Search results for: clinical trial

Authors: Sayantika Biswas, Dipanshu Sur, Amitoj Athwal, Ratnabali Chakravorty

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Title: Impact of serum estrogen and progesterone levels in the outcome pregnancy rate in frozen embryo transfer cycles. A prospective cohort study Objective: The aim of the current study was to evaluate the effect of serum estradiol (E2) and progesterone (P4) levels at different time points on pregnancy outcomes in frozen embryo transfer (FET) cycles. Materials & Method: A prospective cohort study was performed in patients undergoing frozen embryo transfer. Patients under age 37 years of age with at least one good blastocyst or three good day 3 embryos were included in the study. For endometrial preparation, 14 days of oral estradiol use (2X2 mg for 5 days. 3X2 mg for 4 days, and 4X2 mg for 5 days) was followed by vaginal progesterone twice a day and 50 mg intramuscular progesterone twice a day. Embryo transfer was scheduled 72-76 hrs or 116-120hrs after the initiation of progesterone. Serum E2 and P4 levels were examined at 4 times a) at the start of the menstrual cycle prior to the hormone supplementation. b) on the day of P4 start. c) on the day of ET. d) on the third day after ET. Result: A total 41 women were included in this study (mean age 31.8; SD 2.8). Clinical pregnancy rate was 65.55%. Serum E2 levels on at the start of the menstrual cycle prior to the hormone supplementation and on the day of P4 start were high in patients who achieved pregnancy compared to who did not (P=0.005 and P=0.019 respectively). P4 levels on on the day of ET were also high in patients with clinical pregnancy. On the day of P4 start, a serum E2 threshold of 186.4 pg/ml had a sensitivity of 82%, and P4 had a sensitivity of 71% for the prediction of clinical pregnancy at the threshold value 16.00 ng/ml. Conclusion: In women undergoing FET with hormone replacement, serum E2 level >186.4 pg/ml on the day of the start of progesterone and serum P4 levels >16.00 ng/ml on embryo transfer day are associated with clinical pregnancy.

Keywords: serum estradiol, serum progesterone, clinical pregnancy, frozen embryo transfer

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Authors: Ricardo Munguia-Perez, Nayeli Remigio-Alvarado, M.Miriam Hernandez-Arroyo, Elsa Castañeda-Roldan

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Fungi have emerged as important pathogens causing morbidity and mortality mainly in immunosuppressed, malnourished and elderly patients. It has detected an increase in resistance to azoles primarily to fluconazol. The fungal infections have become a problem of public health for the resistance to antifungal agents, they have developed new antifungals with broad-spectrum. The aim of this study was determine the antifungal susceptibility of yeasts isolated from clinical samples (respiratory secretions, exudates, wounds, blood cultures, urine cultures) obtained from inpatients and outpatients of a tertiary hospital from State of Puebla. The antifungal susceptibility of the yeast from several clinical samples were determined by the CLS M44-A disk diffusion methods. 149 samples of yeast were analyzed. All species were 100% susceptible to nystatin and amphotericin B. Candida albicans showed resistance of 95.5 % to fluconazole, 50.7 % to 5-flurocytosine and 55.2 % intermediate susceptibility to ketoconazole. Candida glabrata 81.3 % was susceptibility to ketoconazole and 75 % to fluconazole, for the case of 5-flurocytosine the 56.3 % was susceptible. Candida krusei 100 % was susceptible to ketoconazole, 50 % to fluconazole and 37.5 % to 5-flurocytosine. The internal medicine have greater diversity of yeast, the samples have susceptibility of 64.7% to ketoconazole, 47.1 % to fluconazole and 27.5 % to 5-flurocytosine. Hospitalized patients are more resistant to fluconazole and nystatin, but in the case of outpatients presents resistance to ketoconazole.

Keywords: antifungal, susceptibility, yeast, clinical samples

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Authors: Erwin Chan, Aravind Subramaniyan, Siti Abdullah Fatehah, Steve Lian Kuling

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Foam assisted lift technology is proven across the industry to provide efficient deliquification in gas wells. Such deliquification is typically achieved by delivering the foamer chemical downhole via capillary strings. In highly liquid loaded wells where capillary strings are not readily available, foamer can be delivered via batch injection or bull-heading. The latter techniques differ from the former in that cap strings allow for liquid to be unloaded continuously, whereas foamer batches require that periodic batching be conducted for the liquid to be unloaded. Although batch injection allows for liquid to be unloaded in wells with suitable water to gas (WGR) ratio and condensate to gas (CGR) ratio without well intervention for capillary string installation, this technique comes with its own set of challenges - for foamer to de-liquify liquids, the chemical needs to reach perforation locations where gas bubbling is observed. In highly scaled perforation zones in certain wells, foamer delivered in batches is unable to reach the gas bubbling zone, thus achieving poor lift efficiency. This paper aims to discuss the techniques and challenges for unloading liquid via batch injection in scaled perforation wells X and Y, whose WGR is 6bbl/MMscf, whose scale build-up is observed at the bottom of perforation interval, whose water column is 400 feet, and whose ‘bubbling zone’ is less than 100 feet. Variables such as foamer Z dosage, batching technique, and well flow control valve opening times are manipulated during the duration of the trial to achieve maximum liquid unloading and gas rates. During the field trial, the team has found optimal values between the three aforementioned parameters for best unloading results, in which each cycle’s gas and liquid rates are compared with baselines with similar flowing tubing head pressures (FTHP). It is discovered that amongst other factors, a good agitation technique is a primary determinant for efficient liquid unloading. An average increment of 2MMscf/d against an average production of 4MMscf/d at stable FTHP is recorded during the trial.

Keywords: foam, foamer, gas lift, liquid unloading, scale, batch injection

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Authors: Ahmed Torad

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Background: Knee osteoarthritis (OA) is a prevalent musculoskeletal condition characterized by pain and functional impairment. While various rehabilitation approaches have been employed, the effectiveness of high-intensity interval training (HIIT) compared to traditional rehabilitation exercises remains unclear. Objective: This randomized controlled trial aimed to compare the effects of HIIT and traditional rehabilitation exercises on pain reduction, functional improvement, and quality of life in individuals with knee OA. Methods: A total of 120 participants diagnosed with knee OA were randomly allocated into two groups: the HIIT group (n=60) and the traditional rehabilitation group (n=60). The HIIT group participated in a 12-week supervised program consisting of high-intensity interval exercises, while the traditional rehabilitation group followed a conventional physiotherapy regimen. Outcome measures included visual analog scale (VAS) pain scores, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 Health Survey (SF-36) at baseline and after the intervention period. Results: Both groups showed significant improvements in pain scores, functional outcomes (WOMAC), and quality of life (SF-36) after 12 weeks of intervention. However, the HIIT group demonstrated superior pain reduction (p<0.001), functional improvement (p<0.001), and physical health-related quality of life (p=0.002) compared to the traditional rehabilitation group. No significant differences were observed in mental health-related quality of life between the two groups. Conclusion: High-intensity interval training appears to be a more effective rehabilitation approach than traditional exercises for individuals with knee osteoarthritis, resulting in greater pain reduction, improved function, and enhanced physical health-related quality of life. These findings suggest that HIIT may represent a promising intervention strategy for managing knee OA and enhancing the overall well-being of affected individuals.

