A cluster randomized trial to evaluate physician/pharmacist collaboration to improve blood pressure control.

This was a prospective, cluster randomized controlled trial in patients with uncontrolled hypertension aged 21 to 85 years (mean, 61 years). Pharmacists made recommendations to physicians for patients in the intervention clinics (n=101) but not patients in the control clinics (n=78). The mean adjusted difference in systolic blood pressure (BP) between the control and intervention groups was 8.7 mm Hg (95% confidence interval [CI], 4.4-12.9), while the difference in diastolic BP was 5.4 mm Hg (CI, 2.8-8.0) at 9 months. The 24-hour BP levels showed similar effects, with a mean systolic BP level that was 8.8 mm Hg lower (CI, 5.0-12.6) and a mean diastolic BP level that was 4.6 mm Hg (CI, 2.4-6.8) lower in the intervention group. BP was controlled in 89.1% of patients in the intervention group and 52.9% in the control group (adjusted odds ratio, 8.9; CI, 3.8-20.7; P<.001). Physician/pharmacist collaboration achieved significantly better mean BP values and overall BP control rates, primarily by intensification of medication therapy and improving patient adherence.

Risk factors for insomnia in a rural population.

PURPOSE: This study compared in one data set the relative importance of most previously examined risk factors for different symptoms of insomnia. METHODS: Data were obtained from personal interviews of 1,588 adults in a rural area. Statistical methods evaluated the association of 42 risk factors with any insomnia and each of four insomnia subtypes: difficulty with initiating sleep (DIS), difficulty maintaining sleep (DMS), early morning awakening (EMA), and restless sleep (RS). RESULTS: Insomnia rates were greater in this rural population than most U.S. studies and greater in the United States than other countries. The correlations between insomnia subtype and energy level was highest for RS, -0.29, and lowest for EMA, -0.11. All sleep disturbances increased monotonically with depressive symptoms, but the increase was greatest for RS (r = 0.57) and weakest for EMA (r = 0.24). Anxiety and pain also were independently associated with each insomnia subtype. Insomnia problems of spouses were uncorrelated. Other risk factors were independently associated with some insomnia subtypes but not others. For example, the association of age with difficulty maintaining sleep was independent of health measures. CONCLUSION: The results suggest that different insomnias have different rates and risk factors and therefore possibly different etiologies and management strategies.

Colorectal cancer testing among patients cared for by Iowa family physicians.

BACKGROUND: Colorectal cancer (CRC) can be largely prevented or effectively treated, yet about half of eligible Americans have not been screened. The purpose of this study was to examine patient and physician factors associated with documented CRC testing according to national guidelines. METHODS: Cross-sectional study where 511 randomly selected rural patients aged 55 to 80 years of 16 board-certified Iowa family physicians were enrolled in 2004. Patient survey and medical record information were linked with physician surveys. Predictors of CRC testing were examined using a regression procedure that accommodated random physician effects (2005-2006). RESULTS: Forty-six percent of patients were up-to-date with CRC testing in accordance with national guidelines. This percentage varied from 5% to 75% by physician (p < 0.0001). Of the patients who were up-to-date, 89% had colonoscopy, and 62% had symptoms prior to testing that could indicate CRC. The strongest univariate predictors other than symptoms were patient recollection of physician recommendation (odds ratio [OR] = 6.4, 95% confidence interval [CI] = 4.2-9.6) and physician documentation of recommendation (OR = 14.1, CI = 8.5-23.3). A multivariable regression model showed testing in accordance with guidelines significantly increased with government insurance (OR = 1.6, CI = 1.2-2.3), having a health maintenance visit in the preceding 26 months (OR = 2.4, CI = 1.4-4.1), family history of CRC (OR = 3.1, CI = 1.6-5.8), number of medical conditions (OR = 1.2 for each additional condition, CI = 1.1-1.3), high importance of screening to patient (OR = 2.6, CI = 1.5-4.5), patient satisfaction with doctor's discussions (OR = 3.3, CI = 2.2-4.8), physician trained in flexible sigmoidoscopy (OR = 2.3, CI = 1.6-3.4), and physician report of trying to follow American Cancer Society (ACS) guidelines (OR = 1.7, CI = 1.2-2.5). After excluding patients who had symptoms prior to screening, most of the ORs in the logistic regression analysis increased except that the number of medical conditions and physician trying to follow ACS guidelines became nonsignificant. CONCLUSIONS: Fewer than half of rural patients received CRC testing, and most of those tested had symptoms. Physician recommendations and the manner of presenting the recommendations greatly influenced whether patients were tested.

