Search results for: randomized trials

Authors: Yutong Wan, John N. Wood

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Introduction: SCN9A encoded Nav1.7 is an ideal therapeutic target with minimal side effects for the pharmaceutical industry because SCN9A variants can cause both human gains of function pain-related mutations and loss of function pain-free mutations. This study reviews the clinical effectiveness of existing Nav1.7 inhibitors, which theoretically should be powerful analgesics. Methods: A systematic review is conducted on the effectiveness of current Nav1.7 blockers undergoing clinical trials. Studies were mainly extracted from PubMed, U.S. National Library of Medicine Clinical Trials, World Health Organization International Clinical Trials Registry, ISRCTN registry platform, and Integrated Research Approval System by NHS. Only studies with full text available and those conducted using double-blinded, placebo controlled, and randomised designs and reporting at least one analgesic measurement were included. Results: Overall, 61 trials were screened, and eight studies covering PF 05089771 (Pfizer), TV 45070 (Teva & Xenon), and BIIB074 (Biogen) met the inclusion criteria. Most studies were excluded because results were not published. All three compounds demonstrated insignificant analgesic effects, and the comparison between PF 05089771 and pregabalin/ibuprofen showed that PF 05089771 was a much weaker analgesic. All three drug candidates only have mild side effects, indicating the potentials for further investigation of Nav1.7 antagonists. Discussion: The failure of current Nav1.7 small molecule inhibitors might attribute to ignorance of the key role of endogenous systems in Nav1.7 null mutants, the lack of selectivity and blocking potency, and central impermeability. The synergistic combination of analgesic drugs, a recent UCL patent, combining a small dose of Nav1.7 blockers and opioids or enkephalinase inhibitors dramatically enhanced the analgesic effects. Conclusion: The current clinical testing Nav1.7 blockers are generally disappointing. However, the newer generation of Nav1.7 targeting analgesics has overcome the major constraints of its predecessors.

Keywords: chronic pain, Nav1.7 blockers, SCN9A, systematic review

Procedia PDF Downloads 107

Authors: R. C. Barbuti, M. N. Oliveira, N. P. Perina, C. Haro, P. Bosch, C. S. Bogsan, J. N. Eisig, T. Navarro-Rodriguez

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Background: The management of Helicobacter pylori (H. pylori) eradication is still a matter of discussion, full effectiveness is rarely achieved and it has many adverse effects. Probiotics are believed to have a role in eradicating and possibly preventing H. pylori infection as an adjunctive treatment. The present clinical study was undertaken to see the efficacy of a specially designed fermented milk product containing Bifidobacterium lactis B420 on the eradication of H. pylori infection in a prospective, randomized, double-blind, controlled study in humans. Method: Four test products were specially designed fermented milks, counts of viable cells in all products were 1010 Log CFU. 100 mL-1 for Bifidobacterium lactis-Bifidobacterium species 420, and 1011 Log CFU. 100 mL-1 for Streptococcus thermophiles were administered to subjects infected with H. pylori with a previous diagnosis of functional dyspepsia according to the Rome III criteria in a prospective, randomized, double-blind, placebo-controlled study in humans. Results: After FM supplementation, not all subjects showed a reduction in H. pylori colonization. Conclusion: Bifidobacterium lactis B420, administered twice a day for 90 days did not show an increase in H. pylori eradication effectiveness in Brazilian patients with functional dyspepsia.

Keywords: antibacterial therapy, Bifidobacteria fermented milk, Helicobacter pylori, probiotics

Procedia PDF Downloads 269

Authors: Razieh Karimian, Kim Burton, Mohammad Mehdi Naghizadeh, Maryam Karimian

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Introduction: Habitual upper body postures are associated with online learning during the COVID-19 pandemic. This study explored whether adding an exercise routine to an ergonomic advice intervention improves these postures. Methods: In this randomized trial, 42 male adolescent students with a forward head posture were randomly divided into two equal groups, one allocated to ergonomic advice alone and the other to ergonomic advice plus an exercise routine. The angles of forward head, shoulder, and back postures were measured with a photogrammetric profile technique before and after the 8-week intervention period. Findings: During home quarantine, 76% of the students used their mobile phones, while 35% used a table-chair-computer for online learning. While significant reductions of the forward, shoulder, and back angles were found in both groups (P < 0.001), the effect was significantly greater in the exercise group (P < 0.001: forward head, shoulder, and back angles reduced by some 9, 6, and 5 degrees respectively, compared with 4 degrees in the forward head, and 2 degrees in the shoulder and back angles for ergonomic advice alone. Conclusion: The exercise routine produced a greater improvement in habitual upper body postures than ergonomic advice alone, a finding that may extend beyond online learning at home.

