CpG increases vaccine antigen-specific cell-mediated immunity when administered with hepatitis B vaccine in HIV infection.

BACKGROUND: Lack of adequate adjuvancy is a possible explanation for lack of vaccine immunogenecity. Immunostimulatory CpGs are potent vaccine adjuvants and may be an important component of the development vaccines, particularly those for which a cellular immune response is required for protection. We have previously demonstrated that CpG ODN co-administration with hepatitis B vaccine results in earlier, stronger and more sustained antibody responses to hepatitis B surface antigen in HIV infected individuals, and wished to determine if, in this population, helper T-cell responses were also enhanced. METHODS: We conducted a double-blind, placebo-controlled trial in hepatitis B susceptible, effectively treated HIV-seropositive individuals. Participants received hepatitis B vaccine, with either placebo or CPG 7909 1.0 mg at week 0, 4 and 8. To determine the impact of CpG on cellular immune responses, lymphoproliferative responses (LPR) were evaluated by [3H]-thymidine incorporation at baseline and weeks 4, 8, 12, 24, and 48. Immunophenotyping of lymphocyte subsets was also determined at these time points. RESULTS: Of 36 patients enrolled, 18 received hepatitis B vaccine alone, and 18 received hepatitis B vaccine with CpG. Inclusion of CPG 7909 was associated with a greater proliferative response to HBsAg at all time points following initial vaccination. This increase was statistically significant at 8 weeks (p = 0.042) and 48 weeks (p = 0.024). Similar results were observed when LPR were evaluated as stimulation indices (SI). No differences in proliferative responses to HIV p24 Ag were observed, nor were there any differences in lymphocyte subsets. CONCLUSION: In addition to enhancing humoral responses to vaccination, we describe for the first time that CPG 7909 enhances cellular immunity to vaccine antigen in a typically hyporesponsive population. This adjuvancy may be important in the development of an effective vaccine for which a cellular immune response is required for protection.

Nurses' intentions to provide continuous labor support to women.

OBJECTIVE: To examine the determinants of nurses' intentions to practice continuous labor support. DESIGN: A descriptive survey based on the Theory of Planned Behavior. SETTING: A large, urban Canadian hospital with 2 sites and 7,000 births per year. PARTICIPANTS: Ninety-seven registered nurses from 2 birthing units. RESULTS: Scores measuring nurses' attitudes, subjective norms, and intentions regarding continuous labor support for women with epidural analgesia were significantly lower than those for women without epidural analgesia (p<.0001). Multiple regression analyses revealed that previous labor support courses, subjective norms, and perceived behavioral control explained 55% of the variance in nurses' intentions to provide continuous labor support to women without epidural analgesia while 88% of the variance in intentions to provide continuous labor support to women with epidural analgesia was explained by subjective norms and attitudes. Subjective norms made the most significant contribution to the variance in nurses' intentions to provide continuous labor support. Top perceived organizational barriers to continuous labor support included unit acuity and method of patient assignment. CONCLUSION: Nurses' intentions to provide continuous labor support are lower for women receiving epidural analgesia and are influenced by the perceived social pressures on their unit. Nurses view organizational barriers as important factors influencing their ability to provide continuous labor support.

A comparison of aprotinin and lysine analogues in high-risk cardiac surgery.

BACKGROUND: Antifibrinolytic agents are commonly used during cardiac surgery to minimize bleeding and to reduce exposure to blood products. We sought to determine whether aprotinin was superior to either tranexamic acid or aminocaproic acid in decreasing massive postoperative bleeding and other clinically important consequences. METHODS: In this multicenter, blinded trial, we randomly assigned 2331 high-risk cardiac surgical patients to one of three groups: 781 received aprotinin, 770 received tranexamic acid, and 780 received aminocaproic acid. The primary outcome was massive postoperative bleeding. Secondary outcomes included death from any cause at 30 days. RESULTS: The trial was terminated early because of a higher rate of death in patients receiving aprotinin. A total of 74 patients (9.5%) in the aprotinin group had massive bleeding, as compared with 93 (12.1%) in the tranexamic acid group and 94 (12.1%) in the aminocaproic acid group (relative risk in the aprotinin group for both comparisons, 0.79; 95% confidence interval [CI], 0.59 to 1.05). At 30 days, the rate of death from any cause was 6.0% in the aprotinin group, as compared with 3.9% in the tranexamic acid group (relative risk, 1.55; 95% CI, 0.99 to 2.42) and 4.0% in the aminocaproic acid group (relative risk, 1.52; 95% CI, 0.98 to 2.36). The relative risk of death in the aprotinin group, as compared with that in both groups receiving lysine analogues, was 1.53 (95% CI, 1.06 to 2.22). CONCLUSIONS: Despite the possibility of a modest reduction in the risk of massive bleeding, the strong and consistent negative mortality trend associated with aprotinin, as compared with the lysine analogues, precludes its use in high-risk cardiac surgery. (Current Controlled Trials number, ISRCTN15166455 [controlled-trials.com].).

