Donna M. Zulman

Examining the Evidence: A Systematic Review of the Inclusion and Analysis of Older Adults in Randomized Controlled Trials

ABSTRACTBACKGROUNDDue to a shortage of studies focusing on older adults, clinicians and policy makers frequently rely on clinical trials of the general population to provide supportive evidence for treating complex, older patients.OBJECTIVESTo examine the inclusion and analysis of complex, older adults in randomized controlled trials.REVIEW METHODSA PubMed search identified phase III or IV randomized controlled trials published in 2007 in JAMA, NEJM, Lancet, Circulation, and BMJ. Therapeutic interventions that assessed major morbidity or mortality in adults were included. For each study, age eligibility, average age of study population, primary and secondary outcomes, exclusion criteria, and the frequency, characteristics, and methodology of age-specific subgroup analyses were reviewed.RESULTSOf the 109 clinical trials reviewed in full, 22 (20.2%) excluded patients above a specified age. Almost half (45.6%) of the remaining trials excluded individuals using criteria that could disproportionately impact older adults. Only one in four trials (26.6%) examined outcomes that are considered highly relevant to older adults, such as health status or quality of life. Of the 42 (38.5%) trials that performed an age-specific subgroup analysis, fewer than half examined potential confounders of differential treatment effects by age, such as comorbidities or risk of primary outcome. Trials with age-specific subgroup analyses were more likely than those without to be multicenter trials (97.6% vs. 79.1%, p < 0.01) and funded by industry (83.3% vs. 62.7%, p < 0.05). Differential benefit by age was found in seven trials (16.7%).CONCLUSIONClinical trial evidence guiding treatment of complex, older adults could be improved by eliminating upper age limits for study inclusion, by reducing the use of eligibility criteria that disproportionately affect multimorbid older patients, by evaluating outcomes that are highly relevant to older individuals, and by encouraging adherence to recommended analytic methods for evaluating differential treatment effects by age.

Trust in the Internet as a Health Resource Among Older Adults: Analysis of Data from a Nationally Representative Survey

Background Distrust in the Internet as a source of health information remains common among older adults. The influence of this distrust on Internet use for health-related purposes, however, is unclear. Objective The objective of our study was to explore how older adults’ trust in the Internet influences their online health-related activities, and to identify potential targets for improving health-related Internet resources for older adults. Methods Data were obtained from a nationally representative, random digit-dial telephone survey of 1450 adults 50 years of age and older in the United States. A model was developed to conceptualize the hypothesized relationships among individual characteristics, distrust, and avoidance of the Internet as a health resource. Multivariate logistic regression analyses were conducted to examine the association between trust in online health information and use of the Internet for health-related purposes. Additional multivariate logistic regression analyses were conducted to identify the key characteristics associated with trust in online health information, adding sequentially the variables hypothesized to account for distrust among older adults: sociodemographic and health characteristics, inexperience and technical difficulties with the Internet, negative feelings toward the Internet, and lack of awareness about the sources providing the health information found online. Results The mean (SD) age of the study population was 63.7 (10.6) years. Of the 823 (56.8%) Internet users, 628 (76.3%) reported using the Internet as a health resource. Trust in the Internet as a source of health information was associated with using the Internet for a number of health activities, including searching for information about a specific health condition (adjusted OR 4.43, P < .001), purchasing prescription drugs (adjusted OR 2.61, P = .03), and talking with a health care provider about information found online (adjusted OR 2.54, P = .002). Older adults (age ≥65 years) were less likely to trust the Internet as a source of health information (OR 0.63, P = .04), even after adjusting for other sociodemographic characteristics and health and function. This age effect was only slightly attenuated (adjusted OR 0.69, P = .13) after adjusting for inexperience and technical difficulties with the Internet, but it disappeared entirely (adjusted OR 0.96, P = .91) after adjusting for other hypothesized contributors to distrust (including finding the Internet confusing because it provides “too much information,” and lacking awareness about the source providing health information found online). Conclusions Website design features that clearly identify the source and credibility of information and minimize confusion may build trust among older adults and offer an opportunity to increase the utility of the Internet as a health resource for this population.

