Measuring time use in rural India: Design and validation of a low-cost survey module.

Time use data facilitate understanding of labor supply, especially for women who often undertake unpaid care and home production. Although assisted diary-based time use surveys are suitable for low-literacy populations, they are costly and rarely used. We create a low-cost, scalable alternative that captures contextually-determined broad time categories; here, allocations across market work, household labor, and leisure. Using fewer categories and larger time intervals takes 33% less time than traditional modules. Field experiments show the module measures average time across the broader categories as well as the traditional approach, particularly for our target female population. The module can also capture multitasking for a specific category of interest. Its shortcomings are short duration activity capture and the need for careful category selection. The module's brevity and low cost make it a viable method to use in household and labor force surveys, facilitating tracking of work and leisure patterns as economies develop.

Indian female migrants face greater barriers to post-Covid recovery than males: Evidence from a panel study.

Background: India's abrupt nationwide Covid-19 lockdown internally displaced millions of migrant workers, who returned to distant rural homes. Documenting their labour market reintegration is a critical aspect of understanding the economic costs of the pandemic for India's poor. In a country marked by low and declining female labour force participation, identifying gender gaps in labour market reintegration - as a marker of both women's vulnerability at times of crisis and setbacks in women's agency - is especially important. Yet most studies of pandemic-displaced internal migrants in India are small, rely on highly selected convenience samples, and lack a gender focus. Methods: Beginning in April 2020 we enrolled roughly 4,600 displaced migrants who had, during the lockdown, returned to two of India's poorest states into a cohort observational study which tracked enrolees through July 2021. Survey respondents were randomly selected from the states' official databases of return migrants, with sampling stratified by state and gender. 85% of enrolees (3950) were working prior to the pandemic. Our difference-in-means analysis uses three survey waves conducted in July to August 2020, January to March 2021, and June to July 2021. Our analysis focuses on a balanced panel of 1780 previously working enrolees (the 45% of respondents present in the first wave that also participated in the subsequent two survey rounds). Primary outcomes of interest include labour market re-entry, earnings, and measures of vulnerability by gender. Findings: Before the March 2020 national lockdown, 98% (95% CI [97,99]) of workers were employed in the non-agricultural sector. In July 2020, one month after the end of the lockdown, incomes plummet, with both genders earning roughly 17% of their pre-pandemic incomes. 47% (95% CI [45,49]) were employed in agriculture and 37% (95% CI [35,39]) were unemployed. Remigration is critical to regaining income - by January 2021, male re-migrants report earnings on par with their pre-pandemic incomes, while men remaining in rural areas earn only 23% (95% CI [19,27]) of their pre-pandemic income. Remigration benefits women to a lesser extent - female re-migrants regain no more than 65% (95% CI [57,73]) of their pre-pandemic income at any point. Yet men and women struggle to remigrate throughout - by July 2021, no more than 63% (95% CI [60,66]) of men and 55% (95% CI [51,59]) of women had left their home villages since returning. Gender gaps in income recovery largely reflect higher rates of unemployment among women, both among those remaining in rural areas (9 percentage points (95% CI [6,13]) higher than men across waves) and among those who remigrate (13 percentage points (95% CI [9,17]) higher than men across waves). As a result, we observe gender gaps in well-being: relative to male counterparts, women across waves were 7 percentage points (95% CI [4,10]) more likely to report reduced consumption of essential goods and fared 6 percentage points (95% CI [4,7]) worse on a food insecurity index. Interpretation: Displaced migrants of both genders experienced persistent hardships for over a year after the initial pandemic lockdown. Women fare worse, driven by both lower rates of remigration and lower rates of labour market re-entry both inside and outside home villages. Some women drop out of the labour force entirely, but most unemployed report seeking or being available to work. In short, pandemic-induced labour market displacement has far-reaching, long-term consequences for migrant workers, especially women. Funding: Survey costs were funded by research grants from IZA/FCDO Gender, Growth, and Labour Markets in Low Income Countries Programme, J-PAL Jobs and Opportunity Initiative, and the Evidence-based Measures of Empowerment for Research on Gender Equality (EMERGE) program at University of California San Diego.

