Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

Effectiveness of a School‐Based Educational Intervention to Improve Hypertension Control Among Schoolteachers: A Cluster‐Randomized Controlled Trial

Background The control of hypertension is low in low‐ and middle‐income countries like India. We evaluated the effects of a nurse‐facilitated educational intervention in improving the control rate of hypertension among school teachers in India. Methods and Results This was a cluster‐randomized controlled trial involving 92 schools in Kerala, which were randomly assigned equally into a usual care group and an intervention group. Participants were 402 school teachers (mean age, 47 years; men, 29%) identified with hypertension. Participants in both study groups received a leaflet containing details of a healthy lifestyle and the importance of regular intake of antihypertensive medication. In addition, the intervention participants received a nurse‐facilitated educational intervention on hypertension control for 3 months. The primary outcome was hypertension control. Key secondary outcomes included systolic blood pressure, diastolic blood pressure, and the proportion of participants taking antihypertensive medications. For the primary outcome, we used mixed‐effects logistic regression models. Two months after a 3‐month educational intervention, a greater proportion of intervention participants (49.0%) achieved hypertension control than the usual care participants (38.2%), with an odds ratio of 1.89 (95% CI, 1.06–3.35), after adjusting for baseline hypertension control. The odds of taking antihypertensive medications were 1.6 times higher in the intervention group compared with the usual care group (odds ratio, 1.62; 95% CI, 1.08–2.45). The reduction in mean systolic blood pressure was significantly greater in the intervention group by 4.2 mm Hg (95% CI, −7.2 to −1.1) than in the usual care group. Conclusions A nurse‐facilitated educational intervention was effective in improving the control and treatment rates of hypertension as well as reducing systolic blood pressure among schoolteachers with hypertension. Registration URL: https://www.ctri.nic.in ; Unique Identifier: CTRI/2018/01/011402.

Cost-effectiveness of noninvasive telemedical interventional management in patients with heart failure: health economic analysis of the TIM-HF2 trial

Background Noninvasive remote patient management (RPM) in patients with heart failure (HF) has been shown to reduce the days lost due to unplanned cardiovascular hospital admissions and all-cause mortality in the Telemedical Interventional Management in Heart Failure II trial (TIM-HF2). The health economic implications of these findings are the focus of the present analyses from the payer perspective. Methods and results A total of 1538 participants of the TIM-HF2 randomized controlled trial were assigned to the RPM and Usual Care group. Health claims data were available for 1450 patients (n = 715 RPM group, n = 735 Usual Care group), which represents 94.3% of the original TIM-HF2 patient population, were linked to primary data from the study documentation and evaluated in terms of the health care cost, total cost (accounting for intervention costs), costs per day alive and out of hospital (DAOH), and cost per quality-adjusted life year (QALY). The average health care costs per patient year amounted to € 14,412 (95% CI 13,284–15,539) in the RPM group and € 17,537 (95% CI 16,179–18,894) in the UC group. RPM led to cost savings of € 3125 per patient year (p = 0.001). After including the intervention costs, a cost saving of € 1758 per patient year remained (p = 0.048). Conclusion The additional noninvasive telemedical interventional management in patients with HF was cost-effective compared to standard care alone, since such intervention was associated with overall cost savings and superior clinical effectiveness. Graphical abstract

Tocilizumab improves 28-day survival in hospitalized patients with severe COVID-19: an open label, prospective study

