Biomedical subjects

Roger Goldstein

Publications and source records attributed to Roger Goldstein.

22 records · Page 2Linked to original sources

PubMedDate not supplied

The Canadian Optimal Therapy of COPD Trial: design, organization and patient recruitment.

BACKGROUND: There are no published studies that have assessed whether adding long-acting beta 2-agonist bronchodilators and/or inhaled steroids to chronic therapy with tiotropium would provide additional clinical benefit to patients with moderate to severe chronic obstructive pulmonary disease (COPD). METHODS: The Canadian Optimal Therapy of COPD Trial is a randomized, prospective, double-blind, placebo-controlled, multicentre trial funded by the Canadian Institutes of Health Research that has been designed to determine which combination of inhaled medications will most effectively prevent exacerbations and optimize disease-specific quality of life in patients with COPD. The trial is the first to evolve from the Canadian Thoracic Society Clinical Trials Group. The study will randomize 432 patients with moderate to severe COPD to one of three parallel treatment arms for 52 weeks: tiotropium and fluticasone/salmeterol; tiotropium and salmeterol; or tiotropium and placebo inhaler. The participants will be allowed to use salbutamol as required throughout the trial period. OUTCOMES: The primary outcome measure is the proportion of patients in the three treatment groups who experienced a respiratory exacerbation within 52 weeks of randomization. Other outcomes that will be assessed over the 52-week trial period will include: changes in disease-specific quality of life and changes in dyspnea, health care use and changes in lung function. A pharmacoeconomic analysis will also be performed to evaluate the cost of these therapies. RESULTS: The study commenced recruitment in October 2003. It is currently operating at 22 centres across Canada and has randomized 137 patients during the first four months of recruitment. Recruitment is scheduled to continue until April 2005 or until 432 patients have been randomized. CONCLUSION: The present randomized, placebo-controlled trial offers a unique opportunity to answer the question, what is the best combination of inhaled medications to use for COPD patients? It is hoped that optimal use of inhaled medications will improve patient health and quality of life, reduce patient respiratory exacerbations, and ultimately, reduce health care resource use.

Bronchodilator Agents↗

PubMedDate not supplied

User perspectives on issues that influence the quality of daily life of ventilator-assisted individuals with neuromuscular disorders.

OBJECTIVES: To identify user perspectives on the issues that impact the quality of the daily lives of ventilator-assisted individuals living in the community. METHODS: Semistructured interviews were held with 26 Canadian ventilator-assisted individuals (mean age 44+/-14 [SD] years, range 23 to 60 years; mean ventilator experience 18+/-13 years, range three to 53 years) whose disability from neuromuscular conditions necessitated assistance with activities of daily living. Participants described their daily life experiences and perceptions of the factors that limited or enhanced their quality. Interviews were tape-recorded, transcribed and analyzed for emergent codes and themes. RESULTS: Ventilator users characterized important issues in terms of personal successes and limitations, as well as dependencies on others for daily living. Personal support services, income security, health care and transportation were important positive contributors to their quality of life. Dependency on others was clearly a negative contributor. The ventilator was regarded as a form of assistive technology, similar to a wheelchair. Ventilator users perceived that ventilation was associated with a stigma and negative assumptions about disability, particularly if suctioning was required. CONCLUSIONS: The majority of participants considered home mechanical ventilation to be a positive benefit for independent living, enhancing their overall health. They were clear as to the issues of importance to them, and formulated recommendations for health care providers and policy makers that could improve the quality of their daily lives. Many of the issues identified in the present report are faced by the growing community of ventilator users.

Activities of Daily Living↗

PubMedDate not supplied

State of the Art Compendium: Canadian Thoracic Society recommendations for the management of chronic obstructive pulmonary disease.

