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OBJECTIVE AND CONTEXT: This review was designed to assess the quality and review the outcomes of randomized controlled trials (RCTs) of biofield therapies (external qigong, Healing Touch, Johrei, Reiki, and Therapeutic Touch) that report using only nonphysical touch forms of treatment. RCTs of nonphysical contact biofield therapies have the potential to contribute to an evidence base for health-promoting effects mediated through mechanisms outside the present understanding of biomedicine.Articles meeting inclusion criteria were identified from database and reference list searches and evaluated for a range of reporting and design items. Data were extracted to determine the range of protocol parameters and treatment outcomes. The final set of included RCTs were evaluated via a modified 5-item Jadad scale as well as by a set of 20 criteria that included items relevant to the early-phase nature of the trials and to the examination of nonphysical touch biofield therapy interventions.Of 90 RCTs that assessed effectiveness of a biofield therapy in humans, 28 trials involving 1775 participants met additional inclusion criteria (most importantly a clearly reported use of only nonphysical contact treatment). The research designs of these 28 trials revealed marked heterogeneity in regard to condition treated, number and duration of treatments, nature of the control/comparison group, and outcome measures. Finally, 10 trials were excluded on the basis of low quality assessment scores. Twelve of the remaining 18 trials (7 Therapeutic Touch, 3 external qigong, 1 Reiki, and 1 Healing Touch) reported at least one primary outcome with statistically significant beneficial treatment outcomes.The pilot study nature of essentially all the identified nonphysical contact biofield therapy RCTs, as reflected by low sample sizes alone, precludes drawing robust conclusions. Given this perspective, the finding that two thirds of the higher-scoring trials demonstrated at least partial effectiveness favors a continued research effort, especially in light of the translational value of biofield clinical trials for studies exploring the nature and physiologic basis of biofield healing.

Despite decades of tobacco control efforts, tobacco use remains a pressing public health problem with nearly one in 5 Americans smoking.1 Effective tobacco dependence treatments, both behavioral and pharmaceutical, are more numerous and available than ever before, but continue to be underutilized. Nearly 80% of smokers in the U.S. still attempt to quit without assistance,1 though there is robust evidence that guideline recommended approaches significantly improve a tobacco users’ likelihood of quitting compared with unaided quit attempts.2 Approximately 80% of the U.S. population who are not current tobacco users, but may know or be concerned about someone who does smoke or dip. A community-based social network approach that engages this target audience in providing tobacco cessation brief interventions could provide a complementary and powerful addition to clinical interventions, encouraging more quit attempts and use of effective treatments for greater public health impact.

This dual-site study sought to identify the appropriate role for traditional Chinese medicine (TCM; acupuncture and herbs) in conjunction with a validated psychosocial self-care (SC) intervention for treating chronic temporomandibular disorders (TMD)-associated pain. Participants with Research Diagnostic Criteria for Temporomandibular Disorders–confirmed TMD (n = 168) entered a stepped-care protocol that began with a basic TMD class. At weeks 2 and 10, patients receiving SC whose worst facial pain was above predetermined levels were reallocated by minimization to SC or TCM with experienced practitioners. Characteristic facial pain (CFP: mean of worst pain, average pain when having pain, and current pain; each visual analog scale [VAS] 0–10) was the primary outcome. Social activity interference (VAS 0–10) was a secondary outcome. Patients were monitored for safety. TCM provided significantly greater short-term (8-week) relief than SC (CFP reduction difference, −.60 [standard deviation of the estimate .26], P = .020) and greater reduction in interference with social activities (−.81 [standard deviation of the estimate .33], P = .016). In 2 of 5 treatment trajectory groups, more than two thirds of participants demonstrated clinically meaningful responses (≥30% improvement) in pain interference over 16 weeks. This study provides evidence that TMD patients referred for TCM in a community-based model will receive safe treatment that is likely to provide some short-term pain relief and improved quality of life. Similar designs may also apply to evaluations of other kinds of chronic pain. (ClinicalTrials.gov number NCT00856167). Perspective This short-term comparative effectiveness study of chronic facial pain suggests that TCM is safe and frequently efficacious alone or subsequent to standard psychosocial interventions. TCM is widely available throughout North America and may provide clinicians and patients with a reasonable addition or alternative to other forms of therapy.

Purpose The purpose of this study is to describe the development and implementation of a new diabetes prevention intervention that combines the benefits of family support with the group office model. Intensive lifestyle modification can effectively delay the onset of type 2 diabetes, yet health providers are challenged in translating these results to their patients. The group outpatient visit model can provide a means to address prevention issues in a financially sustainable manner. Methods Materials from the Diabetes Prevention Program and a previously developed group office visit program were combined to create the Families United/Familias Unidas curriculum. The session content utilized a multiculturally tailored approach designed to help participants decrease portion size, decrease carbohydrate intake, increase physical activity, and increase resiliency. Adults aged 18 to 70 were recruited who had any diabetes risk factors but did not have diabetes. Eligible participants enlisted a support person, aged 14 to 70, to join them in the 6-month group office visit intervention. Results Twenty-nine pairs (n = 58) of primary participants plus support persons were recruited. Participants’ average age was 45; 74% were female; 56.9% identified themselves as white and 37.9% as Hispanic/Latino. Over one-third had 4 or more diabetes risk factors. Twelve family group office visits were delivered over 6 months. The attendance rate for those who attended at least one session was 72%. Conclusions Group office visits can provide a new sustainable model for diabetes prevention and are a natural fit for primary care physicians in collaboration with other health care professionals, such as dieticians or diabetes educators.