Background Data on the safety and efficacy profile of tocilizumab in patients with severe COVID-19 needs to be enriched. Methods In this open label, prospective study, we evaluated clinical outcomes in consecutive patients with COVID-19 and PaO2/FiO2 < 200 receiving tocilizumab plus usual care versus usual care alone. Tocilizumab was administered at the time point that PaO2/FiO2 < 200 was observed. The primary outcome was 28-day mortality. Secondary outcomes included time to discharge, change in PaO2/FiO2 at day 5 and change in WHO progression scale at day 10. Findings Overall, 114 patients were included in the analysis (tocilizumab plus usual care: 56, usual care: 58). Allocation to usual care was associated with significant increase in 28-day mortality compared to tocilizumab plus usual care [Cox proportional-hazards model: HR: 3.34, (95% CI: 1.21–9.30), (p = 0.02)]. There was not a statistically significant difference with regards to hospital discharge over the 28 day period for patients receiving tocilizumab compared to usual care [11.0 days (95% CI: 9.0 to 16.0) vs 14.0 days (95% CI: 10.0–24.0), HR: 1.32 (95% CI: 0.84–2.08), p = 0.21]. ΔPaO2/FiO2 at day 5 was significantly higher in the tocilizumab group compared to the usual care group [42.0 (95% CI: 23.0–84.7) vs 15.8 (95% CI: − 19.4–50.3), p = 0.03]. ΔWHO scale at day 10 was significantly lower in the tocilizumab group compared to the usual care group (-0.5 ± 2.1 vs 0.6 ± 2.6, p = 0.005). Conclusion Administration of tocilizumab, at the time point that PaO2/FiO2 < 200 was observed, improved survival and other clinical outcomes in hospitalized patients with severe COVID-19 irrespective of systemic inflammatory markers levels.

Cost-effectiveness of Self-managed Program Versus Usual Physiotherapy Care of Patients With Knee Osteoarthritis in Nigeria

Objectives: This study aims to compare, from a patient’s perspective, the cost-effectiveness between a self-managed program and usual physiotherapy care in treating knee osteoarthritis. Methods: The study participants were assigned into two groups: group I received a weekly physiotherapy treatment plus instructions on self-management skills in goal setting, pain management, exercise, healthy eating, and dealing with fatigue (self-managed group); group II had a physiotherapy session three times a week (usual care group). The osteoarthritis cost and consequence and European quality of life-5 dimension (EQ-5D) were used to generate utility scores. The health effects measure of quality-adjusted life year (QALY) was obtained, and an incremental cost-effective ratio was calculated. Cost-effectiveness was determined by plotting a cost-effectiveness plane of incremental cost against QALY obtained. Results: After 8 weeks of intervention, the self-managed group recorded more significant improvements in pain level, function, and health-related quality of life than the usual care group. Clinical consultation costs (Mean±SD NGN [Nigerian naira]=1800±979), physiotherapy treatment costs (Mean±SD NGN=4000±00), and transportation costs (Mean±SD NGN=1,940±1,150) were less for the self-managed group than the usual care group. Imaging (x-ray) and drug costs did not differ significantly between groups. The QALYs gained over the 8-week intervention period was 0.13 for the self-management group compared to 0.11 for the usual care group. Discussion: From the patient’s perspective, a self-managed program was cost-effective and cheaper for healthcare resource use. Physiotherapists may adopt the program to reduce out-of-pocket expenses for patients with knee osteoarthritis.

Fast-Track in Minimally Invasive Gynecology: A Randomized Trial Comparing Costs and Clinical Outcomes

Study Objective: Evaluate the effects of a fast-track (FT) protocol on costs and post-operative recovery.Methods: One hundred and seventy women undergoing total laparoscopic hysterectomy for a benign indication were randomized in a FT protocol or a usual care protocol. A FT protocol included the combination of minimally invasive surgery, analgesia optimization, early oral refeeding and rapid mobilization of patients was compared to a usual care protocol. Primary outcome was costs. Secondary outcomes were length of stay, post-operative morbidity and patient satisfaction.Main Results: The mean total cost in the FT group was 13,070 ± 4,321 Euros (EUR) per patient, and that in the usual care group was 3.5% higher at 13,527 ± 3,925 EUR (p = 0.49). The FT group had lower inpatient surgical costs but higher total ambulatory costs during the first post-operative month. The mean hospital stay in the FT group was 52.7 ± 26.8 h, and that in the usual care group was 20% higher at 65.8 ± 33.7 h (p = 0.006). Morbidity during the first post-operative month was not significantly different between the two groups. On their day of discharge, the proportion of patients satisfied with pain management was similar in both groups [83% in FT and 78% in the usual care group (p = 0.57)]. Satisfaction with medical follow-up 1 month after surgery was also similar [91% in FT and 88% in the usual care group (p = 0.69)].Conclusion: Implementation of a FT protocol in laparoscopic hysterectomy for benign indications has minimal non-significant effects on costs but significantly reduces hospital stay without increasing post-operative morbidity nor decreasing patient satisfaction.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT04839263.