Do randomized controlled trials always trump case reports? A second look at propranolol and depression.

STUDY OBJECTIVE: To explore reasons for discrepancies between findings from case reports and those from a meta-analysis of randomized controlled trials regarding the association between beta-adrenergic blockers and depression. DESIGN: Systematic review. DATA SOURCE: PubMed/MEDLINE database. MEASUREMENTS AND MAIN RESULTS: We reviewed 24 published case reports showing an association between beta-blockers and depression and eight randomized controlled trials included in a meta-analysis of the adverse effects of these drugs. We abstracted the beta-blocker taken, patients' age and sex, diagnoses, history of depression, type of depressive symptoms reported, and method and timing of the assessment of depression. Naranjo criteria were used to evaluate the strength of evidence from each case report for a possible association between beta-blockers and depression. Twelve case reports had a Naranjo score of 5 or more (suggesting a likely causal relationship), nine of which involved propranolol. In all nine, depression began soon after treatment, and in four, the patient had a history of depression. Three randomized controlled trials assessed propranolol. Depression rates in the control groups of these studies differed substantially from each other (0-40%, p<0.0001). In only one randomized controlled trial did investigators assess depression systematically; they evaluated depression after 1 year of treatment and eliminated patients who had previously been prescribed an antidepressant. CONCLUSION: A criterion standard to assess the true relationship between beta-blockers and depression is lacking. Factors such as the lack of systematic assessment of depression, the timing of assessments, and the selection of patients may have reduced the ability of researchers in the randomized controlled trials to detect depression as an adverse effect. Evidence from case reports should be carefully considered when relevant randomized controlled trials have not been adequately designed to detect adverse effects.

Empirically identified goals for the management of unexplained symptoms.

BACKGROUND AND OBJECTIVES: Effective management of patients with medically unexplained symptoms may be influenced by physicians' goals. This study's objective was to identify physicians' goals for managing primary care patients with unexplained symptoms. METHODS: This was a qualitative study of patients and clinicians from primary care clinics in Iowa and Illinois. Interviews were conducted with 47 patients who had unexplained symptoms and the 36 primary care clinicians who managed them. The interviews were transcribed and coded independently by two investigators. Categories for coding responses were derived from the data and the literature. RESULTS: Eleven goals were identified and grouped into four classes based on whether they were disease centered, patient centered, society centered, or clinician centered. The three goals most commonly held by patients were patient centered: clinician support (62%), functional improvement (45%), and patient coping (43%). The most common clinician goals were symptom alleviation (38%), patient coping (32%), and functional improvement (30%). Only one clinician (2%) cited making the patient feel supported as a goal. CONCLUSIONS: The goals of clinician support and patient coping appear to have value to patients beyond being means for achieving symptom alleviation. Although receiving physician support is an important goal for patients, it was not a commonly recognized goal by physicians. Clearly identified management goals may improve the care of patients with medically unexplained symptoms and help clinicians achieve greater satisfaction with the management of these patients.

Prospective observational study of treatments for unexplained chronic fatigue.

