Reliability of a new hand-held device for the measurement of exhaled nitric oxide.

BACKGROUND: Given the importance of airway inflammation in asthma, there has been an effort to incorporate inflammatory markers into its management. Measurement of fractional exhaled nitric oxide (FeNO) is a noninvasive marker of airway inflammation; however, the use of the available FeNO analyzer is limited by several factors including its cost and lack of transportability. The aim of this study was to compare the performance of a new hand-held FeNO measuring device (NIOX MINO) to the current clinical standard - the chemiluminescence FeNO analyzer (NIOX). METHODS: Subjects 6 years and older presenting to an allergy and asthma clinic underwent FeNO evaluation by NIOX and each of three NIOX MINOs. The mean of two acceptable measurements from the NIOX and the first approved measurement from each NIOX MINO were used for analysis. RESULTS: One hundred ten patients aged 6-86 years completed the study. Intrasubject FeNO levels obtained by each of the three NIOX MINOs revealed no significant difference between the measurements (P = 0.59). There was a very strong correlation between FeNO measurements by NIOX and by NIOX MINO (r = 0.98, P < 0.0001). The mean intrasubject FeNO difference between NIOX and NIOX MINO was -0.5 p.p.b. which was not statistically significantly different from zero (P = 0.21). CONCLUSIONS: Fractional exhaled nitric oxide measurements by the NIOX MINO showed a strong correlation and a high degree of agreement with the current standard stationary device. The NIOX MINO may be reliably used in clinical practice.

Helping women help themselves: developing a menopause discussion group.

Menopause discussion groups are needed to provide women with accurate and up-to-date information, but--more importantly--to facilitate sharing experiences, to help women understand their choices, and to empower them to be informed and take care of themselves. Members of a group who are comfortable expressing their feelings and thoughts find a therapeutic benefit from group participation. Health care providers are urged to develop these groups in their communities to assist women as they approach menopause and beyond.

The North American Menopause Society 1998 Menopause Survey. Part I: Postmenopausal women's perceptions about menopause and midlife.

OBJECTIVE: To collect information relevant to the mission of The North American Menopause Society (NAMS)--i.e., increasing understanding of menopause--by assessing perceptions held by postmenopausal women in the United States aged 50 to 65 years regarding their menopause transition and early postmenopausal years. DESIGN: During the period from June to July 1998, The Gallup Organization conducted 752 telephone interviews with a randomly selected sample of postmenopausal women aged 50 to 65 years from across the United States, based on questions developed by NAMS. In Part I of this survey, women were asked about their personal experiences with menopause, their health-related lifestyle changes since premenopause, their frequency of discussing menopause, and their rating of preparedness for menopause. Part II of this survey, including use of hormone replacement therapy as well as use of healthcare services, will be reported in a future communication from NAMS. RESULTS: The majority (51%) of the postmenopausal women surveyed reported being happiest and most fulfilled between the ages of 50 to 65 years, compared with when they were in their 20s (10%), 30s (17%), or 40s (16%). Many areas of their lives had improved since menopause, including family/home life, sense of personal fulfillment, ability to focus on hobbies or other interests, relationship with spouse/partner, and friendships. A majority (51%) said their sexual relationships had remained unchanged. Approximately three-quarters of women surveyed reported making some type of health-related lifestyle change, such as stopping smoking, at menopause/midlife. Women who had undergone hysterectomy expressed more improvement than women with an intact uterus, especially in the areas of sexual relationships, spouse/partner relationships, personal fulfillment, and physical health; data are not available regarding the health state of these women before surgery or whether they experienced surgical menopause, but this improvement did not appear to be the result of hormone replacement therapy. Women tended to look to women from their own generation for menopause-related information and believed that they have prepared the younger generation for menopause better than they were prepared by their mothers' generation. Those surveyed advised younger women to engage in healthful activities and become knowledgeable so that they could make informed health decisions. CONCLUSIONS: Although the postmenopausal women surveyed had differing views of menopause as well as their perceptions of postmenopause compared with premenopause, the majority viewed menopause and midlife as the beginning of many positive changes in their lives and health. Hysterectomy was a factor associated with improved sexual relationships, spouse/partner relationships, sense of personal fulfillment, and physical health.

Using statistical process control charts for the continual improvement of asthma care.

