Patrick J. O’Connor

Lessons from Experienced Guideline Implementers: Attend to Many Factors and Use Multiple Strategies

BACKGROUND Studies of clinical guideline implementation have focused almost entirely on changing individual clinician behavior with single intervention strategies and without much attention to the situational context. The goal of this project was to learn from clinic leaders, seasoned in the guideline implementation process, what contextual variables they viewed as important and whether implementation success could be expected if only a single implementation strategy was used. METHODS In 1998, 12 people with extensive experience in leading clinical guideline implementation were identified who were thought to have particularly keen insight into the process. They were interviewed to generate variables they considered important, as well as strategies they considered effective when used appropriately. A modified nominal group/Delphi process was then used for rating these variables and strategies, and the reactions of international experts were obtained to add perspective to this information. RESULTS Eighty-seven variables and 25 strategies were identified, clustering in 6 categories (ranked in order of importance by the panel): organizational capabilities for change, infrastructure for implementation, implementation strategies, medical group characteristics, guideline characteristics, and external environment. All six categories were considered to be important, key, or essential by the experienced implementers, although variables within a medical group that directly affect its ability to undertake planned change were rated as much more important than either guideline characteristics or the external environment. DISCUSSION Although the opinions of those experienced in the process of guideline implementation are primarily of value for generating hypotheses, panel members believe that implementation efforts focusing on the individual physician with a single strategy are unlikely to be successful. Rather, implementation efforts must use multiple strategies that take account of multiple characteristics of the guideline, practice organization, and external environment.

The Effect of Exercise Training on Anxiety Symptoms Among Patients: A Systematic Review

BACKGROUND Anxiety often remains unrecognized or untreated among patients with a chronic illness. Exercise training may help improve anxiety symptoms among patients. We estimated the population effect size for exercise training effects on anxiety and determined whether selected variables of theoretical or practical importance moderate the effect. METHODS Articles published from January 1995 to August 2007 were located using the Physical Activity Guidelines for Americans Scientific Database, supplemented by additional searches through December 2008 of the following databases: Google Scholar, MEDLINE, PsycINFO, PubMed, and Web of Science. Forty English-language articles in scholarly journals involving sedentary adults with a chronic illness were selected. They included both an anxiety outcome measured at baseline and after exercise training and random assignment to either an exercise intervention of 3 or more weeks or a comparison condition that lacked exercise. Two co-authors independently calculated the Hedges d effect sizes from studies of 2914 patients and extracted information regarding potential moderator variables. Random effects models were used to estimate sampling error and population variance for all analyses. RESULTS Compared with no treatment conditions, exercise training significantly reduced anxiety symptoms by a mean effect Delta of 0.29 (95% confidence interval, 0.23-0.36). Exercise training programs lasting no more than 12 weeks, using session durations of at least 30 minutes, and an anxiety report time frame greater than the past week resulted in the largest anxiety improvements. CONCLUSION Exercise training reduces anxiety symptoms among sedentary patients who have a chronic illness.

Effect of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Control: A Cluster Randomized Clinical Trial