Pediatric Pain Assessment in the Emergency Department: Patient and Caregiver Agreement Using the Wong-Baker FACES and the Faces Pain Scale-Revised.

OBJECTIVE: This study aimed to assess the agreement between patients presenting to the pediatric emergency department (ED) with acute pain and their caregivers when using the Wong-Baker FACES (WBF) and Faces Pain Scale-Revised (FPS-R). METHODS: This was a prospective, observational study examining patients 3 to 7.5 years old presenting to a pediatric ED with acute pain. Participants completed the WBF and FPS-R twice during their ED evaluation. Caregivers rated their child's pain using both the WBF and FPS-R at the same time points. Intraclass correlations (ICCs) were calculated between caregiver and child reports at each time point, and Bland-Altman plots were created. RESULTS: Forty-six subjects were enrolled over 5 months. Mean age was 5.5 ± 1.2 years. Average initial child pain scores were 6.6 ± 2.8 (WBF) and 6.1 ± 3.3 (FPS-R), and repeat scores were 3.3 ± 3.4 (WBF) and 3.1 ± 3.3 (FPS-R). Average initial caregiver pain scores were 6.3 ± 2.4 (WBF) and 6.2 ± 2.3 (FPS-R), and repeat scores were 3.4 ± 2.0 (WBF) and 3.4 ± 2.1 (FPS-R). On initial assessment, ICCs between children and caregivers using the FPS-R and WBF were 0.33 and 0.22, respectively. On repeat assessment, the ICCs were 0.31 for FPS-R and 0.26 for WBF. Bland-Altman plots showed poor agreement but no systematic bias. CONCLUSION: There was poor agreement between caregivers and children when using the WBF and FPS-R for assessment of acute pain in the ED. Caregiver report should not be used as a substitute for self-report of pain if possible.

On Her Own Account: How Strengthening Women's Financial Control Impacts Labor Supply and Gender Norms.

Can increasing control over earnings incentivize a woman to work, and thereby influence norms around gender roles? We randomly varied whether rural Indian women received bank accounts, training in account use, and direct deposit of public sector wages into their own (versus husbands') accounts. Relative to the accounts only group, women who also received direct deposit and training worked more in public and private sector jobs. The private sector result suggests gender norms initially constrained female employment. Three years later, direct deposit and training broadly liberalized women's own work-related norms, and shifted perceptions of community norms.

Effect of vitamin D3 supplementation on vascular and metabolic health of vitamin D-deficient overweight and obese children: a randomized clinical trial.

BACKGROUND: Obese children are vulnerable to vitamin D deficiency and impaired cardiovascular health; vitamin D replenishment might improve their cardiovascular health. OBJECTIVES: The aims were to determine, in vitamin D-deficient overweight and obese children, whether supplementation with vitamin D3 1000 or 2000 IU/d is more effective than 600 IU/d in improving arterial endothelial function, arterial stiffness, central and systemic blood pressure (BP), insulin sensitivity (1/fasting insulin concentration), fasting glucose concentration, and lipid profile and to explore whether downregulation of adipocytokines and markers of systemic inflammation underlies vitamin D effects. METHODS: We conducted a randomized, double-masked, controlled clinical trial in 225 10- to 18-y-old eligible children. Change in endothelial function at 6 mo was the primary outcome. RESULTS: Dose-response increases in serum 25-hydroxyvitamin D concentrations were significant and tolerated without developing hypercalcemia. Changes at 3 and 6 mo in endothelial function, arterial stiffness, systemic-systolic BP, lipids, and inflammatory markers did not differ between children receiving 1000 or 2000 IU vitamin D and children receiving 600 IU. Some secondary outcomes differed between groups. Compared with the 600-IU group, central-systolic, central-diastolic, and systemic-diastolic BP was lower at 6 mo in the 1000-IU group [-2.66 (95% CI: -5.27, -0.046), -3.57 (-5.97, -1.17), and -3.28 (-5.55, -1.00) mm Hg, respectively]; insulin sensitivity increased at 3 and 6 mo and fasting glucose concentration declined at 6 mo (-2.67; 95% CI: -4.88, -0.46 mg/dL) in the 2000-IU group. CONCLUSIONS: Correction of vitamin D deficiency in overweight and obese children by vitamin D3 supplementation with 1000 or 2000 IU/d versus 600 IU/d did not affect measures of arterial endothelial function or stiffness, systemic inflammation, or lipid profile, but resulted in reductions in BP and fasting glucose concentration and in improvements in insulin sensitivity. Optimization of children's vitamin D status may improve their cardiovascular health. This trial was registered at clinicaltrials.gov as NCT01797302.

