Conventional Care Research Articles

Cost-Effectiveness and Budget Impact Analysis of the Implementation of Differentiated Service Delivery Models for HIV Treatment in Mozambique: a Modelling Study.

In 2018, the Mozambique Ministry of Health launched guidelines for implementing differentiated service delivery models (DSDMs) to optimize HIV service delivery, improve retention in care, and ultimately reduce HIV-associated mortality. The models were fast-track, 3-month antiretrovirals dispensing, community antiretroviral therapy groups, adherence clubs, family approach and three one-stop shop models: adolescent-friendly health services, maternal and child health, and tuberculosis. We conducted a cost-effectiveness analysis and budget impact analysis to compare these models to conventional services. We constructed a decision tree model based on the percentage of enrolment in each model and the probability of the outcome (12-month retention in treatment) for each year of the study period-three for the cost-effectiveness analysis (2019-2021) and three for the budget impact analysis (2022-2024). Costs for these analyses were primarily estimated per client-year from the health system perspective. A secondary cost-effectiveness analysis was conducted from the societal perspective. Budget impact analysis costs included antiretrovirals, laboratory tests and service provision interactions. Cost-effectiveness analysis additionally included start-up, training and clients' opportunity costs. Effectiveness was estimated using an uncontrolled interrupted time series analysis comparing the outcome before and after the implementation of the differentiated models. A one-way sensitivity analysis was conducted to identify drivers of uncertainty. After implementation of the DSDMs, there was a mean increase of 14.9 percentage points (95% CI: 12.2, 17.8) in 12-month retention, from 47.6% (95% CI, 44.9-50.2) to 62.5% (95% CI, 60.9-64.1). The mean cost difference comparing DSDMs and conventional care was US$ -6 million (173,391,277 vs. 179,461,668) and -32.5 million (394,705,618 vs. 433,232,289) from the health system and the societal perspective, respectively. Therefore, DSDMs dominated conventional care. Results were most sensitive to conventional care interaction costs in the one-way sensitivity analysis. For a population of 1.5 million, the base-case 3-year financial costs associated with the DSDMs was US$550 million, compared with US$564 million for conventional care. DSDMs were less expensive and more effective in retaining clients 12 months after antiretroviral therapy initiation and were estimated to save approximately US$14 million for the health system from 2022 to 2024.

Clinical assessment of the efficacy of Ayurvedic management in PCOS: Study protocol for a randomized open-label standard control trial

Abstract INTRODUCTION: Polycystic ovary syndrome (PCOS) is a heterogeneous disorder, typically characterized by anovulation, hormonal imbalances, obesity, infertility, and associated features, with a significant impact on the physiological and psychological wellbeing of females belonging to the reproductive age group. Due to the multifactorial etiology, treatment is often personalized with specific targets, and monotherapy is rarely used. In the present study, the efficacy of an Ayurveda regimen, comprising the Ayush-SSM tablet (a coded Ayurvedic formulation) administered after Virechana therapy (purgation), is being explored against conventional standard care. MATERIALS AND METHODS: This study is an open-label, randomized, controlled clinical trial consisting of 180 participants diagnosed with PCOS. The participants in the trial group will receive Ayurvedic treatment consisting of Virechana therapy followed by administration of Ayush-SSM (500 mg), two tablets twice a day for 6 months. The participants in the control group will receive metformin tablet 500 mg once a day in the first week, 500 mg twice a day in the second week, 500 mg thrice a day in the third week, and 850 mg twice a day from the fourth week till 6 months. The primary outcome is the proportion of study participants who attain normal menstrual cycle length (21–35 days) or ovulation and change in hirsutism as per the modified Ferriman–Gallwey (FG) Score. The secondary outcomes are change in acne score and acanthosis nigricans; change in abdominal girth, waist circumference, and BMI; and clinical safety of the trial interventions. CONCLUSION: The findings of the study could potentially demonstrate that the Ayurveda regimen, including Virechana therapy followed by administration of the Ayush-SSM tablet, may be as effective as conventional standard care. Trial registration: Clinical Trial Registry of India (CTRI/2022/09/045478, dated August 4, 2022).

Effect of Pelvic Floor Function Exercises Based on the ERAS Concept on Lower Urinary Tract Symptoms after Radical Hysterectomy for Cervical Cancer: A Retrospective Cohort Study.

