Correlates of self-rated health in people with diabetic peripheral neuropathy: a longitudinal study.

AIM: Self-rated health, a measure of self-reported general health, is a robust predictor of morbidity and mortality in various populations, including persons with diabetes. This study examines correlates of self-rated health in adults with diabetic peripheral neuropathy (DPN). METHODS: Participants recruited from the UK and USA (n = 295; mean (± sd) age: 61.5 ± 10.7 years; 69% male; 71% type 2 diabetes) rated their health at baseline and 18 months. DPN severity was assessed using the neuropathy disability score and the vibration perception threshold. Validated self-report measures assessed neuroticism, DPN-symptoms of pain, unsteadiness and reduced sensation in feet, DPN-related limitations in daily activities, DPN-specific emotional distress and symptoms of depression. RESULTS: In the fully adjusted baseline model, younger age, presence of cardiovascular disease and higher depression symptom scores showed likely clinically meaningful independent associations with worse health ratings. Being at the UK study site and presence of nephropathy indicated potentially meaningful independent associations with lower baseline health ratings. These predictors were largely consistent in their association with health ratings at 18 months. CONCLUSION: Results identify independent correlates of health ratings among adults with DPN. Future research should investigate the clinical implications of associations and examine changes in these variables over time and potential effects on changes in health perceptions. If these associations reflect causal pathways, our results may guide interventions to target issues that are likely to have an impact on subjectively experienced health as an important patient-reported outcome in DPN care.

Trajectories of PTSD risk and resilience in World Trade Center responders: an 8-year prospective cohort study.

BACKGROUND: Longitudinal symptoms of post-traumatic stress disorder (PTSD) are often characterized by heterogeneous trajectories, which may have unique pre-, peri- and post-trauma risk and protective factors. To date, however, no study has evaluated the nature and determinants of predominant trajectories of PTSD symptoms in World Trade Center (WTC) responders. METHOD: A total of 10835 WTC responders, including 4035 professional police responders and 6800 non-traditional responders (e.g. construction workers) who participated in the WTC Health Program (WTC-HP), were evaluated an average of 3, 6 and 8 years after the WTC attacks. RESULTS: Among police responders, longitudinal PTSD symptoms were best characterized by four classes, with the majority (77.8%) in a resistant/resilient trajectory and the remainder exhibiting chronic (5.3%), recovering (8.4%) or delayed-onset (8.5%) symptom trajectories. Among non-traditional responders, a six-class solution was optimal, with fewer responders in a resistant/resilient trajectory (58.0%) and the remainder exhibiting recovering (12.3%), severe chronic (9.5%), subsyndromal increasing (7.3%), delayed-onset (6.7%) and moderate chronic (6.2%) trajectories. Prior psychiatric history, Hispanic ethnicity, severity of WTC exposure and WTC-related medical conditions were most strongly associated with symptomatic trajectories of PTSD symptoms in both groups of responders, whereas greater education and family and work support while working at the WTC site were protective against several of these trajectories. CONCLUSIONS: Trajectories of PTSD symptoms in WTC responders are heterogeneous and associated uniquely with pre-, peri- and post-trauma risk and protective factors. Police responders were more likely than non-traditional responders to exhibit a resistant/resilient trajectory. These results underscore the importance of prevention, screening and treatment efforts that target high-risk disaster responders, particularly those with prior psychiatric history, high levels of trauma exposure and work-related medical morbidities.

Dimensional structure and course of post-traumatic stress symptomatology in World Trade Center responders.

