Developing patient-reported outcome measures for pain clinical trials: IMMPACT recommendations.
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Clinical Trials as Topic↗
Biomedical subjects
Susan Martin
Publications and source records attributed to Susan Martin.
Double-blind, placebo-controlled, randomised phase II trial of IH636 grape seed proanthocyanidin extract (GSPE) in patients with radiation-induced breast induration.
BACKGROUND AND PURPOSE: Tissue hardness (induration), pain and tenderness are common late adverse effects of curative radiotherapy for early breast cancer. The purpose of this study was to test the efficacy of IH636 grape seed proanthocyanidin extract (GSPE) in patients with tissue induration after high-dose radiotherapy for early breast cancer in a double-blind placebo-controlled randomised phase II trial. PATIENTS AND METHODS: Sixty-six eligible research volunteers with moderate or marked breast induration at a mean 10.8 years since radiotherapy for early breast cancer were randomised to active drug (n = 44) or placebo (n = 22). All patients were given grape seed proanthocyanidin extract (GSPE) 100 mg three times a day orally, or corresponding placebo capsules, for 6 months. The primary endpoint was percentage change in surface area (cm(2)) of palpable breast induration measured at the skin surface 12 months after randomisation. Secondary endpoints included change in photographic breast appearance and patient self-assessment of breast hardness, pain and tenderness. RESULTS: At 12 months post-randomisation, > or =50% reduction in surface area (cm(2)) of breast induration was recorded in 13/44 (29.5%) GSPE and 6/22 (27%) placebo group patients (NS). At 12 months post-randomisation, there was no significant difference between treatment and control groups in terms of external assessments of tissue hardness, breast appearance or patient self-assessments of breast hardness, pain or tenderness. CONCLUSIONS: The study failed to show efficacy of orally-administered GSPE in patients with breast induration following radiotherapy for breast cancer.
Administration, Oral↗
Core outcome measures for chronic pain clinical trials: IMMPACT recommendations.
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Chronic Disease↗
Granular cell tumor of the thyroid: a case report.
We report a rare case of granular cell tumor (GCT) arising within the thyroid parenchyma. The differential diagnosis of GCT in thyroid includes all oncocytic/Hürthle cell lesions of the thyroid, medullary carcinoma and metastasis. The classic histomorphologic features and immunohistochemistry are helpful in arriving at the correct diagnosis.
Adenoma, Oxyphilic↗
Fibromyalgia syndrome.
The objectives of the first OMERACT Fibromyalgia Syndrome (FM) Workshop were to identify and prioritize symptom domains that should be consistently evaluated in FM clinical trials, and to identify aspects of domains and outcome measures that should be part of a concerted research agenda of FM researchers. Such an effort will help standardize and improve the quality of outcomes research in FM. A principal assumption in this workshop has been that there exists a clinical syndrome, generally known as FM, characterized by chronic widespread pain typically associated with fatigue, sleep disturbance, mood disturbance, and other symptoms and signs, and considered to be related to central neuromodulatory dysregulation. FM can be diagnosed using 1990 American College of Rheumatology criteria. In preparation for the workshop a Delphi exercise involving 23 FM researchers was conducted to establish a preliminary prioritization of domains of inquiry. At the OMERACT meeting, the workshop included presentation of the Delphi results; a review of placebo-controlled trials of FM treatment, with a focus on the outcome measures used and their performance; a panel discussion of the key issues in FM trials, from both an investigator and regulatory agency perspective; and a voting process by the workshop attendees. The results of the workshop were presented in the plenary session on the final day of the meeting. A prioritized list of domains of FM to be investigated was thus developed, key issues and controversies in the field were debated, and consensus on a research agenda on outcome measure development was reached.
Delphi Technique↗
Toward performing transplantation in highly sensitized patients.
Performing transplantation in highly sensitized patients represents a challenge for transplant units and organ exchange organizations. There are various approaches that can be adopted in order to transplant these patients, either through kidney exchange programs or by using desensitization protocols. In this article we discuss a number of these approaches, including the system currently used in the United Kingdom. The system encourages understanding of the patient's antibody profile and has resulted in a threefold increase in the number of highly sensitized patients undergoing transplantation.
Humans↗
Timed motor test for wheelchair users: initial development and application in children with spinal cord injury.