Patient interest in sharing personal health record information: a web-based survey.

BACKGROUND Electronic personal health record (PHR) systems are proliferating but largely have not realized their potential for enhancing communication among patients and their network of care providers. OBJECTIVE To explore preferences about sharing electronic health information among users of the U.S. Department of Veterans Affairs (VA) PHR system, My HealtheVet. DESIGN Web-based survey of a convenience sample. SETTING My HealtheVet Web site from 7 July through 4 October 2010. PARTICIPANTS 18 471 users of My HealtheVet. MEASUREMENTS Interest in shared PHR access and preferences about who would receive access, the information that would be shared, and the activities that users would delegate. RESULTS Survey respondents were predominantly men (92%) and aged 50 to 64 years (51%) or 65 years or older (39%); approximately 39% reported poor or fair health status. Almost 4 of 5 respondents (79%) were interested in sharing access to their PHR with someone outside of their health system (62% with a spouse or partner, 23% with a child, 15% with another family member, and 25% with a non-VA health care provider). Among those who selected a family member other than a spouse or partner, 47% lived apart from the specified person. Preferences about degree of access varied on the basis of the type of information being shared, the type of activity being performed, and the respondents relationship with the selected person. LIMITATIONS The survey completion rate was 40.8%. Results might not be generalizable to all My HealtheVet users. CONCLUSION In a large survey of PHR users in the VA system, most respondents were interested in sharing access to their electronic health information with caregivers and non-VA providers. Existing and evolving PHR systems should explore secure mechanisms for shared PHR access to improve information exchange among patients and the multiple persons involved in their health care. PRIMARY FUNDING SOURCE Veterans Health Administration and The Robert Wood Johnson Foundation Clinical Scholars Program.

Patient-Provider Concordance in the Prioritization of Health Conditions Among Hypertensive Diabetes Patients

BACKGROUNDMany patients with diabetes have multiple other chronic conditions, but little is known about whether these patients and their primary care providers agree on the relative importance that they assign these comorbidities.OBJECTIVETo understand patterns of patient-provider concordance in the prioritization of health conditions in patients with multimorbidity.DESIGNProspective cohort study of 92 primary care providers and 1,169 of their diabetic patients with elevated clinic triage blood pressure (≥140/90) at nine Midwest VA facilities.MEASUREMENTSWe constructed a patient-provider concordance score based on responses to surveys in which patients were asked to rank their most important health concerns and their providers were asked to rank the most important conditions likely to affect that patient’s health outcomes. We then calculated the change in predicted probability of concordance when the patient reported having poor health status, pain or depression, or competing demands (issues that were more pressing than his health), controlling for both patient and provider characteristics.RESULTSFor 714 pairs (72%), providers ranked the patients most important concern in their list of three conditions. Both patients and providers ranked diabetes and hypertension most frequently; however, providers were more likely to rank hypertension as most important (38% vs. 18%). Patients were more likely than providers to prioritize symptomatic conditions such as pain, depression, and breathing problems. The predicted probability of patient-provider concordance decreased when a patient reported having poor health status (55% vs. 64%, p < 0.01) or non-health competing demands (46% vs. 62%, p < 0.01).CONCLUSIONSPatients and their primary care providers often agreed on the most important health conditions affecting patients with multimorbidity, but this concordance was lower for patients with poor health status or non-health competing demands. Interventions that increase provider awareness about symptomatic concerns and competing demands may improve chronic disease management in these vulnerable patients.