Keywords: knee osteoarthritis, high-intensity interval training, traditional rehabilitation exercises, randomized controlled trial, pain reduction, functional improvement, quality of life

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Authors: Sajadian Akram, Tavasoli F.

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Breast cancer is the second most common cancer in the world and certainly the most frequent cancer mostly among women. This study was aimed to compare the effectiveness of individual counseling and group narrative therapy on female patients' life expectancy afflicted by breast cancer. The present study is a pre-test-post-test clinical trial. Fifty-five patients with breast cancer were randomly selected in the follow-up period and after their active medical treatment completion. Then, they were randomly divided into two groups: individual counseling and group counseling. Herth hope index (HHI) was used to measure the patients' hope level. Data were analyzed using t-test and SPSS software. hope rate was statistically significant in both groups receiving individual and group narrative therapy in the post-test compared to the pre-test (P <00000). Moreover, the comparative evaluation of hope in both groups (individual & group counseling) in the post-test showed that group narrative counseling is more effective than individual narrative counseling (P <00000). Conclusion: Narrative therapy promotes hope in breast cancer patients effectively. Due to the nature of breast cancer and its psychological effects in the post-treatment period, providing narrative group therapy can improve life quality. Patients' life quality changes in tandem with changes in hope.

Keywords: hope, narrative therapy, counseling, breast cancer

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Authors: Suin Seo, Sung-Il Cho

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Background: The use of mobile apps for smoking cessation has grown exponentially in recent years. Yet, there were limited researches which evaluated the quality of smoking cessation apps to our knowledge. In most cases, a clinical practice guideline which is focused on clinical physician was used as an evaluation tool. Objective: The objective of this study was to develop a user-centered measure for quality of mobile smoking cessation apps. Methods: A literature search was conducted to identify articles containing explicit smoking cessation guideline for smoker published until January 2018. WHO’s guide for tobacco users to quit was adopted for evaluation tool which assesses smoker-oriented contents of smoking cessation apps. Compared to the clinical practice guideline, WHO guideline was designed for smokers (non-specialist). On the basis of existing criteria which was developed based on 2008 clinical practice guideline for Treating Tobacco Use and Dependence, evaluation tool was modified and developed by an expert panel. Results: There were five broad categories of criteria that were identified including five objective quality scales: enhancing motivation, assistance with a planning and making quit attempts, preparation for relapse, self-efficacy, connection to smoking. Enhancing motivation and assistance with planning and making quit attempts were similar to contents of clinical practice guideline, but preparation for relapse, self-efficacy and connection to smoking (environment or habit which reminds of smoking) only existed on WHO guideline. WHO guideline had more user-centered elements than clinical guideline. Especially, self-efficacy is the most important determinant of behavior change in accordance with many health behavior change models. With the WHO guideline, it is now possible to analyze the content of the app in the light of a health participant, not a provider. Conclusion: The WHO guideline evaluation tool is a simple, reliable and smoker-centered tool for assessing the quality of mobile smoking cessation apps. It can also be used to provide a checklist for the development of new high-quality smoking cessation apps.

Keywords: smoking cessation, evaluation, mobile application, WHO, guideline

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Authors: Debjyoti Bhakat, Indranil Mondal, Asish K. Mukhopadayay, Nabendu S. Chatterjee

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Enterotoxigenic Escherichia coli is one of the leading causes of diarrhea in infants and travelers in developing countries. Colonization factors play an important role in pathogenesis and are one of the main targets for Enterotoxigenic Escherichia coli (ETEC) vaccine development. However, ETEC vaccines had poorly performed in the past, as the prevalence of colonization factors is region-dependent. There are more than 25 classical colonization factors presently known to be expressed by ETEC, although all are not expressed together. Further, there are other multiple non-classical virulence factors that are also identified. Here the presence and expression of common classical and non-classical virulence factors were studied. Further studies were done on the expression of prevalent colonization factors in different strains. For the prevalence determination, multiplex polymerase chain reaction (PCR) was employed, which was confirmed by simplex PCR. Quantitative RT-PCR was done to study the RNA expression of these virulence factors. Strains negative for colonization factors expression were confirmed by SDS-PAGE. Among the clinical isolates, the most prevalent toxin was est+elt, followed by est and elt, while the pattern was reversed in the control strains. There were 29% and 40% strains negative for any classical colonization factors (CF) or non-classical virulence factors (NCVF) among the clinical and control strains, respectively. Among CF positive ETEC strains, CS6 and CS21 were the prevalent ones in the clinical strains, whereas in control strains, CS6 was the predominant one. For NCVF genes, eatA was the most prevalent among the clinical isolates and etpA for control. CS6 was the most expressed CF, and eatA was the predominantly expressed NCVF for both clinical and controlled ETEC isolates. CS6 expression was more in strains having CS6 alone. Different strains express CS6 at different levels. Not all strains expressed their respective virulence factors. Understanding the prevalent colonization factor, CS6, and its nature of expression will contribute to designing an effective vaccine against ETEC in this region of the globe. The expression pattern of CS6 also will help in examining the relatedness between the ETEC subtypes.

Keywords: classical virulence factors, CS6, diarrhea, enterotoxigenic escherichia coli, expression, non-classical virulence factors

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Authors: Caio E. G. Reis, Jose G. Dórea, Teresa H. M. da Costa

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Objective: Epidemiological data shows an inverse association of coffee consumption with risk of type 2 diabetes mellitus. However, the clinical effects of coffee consumption on the glucose metabolism biomarkers remain controversial. Thus, this paper reviews clinical trials that evaluated the effects of coffee consumption on glucose metabolism. Research Design and Methods: We identified studies published until December 2014 by searching electronic databases and reference lists. We included randomized clinical trials which the intervention group received caffeinated and/or decaffeinated coffee and the control group received water or placebo treatments and measured biomarkers of glucose metabolism. The Jadad Score was applied to evaluate the quality of the studies whereas studies that scored ≥ 3 points were considered for the analyses. Results: Seven clinical trials (total of 237 subjects) were analyzed involving adult healthy, overweight and diabetic subjects. The studies were divided in short-term (1 to 3h) and long-term (2 to 16 weeks) duration. The results for short-term studies showed that caffeinated coffee consumption may increase the area under the curve for glucose response, while for long-term studies caffeinated coffee may improve the glycemic metabolism by reducing the glucose curve and increasing insulin response. These results seem to show that the benefits of coffee consumption occur in the long-term as has been shown in the reduction of type 2 diabetes mellitus risk in epidemiological studies. Nevertheless, until the relationship between long-term coffee consumption and type 2 diabetes mellitus is better understood and any mechanism involved identified, it is premature to make claims about coffee preventing type 2 diabetes mellitus. Conclusion: The findings suggest that caffeinated coffee may impairs glucose metabolism in short-term but in the long-term the studies indicate reduction of type 2 diabetes mellitus risk. More clinical trials with comparable methodology are needed to unravel this paradox.