BACKGROUND: Unexplained chronic fatigue is a frequent complaint in primary care. A prospective observational study design was used to evaluate whether certain commonly used therapies for unexplained chronic fatigue may be effective. METHOD: Subjects with unexplained chronic fatigue of unknown etiology for at least 6 months were recruited from the Wisconsin Chronic Fatigue Syndrome Association, primary care clinics, and community chronic fatigue syndrome presentations. The primary outcome measure was change in a 5-question fatigue score from 6 months to 2 years. Self-reported interventions tested included prescribed medications, non-prescribed supplements and herbs, lifestyle changes, alternative therapies, and psychological support. Linear regression analysis was used to test the association of each therapy with the outcome measure after adjusting for statistically significant prognostic factors. RESULTS: 155 subjects provided information on fatigue and treatments at baseline and follow-up. Of these subjects, 87% were female and 79% were middle-aged. The median duration of fatigue was 6.7 years. The percentage of users who found a treatment helpful was greatest for coenzyme Q10 (69% of 13 subjects), dehydroepiandrosterone (DHEA) (65% of 17 subjects), and ginseng (56% of 18 subjects). Treatments at 6 months that predicted subsequent fatigue improvement were vitamins (p = .08), vigorous exercise (p = .09), and yoga (p = .002). Magnesium (p = .002) and support groups (p = .06) were strongly associated with fatigue worsening from 6 months to 2 years. Yoga appeared to be most effective for subjects who did not have unclear thinking associated with the fatigue. CONCLUSION: Certain alternative therapies for unexplained chronic fatigue, especially yoga, deserve testing in randomized controlled trials.

The limited effect of screening for depressive symptoms with the PHQ-9 in rural family practices.

CONTEXT: Previous studies have found that routine screening for depression does not improve patient outcome unless it is combined with case management. However, these studies were conducted before the widespread use of SSRIs or in settings other than traditional primary care. PURPOSE: This study investigated whether screening for depressive symptoms improves outcomes for depressed patients seen in rural fee-for-service primary care offices. METHODS: Depression screening was conducted at 2 private rural clinics in Iowa using the PHQ-9. Patients with depressive symptoms were randomized to the control group or the intervention group, where providers were given completed PHQ-9 questionnaires at the baseline visit. The outcome PHQ-9 scores were assessed by telephone at 4, 10, and 24 weeks after the index visit. FINDINGS: A total of 861 patients were screened for depressive symptoms; 51 subjects enrolled in the trial. The intervention and control groups did not significantly differ with respect to changes in PHQ-9 scores at any of the 3 follow-up times. They also did not differ with respect to the proportion of subjects who were actively managed with medication or by referral to a mental health specialist: 46% vs 33% (P = .38) for all subjects and 50% vs 50% (P = .96) for subjects with major depression at baseline. CONCLUSIONS: Screening for depressive symptoms with the PHQ-9 in 2 rural medical clinics did not significantly increase physicians' active management of depression or lead to improved patient outcomes.

Overview of the evidence for clinical interventions in pediatric dentistry.

PURPOSE: The purpose of this report was to describe the quantity of published literature and types of studies supporting the use of 4 pediatric dentistry procedures: (1) ferric sulfate pulpotomy; (2) stainless steel crowns; (3) space maintainers; and (4) atraumatic restorative technique (ART). METHODS: When available, titles and abstracts of reports written in English and published over a 36-year period (1966-2002) concerning these procedures were retrieved from MEDLINE. They were classified using a modified classification scheme that, in addition to the study designs, also considered the 4 dimensions of measuring dental outcomes. RESULTS: The quantity of available literature concerning each dental procedure varied considerably. Even though many reports were published on treatments, only a small proportion of the published literature for each procedure was found to evaluate outcomes, regardless of outcome dimension. Besides outcomes evaluations, studies on techniques, material properties, and review articles comprised a large proportion of the literature. Clinical dimension of outcomes was most commonly studied. Case series and case reports were the most frequently used study designs to report outcomes. CONCLUSIONS: The outcomes-related literature to support some of the commonly performed treatments is limited both in quantity and study types. More reports are needed to develop the evidence base to support the commonly performed procedures in pediatric dental practice. Additional analyses reporting of the literature are also needed to assess internal and external validity of the studies.

Pooled analysis of antidepressant levels in lactating mothers, breast milk, and nursing infants.

