Improving access to medicines for non-communicable diseases in rural primary care: results from a quasi-randomized cluster trial in a district in South India.

BACKGROUND: A large proportion of non-communicable diseases (NCDs) are treatable within primary health care (PHC) settings in a cost-effective manner. However, the utilization of PHCs for NCD care is comparatively low in India. The Access-to-Medicines (ATM) study examined whether (and how) interventions aimed at health service optimization alone or combined with community platform strengthening improve access to medicines at the primary health care level within the context of a local health system. METHOD: A quasi-randomized cluster trial was used to assess the effectiveness of the intervention (18 months) implemented across 39 rural PHCs (clusters) of three sub-districts of Tumkur in southern India. The intervention was allocated randomly in a 1:1:1 sequence across PHCs and consisted of three arms: Arm A with a package of interventions aimed at health service delivery optimization; B for strengthening community platforms in addition to A; and the control arm. Group allocation was not blinded to providers and those who assessed outcomes. A household survey was used to understand health-seeking behaviour, access and out-of-pocket expenditure (OOP) on key anti-diabetic and anti-hypertension medicines among patients; facility surveys were used to assess the availability of medicines at PHCs. Primary outcomes of the study are the mean number of days of availability of antidiabetic and antihypertensive medicines at PHCs, the mean number of patients obtaining medicines from PHC and OOP expenses. RESULT: The difference-in-difference estimate shows a statistically insignificant increase of 31.5 and 11.9 in mean days for diabetes and hypertension medicines availability respectively in the study arm A PHCs beyond the increase in the control arm. We further found that there was a statistically insignificant increase of 2.2 and 3.8 percentage points in the mean proportion of patients obtaining medicines from PHC in arm A and arm B respectively, beyond the increase in the control arm. CONCLUSION: There were improvements in NCD medicine availability across PHCs, the number of patients accessing PHCs and reduction in OOP expenditure among patients, across the study arms as compared to the control arm; however, these differences were not statistically significant. TRIAL REGISTRATION: Trial registration number CTRI/2015/03/005640 . This trial was registered on 17/03/2015 in the Clinical Trial Registry of India (CTRI) after PHCs were enrolled in the study (retrospectively registered). The CTRI is the nodal agency of the Indian Council of Medical Research for registration of all clinical, experimental, field intervention and observation studies.

A Draconian Law: Examining the Navigation of Coalition Politics and Policy Reform by Health Provider Associations in Karnataka, India.

A comprehensive picture of provider coalitions in health policy making remains incomplete because of the lack of empirically driven insights from low- and middle-income countries. The authors examined the politics of provider coalitions in the health sector in Karnataka, India, by investigating policy processes between 2016 and 2018 for developing amendments to the Karnataka Private Medical Establishments Act. Through this case, they explore how provider associations function, coalesce, and compete and the implications of their actions on policy outcomes. They conducted in-depth interviews, document analysis, and nonparticipant observations of two conferences organized by associations. They found that provider associations played a major role in drafting the amendments and negotiating competing interests within and between doctors and hospital associations. Despite the fragmentation, the associations came together to reinterpret the intentions of the amendments as being against the interests of the profession, culminating in a statewide protest and strike. Despite this show of strength, provider associations only secured modest modifications. This case demonstrates the complex and unpredictable influence of provider associations in health policy processes in India. The authors' analysis highlights the importance of further empirical study on the influence of professional and trade associations across a range of health policy cases in low- and middle-income countries.

Daytime Activity Is Associated With Discharge to Home in Older Adults Recovering From Critical Illness.