Keywords: randomized trial, online learning, adolescent, posture, exercise, ergonomic advice

Procedia PDF Downloads 45

Authors: Claire Williams

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Randomised controlled Trials (RCTs) of efficacy are still perceived as the gold standard for the generation of evidence, and whilst advances in data collection methods are well developed, this progress has not been matched for the reporting of adverse events (AEs). Assessment and reporting of AEs in clinical trials are fraught with human error and inefficiency and are extremely time and resource intensive. Recent research conducted into the quality of reporting of AEs during clinical trials concluded it is substandard and reporting is inconsistent. Investigators commonly send reports to sponsors who are incorrectly categorised and lacking in critical information, which can complicate the detection of valid safety signals. In our presentation, we will describe an electronic data capture system, which has been designed to support clinical trial processes by reducing the resource burden on investigators, improving overall trial efficiencies, and making trials safer for patients. This proprietary technology was developed using expertise proven in the delivery of the world’s first prospective, phase 3b real-world trial, ‘The Salford Lung Study, ’ which enabled robust safety monitoring and reporting processes to be accomplished by the remote monitoring of patients’ EHRs. This technology enables safety alerts that are pre-defined by the protocol to be detected from the data extracted directly from the patients EHR. Based on study-specific criteria, which are created from the standard definition of a serious adverse event (SAE) and the safety profile of the medicinal product, the system alerts the investigator or study team to the safety alert. Each safety alert will require a clinical review by the investigator or delegate; examples of the types of alerts include hospital admission, death, hepatotoxicity, neutropenia, and acute renal failure. This is achieved in near real-time; safety alerts can be reviewed along with any additional information available to determine whether they meet the protocol-defined criteria for reporting or withdrawal. This active surveillance technology helps reduce the resource burden of the more traditional methods of AE detection for the investigators and study teams and can help eliminate reporting bias. Integration of multiple healthcare data sources enables much more complete and accurate safety data to be collected as part of a trial and can also provide an opportunity to evaluate a drug’s safety profile long-term, in post-trial follow-up. By utilising this robust and proven method for safety monitoring and reporting, a much higher risk of patient cohorts can be enrolled into trials, thus promoting inclusivity and diversity. Broadening eligibility criteria and adopting more inclusive recruitment practices in the later stages of drug development will increase the ability to understand the medicinal products risk-benefit profile across the patient population that is likely to use the product in clinical practice. Furthermore, this ground-breaking approach to AE detection not only provides sponsors with better-quality safety data for their products, but it reduces the resource burden on the investigator and study teams. With the data taken directly from the source, trial costs are reduced, with minimal data validation required and near real-time reporting enables safety concerns and signals to be detected more quickly than in a traditional RCT.

Keywords: more comprehensive and accurate safety data, near real-time safety alerts, reduced resource burden, safer trials

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Authors: Pitchaporn Purngpiputtrakul, Suttasinee Petsakul, Sunisa Chatmongkolchart

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Nasogastric tube (NGT) insertion in anaesthetized and intubated patients can be challenging even for experienced anesthesiologists. Various techniques have been proposed to facilitate NGT insertion in these patients. This study aimed to compare the success rate and time required for NGT insertion between the GlideScope visualization and neck flexion with lateral neck pressure techniques. This randomized clinical trial was performed at a teaching hospital on 86 adult patients undergoing abdominal surgery under relaxant general anaesthesia who required intraoperative NGT insertion. The patients were randomized into two groups, the GlideScope group (group G) and the neck flexion with lateral neck pressure group (group F). The success rate of first and second attempts, duration of insertion, and complications were recorded. The total success rate was 79.1% in Group G compared with 76.7% in Group F (P=1) The median time required for NGT insertion was significantly longer in Group G, for both first and second attempts (97 vs 42 seconds P<0.001) and (70 vs 48.5 seconds P=0.015), respectively. Complications were reported in 23 patients (53.5%) in group G and 13 patients (30.2%) in group F. Bleeding and kinking were the most common complications in both techniques. Using GlideScope visualization to facilitate NGT insertion was comparable to neck flexion with lateral neck pressure technique in degree of success rate of insertion, while neck flexion with lateral neck pressure technique had fewer complications and was less time-consuming.