Desire for euthanasia or physician-assisted suicide in palliative cancer care.

OBJECTIVE: To investigate the attitudes of terminally ill individuals toward the legalization of euthanasia or physician-assisted suicide (PAS) and to identify those who would personally desire such a death. DESIGN: In the Canadian National Palliative Care Survey, semistructured interviews were administered to 379 patients who were receiving palliative care for cancer. Patients who expressed a desire for physician-hastened death were followed prospectively. MAIN OUTCOME MEASURES: Attitudes toward the legalization of euthanasia or PAS were determined, as was the personal interest in receiving a hastened death. Demographic and clinical characteristics were also recorded, including a 22-item structured interview of symptoms and concerns. RESULTS: There were 238 participants (62.8%) who believed that euthanasia and/or PAS should be legalized, and 151 (39.8%) who would consider making a future request for a physician-hastened death. However, only 22 (5.8%) reported that, if legally permissible, they would initiate such a request right away, in their current situations. This desire for hastened death was associated with lower religiosity (p=.010), reduced functional status (p=.024), a diagnosis of major depression (p<.001), and greater distress on 12 of 22 individual symptoms and concerns (p<.025). In follow-up interviews with 17 participants, 2 (11.8%) showed instability in their expressed desire. CONCLUSION: Among patients receiving palliative care for cancer, the desire to receive euthanasia or PAS is associated with religious beliefs; functional status; and physical, social, and psychological symptoms and concerns. Although this desire is sometimes transitory, once firmly established, it can be enduring.

Depression and anxiety disorders in palliative cancer care.

Depression and anxiety disorders are thought to be common in palliative cancer care, but there is inconsistent evidence regarding their relevance for other aspects of quality of life. In the Canadian National Palliative Care Survey, semi-structured interviews assessing depression and anxiety disorders were administered to 381 patients who were receiving palliative care for cancer. There were 212 women and 169 men, with a median survival of 63 days. We found that 93 participants (24.4%, 95% confidence interval=20.2-29.0) fulfilled Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition diagnostic criteria for at least one anxiety or depressive disorder (20.7% prevalence of depressive disorders, 13.9% prevalence of anxiety disorders). The most frequent individual diagnosis was major depression (13.1%, 95% confidence interval=9.9-16.9). Comorbidity was common, with 10.2% of participants meeting criteria for more than one disorder. Those diagnosed with a disorder were significantly younger than other participants (P=0.002). They also had lower performance status (P=0.017), smaller social networks (P=0.008), and less participation in organized religious services (P=0.007). In addition, they reported more severe distress on 14 of 18 physical symptoms, social concerns, and existential issues. Of those with a disorder, 39.8% were being treated with antidepressant medication, and 66.7% had been prescribed a benzodiazepine. In conclusion, it appears that depression and anxiety disorders are indeed common among patients receiving palliative care. These disorders contribute to a greatly diminished quality of life among people who are dying of cancer.

Exploring quality of life for patients undergoing major surgery: the perspectives of surgeons, other healthcare professionals, and patients.

BACKGROUND: Surgeons, other healthcare professionals, and patients may identify different health-related concerns related to the quality of life of patients undergoing major surgery. METHODS: Semistructured interviews were conducted with surgeons (n =14), other healthcare professionals (n =19), and patients undergoing major elective surgery (n = 52). Themes were extracted by content analysis and organized into major domains. The frequencies with which specific themes were mentioned were compared among groups. RESULTS: A total of 85 themes were extracted from the interviews, 15 of which were mentioned by 50% or more of participants in each group, representing 5 of the 6 domains. The greatest differences were observed in the domains of social well-being, wherein 5 themes were mentioned less often by surgeons than other groups, and spiritual well-being, wherein 2 themes were mentioned more often by patients than other groups. Differences in the physical, emotional, cognitive preparation, and concern about quality of care domains were minimal. CONCLUSIONS: Surgeons, other healthcare professionals, and patients identified many similar concerns related to the well-being of patients undergoing major surgery. However, the importance of social and spiritual themes to patients may be underestimated by surgeons.