A Propensity Score Analysis of Homework Adherence-Outcome Relations in Cognitive Behavioral Therapy for Depression.

Little is known about whether or not a consistently high level of homework adherence over the course of therapy benefits patients. This question was examined in two samples of patients who were receiving individual Cognitive Behavioral Therapy (CBT) for depression (Ns = 128 [Sequenced Treatment Alternatives to Relieve Depression: STAR-D] and 183 [Continuation Phase Cognitive Therapy Relapse Prevention: C-CT-RP]). Logistic and linear regression and propensity score models were used to identify whether or not clinician assessments of homework adherence differentiated symptom reduction and remission, as assessed by the Hamilton Depression Rating Scale-17 (HDRS-17), the Quick Inventory of Depressive Symptomatology-Self-Reported Scale (QIDS-SR), and the QIDS-Clinician Scale (QIDS-C). CBT-related response and remission were equally likely between both high and low homework adherers in both studies and in all models. But in propensity adjusted models that adjusted for session attendance, for both the STAR-D and C-CT-RP samples, greater homework adherence was significantly associated with greater response and remission from depression in the first and last 8 sessions of CBT. Our results suggest that homework adherence can account for response and remission early and late in treatment, with adequate session attendence.

Effectiveness of Later-Stage Exercise Programs vs Usual Medical Care on Physical Function and Activity After Total Knee Replacement: A Randomized Clinical Trial.

Importance: Several functional limitations persist after total knee replacement (TKR). Intensive exercise programs could resolve these limitations but are not well tolerated by many patients until a later stage (>2 months) after surgery. Evidence for exercise at a later stage after TKR is limited. Objectives: To compare the effectiveness of later-stage exercise programs after TKR and to explore heterogeneity of treatment effects. Design, Setting, and Participants: Three-arm single-blind randomized clinical trial (January 7, 2015, to November 9, 2017) using an intent-to-treat approach with follow-ups at 3 months and 6 months. The setting was Allegheny County, Pennsylvania (an outpatient physical therapy clinic and 4 community centers). Participants had primary TKR performed more than 2 months previously, were 60 years or older, experienced moderate functional limitations, and were medically cleared to exercise. Interventions: Clinic-based physical therapy exercise (physical therapy arm), community-based group exercise (community arm), and usual care (control arm). The control arm continued their usual care, whereas the exercise arms participated in supervised exercise programs lasting 12 weeks. Main Outcomes and Measures: The primary outcome was arm differences in the Western Ontario and McMaster Universities Osteoarthritis Index-Physical Function (WOMAC-PF) at 3 months. The secondary outcomes included performance-based tests germane to knee replacement and additional surveys of physical function. Data were analyzed by linear mixed models and responder analysis. Results: A total of 240 participants (mean [SD] age, 70 [7] years; 61.7% female) were allocated to physical therapy (n = 96), community exercise (n = 96), or control (n = 48). All 3 arms demonstrated clinically important improvement. At 3 months, between-arm analyses for the WOMAC-PF demonstrated no differences between physical therapy and community (-2.2; 98.3% CI, -4.5 to 0.1), physical therapy and control (-2.1; 98.3% CI, -4.9 to 0.7), and community and control (0.1; 98.3% CI, -2.7 to 2.9). Performance-based tests demonstrated greater improvement in the physical therapy arm compared with both the community (0.1 z score units; 98.3% CI, 0.0-0.2) and control (0.3 z score units; 98.3% CI, 0.1-0.4) arms and the community arm compared with the control arm (0.2 z score units; 98.3% CI, 0.0-0.3). The physical therapy arm had more than 17.7% responders than the community arm and more than 19.0% responders than the control arm. There was no difference in responder rates between the community and control arms. Conclusions and Relevance: Based on the primary outcome, participation in late-stage exercise programs after TKR offered no benefit over usual care. The benefits of physical therapy identified by the secondary outcomes and responder analysis require confirmation. Trial Registration: ClinicalTrials.gov Identifier: NCT02237911.