BACKGROUND: Post-traumatic stress disorder (PTSD) in response to the World Trade Center (WTC) disaster of 11 September 2001 (9/11) is one of the most prevalent and persistent health conditions among both professional (e.g. police) and non-traditional (e.g. construction worker) WTC responders, even several years after 9/11. However, little is known about the dimensionality and natural course of WTC-related PTSD symptomatology in these populations. METHOD: Data were analysed from 10 835 WTC responders, including 4035 police and 6800 non-traditional responders who were evaluated as part of the WTC Health Program, a clinic network in the New York area established by the National Institute for Occupational Safety and Health. Confirmatory factor analyses (CFAs) were used to evaluate structural models of PTSD symptom dimensionality; and autoregressive cross-lagged (ARCL) panel regressions were used to examine the prospective interrelationships among PTSD symptom clusters at 3, 6 and 8 years after 9/11. RESULTS: CFAs suggested that five stable symptom clusters best represent PTSD symptom dimensionality in both police and non-traditional WTC responders. This five-factor model was also invariant over time with respect to factor loadings and structural parameters, thereby demonstrating its longitudinal stability. ARCL panel regression analyses revealed that hyperarousal symptoms had a prominent role in predicting other symptom clusters of PTSD, with anxious arousal symptoms primarily driving re-experiencing symptoms, and dysphoric arousal symptoms primarily driving emotional numbing symptoms over time. CONCLUSIONS: Results of this study suggest that disaster-related PTSD symptomatology in WTC responders is best represented by five symptom dimensions. Anxious arousal symptoms, which are characterized by hypervigilance and exaggerated startle, may primarily drive re-experiencing symptoms, while dysphoric arousal symptoms, which are characterized by sleep disturbance, irritability/anger and concentration difficulties, may primarily drive emotional numbing symptoms over time. These results underscore the importance of assessment, monitoring and early intervention of hyperarousal symptoms in WTC and other disaster responders.

Effect of a bicultural community health worker on completion of diabetes education in a Hispanic population.

OBJECTIVE: To determine the effect of a bicultural community health worker (CHW) on completion of diabetes education in an inner-city Hispanic patient population and to evaluate the impact of completion of the education program on patient knowledge, self-care behaviors, and glycemic control. RESEARCH DESIGN AND METHODS: Patients were randomized into CHW intervention and non-CHW intervention groups. All patients received individualized, comprehensive diabetes education from a certified diabetes nurse educator after baseline demographic information, diabetes knowledge, diabetes self-care practices, and glycohemoglobin levels were assessed. Rates of education program completion were determined. Diabetes knowledge, self-care practices, and glycohemoglobin levels were reassessed at program completion and at a later postprogram follow-up medical appointment and compared to baseline. Logistic regression analysis and the Mantel-Haenszel chi 2 statistic were used to determine the effect of the CHW assignment on program completion. Analyses of covariance were performed with end-of-treatment behavior scores, knowledge scores, and glycohemoglobin levels as outcome variables, controlling for baseline values and testing for the effect of CHW assignment. RESULTS: Of 64 patients enrolled in the study, 40 (63%) completed and 24 (37%) dropped out before completing the diabetes education program. Of the patients having CHW intervention, 80% completed the education program, compared with 47% of patients without CHW intervention (P = 0.01). "Dropouts" were younger (age 47.5 +/- 12.5 years [mean +/- SD]) compared with patients who completed the program (55.9 +/- 9.9 years) (P = 0.004). Dropout status showed no significant relationship to educational level achieved or literacy level. For the program "completers," knowledge levels and selected self-care practices significantly improved, and glycohemoglobin levels improved from a baseline level of 11.7% to 9.9% at program completion (P = 0.004) and 9.5% at the postprogram follow-up (P < 0.001). The effect of the CHW assignment on program completion, controlling for financial status and language spoken, was extremely robust (P = 0.007). The effect of the CHW on knowledge, self-care behavior, or glycohemoglobin outcome variables was not statistically significant. CONCLUSIONS: These findings suggest that intervention with a bicultural CHW improved rates of completion of a diabetes education program in an inner-city Hispanic patient population irrespective of literacy or educational levels attained. Our data further suggests that completion of individualized diabetes educational strategies leads to improved patient knowledge, self-care behaviors, and glycemic control.

Influenza and pneumococcal vaccination of HIV-infected patients: a policy analysis.