Keywords: coffee, diabetes mellitus type 2, glucose, insulin

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Authors: Kingston Rajiah, Mari Kannan Maharajan, Si Jen Yeen, Sara Lew

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Parkinson’s disease (PD) is a progressive neurodegenerative disorder with evolving layers of complexity. Both motor and non-motor symptoms of PD may affect patients’ quality of life (QoL). Life expectancy for an individual with Parkinson’s disease depends on the level of care the individual has access to, can have a direct impact on length of life. Therefore, improvement of the QoL is a significant part of therapeutic plans. Patients with PD, especially those who are in advanced stages, are in great need of assistance, mostly from their family members or caregivers in terms of medical, emotional, and social support. The role of a caregiver becomes increasingly important with the progression of PD, the severity of motor impairment and increasing age of the patient. The nature and symptoms associated with PD can place significant stresses on the caregivers’ burden. As the prevalence of PD is estimated to more than double by 2030, it is important to recognize and alleviate the burden experienced by caregivers. This study focused on the impact of the clinical features on the QoL of PD patients, and of their caregivers. This study included PD patients along with their caregivers and was undertaken at the Malaysian Parkinson's Disease Association from June 2016 to November 2016. Clinical features of PD patients were assessed using the Movement Disorder Society revised Unified Parkinson Disease Rating Scale (MDS-UPDRS); the Hoehn and Yahr Staging of Parkinson's Disease were used to assess the severity and Parkinson's disease activities of daily living scale were used to assess the disability of Parkinson’s disease patients. QoL of PD patients was measured using the Parkinson's Disease Questionnaire-39 (PDQ-39). The revised version of the Zarit Burden Interview assessed caregiver burden. At least one of the clinical features affected PD patients’ QoL, and at least one of the QoL domains affected the caregivers’ burden. Clinical features ‘Saliva and Drooling’, and ‘Dyskinesia’ explained 29% of variance in QoL of PD patients. The QoL domains ‘stigma’, along with ‘emotional wellbeing’ explained 48.6% of variance in caregivers’ burden. Clinical features such as saliva, drooling and dyskinesia affected the QoL of PD patients. The PD patients’ QoL domains such as ‘stigma’ and ‘emotional well-being’ influenced their caregivers’ burden.

Keywords: carers, quality of life, clinical features, Malaysia

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Authors: Shideh Mohseni Movahed, Mansoureh Safari

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Intelligent drug delivery systems (IDDS) are innovative technological innovations and clinical way to advance current treatments. These systems differ in technique of therapeutic administration, intricacy, materials and patient compliance to address numerous clinical conditions that require different pharmacological therapies. IDDS capable of releasing an active molecule at the proper site and at a amount that adjusts in response to the progression of the disease or to certain functions/biorhythms of the organism is particularly appealing. In this paper, we describe the most recent advances in the development of intelligent drug delivery systems.

Keywords: drug delivery systems, IDDS, medicine, health

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Authors: Sajjad Ur Rahman, Muhammad Tahir, Mukarram Bashir, Jawad, Aoun Muhammad, Muhammad Zohaib, Hannan Khan, Seemal Javaid, Mariam Azam

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The efficiency of natural metabolites obtained from partially fermented soya hulls and wheat bran using Saccharomyces cerevisiae (DL-22 S/N) ensures a potential impact on the total milk yield and quality of milk production. On attaining a moderate number of Saccharomyces cerevisiae cells around 1×10⁹ CFU/ml, the concentrate was further elevated under in-vivo conditions to study the quality of milk production in lactating buffalo. Ten lactating buffalos of the Nili Ravi breed having the same physical factors were given 12 gm of microbial metabolites daily, along with the palleted feed having 22 % proteins. Another group of 10 lactating animals with the same characteristics was maintained without metabolites. The body score, overall health, incidence of mastitis, milk fat, milk proteins, ash and solid not fat (SNF) were elevated on a weekly basis up to thirty days of trial. It was recorded that the average total increase in quality milk production was 0.9 liter/h/d, whereas SNF in the milk was enhanced to 0.71, and fats were decreased to 0.09 %. Moreover, during all periods of the trial, the overall non-specific immunity of buffalo was increased, as indicated by less than 0.2 % of mastitis incidence compared to 1.8% in the untreated buffalos.

Keywords: natural metabolites, quality milk, milk yield, microorganisms, fermentation, nonspecific immunity, better performing animals

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Authors: Manoj Kumar Reddy Pulim, Lakshmi Muthukrishnan, Geetha Jayapathy, Radhika Raman

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Introduction: In the past two decades, noninvasive positive pressure ventilation (NIPPV) emerged as one of the most important advances in the management of both acute and chronic respiratory failure in children. In the acute setting, it is an alternative to intubation with a goal to preserve normal physiologic functions, decrease airway injury, and prevent respiratory tract infections. There is a need to determine the clinical profile and parameters which point towards the need for NIV in the pediatric emergency setting. Objectives: i) To study the clinical profile of children who required non invasive ventilation and invasive ventilation, ii) To study the clinical parameters common to children who required non invasive ventilation. Methods: All children between one month to 18 years, who were intubated in the pediatric emergency department and those for whom decision to commence Non Invasive Ventilation was made in Emergency Room were included in the study. Children were transferred to the Paediatric Intensive Care Unit and started on Non Invasive Ventilation as per our hospital policy and followed up in the Paediatric Intensive Care Unit. Clinical profile of all children which included age, gender, diagnosis and indication for intubation were documented. Clinical parameters such as respiratory rate, heart rate, saturation, grunting were documented. Parameters obtained were subject to statistical analysis. Observations: Airway disease (Bronchiolitis 25%, Viral induced wheeze 22%) was a common diagnosis in 32 children who required Non Invasive Ventilation. Neuromuscular disorder was the common diagnosis in 27 children (78%) who were Intubated. 17 children commenced on Non Invasive Ventilation who later needed invasive ventilation had Neuromuscular disease. High frequency nasal cannula was used in 32, and mask ventilation in 17 children. Clinical parameters common to the Non Invasive Ventilation group were age < 1 year (17), tachycardia n = 7 (22%), tachypnea n = 23 (72%) and severe respiratory distress n = 9 (28%), grunt n = 7 (22%), SPO2 (80% to 90%) n = 16. Children in the Non Invasive Ventilation + INTUBATION group were > 3 years (9), had tachycardia 7 (41%), tachypnea 9(53%) with a male predominance n = 9. In statistical comparison among 3 groups,'p' value was significant for pH, saturation, and use of Ionotrope. Conclusion: Invasive ventilation can be avoided in the paediatric Emergency Department in children with airway disease, by commencing Non Invasive Ventilation early. Intubation in the pediatric emergency department has a higher association with neuromuscular disorders.