A pilot study using high-fidelity simulation to formally evaluate performance in the resuscitation of critically ill patients: The University of Ottawa Critical Care Medicine, High-Fidelity Simulation, and Crisis Resource Management I Study.

OBJECTIVE: Resuscitation of critically ill patients requires medical knowledge, clinical skills, and nonmedical skills, or crisis resource management (CRM) skills. There is currently no gold standard for evaluation of CRM performance. The primary objective was to examine the use of high-fidelity simulation as a medium to evaluate CRM performance. Since no gold standard for measuring performance exists, the secondary objective was the validation of a measuring instrument for CRM performance-the Ottawa Crisis Resource Management Global Rating Scale (or Ottawa GRS). DESIGN: First- and third-year residents participated in two simulator scenarios, recreating emergencies seen in acute care settings. Three raters then evaluated resident performance using edited video recordings of simulator performance. SETTING: A Canadian university tertiary hospital. INTERVENTIONS: : The Ottawa GRS was used, which provides a 7-point Likert scale for performance in five categories of CRM and an overall performance score. MEASUREMENTS AND MAIN RESULTS: Construct validity was measured on the basis of content validity, response process, internal structure, and response to other variables. One variable measured in this study was the level of training. A t-test analysis of Ottawa GRS scores was conducted to examine response to the variable of level of training. Intraclass correlation coefficient scores were used to measure interrater reliability for both scenarios. Thirty-two first-year and 28 third-year residents participated in the study. Third-year residents produced higher mean scores for overall CRM performance than first-year residents (p < .0001) and in all individual categories within the Ottawa GRS (p = .0019 to p < .0001). This difference was noted for both scenarios and for each individual rater (p = .0061 to p < .0001). No statistically significant difference in resident scores was observed between scenarios. Intraclass correlation coefficient scores of .59 and .61 were obtained for scenarios 1 and 2, respectively. CONCLUSIONS: Data obtained using the Ottawa GRS in measuring CRM performance during high-fidelity simulation scenarios support evidence of construct validity. Data also indicate the presence of acceptable interrater reliability when using the Ottawa GRS.

Identification of domains relevant to health-related quality of life in patients undergoing major surgery.

This study examined themes relevant to health-related quality of life as identified by patients undergoing major surgery and by health care providers. Semi-structured interviews were conducted with 52 patients undergoing major abdominal, cardiac, orthopedic, thoracic, or vascular surgical procedures and 33 health professionals from various disciplines. A total of 58 themes were identified by content analysis. These themes were categorized into 6 domains. These were: physical well-being (14 themes), emotional well-being (13 themes), concern about quality of care (12 themes), social well-being (12 themes), cognitive preparation (4 themes), and spiritual well-being (3 themes). In general, we found that most aspects of health-related quality of life were common across various major surgical procedures and between patients and health care providers. However, when we examined the coverage of these themes in seven commonly-used health-related quality of life instruments, we found that many of the most frequently mentioned themes were not assessed with the available measures. A new evaluative instrument tailored to patients undergoing major surgery may therefore be warranted.

The prevalence of airflow obstruction in rural primary care.

UNLABELLED: Spirometry has been reported to be under-utilized, and airflow obstruction may be under-diagnosed, in primary care practice. STUDY OBJECTIVES: The objective of this study was to determine the prevalence and severity of airflow obstruction in rural primary care settings and the degree to which it can be predicted by clinical characteristics. Spirometry was performed in patients 35 years and older who had smoked, presenting for any reason to one of eight rural primary care practices. Obstruction was defined as an FEV(1)/FVC<0.70. A total of 1046 subjects were recruited of whom 1034 had acceptable and reproducible spirometry. Airflow obstruction was detected in 17.4% (180 patients). Of those with obstruction, 77.2% (se 3.1%) had at least one respiratory symptom versus 62.4% (se 1.6%) without obstruction (P=0.0002). Only 44.9% (se 3.7%) of those with airflow obstruction had been previously diagnosed with obstructive lung disease. Of those with an FEV(1)<50% of predicted, 85% (se 5.6%) were breathless on exertion; however, only 63% (se 7.6%) were being treated with respiratory medications. We conclude that airflow obstruction is common in rural primary care practice and cannot be accurately predicted by symptoms. It is undiagnosed half of the time, and often not treated even when symptomatic.

Spirometry in the primary care setting: influence on clinical diagnosis and management of airflow obstruction.