Hospitalized older adults recovering from critical illness after transition of care out of an intensive care unit (ICU) are often inactive, which may affect discharge disposition and hospital length of stay (LOS). The current study explored relationships between early post-ICU activity, discharge disposition, and LOS. Actigraphy measured post-ICU daytime and nighttime activity (mean activity counts/min). Prospective chart review provided discharge disposition and LOS (days). Independent samples t tests compared post-ICU daytime activity by discharge disposition. Multivariate regression examined associations between post-ICU activity and LOS. Post-ICU daytime activity was greater among those discharged home (54.42 [SD = 29.3 counts/min]) than those discharged to a facility (33.26 [SD = 24.26 counts/min]): t(26) = 2.054, p = 0.050). Lower post-ICU daytime activity was associated with longer LOS (ß = -0.322, p = 0.041). Future research should investigate whether post-ICU daytime inactivity during hospitalization is a modifiable risk factor for worse outcomes among older adults discharged from the ICU. [Journal of Gerontological Nursing, 47(2), 13-19.].

Sleep Quality Associated With Motor Function Among Older Adult Survivors of Critical Illness.

BACKGROUND: Poor sleep is associated with worse motor function in older adults. Sleep may affect motor function specifically among older adults recovering from critical illness after transfer out of an intensive care unit (ICU). OBJECTIVES: Describe motor function (grip strength) of older ICU survivors and explore relationships between sleep and ICU-acquired weakness in the early post-ICU transition period. METHODS: We enrolled 30 older adults who were functionally independent prior to hospitalization, mechanically ventilated while in ICU, and within 24-48 hours post-ICU discharge. Handgrip dynamometry assessed post-ICU motor function (fully corrected T score on the National Institutes of Health Motor Battery Grip Strength Test). Actigraphy estimated post-ICU sleep duration (total sleep time [TST]) and fragmentation (wake after sleep onset) over two consecutive nights from 22:00 p.m. to 06:00 a.m.. We identified differences in grip strength by history of obstructive sleep apnea (OSA) using independent-samples t tests. We examined associations between sleep duration and grip strength using exploratory multivariate regression analyses, after adjustment for clinically relevant covariates. RESULTS: Grip strength among this cohort of older ICU survivors was almost 2 SDs below the norm for healthy older adults, indicating considerable ICU-acquired weakness. Grip strength was lower among subjects with history of OSA than those without OSA. Greater TST was associated with worse grip strength, after adjusting for history of OSA and Pittsburgh Sleep Quality Index global score. Moreover, among the subset of male subjects (n = 19), greater TST was significantly and negatively associated with grip strength, after adjusting for Acute Physiology, Age, and Chronic Health Evaluation III score, and Pittsburgh Sleep Quality Index global score. DISCUSSION: Sleep promotion may be a potentially modifiable risk factor to mitigate ICU-acquired weakness in older ICU survivors. We propose that improving sleep throughout recovery from critical illness may indirectly promote better outcomes, as poor grip strength is linked to longer length of hospital stay, higher acuity of discharge disposition, and worsened functional decline in older adults.

Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors.

OBJECTIVE: The purpose of this pilot study was to test the feasibility of delivering the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program using an iPad and to evaluate its impact on symptom improvement. METHODS: A single group, pre-posttest design was implemented among female stages 0-III breast cancer survivors (BCS) who completed treatment. Data were collected at baseline and week 6 on measures of psychological and physical symptoms and quality of life. The mMBSR(BC) program is a standardized, stress-reducing intervention that combines sitting and walking meditation, body scan, and yoga and is designed to deliver weekly 2-hour sessions for 6 weeks using an iPad. RESULTS: The mean age of the 15 enrolled BCS was 57 years; one participant was non-Hispanic black, and 14 were non-Hispanic white. Of the 13 who completed the study, there were significant improvements from baseline to 6 weeks post-mMBSR(BC) in psychological and physical symptoms of depression, state anxiety, stress, fear of recurrence, sleep quality, fatigue, and quality of life (P's < .05). Effect sizes for improvements of multiple symptoms ranged from medium to large. CONCLUSIONS: These results provide preliminary support that the mMBSR(BC) program may be feasible and acceptable, showing a clinical impact on decreasing psychological and physical symptoms. This mobile-based program offers a delivery of a standardized MBSR(BC) intervention to BCS that is convenient for their own schedule while decreasing symptom burden in the survivorship phase after treatment for breast cancer.

