Patti L. Ephraim

Estimating the prevalence of limb loss in the United States: 2005 to 2050.

OBJECTIVE To estimate the current prevalence of limb loss in the United States and project the future prevalence to the year 2050. DESIGN Estimates were constructed using age-, sex-, and race-specific incidence rates for amputation combined with age-, sex-, and race-specific assumptions about mortality. Incidence rates were derived from the 1988 to 1999 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project, corrected for the likelihood of reamputation among those undergoing amputation for vascular disease. Incidence rates were assumed to remain constant over time and applied to historic mortality and population data along with the best available estimates of relative risk, future mortality, and future population projections. To investigate the sensitivity of our projections to increasing or decreasing incidence, we developed alternative sets of estimates of limb loss related to dysvascular conditions based on assumptions of a 10% or 25% increase or decrease in incidence of amputations for these conditions. SETTING Community, nonfederal, short-term hospitals in the United States. PARTICIPANTS Persons who were discharged from a hospital with a procedure code for upper-limb or lower-limb amputation or diagnosis code of traumatic amputation. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURES Prevalence of limb loss by age, sex, race, etiology, and level in 2005 and projections to the year 2050. RESULTS In the year 2005, 1.6 million persons were living with the loss of a limb. Of these subjects, 42% were nonwhite and 38% had an amputation secondary to dysvascular disease with a comorbid diagnosis of diabetes mellitus. It is projected that the number of people living with the loss of a limb will more than double by the year 2050 to 3.6 million. If incidence rates secondary to dysvascular disease can be reduced by 10%, this number would be lowered by 225,000. CONCLUSIONS One in 190 Americans is currently living with the loss of a limb. Unchecked, this number may double by the year 2050.

Epidemiology of limb loss and congenital limb deficiency: A review of the literature

OBJECTIVE To examine the state of research on population-based studies of the incidence of limb amputation and birth prevalence of limb deficiency. DATA SOURCES A total of 18 publication databases were searched, including MEDLINE, CINAHL, and the Cochrane Library. STUDY SELECTION The search was performed by using a hierarchical process. Articles were reviewed for inclusion by 3 reviewers. Inclusion criteria included defined catchment area, calculation of population-based incidence rates, defined etiology of limb loss, and English language. Review articles, animal studies, case reports, cohort studies, letters, and editorials were excluded. DATA EXTRACTION Figures on the estimated incidence of amputation and birth prevalence of congenital limb deficiency were gleaned from selected reports and assembled into a table format by etiology. DATA SYNTHESIS The studies varied in scope, quality, and methodology, making comparisons between studies difficult. Incidence rates of acquired amputation varied greatly between and within nations. Rates of all-cause acquired amputation ranged from 1.2 first major amputations per 10,000 women in Japan to 4.4 per 10,000 men in the Navajo Nation in the United States between 1992 and 1997. Consistent among all nations, the risk of amputation was greatest among persons with diabetes mellitus. CONCLUSIONS Surveillance of congenital limb deficiency exists in much of the developed world. Existing studies of acquired amputation suffer from a host of methodologic problems. Future efforts should be directed toward the application of standardized measures and methods to enable trends to be evaluated over time and comparisons to be made within and between countries.

Self-management improves outcomes in persons with limb loss.

OBJECTIVE To test the acceptance and effectiveness of a community-based self-management (SM) intervention designed to improve outcomes after limb loss. A priori hypothesis was that an SM intervention will be more effective than standard support group activities in improving outcomes. DESIGN Randomized controlled trial. SETTING General community. PARTICIPANTS Intervention (N=287) and control participants (N=235) with major limb loss. INTERVENTION(S) Nine, 90-minute SM group sessions delivered by trained volunteer leaders. Retention rates at immediate postintervention and 6-month follow-up were 97% and 91% for the SM group. MAIN OUTCOME MEASURE(S) Primary outcomes were depression, positive mood, and self-efficacy. Secondary outcomes were improved functional status and quality of life. RESULTS By using intent-to-treat analyses, the odds for being depressed are significantly lower for those in SM group, 50% less likely at treatment completion (95% confidence interval [CI]=0.3-0.9) and 40% less likely at the 6-month follow-up (95% CI=.03-1.1). Treatment completers have a 70% reduction in likelihood of being depressed at posttreatment (P<.01) and this persists at six months (P<.05). For those in the SM group, functional limitations were significantly lower at 6 months (P<.05), and general self-efficacy was significantly higher at immediate posttreatment (P<.05) and at 6 months (P<.05). Treatment completers have generally significantly larger effect sizes at all follow-up points. Pain intensity, self-efficacy for pain control, and quality of life were not significantly different between the groups. Subgroup analyses indicated the impact of the intervention was greater for participants who were less than 3 years postamputation, participants who were less than 65 years of age, or participants who showed at least 1 secondary condition at baseline. CONCLUSIONS The study provides evidence that SM interventions can improve the outcomes of persons with limb loss beyond benefits offered by support groups.