The Relative Merits of Population-Based and Targeted Prevention Strategies

CONTEXT Preventive medicine has historically favored reducing a risk factor by a small amount in the entire population rather than by a large amount in high-risk individuals. The use of multivariable risk prediction tools, however, may affect the relative merits of this strategy. METHODS This study uses risk factor data from the National Health and Nutrition Examination Survey III to simulate a population of more than 100 million Americans aged thirty or older with no history of CV disease. Three strategies that could affect CV events, CV mortality, and quality-adjusted life years were examined: (1) a population-based strategy that treats all individuals with a low- or moderate-intensity intervention (in which the low-intensity intervention represents a public health campaign with no demonstrable adverse effects), (2) a targeted strategy that treats individuals in the top 25 percent based on a single risk factor (LDL), and (3) a risk-targeted strategy that treats individuals in the top 25 percent based on overall CV risk (as predicted by a multivariable prediction tool). The efficiency of each strategy was compared while varying the interventions intensity and associated adverse effects, and the accuracy of the risk prediction tool. FINDINGS The LDL-targeted strategy and the low-intensity population-based strategy were comparable for CV events prevented over five years (0.79 million and 0.75 million, respectively), as were the risk-targeted strategy and moderate-intensity population-based strategy (1.56 million and 1.87 million, respectively). The risk-targeted strategy, however, was more efficient than the moderate-intensity population-based strategy (number needed to treat [NNT] 19 vs. 62). Incorporating a small degree of treatment-related adverse effects greatly magnified the relative advantages of the risk-targeted approach over other strategies. Reducing the accuracy of the prediction tool only modestly decreased this greater efficiency. CONCLUSIONS A population-based prevention strategy can be an excellent option if an intervention has almost no adverse effects. But if the intervention has even a small degree of disutility, a targeted approach using multivariable risk prediction can prevent more morbidity and mortality while treating many fewer people.

Multimorbidity and healthcare utilisation among high-cost patients in the US Veterans Affairs Health Care System

Objectives To investigate the relationship between multimorbidity and healthcare utilisation patterns among the highest cost patients in a large, integrated healthcare system. Design In this retrospective cross-sectional study of all patients in the U.S. Veterans Affairs (VA) Health Care System, we aggregated costs of individuals’ outpatient and inpatient care, pharmacy services and VA-sponsored contract care received in 2010. We assessed chronic condition prevalence, multimorbidity as measured by comorbidity count, and multisystem multimorbidity (number of body systems affected by chronic conditions) among the 5% highest cost patients. Using multivariate regression, we examined the association between multimorbidity and healthcare utilisation and costs, adjusting for age, sex, race/ethnicity, marital status, homelessness and health insurance status. Setting USA VA Health Care System. Participants 5.2 million VA patients. Measures Annual total costs; absolute and share of costs generated through outpatient, inpatient, pharmacy and VA-sponsored contract care; number of visits to primary, specialty and mental healthcare; number of emergency department visits and hospitalisations. Results The 5% highest cost patients (n=261 699) accounted for 47% of total VA costs. Approximately two-thirds of these patients had chronic conditions affecting ≥3 body systems. Patients with cancer and schizophrenia were less likely to have documented comorbid conditions than other high-cost patients. Multimorbidity was generally associated with greater outpatient and inpatient utilisation. However, increased multisystem multimorbidity was associated with a higher outpatient share of total costs (1.6 percentage points per affected body system, p<0.01) but a lower inpatient share of total costs (−0.6 percentage points per affected body system, p<0.01). Conclusions Multisystem multimorbidity is common among high-cost VA patients. While some patients might benefit from disease-specific programmes, for most patients with multimorbidity there is a need for interventions that coordinate and maximise efficiency of outpatient services across multiple conditions.

Quality of care for patients with multiple chronic conditions: the role of comorbidity interrelatedness.