Improving access to medicines for non-communicable diseases in rural India: a mixed methods study protocol using quasi-experimental design.

BACKGROUND: India has the distinction of financing its healthcare mainly through out-of-pocket expenses by individual families contributing to catastrophic health expenditure and impoverishment. Nearly 70 % of the expenditure is on medicines purchased at private pharmacies. Patients with chronic ailments are especially affected, as they often need lifelong medicines. Over the past years in India, there have been several efforts to improve drug availability at government primary health centres. In this study, we aim to understand health system factors that affect utilisation and access to generic medicines for people with non-communicable diseases. METHODS: This study aims to understand if (and how) a package of interventions targeting primary health centres and community participation platforms affect utilisation and access to generic medicines for people with non-communicable diseases in the current district context in India. This study will employ a quasi-experimental design and a qualitative theory-driven approach. PHCs will be randomly assigned to one of three arms of the intervention. In one arm, PHCs will receive inputs to optimise service delivery for non-communicable diseases, while the second arm will receive an additional package of interventions to strengthen community participation platforms for improving non-communicable disease care. The third arm will be the control. We will conduct household and facility surveys, before and after the intervention and will estimate the effect of the intervention by difference-in-difference analysis. Sample size for measuring effects was calculated based on obtaining at least 30 households for each primary health centre spread across three distance-based clusters. Primary outcomes include availability and utilisation of medicines at primary health centres and out-of-pocket expenditure for medicines by non-communicable disease households. Focus group discussions with patients and in-depth interviews with health workers will also be conducted. Qualitative and process documentation data will be used to explain how the intervention could have worked. DISCUSSION: By taking into consideration several health system building blocks and trying to understand how they interact, our study aims to generate evidence for health planners on how to optimise health services to improve access to medicines. TRIAL REGISTRATION: Protocol registered on Clinical Trials Registry of India with registration identifier number CTRI/2015/03/005640 on 17(th) March 2015.

Associations Between Inactivity and Cognitive Function in Older Intensive Care Unit Survivors.

BACKGROUND/INTRODUCTION: Critically ill older adults are profoundly inactive while in the intensive care unit (ICU), and this inactivity persists after discharge from the ICU. Older ICU survivors who were mechanically ventilated are at high risk for post-ICU cognitive impairment. OBJECTIVES/AIMS: The present study examined the relationship between the ratio of daytime to nighttime activity and executive function in older ICU survivors. METHODS: This was a secondary analysis of pooled data from 2 primary studies of older adults who were functionally independent prior to hospitalization, mechanically ventilated while in ICU, and within 24 to 48 hours post-ICU discharge. Actigraphy recorded daytime activity (mean activity counts per minute, 6 am to 9:59 pm) and nighttime activity (mean activity counts per minute, 10 pm to 5:59 am). A daytime-to-nighttime activity ratio was calculated by dividing daytime activity by nighttime activity. The NIH Toolbox Dimensional Change Card Sort Test assessed cognitive flexibility (DCCST: fully corrected T score). Multivariate regression examined the association between the daytime-to-nighttime activity ratio and DCCST scores, adjusting for 2 covariates (age in years and NIH Toolbox Grip Strength fully corrected T score). RESULTS: The mean daytime-to-nighttime activity ratio was 2.10 ± 1.17 (interquartile range, 1.42). Ratios for 6 participants (13.6%) were less than 1, revealing higher activity during nighttime hours rather than daytime hours. Higher daytime-to-nighttime ratios were associated with better DCCST scores (ß = .364, P = .005). CONCLUSIONS: The proportion of daytime activity versus nighttime activity was considerably low, indicating severe alterations in the rest/activity cycle. Higher daytime-to-nighttime activity ratios were associated with better executive function scores, suggesting that assessment of daytime activity could identify at-risk older ICU survivors during the early post-ICU transition period. Promotion of daytime activity and nighttime sleep may accelerate recovery and improve cognitive function.