Impact of shift duration on alertness among air-medical emergency care clinician shift workers.

BACKGROUND: Greater than half of Emergency Medical Services (EMS) shift workers report fatigue at work and most work long duration shifts. We sought to compare the alertness level of EMS shift workers by shift duration. METHODS: We used a multi-site, 14-day prospective observational cohort study design of EMS clinician shift workers at four air-medical EMS organizations. The primary outcome was behavioral alertness as measured by psychomotor vigilance tests (PVT) at the start and end of shifts. We stratified shifts by duration (< 24 h and 24 h), night versus day, and examined the impact of intra-shift napping on PVT performance. RESULTS: One hundred and twelve individuals participated. The distribution of shifts <24 h and 24 h with complete data were 54% and 46%, respectively. We detected no differences in PVT performance measures stratified by shift duration (P > 0.05). Performance for selected PVT measures (lapses and false starts) was worse on night shifts compared to day shifts (P < 0.05). Performance also worsened with decreasing time between waking from a nap and the end of shift PVT assessment. CONCLUSIONS: Deficits in performance in the air-medical setting may be greatest during night shifts and proximal to waking from an intra-shift nap. Future research should examine alertness and performance throughout air-medical shifts, as well as investigate the timing and duration of intra-shift naps on outcomes.

Aiming to Improve Readmissions Through InteGrated Hospital Transitions (AIRTIGHT): a Pragmatic Randomized Controlled Trial.

BACKGROUND: Despite years of intense focus, inpatient and observation readmission rates remain high and largely unchanged. Hospitals have little, robust evidence to guide the selection of interventions effective at reducing 30-day readmissions in real-world settings. OBJECTIVE: To evaluate if implementation of recent recommendations for hospital transition programs is effective at reducing 30-day readmissions in a population discharged to home and at high-risk for readmission. DESIGN: A non-blinded, pragmatic randomized controlled trial ( Clinicaltrials.gov : NCT02763202) conducted at two hospitals in Charlotte, North Carolina. PATIENTS: A total of 1876 adult patients, under the care of a hospitalist, and at high risk for readmissions. INTERVENTION: Random allocation to a Transition Services (TS) program (n = 935) that bridges inpatient, outpatient, and home settings, providing patients virtual and in-person access to a dedicated multidisciplinary team for 30-days, or usual care (n = 941). MAIN MEASURE: Thirty-day, unplanned, inpatient, or observation readmission rate. KEY RESULTS: The 30-day readmission rate was 15.2% in the TS group and 16.3% in the usual care group (RR 0.93; 95% [CI, 0.76 to 1.15]; P = 0.52). There were no significant differences in readmissions at 60 and 90 days or in 30-day Emergency Department visit rates. Patients, who were referred to TS and readmitted, had less Intensive Care Unit admissions 15.5% vs. 26.8% (RR 0.74; 95% [CI, 0.59 to 0.93]; P = 0.02). CONCLUSIONS: An intervention inclusive of contemporary recommendations does not reduce a high-risk population's 30-day readmission rate. The high crossover to usual care (74.8%) reflects the challenge of non-participation that is ubiquitous in the real-world implementation of population health interventions. TRIAL REGISTRY: ClinicalTrials.gov ; registration ID number: NCT02763202, URL: https://clinicaltrials.gov/ct2/show/NCT02763202.

Real-Time Fatigue Mitigation with Air-Medical Personnel: The SleepTrackTXT2 Randomized Trial.