IMPORTANCE Only about half of patients with high blood pressure (BP) in the United States have their BP controlled. Practical, robust, and sustainable models are needed to improve BP control in patients with uncontrolled hypertension. OBJECTIVES To determine whether an intervention combining home BP telemonitoring with pharmacist case management improves BP control compared with usual care and to determine whether BP control is maintained after the intervention is stopped. DESIGN, SETTING, AND PATIENTS A cluster randomized clinical trial of 450 adults with uncontrolled BP recruited from 14,692 patients with electronic medical records across 16 primary care clinics in an integrated health system in Minneapolis-St Paul, Minnesota, with 12 months of intervention and 6 months of postintervention follow-up. INTERVENTIONS Eight clinics were randomized to provide usual care to patients (n = 222) and 8 clinics were randomized to provide a telemonitoring intervention (n = 228). Intervention patients received home BP telemonitors and transmitted BP data to pharmacists who adjusted antihypertensive therapy accordingly. MAIN OUTCOMES AND MEASURES Control of systolic BP to less than 140 mm Hg and diastolic BP to less than 90 mm Hg (<130/80 mm Hg in patients with diabetes or chronic kidney disease) at 6 and 12 months. Secondary outcomes were change in BP, patient satisfaction, and BP control at 18 months (6 months after intervention stopped). RESULTS At baseline, enrollees were 45% women, 82% white, mean (SD) age was 61.1 (12.0) years, and mean systolic BP was 148 mm Hg and diastolic BP was 85 mm Hg. Blood pressure was controlled at both 6 and 12 months in 57.2% (95% CI, 44.8% to 68.7%) of patients in the telemonitoring intervention group vs 30.0% (95% CI, 23.2% to 37.8%) of patients in the usual care group (P = .001). At 18 months (6 months of postintervention follow-up), BP was controlled in 71.8% (95% CI, 65.0% to 77.8%) of patients in the telemonitoring intervention group vs 57.1% (95% CI, 51.5% to 62.6%) of patients in the usual care group (P = .003). Compared with the usual care group, systolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-10.7 mm Hg [95% CI, -14.3 to -7.3 mm Hg]; P<.001), at 12 months (-9.7 mm Hg [95% CI, -13.4 to -6.0 mm Hg]; P<.001), and at 18 months (-6.6 mm Hg [95% CI, -10.7 to -2.5 mm Hg]; P = .004). Compared with the usual care group, diastolic BP decreased more from baseline among patients in the telemonitoring intervention group at 6 months (-6.0 mm Hg [95% CI, -8.6 to -3.4 mm Hg]; P<.001), at 12 months (-5.1 mm Hg [95% CI, -7.4 to -2.8 mm Hg]; P<.001), and at 18 months (-3.0 mm Hg [95% CI, -6.3 to 0.3 mm Hg]; P = .07). CONCLUSIONS AND RELEVANCE Home BP telemonitoring and pharmacist case management achieved better BP control compared with usual care during 12 months of intervention that persisted during 6 months of postintervention follow-up. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00781365.

A Review of Physical Activity Patterns in Pregnant Women and Their Relationship to Psychological Health

Regular physical activity contributes positively to physical and psychological health. Adverse consequences of inactivity may be an especially important problem among pregnant women. Up to 60% are inactive during pregnancy. This review found consistent evidence that physical activity is reduced during pregnancy; however, few investigators have sought to quantify physical activity patterns among pregnant women using well validated measures. Some of the barriers to physical activity during pregnancy, such as depression, anxiety and fatigue, have been shown to be attenuated by regular exercise performed by non-pregnant samples. There is a need to better understand the relationships between these factors and physical activity during pregnancy.Available retrospective and prospective results suggest that both leisure time and work-related physical activities are decreased across pregnancy. Intensity and duration decrease both during pregnancy compared with pre-pregnancy and in the third trimester compared with the first. There is a need for well designed longitudinal investigations that document pregnancy-related changes in physical activity at frequent intervals during pregnancy using validated and more precise measures of physical activity.Reductions in physical activity and a worsening mood are common during pregnancy. If the relationship between physical inactivity and mood disturbances is indeed observed and maintained during pregnancy, then decreases in physical activity in the third trimester would be expected to result in a worsening mood. In recent years, increased attention has been paid to antenatal mood disturbances, and this research has yielded a host of important findings. Prior correlational and experimental research with non-pregnant samples has demonstrated a consistent relationship between physical inactivity and mood disturbances. Whether this relationship occurs among pregnant women and/or is maintained as women progress during pregnancy is uncertain. Prior investigations have revealed that there is higher rate of mood disturbance during pregnancy than following pregnancy but little is known about the mechanisms that cause these mood disturbances. It is important to better understand changes in mood with pregnancy because mood disturbances can have major negative consequences for a pregnant woman. The major adverse consequences of depression among pregnant women are largely the same as those of non-pregnant individuals. Only six investigations have quantified the relationship between changes in physical activity and changes in mood during pregnancy. The available evidence suggests that inactivity is associated with worse mood. Additional research into this topic is warranted due to the limited number of published papers and the design and methodology limitations of these investigations.

Functional neuroimaging correlates of mental fatigue induced by cognition among chronic fatigue syndrome patients and controls.