OBJECTIVE: To analyze the policy of vaccinating human immunodeficiency virus (HIV)-infected young adults against influenza and pneumococcal infections. METHODS: Transition state model of clinical immune deterioration of HIV infection, published data, and experts' estimates for the uncertain variables. Outcome measures are the number of influenza and pneumococcal infection hospitalizations and deaths prevented over 10 years and cost-effectiveness ratios. PATIENTS: Hypothetical cohort of HIV-infected 30-year-old patients. RESULTS: Although pneumococcal vaccine effectiveness diminishes with advanced HIV disease, the risks of pneumococcal infection rise substantially. Pneumococcal vaccination was therefore found to be a reasonable prevention strategy at all HIV disease stages: few vaccinations are needed to prevent hospitalizations and deaths, and the vaccination strategy is cost-effective. By contrast, influenza incidence is low among young adults, and HIV-related immunodeficiency increases influenza risks only minimally. Because the vaccine is administered yearly, many more vaccinations must be administered and fewer hospitalizations and deaths are prevented than with pneumococcal vaccination. The costs to extend life expectancy are high, and beyond the costs of other prevention strategies for persons with moderate to severe immunodeficiency. CONCLUSIONS: Pneumococcal vaccination is a reasonable prevention strategy for HIV-infected patients at all stages of immunodeficiency. Fewer hospitalizations and deaths are prevented by influenza vaccination, making it a far less cost-effective prevention strategy than pneumococcal vaccination.

The utility of an in-hospital observation period after discontinuing intravenous antibiotics.

PURPOSE: To determine whether observing patients overnight in the hospital after intravenous antibiotics have been discontinued is a useful way to identify important clinical events. SUBJECTS AND METHODS: We performed a retrospective chart review of patients admitted during a 6-month period to a tertiary care teaching hospital with a primary diagnosis of either pneumonia, urinary tract infection, or cellulitis who were treated with intravenous antibiotics. Charts were abstracted for patient characteristics, including comorbid illnesses and laboratory values, as well as for evidence of recurrent infection or other adverse events. RESULTS: Of the 374 patients in the study, 63 (17%) were discharged on the day intravenous antibiotics were discontinued. These patients were 10 years younger (P = 0.0009) and had fewer comorbid illnesses (P = 0.02) than those who were observed in the hospital. Recurrent infection was noted in 3 (1%; 95% confidence interval 0.2% to 3%) of the 308 patients who were observed. A mild adverse antibiotic reaction was also noted in three observed patients. The readmission rate to the same institution for recurrent infection was 3% for patients with an observation period and 2% for patients without an observation period (P = 0.70). CONCLUSIONS: Observing patients overnight in the hospital after discontinuing intravenous antibiotics is a common clinical practice. There was an extremely low incidence of adverse events during the observation period, and the events that did occur would have been discovered in an outpatient setting. In-hospital observation after discontinuing intravenous antibiotics is unnecessary for most patients with pneumonia, urinary tract infection, or cellulitis and greatly increases health-care costs.

Effects of practice setting on quality of lipid-lowering management in patients with coronary artery disease.

We undertook a study to determine whether there were differences in the quality of lipid management in patients with coronary artery disease (CAD) in 2 different practice settings (which represent different socioeconomic classes), and to determine the level of compliance with the National Cholesterol Education Program guidelines by academic physicians in managing patients with CAD. A retrospective cross-sectional study was performed using a systematic chart review of 270 medical records (131 from the cardiology clinic, 139 from the cardiology private practice) of patients with known CAD at an academic tertiary care center in New York City. The total proportion of patients with CAD having a lipid profile ordered in the clinic and private suite was 43%. Of these people, 22% had a low-density lipoprotein cholesterol (LDL) < or = 100 mg/dl and 54% had an LDL < or = 130 mg/dl (10% and 23% of the total population, respectively). The total proportion of patients taking lipid-lowering medications was 29%. When comparing the quality of treatment between the 2 settings, there were no statistically significant differences in the percentages of patients who had lipid profiles measured (40% clinic vs 47% private suite, p >0.10), in the percentage of patients with LDL < or = 130 mg/dl (50% clinic vs 57% private suite, p >0.10) or in the weighted percentage of patients taking lipid-lowering medications (29% clinic vs 48% private suite, p = 0.099). The performances of individual physicians, however, varied widely. The percentages of patients with lipid profiles measured by individual physicians ranged from 0% to 83%, while the percentages of patients on drug treatment by a physician ranged between 10% and 88%. These findings indicate that socioeconomic differences, represented by different practice settings, do not account for differences in the screening for, control of, or use of medications in managing hyperlipidemia. Rather, individual physicians are accountable for differences in lipid management.