Inactivity May Identify Older Intensive Care Unit Survivors at Risk for Post-Intensive Care Syndrome.

BACKGROUND: Older adults (≥age 65) admitted to an intensive care unit (ICU) are profoundly inactive during hospitalization. Older ICU survivors often experience life-changing symptoms, including cognitive dysfunction, physical impairment, and/or psychological distress, which are components of post-intensive care syndrome (PICS). OBJECTIVES: To explore trends between inactivity and symptoms of PICS in older ICU survivors. METHODS: This study was a secondary analysis of pooled data obtained from 2 primary, prospective, cross-sectional studies of older ICU survivors. After ICU discharge, 49 English- and Spanish-speaking participants who were functionally independent before admission and who had received mechanical ventilation while in the ICU were enrolled. Actigraphy was used to measure post-ICU hourly activity counts (12:00 AM to 11:59 PM). Selected instruments from the National Institutes of Health Toolbox and Patient-Reported Outcomes Measurement Information System were used to assess symptoms of PICS: cognitive dysfunction, physical impairment, and psychological distress. RESULTS: Graphs illustrated trends between inactivity and greater symptom severity of PICS: participants who were less active tended to score worse than one standard deviation of the mean on each outcome. Greater daytime activity was concurrently observed with higher performances on cognitive and physical assessments and better scores on psychological measures. CONCLUSIONS: Post-ICU inactivity may identify older ICU survivors who may be at risk for PICS and may guide future research interventions to mitigate symptom burden.

Effective communication with linguistically diverse patients: A concept analysis.

OBJECTIVE: Effective communication is essential to providing high-quality healthcare. For linguistically diverse patients, communication remains a barrier to receiving equitable healthcare throughout the globe. It is necessary to examine the concept of effective communication with linguistically diverse patients. METHODS: The Walker and Avant method was used to analyze the concept. RESULTS: We define effective communication with linguistically diverse patients as any verbal or written communication between two or more individuals who do not speak the same language that utilizes accurate translation techniques to reach a shared message or understanding, where all parties involved are listened to and actively engaged. The antecedents, attributes, consequences, and empirical referents are mapped. CONCLUSION: Effective communication with linguistically diverse patients is limited by a lack of access to professional language assistance, structural racism/discrimination, and policy barriers. PRACTICE IMPLICATIONS: Healthcare workers hold the power to provide language assistance to patients and should therefore receive training in cultural competency, cultural humility, and how to work with professional medical interpreters and language access programs. Institutions should invest in multimodal approaches to provide equitable healthcare to linguistically diverse patients.

Associations, unions and everything in between: contextualising the role of representative health worker organisations in policy.

Associations, unions and other organised groups representing health workers play a significant role in the development, adoption and implementation of health policy. These representative health worker organisations (RHWOs) are a key interface between employers, governments and their members (both actual and claimed), with varying degrees of influence and authority within and across countries. Existing research in global health often assumes-rather than investigates-the roles played by RHWOs in policy processes and lacks analytical specificity regarding the definitional characteristics of RHWOs. In this article, we seek to expand and complicate conceptualisations of RHWOs as key actors in global health by unpacking the heterogeneity of RHWOs and their roles in policy processes and by situating RHWOs in context. First, we define RHWOs, present a typology of RHWO dimensions and discuss perceived legitimacy of RHWOs as policy actors. Next, we unpack the roles of RHWOs in policy processes and distinguish RHWO roles in regulation from those of regulatory agencies. The final sections situate RHWOs in political and labour relations contexts, and in sociohistorical contexts, with attention to institutional frameworks, professional hierarchies and intersectional factors such as race, gender, sexuality, class, caste and religion. We conclude by outlining research gaps in the study of RHWOs and policy, and by encouraging global health researchers and practitioners to incorporate an expanded focus on these actors. Taking this approach will generate a wider range of strategies to better engage these organisations in policy processes and will ensure stronger health workforce policies globally.