This study aimed to analyse the effect of pelvic floor function exercises based on the enhanced recovery after surgery (ERAS) concept on lower urinary tract symptoms after radical hysterectomy for cervical cancer. The retrospective study was conducted using clinical data of patients admitted to our hospital from January 2021 to December 2022 and underwent radical hysterectomy for cervical cancer. In accordance with the nursing method, the patients were divided into the routine group (conventional care) and the ERAS pelvic floor function exercise group, for which ERAS concept-based pelvic floor function exercises were carried out on the basis of the former group. The confounders between the two groups were matched by propensity score, and the scores of urination, pelvic floor muscle strength, lower urinary tract symptoms and quality of life (QoL) were compared between the two groups after matching. A total of 180 patients were included in the study, of whom 60 patients were identified after propensity score matching, consisting of 30 patients each in the ERAS and routine groups. The baseline characteristics of the two groups were balanced, and the difference was not statistically significant (p > 0.05). Compared with the routine group, the observation group showed significantly shorter first spontaneous urination time, greater first urination volume (p < 0.05), better pelvic floor muscle strength, considerably lower urinary tract symptoms and better QoL at discharge and 3 months after discharge (p < 0.05). Pelvic floor function exercises based on the ERAS concept can relieve lower urinary tract symptoms, accelerate urination and improve pelvic floor muscle strength and QoL after radical hysterectomy for cervical cancer.

Role of Polyphenols, Their Nano-formulations, and Biomaterials in Diabetic Wound Healing.

A diabetic wound is one of the major complications arising from hyperglycemia, neuropathy, and oxidative stress in diabetic patients. Finding effective treatments for diabetic wounds has been difficult owing to the complex pathophysiology of diabetic wound environments. Chronic wounds are notoriously difficult to treat with conventional wound care methods. In recent years, polyphenols found in plants have received much interest as a potential treatment for diabetic wounds. Their key benefits are their safety and the fact that they act through many molecular routes to treat diabetic wounds. However, problems with their formulation development, including lipophilicity, light sensitivity, limited membrane permeability, rapid systemic elimination, and enzymatic degradation, prevented them from gaining clinical attention. This article highlights and discusses the mechanism of polyphenols and various polyphenol-based drug delivery systems used till now to treat diabetic wounds. The consideration that should be taken in polyphenols-based nano-formulations and their prospect for diabetic wounds are also discussed briefly.

Economic Evaluation of an Integrated Care Program Compared to Conventional Care for Patients With Chronic Kidney Disease in Rural Communities of Thailand

IntroductionAn integrated care program for chronic kidney disease in Thailand has shown its effectiveness in delaying the decline in kidney function, as evidenced by the ESCORT-1 randomized control trial and the ESCORT-2 prospective cohort study. Designed for sustainability within the primary healthcare system, the program optimizes the use of the existing workforce by fostering collaboration among local multidisciplinary care teams and community care networks. MethodsA Markov model with a lifetime horizon was used to conduct a cost-utility analysis from a societal perspective. Individual participant level data from ESCORT studies, national registries, and relevant literature were used to estimate model parameters. A budget impact analysis from the payer’s perspective was also assessed over a five-year period. ResultsThe integrated care program yielded a dominant result with 1.84 QALYs gained with “less” lifetime cost, resulting in a negative incremental cost-effectiveness ratio. Probabilistic analysis showed that the intervention being cost-effective almost 100% of the time at the local willingness-to-pay threshold. The intervention maximized cost-effectiveness when delivered as early as possible, both in terms of age and stage. The budget impact analysis estimated that the introduction of the intervention could save about 7% of the Thai government's total health expenditure or 205 billion Thai-Baht ($5.9 billion) over five years with cost savings beginning from the third year onwards. ConclusionThe integrated care program for CKD offers potential benefits and cost savings for patients, caregivers, and payers. Future efforts should focus on the screening and implementation processes across various regions and healthcare settings.

