Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: The SMILE study

Weisbord, Steven D.; Shields, Andrew; Mor, Maria K.; Sevick, Mary Ann; Homer, Marcia; Peternel, Janet; Porter, Patricia; Rollman, Bruce L.; Palevsky, Paul M.; Arnold, Robert M.; Fine, Michael J.

doi:10.1016/j.cct.2010.06.005

Cited by 28 publications

(28 citation statements)

References 38 publications

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“…In fact, we could find no RCTs studying the most commonly prescribed opioids in ESRD. Currently, one group is attempting to address this deficiency (37), but more trials are needed.…”

Section: Discussionmentioning

confidence: 99%

Opioid and Benzodiazepine Use in End-Stage Renal Disease

Wyne

Rai

Cuerden

et al. 2011

Clinical Journal of the American Society of Nephrology

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SummaryBackground and objectives Chronic pain and psychiatric disorders are common in dialysis patients, but the extent to which opioids and benzodiazepines are used is unclear. We conducted a systematic review to determine the: (1) prevalence of opioid and benzodiazepine use among dialysis patients; (2) reasons for use; (3) effectiveness of symptom control; and (4) incidence of adverse events.Design, setting, participants, & measurements Two authors reviewed all relevant citations in MEDLINE/ EMBASE/CINAHL/BIOSIS Previews/Cochrane and hand-searched bibliographies. Studies after 1990 reporting prevalence estimates for opioid and/or benzodiazepine use in Ն50 dialysis patients were included. ResultsWe identified 15 studies from 12 countries over 1995 to 2006. Sample size ranged from 75 to 12,782. Prevalence of opioid and benzodiazepine use was variable, ranging from 5 to 36% (95% CI, 4.1 to 45.5%; n ϭ 10) and 8 to 26% (95% CI, 7.1 to 27.3%; n ϭ 9), respectively. Prevalence was positively correlated with years on dialysis. Five studies reported on the same cohorts but gave different prevalence estimates. One study verified medication use through patient interviews. Reasons for use were reported in one study. Effectiveness of pain control varied from 17 to 38%, and 72 to 84% of patients with significant pain had no analgesia (n ϭ 2). No study rigorously examined for adverse events. ConclusionsThe prevalence of opioid and benzodiazepine use in dialysis patients is highly variable between centers. Further information is needed regarding the appropriateness of these prescriptions, adequacy of symptom control, and incidence of adverse effects in this population.

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“…In fact, we could find no RCTs studying the most commonly prescribed opioids in ESRD. Currently, one group is attempting to address this deficiency (37), but more trials are needed.…”

Section: Discussionmentioning

confidence: 99%

Opioid and Benzodiazepine Use in End-Stage Renal Disease

Wyne

Rai

Cuerden

et al. 2011

Clinical Journal of the American Society of Nephrology

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“…This study used data collected from participants of the Symptom Management Involving End-Stage Renal Disease (SMILE) trial, a multicenter, randomized trial comparing two strategies (feedback to renal providers versus nurse-driven intervention) for the management of pain, depression, and sexual dysfunction in patients receiving chronic hemodialysis (26,27). The SMILE trial, which was conducted between 2009 and 2011, enrolled cognitively intact (Mini Cog score=3), English-speaking adults receiving outpatient hemodialysis at one of nine dialysis units in Western Pennsylvania.…”

Section: Patient Populationmentioning

confidence: 99%

Associations of Depressive Symptoms and Pain with Dialysis Adherence, Health Resource Utilization, and Mortality in Patients Receiving Chronic Hemodialysis

Weisbord

Mor

Sevick

et al. 2014

Clinical Journal of the American Society of Nephrology

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124

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“…Subjects included in this analysis were enrolled in the SMILE study, a multicenter randomized clinical trial comparing symptom management strategies in patients treated with chronic hemodialysis (27). Study personnel recruited patients from nine outpatient dialysis units in and around Pittsburgh, Pennsylvania between January 2009 and January 2010.…”

Section: Patient Populationmentioning

confidence: 99%

Prevalence and Demographic and Clinical Associations of Health Literacy in Patients on Maintenance Hemodialysis

Green

Mor

Shields

et al. 2011

Clinical Journal of the American Society of Nephrology

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101

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SummaryBackground and objectives Although limited health literacy is estimated to affect over 90 million Americans and is recognized as an important public health concern, there have been few studies examining this issue in patients with chronic kidney disease. We sought to characterize the prevalence of and associations of demographic and clinical characteristics with limited health literacy in patients receiving maintenance hemodialysis.Design, setting, participants, & measurements As part of a prospective clinical trial of symptom management strategies in 288 patients treated with chronic hemodialysis, we assessed health literacy using the Rapid Estimate of Adult Literacy in Medicine (REALM). We defined limited health literacy as a REALM score Յ60 and evaluated independent associations of demographic and baseline clinical characteristics with limited health literacy using multivariable logistic regression. ResultsOf the 260 patients who completed the REALM, 41 demonstrated limited health literacy. AfricanAmerican race, lower educational level, and veteran status were independently associated with limited health literacy. There was no association of limited health literacy with age, gender, serologic values, dialysis adequacy, overall symptom burden, quality of life, or depression.Conclusions Limited health literacy is common among patients receiving chronic hemodialysis. AfricanAmerican race and socioeconomic factors are strong independent predictors of limited health literacy. These findings can help inform the design and implementation of interventions to improve health literacy in the hemodialysis population.

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Methodology of a randomized clinical trial of symptom management strategies in patients receiving chronic hemodialysis: The SMILE study

Cited by 28 publications

References 38 publications

Opioid and Benzodiazepine Use in End-Stage Renal Disease

Opioid and Benzodiazepine Use in End-Stage Renal Disease

Associations of Depressive Symptoms and Pain with Dialysis Adherence, Health Resource Utilization, and Mortality in Patients Receiving Chronic Hemodialysis

Prevalence and Demographic and Clinical Associations of Health Literacy in Patients on Maintenance Hemodialysis

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