Background Investigators of homeopathy have proposed that nonlinear dynamical systems (NDS) and complex systems science offer conceptual and analytic tools for evaluating homeopathic remedy effects. Previous animal studies demonstrate that homeopathic medicines alter delta electroencephalographic (EEG) slow wave sleep. The present study extended findings of remedy-related sleep stage alterations in human subjects by testing the feasibility of using two different NDS analytic approaches to assess remedy effects on human slow wave sleep EEG. Methods Subjects ( N = 54) were young adult male and female college students with a history of coffee-related insomnia who participated in a larger 4-week study of the polysomnographic effects of homeopathic medicines on home-based all-night sleep recordings. Subjects took one bedtime dose of a homeopathic remedy ( Coffea cruda or Nux vomica 30c). We computed multiscale entropy (MSE) and the correlation dimension (Mekler-D2) for stages 3 and 4 slow wave sleep EEG sampled in artifact-free 2-min segments during the first two rapid-eye-movement (REM) cycles for remedy and post-remedy nights, controlling for placebo and post- placebo night effects. Results MSE results indicate significant, remedy-specific directional effects, especially later in the night (REM cycle 2) (CC: remedy night increases and post-remedy night decreases in MSE at multiple sites for both stages 3 and 4 in both REM cycles; NV: remedy night decreases and post-remedy night increases, mainly in stage 3 REM cycle 2 MSE). D2 analyses yielded more sporadic and inconsistent findings. Conclusions Homeopathic medicines Coffea cruda and Nux vomica in 30c potencies alter short-term nonlinear dynamic parameters of slow wave sleep EEG in healthy young adults. MSE may provide a more sensitive NDS analytic method than D2 for evaluating homeopathic remedy effects on human sleep EEG patterns.

Objective There are many commercially available instruments for measuring electrical conductance, but there is little information about their reliability. The aim of this study was to quantify measurement variability and assess reliability of the AcuGraph system—a commonly used electrodermal screening device. Methods Four experiments were conducted to measure variability in electrical conductance readings obtained by the AcuGraph system. The first involved measuring known resistors. The second measured non-human organic matter. The third was a test–retest assessment of the Yuan-Source and Jing-Well points in 30 healthy volunteers who were measured by a single operator. The fourth was an interoperator reliability evaluation of seven acupuncturists at the Yuan-Source and Jing-Well acupoints on four individuals at two time points. Results Against known resistors, the AcuGraph had an average coefficient of variability (CV) of 1.8% between operators and test–retests. On non-human organic material the AcuGraph had an average CV of 0.9% and 2.8%. When a single operator tested 30 participants, the average reliability for the Yuan-Source points was 0.86 and 0.76 for Jing-Well points with a CV of 23.2% and 25.9% respectively. The average CV for the seven acupuncturists was 24.5% on Yuan-Source points and 23.7% on Jing-Well points. Conclusions The AcuGraph measures known resistors and organic matter accurately and reliably. Skin conductance at acupoints recorded by one operator was also reliable. There was less consistency in electrodermal recordings obtained by seven different operators. Operator training and technical improvements to the AcuGraph may improve consistency among operators.

Homeopathy, a common form of alternative medicine worldwide, relies on subjective patient reports for diagnosis and treatment. Polysomnography offers a modern methodology for evaluating the objective effects of taking homeopathic remedies that clinicians claim exert effects on sleep quality in susceptible individuals. Animal studies have previously shown changes in non rapid eye movement sleep with certain homeopathic remedies.Young adults of both sexes (ages 18-31) with above-average scores on standardized personality scales for either cynical hostility or anxiety sensitivity (but not both) and a history of coffee-induced insomnia participated in the month-long study. At-home polysomnographic recordings were obtained on successive pairs of nights once per week for a total of eight recordings (nights 1, 2, 8, 9, 15, 16, 22, 23). Subjects (N=54) received placebo pellets on night 8 (single-blind) and verum pellets on night 22 (double-blind) in 30c doses of one of two homeopathic remedies, Nux Vomica or Coffea Cruda. Subjects completed daily morning sleep diaries and weekly Pittsburgh sleep quality index scales, as well as profile of mood states scales at bedtime on polysomnography nights.Verum remedies significantly increased PSG total sleep time and NREM, as well as awakenings and stage changes. Changes in actigraphic and self-rated scale effects were not significant.The study demonstrated the feasibility of using in-home, all-night sleep recordings to study homeopathic remedy effects. Findings are similar though not identical to those reported in animals with the same remedies. Possible mechanisms include initial disruption of the nonlinear dynamics of sleep patterns by the verum remedies.

Hypothesis Studies indicate that menopausal symptoms are relieved by acupuncture. Additional studies have suggested that acupuncture may affect heart rate variability (HRV). This paper reports a pilot study that investigated whether menopausal symptoms responded to acupuncture, and if changes in the spectral analysis of HRV, either suppression of low frequency or augmentation of high frequency bands, corresponded with symptom report. Methods/interventions 12 healthy menopausal subjects were enrolled in this feasibility study. At baseline, subjects were experiencing moderately distressing menopausal symptoms, scoring at least 22 of a possible 44 points on the Menopausal Rating Scale. 10 traditional Chinese medicine-based, protocol acupuncture treatments were administered over a 4 week period, three times a week for 2 weeks, followed by twice a week for 2 weeks. Outcome measures Menopausal Rating Scale questionnaire, 11 menopausal symptoms were evaluated on a zero to four severity scale via self-administered daily checklist for 4 weeks. Dynamic measures of HRV (autoregressive model) were captured before, during and after acupuncture at each session. Spectral analysis of the heart rate was used to compute power in the low frequency and high frequency bands, and their ratio. Results All subjects complied fully with the protocol without any reported adverse events. While all 11 symptoms showed significant improvement, and one HRV measure changed, on average over the study period, there was essentially no support for a relationship between HRV, menopausal symptom report and acupuncture intervention.