Analysis of the Effect of Comfort Care in The Perioperative Care of Patients with Uterine Myomectomy and its Influence on Self-Care Ability

Objective: To analyze the effect of perioperative comfort care for patients with hysteromyomectomy (HYS). Methods: Seventy cases of HYS patients admitted to our hospital from October 2022 to October 2023 were randomly selected and divided into Group A (control group, 35 cases, conventional care) and Group B (observation group 35 cases, comfort care). The effects of the two groups before and after nursing care were compared. Results: The self-rating anxiety (SAS) scores, exercise of self-care agency (ESCA) scores, and nursing satisfaction scores at the time of discharge of Group B were better than in Group A after nursing care (P &lt; 0.05). Conclusion: Perioperative comfort care for HYS patients improved the patient’s adverse emotions, self-care ability, and nursing satisfaction.

Application Effect of WeChat Platform Continuity of Care Model Based on KAP Theory on Self-Management of Stroke Patients with Hypertension

Objective: To explore the impact of the WeChat platform continuity of care model based on the KAP (knowledge, attitudes, and practices) theory on the self-management of stroke patients with hypertension after discharge from the hospital. Methods: 62 stroke patients with hypertension discharged from the rehabilitation department of a tertiary A hospital in Nanning City, Guangxi Zhuang Autonomous Region, from October 2022 to April 2023 were sampled by convenience sampling method. Patients discharged from Rehabilitation I were included in the control group, and conventional nursing care was used; while patients discharged from Rehabilitation II were included in the observation group, and WeChat platform continuity of nursing care model based on the KAP theory was implemented. The intervention effect of the two groups was compared. Results: After 4 and 12 weeks of intervention, the diastolic and systolic blood pressure of the patients in the observation group were lower than those in the control group (P &lt; 0.05); after 12 weeks of intervention, the rate of medication adherence and the score of adherence to hypertension treatment in the observation group were significantly higher than those in the control group (P &lt; 0.05). Conclusion: The application of the WeChat platform continuity of care model based on KAP theory to stroke patients with hypertension can improve blood pressure, medication adherence rate, hypertension treatment adherence, and overall enhance the self-management level of these patients.

Profile of Multisystem Inflammatory Syndrome in Children (MIS-C) in Infants in North India during the Second Wave of SARS-CoV-2 Pandemic

Abstract Background: Multisystem inflammatory syndrome in children (MIS-C) secondary to severe acute respiratory syndrome coronavirus-2 has affected not only older children, adolescents, and adults but also infants, more so during the second wave of the global pandemic. Materials and Methods: All sequentially admitted infants hospitalized during 6 months who fulfilled the World Health Organization criteria for MIS-C or American Heart Association 2017 criteria for Kawasaki disease (KD) (and positive coronavirus disease-2019 [COVID-19] serology) were included in the present study. Results: A total of 19 infants were studied. Thirteen (68.3%) had evidence of recent COVID-19 infection. The median age of presentation was 2 months (interquartile range 25–75th, 0.5–3). The most common presenting symptoms were fever (68.4%), gastrointestinal complaints (63.1%), and edema (36.8%). Other predominant signs were shock (78.9%), myocarditis (52.6%), and neurological complaints (26.3%). Incomplete KD was present in 21% of patients. Elevated C-reactive protein, ferritin, D-Dimer, N-terminal prohormone of brain natriuretic peptide, and reduced fibrinogen were markers of severe illness. All subjects received intravenous immunoglobulin (IVIG) (100%), 31.5% received a second dose of IVIG, and 63.1% received pulse intravenous methylprednisolone. A total of 5 (26.3%) died as a result of the disease process. Conclusion: The spectrum of MIS-C in infants can be varied and is different from older children. A high index of suspicion is therefore needed in infants who present with critical illness and do not respond appropriately to conventional antibiotics and supportive care. The addition of IVIG and corticosteroids to the treatment regimen leads to a favorable outcome.