In vitro glycolysis of whole blood can detect primed neutrophils in septic ICU patients.

The purpose of this study was to develop a bedside assay based on the in vitro glycolysis of a whole blood sample that could detect primed neutrophils (PMNs). A mathematical index of the PMN response to exogenous stimulation with phorbol myristate 13-acetate (PMA), called the Delta value, was derived by comparing the increase in glycolysis for paired blood samples with and without PMA to that expected from normal subjects. Delta values for systemic inflammatory response syndrome/sepsis patients (9.09 +/- 7.61) (N = 36) were significantly higher than normal controls (2.02 +/- 1.76) (N = 51), nonsepsis ICU patients (3.81 +/- 2.80) (N = 14) and patients in septic shock (2.33 +/- 3.04) (N = 10) (p < .05). Delta values were consistently reflected in parallel measurements of increased reactive oxygen species production by neutrophils detected cytofluorometrically. PMN priming can be simply and rapidly detected by an assay based on the numbers of PMNs and erythrocytes and the measured rates of in vitro glycolysis of paired whole blood samples with and without PMA.

Study of a needleless intermittent intravenous-access system for peripheral infusions: analysis of staff, patient, and institutional outcomes.

OBJECTIVE: To assess the effect on staff- and patient-related complications of a needleless intermittent intravenous access system with a reflux valve for peripheral infusions. DESIGN: A 6-month cross-over clinical trial (phase I, 13 weeks; phase II, 12 weeks) of a needleless intermittent intravenous access system (NL; study device) compared to a conventional heparin-lock system (CHL, control device) was performed during 1991 on 16 medical and surgical units. A random selection of patients was assessed for local intravenous-site complications; all patients were assessed for the development of nosocomial bacteremia and device-related complications. Staff were assessed for percutaneous injuries and participated in completion of product evaluations. A cost analysis of the study compared to the control device was performed. SETTING: A 1,100-bed, teaching, referral medical center. PATIENTS AND STAFF PARTICIPANTS: 594 patients during 602 patient admissions, comprising a random sample of all patients with a study or control device inserted within a previous 24-hour period on study and control units, were assessed for local complications. The 16 units included adult inpatient general medicine, surgical, and subspecialty units. Pediatrics, obstetrics-gynecology, and intensive-care units were excluded. All patients on study and control units were assessed for development of nosocomial bacteremia and device-related complications. All staff who utilized, manipulated, or may have been exposed to sharps on study and control units were assessed for percutaneous injuries. Nursing staff completed product evaluations. INTERVENTION: The study device, a needleless intermittent intravenous access system with a reflux valve, was compared to the control device, a conventional heparin lock, for peripheral infusions. RESULTS: During the study, 35 percutaneous injuries were reported. Eight injuries were CHL-related; no NL-related injuries were reported (P=.007). An evaluation of 602 patient admissions, 1,134 intermittent access devices, and 2,268 observed indwelling device days demonstrated more pain at the insertion site for CHL than NL; however, no differences in objective signs of phlebitis were noted. Of 773 episodes of positive blood cultures on study and control units, 6 (0.8%) were device-related (assessed by blinded investigator), with no difference between NL and CHL. Complications, including difficulty with infusion (P<.001) and disconnection of intravenous tubing from device (P<.001), were reported more frequently with CHL than with NL. Of nursing staff responding to a product evaluation survey, 95.2% preferred the study over control device. The projected annual incremental cost to our institution for hospitalwide implementation of NL for intermittent access for peripheral infusions was estimated at $82,845, or $230 per 1,000 patient days. CONCLUSIONS: A needleless intermittent intravenous access system with a reflux valve for peripheral infusions is effective in reducing percutaneous injuries to staff and is not associated with an increase in either insertion-site complications or nosocomial bacteremia. Institutions should consider these data, available institutional resources, and institution-specific data regarding the frequency and risk of intermittent access-device-related injuries and other types of sharps injuries in their staff when selecting the above or other safety devices.

Tuberculosis prevention: cost-effectiveness analysis of isoniazid chemoprophylaxis.