BACKGROUND: Home monitoring of lung function using simple, inexpensive tools to measure peak expiratory flow rate (PEFR) has been possible since the 1970s. Yet although current national and international guidelines recommend monitoring of PEFRs via traditional run charts, their use by both patients and physicians remains low. The role of statistical process control (SPC) theory and charts in the serial monitoring of lung function at home were explored and applied to the direct care of patients with asthma. The method represents an integration of collective professional and improvement knowledge with the related disciplines of continual improvement, SPC, system thinking/system dynamics, paradigms, and the learning community/organization. CASE STUDIES: Use of PEFR control charts for four patients cared for at the Asthma-Allergy Clinic and Research Center (Shreveport, La) is described. The key to good asthma control is the ability to optimize lung function by reducing the variation between serial lung function measurements and thereby generate a safe range of function. Knowledge of the type of variation (special cause or common cause) in the system helps in focusing clinical decision making. Case 4, an 11-year-old boy, for example, shows how control charts were used to learn the effects of a new inhaled corticosteroid. Comparison of the last 14 days of baseline and the last 14 days of open label use of the inhaled corticosteroid showed an obvious improvement in actual PEFR values--which a run chart or comparison of means would have easily demonstrated. The control chart showed that this child's care process at baseline was functionally at risk for severe asthma (46% personal best) and that the effect of the new medication not only elevated the mean function but shifted the range of function from 46%-72% personal best to 78%-102% personal best. At this new range of function the patient's system of care was not capable of delivering values that are at risk for severe asthma. Unless the range of function the change in care is capable of producing is specifically quantitated, misinterpretation of improvement data can occur. DISCUSSION: Developing the concept of the PEFR control chart involved examining and challenging traditional mental models for monitoring PEFR at home in the care of asthma, acquiring a better understanding of the workings of dynamic systems and with system thinking, and sharing what was learned with patients and seeking their input. CONCLUSIONS: The PEFR control chart employs an interesting statistical platform that enables the integration of knowledge of serial measurements and knowledge of the variation between those measurements into a tool with which to better assess the asthma care process being followed. This tool provides clinical insights, practical knowledge, and opportunities unavailable to patients and physicians via traditional PEFR charting.

The North American Menopause Society develops consensus opinions.

Considerable consultation with experts in the field has led to the conclusions reached in the article entitled "NAMS Consensus Opinion." Both published literature and clinical experience were evaluated by a panel of distinguished experts who convened to prepare their recommendations for the NAMS Board of Trustees. The article may not express the only valid approach to the topic, but readers can be assured that, like all official NAMS materials, it has been drafted and reviewed with the full benefit of the Society's considerable expertise. The Society is grateful to the panelists, and to Novartis Pharmaceuticals Corporation, whose unrestricted educational grant helped to defray costs associated with the conference. We also wish to clarify that although the term "NAMS consensus" is used, one should not assume that every single member of the Society agrees with the published findings. Such a constraint would necessarily prevent any organization from publishing its opinions. The Society hopes that the advice offered will be of assistance to the many different specialists charged with providing health care for the 4,000 women (in the U.S. alone) who are reaching menopause every day. We encourage your comments. You, our readers, will determine the way that future Society opinions will be presented.

Women and menopause: beliefs, attitudes, and behaviors. The North American Menopause Society 1997 Menopause Survey.

OBJECTIVE: The main purpose in organizing this survey was to collect information relevant to The North American Menopause Society's (NAMS) educational mission and to document women's knowledge of, and attitudes toward, menopause. DESIGN: During June-July 1997, The Gallup Organization conducted 750 telephone interviews with a randomly selected sample of women 45-60 years of age from across the United States. Women were asked about their sources of information on menopause, what changes in health they anticipated as a result of menopause, why they used hormone therapy, and their attitudes toward menopause as a natural or a medical event. RESULTS: Women are more likely to believe that depression and irritability are associated with menopause than heart disease, but only a few associate menopause with an increasing vulnerability to either memory loss or Alzheimer's disease. Relief of physical symptoms of menopause was mentioned as the reason for starting hormone therapy more often than to protect against osteoporosis (25% relative to 15%), or to prevent stroke or a heart attack (10%), or to reduce the risk of developing Alzheimer's disease (2%). The single main source of women's information on menopause was a health professional (49%). The majority of women who were already menopausal or experiencing menstrual changes expressed an attitude toward menopause that was either neutral (42%) or positive (36%). CONCLUSIONS: Women are divided in their views of menopause, some seeing it as a medical condition requiring medical treatment, whereas others see it as a natural transition to be managed by "natural" means. Providing women with accurate, up-to-date information and enhancing communication between healthcare providers and menopausal women remain the challenges for NAMS.

Peak expiratory flow rate control chart in asthma care: chart construction and use in asthma care.