OBJECTIVES: To prospectively examine the relationship between anemia and incident fractures of the hip, spine, and all skeletal sites in women from diverse racial and ethnic backgrounds enrolled in the Women's Health Initiative (WHI) Observational Study and Clinical Trials. DESIGN: Prospective cohort study. SETTING: Forty WHI clinical centers across the United States. PARTICIPANTS: Postmenopausal women (n=160,080), mean age 63.2 ± 7.2, were recruited and followed for an average of 7.8 years. MEASUREMENTS: Anemia was defined as hemoglobin levels at baseline less than 12 g/dL. All fractures were self-reported. Trained physicians further confirmed hip fractures using medical records. RESULTS: Eight thousand seven hundred thirty-nine of the participants (5.5%) were anemic. The age-adjusted incidence rate of hip fractures per 10,000 person-years was 21.4 in women with anemia and 15.0 in women without anemia; higher incidence rates for spine and all fractures were also observed in anemic women. After multiple covariates were included in the Cox proportional hazards models, significantly greater fracture risk associated with anemia still existed, as demonstrated by hazard ratios of fractures associated with anemia of 1.38 (95% confidence interval (CI)=1.13�1.68) for hip, 1.30 (95% CI=1.09�1.55) for spine, and 1.07 (95% CI=1.01�1.14) for all types. No significant racial or ethnic difference was found in these relationships. CONCLUSION: A significantly greater fracture risk was observed in multiethnic postmenopausal women with anemia. Given the high prevalence of anemia in the elderly population, it is important to better understand the relationship and mechanisms linking anemia to fracture risk.

This study was designed to assess the effects of 18 months of resistance exercise on regional and total bone mineral density (BMD) and soft tissue lean mass (STL) in premenopausal women aged 28-39 randomly assigned to an exercise or control group. Twenty-two exercise and 34 control subjects completed the 18-month training study. All subjects were previously inactive and untrained women. Initial, 5-, 12- and 18-month assessments were made of total and regional BMD and total and regional STL using dual energy X-ray absorptiometry. All subjects consumed a 500 mg/day elemental calcium supplement throughout the study. Initial Ca intake without supplement averaged 1,023 mg/day in total sample. Serum levels of bone osteocalcin and dietary assessments using 12 randomly assigned days of diet records were also completed. Muscular strength was assessed from both 1 repetition maximum (RM) testing of 10 weightlifting exercises and by peak torque for hip abduction/adduction and knee extension/flexion. Training increased strength by 58.1% based on 1 RM testing and by 33.8% based on isokinetic testing at 18 months versus baseline. BMD increased significantly above baseline at the lumbar spine for the exercise group at 5 months (2.8%), 12 months (2.3%), and 18 months (1.9%) as compared with controls. Femur trochanter BMD increased significantly (p < 0.05) in the exercise group at 12 months (1.8%) and 18 months (2.0%) but not at 5 months (0.7%) as compared with controls. No changes in total BMD, arm BMD, or leg BMD were found. There was a 20% increase in BGP in the exercise group as compared with controls at 5 months and this difference was maintained throughout the study. For STL, significant increases for total, arm, and leg were found at 5, 12, and 18 months for the exercise group versus control ranging from 1-6% over baseline. These results support the use of strength training for increasing STL and muscular strength with smaller but significant regional increases in BMD in the premenopausal population.

The United States and Norway are among the countries that have the highest total expenditure on health per capita and also high utilization of complementary and alternative medicine (CAM). However, these countries have fundamentally different health care systems. The aim was therefore to compare characteristics of adults who have seen a CAM practitioner during the last year in the United States and Norway.Data from the National Health Interview Survey in the United States from 2002 and the Level of Living survey in Norway from 2002 were used. Both surveys were nationally representative household surveys of the noninstitutionalized civilian population. The data consist of 6612 individuals from Norway and 31,044 individuals from the United States.In the United States, 7.4% of the population had seen a CAM practitioner during the last 12 months compared to 8.7% in Norway (p0.001 for difference). In both the United States and Norway, seeing a CAM practitioner was most strongly associated with seeing other health care practitioners and having experienced better or worse self-reported health in the last year. Being male and a daily smoker reduced the odds of seeing a CAM practitioner in both countries. In the United States, but not Norway, having higher education was strongly associated with seeing a CAM practitioner. Higher education was the variable with the biggest difference between the two countries.This study indicates that in a country that provides health care services for all based on need regardless of personal income (Norway), the utilization of CAM practitioners is higher and less associated with use of other health care providers than a country with low government expenditure on health (the United States).

Assignment to treatment group by randomization has been advocated with great success in biomedical trials. Research on optimal experimental design suggests, however, that it should be possible to obtain efficiency gains over randomization by balancing treatment groups with regard to prognostic factors. The only practical way of doing this involves sequential allocation to treatment that evolves during the recruitment period, but any such method has been questioned on the grounds that statistical inference using the estimated treatment effect is suspect. Results reported here show by means of a regression simulation that the estimate obtained from a dynamically balanced trial is unbiased, and a new estimate of its standard deviation is similarly shown to be unbiased. If one does not adjust for the balancing factors in the analysis, then randomization is frequently unacceptably inefficient. If one does adjust, then the efficiency advantage of balancing is modest on average, but still important in an appreciable fraction of trials with small sample sizes.

BACKGROUND. The Gail model has been commonly used to estimate a woman's risk of breast cancer within a certain time period. High bone mineral density (BMD) is also a significant risk factor for breast cancer, but it appears to play no role in the Gail model. The objective of the current study was to investigate whether hip BMD predicts postmenopausal breast cancer risk independently of the Gail score. METHODS. In this prospective study, 9941 postmenopausal women who had a baseline hip BMD and Gail score from the Women's Health Initiative were included in the analysis. Their average age was 63.0 ± 7.4 years at baseline. RESULTS. After an average of 8.43 years of follow-up, 327 incident breast cancer cases were reported and adjudicated. In a multivariate Cox proportional hazards model, the hazards ratios (95% confidence interval [95% CI]) for incident breast cancer were 1.35 (95% CI, 1.05-1.73) for high Gail score (≥1.67%) and 1.25 (95% CI, 1.11-1.40) for each unit of increase in the total hip BMD T-score. Restricting the analysis to women with both BMD and a Gail score above the median, a sharp increase in incident breast cancer for women with the highest BMD and Gail scores was found (P < .05). CONCLUSIONS. The contribution of BMD to the prediction of incident postmenopausal breast cancer across the entire population was found to be independent of the Gail score. However, among women with both high BMD and a high Gail score, there appears to be an interaction between these 2 factors. These findings suggest that BMD and Gail score may be used together to better quantify the risk of breast cancer. Cancer 2008. © 2008 American Cancer Society.