Isoniazid chemoprophylaxis is not recommended for all persons infected with tubercle bacilli. Because of the small but significant risk of isoniazid hepatotoxicity, chemoprophylaxis is reserved for only those at the highest risk of tuberculosis activation. To evaluate this policy, we performed a cost-effectiveness analysis of isoniazid chemoprophylaxis for two populations with positive tuberculin skin tests: recent tuberculin converters, who are at high risk for activation, and older tuberculin reactors, who have a low risk for activation and for whom chemoprophylaxis is not now recommended. The cost-effectiveness ratios found were stable, despite wide variations in model assumptions and probability estimates. For high-risk tuberculin reactors, chemoprophylaxis resulted in net medical care monetary savings, extended life expectancy, and fewer fatal illnesses. For low-risk tuberculin reactors, chemoprophylaxis resulted in positive, but small, health effects. Because the cost to gain these positive effects were also small, the resulting cost-effectiveness ratios were reasonable and in the realm of accepted prevention strategies: $12,625 to gain one year of life and $35,011 to avert one death. These findings suggest that the current policy is too restrictive and that many in the large population of low-risk tuberculin reactors should be considered for isoniazid chemoprophylaxis.

Tuberculin screening: cost-effectiveness analysis of various testing schedules.

Because there is no tuberculin screening schedule currently recommended for adults, we used a Markov process in a cost-effectiveness analysis to determine an optimal strategy. We simulated the prognosis of a cohort of black 20-year-olds to evaluate the effects of various screening schedules with intradermal tuberculin and administration of isoniazid prophylaxis to those with positive results. The schedule with the lowest cost-effectiveness ratio is a single screening at 50 years of age, which costs $41,672 per quality-adjusted life year (QALY) gained. The cost-effectiveness ratio is nearly the same for all schedules involving a single screening between 30 and 70 years of age. Repeated screening strategies are less cost effective. Sensitivity analysis shows that the range of acceptable screening strategies changes significantly under alternate assumptions about the mortality from isoniazid hepatitis. However, screening at 50 years of age remains nearly optimal under the alternatives considered. Altering the values of other parameters generally produced only small changes. Tuberculin screening at 50 years of age should be added to primary care preventive practices because the strategy is as cost effective as standard health interventions and is robust to alternative assumptions. If further research confirms the base case assumptions about isoniazid toxicity, consideration should be given to increasing screening to every 10 years, which would produce a larger health benefit, albeit at substantially higher cost.

Decision analysis in formulary decision making.

Although decision making about what drugs to include in an institutional formulary appears to lend itself readily to quantitative techniques such as decision analysis and cost-benefit analysis, a review of the literature reveals that very little has been published in this area. Several of the published decision analyses use non-standard techniques that are, at best, of unproved validity, and may seriously distort the underlying issues through covert under-counting or double-counting of various drug attributes. Well executed decision analyses have contributed to establishing that drug acquisition costs are not an adequate measure of the total economic impact of formulary decisions and that costs of labour and materials associated with drug administration must be calculated on an institution-specific basis to reflect unique staffing patterns, bulk purchasing practices, and the availability of surplus capacity within the institution which might be mobilised at little marginal cost. Clinical studies of newly introduced drugs frequently fail to answer the questions that weigh most heavily on the structuring of a formal assessment of a proposed formulary acquisition. Studies comparing a full spectrum of therapeutically equivalent drugs are rarely done, and individual studies of particular pairs of drugs can rarely be used together because of differences in methodology or patient populations studied. Gathering of institution-specific economic and clinical data is a daunting, labour-intensive task. In many institutions, incentive and reward structures discourage behaviour that takes the broad institutional perspective that is intrinsic to a good decision analysis.(ABSTRACT TRUNCATED AT 250 WORDS)

Sequential analysis in a Bayesian model of diastolic blood pressure measurement.