Keywords: anaesthesia, nasogastric tube, GlideScope, intubation

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Authors: Farnaz Firuzian, Farhad Choobdar, Ali Mazouri

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As Very Low Birth Weight (VLBW) neonates cannot tolerate enteral feeding, parenteral nutrition (PN) must be administered shortly after birth. To find an optimal combination of nutrition, in this study, we compare administering high glucose versus high protein intake as a component of total parenteral nutrition (TPN) to test their effect on birth weight (BW) regain in VLBW. This study employs a multi-arm randomized trial: 145 newborns with BW < 1500 g were randomized to control (C) or experimental groups: high glucose (G) or high protein (P). All samples in each group received the same TPN regimens except glucose and protein intake: Glocuse was provided by dextrose water (DW) serum: 7-15 g/kg/d (10% DW) in groups C and P versus 8.75-18.75 g/kg/d (12.5% DW) in group G. Protein provided by amino acids 3 g/kg/d for groups C and G versus 4 g/kg/d for group P. Outcomes (weight, height, and head circumference) was monitored on a daily basis until the BW was regained. Data has been gathered recently and is being processed. We hypothesize that neonates with higher amino acid intake will result in sooner BW regain than other groups. The result will be presented at the conference. The findings of this study not only can help optimize nutrition, cost reduction, and shorter NICU admission of VLBW neonates at the hospital level but eventually contribute to reduced healthcare-associated infections (HAIs) and an improved health economy.

Keywords: very low birth weight neonates, weight gain, parenteral nutrition, glucose, amino acids

Procedia PDF Downloads 63

Authors: Maria Luiza D. Ramiento, Maria Lissette D. Lucas

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Electricity is said to serve as the backbone of modern technology. Considering this, electricity consumption has dynamically grown due to the continuous demand. An alternative producer of energy concerning electricity must therefore be given focus. Microbial fuel cell wholly characterizes a new method of renewable energy recovery: the direct conversion of organic matter to electricity using bacteria. Electricity is produced as fuel or new food is given to the bacteria. The study concentrated in determining the feasibility of electricity production from local benthic zones. Microbial fuel cells were constructed to harvest the possible electricity and to test the presence of electricity producing microorganisms. Soil samples were gathered from Calumpang River, Palawan Mangrove Forest, Rosario River and Batangas Port. Eleven modules were constructed for the different trials of the soil samples. These modules were made of cathode and anode chambers connected by a salt bridge. For 85 days, the harvested voltage was measured daily. No parameter is added for the first 24 days. For the next 61 days, acetic acid was included in the first and second trials of the modules. Each of the trials of the soil samples gave a positive result in electricity production.There were electricity producing microbes in local benthic zones. It is observed that the higher the organic content of the soil sample, the higher the electricity harvested from it. It is recommended to identify the specific species of the electricity-producing microorganism present in the local benthic zone. Complement experiments are encouraged like determining the kind of soil particles to test its effect on the amount electricity that can be harvested. To pursue the development of microbial fuel cells by building a closed circuit in it is also suggested.

Keywords: microbial fuel cell, benthic zone, electricity, reduction-oxidation reaction, bacteria

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Authors: Abdelfatah Elsenosy, Mahmoud Ebrahim

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Background: Distal radius fractures are commonly encountered in orthopedic practice, especially in elderly patients. A number of clinical papers have supported the idea that anatomic restoration of the distal end of the radius is essential to gain superior results. Aim and objectives: The aim of the study is to systematically review the literature for the management of distal end radius in elderly persons (conservative treatment versus percutaneous wire fixation) as regards radiological and functional outcomes. Subjects and methods: Studies were identified from the Medline, Cochrane, EMBASE, and Google Scholar databases were searched until 2019 using combinations of the following search terms: distal radius fracture, conservative treatment, non-operative treatment, and nonsurgical treatment, surgical treatment, operative, elderly, and older. Reference lists of relevant studies were manually searched. Results: There was no statistical significance difference between CI and PKF groups’ frequency of complication in all of the selected studies. Based on the results, we recommend more analysis regarding every parameter of the radiographic and functional results and specific complications related to each fixation need to be accomplished, which requires more Randomized controlled trials (RCTs) with high quality. Conclusion: Surgical treatment seems to be more effective distal radius fracture compared with conservative treatment when the radiographic outcomes were analyzed, and no significant differences were detected in the functional outcomes and complication rate.

Keywords: radius, fracture, surgical, RCTs, conservative, radiographic, outcomes, orthopedic

Procedia PDF Downloads 131

Authors: Fahmi Hassan, Noorizan Abdul Aziz, Yahaya Hassan, Hazlinda Abu Hassan

Abstract:

Sepsis incidence in critical care settings is a major problem in health care. Extended antibiotic infusion is thought to be superior to traditional dosing especially when treating critically ill patients with sepsis. We compared clinical outcomes of critically ill patients with sepsis receiving 30-minute meropenem infusion and three-hour meropenem infusion. A retrospective case-control study was conducted among septic patients treated with meropenem infusion in ICUs of three hospitals. Patients included in the study received either extended or standard meropenem infusion as per the practice of individual settings. Outcomes and clinical data were retrospectively collected from the electronic databases and patients’ files. A total of 108 patients received extended meropenem infusion while another 117 patients received standard meropenem infusion. Patients receiving the extended meropenem infusion were found to have a significantly lower shorter length of hospital and ICU stay. It was also found that among those receiving extended meropenem infusion, 54.7% (64/117) had a reduction of SAPS II score, while only 44% (48/108) of patients receiving standard meropenem infusion had reduced scores. This study will strengthen the evidence in using extended meropenem infusion as a standard practice in critical care settings. As this is the first study of its kind done in Malaysia, it proves that prolonged meropenem infusion may be beneficial to critically ill patients with sepsis. However, randomized clinical trials with large sample size should be carried out in local settings in order to minimize other confounders that may influence with the result of the study.

