinical trials design: structure modifying agents for osteoarthritis. Future guidelines: areas for development.

Clinical trials guidelines should offer evidence-based recommendations, and, where evidence is lacking or absent, should reflect the considered opinion of experts in the field. Recent OsteoArthritis Research Society International (OARSI) guidelines encompass these principles and are the result of a Task Force Workshop involving representatives from academia, regulatory authorities and industry. Areas for continued development for trials of Structure Modifying Osteoarthritis Drugs (STMOAD) include patient selection, study duration, sample size estimation, outcome assessment, imaging, response definition and pharmoeconomics. As developments occur in these and related areas, guideline documents will require revision to reflect this evolution. Notwithstanding these issues, there is opportunity to identify STMOAD class agents using current methodologies.

Clinical Trials as Topic↗
PubMed1999

Perceptual variation in grading hand, hip and knee radiographs: observations based on an Australian twin registry study of osteoarthritis.

OBJECTIVE: The radiographic diagnosis of osteoarthritis (OA) in the peripheral skeleton is dependent on the skilled examination of several morphological characteristics of the condition as visualised on plain radiographs. However, the process is perceptual and generally enhanced by comparison against photographic standards. This study assessed the intra-rater and inter-rater reliability of radiologists experienced in reporting hand, hip and knee films derived from a community-based sample when using the photographic atlas recently developed by Burnett et al. METHODS: This study was part of a multifaceted diagnostics protocol, evaluating methodological issues, in the conduct of genetic research in osteoarthritis. From a cohort of 118 twin pairs, registered with the Australian Twins Registry (ATR), standard clinical examinations were performed on 74 complete and 11 incomplete pairs of twins over age 50 years, followed by standard AP hand, AP pelvis and AP standing radiographs of the knees. The pairs were selected both to represent twin pairs who had previously self reported a diagnosis of OA, as well as those who had not. Radiologists read the films blind to the original self reported diagnosis and without reference to their pairing. The films were read by comparison against photographic standards and were scored according to specific features. All films were read independently by two consultant radiologists blind to one another's assessments, and selected films were thereafter assigned for rereading. Inter-rater and intra-rater agreement were different for different features, different anatomic areas, and, for the former, were different for the two radiologists. RESULTS: Inter-rater agreement was different for different anatomic areas, different radiographic features, and the two radiologists. Intra-rater agreement for the presence or absence of OA was as follows: actual observed agreement = 0.79 to 0.97 and 0.83 to 0.98; adjusted kappa statistic = 0.58 to 0.94 and 0.67 to 0.96; inter-rater agreement was as follows: actual observed agreement = 0. 77 to 0.97; adjusted kappa statistic = 0.54 to 0.94. Agreement was generally high in most of the principal target joints for OA: DIP, PIP, 1st CMC, hip and knee. CONCLUSIONS: Although assessor agreement was not perfect, it is concluded that for genetic epidemiology purposes, while duplicate assessments may be advantageous, it is possible for radiographs to be examined accurately by a single experienced assessor. However, for less experienced assessors independent examinations should be made by at least two assessors and either a consensus reached on disparate examinations or an algorithm developed to adjudicate any discrepancies.

Adult↗
PubMed1999

Comparative study of self-rating pain scales in osteoarthritis patients.

Although progress has been made in the clinical metrology of pain in osteoarthritis, much further work remains. The preferred methods of measurement remain debatable. In this longitudinal, open study, a comparison of eight self-rating pain scales has been conducted. A total of 333 patients entered the four-week study after completing a 3-7 day NSAID-free washout period. Patients were assigned to treatment with oxaprozin 1200 mg p.o. once daily with titration permitted between 600 mg and 1800 mg. Rescue analgesia with acetaminophen (paracetamol) 325 mg (maximum 2600 mg) was allowed. At the end of the washout and the treatment period, patients completed eight self-administered pain scales. All pain measures detected clinically important and statistically significant improvements in pain. The pain scales differed in their degree of responsiveness. The Likert and visual analogue scales and their primary variations (continuous chromatic analogue and numerical scales) were more responsive than more complex measures. A positive correlation between initial pain rating and subsequent pain relief was confirmed in this study. We conclude that, while pain is a subjective sensory phenomenon, its perceived severity can be evaluated using a variety of self-administered pain scales, all of which are capable of detecting improvements in health status following effective pharmacological intervention.

Adult↗
PubMed1999

Comparative study of self-rating pain scales in rheumatoid arthritis patients.