Intravenous Iron Exposure and Mortality in Patients on Hemodialysis

BACKGROUND AND OBJECTIVES Clinical trials assessing effects of larger cumulative iron exposure with outcomes are lacking, and observational studies have been limited by assessment of short-term exposure only and/or failure to assess cause-specific mortality. The associations between short- and long-term iron exposure on all-cause and cause-specific mortality were examined. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS The study included 14,078 United States patients on dialysis initiating dialysis between 2003 and 2008. Intravenous iron dose accumulations over 1-, 3-, and 6-month rolling windows were related to all-cause, cardiovascular, and infection-related mortality in Cox proportional hazards models that used marginal structural modeling to control for time-dependent confounding. RESULTS Patients in the 1-month model cohort (n=14,078) were followed a median of 19 months, during which there were 27.6% all-cause deaths, 13.5% cardiovascular deaths, and 3% infection-related deaths. A reduced risk of all-cause mortality with receipt of >150-350 (hazard ratio, 0.78; 95% confidence interval, 0.64 to 0.95) or >350 mg (hazard ratio, 0.79; 95% confidence interval, 0.62 to 0.99) intravenous iron compared with >0-150 mg over 1 month was observed. There was no relation of 1-month intravenous iron dose with cardiovascular or infection-related mortality and no relation of 3- or 6-month cumulative intravenous iron dose with all-cause or cardiovascular mortality. There was a nonstatistically significant increase in infection-related mortality with receipt of >1050 mg intravenous iron in 3 months (hazard ratio, 1.69; 95% confidence interval, 0.87 to 3.28) and >2100 mg in 6 months (hazard ratio, 1.59; 95% confidence interval, 0.73 to 3.46). CONCLUSIONS Among patients on incident dialysis, receipt of ≤ 1050 mg intravenous iron in 3 months or 2100 mg in 6 months was not associated with all-cause, cardiovascular, or infection-related mortality. However, nonstatistically significant findings suggested the possibility of infection-related mortality with receipt of >1050 mg in 3 months or >2100 mg in 6 months. Randomized clinical trials are needed to assess the safety of exposure to greater cumulative intravenous iron doses.

African American and Non-African American Patients’ and Families’ Decision Making About Renal Replacement Therapies

We conducted focus group meetings of African American and non-African American patients with end-stage renal disease (six groups) and their family members (six groups), stratified by race/ethnicity and treatment. We elicited differences in participants’ experiences with shared decision making about initiating renal replacement therapy (RRT; that is, hemodialysis, peritoneal dialysis, or a kidney transplant). Patients were often very sick when initiating RRT, and had little, if any, time to make a decision about what type of RRT to initiate. They also lacked sufficient information about alternative treatment options prior to initiation. Family members played supportive roles and shared in decision making when possible. Reports were similar for African American and non-African American participants. Our findings suggest that a greater emphasis on the improved engagement of patients and their families in shared decision making about RRT initiation is needed for both ethnic/racial minorities and nonminorities.

Facilitators and barriers to hypertension self-management in urban African Americans: perspectives of patients and family members

Introduction We aimed to inform the design of behavioral interventions by identifying patients’ and their family members’ perceived facilitators and barriers to hypertension self-management. Materials and methods We conducted focus groups of African American patients with hypertension and their family members to elicit their views about factors influencing patients’ hypertension self-management. We recruited African American patients with hypertension (n = 18) and their family members (n = 12) from an urban, community-based clinical practice in Baltimore, Maryland. We conducted four separate 90-minute focus groups among patients with controlled (one group) and uncontrolled (one group) hypertension, as well as their family members (two groups). Trained moderators used open-ended questions to assess participants’ perceptions regarding patient, family, clinic, and community-level factors influencing patients’ effective hypertension self-management. Results Patient participants identified several facilitators (including family members’ support and positive relationships with doctors) and barriers (including competing health priorities, lack of knowledge about hypertension, and poor access to community resources) that influence their hypertension self-management. Family members also identified several facilitators (including their participation in patients’ doctor’s visits and discussions with patients’ doctors outside of visits) and barriers (including their own limited health knowledge and patients’ lack of motivation to sustain hypertension self-management behaviors) that affect their efforts to support patients’ hypertension self-management. Conclusion African American patients with hypertension and their family members reported numerous patient, family, clinic, and community-level facilitators and barriers to patients’ hypertension self-management. Patients’ and their family members’ views may help guide efforts to tailor behavioral interventions designed to improve hypertension self-management behaviors and hypertension control in minority populations.