BACKGROUND: The home monitoring of peak expiratory flow rate (PEFR), although recommended in current asthma guidelines, remains seriously underutilized by both patients and physicians. Our assessment is that this is more a statement regarding the inability of current charting methods to fulfill the promises made for PEFR monitoring, rather than a commentary regarding the usefulness of peak expiratory flow rate monitoring per se. We have adapted the theory and charting tool of the discipline of statistical process control to the daily monitoring of PEFR in the care of patients with asthma. Statistical process control charts integrate the actual PEFR values and their day-to-day variation in a manner that permits more informed decision-making. This article introduces our adaptation of statistical process control theory and charts via three case presentations. OBJECTIVE: Report our experience in the use of statistical process control theory and charting to the monitoring of peak expiratory flow in the care of patients with asthma. METHODS: Discussion of methodology and case reports. CONCLUSION: This is the first report of the application of statistical process control (SPC) theory and charting to the home monitoring of peak expiratory flow rate and the clinical decision-making processes involved in the day-to-day care of patients with asthma. SPC charts integrate knowledge of actual serial PEFR measurements with knowledge of their associated serial variation. Our adaptation of this theory and its charting methodology results in a tool that loses nothing provided by the charting methods suggested in current guidelines and, at the same time, provides patient specific, statistically driven signals of significant change; facilitates identification of the reason(s) for the change in PEFR; predicts the range in which future function will occur; permits decision-making and care to be provided in an anticipatory manner; and, importantly, permits the early identification of the functionally at-risk patient. This report demonstrates that home monitoring of peak expiratory flow is a robust tool whose usefulness in the care of patients with asthma has been limited more by the paradigm in which we have required it be used than by any of the limitations of the measurement per se.

Comparative efficacy and safety of a once-daily loratadine-pseudoephedrine combination versus its components alone and placebo in the management of seasonal allergic rhinitis.

BACKGROUND: The treatment of symptoms of seasonal allergic rhinitis often requires the use of a decongestant to improve nasal congestion, along with an antihistamine to adequately control other nasal, as well as nonnasal symptoms. METHODS: In this double-blind, placebo-controlled, multicenter study, 874 patients with moderate to severe symptoms of seasonal allergic rhinitis were treated with one of the following: SCH 434 QD (a combination of 10 mg of loratadine in the coating and 240 mg of pseudoephedrine sulfate in an extended-release core) once daily, 10 mg of loratadine once daily, 120 mg of pseudoephedrine sulfate every 12 hours, or placebo for 2 weeks. RESULTS: SCH 434 QD was consistently superior to placebo in controlling the symptoms of seasonal allergic rhinitis. Composite symptom scores (total, total nasal, and total nonnasal) were reduced significantly in patients treated with SCH 434 QD as compared with placebo (p < 0.01). When compared with its individual components, reductions in mean symptom scores were consistently greater, numerically, in patients treated with SCH 434 QD than in patients who were treated with either loratadine or pseudoephedrine alone. SCH 434 QD was superior to pseudoephedrine in reducing nonnasal symptoms at all time points (p < 0.01), and superior to loratadine in relieving nasal stuffiness at end point (p < 0.01). In the physicians' evaluation of therapeutic response, the SCH 434 QD group had the greatest number of patients with a good or excellent response at end point (58%). All treatments were generally well tolerated with no serious or unusual adverse events. Insomnia and nervousness, adverse events commonly associated with pseudoephedrine, were noted in a significantly greater number of patients treated with SCH 434 QD or pseudoephedrine (p < or = 0.04) as compared with those treated with loratadine or placebo. CONCLUSIONS: The results of the study demonstrate that SCH 434 QD is more effective than placebo or either of its components alone in the treatment of seasonal allergic rhinitis.

Use of ipratropium bromide nasal spray in chronic treatment of nonallergic perennial rhinitis, alone and in combination with other perennial rhinitis medications.

To study the long-term safety and effectiveness of ipratropium bromide nasal spray 0.03% in the treatment of nonallergic perennial rhinitis, we administered this medication for 1 year in an open-label trial involving 285 patients. Our intention was to maintain the highest protocol dose possible to gain a clearer picture of the long-term side effect profile of the compound. Ipratropium bromide was well tolerated with no serious side effects in this patient population. It provided a significant improvement in rhinorrhea throughout the year-long trial; only 17 of 285 patients (6%) were considered treatment failures. There was an improvement in patient quality of life, as well as a substantial reduction in the need for other medications (antihistamines, decongestants, and nasal steroids) used to treat perennial rhinitis symptoms.

Ipratropium bromide nasal spray in non-allergic rhinitis: efficacy, nasal cytological response and patient evaluation on quality of life.