To assess the feasibility and acceptability of studying whole systems of Traditional Chinese Medicine (TCM) and Naturopathic medicine (NM) in the treatment of temporomandibular disorders (TMD), and to determine whether there is indication to support further research.A pilot study using a randomized controlled clinical trial design of whole system TCM and NM versus state-of-the-art specialty care (SC).Kaiser Permanente Northwest (KPNW), and practitioner offices in Portland, Oregon.One hundred and sixty (160) women 25-55 years of age attending a KPNW TMD specialty clinic.Whole system TCM and NM, and KPNW TMD clinic SC; the intervention protocols were designed to model the individually tailored type of community care offered in alternative medicine practices in Portland and in the KPNW TMD clinic, using protocols that enhanced similarities among practitioners within each system and permitted full descriptions of the treatments provided.TMD was ascertained using the Research Diagnostic Criteria/TMD; outcomes were self-reported worst and average facial pain and interference with activities (scaled 0-10 where 10 is worst).Of 948 consecutive eligible patients, 160 were randomized to one of three arms; 128 provided endpoint data. TCM and NM demonstrated significantly greater in-treatment reductions for worst facial pain compared to SC (adjusted regression analysis; higher negative values indicate greater improvement, = -1.11 +/- 0.43, p = 0.010 and -1.02 +/- 0.45, p = 0.025 for TCM and NM, respectively, compared to SC) and at 3 months post-treatment (-1.07 +/- 0.51, p = 0.037 and -1.27 +/- 0.54, p = 0.019 for TCM and NM versus SC, respectively). Additionally, TCM provided significantly greater decreases in average pain than SC; NM provided significantly greater decreases than SC or TCM in TMD-related psychosocial interference.These alternative medicine approaches each resulted in significantly greater reduction of pain and psychosocial interference than SC. Further research on the potential benefits of traditional whole systems of medicine for TMD appears warranted.

Background The Prevention Index is a methodology for using electronic medical records to identify and evaluate practice variations in the delivery of preventive care. Methods The Prevention Index was used to evaluate the provision of 10 recommended adult preventive services using electronic medical record data for the years 1999 through 2002 among the 450,000 members of a large Northwest integrated care system. The analyses were conducted in 2005. The Prevention Index determines the proportion of person-time that is covered using consensus guidelines as a standard of care. It is analyzed at the population level and produces quality measures at the individual, practice, clinic, and system levels. The Prevention Index also removes diagnostic services in evaluating preventive care. Results Overall, about 47% of recommended person-time was actually covered by the services in 2002. For nine services with care guidelines, the percent of covered person-time ranged from 19% for chlamydia screening to 80% for blood pressure screening. The percent of recommended person-time covered by these preventive services varied widely across clinical practices. From 17% to 53% of preventive screening tests were delivered for non-screening purposes. Conclusions There are wide variations across clinical practices in the adherence to standard prevention guidelines, and also wide variations across different recommended clinical services. The Prevention Index methodology may allow the identification of the source of these variations, allowing system corrections and other remedial actions to be applied precisely and efficiently.

Early phase research in complementary and alternative medicine (CAM) is especially important because of the large influence it has on the subsequent expenditure of money and effort in particular areas of CAM therapies. The culture of biomedical research has, however, blurred the distinction between early and late-phase research, and this has distorted the very distinct aims of these two activities. The purpose of this paper is to reaffirm the critical role of early phase CAM research and to encourage CAM researchers to value and conduct early phase studies for their proper purposes.

Objective: The extent to which modifiable dietary factors may account for some of the variability demonstrated in mammographic density across ethnic groups is unknown. The purpose of this study was to provide pilot data describing the relationship between dietary variables and mammographic density in pre- and postmenopausal Hispanic and non-Hispanic white (NHW) women (N = 238) ranging in age from 41 to 50 years (premenopausal only) or 56 to 70 years (postmenopausal only). Design: Using a cross-sectional design, computer-assisted density assessments were performed on mammograms of both breasts and averaged for analysis. The Arizona Food Frequency Questionnaire was used to estimate dietary intake. Results: Study participants were well educated and overweight, with mean mammographic densities ranging from 20.25% for postmenopausal Hispanic women to 46.94% for premenopausal NHW women. Hispanic women reported higher energy intake than NHW women, but energy-adjusted intake of other nutrients was generally comparable. There was preliminary evidence of ethnic variability in dietYmammographic density associations. Among premenopausal Hispanic women, density was inversely associated with dairy, calcium, and vitamin D intakes (P e 0.05 for all). Among premenopausal NHW women, lower mammographic density was associated with greater intake of vegetables (P e 0.05), and higher density was associated with greater fruit intake (P e 0.05). Among postmenopausal Hispanic women, for every 4.54 increase in the polyunsaturated-to-saturated fat ratio, there was a 9.0% reduction in mammograph density. Conclusions: These preliminary results suggest that a differential pattern of dietary nutrient associations with mammographic density could potentially exist among Hispanic and NHW women. These ethnic differences in diet and mammographic density associations need to be further explored in larger studies.

Biological processes are often accompanied by occurrences of multiple events, such as activation of certain cell types, change in prevalence of cell subpopulations (such as T cells), changes in concentration of proteins or peptides, or breaks in chromosomes. Some co-occurrences of these events are by chance, but others may have meaningful relations to the underlying biological process. The methodology of linksets is designed to detect the presence of potentially meaningful co-occurrences. Due to the complex ways in which linksets can determine the observed occurrences of multiple events, some moderately powerful computational methods are necessary for statistical estimation. Here, linkset models are fitted to data on chromosome breakpoints in ovarian adenocarcinomas, in order to answer the question motivating the project that collected them—whether there are nonrandom co-occurrences of breakpoints in particular chromosome regions, and whether these might be of prognostic significance. The results identify breakpoints in 1p1 as associated with early mortality when they occur in linksets of breakpoints in 1p3 and any one of 11q1, 11q2, or 6q2. Conversely, breakpoints in 6p2, 1q3, and 7p1 occur in linksets associated with late mortality. This is, to our knowledge, the first demonstration of a new method for analyzing patterns of event occurrence in biological data.