Critical illness myopathy in intensive care setting

Aim of the Work to provide cumulative data about the efficacy and safety of neuro-muscular electrical stimulation (NMES) combined with usual care (UC) versus usual care alone in ICU patients with Critical Illness Myopathy (CIM). Methodology The current systematic review was done on studies published between 2009 and 2019. The total number of patients in all the included studies was 1259 patients; 652 in NMES group, and 607 in UC group. Our data were divided into two groups: NMES (652 patients), and UC (607 patients). Metaanalysis study was done on 11 studies which described and compared the 2 different techniques for treatment of CIM; with overall number of patients (N = 1259). Results Regarding 1ry outcome measures, we found 8 studies reported critical Critical illness myopathy (CIM), critical illness polyneuropathy (CIP), and the overlap, critical care setting MRC scale for muscle strength, with total number of patients (N = 968). The random-effects model of the meta-analysis study showed non-significant difference in mean MRC scale in NMES group compared to usual care group (p &gt; 0.05). We also found 11 studies reported ICU stay with total number of patients (N = 1259). The random-effects model of the meta-analysis study showed nonsignificant difference in mean ICU stay in NMES group compared to usual care group (p &gt; 0.05). We also found only 2 studies reported SF-36 scale for quality of life, with total number of patients (N = 270). The fixed-effects model of the metaanalysis study showed highly significant decrease in mean SF-36 scale in NMES group compared to usual care group (p = 0.003). Regarding 2ry outcome measure, we found 3 studies reported CIM incidence with total number of patients (N = 394). The fixed-effects model of the meta-analysis study showed marked decrease in CIM incidence in NMES group compared to usual care group, but not reaching statistical significance (p &gt; 0.05). We also found 9 studies reported mortality rate with total number of patients (N = 1044). The fixed-effects model of the meta-analysis study showed non-significant difference in mortality rate in NMES group compared to usual care. Our systematic review and meta-analysis showed that NMES combined with usual care was not associated with significant differences in global muscle strength, ICU stay, quality of life score, CIM incidence and mortality rate in comparison with usual care alone in critically ill patients. Conclusion NMES is not superior to usual care in management of CIM. Usual care remains the mainstay of management of CIM with significant better outcomes, in addition to preventive measures as early aggressive treatment of sepsis and MOF, blood glucose control, optimizing certain drugs use, early enteral nutrition, maintaining water, electrolyte and acidbase balance.

Effectiveness of anisodamine for the treatment of critically ill patients with septic shock: a multicentre randomized controlled trial

Background Septic shock is characterized by an uncontrolled inflammatory response and microcirculatory dysfunction. There is currently no specific agent for treating septic shock. Anisodamine is an agent extracted from traditional Chinese medicine with potent anti-inflammatory effects. However, its clinical effectiveness remains largely unknown. Methods In a multicentre, open-label trial, we randomly assigned adults with septic shock to receive either usual care or anisodamine (0.1–0.5 mg per kilogram of body weight per hour), with the anisodamine doses adjusted by clinicians in accordance with the patients’ shock status. The primary end point was death on hospital discharge. The secondary end points were ventilator-free days at 28 days, vasopressor-free days at 28 days, serum lactate and sequential organ failure assessment (SOFA) score from days 0 to 6. The differences in the primary and secondary outcomes were compared between the treatment and usual care groups with the χ2 test, Student’s t test or rank-sum test, as appropriate. The false discovery rate was controlled for multiple testing. Results Of the 469 patients screened, 355 were assigned to receive the trial drug and were included in the analyses—181 patients received anisodamine, and 174 were in the usual care group. We found no difference between the usual care and anisodamine groups in hospital mortality (36% vs. 30%; p = 0.348), or ventilator-free days (median [Q1, Q3], 24.4 [5.9, 28] vs. 26.0 [8.5, 28]; p = 0.411). The serum lactate levels were significantly lower in the treated group than in the usual care group after day 3. Patients in the treated group were less likely to receive vasopressors than those in the usual care group (OR [95% CI] 0.84 [0.50, 0.93] for day 5 and 0.66 [0.37, 0.95] for day 6). Conclusions There is no evidence that anisodamine can reduce hospital mortality among critically ill adults with septic shock treated in the intensive care unit. Trial registration ClinicalTrials.gov (NCT02442440; Registered on 13 April 2015).