Objective: The aims of this study were: 1) to determine the short-term impact of the SleepTrackTXT2 intervention on air-medical clinician fatigue during work shifts and 2) determine the longer-term impact on sleep quality over 120 days. Methods: We used a multi-site randomized controlled trial study design with a targeted enrollment of 100 (ClinicalTrials.gov NCT02783027). The intervention was behavioral (non-pharmacological) and participation was scheduled for 120 days. Participation was voluntary. All consented participants answered baseline as well as follow-up surveys. All participants answered text message queries, which assessed self-rated fatigue, sleepiness, concentration, recovery, and hours of sleep. Intervention participants received additional text messages with recommendations for behaviors that can mitigate fatigue. Intervention participants received weekly text messages that promoted sleep. Our analysis was guided by the intent-to-treat principle. For the long-term outcome of interest (sleep quality at 120 days), we used a two-sample t-test on the change in sleep quality to determine the intervention effect. Results: Eighty-three individuals were randomized and 2,828 shifts documented (median shifts per participant =37, IQR 23-49). Seventy-one percent of individuals randomized (n = 59) participated up to the 120-day study period and 52% (n = 43) completed the follow-up survey. Of the 69,530 text messages distributed, participants responded to 61,571 (88.6%). Mean sleep quality at 120 days did not differ from baseline for intervention (p > 0.05) or control group participants (p > 0.05), and did not differ between groups (p > 0.05). There was no change from baseline to 120 days in the proportion with poor sleep quality in either group. Intra-shift fatigue increased (worsened) over the course of 12-hour shifts for participants in both study arms. Fatigue at the end of 12-hour shifts was higher among control group participants than participants in the intervention group (p < 0.05). Pre-shift hours of sleep were often less than 7 hours and did not differ between the groups over time. Conclusions: The SleepTrackTXT2 behavioral intervention showed a positive short-term impact on self-rated fatigue during 12-hour shifts, but did not impact longer duration shifts or have a longer-term impact on sleep quality among air-medical EMS clinicians.

Recruitment of patients with de novo Parkinson disease: successful strategies in a randomized exercise clinical trial.

INTRODUCTION: Recruitment of sufficient patients with Parkinson disease into clinical trials is a barrier to successful, timely study completion. Non-pharmacologic studies have shown to be even more challenging for recruitment, despite some studies focusing on de novo Parkinson disease populations. This paper describes successful recruitment techniques from a randomized exercise clinical trial in Parkinson disease. METHODS: Several recruitment strategies were used to enroll de novo patients with Parkinson disease into a year-long clinical trial. Strategies focused on infrastructure included fast-track clinic scheduling, weekly research meetings, an established clinical repository, real-time clinic recruitment, and outreach to the community. The nature of the study facilitated recruitment by offering a wait-listed control group, exercise at a local fitness center with a paid membership, and collection of data by shipping equipment foregoing some visits. An experienced nurse study coordinator involved in recruitment and training of the principal investigator in recruitment of minorities enhanced overall recruitment. Finally, the patient population chosen for this study, patients with de novo Parkinson disease, may be more likely to enroll in an exercise study than patients with later stage disease. RESULTS: Seventy-six patients with de novo Parkinson disease were successfully enrolled into the exercise clinical trial from a single site. CONCLUSION: Targeted recruitment strategies were successful in this study. Additional modifications to the study protocol, such as eliminating treadmill stress tests before randomization, travel to an urban downtown location for study visits, and a relatively healthy Parkinson disease population, may also have impacted this study. These strategies could all be adopted for other studies in Parkinson disease, neurodegenerative diseases, or other chronic disorders. TRIAL REGISTRATION: Clinicaltrials.gov, NCT01506479 . Registered on 10 January 2012.

Blood Loss Trends and Financial Implications in Adolescent Idiopathic Scoliosis.