Keywords: clinical parameters, indications, non invasive ventilation, paediatric emergency room

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Authors: Shekoufeh Behdad, Sahar Yadegari, Alireza Ghehrazad, Amirhossein Yadegari

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Background: In this study, we compared the effect of intravenous dexamethasone with placebo on hemodynamic variables and hypotension in patients undergoing cesarean section under spinal anesthesia. Materials and methods: This double-blind, randomized clinical trial was conducted with the approval of the university ethics committee. Written informed consent was obtained from all participating patients. Before spinal anesthesia, patients were randomly assigned to receive either dexamethasone (8 mg IV) or placebo (normal saline). Hemodynamic variables, including systolic, diastolic, and mean arterial blood pressures, as well as heart rate, were measured before drug administration and every 3 minutes until the birth of the neonate and then every 5 minutes until the end of surgery. Side effects such as hypotension, bradycardia, nausea, and vomiting were assessed and recorded for all the patients. Results: There were no significant differences in mean systolic, diastolic, and mean arterial blood pressures before and after administration of the studied drugs in both groups (P.Value>0.05), but heart rate and the incidence of hypotension in the dexamethasone group were less than placebo significantly. Conclusions: Intravenous administration of 8 mg dexamethasone before spinal anesthesia in females undergoing cesarean section can reduce the incidence of post-spinal hypotension without causing serious side effects.

Keywords: cesarean section, hypotension, spinal anesthesia, dexamethasone

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Authors: Milad Yousefi, Moslem Yousefi, Ricarpo Poley, Amer Nordin Darus

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Design optimization of heat exchangers is a very complicated task that has been traditionally carried out based on a trial-and-error procedure. To overcome the difficulties of the conventional design approaches especially when a large number of variables, constraints and objectives are involved, a new method based on a well-stablished evolutionary algorithm, particle swarm optimization (PSO), weighted sum approach and a novel constraint handling strategy is presented in this study. Since, the conventional constraint handling strategies are not effective and easy-to-implement in multi-objective algorithms, a novel feasibility-based ranking strategy is introduced which is both extremely user-friendly and effective. A case study from industry has been investigated to illustrate the performance of the presented approach. The results show that the proposed algorithm can find the near pareto-optimal with higher accuracy when it is compared to conventional non-dominated sorting genetic algorithm II (NSGA-II). Moreover, the difficulties of a trial-and-error process for setting the penalty parameters is solved in this algorithm.

Keywords: Heat exchanger, Multi-objective optimization, Particle swarm optimization, NSGA-II Constraints handling.

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Authors: Daly M. J, Condron C, Mulhall C, Eppich W, O'Neill J.

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Introduction: In contemporary clinical cardiology, comprehensive and holistic bedside evaluation including accurate cardiac auscultation is in decline despite having positive effects on patients and their outcomes. Methods: Scripted histories and scoring checklists for three clinical scenarios in cardiology were co-created and refined through iterative consensus by a panel of clinical experts; these were then paired with recordings of auscultatory findings from three actual patients with known valvular heart disease. A wearable vest with embedded pressure-sensitive panel speakers was developed to transmit these recordings when examined at the standard auscultation points. RCSI medical students volunteered for a series of three formative long case examinations in cardiology (LC1 – LC3) using this hybrid simulation. Participants were randomised into two groups: Group 1 received individual teaching from an expert trainer between LC1 and LC2; Group 2 received the same intervention between LC2 and LC3. Each participant’s long case examination performance was recorded and blindly scored by two peer participants and two RCSI examiners. Results: Sixty-eight participants were included in the study (age 27.6 ± 0.1 years; 74% female) and randomised into two groups; there were no significant differences in baseline characteristics between groups. Overall, the median total faculty examiner score was 39.8% (35.8 – 44.6%) in LC1 and increased to 63.3% (56.9 – 66.4%) in LC3, with those in Group 1 showing a greater improvement in LC2 total score than that observed in Group 2 (p < .001). Using the novel checklist, intraclass correlation coefficients (ICC) were excellent between examiners in all cases: ICC .994 – .997 (p < .001); correlation between peers and examiners improved in LC2 following peer grading of LC1 performances: ICC .857 – .867 (p < .001). Conclusion: Hybrid simulation and quantitative grading improve learning, standardisation of assessment, and direct comparisons of both performance and acumen in clinical cardiology.

Keywords: cardiology, clinical skills, long case examination, hybrid simulation, checklist

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Authors: Jui-Chien Hsieh

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Background:12-lead electrocardiography(ECG) is one of frequently-used tools to detect atrial fibrillation (AF), which might degenerate into life-threaten stroke, in clinical Practice. Based on this study, the AF detection by the clinically-used 12-lead ECG device has only 0.73~0.77 positive predictive value (ppv). Objective: It is on great demand to develop a new algorithm to improve the precision of AF detection using 12-lead ECG. Due to the progress on artificial intelligence (AI), we develop an ECG deep model that has the ability to recognize AF patterns and reduce false-positive errors. Methods: In this study, (1) 570-sample 12-lead ECG reports whose computer interpretation by the ECG device was AF were collected as the training dataset. The ECG reports were interpreted by 2 senior cardiologists, and confirmed that the precision of AF detection by the ECG device is 0.73.; (2) 88 12-lead ECG reports whose computer interpretation generated by the ECG device was AF were used as test dataset. Cardiologist confirmed that 68 cases of 88 reports were AF, and others were not AF. The precision of AF detection by ECG device is about 0.77; (3) A parallel 4-layer 1 dimensional convolutional neural network (CNN) was developed to identify AF based on limb-lead ECGs and chest-lead ECGs. Results: The results indicated that this model has better performance on AF detection than traditional computer interpretation of the ECG device in 88 test samples with 0.94 ppv, 0.98 sensitivity, 0.80 specificity. Conclusions: As compared to the clinical ECG device, this AI ECG model promotes the precision of AF detection from 0.77 to 0.94, and can generate impacts on clinical applications.