Chronic obstructive pulmonary disease (COPD) is a common cause of disability and death in Canada. Moreover, morbidity and mortality from COPD continue to rise, and the economic burden is enormous. The main goal of the Canadian Thoracic Society's evidence-based guidelines is to optimize early diagnosis, prevention and management of COPD in Canada. The main message of the guidelines is that COPD is a preventable and treatable disease. Targeted spirometry is strongly recommended to expedite early diagnosis in smokers and former smokers who develop respiratory symptoms, and who are at risk for COPD. Smoking cessation remains the single most effective intervention to reduce the risk of COPD and to slow its progression. Education, especially self-management plans, are key interventions in COPD. Therapy should be escalated on an individual basis in accordance with the increasing severity of symptoms and disability. Long-acting anticholinergics and beta-2-agonist inhalers should be prescribed for patients who remain symptomatic despite short-acting bronchodilator therapy. Inhaled steroids should not be used as first line therapy in COPD, but have a role in preventing exacerbations in patients with more advanced disease who suffer recurrent exacerbations. Acute exacerbations of COPD cause significant morbidity and mortality and should be treated promptly with bronchodilators and a short course of oral steroids; antibiotics should be prescribed for purulent exacerbations. Patients with advanced COPD and respiratory failure require a comprehensive management plan that incorporates structured end-of-life care. Management strategies, consisting of combined modern pharmacotherapy and nonpharmacotherapeutic interventions (eg, pulmonary rehabilitation and exercise training) can effectively improve symptoms, activity levels and quality of life, even in patients with severe COPD.

Canada↗

PubMedDate not supplied

A clinical trial to evaluate the measurement properties of 2 direct preference instruments administered with and without hypothetical marker states.

BACKGROUND: Health economists recommend that when patients provide preference ratings of their own health state using utility and health state preference measures such as the feeling thermometer (FT) and standard gamble (SG), they first rate hypothetical health states (clinical marker states [CMS]). However, there is no evidence to support improvement in measurement properties with the use of CMS. The authors evaluated validity and responsiveness of the SG and FT with and without administration of the CMS. METHODS: Respiratory rehabilitation improves health-related quality of life in patients with chronic airflow limitation. The authors randomized 84 patients undergoing pulmonary rehabilitation to administration of the FTand SG with (FT+ or SG+) or without (FT- or SG-) CMS before and after a standard 12-week respiratory rehabilitation program. Patients also completed the Health Utilities Index 3 (HUI3), the Chronic Respiratory Questionnaire (CRQ), and the St. George Respiratory Questionnaire (SGRQ) to evaluate longitudinal validity. RESULTS: Marker state status did not significantly affect baseline scores on either FT or SG (FT+ 0.54, FT- 0.60, SG+ 0.68, SG- 0.66, on a scale from 0 [dead] to 1.0 [full health]). The improvement after the rehabilitation program was 0.14 (P < 0.001) in the FT+ group and 0.08 (P = 0.02) in the FT- group (difference between FT+ and FT- = 0.06; 95% confidence interval [CI] = -0.03 to 0.15, P = 0.17). The corresponding improvement was 0.12 (P = 0.009) in the SG+ group and 0.07 in the SG- group (P = 0.11) (difference between SG+ and SG- = 0.05; 95% CI= -0.07 to 0.17, P = 0.39). Correlations between change in the FT+ with the CRQ and SGRQ were slightly but not significantly lower than between the change in FT- and these 2 specific instruments. The correlations between change in the SG with the CRQ and the SGRQ were weaker in patients randomized to SG+ (from 0.00 to 0.17) compared to the SG- group (from 0.21 to 0.58). These differences were statistically significant for the CRQ domains of dyspnea and fatigue. CONCLUSION: The authors found nonsignificant trends toward superior responsiveness when patients rated hypothetical health states before rating their own health state. Although including hypothetical health states did not significantly influence the validity of the FT, it decreased the longitudinal validity of the SG. This study fails to show convincing advantage for use of marker states. Theoretical arguments in favor of marker states cannot stand alone without empirical support.

Aged↗