OBJECTIVES: Osteoporosis treatment rates after a fracture are low. This study evaluated methods to increase guideline-recommended osteoporosis care postfracture. DESIGN: Participants were randomly assigned to usual care or one of two interventions. Analysis of primary outcomes used electronic data and linear regression. SETTING: A Pacific Northwest nonprofit health maintenance organization. PARTICIPANTS: Female patients aged 50 to 89 who suffered a fracture in 1999 and had not received bone mineral density (BMD) measurement or medication for osteoporosis (n=311) and their primary care providers (n=159). INTERVENTION: Patient-specific clinical guideline advice to the primary care provider delivered by electronic medical record (EMR) message or electronic reminder to the provider plus an educational letter mailed to the patient. MEASUREMENTS: BMD measurement and osteoporosis medication. RESULTS: At 6 months, provider reminder resulted in 51.5% of patients receiving BMD measurement or osteoporosis medication, provider reminder plus patient education resulted in 43.1%, and usual care resulted in 5.9% (P

The burden of osteoporotic fractures in older men is significant. The objectives of our study were to: (1) characterize older men with fractures associated with osteoporosis, (2) determine if medication treatment rates for osteoporosis are improving and (3) identify patient, healthcare benefit and utilization, and clinician characteristics that are significantly associated with treatment. This retrospective cohort study assessed 1,171 men aged 65 or older with any new fracture associated with osteoporosis between 1 January 1998 and 30 June 2001 in a non-profit health maintenance organization in the United States. Multiple logistic regression was used to evaluate pre-fracture factors for their association with osteoporosis treatment in the 6-month post-fracture period. The main outcome measure was pharmacologic treatment for osteoporosis in the 6 months after the index fracture. Subjects’ average age was 76.7 years; 3.3% had a diagnosis of osteoporosis and 15.2% a diagnosis or medication associated with secondary osteoporosis. Only 7.1% of the study population and 16.0% of those with a hip or vertebral fracture received a medication for osteoporosis following the index fracture, and treatment rates did not improve over time. In the multivariate model, factors significantly associated with drug treatment were a higher value on the Charlson Comorbidity Index (odds ratio 1.26, 95% confidence interval 1.05–1.51), having an osteoporosis diagnosis (odds ratio 8.11, 95% confidence interval 3.08–21.3), chronic glucocorticoid use (odds ratio 5.37, 95% confidence interval 2.37–12.2) and a vertebral fracture (odds ratio 16.6, 95% confidence interval 7.8–31.4). Bone mineral density measurement was rare ( n =13, 1.1%). Our findings suggest that there is under-ascertainment and under-treatment of osteoporosis and modifiable secondary causes in older men with fractures. Information systems merging diagnostic and treatment information can help delineate gaps in patient management. Interventions showing promise in other conditions should be evaluated to improve care for osteoporosis.

This report describes cross-sectional associations among physical activity, cardiorespiratory fitness, dietary habits, and cardiovascular disease (CVD) risk factors in a large sample (n = 810) of African Americans (n = 279) and non-African Americans (n = 531) with above-optimal blood pressure. Participants in PREMIER, a clinical trial for blood pressure control through lifestyle approaches, underwent baseline assessments to determine physical activity level, cardiorespiratory fitness category, dietary intake, and CVD risk factors. Mean levels of body mass index (BMI), total cholesterol, LDL cholesterol, HDL cholesterol, daily percent calories from fat and saturated fat, daily servings of fruits and vegetables, and daily fiber intake were examined across three physical activity levels and two fitness categories. Hypertension status was also assessed. Data were stratified by sex and ethnicity. For all participants, those in the low fitness category had higher BMI levels. Total cholesterol was lower in African American women in the high fitness category. Mean values of more than five daily servings of fruits and vegetables were reported by non-African American women and African American men in the high activity category. Higher intake of dietary fiber was found for non-African American women at the high activity level, with a similar trend observed for African American women. Future work examining these associations prospectively should include sufficient minority representation to enhance generalizability to all population groups and determine the beneficial effects from increased physical activity and improved cardiorespiratory fitness.

There are some substantial ways in which the current approach to establishing an evidence base for a treatment effect works against complementary and alternative medicine (CAM) research. The standard statistical method in comparative trials is the null hypothesis test, which requires a decision that the ‘no treatment effect’ hypothesis is confirmed, or it is rejected. While this approach is appropriate for evidence-based medicine, the requirement for a decisive result drives sample sizes upward, or leaves small trials subject to being criticised for being underpowered. Employing the fundamental theory of hypothesis tests, as developed by Neyman and Pearson, it is possible to define a ‘separation test’ that avoids this problem, by invoking a different inferential rationale. The purpose of a separation test is to find an indication that further research is justified, or that it is not. This change in strategy can considerably lower the required sample size. Since many CAM comparative trials are in early phases of research, where both budgetary and safety considerations argue for a small sample size, separation tests may be especially of interest to CAM researchers. There is, therefore, an opportunity for evidence-based medicine to generate a new kind of study, in which the purpose is to assess whether it is worthwhile to pursue research on an alternative treatment, rather than to determine whether it has been proved effective.

Background and objectives Classical statistical inference has attained a dominant position in the expression and interpretation of empirical results in biomedicine. Although there have been critics of the methods of hypothesis testing, significance testing ( P -values), and confidence intervals, these methods are used to the exclusion of all others. Methods An alternative metaphor and inferential computation based on credibility is offered here. Results It is illustrated in three datasets involving incidence rates, and its advantages over both classical frequentist inference and Bayesian inference, are detailed. Conclusion The message is that for those who are unsatisfied with classical methods but cannot make the transition to Bayesianism, there is an alternative path.