Digital Health Interventions and Patient Safety in Abdominal Surgery

Over the past 2 decades, several digital technology applications have been used to improve clinical outcomes after abdominal surgery. The extent to which these telemedicine interventions are associated with improved patient safety outcomes has not been assessed in systematic and meta-analytic reviews. To estimate the implications of telemedicine interventions for complication and readmission rates in a population of patients with abdominal surgery. PubMed, Cochrane Library, and Web of Science databases were queried to identify relevant randomized clinical trials (RCTs) and nonrandomized studies published from inception through February 2023 that compared perioperative telemedicine interventions with conventional care and reported at least 1 patient safety outcome. Two reviewers independently screened the titles and abstracts to exclude irrelevant studies as well as assessed the full-text articles for eligibility. After exclusions, 11 RCTs and 8 cohort studies were included in the systematic review and meta-analysis and 7 were included in the narrative review. Data were extracted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline and assessed for risk of bias by 2 reviewers. Meta-analytic estimates were obtained in random-effects models. Number of complications, emergency department (ED) visits, and readmissions. A total of 19 studies (11 RCTs and 8 cohort studies) with 10 536 patients were included. The pooled risk ratio (RR) estimates associated with ED visits (RR, 0.78; 95% CI, 0.65-0.94) and readmissions (RR, 0.67; 95% CI, 0.58-0.78) favored the telemedicine group. There was no significant difference in the risk of complications between patients in the telemedicine and conventional care groups (RR, 1.05; 95% CI, 0.77-1.43). Findings of this systematic review and meta-analysis suggest that perioperative telehealth interventions are associated with reduced risk of readmissions and ED visits after abdominal surgery. However, the mechanisms of action for specific types of abdominal surgery are still largely unknown and warrant further research.

Dysphagia Rehabilitation in Dysphagic Patients with Acute or Critical Illness: A Systematic Review and Meta-Analysis.

Dysphagia or swallowing dysfunction is common in patients with acute or critical illness, and diverse methods of dysphagia rehabilitation are provided worldwide. We aimed to examine the efficacy of rehabilitation to treat dysphagia in patients with acute or critical illness. We searched PubMed, ICHUSHI, and Cochrane Central Register of Controlled Trials databases from inception to November 22, 2023 for relevant randomized controlled trials. We focused on dysphagic patients with acute or critical illness who were not orotracheally intubated. Our target intervention included conventional rehabilitation and nerve stimulation/neuromodulation techniques as dysphagia rehabilitation. Comparators were conventional or standard care or no dysphagia interventions. Primary outcomes included mortality, incidence of pneumonia during the study period, and health-related quality of life (HRQoL) scores within 90 days of hospital discharge. We pooled the data using a random-effects model, and classified the certainty of evidence based on the Grading of Recommendations, Assessment, Development, and Evaluation system. Nineteen randomized controlled trials involving 1,096 participants were included. Dysphagia rehabilitation was associated with a reduced incidence of pneumonia (risk ratio [RR], 0.66; 95% confidence interval [CI], 0.54-0.81; moderate certainty), but not with reduced mortality (RR, 0.92; 95% CI, 0.61-1.39; very low certainty) or improved HRQoL scores (mean difference, -0.20; 95% CI, -20.34 to 19.94; very low certainty). Based on the available moderate- or very low- quality evidence, while dysphagia rehabilitation had no impact on mortality or HRQoL, they might reduce the incidence of pneumonia in dysphagic patients with acute or critical illness.

P114 Promoting physical activity using mobile health technology in people living with Rheumatoid Arthritis: MOTIVATE RA