Tocilizumab in Hospitalized Patients with Severe COVID-19: An Open Label, Prospective Study

Background: Data on the safety and efficacy profile of tocilizumab in patients with severe COVID-19 needs to be enriched.Methods: In this open label, prospective study, we evaluated clinical outcomes in consecutive patients with COVID-19 and PaO2/FiO2<200 receiving tocilizumab plus usual care versus usual care alone. The primary outcome was 28-day mortality. Secondary outcomes included time to discharge, change in PaO2/FiO2 at day 5 and change in WHO progression scale at day 10.Findings: Overall, 114 patients were included in the analysis (tocilizumab plus usual care: 56, usual care: 58). Allocation to usual care was associated with significant increase in 28-day mortality compared to tocilizumab plus usual care [Cox proportional-hazards model: HR: 3.34, (95%CI: 1.21 to 9.30), (p=0.02)]. There was not a statistically significant difference with regards to hospital discharge over the 28-day period for patients receiving tocilizumab compared to usual care [11.0 days (95%CI: 9.0 to 16.0) vs 14.0 days (95%CI: 10.0 to 24.0), HR: 1.32 (95%CI: 0.84 to 2.08), p=0.21]. ΔPaO2/FiO2 at day 5 was significantly higher in the tocilizumab group compared to the usual care group [42.0 (95%CI: 23.0 to 84.7) vs 15.8 (95%CI: -19.4 to 50.3), p=0.03]. ΔWHO scale at day 10 was significantly lower in the tocilizumab group compared to the usual care group (-0.5±2.1 vs 0.6±2.6, p=0.005). Conclusion: This is the first study administrating tocilizumab in patients with COVID-19 based on PaO2/FiO2. Tocilizumab improved survival and other clinical outcomes in hospitalized patients with COVID-19 and PaO2/FiO2<200 irrespective of systemic inflammatory markers levels.

Abstract P115: Feasibility Of Implementing A Remote Blood Pressure Monitoring And Management Program

Introduction: Hypertension guidelines recommend remote monitoring of blood pressure (BP) but widespread implementation is lacking due to several multi-level barriers. Hypothesis: Barriers to remote monitoring and management of hypertension are largely surmountable by reorganization of the current model of hypertension management and leveraging new technology, implementation science, and team-based system-wide processes. Methods: We conducted a NIH funded multi-disciplinary pragmatic type 1 hybrid effectiveness implementation pilot study to lower BP in patients ≥65 years old, combining evidence-based strategies and incorporating them in the clinic flow. We used the electronic health record for real time identification of patients with poorly controlled hypertension and approached them for enrollment. Enrolled participants were randomized to either the virtual collaborative care clinic (vCCC) where trained pharmacists monitored and managed BP through telehealth or to usual care with education. All patients were provided with electronic BP cuffs. The entire study was conducted remotely due to the COVID-19 pandemic. We used surveys and interviews to assess feasibility, acceptability, and satisfaction scores. Results: There was a high enrollment rate with 31 of the 93 potentially eligible patients participating in the 12-week feasibility study. Twenty-nine patients have completed the study: 15 in the vCCC and 14 in the usual care group. SBP decline was 13.7 ± 18.6 mmHg in the vCCC group compared to 4.3 ± 20.5 mmHg in the usual care. Additionally, patients in the vCCC group used their home BP monitors more often, with mean usage 6.3 times per week compared to 0.6 times in the usual care group. The vCCC program had high patient, pharmacist, and physician satisfaction scores. Provider acceptability and feasibility was also high. Conclusion: The vCCC program may be an effective strategy to manage hypertension in the future. The program had high acceptability and satisfaction, along with better reduction in SBP. These data support a larger health system wide study using the vCCC for hypertension management.