To test the substitution hypothesis, that community-based care reduces the probability of institutional placement for at-risk elderly.The closure of the Social Health Maintenance Organization (Social HMO) at HealthPartners (HP) in Minnesota in 1994 and the continuation of the Social HMO at Kaiser Permanente Northwest (KPNW) in Oregon/Washington comprised a "natural experiment." Using multinomial logistic regression analyses, we followed cohorts of Social HMO enrollees for up to 5 years, 1995 to 1999. To adjust for site effects and secular trends, we also followed age- and gender-matched Medicare-Tax Equity and Fiscal Responsibility Act (TEFRA) cohorts, enrolled in the same HMOs but not in the Social HMOs.All enrollees in the Social HMO for at least 4 months in 1993 and an age-gender matched sample of Medicare-TEFRA enrollees. To be included, individuals had to be alive and have a period out of an institution after January 1, 1995 (total n = 18,143).The primary data sources were the electronic databases at HP and KPNW. The main outcomes were long-term nursing home placement (90+ days) or mortality. Covariates were age, gender, a comorbidity index, and geographic site effect.Adjusting for variations in the 2 sites, we found no difference in probability of mortality between the 2 cohorts, but approximately a 40% increase in long-term institutional placement associated with the termination of the Social HMO at HealthPartners (odds ratio, 1.43; 95% confidence interval, 1.15-1.79).The Social HMO appears to help at-risk elderly postpone long-term nursing home placement.

Background: Many older patients with fractures are not managed in accordance with evidence-based clinical guidelines for osteoporosis. Guidelines recommend that these patients receive treatment for clinically apparent osteoporosis or have bone mineral density measurements followed by treatment when appropriate. This cohort study was conducted to further characterize the gap between guidelines and actual practice with regard to bone mineral density measurement and treatment of older women after a fracture. Our purpose was to aid in the design of more effective future interventions. Methods: We identified female members of a not-for-profit group-model health maintenance organization who were fifty years of age or older and who had a diagnosis of a new fracture as defined in the study. We used administrative databases and the clinical electronic medical records to obtain data on demographics, diagnoses, drugs dispensed by the pharmacy, and the measurement of bone mineral density. Results: The study population included 3812 women with an average age of 71.3 years. Fewer than 12% of the women had a diagnosis of osteoporosis prior to the index fracture; 10.7% had an increased risk for secondary osteoporosis and 38.8%, for falls because of a diagnosis or medication. It was found that 46.4% of the study population had been managed as specified by clinical guidelines. The patients who had been managed as specified by the guidelines were younger and less likely to have the risk factor of a weight of

Participant-centered analysis involves applying the customary methods of statistical decision making at the level of the individual research participant. Consequently, each individual is declared a responder who benefited, a nonresponder, or possibly a responder who was harmed, using intensively collected data that were specific to that individual. There are several implications of the participant-centered approach. More data actually relevant to the important outcome need to be collected on individuals. The study results can be summarized in a simple table of responders/nonresponders by treatment group, and probabilities of true response can be estimated. The actual nature of the data collected and the statistical models used to analyze them drop into the background. Finally, production of individual-level decisions permits standard statistical approaches to be applied to the issue of which modality should be recommended for which person, instead of focusing on average effects and which modality should be recommended for everyone.

PURPOSE: To describe PREMIER, a randomized trial to determine the effects of multi-component lifestyle interventions on blood pressure (BP). METHODS: Participants with above optimal BP through stage 1 hypertension were randomized to: 1) a behavioral lifestyle (BLS) intervention that implements established recommendations, 2) a BLS intervention that implements established recommendations plus the DASH diet, or 3) an advice only standard of care group. The two BLS interventions consist of group and individual counseling sessions for 18 months. The primary outcome is systolic BP at 6 months. Additional outcomes include diastolic BP and homocysteine at 6 months; systolic and diastolic BP at 18 months; fasting lipids, glucose and insulin at 6 and 18 months; and effects in subgroup. CONCLUSION: Results from the PREMIER trial will provide scientific rationale for implementing multi-component behavioral lifestyle intervention programs to control BP and prevent CVD.

Background Worldwide, type 2 diabetes prevalence is increasing, with Native American populations particularly at risk. The Zuni Pueblo, with a history of wellness activities, volunteered to test the feasibility and efficacy of a high school-based diabetes prevention intervention. Methods This school-based intervention used a multiple cross-sectional design to evaluate outcome measures at 0, 1.5, and 3 years against an Anglo comparison group. The Zuni high school diabetes prevention program included an educational component targeting decreased consumption of sugared beverages, knowledge of diabetes risk factors, and a youth-oriented fitness center. Main outcome measures were plasma glucose and insulin measured fasting and 30 min after a 75-g glucose challenge. Results Plasma glucose levels were normal at baseline for Zuni ( n = 72) and Anglo ( n = 37) youth and did not significantly change throughout the study. At baseline, fasting and 30-min plasma insulin levels were significantly elevated for Zuni youth; they showed significant steady declines for both males and females throughout the study ( P = 0.06 to P = 0.000 for trends using quantile regression). By Year 3, values for Zuni males ( n = 29) equaled Anglo comparison values, while Zuni female ( n = 26) values had declined but were still higher than Anglo comparison values. Conclusions Among at-risk youth, an environmentally based lifestyle intervention may significantly suppress markers of type 2 diabetes risk.

This study was conducted to assess the oral health status and dental care needs of elderly adults living in long-term care facilities. Dentists examined 601 elderly adults, living in one of six extended-or intermediate-care facilities, between September 1999 and May 2000. Data from 532 of the subjects were analyzed with descriptive statistics and zero-order inverse polynomials. Using a computer program, the authors compiled summaries of oral health data on individuals and institutional levels. This study suggests that there are numerous unmet dental needs among elderly adults who live in institutions. The CODE index used to assess the oral health of these residents offers a systematic portrayal of oral disorders in terms of severity. As the authors demonstrated, this index can be readily analyzed using zero-order inverse polynomials to summarize collected data into a graphic description, which can be helpful in managing and administrating oral health care interventions in long-term care facilities.