Abstract Background/Aims People living with rheumatoid arthritis (RA) tend to be less active than the general population which may be due to RA associated musculoskeletal pain, stiffness and fatigue. The health benefits of physical activity (PA) are widely recognised in the general population and studies in RA have also highlighted improvement in RA associated symptoms. However, encouraging increased PA in people living with RA is challenging and adherence to PA is usually low. Mobile health (mHealth) technology (i.e., fitness watches and apps) may provide an effective and economical solution to promoting PA in this high-risk population. The aims of the current study were to assess whether use of mHealth technology in RA i) increases PA levels and ii) reduces RA disease activity. Methods People with RA were randomised to either the MOTIVATE (mHealth intervention) or conventional care (CC) groups. The CC group were provided with online educational materials, as provided in routine care (e.g., PA information leaflets), to increase PA whereas the MOTIVATE group were provided with a personalised, progressive walking programme delivered via mHealth technology with ongoing, individualised support throughout the 12-week intervention. All participants received a self-testing kit, via mail, at baseline (week 0) and post-intervention (12 weeks). Measures included anthropometrics, blood pressure, PA monitoring, health questionnaires and all were requested to self-report RA disease activity using RADAI-5. Change data between weeks 0 and 12 were compared between groups using One-Way ANCOVA, controlling for baseline, and reported as mean difference (95% CI). Results Of 50 participants, 25 were randomised to the MOTIVATE group (age 50±11years; BMI 29±7kg/m2; females n=23), and 25 to CC (n=25, age 50±11years; BMI 26±6 kg/m2; females n=24). An increase in moderate-to-vigorous PA was observed in the MOTIVATE group, compared to a decrease in CC [81min (1, 160) vs. -35min (-123, 53); P=0.09)]. This was accompanied by an increase in steps per day in the MOTIVATE group, and a decrease in CC [763 (-432, 1957) vs. -76 (-1267, 1115); P=0.40]. A reduction in PHQ-9 depression score was evident in the MOTIVATE group whilst CC were unchanged [-2 (-2, -3) vs. 0 (-2, 0); P=0.07]. RADAI-5 decreased in the MOTIVATE group and stayed the same in CC [-2 (-2, 0) vs. 0(-2, 0), P=0.27]. Conclusion These findings identify the potential effectiveness of an mHealth PA programme to increase PA levels in people living with RA. Use of remote PA monitoring, with support from exercise specialists, may be an effective strategy to improve engagement in exercise and PA in the RA population. Data is suggestive this could improve RA related symptoms, although we did not observe statistical significance. Disclosure D.J. Bannell: Grants/research support; Research grant from the Aintree Arthritis Trust. M. France-Ratcliffe: None. K.L. Hesketh: None. M. Cocks: None. N. Goodson: None. C. Taylor: None. T. Pecanha: None. H. Jones: None. D.A. Low: None. V.S. Sprung: None.

A Study on the Application of Evidence-Based Nursing in The Care of Patients with Severe Acute Pancreatitis

Objective: To explore the application research of evidence-based nursing in the care of patients with severe acute pancreatitis. Methods: This study focuses on evidence-based nursing care of severe acute pancreatitis. Patients with severe acute pancreatitis who received treatment in our hospital were selected, from which 80 cases were chosen for detailed analysis. The patients were randomly grouped into a control group (conventional nursing care) and a study group (evidence-based nursing care), with 40 patients each. Relevant research data were recorded during the nursing process, analyzed, and used as research indicators. Results: The hospitalization time and morbidity and mortality rate of the research group were shorter than those of the control group, and the recovery rate was higher than that of the control group (P &lt; 0.05). Patient satisfaction with nursing care in the observation group was higher than in the control group (P &lt; 0.05). Conclusion: For patients with severe acute pancreatitis, the use of evidence-based nursing methods effectively reduced the patient’s mortality rate, improved its curative effect, and also shortened the patient’s hospitalization time.

Enhanced Recovery After Surgery for Craniotomies: A Systematic Review and Meta-analysis.

The efficacy of the enhanced recovery after surgery (ERAS) protocols in neurosurgery has not yet been established. We performed a systematic review and meta-analysis of randomized controlled trials to compare the effects of ERAS protocols and conventional perioperative care on postoperative outcomes in patients undergoing craniotomy. The primary outcome was postoperative length of hospital stay. Secondary outcomes included postoperative pain visual analog pain scores, incidence of postoperative nausea and vomiting (PONV), postoperative complications, all-cause reoperation, readmission after discharge, and mortality. A literature search up to August 10, 2023, was conducted using PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus databases. Five studies, including 871 patients, were identified for inclusion in this review. Compared with conventional perioperative care, ERAS protocols reduced the length of postoperative hospital stay (difference of medians, -1.52 days; 95% CI: -2.55 to -0.49); there was high heterogeneity across studies (I2, 74%). ERAS protocols were also associated with a lower risk of PONV (relative risk, 0.79; 95% CI: 0.69-0.90; I2, 99%) and postoperative pain with a visual analog scale score ≥4 at postoperative day 1 (relative risk, 0.37; 95% CI: 0.28-0.49; I2, 14%). Other outcomes, including postoperative complications, did not differ between ERAS and conventional care groups. ERAS protocols may be superior to conventional perioperative care in craniotomy patients in terms of lower length of hospital stay, lower incidence of PONV, and improved postoperative pain scores. Further randomized trials are required to identify the impact of ERAS protocols on the quality of recovery after craniotomy.