Although progress has been made in the clinical metrology of pain in rheumatoid arthritis, much further work remains. The preferred methods of measurement remain debatable. In this longitudinal, open study, a comparison of eight self-rating pain scales has been conducted. A total of 124 patients entered the four-week study after completing a 3-7-day NSAID-free washout period. Patients were assigned to treatment with oxaprozin 1200 mg p.o. once daily with titration permitted between 600 mg and 1800 mg. Rescue analgesia with acetaminophen (paracetamol) 325 mg (maximum 2600 mg) was permitted. At the end of the washout and treatment period, patients completed eight self-administered pain rating scales. All pain measures detected clinically important and statistically significant improvements in pain. The pain scales differed in their degree of responsiveness. The Likert and visual analogue scales and their primary variations (continuous chromatic analogue and numerical scales) were more responsive than more complex measures. A positive correlation between initial pain rating and subsequent pain response was confirmed in this study. We conclude that, while pain is a subjective sensory phenomenon, its perceived severity can be evaluated using a variety of self-administered pain scales, all of which are capable of detecting improvements in health status following effective pharmacological intervention.

Adult↗
PubMed1999

Clinimetric concepts in outcome assessment: the OMERACT filter.

Validation is the process by which the clinical measurement (clinimetric) properties of an assessment procedure are formally evaluated. In the case of outcome measures, this process traditionally establishes the reliability, validity, and responsiveness of the measurement technique. Although the statistical methods used are diverse, the principles to be followed have been well established and are generally accepted. The basic issues are similar and transcend outcome measurement in different medical conditions. In addition to fulfilling clinimetric requirements, outcome measures are required to be practical in their application. The OMERACT group have recently proposed a novel user-friendly paradigm to capture the essential elements of truth, discrimination, and feasibility. This paradigm is termed the OMERACT filter.

Clinical Trials as Topic↗
PubMed1999

Selection of instruments in the core set for DC-ART, SMARD, physical therapy, and clinical record keeping in ankylosing spondylitis. Progress report of the ASAS Working Group. Assessments in Ankylosing Spondylitis.

To select specific instruments for each domain of the core set for endpoints in ankylosing spondylitis (AS), we gathered all instruments described in the literature to assess the domains chosen as endpoints in AS and sent them to 43 members of the Assessments in Ankylosing Spondylitis (ASAS) Working Group. The following domains were taken into account: function, pain, spinal mobility, patient global assessment, morning stiffness, peripheral joints and entheses, acute phase reactants, x-ray spine, x-ray hips, fatigue. For each instrument the members were asked to judge if the instrument was feasible and relevant. If an instrument was judged to be not feasible or not relevant by more than 50% of the respondents the instrument was deleted from the list. These data were presented during an ASAS workshop and the final decisions were about which instruments to include in the core set. This process was repeated separately for the settings disease controlling antirheumatic therapy (DC-ART), symptom modifying antirheumatic drugs (SMARD) and physical therapy, and clinical record keeping. The response rate to the questionnaire was 72%. For each domain one or more instruments were selected, except for Entheses and Fatigue. The chosen instruments were similar for the 3 above settings. Core sets of specific instruments were selected for the OMERACT filter test for relevance and feasibility. For all these instruments the remaining aspects of the OMERACT filter (truth and discrimination) should be assessed by literature review and if needed by additional research. It is recommended to use these instruments in all research projects in AS.

Antirheumatic Agents↗
PubMed1999

A survey of outcome measurement procedures in routine rheumatology outpatient practice in Australia.

OBJECTIVE: To assess the extent to which quantitative clinical measurement is performed by rheumatologists in the longitudinal followup of patients with rheumatoid arthritis (RA), osteoarthritis (OA), ankylosing spondylitis (AS), and fibromyalgia (FM) in routine outpatient practice in Australia. METHODS: A cross sectional postal survey was conducted using an 18-item self-administered questionnaire sent to Australian Rheumatology Association (ARA) members. RESULTS: Rheumatologists (response rate = 76%, completion rate = 72%) were more likely to longitudinally follow patients with RA and AS than those with OA or FM. There was a high degree of variability in the methods used to monitor patients longitudinally. Many measures used in clinical research were used infrequently in routine clinical practice. In general, the major health status measures surveyed were not used in clinical monitoring. There was a high level of agreement (> 80%) that the characteristics required of an outcome measure for use in clinical practice should include simplicity, brevity, ease of scoring, reliability, validity, and sensitivity to change. CONCLUSION: The majority of Australian rheumatologists perform outcome measurement during the longitudinal followup of their outpatients with RA, AS, OA, and FM. However, the process lacks standardization. High performance health status measures developed for clinical research have not been widely adopted in rheumatology practices. There is agreement on the characteristics required by Australian rheumatologists for measurement procedures used in routine clinical care. Quantitative measurement in clinical practice using standardized procedures is an attainable, but as yet, unrealized opportunity.