Keywords: antibiotics, beta lactams, critical care, extended infusion, meropenem

Procedia PDF Downloads 379

Authors: Eva Masson, Andrea Kübler

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Anxiety disorders (AD) are the most prevalent psychological disorders. However, far from most affected individuals are diagnosed and receive treatment. This gap is probably due to the diagnosis criteria, relying on symptoms (according to the DSM-5 definition) with no objective biomarker. Approach-avoidance conflict tasks are one common approach to simulate such disorders in a lab setting, with most of the paradigms focusing on the relationships between behavior and neurophysiology. Approach-avoidance conflict tasks typically place participants in a situation where they have to make a decision that leads to both positive and negative outcomes, thereby sending conflicting signals that trigger the Behavioral Inhibition System (BIS). Furthermore, behavioral validation of such paradigms adds credibility to the tasks – with overt conflict behavior, it is safer to assume that the task actually induced a conflict. Some of those tasks have linked asymmetrical frontal brain activity to induced conflicts and the BIS. However, there is currently no consensus for the direction of the frontal activation. The authors present here a modified version of the T-Maze paradigm, a motivational conflict desktop task, in which behavior is recorded simultaneously to the recording of high-density EEG (HD-EEG). Methods: In this within-subject design, HD-EEG and behavior of 35 healthy participants was recorded. EEG data was collected with a 128 channels sponge-based system. The motivational conflict desktop task consisted of three blocks of repeated trials. Each block was designed to record a slightly different behavioral pattern, to increase the chances of eliciting conflict. This variety of behavioral patterns was however similar enough to allow comparison of the number of trials categorized as ‘overt conflict’ between the blocks. Results: Overt conflict behavior was exhibited in all blocks, but always for under 10% of the trials, in average, in each block. However, changing the order of the paradigms successfully introduced a ‘reset’ of the conflict process, therefore providing more trials for analysis. As for the EEG correlates, the authors expect a different pattern for trials categorized as conflict, compared to the other ones. More specifically, we expect an elevated alpha frequency power in the left frontal electrodes at around 200ms post-cueing, compared to the right one (relative higher right frontal activity), followed by an inversion around 600ms later. Conclusion: With this comprehensive approach of a psychological mechanism, new evidence would be brought to the frontal asymmetry discussion, and its relationship with the BIS. Furthermore, with the present task focusing on a very particular type of motivational approach-avoidance conflict, it would open the door to further variations of the paradigm to introduce different kinds of conflicts involved in AD. Even though its application as a potential biomarker sounds difficult, because of the individual reliability of both the task and peak frequency in the alpha range, we hope to open the discussion for task robustness for neuromodulation and neurofeedback future applications.

Keywords: anxiety, approach-avoidance conflict, behavioral inhibition system, EEG

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Authors: Lukman Thalib, Luis Furuya-Kanamori, Rachel Walker, Brigid Gillespie, Suhail Doi

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Background and objectives: There are many topical treatments available for Pressure Injury (PI) treatment, yet there is a lack of evidence with regards to the most effective treatment. The objective of this study was to compare the effect of various topical treatments and identify the best treatment choice(s) for PI healing. Methods: Network meta-analysis of published randomized controlled trials that compared the two or more of the following dressing groups: basic, foam, active, hydroactive, and other wound dressings. The outcome complete healing following treatment and the generalised pair-wise modelling framework was used to generate mixed treatment effects against hydroactive wound dressing, currently the standard of treatment for PIs. All treatments were then ranked by their point estimates. Main Results: 40 studies (1,757 participants) comparing 5 dressing groups were included in the analysis. All dressings groups ranked better than basic (i.e. saline gauze or similar inert dressing). The foam (RR 1.18; 95%CI 0.95-1.48) and active wound dressing (RR 1.16; 95%CI 0.92-1.47) ranked better than hydroactive wound dressing in terms of healing of PIs when the latter was used as the reference group. Conclusion & Recommendations: There was considerable uncertainty around the estimates, yet, the use of hydroactive wound dressings appear to perform better than basic dressings. Foam and active wound dressing groups show promise and need further investigation. High-quality research on clinical effectiveness of the topical treatments are warranted to identify if foam and active wound dressings do provide advantages over hydroactive dressings.