OBJECTIVE: The available data on antidepressant levels in nursing infants were analyzed in order to calculate average infant drug levels and determine what factors influence plasma drug levels in breast-feeding infants of mothers treated with antidepressants. METHOD: Electronic searches of MEDLINE, PreMEDLINE, Current Contents, Biological Abstracts, and PsycINFO from 1966 through July 2002 followed by bibliographic searches identified 67 relevant studies (two unpublished). By consensus the authors identified 57 studies of maternal plasma, breast milk, and/or infant plasma antidepressant levels from nursing mother-infant pairs, measured by liquid chromatography. RESULTS: Infants with recent prenatal exposure and symptomatic infants included in case reports were analyzed separately. Infant plasma levels were standardized against the average maternal level for each drug. The average infant-maternal plasma ratio was calculated for each drug, and correlations of infant plasma level to maternal dose, maternal plasma level, and breast milk level were calculated. Nortriptyline, paroxetine, and sertraline usually produce undetectable infant levels. Of drugs currently used, fluoxetine produces the highest proportion (22%) of infant levels that are elevated above 10% of the average maternal level. Based on smaller numbers, the data on citalopram indicate that it produces elevated levels in 17% of infants. The milk-to-plasma ratios for 11 antidepressants had a statistically significant negative association with the percentage of the drug bound to protein. CONCLUSIONS: Nortriptyline, paroxetine, and sertraline may be preferred choices in breast-feeding women. Minimizing the maternal dose may be helpful with citalopram. Current data do not support monitoring breast milk levels in individual patients. Future researchers should report maternal, breast milk, and infant antidepressant levels along with other appropriate variables.

The effectiveness of citalopram for idiopathic chronic fatigue.

BACKGROUND: Chronic fatigue greatly affects quality of life and is a common reason for physician visits. Patients with chronic fatigue are often treated with antidepressants. METHOD: Prior to enrollment, all subjects had substantial fatigue for 6 months or more that was not explained by depression, organic illness, or lifestyle behaviors. Patients already taking an antidepressant were excluded from the study. Two designs were used. (1) Thirty-one subjects were given placebo for 1 week and then citalopram, 20 to 40 mg/day, for 2 months. Statistical testing evaluated whether fatigue (measured with the Rand Vitality Index) was reduced after citalopram was started. (2) Fatigue changes for subjects taking citalopram were compared with fatigue changes after 1 month and 2 months for 76 similar subjects taking an ineffective treatment. RESULTS: In design 1, fatigue for subjects taking citalopram was significantly and substantially reduced when subjects were switched from placebo to citalopram, p <.05. Benefits at 2 months were greatest for subjects who had fatigue less than 5 years, p <.01, and women, p <.01. In design 2, fatigue scores for subjects taking citalopram were not significantly better than the comparison group for all subjects but were significantly better at 2 months for subjects with less severe fatigue at baseline, p =.005, and for women, p =.08. Depression scores were not significantly better for citalopram subjects overall (p >.10) but were for certain subgroups. For all subjects, citalopram was associated with greater decrease in headaches and muscle aches at 1 month, p <.01. CONCLUSION: Citalopram may improve fatigue and symptoms associated with fatigue for some patients.

Specific phobia of illness in the community.

This study evaluated the prevalence, risk factors and morbidity associated with specific phobia of illness. Subjects were from a random, community telephone survey of 500 persons age 40 to 65 who lived in Johnson County, Iowa, USA. Forty-three subjects reported that illness fears substantially bothered them personally or affected their medical care, work, or social life. Twenty-one of these subjects could be contacted and agreed to a semistructured interview designed to diagnose specific phobia of illness and screen for other common psychiatric disorders. Based on the interview, 10 subjects met the criteria for specific phobia of illness, 10 for major depressive disorder, 5 for obsessive-compulsive disorder, 5 for generalized anxiety disorder, 4 for hypochondriasis, 4 for panic disorder and 4 for specific phobia other than illness. Assuming subjects not interviewed were similar to subjects who were, the community prevalence of specific phobia of illness is 4.0%. Among the 10 subjects with specific phobia of illness, 7 had prior negative experiences with illness and 8 had comorbid Axis I disorders. The phobia interfered with medical care as well as social functioning for many subjects. These results suggest a prevalence rate and risk factors that will be useful for additional studies of illness phobia.