STUDY OBJECTIVE: To determine if screening spirometry in the primary care setting influences the physician's diagnosis and management of obstructive lung disease. DESIGN: Diagnosis and management assessed before and after the intervention of screening spirometry. PARTICIPANTS: A total of 1,034 patients who had ever smoked and were at least 35 years of age presenting to primary care practices for any reason. SETTING: Rural primary care practices. MEASUREMENTS AND RESULTS: Physicians were asked prior to and following presentation of spirometry test results if they thought airflow obstruction was present and if they planned to change management based on the results. A new diagnosis of unsuspected airflow obstruction was made by the physician in 93 patients (9%), and a prior diagnosis of airflow obstruction was removed after spirometry in 115 patients (11%). After viewing the spirometry results, physicians reported that they would change patient management in 154 patients (15%). Most planned management changes occurred when airflow obstruction was newly diagnosed (57 of 93 patients, 61%) and when the diagnosis of airflow obstruction remained unchanged (80 of 195 patients, 41%). A 6-month chart review documented the addition of respiratory medications in 8% of patients. CONCLUSION: Screening spirometry influences physicians' diagnosis of airflow obstruction and management plans especially in patients with moderate-to-severe obstruction.

A pilot trial evaluating the clinical effects of prolonged storage of red cells.

The clinical consequences of prolonged storage of red cells have not been established. In this pilot study, we evaluated whether it would be feasible to provide a continuous supply of red cells stored <8 days. In addition, we examined the potential benefits attributed to "fresh" as compared to standard red cells in 66 critically ill and cardiac surgical patients. Nine patients were issued red cells but were not transfused. From the 57 remaining patients, the number of units transfused averaged 5.5 +/- 8.43 red cell units in the experimental group compared to 3.3 +/- 3.27 red cell units in the standard group (P = 0.25). The median storage time was 4 days in the experimental group compared to 19 days in the standard group (difference of 15 days; interquartile range of 12-16 days; P < 0.001). Overall, 73% of patients received red cells with storage times that corresponded to the treatment allocation more than 90% of the time. The group receiving red cells <8 days old tended to be older on average (68 +/- 8.54 yr versus 63 +/- 15.30 yr; P = 0.13) and have more comorbid illnesses (85% versus 65%; P = 0.09). In total, 27% of patients in the experimental group died or had a life-threatening complication as compared to 13% in the standard group (P = 0.31). There were no differences in prolonged respiratory, cardiovascular, or renal support after randomization (P > 0.05). A large clinical trial comparing red cell storage times is feasible and warranted given the limited available evidence.

Mapping the journey of cancer patients through the health care system. Part 3: An approach to staging.

This is the third in a series of articles relating results from a line of research whose intent was to construct a complete history of patient interactions with the health care system using available data sources for all patients diagnosed in 1990 with a primary breast, colorectal, or lung tumour in Manitoba. This article presents details of the development and application of methods to produce TNM staging data on the roughly 2,000 patients in this population. The operational definitions constructed for this research can be adapted for other tumour sites and data sources. Findings include methods developed to overcome the sometimes ambiguous and inconsistent available documentation, which ultimately produced reliable TNM staging data. Survival data for this population by stage of disease are given.

Thrombophilia and the risk for hemodialysis vascular access thrombosis.

Vascular access thrombosis is the most common and costly complication in hemodialysis patients. The role of thrombophilia in access thrombosis is not established. A case-control study was conducted of 419 hemodialysis patients to determine whether thrombophilia was associated with arteriovenous fistula or graft thrombosis. Participants were enrolled from three in-center and five satellite dialysis units associated with a Canadian academic health science center that provides dialysis services in a catchment area of one million. Patients were tested for factor V Leiden, prothrombin gene mutation, factor XIII genotype, methylenetetrahydrofolate reductase genotype, lupus anticoagulant, anticardiolipin antibody, factor VIII, homocysteine, and lipoprotein (a) concentrations. Overall, 59 (55%) patients with access thrombosis had at least one thrombophilia compared with 122 (39%) patients without access thrombosis (unadjusted odds ratio [OR], 1.91; 95% confidence interval [CI], 1.23 to 2.98). After controlling for important risk factors, the association between any thrombophilia and access thrombosis remained (adjusted OR, 2.42; 95% CI, 1.47 to 3.99). For each additional thrombophilic disorder, the odds of access thrombosis increased significantly (adjusted OR, 1.87; 95% CI, 1.34 to 2.61). This study suggests that thrombophilia is associated with access thrombosis in dialysis patients. Large, multicenter, prospective cohort studies are needed to confirm the observations from this case-control study.