A sequential method for diagnosing or excluding hypertension based on the Bayesian model of diastolic blood pressure presented in a companion article is presented. The likelihood ratio method of Wald is modified to include the effects of a prior probability distribution and to constrain the strategy to achieve specified positive and negative predictive values. The resulting formulas for upper and lower limits to diagnose and exclude diastolic hypertension can be evaluated using a hand calculator and a table of areas of the standard normal distribution. The strategy is illustrated for a population having a blood pressure distribution similar to that of the cohort screened for participation in the Hypertension Detection and Follow-up Program, with 90 mm Hg as the cutoff defining hypertension and required positive and negative predictive values of 95%. The performance of the strategy was simulated using Monte Carlo methods. The median number of readings required for diagnosis is three, and 80% of subjects are diagnosed in 11 or fewer readings. In contrast to the strategy's 95% predictive values, a fixed-number-of-measurements strategy requiring the same mean number of measurements has a positive predictive value of only 83% and a negative predictive value of 96%. When the parameters of the model have been properly measured or estimated, this method is practical, efficient, and accurate for diagnosing hypertension in a known population.

Sequential decision making with continuous disease states and measurements: I. Theory.

The question of whether to perform a continuous valued test to assess a continuous valued health state such as blood pressure or serum cholesterol is explored by decision analysis. Principal assumptions are that the underlying health state and measurement variability are both normally distributed, and that the impact of treatment on the utility of outcomes varies linearly with the underlying health state. Using Bayes' theorem, an expression for the expected utility of performing the test is derived and compared with immediate treatment or decision to withhold treatment. The calculations can be carried out with a pocket calculator and a table of the normal distribution. Iterating the analysis, a sequential decision making process is developed, leading to a series of no treat/test again and test again/treat thresholds with which a running average of independently obtained measurements can be compared to produce stepwise optimal results. The thresholds are readily calculated on a microcomputer. Finally, the conjugate-normal-linear model is extended to encompass the correlated observations that may be made on a single visit. This paper concentrates on the mathematics of decision making with continuous variables. The companion paper illustrates its application to diastolic blood pressure.

Sequential decision making with continuous disease states and measurements: II. Application to diastolic blood pressure.

The model and strategy for sequential decision making using normally distributed measurements proposed in a companion paper are applied to the problem of diagnosing diastolic hypertension. The assumptions of the model are discussed and justified clinically. Methods for assigning values to the model's parameters are explained and illustrated in the context of a hypothetical "generic" patient. Although current national recommendations and the sequential strategy both lead to an average of 1.89 measurements per patient prior to diagnosis, the sequential strategy applies a sequence of four or more measurements to 12% of patients. Fewer than 1% of patients would require ten or more measurements under this strategy. The sequential strategy leads to fewer patients' receiving unnecessary treatment and substantially higher expected utility for the patient. The role of multiple blood pressure determinations per visit is explored in the absence of appropriate estimates. Even under "best-case" assumptions, however, it is shown that obtaining more than one observation per visit is called for only in about 15% of visits. While the exact role of multiple determinations cannot be specified from existing data, it is likely to be much more limited than current recommendations suggest.

Bayesian analysis of diastolic blood pressure measurement.

A mathematical model is presented for measurements that include substantial fluctuation and error. Under the assumptions that the fluctuation-error variance is the same for all subjects, and that the distributions of fluctuation-error variance within subjects and "true" values of the measurements in the population are normal, Bayes' theorem produces a simple estimate of the "true" value of a measurement, and a standard error, conditional on a single observation. The model is easily extended to several observations. Methods for estimating the parameters of the model from a data set are presented, and applied to diastolic blood pressures of patients in the authors' primary care clinic. The test-retest reliability of a single blood pressure measurement for this population is 0.41. Because continuous measurements are often dichotomized into "normal" and "abnormal" ranges by a threshold criterion, the authors present formulas for the positive predictive value when a decision rule based on a given number of observations is used in a population with respect to a threshold criterion for the "true" values. For example, classifying their patients as hypertensive on the basis of the average of two readings exceeding 90 mm Hg diastolic pressure would have a positive predictive value of 52% for the "gold standard" of average diastolic pressure exceeding 90 mm Hg. Formulas to calculate the frequency with which patients will be classified "abnormal" by one decision rule but will be classified "normal" by later application of another rule are provided and used to "predict" the frequency with which this crossover phenomenon should have occurred in the enrollment phase of the Hypertension Detection and Follow-up Programs.(ABSTRACT TRUNCATED AT 250 WORDS)

Passive smoking and croup.