Clinicians use patients' recall of pain and disability relief as indicators of therapeutic effectiveness. Recall can change over time, however, and is influenced by factors other than true relief, including current health status. We have determined the trend in the relative contribution of current pain/disability and actual relief (current-baseline score) to relief recall over the course of 1 year. Self-referred patients (n=1182) seeking treatment from primary-care medical doctors and chiropractors in community-based clinics were asked to record present pain and disability, as well as perceived relief at five follow-up time points from 2 weeks to 12 months after initial consultation for acute and chronic low back pain (LBP). Multiple regression analysis was performed at each time point and over the five follow-up time points. We found a clear logarithmic time trend of increasing dependence of pain relief recall on present pain (P

Context Bacterial vaginosis (BV) is a strong independent risk factor for adverse pregnancy outcomes. BV is found in 9% to 23% of pregnant women. Symptoms include vaginal discharge, pruritus, or malodor, but often women with BV are asymptomatic. Objectives To determine whether screening and treating pregnant women for BV reduces adverse pregnancy outcomes, as part of an assessment for the U.S. Preventive Services Task Force. Data sources Randomized clinical trials of BV treatment in pregnancy that measured pregnancy outcomes were identified from multiple searches in MEDLINE from 1966 to 1999, the Cochrane Controlled Trials Register and Library, and national experts. Study selection All randomized controlled trials of BV treatment in pregnancy that specifically measured pregnancy outcomes. Data extraction The following information was abstracted: study design and blinding, diagnostic methods, antibiotic interventions, timing of antibiotic treatment in pregnancy, criteria for treatment, comorbidities, demographic details, risk factors for preterm delivery such as previous preterm delivery, compliance, rates of spontaneous and total preterm delivery less than 37 weeks and less than 34 weeks, preterm premature rupture of membranes, low birth weight less than 2500 grams, spontaneous abortion, postpartum endometritis, and neonatal sepsis. For each study, we measured the effect of treatment by calculating the difference in the rate of a given pregnancy outcome in the control group minus the treatment group (the absolute risk reduction [ARR]). A stepwise procedure based on the profile likelihood was applied to assess heterogeneity, to pool studies when appropriate, and to calculate the mean and 90% confidence intervals (CIs) for the effect of treatment. Data synthesis Seven randomized controlled trials met inclusion criteria for the meta-analysis. We found no benefit to BV treatment in average-risk women for any pregnancy outcome. Results of studies of high-risk populations, women with previous preterm delivery, were statistically heterogeneous. They clustered into two groups; one showed no benefit (ARR=-0.08, 90% CI=-0.19 to 0.04), whereas the three homogeneous studies showed potential benefit of BV treatment (pooled ARR=0.22; 90% CI=0.13 to 0.31) for preterm delivery before 37 weeks. Four high-risk studies reported results for preterm delivery less than 34 weeks. The pooled estimate showed no benefit (ARR=0.04; 90% CI=-0.02 to 0.09), but variation was noted among individual studies. Two trials of high-risk women found an increase in preterm delivery less than 34 weeks in women who did not have BV but received BV treatment. Comparisons of patient populations, treatment regimens, and study designs did not explain the heterogeneity among studies. Conclusions We found no benefit to routine BV screening and treatment. A subgroup of high-risk women may benefit from BV screening and treatment; however, there may be a subgroup for whom BV treatment could increase the occurrence of preterm delivery.

Few topics have stirred as much discussion and controversy as randomization. A reading of the literature suggests that clinical trialists generally feel randomization is necessary for valid inference, while biostatisticians using model-based inference often appear to prefer nearly optimal designs irrespective of any induced randomness. Dissection of the methods of treatment assignment shows that there are five basic approaches; pure randomizers, true randomizers, quasi-randomizers, permutation testers, and conventional modelers. Four of these have coherent design and analysis strategies, even though they are not mutually consistent, but the fifth and most prevalent approach (quasi-randomization) has little to recommend it. Design-adaptive allocation is defined, it is shown to provide valid inference, and a simulation indicates its efficiency advantage. In small studies, or large studies with many important prognostic covariates or analytic subgroups, design-adaptive allocation is an extremely attractive method of treatment assignment.

Background The effect of dietary composition on blood pressure is a subject of public health importance. We studied the effect of different levels of dietary sodium, in conjunction with the Dietary Approaches to Stop Hypertension (DASH) diet, which is rich in vegetables, fruits, and low-fat dairy products, in persons with and in those without hypertension. Methods A total of 412 participants were randomly assigned to eat either a control diet typical of intake in the United States or the DASH diet. Within the assigned diet, participants ate foods with high, intermediate, and low levels of sodium for 30 consecutive days each, in random order. Results Reducing the sodium intake from the high to the intermediate level reduced the systolic blood pressure by 2.1 mm Hg (P

Graphical representations of causation have been usedfor at least seventy years, and the modern developmentof directed acyclic graphs to portray causal systemscontinues the trend. It is sometimes difficult tounderstand, however, what it is about these diagramsthat is `causal'. The approach to causal graphicsthat is taken here is to base the development ofgraphics on the concepts of an underlying causaltheory, the minimal sufficient cause model. Thisleads to defining a Boolean `and' for arrows thatrepresent causal pathways, and a Boolean `or' forcollections of pathways. Complementation is a morecomplex operation in the minimal sufficient causetheory than simply inverting the sense of a causalrelationship, and this also is represented in thegraphics. By using diagrams that are more faithful tounderlying causal systems, and using a coherent causaltheory, both the perception of causation and itsanalysis might be enhanced.