Treatment of AIDS-associated Kaposi's sarcoma in Zimbabwe: results of a randomized quality of life focused clinical trial.

Kaposi's sarcoma is currently the most common tumor in Zimbabwe. The purpose of our study is to compare the effectiveness of supportive care vs. 3 intervention approaches, namely oral Etoposide, a 3-drug combination, and radiotherapy using quality of life (QOL) as the primary measure of success. In addition, our study was to determine whether a disease-specific module has greater sensitivity to group differences than a generic QOL questionnaire and to determine the most pragmatic approach to treating epidemic Kaposi's sarcoma (EKS) in Zimbabwe. Histologically confirmed HIV-positive patients with Kaposi's sarcoma were randomized to receive supportive care only or supportive care plus either radiotherapy, oral Etoposide or a 3-drug combination consisting of actinomycin-D, vincristine and bleomycin. No patient received antiretroviral therapy. The primary outcome was QOL measured by the functional living index-cancer (FLI-C) and supplemented by the Kaposi's sarcoma module (KSM). From 1994-1999, 495 EKS patients were accrued, and 470 were evaluable. Of these, 433 are known to be dead, 26 are lost to follow-up and 11 are still alive. The group treated with oral Etoposide had a significantly better QOL than the radiotherapy group for the total FLI-C score (adjusted mean plus standard error at 3-months 89 +/- 3 vs. 76 +/- 3; p = 0.004) and for the hardship (11 +/- 0.4 vs. 9 +/- 0.4; p = 0.001); social (10 +/- 0.4 vs. 8 +/- 0.4; p = 0.001) and nausea (9 +/- 0.4 vs. 8 +/- 0.4; p = 0.002) subscales. In addition, on the physical and psychological subscales, the Etoposide group had a significantly better QOL than the other 3 treatment groups (p < 0.04). The 3-drug combination, supportive care and radiotherapy groups did not differ significantly from each other with respect to the total FLI-C score or its subscales. There were no group differences with respect to survival. Oral Etoposide therapy resulted in better total FLI-C QOL score than radiotherapy. As well, Etoposide resulted in better physical and psychological subscale scores than radiotherapy, 3-drugs and supportive care. Thus, funds permitting, oral Etoposide is a pragmatic approach to treating EKS in an environment where antiretroviral drugs are not universally available. The study underscores the value of undertaking studies in areas of disease prevalence and the necessity of selecting appropriate outcome measures.

Mapping the journey of cancer patients through health care system. Part 1: developing the research question.

This is the first in a series of articles relating results from research which constructed a complete history of interactions with the health care system from available data sources for all patients diagnosed in 1990 with primary breast, colorectal, or lung tumours in Manitoba from one year prior to diagnosis through to two years post-diagnosis. This article presents the motivation and genesis for this line of research. The study evolved from the question of "What happens to a person who is diagnosed with cancer?" into a major research endeavour encompassing a broad spectrum of philosophic and clinical research questions. A large interdisciplinary team collaborated on developing operational methods to combine existing data sources into unified cancer patient histories.

Family caregiver burden: results of a longitudinal study of breast cancer patients and their principal caregivers.

BACKGROUND: The vital role played by family caregivers in supporting dying cancer patients is well recognized, but the burden and economic impact on caregivers is poorly understood. We prospectively examined the psychosocial, occupational and economic impact of caring for a person with a terminal illness. METHODS: We studied 89 caregivers of women with advanced breast cancer receiving care at either the Ottawa or Hamilton regional cancer centres in Ontario. Patients were followed until their death or study completion at 3 years. Patients identified a principal caregiver to participate in the study. The Karnofsky Performance Status (KPS) index, the Medical Outcomes Study 36-item Short Form (SF-36), the Hospital Anxiety and Depression Scale, the Zarit Burden Inventory, FAMCARE and the Medical Outcomes Study Social Support Survey were administered during follow-up. Economic data were collected by means of a questionnaire administered by an interviewer. Assessments were conducted every 3 months during the palliative period (KPS score > 50) and every 2 weeks during the terminal period (KPS score < or = 50). RESULTS: Over half of the caregivers were male (55%) and the patient's spouse or partner (52%), with a mean age of 53 years. At the start of the palliative period, the caregivers' mean physical functioning score was better than the patients' (51.3 v. 35.1, 95% confidence interval [CI] 13.3-20.0); there were similar mean mental functioning scores (46.6 and 47.1 respectively); similar proportions were depressed (11% and 12%); and significantly more caregivers than patients were anxious (35% v. 19%, p = 0.009). More caregivers were depressed (30% v. 9%, p = 0.02) and had a higher level of perceived burden (26.2 v. 19.4, p = 0.02) at the start of the terminal period than at the start of the palliative period. Burden was the most important predictor of both anxiety and depression. Of employed caregivers, 69% reported some form of adverse impact on work. In the terminal period 77% reported missing work because of caregiving responsibilities. Prescription drugs were the most important component of financial burden. INTERPRETATION: Caregivers' depression and perceived burden increase as patients' functional status declines. Strategies are needed to help reduce the psychosocial, occupational and economic burden associated with caregiving.