Keywords: 12-lead ECG, atrial fibrillation, deep learning, convolutional neural network

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Authors: Akalu Banbeta, Emmanuel Lesaffre, Reynaldo Martina, Joost Van Rosmalen

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Including data from previous studies (historical data) in the analysis of the current study may reduce the sample size requirement and/or increase the power of analysis. The most common example is incorporating historical control data in the analysis of a current clinical trial. However, this only applies when the historical control dataare similar enough to the current control data. Recently, several Bayesian approaches for incorporating historical data have been proposed, such as the meta-analytic-predictive (MAP) prior and the modified power prior (MPP) both for single control as well as for multiple historical control arms. Here, we examine the performance of the MAP and the MPP approaches for the analysis of (over-dispersed) count data. To this end, we propose a computational method for the MPP approach for the Poisson and the negative binomial models. We conducted an extensive simulation study to assess the performance of Bayesian approaches. Additionally, we illustrate our approaches on an overactive bladder data set. For similar data across the control arms, the MPP approach outperformed the MAP approach with respect to thestatistical power. When the means across the control arms are different, the MPP yielded a slightly inflated type I error (TIE) rate, whereas the MAP did not. In contrast, when the dispersion parameters are different, the MAP gave an inflated TIE rate, whereas the MPP did not.We conclude that the MPP approach is more promising than the MAP approach for incorporating historical count data.

Keywords: count data, meta-analytic prior, negative binomial, poisson

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Authors: A. Fordham, A. Hudson

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Background: Studies have suggested 16-25% of normotensive trauma patients with no clinical signs of shock have abnormal lactate and BD readings evidencing shock; a phenomenon known as occult hypoperfusion (OH). In light of the scarce quantity of evidence currently documenting OH, this study aimed to identify the prevalence of OH in the pre-hospital setting and explore ways to improve its identification and management. Methods: A quantitative retrospective data analysis was carried out on 75 sets of patient records for trauma patients treated by Kent Surrey Sussex Air Ambulance Trust between November 2013 and October 2014. The KSS HEMS notes and subsequent ED notes were collected. Trends between patients’ SBP on the scene, whether or not they received PRBCs on the scene as well as lactate and BD readings in the ED were assessed. Patients’ KSS HEMS notes written by the HEMS crew were also reviewed and recorded. Results: -Suspected OH was identified in 7% of the patients who did not receive PRBCs in the pre-hospital phase. -SBP heavily influences the physicians’ decision of whether or not to transfuse PRBCs in the pre-hospital phase. Preliminary conclusions: OH is an under-studied and underestimated phenomenon. We suggest a prospective trial is carried out to evaluate whether detecting trauma patients’ tissue perfusion status in the pre-hospital phase using portable devices capable of measuring serum BD and/or lactate could aid more accurate detection and management of all haemorrhaging trauma patients, including patients with OH.

Keywords: occult hypoperfusion, PRBC transfusion, point of care testing, pre-hospital emergency medicine, trauma

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Authors: Felix Lankester, Alicia Davis, Safari Kinung'hi, Catherine Bunga, Shayo Alkara, Imam Mzimbiri, Jonathan Yoder, Sarah Cleaveland, Guy H. Palmer

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Achieving the London Declaration goal of a 90% reduction in neglected tropical diseases (NTDs) by 2030 requires cost-effective strategies that attain high and comprehensive coverage. The first objective of this trial was to assess the impact on cost and coverage of employing a novel integrative One Health approach linking two NTD control programs: mass drug administration (MDA) for soil-transmitted helminths in humans (STH) and mass dog rabies vaccination (MDRV). The second objective was to compare the coverage achieved by the MDA, a community-wide deworming intervention, with that of the existing national primary school-based deworming program (NSDP), with particular focus on the proportion of primary school-age children reached and their school enrolment status. Our approach was unconventional because, in line with the One Health approach to disease control, it coupled the responsibilities and resources of the Ministries responsible for human and animal health into one program with the shared aim of preventing multiple NTDs. The trial was carried out in hard-to-reach pastoral communities comprising 24 villages of the Ngorongoro District, Tanzania, randomly allocated to either Arm A (MDA and MDRV), Arm B (MDA only) or Arm C (MDRV only). Objective one: The percentage of people in each target village that received treatment through MDA in Arms A and B was 63% and 65%, respectively (χ2 = 1, p = 0.32). The percentage of dogs vaccinated in Arm A and C was 70% and 81%, respectively (χ2 =9, p = 0.003). It took 33% less time for a single person and a dog to attend the integrated delivery than two separate events. Cost per dose (including delivery) was lower under the integrated strategy, with delivery of deworming and rabies vaccination reduced by $0.13 (54%) and $0.85 (19%) per dose, respectively. Despite a slight reduction in the proportion of village dogs vaccinated in the integrated event, both the integrated and non-integrated strategies achieved the target threshold of 70% required to eliminate rabies. Objective two: The percentages of primary school age children enrolled in school that was reached by this trial (73%) and the existing NSDP (80%) were not significantly different (F = 0.9, p = 0.36). However, of the primary school age children treated in this trial, 46% were not enrolled in school. Furthermore, 86% of the people treated would have been outside the reach of the NSDP because they were not primary school age or were primary school age children not enrolled in school. The comparable reach, the substantial reductions in cost per dose delivered and the decrease in participants’ time support this integrated One Health approach to control multiple NTDs. Further, the recorded level of non-enrolment at primary school suggests that, in remote areas, school-based delivery strategies could miss a large fraction of school-age children and that programs that focus delivery solely at the level of the primary school will miss a substantial proportion of both primary school age children as well as other individuals from the community. We have shown that these populations can be effectively reached through extramural programs.

Keywords: canine mediated human rabies, integrated health interventions, mass drug administration, neglected tropical disease, One Health, soil-transmitted helminths

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Authors: Chao Hsing Yeh, Wei Chun Lin

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Background: Current management of aromatase inhibitor-induced arthralgia (AIA) in postmenopausal breast cancer survivors (PBCS) has limited effect. Method: In this prospective randomized clinical trial (RCT), a 4-week APA treatment was used to manage AIA. Twenty PBCS participated. After baseline data was collected, participants were waited for a month before they receive APA at a convenient time once a week for 4 weeks. Blood samples from participants in both groups were collected at baseline and after 4 weeks of treatment. The primary outcomes included: pain intensity, pain interference, stiffness, and physical function. Results: After the 4-week APA treatment, the pro-inflammatory cytokines and chemokines display a trend of mean percentage reduction (i.e., -22% in IL-1α, -4% in IL-1β, -1% in IL-2, -3% in IL-6, -19% in IL-12, -9% in Eotaxin, and -2% in MCP-1). The anti-inflammatory cytokine IL-10 and IL-13 (i.e., 5% in IL-10 and 29% in IL-13) increased from pre- to post-APA treatment. Significant positive correlation of percentage mean change was observed between symptom severity and eotaxin (ρ = 0.56; p < 0.01) & MCP-1 (ρ = 0.65; p < 0.01). Interference and chemokines (eotaxin & MIP-1) also shows positive correlation (ρ = 0.48; p < 0.01 & ρ = 0.39; p < 0.05). Another positive correlation was found between worst pain and chemokines (eotaxin, ρ = 0.48; p < 0.01 & MIP-1, ρ = 0.39; p < 0.05). Additionally, interference also shows positive correlation among IL-1α (ρ = 0.36; p < 0.05) and IL-β (ρ = 0.33; p < 0.05). Conclusion: These findings suggest that APA intervention may inhibit inflammation of AIA patients and chemokine could be one of the key factors of AIA symptom improvement.