The Impact of Specialized Nursing Care at Fracture Sites Coordinated with Disease Progression Monitoring in Thoracolumbar Spine Fractures

This study aims to investigate the impact of specialized nursing care at fracture sites coordinated with disease progression monitoring in thoracolumbar spine fractures. Patients diagnosed with definitive thoracolumbar spine fractures and underwent surgical treatment at our hospital between February 2022 and August 2023 were selected. Patients were divided into a treatment group (specialized nursing care at fracture sites coordinated with disease progression monitoring)and a control group (conventional care) based on different nursing methods. A comparative assessment was conducted to evaluate the role and significance of specialized nursing care at fracture sites coordinated with disease progression monitoring in thoracolumbar spine fracture rehabilitation. The results showed that compared to conventional care, specialized nursing care at fracture sites coordinated with disease progression monitoring could better promote the recovery of patients' neurological functions, alleviate pain, and effectively improve symptoms and functional recovery, thus enhancing patients' quality of life and satisfaction. The study confirms the effectiveness of specialized nursing care at fracture sites coordinated with disease progression monitoring in clinical practice post thoracolumbar spine fractures.

Study on the Application of Refined Nursing Care in The Care for Elderly Patients with Reflux Esophagitis

Objective: To investigate the application effect of refined nursing care in the care for elderly patients with reflux esophagitis. Methods: Following the difference in nursing style, 84 cases of elderly patients with reflux esophagitis admitted to our hospital from May 2022 to May 2023 were randomly grouped into a control group and a research group, with 42 cases each. The control group was given conventional nursing care and the research group was given refined nursing care. The psychological state and treatment adherence of the two groups of patients after the nursing intervention were compared. Results: After the nursing intervention, the self-rating anxiety scale (SAS) and self-rating depression scale (SDS) scores of the research group were lower than those of the control group (P &lt; 0.05). The treatment compliance of the research group was better than the control group (P &lt; 0.05). Conclusion: The implementation of refined nursing care for elderly patients with reflux esophagitis exhibited a significant effect on improving the patient’s psychological state, treatment compliance, and rehabilitation.

Maximum burn prevention practice vs conventional care after direct current cardioversion treatment: The BURN-PREVENTION trial

Maximum burn prevention practice vs conventional care after direct current cardioversion treatment: The BURN-PREVENTION trial

Nurses' Views on Caring for Lonely Patients During the Pandemic: A Qualitative Study.

The implementation of safety measures in hospitals due to the COVID-19 pandemic, including family visitation restrictions, forced the family to be absent during the patient's hospitalization. Nurses were confronted with new roles and responsibilities, as caring for lonely patients was a new phenomenon that emerged during the pandemic. The purpose of this study was to explore the nurses' views on caring for lonely patients during the COVID-19 pandemic. A qualitative research method based on an inductive content analysis approach was used. Data collection was carried out using semi-structured interviews. The sample consisted of 11 nurses who worked in COVID-19 wards and units. Content analysis was used to analyze the interview data. The analysis of the data revealed three main themes: 1) caring for the patient and the family; 2) extending conventional care; and 3) developing supportive mechanisms for better care. Caring for lonely patients brought about changes in patients's management and care and significantly affected communication patterns as well as nurses' roles and responsibilities. Providing care beyond limits, supporting care through the utilization of new technologies, and transforming organization and care were mentioned as areas of challenge for nursing practice. Conclusions: Maintaining communication and supporting the family's involvement in patient care are considered to be equal to healing for the lonely patient. Reshaping working conditions and caring practices to meet the needs of the nurses, the patients, and their families during health crises may contribute positively to the provision of holistic care for patients and their families.

Assessing the Feasibility of a Two-Cohort Design to Assess the Potential of Homeopathic Medicinal Products to Reduce Antimicrobial Resistance in Turkeys (The HOMAMR Project)-Study Protocol.