Cohort study of risk factors for breast cancer in post menopausal women.

OBJECTIVES: The present study assessed more than 800 potential risk factors to identify new predictors of breast cancer and compare the independence and relative importance of established risk factors. METHODS: Data were collected by the Women's Health Initiative and included 147,202 women ages 50 to 79 who were enrolled from 1993 to 1998 and followed for 8 years. Analyses performed in 2011 and 2012 used the Cox proportional hazard regression to test the association between more than 800 baseline risk factors and incident breast cancer. RESULTS: Baseline factors independently associated with subsequent breast cancer at the p<0.001 level (in decreasing order of statistical significance) were breast aspiration, family history, age, weight, history of breast biopsies, estrogen and progestin use, fewer live births, greater age at menopause, history of thyroid cancer, breast tenderness, digitalis use, alcohol intake, white race, not restless, no vaginal dryness, relative with prostate cancer, colon polyps, smoking, no breast augmentation, and no osteoporosis. Risk factors previously reported that were not independently associated with breast cancer in the present study included socioeconomic status, months of breast feeding, age at first birth, adiposity measures, adult weight gain, timing of initiation of hormone therapy, and several dietary, psychological, and exercise variables. Family history was not found to alter the risk associated with other factors. CONCLUSIONS: These results suggest that some risk factors not commonly studied may be important for breast cancer and some frequently cited risk factors may be relatively unimportant or secondary.

Lower mortality rates at cardiac specialty hospitals traceable to healthier patients and to doctors' performing more procedures.

Physician-owned cardiac specialty hospitals advertise that they have outstanding physicians and results. To test this assertion, we examined who gets referred to these hospitals, as well as whether different results occur when specialty physicians split their caseloads among specialty and general hospitals in the same markets. Using data on 210,135 patients who underwent percutaneous coronary interventions in Texas during 2004-07, we found that the risk-adjusted in-hospital mortality rate for patients treated at specialty hospitals was significantly below the rate for all hospitals in the state (0.68 percent versus 1.50 percent). However, the rate was significantly higher when physicians who owned cardiac specialty hospitals treated patients in general hospitals (2.27 percent versus 1.50 percent). In addition, several patient characteristics were associated with a lower likelihood of being admitted to a cardiac hospital for cardiac care, such as being African American or Hispanic and having Medicaid or no health insurance. After adjustment for patient severity and number of procedures performed, the overall outcomes for cardiologists who owned specialty hospitals were not significantly different from the "average outcomes" obtained at noncardiac hospitals. In contrast to previous studies, patient outcomes were found to be highly dependent on the type of hospital where the procedure was performed. To remove a potential source of bias and achieve a more balanced comparison, the quality statistics reported by physician-owned cardiac hospitals should be adjusted to incorporate the high rates of poor outcomes for the many procedures done by their cardiologists at nearby noncardiac hospitals.

An assessment of attitudes, behaviors, and outcomes of patients with type 2 diabetes.

OBJECTIVES: Patient self-care behaviors, including taking medication, following a meal plan, exercising regularly, and testing blood glucose, influence diabetes control. The purpose of this research was to identify (1) which barriers to diabetes management are associated with problem behaviors and (2) which patient behaviors and barriers are associated with diabetes control. METHODS: This was a cross-sectional study of linked medical record and self-reported information from patients with type 2 diabetes. A randomly selected sample of 800 clinic patients was mailed an investigator-developed survey. The study sample consisted of 253 (55%) individuals who had measured glycosylated hemoglobin (HbA1c) within 3 months of the survey date. RESULTS: The barriers to each diabetes self-care behavior differed. Cost was the most common barrier to the 4 self-care behaviors. In a multivariable regression model, the belief that type 2 diabetes is a serious problem and depression were strongly associated with higher HbA1c levels. Lower HbA1c levels were significantly associated with being married and greater self-reported adherence-satisfaction with taking medication and testing blood glucose. CONCLUSION: This study expanded earlier research by focusing on 4 specific self-care behaviors, their barriers, and their association with HbA1c. Barriers that were significantly associated with HbA1c were specific to the behavior and varied across behaviors.