Intranasal fluorocarbon anticholinergic agents have been used to treat the nasal hypersecretion of perennial non-allergic rhinitis, but chronic use has been restricted either due to the potential for systemic anticholinergic adverse events or due to the irritating properties of the fluorocarbon metered dose formulations. This study evaluates a new aqueous nasal formulation of ipratropium bromide (Atrovent Nasal Spray 0.03%) in subjects with perennial non-allergic rhinitis in a double-blind, placebo-controlled trial. Two hundred and twenty-eight patients were randomized to receive two sprays per nostril of either ipratropium bromide (42 micrograms/nostril) or placebo-administered three times a day as an aqueous nasal spray over an 8-week interval. Patients were evaluated bi-weekly and maintained daily diaries for duration and severity of nasal symptoms. Ipratropium bromide reduced the mean severity and duration of rhinorrhoea within the first week and throughout the 8 weeks of active treatment compared with placebo (P < 0.05). Secondary endpoints of efficacy (patient and physician global assessments and a quality of life assessment) also supported the use of ipratropium bromide nasal spray for rhinitis symptom control. With the reduction in rhinorrhoea by the ipratropium bromide nasal spray, patients reported a marked improvement in daily moods vs placebo (P < 0.01). Both placebo and ipratropium bromide nasal spray induced a modest reduction of nasal congestion, sneezing and postnasal drip. This improvement in these other nasal symptoms was consistent with the known soothing effects of a nasal saline vehicle. There were no drug-related serious or systemic anticholinergic adverse events.(ABSTRACT TRUNCATED AT 250 WORDS)

Once daily loratadine versus astemizole once daily.

This study was designed to compare the efficacy and safety of loratadine and astemizole for the treatment of seasonal allergic rhinitis. A total of 167 adult patients with seasonal allergic rhinitis was enrolled in a randomized double-blind, parallel group study. Patients were treated once daily for 2 months during a spring allergy season. Both treatment groups showed significant reduction of symptoms (P < .01) from baseline. The physicians' and patients' evaluations of response to treatment were generally higher for loratadine than astemizole but only reached statistical significance (P < .05) at the 1-week evaluation. Astemizole-treated patients showed statistically significantly more weight gain than did loratadine-treated patients. Loratadine and astemizole were comparable in reducing the signs and symptoms of seasonal allergic rhinitis. Both treatments were well tolerated, although less weight gain was observed in patients treated with loratadine.

Double-blind study of intranasal ipratropium bromide in nonallergic perennial rhinitis.

We undertook this trial to determine whether ipratropium bromide nasal spray 0.03% (IB) reduced the nasal hypersecretion associated with nonallergic perennial rhinitis (NAPR) without causing excessive dryness or irritation of the nasal mucosa. We compared two drug doses of IB (21 micrograms and 42 micrograms per nostril) to a placebo, administered as two sprays to each nostril twice daily. The study design consisted of a 1-week screening period without treatment, a 1-week single-blind placebo period, a 4-week double-blind treatment comparison period, and a 1-week follow-up period without medication to evaluate nasal rebound. One hundred fifty-two patients were entered and 140 completed the trial. Both doses of IB reduced the severity and duration of rhinorrhea compared with placebo (P = .05 and .03, respectively). Treatment differences were noticeable during the first week of therapy, continued to widen during the second week, and then remained stable throughout the next 2 weeks. There was no evidence of nasal rebound observed during the week after treatment. The drug was well tolerated with side effects limited to infrequent nasal adverse events of nasal dryness, blood-tinged mucus, and epistaxis occurring in 2% to 6% of patients. We conclude that IB is a safe and effective therapy for control of rhinorrhea associated with NAPR.

Double-blind, placebo-controlled study of terfenadine and hydroxyzine in patients with chronic idiopathic urticaria.

Results of a double-blind, randomized, placebo-controlled, parallel study in 37 patients indicate that terfenadine, 60 mg bid, is significantly more effective than placebo and as effective as hydroxyzine, 25 mg qid, in the treatment of chronic idiopathic urticaria without causing the somnolence that was associated with the use of hydroxyzine.

Use of respiratory care procedures in the management of hospitalized asthmatics.

The current management of the hospitalized asthmatic includes a number of respiratory therapy techniques, both diagnostic and therapeutic. These include measures to increase arterial oxygen content, monitoring of gas exchange, administration of bronchodilator aerosols, chest physiotherapy techniques, breathing exercises, and mechanical ventilation. While many of these are potentially helpful, some are misused or are not of proven benefit. This review is designed to acquaint the clinician with the procedures commonly used, their potential benefits, or lack thereof, and their possible hazards. Recommendations are given for the rational use of these techniques, based upon the experience of the authors.