We report the cytogenetic abnormalities from a series of 206 primary malignant melanoma specimens referred to a single institution. A total of 169 out of 206 unique cases had chromosome breakpoints. A previously described statistical method was used to detect nonrandom distribution of chromosome breakpoints at the level of chromosome regions. Nonrandom occurrence of chromosome breakpoints (indicating that the observed number of breaks significantly exceeded the expected number of breaks) was detected in 28 regions, suggesting a hierarchy of genetic abnormalities in melanoma. Clinical variables and tumor characteristics were analyzed for associations with the presence of any nonrandom chromosome breakpoints; with individual, nonrandomly involved chromosome regions; and with paired, nonrandomly involved chromosome regions. No nonrandomly involved chromosome regions or pairs of regions appeared to significantly affect survival. These results identify recurring, nonrandom chromosome abnormalities in malignant melanoma. These results suggest that recurring, nonrandom chromosome alterations play a key role in the etiology and/or progression of malignant melanoma and identify targets within the genome for molecular genetic studies.

Peer education in the Arizona 5-a-Day project achieved lasting improvements in fruit and vegetable intake among multicultural employees. Measures monitored implementation of peer education from peer educators’ logs, the program’s reach from employee surveys, and employees’ use in terms of employees’ dietary change. Peer educators logged 9,182 coworker contacts. Contacts averaged 10.9 minutes, according to coworkers. Coworkers read an average of 4.7 booklets and 2.23 newsletters. Many employees talked with peer educators (59%) and read materials (54%) after the program finished. Employee reports of peer educator contact were positively associated with fruit and vegetable intake. Peer education was implemented as intended and reached many coworkers. It continued after program completion, reached into coworkers’ families, and was used by employees to improve intake. This method can be used with employees who rely on informal sources and whose work presents barriers to wellness activities.

The Dempster–Shafer approach to expressing beliefabout a parameter in a statistical model is notconsistent with the likelihood principle. Thisinconsistency has been recognized for some time, andmanifests itself as a non-commutativity, in which theorder of operations (combining belief, combininglikelihood) makes a difference. It is proposed herethat requiring the expression of belief to be committed to the model (and to certain of itssubmodels) makes likelihood inference very nearly aspecial case of the Dempster–Shafer theory.

Background: The National Cancer Institute recommends that Americans eat at least five daily servings of fruits and vegetables. National strategies to increase consumption may not reach minority and lower socioeconomic populations. In a randomized trial, peer education was tested for effectiveness at increasing fruit and vegetable intake among lower socioeconomic, multicultural labor and trades employees. Methods: Employees (n = 2091) completed a baseline survey and received an 18-month intervention program through standard communication channels (e.g., workplace mail, cafeteria promotions, and speakers). Ninety-three social networks (cliques) of employees were identified, which were pair matched on intake. At an interim survey (during months 8 and 9), 11 cliques no longer existed and 41 matched pairs of cliques containing 905 employees remained, with one clique per pair being randomly assigned to the peer education intervention. Employees who were central in the communication flow of the peer intervention cliques served as peer educators during the last 9 months of the intervention program. Fruit and vegetable intake was measured with 24-hour intake recall and with food-frequency questions in baseline, outcome (i.e., at 18 months), and 6-month follow-up surveys. All P values are two-sided. Results : By use of multiple regression, statistically significant overall effects of the peer education program were seen in the intake recall (increase of 0.77 total daily servings; P

The DASH Diet, Sodium Intake and Blood Pressure Trial (DASH-Sodium) is a multicenter, randomized trial comparing the effects of 3 levels of sodium intake and 2 dietary patterns on blood pressure among adults with higher than optimal blood pressure or with stage 1 hypertension (120–159/80–95 mm Hg). The 2 dietary patterns are a control diet typical of what many Americans eat, and the DASH diet, which, by comparison, emphasizes fruits, vegetables, and low-fat dairy foods, includes whole grains, poultry, fish, and nuts, and is reduced in fats, red meat, sweets, and sugar-containing beverages. The 3 sodium levels are defined as higher (typical of current US consumption), intermediate (reflecting the upper limit of current US recommendations), and lower (reflecting potentially optimal levels). Participants are randomly assigned to 1 of the 2 dietary patterns using a parallel group design and are fed each of the 3 sodium levels using a randomized crossover design. The study provides participants with all of their food during a 2-week run-in feeding period and three 30-day intervention feeding periods. Participants attend the clinic for 1 meal per day, 5 days per week, and take home food for other meals. Weight is monitored and individual energy intake adjusted to maintain baseline weight. The primary outcome is systolic blood pressure measured at the end of each intervention feeding period. Systolic blood pressure is compared across the 3 sodium levels within each diet and across the 2 diets within each sodium level. If effects previously observed in clinical trials are additive, sodium reduction and the DASH diet together may lower blood pressure to an extent not as yet demonstrated for nonpharmacologic treatment. The DASH-Sodium results will have important implications for the prevention and treatment of high blood pressure. J Am Diet Assoc. 1999;99(suppl):S96–S104.

In a large series of ovarian carcinomas from 244 patients, 134 cases had chromosome rearrangements. We showed before that the pattern of chromosome breakpoints involved 21 separate chromosome regions nonrandomly and, in 90% of cases with breaks, the breakpoints occurred within 13 commonly involved regions. Log-rank and proportional hazards regression analyses showed that the aggregate presence of a chromosome breakpoint in any of 21 nonrandomly involved regions and breaks in 9 distinct regions (1p1, 1q2, 1p3, 3p1, 6p2, 11p1, 11q1, 12q2, and 13p1) were associated with reduced patient survival. Breakpoints in other areas of the genome, including other nonrandomly involved regions, were not associated with decreased survival. Because many cases had breakpoints in more than one nonrandomly involved region, proportional hazards regression was also used to analyze for effects of each nonrandomly involved region, controlling for effects of other regions. With this approach, only breakpoints within 1p1 and 3p1 retained independent, deleterious effects on survival. Similarly, when nonrandomly involved regions were entered into a proportional hazards model containing clinical variables associated with altered patient survival (tumor grade, tumor stage, and residual disease > 1 cm after resection), only 1p1 (P = 0.007) and 3p1 (P = 0.04) were associated with independent, negative effects on survival. These studies demonstrate that chromosome breakpoints within specific, nonrandomly involved chromosome regions are associated with impaired survival in ovarian cancers. Regions 1p1 and 3p1 are identified as areas of particular significance and are appropriate targets for analytical techniques such as SAGE and microarray analysis.