State policies and nursing home characteristics associated with rates of resident mistreatment.

BACKGROUND: A federal complaint/incident system was implemented in 2004 with the stated purpose of promoting and protecting the health, safety, and the welfare of residents receiving health care services. This system provided the first national database of mistreatment in the nursing home setting. METHODS: The purpose of this research was to identify state and nursing home characteristics associated with the rates of nursing home resident mistreatment. Outcomes were incident reports filed by nursing home staff and complaints filed by persons other than service providers obtained from the federal complaints/incidents tracking system. Predictor variables used in the analysis of the reporting system included state legislation, census demographic data, and characteristics of the nursing home including aggregate characteristics of the residents. RESULTS: In 2004, based on complaint and incident reports, 1.6% of the nursing home population was reported to be mistreated. The average rates per 1000 residents were 16 reports, 14 investigations, and 4 substantiations. Incident report rates per 1000 ranged from 0.04 in Virginia to 46 in Alabama. Complaint report rates ranged from 0.42 in Hawaii to 52 in New Mexico. Incident outcomes were significantly lower in states that had nursing home statutes that require the facility, rather than the individual, to report mistreatment or in states that defined mistreatment in the nursing home differently from the definitions used by adult protective service statutes. Higher complaint outcomes were associated with lower levels of staffing. After controlling for resident characteristics, mistreatment measures remained associated with nursing home staffing levels but not with elements of statutes. CONCLUSIONS: Documentation of nursing home mistreatment shows substantial differences in report rates across states. These differences cannot be explained by variations in the laws.

The natural history of primary dysmenorrhoea: a longitudinal study.

OBJECTIVE: To describe the prevalence, severity, course and predictive factors of primary dysmenorrhoea in women of all reproductive ages. DESIGN: Prospective mailed surveys in 1985 and 1991. SETTING: University of Iowa, College of Nursing. POPULATION: We began with a stratified sample of 996 nurses who graduated between 1963 and 1984. We analysed data from 404 women who responded to both surveys, but denied endometriosis, pelvic inflammatory disease or uterine fibroids. METHODS: Participants were surveyed twice at an interval of six years (response rates 73% and 78%) regarding menstrual cycle characteristics. For analysis, dysmenorrhoea was dichotomised as none/mild or moderate/severe. We analysed predictive factors using chi2 tests and stepwise logistic regression. MAIN OUTCOME MEASURE: Severity of dysmenorrhoea. Menstrual cramps as experienced when not taking medication to prevent discomfort were rated on a four-point scale: 0 = no dysmenorrhoea, 1 = minimal (can work, somewhat uncomfortable), 2 = moderate (can work, but quite uncomfortable) or 3 = severe dysmenorrhoea (miss work, have to be in bed). RESULTS: In 1985, 80% of respondents were >25 years old and 60% were parous. There were few changes over six years in the prevalence of mild (51% to 53%), moderate (22% to 20%) or severe dysmenorrhoea (4% to 2%). After adjusting for dysmenorrhoea in 1985, each live birth during follow up (OR = 0.20, 95% CI = 0.08 to 0.53) and older age (OR = 0.92, 95% CI = 0.86 to 0.98) were associated with less dysmenorrhoea in 1991. CONCLUSIONS: Primary dysmenorrhoea affects most women throughout the menstrual years. Dysmenorrhoea severe enough to cause absence from work occurs in less than 5% of women. Although improvement and worsening are equally likely for all women, improvement is more likely in women who bear children.