Antimicrobial resistance (AMR) is a serious public health concern worldwide. The European Union requires a reduction in the use of antibiotics by 50% by 2030, with separate regulations on organic production that give preference to homeopathy and phytotherapy in organic farms before the use of conventional medicines (including antibiotics). We have therefore designed a two-phased project whose overarching aim is to investigate the potential role of homeopathic medicinal products (HMPs) in combating AMR in turkeys (the HOMAMR project): a two-cohort feasibility study using turkey-farm data that have been collected and analyzed retrospectively, followed by a prospective two-cohort study in turkey farms that would examine the impact of HMPs on changing antibiotic use. The objective of this paper is to describe the protocol for the first phase of HOMAMR, which is a study under field conditions to assess the feasibility of collecting data retrospectively about turkeys that have been managed conventionally only or with HMPs. Surveys performed on farms in Germany and Austria, including interviews with consenting farmers, will determine the feasibility of comparing retrospectively gathered data on antibiotic use and performance/production data in two cohorts of turkeys: (1) homeopathic treatment with conventional care (antibiotics) added if necessary or (2) conventional care (antibiotics) only. Co-primary outcomes to be studied are the amount of antimicrobial use and production period-related mortality. In addition, other production/performance parameters will be compared between the two treated cohorts. To our knowledge, this is the first feasibility study on the treatment of turkeys using homeopathy, and whose retrospectively obtained data will inform a prospective study that would examine the impact of HMPs on antibiotic use in commercial turkey raising, fattening and breeding production.

Implementing Multilevel Network Meta-Regression for Time-To-Event Outcomes: A Case Study in Relapsed Refractory Multiple Myeloma

ObjectivesMultilevel network meta-regression (ML-NMR) leverages individual patient data (IPD) and aggregate data from a network of randomized controlled trials (RCTs) to assess the comparative efficacy of multiple treatments, while adjusting for between-study differences. We provide an overview of ML-NMR for time-to-event outcomes and apply it to an illustrative case study, including example R code. MethodsThe case study evaluated the comparative efficacy of idecabtagene vicleucel (ide-cel), selinexor+dexamethasone (Sd), belantamab mafodotin (BM), and conventional care (CC) for patients with triple-class exposed relapsed/refractory multiple myeloma in terms of overall survival. Single-arm clinical trials and real-world data were naively combined to create an aggregate data artificial RCT (aRCT) (MAMMOTH-CC versus DREAMM-2-BM versus STORM-2-Sd) and an IPD aRCT (KarMMa-ide-cel versus KarMMa-RW-CC). With some assumptions, we incorporated continuous covariates with skewed distributions, reported as median and range. The ML-NMR models adjusted for number of prior lines, triple-class refractory status, and age and were compared using the leave-one-out information criterion. We summarized predicted hazard ratios and survival (95% credible intervals) in the IPD aRCT population. ResultsThe Weibull ML-NMR model had the lowest leave-one-out information criterion. Ide-cel was more efficacious than Sd, BM, and CC in terms of overall survival. Effect modifiers had minimal impact on the model, and only triple-class refractory was a prognostic factor. ConclusionsWe demonstrate an application of ML-NMR for time-to-event outcomes and introduce code that can be used to aid implementation. Given its benefits, we encourage practitioners to utilize ML-NMR when population adjustment is necessary for comparisons of multiple treatments.

Efficacy of Integrated Ayurveda Treatment in Type 2 Diabetes mellitus with special reference to Prameha: A Randomised controlled Trial

Background: Diabetes mellitus (DM) is marked by persistent hyperglycemia, often due to insulin resistance. Type 2 diabetes mellitus (T2DM) constitutes 90% of cases and shares similarities with Prameha, a disorder characterized by frequent urination. Aims and objectives: This study aimed to compare Integrated Ayurveda Treatment (IAT) with standard diabetic treatment for Prameha. Materials and methods: A randomized, controlled open-label trial involved 200 T2DM subjects with HbA1C above 7%, taking metformin (≥1g /day). They were assigned to Standard Dietary Treatment (SDT) or IAT. SDT comprised metformin, dietary, and lifestyle modifications, while IAT included metformin with Ayurvedic medicine, specific Ayurveda diet, and yoga. Observation and result: Observations favoured Ayurveda treatment over standard diabetes treatment for most Prameha preliminary symptoms (purvarupa). Regarding Prameha rupa (symptoms), IAT significantly outperformed than SDT. Also, Ayurveda treatment group, led to improvements in HbA1C, fasting and postprandial blood sugar, and insulin resistance parameters compared to standard treatment group. Conclusion: Integrating Madhumeha ghana vati, ayurveda diet, and yoga with standard treatment yielded positive subjective and objective outcomes for Prameha, without significant adverse events. This suggests the potential benefits of combining Ayurvedic approaches with conventional care in managing prameha.