Fostering Innovation in Symptom Management among Hemodialysis Patients: Paths Forward for Insomnia, Muscle Cramps, and Fatigue.

Individuals receiving in-center maintenance hemodialysis bear a high burden of both physical and mood symptoms. More than half of patients on hemodialysis report sleep disturbance, muscle cramps, and fatigue. Patients describe symptoms as having a deleterious effect on their quality of life, suggesting that symptom alleviation may meaningfully improve patient-reported outcomes. Moreover, patients on hemodialysis have identified symptom management as a key area for research and innovation, prioritizing symptom alleviation over other health outcomes such as mortality and biochemical indices. Despite the importance of symptoms to patients, there has been little research explicitly geared toward improving patient symptoms, and therefore minimal innovation in symptom management. In general, the physiologic underpinnings of symptoms are poorly understood, hampering the development of targeted therapies. In fact, there have been few drugs or devices approved by the US Food and Drug Administration for the indication of improving any patient-reported outcomes for patients on hemodialysis. Recognizing this gap in innovation, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and US Food and Drug Administration, convened a workgroup to first prioritize symptoms for the development of therapeutic interventions, and then identify near-term actionable research goals for the prioritized physical symptoms of insomnia, muscle cramps, and fatigue. This paper summarizes the pathophysiology of the three prioritized symptoms, identifies key knowledge gaps, acknowledges factors that challenge development of new therapies, and offers the nephrology community actionable research goals for insomnia, muscle cramps, and fatigue.

A Two-Wave Observational Study of Compliance With Youth Access and Tobacco Advertising Provisions of the Cigarettes and Other Tobacco Products Act in India.

INTRODUCTION: The Indian Cigarettes and Other Tobacco Products Act prohibits youths' access to tobacco products at points-of-sale and near educational institutions, requires signage stating these restrictions in these venues, and bans outdoor advertisements. This observational study examined compliance with these provisions, changes in compliance over 1 year, and factors associated with compliance. METHODS: Data were collected in 2012 and 2013 from points-of-sale (n = 555 in 2012, n = 718 in 2013), educational institutions (n = 277 in 2012, n = 276 in 2013), and neighborhoods (n = 104 in 2012, n = 125 in 2013) in 25 urban and rural towns in five states. Compliance across years was compared using chi-square tests. Multilevel regression equations assessed factors associated with compliance at Wave 2 and change in compliance from Wave 1 to Wave 2. RESULTS: Most points-of-sale had no/low compliance, with little change over time (58% to 63%, P = .108). The proportion of educational institutions observing just 1-2 provisions increased (39% to 52%, P = .002). Most neighborhoods complied with the advertisement ban at both waves (91% to 96%, P = .172). In the multilevel analysis, point-of-sale compliance increased in small cities; compliance decreased at points-of-sale and increased at institutions in mid-sized cities. Changes in point-of-sale compliance were due to compliance with access restrictions and signage requirements; changes in educational institution compliance were due to compliance with the sales ban. CONCLUSIONS: Compliance with provisions regarding the sale and display of tobacco products is moderate, while compliance with the advertisement ban remains high in these five Indian states. Greater enforcement will further reduce youths' exposure to tobacco products. IMPLICATIONS: The study adds to the literature on compliance and changes in compliance with policy to prohibit youth access to tobacco products in India, a country that has large geographic disparities in youth smoking prevalence. The findings highlight several important areas on which efforts can focus to improve compliance among points-of-sale, educations institutions, and neighborhoods to limit youths' exposure and access to tobacco products. Rural areas and large cities in particular need more concerted efforts.