Ambulatory Care↗
PubMed1999

Perceptual variation in categorizing individuals according to American College of Rheumatology classification criteria for hand, knee, and hip osteoarthritis (OA): observations based on an Australian Twin Registry study of OA.

OBJECTIVE: The American College of Rheumatology (ACR) classification criteria for osteoarthritis (OA) permit the categorization of individuals for hand, knee, and hip OA and are of defined sensitivity and specificity. They depend on both clinical and radiographic aspects of OA. The clinical diagnosis of OA in the peripheral skeleton is dependent on the skilled examination of several clinical features characteristic of the condition, while the interpretation of radiographs is a perceptual skill based on appreciating specific structural features on plain radiographs. We investigated the interrater reliability of the ACR classification criteria for OA when applied in a community based sample. METHODS: The study was part of a multifaceted diagnostics protocol, evaluating methodologic issues, in the conduct of genetic research in OA. From a cohort of 118 pairs of twins registered with the Australian Twins Registry (ATR), standard clinical examinations of hands, knees, and hips were performed on 74 complete and 11 incomplete pairs of twins over age 50 years. The pairs were selected to represent both twin pairs who had previously self-reported a diagnosis of OA, as well as those who had not. Rheumatologists who performed the assessments were blind to the original self-report. All subjects were examined independently by one of 2 pairs (NB/AK or NB/KM) of consultant rheumatologists, blind to one another's assessments. Each rheumatologist separately assessed the hands, knees, and hips, rating them clinically by ACR criteria for OA. The observations were made without reference to any radiographic or serologic information. RESULTS: Interrater agreement was different for the 3 different anatomic areas and was different for the 2 pairs of rheumatologists. The actual (observed) interrater agreements based on ACR clinical criteria were as follows: hand OA NB/AK = 0.92, NB/KM = 1.00; knee OA NB/AK = 0.94, NB/KM = 0.92; hip OA NB/AK = 0.98, NB/KM = 0.97. Interrater agreement based on ACR clinical criteria, as assessed by the adjusted kappa statistic, was as follows: hand OA NB/AK = 0.84, NB/KM = 1.00; knee OA NB/AK = 0.87, NB/KM = 0.84; hip OA NB/AK = 0.95, NB/KM = 0.93. CONCLUSION: Since clinical agreement was extremely high in all 3 anatomic sites, and for both pairs of assessors, we conclude that for genetic epidemiology purposes, subjects can be examined by a single experienced rheumatologist using the ACR classification criteria.

Australia↗
PubMed1998

A standardized protocol for measurement of range of movement of the shoulder using the Plurimeter-V inclinometer and assessment of its intrarater and interrater reliability.

OBJECTIVE: To develop a standardized protocol for measurement of shoulder movements using a gravity inclinometer designed for use in clinical trials, and to assess its intra- and interrater reliability in a group of manipulative physiotherapists. METHODS: After instruction, 6 manipulative physiotherapists independently assessed 8 movements of the shoulder, including total and glenohumeral flexion (TF, GHF), total and glenohumeral abduction (TA, GHA), external rotation in neutral (ERN) and abduction (ERA), internal rotation in abduction (IRA), and hand behind back (HBB), in random order in 6 patients with shoulder pain and stiffness according to a 6 x 6 Latin square design using the standardized protocol. The assessments were then repeated. Analysis of variance was used to partition total variability into components of variance in order to calculate intraclass correlation coefficients (ICCs). RESULTS: The intra- and interrater reliability of the different movements varied widely. Reliability was higher for TF and TA than for the corresponding glenohumeral movements (e.g., intrarater ICCs: TF = 0.80, GHF = 0.65, TA = 0.75, GHA = 0.62). Interrater reliability was higher in the second round suggesting a practice effect (e.g., round 1, 2 interrater ICCs TF = 0.62, 0.82; TA = 0.62, 0.88; ERN = 0.85, 0.95). CONCLUSION: The measurement of the active range of TF, TA, ERN, and HBB, measured by manipulative physiotherapists following the standardized protocol, has intra- and interrater reliability acceptable for use as an outcome measure in clinical trials assessing interventions for shoulder pain.