STUDY DESIGN: This was a retrospective cohort study. OBJECTIVE: The primary goal was to evaluate risk factors related to increased blood loss in adolescent idiopathic surgery (AIS) surgery with the secondary goal being to evaluate the financial implications around the use of intraoperative cell salvage (ICS) and the routine preallocation of autogenous blood products. SUMMARY OF BACKGROUND DATA: Deformity correction for AIS is a complex procedure and can be associated with significant blood loss. METHODS: A retrospective cohort study was conducted on consecutive patients between the ages of 10 and 18 years who underwent posterior spinal fusion of 7-12 levels over a 3-year period between January 2013 and December 2015. Demographic information and surgical characteristics were recorded. All patients had a preoperative type and cross of 2 units and ICS was used in all cases. Charges for preoperative type and cross and ICS were also measured. Univariate and multivariable analyses were performed to identify pertinent variables affecting blood loss. RESULTS: In total, 134 patients met inclusion criteria. ICS was used in all cases. In total, 51 patients were transfused cell saver blood intraoperatively/postoperatively at the discretion of the surgeon. On average 133 mL were returned to the patient. No complications related to ICS were observed. Multivariable analysis identified male sex, lower body mass index and higher surgical time to be associated with increased blood loss (P<0.05). All 134 patients had a preoperative type and cross, with an average charge to patient of $311. Patients were charged $1037 for intraoperative use of ICS and $242 for centrifugation. Patients who had allogeneic transfusion were charged $1047. CONCLUSIONS: Several blood conservation strategies, including use of ICS, exist to minimize the consequences of blood loss. Routine use of preoperative type and cross may be avoided except in cases where significant blood loss is anticipated-that is adolescent male individuals, those with a lower body mass index and in whom a longer surgical time is anticipated.

Longitudinal Assessment of Left Ventricular Mass in Autosomal Dominant Polycystic Kidney Disease.

INTRODUCTION: The high burden of cardiovascular morbidity and mortality in autosomal dominant polycystic kidney disease (ADPKD) is related to development of hypertension and left ventricular hypertrophy. Blood pressure reduction has been shown to reduce left ventricular mass in ADPKD; however, moderators and predictors of response to lower blood pressure are unknown. METHODS: This was a post hoc cohort analysis of HALT PKD study A, a randomized placebo controlled trial examining the effect of low blood pressure and single versus dual renin-angiotensin blockade in early ADPKD. Participants were hypertensive ADPKD patients 15 to 49 years of age with estimated glomerular filtration rate (eGFR) > 60 ml/min per 1.73 m2 across 7 centers in the United States. Predictors included age, sex, baseline eGFR, systolic blood pressure, total kidney volume, serum potassium, and urine sodium, potassium, albumin, and aldosterone. Outcome was left ventricular mass index (LVMI) measured using 1.5-T magnetic resonance imaging at months 0, 24, 48, and 60. RESULTS: Reduction in LVMI was associated with higher baseline systolic blood pressure and larger kidney volume regardless of blood pressure control group assignment (P < 0.001 for both). Male sex and baseline eGFR were associated with a positive annual slope in LVMI (P < 0.001 and P = 0.07, respectively). CONCLUSION: Characteristics associated with higher risk of progression in ADPKD, including higher systolic blood pressure, larger kidney volume, and lower eGFR are associated with improvement in LVMI with intensive blood pressure control, whereas male sex is associated with a smaller slope of reduction in LVMI.

Impact of Oral Side Effects from Conditioning Therapy Before Hematopoietic Stem Cell Transplantation: Protocol for a Multicenter Study.