Keywords: Net work Meta Analysis, Pressure Injury, Dresssing, Pressure Ulcer

Procedia PDF Downloads 97

Authors: Naureen Naeem, M. S. Aslam

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Chia seeds found to be a rich source of dietary fiber contain oil which is high in omega 6 and omega 3 fatty acids and helpful in the control of cardiovascular diseases. Owing to its spectacular significance, present research had been designed to explore its effect on cholesterol level of the individuals after consumption of chia seed oil supplemented ice cream. The project was designed in such a manner that fat of ice cream was replaced with chia seed oil in different proportions i.e., 25%, 50%, 75%, 100%. After physico-chemical and sensory evaluation of ice cream, best treatment was selected and used for efficacy trials. After baseline line study and thorough inclusion criteria 10 individuals were selected and divided into two groups. One group treated as control and the other was given chia seed oil supplemented l(50%) ice cream. Significant decrease in cholesterol level was observed in the treated group. 18% decrease in cholesterol level was observed at 40th day followed by 8% at 20th day. Similarly 20% decrease in LDL cholesterol with 14% increase in HDL cholesterol. It was recommended that further trials be conducted with sophisticated techniques to completely replace saturated fat in ice cream with unsaturated fats and to study its effect in hyperglycemia and oxidative stress.

Keywords: hypercholesterolemia, chia seed oil, HDL, triglycerides

Procedia PDF Downloads 283

Authors: Siti Hajar Muhamad Rosli, Xin Yi Lim, Terence Yew Chin Tan, Muhammad nor Farhan Sa’At, Syazwani Sirdar Ali, Ami Fazlin Syed Mohamed

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A growing interest on therapeutic benefits of hemp (Cannabis sativa subsp. sativa) is evident in the pharmaceutical market, attributed to its lower levels of psychoactive constituent delta-9-tetrahydronannabidiol (THC). Deemed as a legal and safer alternative to its counterpart marijuana, the use of medicinal hemp is highly debatable as current scientific evidence on the efficacy for clinical use is yet to be established This study was aimed to provide an overview of the current landscape of hemp research, through recent clinical findings specific to the pharmacological properties of the hemp plant and its derived compounds. A systematic search was conducted following the Preferred Reporting Items for Systematic Review and Meta-Analysis-ScR (PRISMA) checklist on electronic databases (MEDLINE, OVID, Cochrane Library Central, and Clinicaltrials.gov) for articles published from 2009 to 2019. With predetermined inclusion criteria, all human trials with hemp intervention were included. A total of 18 human trials were identified, investigating therapeutic effects on the neuronal, gastrointestinal, musculoskeletal and immune system, with sample sizes ranging from one to 194 subjects. Three randomised controlled trials showed hempseed pills (in Traditional Chinese Medicine formulation MaZiRenWan) consumption significantly improved spontaneous bowel movement in functional constipation. The use of commercial cannabidiol (CBD) sourced from hemp suggested benefits in cannabis dependence, epilepsy, and anxiety disorders. However, there was insufficient evidence to suggest analgesic or anxiolytics effects of hemp being equivalent to marijuana. All clinical trials reviewed varied in terms of test item formulation and standardisation, which made it challenging to confirm overall efficacy for a specific disease or condition. Published efficacy data on hemp are still at a preliminary level, with limited high quality clinical evidence for any specific therapeutic indication. With multiple variants of this plant having different phytochemical and bioactive compounds, future empirical research should focus on uniformity in experimental designs to further strengthen the notion of using medicinal hemp.

Keywords: cannabis, complementary medicine, hemp, herbal medicine.

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Authors: Mehdi Sheikhi, Marjan Nassiri-Asl, Esmail Abbasi, Mahsa Shafiee

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Various synthetic derivatives of natural flavonoids are known to have neuroactive properties. The present study aimed to investigate the effects of vitexin (5, 7, 4-trihydroxyflavone-8-glucoside), a flavonoid found in such plants as tartary buckwheat sprouts, wheat leaves phenolome, Mimosa pudica Linn and Passiflora spp, on scopolamine-induced memory impairment in rats. To achieve this goal, we assessed the effects of vitexin on memory retrieval in the presence or absence of scopolamine using a step-through passive avoidance trial. In the first part of the study, vitexin (25, 50, and 100 μM) was administered intracerebroventricularly (i.c.v.) before acquisition trials. In the second part, vitexin, at the same doses, was administered before scopolamine (10 μg, i.c.v.) and before the acquisition trials. During retention tests, vitexin (100 μM) in the absence of scopolamine significantly increased the stepthrough latencies compared to scopolamine. In addition, vitexin (100 μM) significantly reversed the shorter step-through latencies induced by scopolamine (P < 0.05). These results indicate that vitexin has a potential role in enhancing memory retrieval. A possible mechanism is modulation of cholinergic receptors; however, other mechanisms may be involved in its effects in acute exposure.