Humans↗
PubMed1998

Quantitative rheumatology: a survey of outcome measurement procedures in routine rheumatology outpatient practice in Canada.

OBJECTIVE: To assess the extent to which quantitative clinical measurement is performed by rheumatologists in the longitudinal followup of patients with rheumatoid arthritis (RA), osteoarthritis (OA), ankylosing spondylitis (AS), and fibromyalgia (FM) in routine outpatient practice in Canada. METHODS: A cross sectional postal survey was conducted using an 18 item self-administered questionnaire sent to Canadian Rheumatology Association members. RESULTS: Rheumatologists (response rate 85%) were more likely to longitudinally follow patients with RA and AS than those with OA or FM. There was a high degree of variability in the methods used to monitor patients longitudinally. Many measures used in clinical research were used infrequently in routine clinical practice. In general, the major health status measures surveyed were not used in clinical monitoring. There was a high level of agreement (>80%) that the characteristics required of an outcome measure for use in clinical practice should include simplicity, brevity, ease of scoring, reliability, validity, and sensitivity to change. CONCLUSION: The majority of Canadian rheumatologists perform outcome measurement during the longitudinal followup of their outpatients with RA, AS, OA, and FM. However, the process lacks standardization. High performance health status measures, developed for clinical research, have not been widely adopted in rheumatology practices. There is agreement on the characteristics required by Canadian rheumatologists for measurement procedures used in routine clinical care. Quantitative measurement in clinical practice using standardized procedures is an attainable, but as yet, unrealized opportunity.

Ambulatory Care↗
PubMed1997

Osteoarthritis clinical trials: candidate variables and clinimetric properties.

Outcome assessment in osteoarthritis (OA) clinical trials requires the use of valid, reliable, and responsive measurement techniques. Clinical assessment procedures examine patient relevant issues, while imaging procedures and biologic marker assays probe different aspects of the underlying disease process. At present, there is no international agreement on which standardized procedures should be used in future studies or which domains should be included. Nevertheless, significant progress has been made in recent years toward attaining that goal and there are numerous measurement procedures, differing in their conceptual and clinimetric properties, from which to select a core set. The following review provides a description of candidate variables that merit consideration in reaching international harmonization on outcome measures for future OA clinical trials.

Biomarkers↗
PubMed1997

Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III.

Significant progress has been made in outcome measurement procedures for osteoarthritis (OA) clinical trials, and guidelines have been established by the US Food and Drug Administration, European League Against Rheumatism, the World Health Organization/International League of Associations for Rheumatology, and the Group for the Respect of Ethics and Excellence in Science. However, there remains a need for further international harmonization of measurement procedures used to establish beneficial effects in Phase III clinical trials. A key objective of the OMERACT III conference was to establish a core set of outcome measures for future phase III clinical trials. During the conference, using a combination of discussion and polling procedures, a consensus was reached by at least 90% of participants that the following 4 domains should be evaluated in future phase III trials of knee, hip, and hand OA: pain, physical function, patient global assessment, and, for studies of one year or longer, joint imaging (using standardized methods for taking and rating radiographs, or any demonstrably superior imaging technique). These evidence based preferences, achieved with a high degree of consensus, establish an international standard for future phase III trials and will also facilitate metaanalysis and Cochrane Collaborative Project goals.

Clinical Trials, Phase III as Topic↗
PubMed1997

Preliminary core sets for endpoints in ankylosing spondylitis. Assessments in Ankylosing Spondylitis Working Group.

An international working group was formed to select core sets to be used as endpoints in clinical trials in ankylosing spondylitis (AS). The results of the first steps of the selection of these core sets are described. The definition of the settings for which the core set will be intended are defined. The methods used to select the core sets were a combination of literature search, nominal group discussions, and plenary discussions. The following settings were defined: disease controlling antirheumatic therapy (DC-ART), symptom modifying antirheumatic drugs (SMARD)/physical therapy, and clinical record keeping. Over 110 variables used as endpoints in AS were found in the literature. The preliminary core set for DC-ART consists of physical function, pain, spinal mobility, patient global assessment, peripheral joints/entheses, x-ray spine. The selected core set for SMARD/physical therapy includes physical function, pain, spinal mobility, spinal stiffness, and patient global assessment. The core set for clinical record keeping includes all measures of the SMARD/physical therapy core set completed by peripheral joints/entheses, and acute phase reactants. Three preliminary core sets for AS have been defined. Further research will be performed to select specific measures for all domains.

Antirheumatic Agents↗