BACKGROUND: The oral cavity is a common site of complications related to the cytotoxic effect of high-dose chemotherapy and radiation therapy. Considering our limited understanding of the burden of illness in the oral cavity from various cytotoxic therapies, it is difficult to produce evidence-based, preventive and management protocols. A prospective multicenter study is necessary to collect data on the burden of illness from various cytotoxic regimens. OBJECTIVE: The objectives of this prospective international observational multicenter study in hematopoietic stem cell transplant (HSCT) patients are to establish the nature, incidence and temporal relationship of oral complications related to conditioning regimens (chemotherapy with or without total body irradiation), stem cell transplantation and the immunologic reactions (mainly graft-vs-host-disease) that may follow, and to determine what subjective and objective oral complications related to treatment can predict negative clinical and economic outcomes and reduced quality of life. METHODS: Adult patients at six study sites receiving full intensity conditioning, reduced intensity conditioning or nonmyeloablative conditioning, followed by autologous or allogeneic hematopoietic stem cell infusion, are included. A pre-treatment assessment includes medical conditions, planned chemo- and radiation therapy regimen, medications, allergies, social history, patient report of oral problems, dental history, subjective oral complaints, objective measures of oral conditions, current laboratory values, dental treatment recommended and untreated dental disease. Starting 1-3 days after hematopoietic stem cell infusion, a bedside assessment is completed 3 days per week until resolution of neutropenia. A patient questionnaire is also completed during hospitalization. Beyond this time, patients with continued oral mucositis or other oral problems are followed 1 day per week in an inpatient or outpatient setting. Additional visits for urgent care for acute oral problems after hospitalization are documented. Autologous transplant patients are being followed up at 100 days (SD 30 days) and at 1 year (SD 30 days) post-transplantation to identify any long-term side effects. Patients treated with allogeneic transplantation are being followed at 100 days (SD 30 days), 6 months (SD 30 days), and 12 months (SD 30 days). The follow-up assessments include cancer response to therapy, current medical conditions, medications, subjective and objective oral findings, quality of life measures and laboratory values. The targeted enrollment is 254 patients who have received HSCT. RESULTS: A total of 260 participants have been enrolled, with 233 (91%) who have received HSCT. We anticipate enrollment of 20-30 additional participants to obtain the sample size of 254 enrolled participants who have received HSCT. CONCLUSIONS: The results of the ongoing prospective study will provide a unique dataset to understand the impact of oral complications on patients undergoing HSCT and provide needed evidence for guidelines regarding the management of this patient cohort.

Determinants of Progression in Early Autosomal Dominant Polycystic Kidney Disease: Is it Blood Pressure or Renin-Angiotensin-Aldosterone-System Blockade?

BACKGROUND: The HALT PKD trial in early autosomal dominant polycystic kidney disease (ADPKD) showed that intensive control of systolic blood pressure to 95-110 mmHg was associated with a 14% slower rate of kidney volume growth compared to standard control. It is unclear whether this result was due to greater blockade of the renin-angiotensin-aldosterone system (RAAS) by allowing the use of higher drug doses in the low blood pressure arm, or due to the lower blood pressure per se. METHODS: In this secondary analysis of HALT PKD Study A, we categorized participants into high and low dose groups based on the median daily equivalent dose of RAAS blocking drugs used after the initial dose titration period. Using linear mixed models, we compared the percent change in total kidney volume and the slope of estimated glomerular filtration rate (eGFR) between the 2 groups. We also assessed the effects of time-varying dose and time-varying blood pressure parameters on these outcomes. RESULTS: Subjects in the high dose group (n=252) did not experience a slower increase in total kidney volume than those in the low-dose (n=225) group, after adjustment for age, sex, genotype, and BP arm. The chronic slope of eGFR decline was similar in the 2 groups. Higher time-varying systolic blood pressure was associated with a steeper decline in eGFR. CONCLUSION: ADPKD progression (as detected by eGFR decline and TKV increase) was ameliorated by intense blood pressure control as opposed to pharmacologic intensity of RAAS blockade.

Patterns of Kidney Function Decline in Autosomal Dominant Polycystic Kidney Disease: A Post Hoc Analysis From the HALT-PKD Trials.

BACKGROUND: Previous clinical studies of autosomal dominant polycystic kidney disease (ADPKD) reported that loss of kidney function usually follows a steep and relentless course. A detailed examination of individual patterns of decline in estimated glomerular filtration rate (eGFR) has not been performed. STUDY DESIGN: Longitudinal post hoc analysis of data collected during the Halt Progression of Polycystic Kidney Disease (HALT-PKD) trials. SETTING & PARTICIPANTS: 494 HALT-PKD Study A participants (younger; preserved eGFR) and 435 Study B participants (older; reduced eGFR) who had more than 3 years of follow-up and 7 or more eGFR assessments. MEASUREMENTS: Longitudinal eGFR assessments using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) creatinine equation. PREDICTORS: Demographic, clinical, laboratory, and imaging features of participants. OUTCOMES: Probability of linear and nonlinear decline patterns or of stable eGFR calculated for each participant from a Bayesian model of individual eGFR trajectories. RESULTS: Most (62.5% in Study A and 81% in Study B) participants had a linear decline in eGFR during up to 8 years of follow-up. A proportion (22% in Study A and 13% in Study B) of progressors had a nonlinear pattern. 15.5% of participants in Study A and 6% in Study B had a prolonged (≥4.5 years) period of stable eGFRs. These individuals (Study A) had significantly smaller total kidney volumes, higher renal blood flows, lower urinary albumin excretion, and lower body mass index at baseline and study end. In Study B, participants with reduced but stable eGFRs were older than the progressors. Two-thirds of nonprogressors in both studies had PKD1 mutations, with enrichment for weak nontruncating mutations. LIMITATIONS: Relatively short follow-up of a clinical trial population. CONCLUSIONS: Although many individuals with ADPKD have a linear decline in eGFR, prolonged intervals of stable GFRs occur in a substantial fraction. Lower body mass index was associated with more stable kidney function in early ADPKD.