Keywords: acupressure, cytokine, pain management, breast cancer survivors

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Authors: H. Zidoum, A. AlShareedah, S. Al Sawafi, A. Al-Ansari, B. Al Lawati

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Systemic lupus erythematosus (SLE) is an autoimmune disease with genetic and environmental components. SLE is characterized by a wide variability of clinical manifestations and a course frequently subject to unpredictable flares. Despite recent progress in classification tools, the early diagnosis of SLE is still an unmet need for many patients. This study proposes an interpretable disease classification model that combines the high and efficient predictive performance of CatBoost and the model-agnostic interpretation tools of Shapley Additive exPlanations (SHAP). The CatBoost model was trained on a local cohort of 219 Omani patients with SLE as well as other control diseases. Furthermore, the SHAP library was used to generate individual explanations of the model's decisions as well as rank clinical features by contribution. Overall, we achieved an AUC score of 0.945, F1-score of 0.92 and identified four clinical features (alopecia, renal disorders, cutaneous lupus, and hemolytic anemia) along with the patient's age that was shown to have the greatest contribution on the prediction.

Keywords: feature selection, classification, systemic lupus erythematosus, model interpretation, SHAP, Catboost

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Authors: Onder Aldemir, Ercan Ceyhan

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The research was conducted to determine effects of salt concentrations on emergence and seedling development of chickpea genotypes. Trials were performed during the year of 2013 on the laboratory and greenhouse of Agricultural Faculty, Selcuk University. Emergency trial was set up according to ‘Randomized Plots Design’ by two factors and four replications; greenhouse trial was also set up according to ‘Randomized Plots Design’ by two factors with three replications. The chickpea genotypes; CA119, CA132, CA149, CA150, CA215, CA222, CA235, CA261, Bozkır and Gokce were used as material for both of the trials. Effects of the five doses of salt concentrations (control, 30 mM, 60 mM, 90 mM and 120 mM) on the ratio of emergency, speed of emergency, average time for emergency, index of sensibility, length of shoot and root, fresh weight of shoot and root, dry weight of shoot and root, index of salt tolerance were evaluated. Responses of the chickpea genotypes for salt concentrations were found different. Comparing to the control, all of the investigated characteristics on the chickpea genotypes showed significant reduction by depending on the increasing salt level. According to the effects of salt application, the chickpea genotypes Gokce, CA215 and CA222 were the most tolerant in respect to plant dry weights while the chickpea genotypes CA149 and CA150 were the most sensitive.

Keywords: chickpea, emergence, salt tolerant, seedling development

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Authors: Jungbin Lim, Bohee Kang, Heelim Lee, Sunjin Kim, GeumHee Choi, Jae-Suk Jung, Suk Ji

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Nonsurgical periodontal therapies have, for several decades, been the basis of periodontal treatment concepts. The aim of this paper is to investigate the effectiveness of non-surgical periodontal therapy according to the severity of periodontitis disease. Methods: Retrospective data of patients who visited Department of periodontics in Ajou University Medical Center from 2016 to 2022 were collected. Among the patients, those who took full mouth examination of clinical parameters and non-surgical periodontal therapy were chosen for this study. Selected patients were divided into initial, moderate, and severe periodontitis based on severity and complexity of management (2018 World Workshop EFP/AAP consensus). Recall visits with clinical periodontal examination were scheduled for 1,2,3 months or 1,3,6 months after the treatment. The results were evaluated by recordings of mean probing pocket depth (mean PD), mean clinical attachment levels (mean CAL), bleeding on probing (BOP%), mean gingival index (mean GI), mean regression, mean sulcus bleeding index (mean SBI), mean plaque scores (mean PI). All statistical analyses were performed with R software, version 4.3.0. A level of significance, P<0.05, was considered to be statistically significant. Results: A total of 92 patients were included in this study. 15 patients were diagnosed as initial periodontitis, 14 moderate periodontitis, and 63 severe periodontitis. The all parameters except for mean recession decreased over time in all groups. The amount of mean PD decreased were the greatest in severe periodontitis group followed by moderate and initial, which was found to be statistically significant. The changes of mean PD were 0.15±0.05 mm, 0.37±0.06 mm, and 1.01±0.07 mm (initial, moderate, and severe, respectively, P<0.001). When comparing before and after treatment, the reductions in BOP(%), mean GI, mean SBI, and mean PI were statistically significant. Conclusion: All patients who received non-surgical periodontal therapy showed periodontal healing in terms of improvements in clinical parameters, and it was greater in the severe group.

Keywords: periodontology, clinical periodontology, oral treatment, comprehensive preventive dentistry, non-surgical periodontal therapy

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Authors: Karl Owen L. Suan, Juliet Marie S. Lambayan, Floramay P. Salo-Curato

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Objective: To predict the outcome among patients admitted with community-acquired pneumonia (ages 3 months to 59 months old) admitted in Visayas Community Medical Center using the Respiratory Index of Severity in Children (RISC). Design: A cross-sectional study design was used. Setting: The study was done in Visayas Community Medical Center, which is a private tertiary level in Cebu City from January-June 2013. Patients/Participants: A total of 72 patients were initially enrolled in the study. However, 1 patient transferred to another institution, thus 71 patients were included in this study. Within 24 hours from admission, patients were assigned a RISC score. Statistical Analysis: Cohen’s kappa coefficient was used for inter-rater agreement for categorical data. This study used frequency and percentage distribution for qualitative data. Mean, standard deviation and range were used for quantitative data. To determine the relationship of each RISC score parameter and the total RISC score with the outcome, a Mann Whitney U Test and 2x2 Fischer Exact test for testing associations were used. A p value less of than 0.05 alpha was considered significant. Results: There was a statistical significance between RISC score and clinical outcome. RISC score of greater than 4 was correlated with intubation and/or mortality. Conclusion: The RISC scoring system is a simple combination of clinical parameters and a reliable tool that will help stratify patients aged 3 months to 59 months in predicting clinical outcome.