The relationship between croup and the presence of household cigarette consumption was assessed in a matched-pair case control study. Fifty subjects with a primary hospital discharge diagnosis of croup were paired with children with a primary hospital discharge diagnosis of abdominal hernia. The results yielded an estimated relative risk of 0.82. The power of this study to detect a relative risk of 2.0 was 38%. This study fails to show a relationship between passive smoking and croup in early childhood.

Cost-effectiveness of rescreening conventionally prepared cervical smears by PAPNET testing.

OBJECTIVE: This study explored the cost-effectiveness of the use of PAPNET testing-supplemental, neural network-based testing used to increase the accuracy of cervical smear screening practice. STUDY DESIGN: Using a model adapted from one developed under contract from the United States Congress Office of Technology Assessment to evaluate cost-effectiveness of cervical cancer screening in elderly women, the study evaluated U.S. women aged 20-64. The study reviewed various screening intervals and examined the course of follow-up (i.e., repeat abnormal smear vs. immediate colposcopy) to offer a range into which most routine medical practice will fall. RESULTS: Assuming a false negative rate of 25% for low grade squamous intraepithelial lesion (SIL) and 15% for high grade SIL and applying increased sensitivity of 30% from PAPNET, we can expect a cost of $48,474 per life-year saved among biennially screened women. For women screened triennially, as recommended by most groups, the cost per life-year saved is $25,185. CONCLUSION: The PAPNET rescreening program is an economical approach to decreasing mortality and morbidity from cervical cancer and compares favorably to other commonly used interventions and diagnostic procedures.

Evaluation of costs and benefits of advances in cytologic technology. International Academy of Cytology Task Force summary. Diagnostic Cytology Towards the 21st Century: An International Expert Conference and Tutorial.

ISSUES: Uterine cervical cytology smears are among the most cost-effective cancer prevention interventions available, but they are not infallible, and new or modified technologies have been and will be proposed to improve diagnostic accuracy. Before these new technologies are accepted, their performance attributes will be carefully studied and defined. Equally important in this era of fiscal constraints are cost/benefit analyses, for which we review certain guidelines. CONSENSUS POSITION: In an effort to control rising costs in the health care sector, there has been a strong incentive to move toward a market system, and a variety of forces are acting to drive down expenditures. These same pressures will continue to be brought to bear on the providers of cervical cytology services. It must be emphasized that the technical knowledge required to define cost-effective medical practice lies within the medical profession itself, which must recognize the following: (a) Resources are finite; (b) Elimination of fraud, abuse and waste is not enough to bring health care expenditures down to levels considered acceptable to government and business; (c) The medical profession must take the responsibility to identify the health and economic consequences of the services it provides and make wise recommendations for allocation of resources to optimize health consequences. The analysis of costs and benefits must be viewed from a societal perspective and presented in terms of the marginal impact on current practice. This does not mean that new technologies must reduce cost; on the contrary, improvements in health can be expected to come at a price, but at a price commensurate with value gained in lives saved or in added quality adjusted life years. To be of value, a new technology for cervical cytology must be more effective in preventing cervical carcinoma. Dysplasia is considered a precursor of carcinoma, and detection of dysplasia has been a surrogate for prevention of cervical carcinoma, but dysplasia does not always lead to carcinoma, least of all mild dysplasia, and policy makers ultimately will insist that a favorable change in health outcome be effected by new technology before it is allocated resources. Alternatively, new technologies may lower cost, perhaps by modifying screening or rescreening procedures according to known risk; by improved cytopreparatory techniques that simplify, improve or speed screening; or by monitoring devices that minimize screening error. In each case the performance attributes of the instrument or human instrument process should be evaluated in the intended use environment. ONGOING ISSUES: While current cervical cytology methodology is one of the most effective means of cancer prevention, there continues to be development of new techniques to increase the sensitivity and specificity of this test. With present fiscal constraints, these will be subject to stringent cost/benefit analyses in which the medical profession must play a key role. Such analyses can be quite complicated, considering the additional costs or cost savings of clinical follow-up procedures and the reliability of dysplasias detected by cytology as a surrogate for cervical carcinoma in calculating quality of life years saved.