Accessibility and quality of haemodialysis services in an urban setting in South India: a qualitative multiperspective study.

OBJECTIVE: To explore the accessibility and quality of existing haemodialysis services in an urban setting. SETTING: The study was conducted in Bangalore city, India. PARTICIPANTS: A total of 28 stakeholders including 2 nephrologists, 7 duty doctors, 13 dialysis technicians and 6 patients on long-term haemodialysis were selected from 20 dialysis centres in Bangalore city. DESIGN AND METHODS: Qualitative study using in-depth interviews. A thematic analysis was done using the Availability, Accessibility, Acceptability and Quality Framework of WHO and the Bruce's Quality of Care Framework. RESULTS: The study found several gaps with regard to the access and quality of existing services for patients with end-stage kidney disease (ESKD). The charges for dialysis sessions across settings displayed a wide variance. Patients often started dialysis services in private and later shifted to government and non-governmental organisations-run centres and reduced the number of weekly dialysis sessions due to financial constraints. Most standalone dialysis centres did not have the facilities to manage any emergencies. Most centres did not admit patients with hepatitis or HIV. The quality of care in dialysis centres seemed to be variable and most centres were managed solely by dialysis technicians. There were no psychosocial interventions available to the patients irrespective of the settings. Cost-cutting practices such as employing underqualified technicians, reusing dialysis equipment and using substandard water for dialysis were common. CONCLUSION: The study highlights the need for more financial and personnel investments in ESKD care in India to ensure optimal care for the growing patient population. The study points towards the need for comprehensive management practices, including diet counselling and psychosocial support. While there are comprehensive guidelines on the establishment and management of dialysis services, more policy attention needs to be on effective implementation of these, to ensure better accessibility and quality of existing services.

Adolescents' perceptions about smokers in Karnataka, India.

BACKGROUND: Prevalence of tobacco use among adolescents in India is very high. Despite many epidemiological studies exploring tobacco use among youth, there is no published data on adolescents' perceptions about smokers in Indian society and its implications on tobacco control. METHODS: A cross-sectional study was conducted using a stratified random sampling with probability proportional to school-type (government or private owned). Data was collected using a pretested, self-administered, anonymous questionnaire with a mix of close and open-ended questions from a sample of 1087 students. Chi-square test was used to measure associations. Qualitative data was analysed through inductive coding. RESULTS: The response rate for the study was 82.5% and the sample population had a mean age of 16.9 years (SD = 1.9) with 57.8% male students. Majority of respondents (84.6%) reported negative perceptions about smokers while 20.4% of respondents reported positive perceptions. Female students reported significantly higher disapproval rate (negative perceptions) for smoking compared to male students (89.7% Vs 71.6% in case of male smoker; 81.2% Vs 67.3% in case of female smoker). Dominant themes defining perceptions about smokers included 'hatred/hostility/Intolerance', 'against family values/norms', 'not aware of tobacco harms' and 'under stress/emotional trauma'. Themes like 'culture', 'character' and 'power' specifically described negative social image of female smoker but projected a neutral or sometimes even a positive image of male smoker. There was a significant association between adolescents' positive perceptions of smokers and tobacco use by themselves as well as their close associates. CONCLUSIONS: Adolescents' stereotypes of smokers, especially female smokers are largely negative. We suggest that tobacco control interventions targeting adolescents should be gender specific, should also involve their peers, family and school personnel, and should go beyond providing knowledge on harmful effects of smoking to interventions that influence adolescents' social construct of smoking/smoker.

Assessment and Monitoring of Sleep in the Intensive Care Unit.