Effect of Fatigue Training on Safety, Fatigue, and Sleep in Emergency Medical Services Personnel and Other Shift Workers: A Systematic Review and Meta-Analysis.

BACKGROUND: Fatigue training may be an effective way to mitigate fatigue-related risk. We aimed to critically review and synthesize existing literature on the impact of fatigue training on fatigue-related outcomes for Emergency Medical Services (EMS) personnel and similar shift worker groups. METHODS: We performed a systematic literature review for studies that tested the impact of fatigue training of EMS personnel or similar shift workers. Outcomes of interest included personnel safety, patient safety, personnel performance, acute fatigue, indicators of sleep duration and quality, indicators of long-term health (e.g., cardiovascular disease), and burnout/stress. A meta-analysis was performed to determine the impact of fatigue training on sleep quality. RESULTS: Of the 3,817 records initially identified for review, 18 studies were relevant and examined fatigue training in shift workers using an experimental or quasi-experimental design. Fatigue training improved patient safety, personal safety, and ratings of acute fatigue and reduced stress and burnout. A meta-analysis of five studies showed improvement in sleep quality (Fixed Effects SMD -0.87; 95% CI -1.05 to -0.69; p < 0.00001; Random Effects SMD -0.80; 95% CI -1.72, 0.12; p < 0.00001). CONCLUSIONS: Reviewed literature indicated that fatigue training improved safety and health outcomes in shift workers. Further research is required to identify the optimal components of fatigue training programs to maximize the beneficial outcomes.

Systematic Review and Meta-analysis of the Effects of Caffeine in Fatigued Shift Workers: Implications for Emergency Medical Services Personnel.

BACKGROUND: Emergency Medical Services (EMS) workers may experience fatigue as a consequence of shift work. We reviewed the literature to determine the impact of caffeine as a countermeasure to fatigue in EMS personnel and related shift workers. METHODS: We employed the GRADE methodology to perform a systematic literature review and search multiple databases for research that examined the impact of caffeine on outcomes of interest, such as patient and EMS personnel safety. For selected outcomes, we performed a meta-analysis of pooled data and reported the pooled effect in the form of a Standardized Mean Difference (SMD) with corresponding 95% confidence intervals. RESULTS: There are no studies that investigate caffeine use and its effects on EMS workers or on patient safety. Four of 8 studies in shift workers showed that caffeine improved psychomotor vigilance, which is important for performance. Caffeine decreased the number of lapses on a standardized test of performance [SMD = 0.75 (95% CI: 0.30 to 1.19), p = 0.001], and lessened the slowing of reaction time at the end of shifts [SMD = 0.52 (95% CI: 0.19 to 0.85); p = 0.002]. Finally, 2 studies reported that caffeine reduced sleep quality and sleep duration. CONCLUSIONS: Although the quality of evidence was judged to be low to moderate, when taken together, these studies demonstrate that caffeine can improve psychomotor performance and vigilance. However, caffeine negatively affects sleep quality and sleep duration. More systematic, randomized studies need to be conducted in EMS workers in order to address the critical outcomes of health and safety of EMS personnel and patients. The risk/benefit ratio of chronic caffeine use in shift workers is currently unknown.