The neural mechanisms underlying feelings of fatigue are poorly understood. The primary purpose of the study was to use functional magnetic resonance imaging (fMRI) to determine the association between feelings of mental fatigue and blood oxygen level dependent (BOLD) brain responses during a mentally fatiguing cognitive task. Healthy, non-fatigued controls and chronic fatigue syndrome (CFS) patients were included to determine the influence of chronic levels of fatigue on brain responses. We hypothesized that mental fatigue would be significantly related to brain activity during a fatiguing cognitive task but not during either a non-fatiguing motor (finger tapping) or cognitive (auditory monitoring) task. Patients (n=9) and controls (n=11) completed a finger tapping task, a simple auditory monitoring task and a challenging working memory task, designed to induce mental fatigue, while undergoing fMRI. Fatigue was measured prior to scanning and following each task during fMRI data collection. Results showed that mental fatigue was significantly related to brain activity during the fatiguing cognitive task but not the finger tapping or simple auditory monitoring tasks. Significant (p< or =0.005) positive relationships were found for cerebellar, temporal, cingulate and frontal regions. A significant (p=0.001) negative relationship was found for the left posterior parietal cortex. CFS participants did not differ from controls for either finger tapping or auditory monitoring tasks, but exhibited significantly greater activity in several cortical and subcortical regions during the fatiguing cognitive task. Our results suggest an association between subjective feelings of mental fatigue and brain responses during fatiguing cognition.

Effect of exercise training on depressive symptoms among patients with a chronic illness: a systematic review and meta-analysis of randomized controlled trials

BACKGROUND Physical inactivity and comorbid depressive symptoms are prevalent among patients with a chronic illness. To our knowledge, randomized controlled trials of the effects of exercise training on depressive symptoms among patients with a chronic illness have not been systematically reviewed. We estimated the population effect of exercise training on depressive symptoms and determined whether the effect varied according to patient characteristics and modifiable features of exercise exposure and clinical settings. METHODS Articles published before June 1, 2011, were located using the Physical Activity Guidelines for Americans Scientific Database, Google Scholar, MEDLINE, PsycINFO, PubMed, and Web of Science. Ninety articles involving 10,534 sedentary patients with a chronic illness were selected. Included articles required (1) randomized allocation to an exercise intervention or nonexercise comparison condition and (2) a depression outcome assessed at baseline and at mid- and/or postintervention. Hedges d effect sizes were computed, study quality was evaluated, and random effects models were used to estimate sampling error and population variance of the observed effects. RESULTS Exercise training significantly reduced depressive symptoms by a heterogeneous mean effect size delta (Δ) of 0.30 (95% CI, 0.25-0.36). Larger antidepressant effects were obtained when (1) baseline depressive symptoms were higher, (2) patients met recommended physical activity levels, and (3) the trial primary outcome, predominantly function related, was significantly improved among patients having baseline depressive symptoms indicative of mild-to-moderate depression. CONCLUSIONS Exercise reduces depressive symptoms among patients with a chronic illness. Patients with depressive symptoms indicative of mild-to-moderate depression and for whom exercise training improves function-related outcomes achieve the largest antidepressant effects.

Effect of caffeine on perceptions of leg muscle pain during moderate intensity cycling exercise

This double-blind, within-subjects experiment examined the effect of ingesting a large dose of caffeine on perceptions of leg muscle pain during moderate intensity cycling exercise. Low-caffeine-consuming college-aged males (n = 16) ingested either caffeine (10 mg x kg(-1) body weight) or placebo and 1 hour later completed 30 minutes of moderate intensity cycling exercise (60% VO(2peak)). The order of drug administration was counter-balanced. Perceptions of leg muscle pain as well as work rate, heart rate, and oxygen uptake (VO(2)) were recorded during exercise. Leg muscle pain ratings were significantly and moderately reduced after a high dose of caffeine. This observation suggests that prior reports showing caffeine improves endurance exercise performance might be partially explained by caffeines hypoalgesic properties. It also suggests that moderate intensity cycling exercise has promise as a useful experimental model for the study of naturally occurring muscle pain.