Keywords: RISC, clinical outcome, community-acquired pneumonia, patients

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Authors: Eimar Yadir Quintero Tapias

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Background: Science is not generally self-correcting; many clinical studies end with the same conclusion "more research is needed." This study hypothesizes that first, we need a better appraisal of the available (and unavailable) evidence instead of creating more of the same false inquiries. Methods: Systematic review of ClinicalTrials.gov study records using the following Boolean operators: (food OR nut OR milk OR egg OR shellfish OR wheat OR peanuts) AND (allergy OR allergies OR hypersensitivity OR hypersensitivities). Variables included the status of the study (e g., active and completed), availability of results, sponsor type, sample size, among others. To determine the rates of non-publication in journals indexed by PubMed, an advanced search query using the specific Number of Clinical Trials (e.g., NCT000001 OR NCT000002 OR...) was performed. As a prophylactic measure to prevent P-hacking, data analyses only included descriptive statistics and not inferential approaches. Results: A total of 2092 study records matched the search query described above (date: September 13, 2019). Most studies were interventional (n = 1770; 84.6%) and the remainder observational (n = 322; 15.4%). Universities, hospitals, and research centers sponsored over half of these investigations (n = 1208; 57.7%), 308 studies (14.7%) were industry-funded, and 147 received NIH grants; the remaining studies got mixed sponsorship. Regarding completed studies (n = 1156; 55.2%), 248 (21.5%) have results available at the registry site, and 417 (36.1%) matched NCT numbers of journal papers indexed by PubMed. Conclusions: The internal and external validity of human research is critical for the appraisal of medical evidence. It is imperative to analyze the entire dataset of clinical studies, preferably at a patient-level anonymized raw data, before rushing to conclusions with insufficient and inadequate information. Publication bias and non-registration of clinical trials limit the evaluation of the evidence concerning therapeutic interventions for food allergy, such as oral and sublingual immunotherapy, as well as any other medical condition. Over half of the food allergy human research remains unpublished.

Keywords: allergy, clinical trials, immunology, systematic reviews

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Authors: Sonia Alberti

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The Regional Conference to Restructure Psychiatric Care in Latin America, convened by the Pan American Health Organization (PAHO) in 1990, oriented the Brazilian Federal Act in 2001 that stipulated the psychiatric reform which requires deinstitutionalization and community-based treatment. Since then, the 15 years’ experience of different working teams in mental health led an academic working group – supervisors from personal practices, professors and researchers – to discuss certain clinical issues, as well as supervisions, and to organize colloquia in different cities as a methodology. These colloquia count on the participation of different working teams from the cities in which they are held, with team members with different levels of educational degrees and prior experiences, in order to increase dialogue right where it does not always appear to be possible. The principal aim of these colloquia is to gain interlocution between practitioners and academics. Working with the theory of case constructions, this methodology revealed itself helpful in unfolding new solutions. The paper also observes that there is not always harmony between what the psychiatric reform demands and clinical ethics.

Keywords: mental health, supervision, clinical cases, Brazilian experience

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Authors: Yu-Ching Lin, Meei-Ling Gau, Ghi-Hwei Kao, Hung-Chang Lee

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Objective: To compare the pushing experiences and birth outcomes of three different pushing positions during the second stage of labor. The three positions were: semi-recumbent, squatting, and squatting with the aid of ergonomically designed ankle supports. Methods: A randomized controlled trial was conducted at a regional teaching hospital in northern Taiwan. Data were collected from 168 primiparous women in their 38th to 42nd gestational week. None of the participants received epidural analgesia during labor and all were free of pregnancy and labor-related complications. Intervention: During labor, after full cervical dilation and when the fetal head had descended to at least the +1 station and had turned to the occiput anterior position, the experimental group was asked to push in the squatting position while wearing the ergonomically designed ankle supports; comparison group A was asked to push in the squatting position without the use of these supports; and comparison group B was asked to push in a standard semi-recumbent position. Measures: The participants completed a demographic and obstetrics datasheet, the Short Form McGill Pain Questionnaire (MPQ-SF), and the Labor Pushing Experience scale within 4-hours postpartum. Conclusion: In terms of delivery time, the duration between the start of pushing to crowning for the experimental group (squatting with ankle supports) averaged 25.52 minutes less (F =6.02, p< .05) than the time for comparison group B (semi-recumbent). Furthermore, the duration between the start of pushing to infant birth averaged 25.21 minutes less for the experimental group than for comparison group B (F =6.14, p< .05). Moreover, the experimental group had a lower average VAS pain score (5.05±3.22) than comparison group B and the average McGill pain score for the experimental group was lower than both comparison groups (F=18.12, p< .001). In summary, the participants in the group that delivered from a squatting position with ankle supports had better labor pushing experiences than their peers in the comparison groups. Results: In comparison to both unsupported squatting and semi-recumbent pushing, squatting with the aid of ergonomically designed ankle supports reduced pushing times, ameliorated labor pain, and improved the pushing experience. Clinical application and suggestion: The squatting with ankle-support intervention introduced in the present study may significantly reduce tiredness and difficulties in maintaining balance as well as increase pushing efficiency. Thus, this intervention may reduce the caring needs of women during the second stage of labor. This intervention may be introduced in midwifery education programs and in clinical practice as a method to improve the care of women during the second stage of labor.

Keywords: second stage of labor, pushing, squatting with ankle supports, squatting

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Authors: Priyanka Patil, Logan Manikam

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Background: The first 1000 days of life are a critical window and can result in adverse health consequences due to inadequate nutrition. South-Asian (SA) communities face significant health disparities, particularly in maternal and child health. Community-based interventions, often employing Participatory-Learning and Action (PLA) approaches, have effectively addressed health inequalities in lower-income nations. The aim of this study was to assess the feasibility of implementing a PLA intervention to improve infant feeding and care practices in SA communities living in London. Methods: Comprehensive analyses were conducted to assess the feasibility/fidelity of this pilot randomized controlled trial. Summary statistics were computed to compare key metrics, including participant consent rates, attendance, retention, intervention support, and perceived effectiveness, against predefined progression rules guiding toward a definitive trial. Secondary outcomes were analyzed, drawing insights from multiple sources, such as The Children’s-Eating-Behaviour Questionnaire (CEBQ), Parental-Feeding-Style Questionnaires (PFSQ), Food-diary, and the Equality-Impact-Assessment (EIA) tool. A video analysis of children's mealtime behavior trends was conducted. Feedback interviews were collected from study participants. Results: Process-outcome measures met predefined progression rules for a definitive trial, which deemed the intervention as feasible and acceptable. The secondary outcomes analysis revealed no significant changes in children's BMI z-scores. This could be attributed to the abbreviated follow-up period of 6 months, reduced from 12 months, due to COVID-19-related delays. CEBQ analysis showed increased food responsiveness, along with decreased emotional over/undereating. A similar trend was observed in PFSQ. The EIA tool found no potential discrimination areas, and video analysis revealed a decrease in force-feeding practices. Participant feedback revealed improved awareness and knowledge sharing. Conclusion: This study demonstrates that a co-adapted PLA intervention is feasible and well-received in optimizing infant-care practices among South-Asian community members in a high-income country. These findings highlight the potential of community-based interventions to enhance health outcomes, promoting health equity.