Sleep affects physiologic and psychological recovery throughout critical illness. Patients often describe poor sleep as a major source of distress while hospitalized in an intensive care unit. The intensive care unit environment poses unique challenges for sleep assessment and monitoring. The purpose of this literature review is to discuss methods of assessment and monitoring of sleep within the intensive care unit setting. The advantages and disadvantages of physiologic monitoring of sleep (eg, polysomnography, bispectral index, and actigraphy) are compared with those of subjective measures of sleep quality (eg, validated patient-oriented sleep questionnaires, and informal nursing assessments).

Daytime activity and sleep are associated with motor function in older intensive care unit survivors.

BACKGROUND: Hospitalized older intensive care unit (ICU) survivors are often inactive and experience sleep disturbances. OBJECTIVE: We explored associations between post-ICU activity, sleep/rest, and motor function among hospitalized older ICU survivors. METHODS: We enrolled 30 older ICU survivors, ages 65 and older, within 24-48 h of ICU discharge. Actigraphy measured post-ICU activity and sleep/rest. Selected measures from the National Institutes of Health Toolbox Motor Battery assessed grip strength and dexterity. Multivariate regression examined associations between post-ICU activity, sleep/rest, and motor function, adjusting for covariates. RESULTS: Lower daytime activity (ß = 0.258, p = .035) and greater daytime sleep/rest (ß = -0.295, p = .022) were associated with worse grip strength. Lower daytime activity (ß = -0.376, p = .037) and greater daytime sleep/rest (ß = 0.409, p = .026) were associated with worse dexterity. CONCLUSION: Post-ICU inactivity and prolonged rest periods are associated with worse motor function in hospitalized older ICU survivors.

Daytime-to-Nighttime Sleep Ratios and Cognitive Impairment in Older Intensive Care Unit Survivors.

BACKGROUND: Sleep duration and proportion of daytime versus nighttime sleep may affect cognitive function in older patients in the transition out of the intensive care unit. OBJECTIVE: To explore the relationship between the daytime-to-nighttime sleep ratio and cognitive impairment in older intensive care unit survivors. METHODS: The study enrolled 30 older adults within 24 to 48 hours after intensive care unit discharge. All participants were functionally independent before admission and underwent mechanical ventilation in the intensive care unit. Actigraphy was used to estimate daytime (6 AM to 9:59 PM) and nighttime (10 PM to 5:59 AM) total sleep duration. Daytime-to-nighttime sleep ratios were calculated by dividing the proportion of daytime sleep by the proportion of nighttime sleep. The National Institutes of Health Toolbox Cognition Battery Dimensional Change Card Sort Test (DCCST) was used to assess cognition. Associations between sleep and cognition were explored using multivariate regression after adjusting for covariates. RESULTS: The mean (SD) daytime sleep duration was 7.55 (4.30) hours (range, 0.16-14.21 hours), and the mean (SD) nighttime sleep duration was 4.99 (1.95) hours (range, 0.36-7.21 hours). The mean (SD) daytime-to-nighttime sleep ratio was 0.71 (0.30) (range, 0.03-1.10). Greater daytime sleep duration (ß = -0.351, P = .008) and higher daytime-to-nighttime sleep ratios (ß = -0.373, P = .008) were negatively associated with DCCST scores. CONCLUSIONS: The daytime-to-nighttime sleep ratio was abnormally high in the study population, revealing an altered sleep/wake cycle. Higher daytime-to-nighttime sleep ratios were associated with worse cognition, suggesting that proportionally greater daytime sleep may predict cognitive impairment.

Graphic Representation of Hourly Activity Counts May Identify Discharge Outcomes for Older Adults After Critical Illness.