Keywords: flavonoid, memory retrieval, passive avoidance, scopolamine, vitexin

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Authors: Hadi O. Tohme

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This study is a review on the effectiveness of new physiotherapy techniques with external sensory stimulus compared to standard physiotherapy in the daily activities of patients with Parkinson's disease. Twenty studies from 1996 to 2015 were analyzed and discussed in this review, using the rehabilitation strategy with external sensory stimulus evaluating walking, freezing episodes, balance, transfers, and daily activities of parkinsonian patients. The study highlights the effectiveness of the variety of rehabilitation with cueing strategy used in the treatment of Parkinson's disease. Based on the literature review completed, there is a need for more specific trials with better treatment strategies to support the most appropriate choice of physiotherapy intervention using external sensory stimulus to the type and frequency of this stimulus. In addition, no trials examined the long-term benefits of the physiotherapy intervention with the external sensory stimulus. In order to determine if, or how long the improvements due to the external sensory stimulus physiotherapy intervention can last, long-term follow-up should be performed.

Keywords: cueing strategy, external sensory stimulus, parkinson disease, rehabilitation for parkinson, sensory attention focused exercises, sensory strategy reeducation

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Authors: Gregory Chown, Benjamin Infantolino, Christopher Wise, Rachel Holmes, Samantha O'Donnell, Katelyn Pfeiffer, Victoria Ward

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Background: There is a lack of understanding of how Kinesio Tape® physiologically works. Furthermore, few studies compare Kinesio Tape® to other forms of taping. The research question is: Does Kinesio Tape® cause a difference in muscle facilitation, inhibition, and pain, between Kinesio Tape® and no tape for collegiate athletes with self-reported shoulder pain? Method: This quantitative non-randomized design used a convenience sampling method. There were eleven participants with self-reported shoulder pain who were athletes on the men’s and women’s lacrosse and tennis teams. Participants attended one 30-45 minute session for data collection. Each participant received all three taping conditions and performed four repetitions of 120 degrees of active shoulder flexion for the three separate trials (no tape, Kinesio Tape® inhibition, and Kinesio Tape® facilitation). Surface electromyography (sEMG) electrodes were placed on the anterior deltoid, supraspinatus, and lower trapezius to measure muscle facilitation and inhibition. Each participant completed the visual analogue scale (VAS) before and after each trial to measure pain. Results: No statistical significance was found for pain scores on the VAS between the taping methods of facilitation, inhibition, and no tape (p = .118). No statistical significance was found for the percentage of change in muscle function for each taping method; Anterior deltoid (p = .993), supraspinatus (p = .997) and lower trapezius (p = .922). Conclusion: Based on the results, Kinesio Tape® appears to not have an effect on muscle function or pain when utilizing the facilitation or inhibition taping method when compared to no tape.

Keywords: Kinesio tape, muscle facilitation, muscle inhibition, pain

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Authors: Lingyu Ding, Hongxia Hua, Hanfei Zhu, Jinling Lu, Qin Xu

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Background: Postoperative pain is a prevalent problem leading to many adverse outcomes in surgical patients. Virtual reality (VR) is an emerging non-pharmacological method of postoperative pain relief, but the effects of it are not clear. This review aimed to explore the effects of VR on relieving postoperative pain. Methods: We searched PubMed, Embase, Web of Science, and other databases from inception to November 2019 to get the eligible studies. Meta-analyses were conducted to compare VR and usual care for relieving postoperative pain. Subgroup analyses and sensitivity analyses were performed to explain the heterogeneity. Results: Overall, 8 randomized control trials (RCTs) enrolling 723 participants were included. Our results demonstrated that the patients receiving the VR intervention had lower postoperative pain scores than those receiving the usual care. One subgroup analysis revealed that VR could relieve postoperative pain both in minor surgery and major surgery. Another subgroup analysis demonstrated a significant reduction in postoperative pain among patients receiving VR during the intraoperative and the postoperative periods. However, there was no significant postoperative pain relief when receiving VR during the preoperative period. Additionally, significant improvements in postoperative satisfaction were reported in two studies. However, another two studies included found that VR could not affect physiological parameters related to pain. Conclusion: Applying VR can relieve postoperative pain effectively. The type of surgery and timing of using VR are the main sources of heterogeneity. More rigorous studies about the relationship between VR and postoperative pain relief will be needed.