Mapping the journey of cancer patients through the health care system. Part 2: Methodological approaches and basic findings.

This is the second in a series of articles from a line of research whose intent was to construct a complete history of interactions with the health care system. This paper provides details of the methods developed to collect and collate the scattered information regarding the event history (trajectory) that a cancer patient experiences in traveling through the Manitoba health care system from one year prior to diagnosis through to two years post-diagnosis. Survival data were obtained through 1994. Basic population data obtained from this work are also presented, including survival information through to four years post-diagnosis. Issues regarding standardized data recording and detail level of clinical events in the chart record are discussed. This part of the research demonstrates that diverse data sources in the health care system can be linked with a high degree of accuracy and completeness of data.

Quality of life in patients with rheumatoid arthritis : which drugs might make a difference?

Rheumatoid arthritis (RA) is a chronic, disabling, inflammatory polyarthritis that affects patient well-being and QOL. Many disease-modifying antirheumatic drugs (DMARDs) are available for treating RA but patients are often refractory to treatment. The goal of treatment is to improve both general health and health-related QOL. Generic and disease-specific instruments exist to measure QOL. Using these instruments, one can determine if QOL improves with treatment. If the minimal clinically important difference (MCID) for the instrument is known, one can determine if the change is clinically significant. The literature was reviewed in a systematic manner to determine which drugs could affect QOL in patients with refractory RA. Refractory RA is poorly defined but we used the definition of failing at least two DMARDs. Methotrexate, leflunomide, cyclosporin, glucocorticoids, etanercept and infliximab clinically and statistically significantly improved QOL in patients with RA. Gold and epoetin-alpha (erythropoietin) statistically improved QOL in patients with RA but the clinical significance of the improvements could not be determined. These studies were either in non-refractory populations or the refractoriness could not be determined. Further study is required to determine the response of QOL to treatment in patients with refractory RA and instruments with known MCIDs should be used so that the clinical significance of the improvement can be determined.

Program evaluation of hospital-based antenatal home care for high-risk women.

In light of the emphasis on increased efficiency in the delivery of hospital-based healthcare services in Canada, healthcare administrators need to advocate for greater care in the community. The implementation of an antenatal home-care program for women with high-risk pregnancies at the Ottawa Hospital presented the opportunity to develop a comprehensive framework to evaluate the value and outcomes of the new community-based program.

A spirometry-based algorithm to direct lung function testing in the pulmonary function laboratory.

OBJECTIVE: To design a spirometry-based algorithm to predict pulmonary restrictive impairment and reduce the number of patients undergoing unnecessary lung volume testing. DESIGN: Two prospective studies of 259 consecutive patients and 265 consecutive patients used to derive and validate the algorithm, respectively. SETTING: A pulmonary function laboratory of a tertiary care hospital. PATIENTS: Consecutive adults referred to the laboratory for lung volume measurements and spirometry. MEASUREMENTS: The sensitivity of the algorithm for predicting pulmonary restriction and the cost savings associated with its use. RESULTS: Total lung capacity correlated strongly with FVC (r = 0.66) and showed an inverse correlation with the FEV(1)/FVC ratio (r = - 0.41). According to the algorithm, only patients with an FVC < 85% of predicted and an FEV(1)/FVC ratio >or= 55% required lung volume measurements following spirometry. The algorithm had a high sensitivity for predicting restriction and a high negative predictive value (NPV) for excluding restriction (sensitivity, 96%; NPV, 98%). The diagnostic properties of the algorithm were reproducible in the validation study. Application of the algorithm would eliminate the need for lung volume testing in 48 to 49% of patients referred to the pulmonary function test (PFT) laboratory, reducing costs by 33%. CONCLUSIONS: A spirometry-based algorithm accurately excludes pulmonary restriction and reduces unnecessary lung volume testing in the PFT laboratory almost in half.