Keywords: child health, childhood obesity, community-based, infant nutrition

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Authors: Shivakumar M, Leslie Edward S Lewis, Shashikala Devadiga, Sonia Khurana

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Introduction: Methylxanthines are used for the treatment of AOP, to facilitate extubation and as a prophylactic agent to prevent apnea. Though the popularity of Caffeine has risen, it is expensive in a resource constrained developing countries like India. Objective: To evaluate the cost-effectiveness of Caffeine compared with Aminophylline treatment for AOP with respect to additional ventilatory resource utilized in different birth weight categorization. Design, Settings and Participants – Single centered, retrospective economic evaluation was done. Participants included preterm newborns with < 34 completed weeks of gestation age that were recruited under an Indian Council of Medical Research funded randomized clinical trial. Per protocol data was included from Neonatal Intensive Care Unit, Kasturba Hospital, Manipal, India between April 2012 and December 2014. Exposure: Preterm neonates were randomly allocated to either Caffeine or Aminophylline as per the trial protocol. Outcomes and Measures – We assessed surfactant requirement, duration of Invasive and Non-Invasive Ventilation, Total Methylxanthine cost and additional cost for respiratory support bared by the payers per day during hospital stay. For the purpose of this study Newborns were stratified as Category A – < 1000g, Category B – 1001 to 1500g and Category C – 1501 to 2500g. Results: Total 146 (Caffeine -72 and Aminophylline – 74) babies with Mean ± SD gestation age of 29.63 ± 1.89 weeks were assessed. 32.19% constitute of Category A, 55.48% were B and 12.33% were C. The difference in median duration of additional NIV and IMV support was statistically insignificant. However 60% of neonates who received Caffeine required additional surfactant therapy (p=0.02). The total median (IQR) cost of Caffeine was significantly high with Rs.10535 (Q3-6317.50, Q1-15992.50) where against Aminophylline cost was Rs.352 (Q3-236, Q1-709) (p < 0.001). The additional costs spent on respiratory support per day in neonates on either Methylxanthines were found to be statistically insignificant in the entire weight based category of our study. Whereas in Category B, the median O2 charges per day were found to have more in Caffeine treated newborns (p=0.05) with border line significance. In category A, providing one day NIV or IMV support significantly increases the unit log cost of Caffeine by 13.6% (CI – 95% ranging from 4 to 24; p=0.005) over log cost of Aminophylline. Conclusion: Cost of Caffeine is expensive than Aminophylline. It was found to be equally efficacious in reducing the number duration of NIV or IMV support. However adjusted with the NIV and IMV days of support, neonates fall in category A and category B who were on Caffeine pays excess amount of respiratory charges per day over aminophylline. In perspective of resource poor settings Aminophylline is cost saving and economically approachable.

Keywords: methylxanthines include caffeine and aminophylline, AOP (apnea of prematurity), IMV (invasive mechanical ventilation), NIV (non invasive ventilation), category a – <1000g, category b – 1001 to 1500g and category c – 1501 to 2500g

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Authors: Narottam Puri, Bishnu Panigrahi, Narayan Pendse

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Background: Clinical Outcomes are the globally agreed upon, evidence-based measurable changes in health or quality of life resulting from the patient care. Reporting of outcomes and its continuous monitoring provides an opportunity for both assessing and improving the quality of patient care. In 2012, International Consortium Of HealthCare Outcome Measurement (ICHOM) was founded which has defined global Standard Sets for measuring the outcome of various treatments. Method: Monitoring of Clinical Outcomes was identified as a pillar of Fortis’ core value of Patient Centricity. The project was started as an in-house developed Clinical Outcomes Reporting Portal by the Fortis Medical IT team. Standard sets of Outcome measurement developed by ICHOM were used. A pilot was run at Fortis Escorts Heart Institute from Aug’13 – Dec’13.Starting Jan’14, it was implemented across 11 hospitals of the group. The scope was hospital-wide and major clinical specialties: Cardiac Sciences, Orthopedics & Joint Replacement were covered. The internally developed portal had its limitations of report generation and also capturing of Patient related outcomes was restricted. A year later, the company provisioned for an ICHOM Certified Software product which could provide a platform for data capturing and reporting to ensure compliance with all ICHOM requirements. Post a year of the launch of the software; Fortis Healthcare has become the 1st Healthcare Provider in Asia to publish Clinical Outcomes data for the Coronary Artery Disease Standard Set comprising of Coronary Artery Bypass Graft and Percutaneous Coronary Interventions) in the public domain. (Jan 2016). Results: This project has helped in firmly establishing a culture of monitoring and reporting Clinical Outcomes across Fortis Hospitals. Given the diverse nature of the healthcare delivery model at Fortis Network, which comprises of hospitals of varying size and specialty-mix and practically covering the entire span of the country, standardization of data collection and reporting methodology is a huge achievement in itself. 95% case reporting was achieved with more than 90% data completion at the end of Phase 1 (March 2016). Post implementation the group now has one year of data from its own hospitals. This has helped identify the gaps and plan towards ways to bridge them and also establish internal benchmarks for continual improvement. Besides the value created for the group includes: 1. Entire Fortis community has been sensitized on the importance of Clinical Outcomes monitoring for patient centric care. Initial skepticism and cynicism has been countered by effective stakeholder engagement and automation of processes. 2. Measuring quality is the first step in improving quality. Data analysis has helped compare clinical results with best-in-class hospitals and identify improvement opportunities. 3. Clinical fraternity is extremely pleased to be part of this initiative and has taken ownership of the project. Conclusion: Fortis Healthcare is the pioneer in the monitoring of Clinical Outcomes. Implementation of ICHOM standards has helped Fortis Clinical Excellence Program in improving patient engagement and strengthening its commitment to its core value of Patient Centricity. Validation and certification of the Clinical Outcomes data by an ICHOM Certified Supplier adds confidence to its claim of being leaders in this space.

Keywords: clinical outcomes, healthcare delivery, patient centricity, ICHOM

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