Keywords: meta-analysis, postoperative pain, systematic review, virtual reality

Procedia PDF Downloads 115

Authors: Teris Cheung, Joyce Yuen Ting Lam, Kwan Hin Fong, Calvin Pak-Wing Cheng, Julie Sittlington, Yu-Tao Xiang, Tim Man Ho Li

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Insomnia is one of the most common health problems in the general population. Insomnia can be acute, intermittent, and become chronic, often due to comorbidity with other physical and mental health conditions. Although there are conventional pharmaceutical and psychotherapeutic treatments to treat symptoms of insomnia, however; there is no robust and novel randomized controlled trial (RCT) using transdermal neurostimulation on individuals with insomnia symptoms. This gives us the impetus to execute the first nationwide RCT. Aim: To evaluate the efficacy of Electrical Vestibular Stimulation (VeNS) on individuals with insomnia in Hong Kong. Design: This study was a two-armed, double blinded, randomized, sham-controlled trial. Sampling: 60 community-dwelling adults aged 18 and 60 years with moderate insomnia symptoms or above (Insomnia Severity Index > 14) were recruited. All subjects were computerized randomized into either the active VeNS group or the sham VeNS group on a 1:1 ratio. Intervention: All participants received a home-use VeNS device and used 30-min VeNS sessions during five consecutive days across a 4-week period (total treatment hours: 10). Baseline measurements and post-VeNS evaluation of the psychological outcomes, including 1) insomnia severity, 2) sleep quality, and 3) quality of life were investigated. The short-and long-term sustainability of the VeNS intervention was assessed immediately after poststim and at a 1-month and 3-month follow-up period. Data analysis: A mixed GEE model was used to analyze the repeated measures data. Missing data were managed by multiple imputations. The level of significance was set to p < 0.05. Significance of the study: This is the first trial to examine the efficacy and safety of VeNS among adults with insomnia symptoms in Hong Kong. Findings that emerged were used to determine whether this VeNS device can be considered a self-help technological device to reduce the severity of insomnia in the community setting and to reduce the global disease burden. Clinical Trial Registration: ClinicalTrials.gov, identifier: NCT04452981.

Keywords: adults, insomnia, neuromodulation, rct, vestibular stimulation

Procedia PDF Downloads 56

Authors: Maryam Bahreini, Mostafa Talebi Garekani, Fatemeh Rasooli, Atefeh Abdollahi

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Introduction: Procedural sedation and analgesia have been desirable to handle painful procedures. The trend to find the agent with more efficacy and less complications is still controversial; thus, many sedative regimens have been studied. This study tried to assess the effectiveness and adverse effects of thiopental sodium-fentanyl with the known medication, ketamine-propofol for procedural sedation in the emergency department. Methods: Consenting patients were enrolled in this randomized double-blind trial to receive either 1:1 ketamine-propofol (KP) or thiopental-fentanyl (TF) 1:1 mg: Mg proportion on a weight-based dosing basis to reach the sedation level of American Society of Anesthesiologist class III/IV. The respiratory and hemodynamic complications, nausea and vomiting, recovery agitation, patient recall and satisfaction, provider satisfaction and recovery time were compared. The study was registered in Iranian randomized Control Trial Registry (Code: IRCT2015111325025N1). Results: 96 adult patients were included and randomized, 47 in the KP group and 49 in the TF group. 2.1% in the KP group and 8.1 % in the TF group experienced transient hypoxia leading to performing 4.2 % versus 8.1 % airway maneuvers for 2 groups, respectively; however, no statistically significant difference was observed between 2 combinations, and there was no report of endotracheal placement or further admission. Patient and physician satisfaction were significantly higher in the KP group. There was no difference in respiratory, gastrointestinal, cardiovascular and psychiatric adverse events, recovery time and patient recall of the procedure between groups. The efficacy and complications were not related to the type of procedure or patients’ smoking or addiction trends. Conclusion: Ketamine-propofol and thiopental-fentanyl combinations were effectively comparable although KP resulted in higher patient and provider satisfaction. It is estimated that thiopental fentanyl combination can be as potent and efficacious as ketofol with relatively similar incidence of adverse events in procedural sedation.

Keywords: adverse effects, conscious sedation, fentanyl, propofol, ketamine, safety, thiopental

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Authors: Jiayan Gou, Kexin He, Xin Zhang, Fei Wang, Liuni Zou