OBJECTIVE: The objective of this study was to describe the development and preliminary results of reliability testing of the timed motor test (TMT), a performance-based measure of functional status for children with a spinal cord injury (SCI) who use a manual wheelchair. This study will also provide pilot data using the TMT to examine the impact of thoracolumbosacral orthoses (TLSO) on function in children with a SCI. STUDY DESIGN: Cross-sectional observational study. METHODS/PARTICIPANTS: This study enrolled 11 subjects with SCI. The TMT consisted of donning a shirt, donning pants, even transfers, uneven transfers, and propelling a wheelchair 80 feet and up a ramp of 45 feet. Nine subjects completed the TMT with and without a TLSO, and 6 subjects (4 of whom also completed the TMT with and without a TLSO) completed the reliability testing. RESULTS: Except for donning pants, the intertester and intratester reliability of the TMT was fair-to-good with intraclass correlation coefficients (ICCs) of 0.60 or greater. When wearing a TLSO, participants were slower at donning a shirt, donning pants, performing even and uneven transfers, and hallway propulsion (P < 0.05). There was a preference for not wearing a TLSO for dressing and transfer skills. CONCLUSION: In general, the TMT for wheelchair users had fair-to-good intertester and intratester reliability. Based on these pilot data, there was an increase in time to complete several functional tasks because of the use of a TLSO as measured by the TMT in children with a SCI.
Activities of Daily Living↗
Posttransplantation production of donor HLA-specific antibodies as a predictor of renal transplant outcome.
BACKGROUND: This study aimed to determine whether the production, in renal transplant recipients, of antibodies directed against donor HLA mismatches is predictive of transplant failure. METHODS: The failure study group comprised 112 adult recipients of primary renal transplants who had re-entered the transplant waiting list after failure of the first graft. A control group of 123 recipients with functioning transplants was selected from transplantations performed during the same time period, in which patients had equivalent HLA matching and immunosuppression and a minimum of 5 years of follow-up. Sera taken before transplantation and at 1, 3, and 6 months and annually after transplantation were tested by enzyme-linked immunoabsorbent assay (ELISA) for the presence of HLA class I- and class II-specific antibodies. Antibody specificity was defined by a combination of cytotoxicity, ELISA, and flow cytometry techniques to determine whether the antibodies were directed against donor mismatches. RESULTS: All recipients were negative for donor HLA-specific antibodies before transplantation. After transplantation, 57 (50.9%) of the 112 patients in the failure group produced donor HLA-specific antibodies compared with 2 (1.6%) of the 123 controls (P<0.0001; odds ratio [OR]=64.98; confidence interval [CI], 14.78-399.51). For 60% of the donor-specific antibody-positive patients, antibodies were detected before transplant failure. In 17 cases, these were class I specific; in 14 cases, class II specific; and in 3 cases, specific for both class I and II. CONCLUSIONS: This study has demonstrated that the production of posttransplantation antibodies directed against donor HLA-A, -B, -Cw, -DR, and -DQ mismatches are all strongly predictive of transplant failure.
Adult↗
The detection and definition of IgM alloantibodies in the presence of IgM autoantibodies using flowPRA beads.
We have developed a flow cytometry-based screening method using FlowPRA (One Lambda) human leukocyte antigen (HLA) class I panel beads and FlowPRA (One Lambda) HLA class I specificity beads for the detection and definition of immunoglobulin (Ig)M HLA-specific antibodies in the presence of IgM autoantibodies. Forty-six autoantibody-positive patients who were on the waiting list for a renal transplant (56 sera) were tested in parallel with FlowPRA (One Lambda) HLA class I beads and FlowPRA (One Lambda) control beads. Sera that were positive for IgM HLA class I antibodies were subsequently tested with FlowPRA HLA class I specificity beads to determine the HLA specificities. Thirteen of the 46 patients were positive for IgM HLA class I-specific antibodies. Eleven of the 13 had previous failed transplants and 2 were awaiting a primary transplant. For 9 of the 13 positive patients, IgM HLA class I specificities were defined. We have demonstrated the presence of IgM HLA-specific antibodies in patients with IgM autoantibodies. This study demonstrates the value of FlowPRA HLA class I panel and specificity beads for the detection and definition of IgM HLA class I-specific antibodies.
Autoantibodies↗
Using SERVQUAL in health libraries across Somerset, Devon and Cornwall.
This study provides the results of a survey conducted in the autumn of 2001 by ten NHS library services across Somerset, Devon and Cornwall. The aim of the project was to measure the service quality of each individual library and to provide an overall picture of the quality of library services within the south-west peninsula. The survey was based on SERVQUAL, a diagnostic tool developed in the 1980s, which measures service quality in terms of customer expectations and perceptions of service. The survey results have provided the librarians with a wealth of information about service quality. The service as a whole is perceived to be not only meeting but also exceeding expectations in terms of reliability, responsiveness, empathy and assurance. For the first time, the ten health library services can measure their own service quality as well as benchmark themselves against others.