PURPOSE: After transitioning from an intensive care unit (ICU), hospitalized older adults are inactive, which may affect discharge outcomes. We examined trends between post-ICU hourly activity counts and discharge disposition among hospitalized older ICU survivors. DESIGN: A prospective, exploratory research design was used in this study. METHODS: We enrolled older ICU survivors within 24-48 hours of ICU discharge. Actigraphy measured post-ICU hourly activity counts (0:00 a.m.-23:59 p.m.). Chart review provided discharge disposition. Analyses were conducted to illustrate trends between post-ICU hourly activity counts and discharge disposition. FINDINGS: Mean hourly activity was about 2,233 ± 569 counts/hour. Graphs revealed trends between hourly activity counts and discharge disposition. Participants with lower post-ICU activity counts, especially during daytime hours, tended to be discharged to a care facility. CONCLUSIONS: Future nursing research should determine whether post-ICU inactivity during hospitalization is a modifiable risk factor for worse discharge outcomes. CLINICAL RELEVANCE: Activity could be a prognostic indicator of discharge disposition for older ICU survivors.

Sleep and Activity Patterns Are Altered During Early Critical Illness in Mechanically Ventilated Adults.

BACKGROUND: Mechanically ventilated (MV) patients in the intensive care unit (ICU) often experience disturbed sleep and profound inactivity. OBJECTIVES: The aim of this study was to report 5 consecutive days' descriptive analyses on sleep efficiency (SE), total sleep time (TST), daytime activity ratio (DAR), and hourly activity counts among critically ill MV adults from 9 ICUs across 2 hospitals. METHODS: A secondary analysis was undertaken from our parent National Institutes of Health-funded randomized controlled trial (NIH R01 NR016702). Subjects included 31 critically ill patients from multiple ICUs. Wrist actigraphy estimated SE and TST. Mean DAR, an indicator of altered sleep-wake cycles, was calculated. Continuous 24-hour activity counts over 5 consecutive days were summarized. Descriptive analyses were used. RESULTS: A total of 31 subjects with complete actigraphy data were included. Mean age was 59.6 (SD, 17.3) years; 41.9% were male; 83.9% were White, and 67.7% were Hispanic/Latino; and the mean APACHE III (Acute Physiology and Chronic Health Evaluation III) severity of illness score was 74.5 (SD, 25.5). The mean nighttime SE and TST over the 5-day ICU period were 83.1% (SD, 16.14%) and 6.6 (SD, 1.3) hours, respectively. The mean DAR over the 5-day ICU period was 66.5% (SD, 19.2%). The DAR surpassed 80% on only 17.5% of subject days. The majority of subjects' activity level was low, falling below 1000 activity counts per hour. CONCLUSION: Our study revealed poor rest-activity cycle consolidation among critically ill MV patients during the early ICU period. Future interventional studies should promote quality sleep at nighttime and promote mobilization during the daytime.

Family automated voice reorientation (FAVoR) intervention for mechanically ventilated patients in the intensive care unit: Study protocol for a randomized controlled trial.

Delirium in the intensive care unit (ICU) affects up to 80% of critically ill, mechanically ventilated (MV) adults. Delirium is associated with substantial negative outcomes, including increased hospital complications and long-term effects on cognition and health status in ICU survivors. The purpose of this randomized controlled trial is to test the effectiveness of a Family Automated Voice Reorientation (FAVoR) intervention on delirium among critically ill MV patients. The FAVoR intervention uses scripted audio messages, which are recorded by the patient's family and played at hourly intervals during daytime hours. This ongoing orientation to the ICU environment through recorded messages in a voice familiar to the patient may enable the patient to more accurately interpret the environment and thus reduce risk of delirium. The study's primary aim is to test the effect of the FAVoR intervention on delirium in critically ill MV adults in the ICU. The secondary aims are to explore: (1) if the effect of FAVoR on delirium is mediated by sleep, (2) if selected biobehavioral factors moderate the effects of FAVoR on delirium, and (3) the effects of FAVoR on short-term and long-term outcomes, including cognition and health status. Subjects (n = 178) are randomly assigned to the intervention or control group within 48 h of initial ICU admission and intubation. The intervention group receives FAVoR over a 5-day period, while the control group receives usual care. Delirium-free days, sleep and activity, cognition, patient-reported health status and sleep quality, and data regarding iatrogenic/environmental and biobehavioral factors are collected.