ABSTRACTMultimorbidity—the presence of multiple chronic conditions in a patient—has a profound impact on health, health care utilization, and associated costs. Definitions of multimorbidity in clinical care and research have evolved over time, initially focusing on a patient’s number of comorbidities and the associated magnitude of required care processes, and later recognizing the potential influence of comorbidity characteristics on patient care and outcomes. In this article, we review the relationship between multimorbidity and quality of care, and discuss how this relationship may be mediated by the degree to which conditions interact with one another to generate clinical complexity (comorbidity interrelatedness). Drawing on established theoretical frameworks from cognitive engineering and biomedical informatics, we describe how interactions among conditions result in clinical complexity and may affect quality of care. We discuss how this comorbidity interrelatedness influences the value of existing quality guidelines and performance metrics, and describe opportunities to quantify this construct using data widely available through electronic health records. Incorporating comorbidity interrelatedness into conceptualizations of multimorbidity has the potential to enhance clinical and research efforts that aim to improve care for patients with multiple chronic conditions.

The influence of diabetes psychosocial attributes and self-management practices on change in diabetes status.

OBJECTIVE To examine the influence of diabetes psychosocial attributes and self-management on glycemic control and diabetes status change. METHODS Using data from the Health and Retirement Study, a nationally representative longitudinal study of U.S. adults >51 years, we examined cross-sectional relationships among diabetes psychosocial attributes (self-efficacy, risk awareness, care understanding, prioritization of diabetes, and emotional distress), self-management ratings, and glycemic control. We then explored whether self-management ratings and psychosocial attributes in 2003 predicted change in diabetes status in 2004. RESULTS In multivariate analyses (N=1834), all diabetes psychosocial attributes were associated with self-management ratings, with self-efficacy and diabetes distress having the strongest relationships (adj coeff=8.1, p<0.01 and -4.1, p<0.01, respectively). Lower self-management ratings in 2003 were associated cross-sectionally with higher hemoglobin A1C (adj coeff=0.16, p<0.01), and with perceived worsening diabetes status in 2004 (adj OR=1.36, p<0.05), with much of this latter relationship explained by diabetes distress. CONCLUSION Psychosocial attributes, most notably diabetes-related emotional distress, contribute to difficulty with diabetes self-management, poor glycemic control, and worsening diabetes status over time. PRACTICE IMPLICATIONS Self-management and adherence interventions should target psychosocial attributes such as disease-related emotional distress.

Costs Associated With Multimorbidity Among VA Patients

Background:Multimorbidity (the presence of multiple chronic conditions) is associated with high levels of healthcare utilization and associated costs. We investigated the association between number of chronic conditions and costs of care for nonelderly and elderly Veterans Affairs (VA) patients, and estimated mean VA healthcare costs for the most prevalent and most costly combinations of 3 conditions (triads). Methods:We identified a cohort of 5,233,994 patients who received care within the VA system in fiscal year 2010. We estimated the costs of VA care for each patient using established methods and aggregated costs for inpatient care, outpatient care, prescription drugs, and contract care. Using ICD-9 diagnosis fields from all inpatient and outpatient records, we determined the prevalence of 28 chronic conditions and all condition triads. We then compared the condition-cost gradient, most prevalent triads, and most costly triads among nonelderly (below 65 y) and elderly (65 y and above) patients. Results:Almost one third of nonelderly and slightly more than a third of elderly VA patients had ≥3 conditions, but these patients accounted for 65% and 67% of total VA healthcare costs, respectively. The most common triad of chronic conditions for both nonelderly and elderly patients was diabetes, hyperlipidemia, and hypertension (24% and 29%, respectively). Conditions that were present in the most costly triads included spinal cord injury, heart failure, renal failure, ischemic heart disease, peripheral vascular disease, stroke, and depression. Although patients with the most costly triads had average costs that were 3 times higher than average costs among patients with ≥3 conditions, the prevalence of these costly triads was extremely low (0.1%–0.4%). Conclusions:Patients with multiple chronic conditions account for a disproportionate share of VA healthcare expenditures. Interventions that aim to optimize care and contain costs for multimorbid patients need to incorporate strategies specific to the most prevalent and the most costly combinations of conditions.

Adapting an in-person patient–caregiver communication intervention to a tailored web-based format

Background: Interventions that target cancer patients and their caregivers have been shown to improve patient‐caregiver communication, support, and emotional well‐being.