Neighborhood Socioeconomic Status, Race, and Mortality in Young Adult Dialysis Patients

Young blacks receiving dialysis have an increased risk of death compared with whites in the United States. Factors influencing this disparity among the young adult dialysis population have not been well explored. Our study examined the relation of neighborhood socioeconomic status (SES) and racial differences in mortality in United States young adults receiving dialysis. We merged US Renal Data System patient-level data from 11,027 black and white patients ages 18-30 years old initiating dialysis between 2006 and 2009 with US Census data to obtain neighborhood poverty information for each patient. We defined low SES neighborhoods as those neighborhoods in U.S. Census zip codes with ≥20% of residents living below the federal poverty level and quantified race differences in mortality risk by level of neighborhood SES. Among patients residing in low SES neighborhoods, blacks had greater mortality than whites after adjusting for baseline demographics, clinical characteristics, rurality, and access to care factors. This difference in mortality between blacks and whites was significantly attenuated in higher SES neighborhoods. In the United States, survival between young adult blacks and whites receiving dialysis differs by neighborhood SES. Additional studies are needed to identify modifiable factors contributing to the greater mortality among young adult black dialysis patients residing in low SES neighborhoods.

Selecting renal replacement therapies: what do African American and non-African American patients and their families think others should know? A mixed methods study

BackgroundLittle is known regarding the types of information African American and non-African American patients with chronic kidney disease (CKD) and their families need to inform renal replacement therapy (RRT) decisions.MethodsIn 20 structured group interviews, we elicited views of African American and non-African American patients with CKD and their families about factors that should be addressed in educational materials informing patients’ RRT selection decisions. We asked participants to select factors from a list and obtained their open-ended feedback.ResultsTen groups of patients (5 African American, 5 non-African American; total 68 individuals) and ten groups of family members (5 African American, 5 non-African American; total 62 individuals) participated. Patients and families had a range (none to extensive) of experiences with various RRTs. Patients identified morbidity or mortality, autonomy, treatment delivery, and symptoms as important factors to address. Family members identified similar factors but also cited the effects of RRT decisions on patients’ psychological well-being and finances. Views of African American and non-African American participants were largely similar.ConclusionsEducational resources addressing the influence of RRT selection on patients’ morbidity and mortality, autonomy, treatment delivery, and symptoms could help patients and their families select RRT options closely aligned with their values. Including information about the influence of RRT selection on patients’ personal relationships and finances could enhance resources’ cultural relevance for African Americans.

Developing, testing, and sustaining rehabilitation interventions via participatory action research.

Few published intervention studies in the rehabilitation literature have included consumers in the research process other than as study participants. This lack of consumer involvement in intervention research may contribute to the challenges encountered developing, translating, disseminating, and sustaining evidence-based rehabilitation interventions in clinical practice. The overall objective of this article is to promote the integration of participatory action research (PAR) into rehabilitation intervention research as a mechanism for addressing these gaps. First, we outline essential components of a PAR model across 5 key phases of intervention research, specifically: agenda setting, methods, implementation, diffusion/dissemination, and sustainability. Second, we describe the use of PAR in rehabilitation intervention research within each of these phases by reviewing relevant literature and by providing an illustrative research example from a randomized controlled trial that integrated PAR throughout the research process. Finally, we conclude with a discussion of 5 specific recommendations for promoting the integration of PAR into rehabilitation intervention research.

Development of a decision aid to inform patients’ and families’ renal replacement therapy selection decisions

BackgroundFew educational resources have been developed to inform patients’ renal replacement therapy (RRT) selection decisions. Patients progressing toward end stage renal disease (ESRD) must decide among multiple treatment options with varying characteristics. Complex information about treatments must be adequately conveyed to patients with different educational backgrounds and informational needs. Decisions about treatment options also require family input, as families often participate in patients’ treatment and support patients’ decisions. We describe the development, design, and preliminary evaluation of an informational, evidence-based, and patient-and family-centered decision aid for patients with ESRD and varying levels of health literacy, health numeracy, and cognitive function.MethodsWe designed a decision aid comprising a complementary video and informational handbook. We based our development process on data previously obtained from qualitative focus groups and systematic literature reviews. We simultaneously developed the video and handbook in “stages.” For the video, stages included (1) directed interviews with culturally appropriate patients and families and preliminary script development, (2) video production, and (3) screening the video with patients and their families. For the handbook, stages comprised (1) preliminary content design, (2) a mixed-methods pilot study among diverse patients to assess comprehension of handbook material, and (3) screening the handbook with patients and their families.ResultsThe video and handbook both addressed potential benefits and trade-offs of treatment selections. The 50-minute video consisted of demographically diverse patients and their families describing their positive and negative experiences with selecting a treatment option. The video also incorporated health professionals’ testimonials regarding various considerations that might influence patients’ and families’ treatment selections. The handbook was comprised of written words, pictures of patients and health care providers, and diagrams describing the findings and quality of scientific studies comparing treatments. The handbook text was written at a 4th to 6th grade reading level. Pilot study results demonstrated that a majority of patients could understand information presented in the handbook. Patient and families screening the nearly completed video and handbook reviewed the materials favorably.ConclusionsThis rigorously designed decision aid may help patients and families make informed decisions about their treatment options for RRT that are well aligned with their values.