Impact of an Electronic Medical Record on Diabetes Quality of Care

PURPOSE This study was designed to evaluate the impact of electronic medical record (EMR) implementation on quality of diabetes care. METHODS We conducted a 5-year longitudinal study of 122 adults with diabetes mellitus at an intervention (EMR) clinic and a comparison (non-EMR) clinic. Clinics had similarly trained primary care physicians, similar patient populations, and used a common diabetes care guideline that emphasized the importance of glucose control. The EMR provided basic decision support, including prompts and reminders for diabetes care. Preintervention and postintervention frequency of testing for glycated hemoglobin (HbA1c) and low-density lipoprotein (LDL) levels were compared with and without adjustment for patient age, sex, comorbidity, and baseline HbA1c level. RESULTS Frequency of HbA1c tests increased at the EMR clinic compared with the frequency at the non-EMR clinic (P <.001). HbA1c levels improved in both clinics (P <.05) with no significant differences between clinics 2 years (P = .10) or 4 years (P = .27) after EMR implementation. Similar results were observed for LDL levels. CONCLUSIONS In this controlled study, EMR use led to an increased number of HbA1c and LDL tests but not to better metabolic control. If EMRs are to fulfill their promise as care improvement tools, improved implementation strategies and more sophisticated clinical decision support may be needed.

Outcomes of Combined Cardiovascular Risk Factor Management Strategies in Type 2 Diabetes: The ACCORD Randomized Trial

OBJECTIVE To compare effects of combinations of standard and intensive treatment of glycemia and either blood pressure (BP) or lipids in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. RESEARCH DESIGN AND METHODS ACCORD enrolled 10,251 type 2 diabetes patients aged 40–79 years at high risk for cardiovascular disease (CVD) events. Participants were randomly assigned to hemoglobin A1c goals of <6.0% (<42 mmol/mol; intensive glycemia) or 7.0–7.9% (53–63 mmol/mol; standard glycemia) and then randomized a second time to either 1) systolic BP goals of <120 mmHg (intensive BP) or <140 mmHg (standard BP) or 2) simvastatin plus fenofibrate (intensive lipid) or simvastatin plus placebo (standard lipid). Proportional hazards models were used to assess combinations of treatment assignments on the composite primary (deaths due to CVD, nonfatal myocardial infarction [MI], and nonfatal stroke) and secondary outcomes. RESULTS In the BP trial, risk of the primary outcome was lower in the groups intensively treated for glycemia (hazard ratio [HR] 0.67; 95% CI 0.50–0.91), BP (HR 0.74; 95% CI 0.55–1.00), or both (HR 0.71; 95% CI 0.52–0.96) compared with combined standard BP and glycemia treatment. For secondary outcomes, MI was significantly reduced by intensive glycemia treatment and stroke by intensive BP treatment; most other HRs were neutral or favored intensive treatment groups. In the lipid trial, the general pattern of results showed no evidence of benefit of intensive regimens (whether single or combined) compared with combined standard lipid and glycemia treatment. The mortality HR was 1.33 (95% CI 1.02–1.74) in the standard lipid/intensive glycemia group compared with the standard lipid/standard glycemia group. CONCLUSIONS In the ACCORD BP trial, compared with combined standard treatment, intensive BP or intensive glycemia treatment alone improved major CVD outcomes, without additional benefit from combining the two. In the ACCORD lipid trial, neither intensive lipid nor glycemia treatment produced an overall benefit, but intensive glycemia treatment increased mortality.

Changes in physical activity and short-term changes in health care charges: a prospective cohort study of older adults

BACKGROUND Better understanding the impact of changes in physical activity behavior on short-term health care charges may inform resource allocation decisions to increase population levels of physical activity. This study examines the prospective relationship of changes in physical activity status on short-term changes in health care charges for older adults. METHODS A prospective cohort study was done on a stratified random sample of 2,393 adults aged 50 and older enrolled in a Minnesota health plan, predicting changes in resource use between two periods (September 1994 to August 1995 and September 1996 to August 1997) based on billed health care charges. RESULTS After adjustment for age, gender, comorbidity, smoking status, and body mass index, all physical activity states had declining health care charges, relative to those who were consistently inactive. Subjects who increased their physical activity from 0-1 to 3+ days/week had significant declines in their mean annualized total charges (-2,202 dollars, P < 0.01) relative to those who remained inactive. CONCLUSIONS Increased physical activity among older adults is associated with lower health care charges within 2 years, relative to charges for those who were persistently inactive. These cost savings may justify investments in effective interventions to increase physical activity in older adults.