Parental and professional perceptions of informed consent and participation in a time-critical neonatal trial: a mixed-methods study in India, Sri Lanka and Bangladesh.

INTRODUCTION: Time-critical neonatal trials in low-and-middle-income countries (LMICs) raise several ethical issues. Using a qualitative-dominant mixed-methods design, we explored informed consent process in Hypothermia for encephalopathy in low and middle-income countries (HELIX) trial conducted in India, Sri Lanka and Bangladesh. METHODS: Term infants with neonatal encephalopathy, aged less than 6 hours, were randomly allocated to cooling therapy or usual care, following informed parental consent. The consenting process was audio-video (A-V) recorded in all cases. We analysed A-V records of the consent process using a 5-point Likert scale on three parameters-empathy, information and autonomy. In addition, we used exploratory observation method to capture relevant aspects of consent process and discussions between parents and professionals. Finally, we conducted in-depth interviews with a subgroup of 20 parents and 15 healthcare professionals. A thematic analysis was performed on the observations of A-V records and on the interview transcripts. RESULTS: A total of 294 A-V records of the HELIX trial were analysed. Median (IQR) score for empathy, information and autonomy was 5 (0), 5 (1) and 5 (1), respectively. However, thematic analysis suggested that the consenting was a ceremonial process; and parental decision to participate was based on unreserved trust in the treating doctors, therapeutic misconception and access to an expensive treatment free of cost. Most parents did not understand the concept of a clinical trial nor the nature of the intervention. Professionals showed a strong bias towards cooling therapy and reported time constraints and explaining to multiple family members as key challenges. CONCLUSION: Despite rigorous research governance and consent process, parental decisions were heavily influenced by situational incapacity and a trust in doctors to make the right decision on their behalf. Further research is required to identify culturally and context-appropriate strategies for informed trial participation.

Executive Function, Dexterity, and Discharge Disposition in Older Intensive Care Unit Survivors.

BACKGROUND: Dexterity is a component of motor function. Executive function, a subdomain of cognition, may affect dexterity in older adults recovering from critical illness after discharge from an intensive care unit (ICU). OBJECTIVES: To explore associations between executive function (attention and cognitive flexibility) and dexterity (fine motor coordination) in the early post-ICU period and examine dexterity by acuity of discharge disposition. METHODS: The study involved 30 older adults who were functionally independent before hospitalization, underwent mechanical ventilation in the ICU, and had been discharged from the ICU 24 to 48 hours previously. Dexterity was evaluated with the National Institutes of Health Toolbox (NIHTB) Motor Battery 9-Hole Pegboard Dexterity Test (PDT); attention, with the NIHTB Cognition Battery Flanker Inhibitory Control and Attention Test (FICAT); and cognitive flexibility, with the NIHTB Cognition Battery Dimensional Change Card Sort Test (DCCST). Exploratory regression was used to examine associations between executive function and dexterity (fully corrected T scores). Independent-samples t tests were used to compare dexterity between participants discharged home and those discharged to a facility. RESULTS: FICAT (ß = 0.375, P = .03) and DCCST (ß = 0.698, P = .001) scores were independently and positively associated with PDT scores. Further, PDT scores were worse among participants discharged to a facility than among those discharged home (mean [SD], 26.71 [6.14] vs 36.33 [10.30]; t24 = 3.003; P = .006). CONCLUSIONS: Poor executive function is associated with worse dexterity; thus, dexterity may be a correlate of both post-ICU cognitive impairment and functional decline. Performance on dexterity tests could identify frail older ICU survivors at risk for worse discharge outcomes.