Benchmarking↗
Monitoring gaseous exchange: implications for nursing care.
The purpose of this study is to examine whether a relationship exists between arterial and end-tidal carbon dioxide tension (PaCO2 and PETCO2 respectively) in patients admitted to intensive care units (ICUs), and what the implications it has for nursing care. PaCO2 and PETCO2 are indicators of ventilatory adequacy which is an important aspect of respiratory function. These measures of carbon dioxide tension are obtained via invasive and non-invasive monitoring tools. Measurement of PETCO2 has only recently been introduced into ICUs and its usefulness in these environments is open to debate. A population of 30 intubated patients had 214 simultaneous measurements of PaCO2 and PETCO2 taken over a period of 10 months. The findings indicate that, despite strong significant correlations, PETCO2 cannot be used safely as a substitute for PaCO2 as the arterial/end-tidal carbon dioxide gradient is not constant, nor does capnography provide a consistently reliable indicator of PaCO2.
Adult↗
The outcome of pediatric cadaveric renal transplantation in the UK and Eire.
An analysis of all pediatric cadaveric renal transplant recipients in the UK and Eire was undertaken to review the outcomes of pediatric cadaveric renal transplantation and to consider the implications for organ allocation procedures for pediatric recipients. Factors influencing the outcome of 1,252 pediatric cadaveric renal transplants in the UK and Eire in the 10-yr period from 1 January 1986 to 31 December 1995 were analyzed by Cox proportional hazards regression, including analysis of four distinct post-transplant epochs (0-3 months, 3-12 months, 12-36 months, and beyond 36 months). At the time of analysis (December 2000), 113 (11%) recipients had died and 47% of grafts had failed. In the multi-factorial modelling, the factors significantly affecting transplant outcome were cold ischaemia time, donor and recipient age and human leucocyte antigen (HLA) matching. Epoch analysis demonstrated that these factors operated at different times post-transplant. Cold ischaemia time had a strong influence on outcome at 3 months. A highly significant increased risk of graft failure was associated with donors under 5 yr of age. Young recipients had an increased risk of failure in the short term, but beyond 1 yr post-transplant there were few failures in young recipients while a steady rate of graft loss persisted in the older children. In terms of HLA matching, the worst outcome was observed for two HLA-DR mismatched grafts, while 000 and favorably matched kidneys (100, 010, 110 HLA-A, -B, -DR mismatches) survived longest. Hence, a policy of exchanging organs on the basis of HLA matching is justified for 000 mismatched and favorably matched kidneys. The poor outcome associated with very young donors should discourage pediatric units from transplanting kidneys from such young donors. The reasons for late losses in older recipients need investigation.
Cause of Death↗
Chemotherapy-handling practices of outpatient and office-based oncology nurses.
PURPOSE/OBJECTIVES: To determine the current patterns of use of personal protective equipment among oncology nurses while handling antineoplastic chemotherapeutic agents in outpatient and office-based settings. DESIGN: Descriptive-correlational, mailed survey. SETTING: National survey of oncology nurses. SAMPLE: 500 randomly selected members of the Oncology Nursing Society who identified their work settings as office, clinic, or outpatient private practice; 263 responded for an overall response rate of 53%. METHODS: Mailed, self-report survey based on the current Occupational Safety and Health Administration's (OSHA's) guidelines for the handling of hazardous drugs. MAIN RESEARCH VARIABLE: Chemotherapy-handling practices. FINDINGS: More than 94% of participants reported usually wearing gloves during chemotherapy handling; 55% reported using laboratory coats as protective garments. Usual use of face and respiratory protection was less than 6%. Chemotherapy was reported to be prepared in laminar air flow hoods in 99% of work settings. Only 46% of sites reportedly provided any type of medical monitoring. CONCLUSION: Use and availability of personal protective equipment when handling chemotherapy have increased, but medical monitoring of exposed employees still is neither widely practiced nor consistent with OSHA guidelines. IMPLICATIONS FOR NURSING: Safety concerns and potential adverse health effects associated with the occupational handling of chemotherapeutic agents have been reported. Historically, nurses' adherence to chemotherapy-handling guidelines has been poor. Results suggest that adherence is increasing; however, research is lacking regarding nurses' level of knowledge of and specific barriers to safe handling of chemotherapy.
Ambulatory Care↗