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Background: Homocysteine is a high-risk factor for cognitive decline, and folic acid supplementation can lower homocysteine levels. However, current clinical research results are inconsistent, and the effects of folic acid on homocysteine levels and cognitive function in older people are inconsistent. Objective: The objective of this study is to systematically evaluate the effects of folic acid alone or in combination with other nutrients on homocysteine levels and cognitive function in older adults. Methods: Systematic searches were conducted in five databases, including PubMed, Embase, the Cochrane Library, Web of Science, and CINAHL, from inception to June 1, 2023. Randomized controlled trials were included investigating the effects of folic acid alone or in combination with other nutrients on cognitive function in older people. Results: 17 articles were included, with six focusing on the effects of folic acid alone and 11 examining folic acid in combination with other nutrients. The study included 3,100 individuals aged 60 to 83.2 years, with a relatively equal gender distribution (approximately 51.82% male). Conclusion: Folic acid alone or combined with other nutrients can effectively lower homocysteine level and improve cognitive function in patients with mild cognitive impairment. But for patients with Alzheimer's disease and dementia, the intervention only can reduce the homocysteine level, but the improvement in cognitive function is not significant. In healthy older people, high baseline homocysteine levels (>11.3 μmol/L) and good ω-3 fatty acid status (>590 μmol/L) can enhance the improvement effect of folic acid on cognitive function. This trial has been registered on PROSPERO as CRD42023433096.

Keywords: B-complex vitamins, cognitive function, folic acid, homocysteine

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Authors: Zhipeng Yan, Janice Wing-Tung Kwong, Ching-Lung Lai

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Background: Advanced melanoma accounts for the majority of skin cancer death due to its poor prognosis. Nivolumab and ipilimumab are monoclonal antibodies targeting programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocytes antigen 4 (CTLA-4). Nivolumab and ipilimumab combination therapy has been proven to be effective for advanced melanoma. This systematic review and meta-analysis are to evaluate its clinical efficacy and adverse events. Method: A systematic search was done on databases (Pubmed, Embase, Medline, Cochrane) on 21 June 2020. Search keywords were nivolumab, ipilimumab, melanoma, and randomised controlled trials. Clinical trials fulfilling the inclusion criteria were selected to evaluate the efficacy of combination therapy in terms of prolongation of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). The odd ratios and distributions of grade 3 or above adverse events were documented. Subgroup analysis was performed based on PD-L1 expression-status and BRAF-mutation status. Results: Compared with nivolumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR in combination therapy were 0.64 (95% CI, 0.48-0.85; p=0.002), 0.84 (95% CI, 0.74-0.95; p=0.007) and 1.76 (95% CI, 1.51-2.06; p < 0.001), respectively. Compared with ipilimumab monotherapy, the hazard ratios of PFS, OS and odd ratio of ORR were 0.46 (95% CI, 0.37-0.57; p < 0.001), 0.54 (95% CI, 0.48-0.61; p < 0.001) and 6.18 (95% CI, 5.19-7.36; p < 0.001), respectively. In combination therapy, the odds ratios of grade 3 or above adverse events were 4.71 (95% CI, 3.57-6.22; p < 0.001) compared with nivolumab monotherapy, and 3.44 (95% CI, 2.49-4.74; p < 0.001) compared with ipilimumab monotherapy, respectively. High PD-L1 expression level and BRAF mutation were associated with better clinical outcomes in patients receiving combination therapy. Conclusion: Combination therapy is effective for the treatment of advanced melanoma. Adverse events were common but manageable. Better clinical outcomes were observed in patients with high PD-L1 expression levels and positive BRAF-mutation.

Keywords: nivolumab, ipilimumab, advanced melanoma, systematic review, meta-analysis

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Authors: Christoph Schuler, Oriana Ponta

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Public Financial Management (PFM) reforms are promoted by various international organizations such as the International Monetary Fund (IMF) or the World Bank, local development banks and the donor country community to strengthen governance and accountability in developing countries across the world. Reform efforts undertaken are often systematically measured against international best practice by the application of standardized analytical instruments such as the Public Expenditure and Financial Accountability Framework (PEFA) or the Poverty Reduction Action Plan (PARP). While those instruments analyze direct achievements of PFM reforms, the long-term benefits of such reforms for society remain untapped. This gives rise to the question why the concept of impact evaluation with its experimental or quasi-experimental settings in the form of randomized control trials has rarely been applied in the context of PFM reforms. To close this gap, this study provides examples where the concept of impact evaluation can be applied to PFM reforms and thereby shifting the focus from outcome towards a long-term impact. As it is a new approach, this study does not attempt to conduct a fully flagged impact evaluation of a certain PFM reform. However, it will outline, as a form of pre-test the applicability of the impact evaluation methodology in this context, for example, by more closely analyzing the commonly used indicators (for example within PEFA or PARP). This would mean to scrutinize these indicators as to how they were designed and how they are related to the long-term impact, they should be producing. The analysis of PFM reform indicators and their relation to long-term impacts should provide practitioners and scholars alike with new insights on how to strengthen the accountability of public service delivery through successful and sustainable PFM reforms.

Keywords: accountability, impact evaluation, PFM reforms, public financial management

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Authors: Mbanzulu Kennedy, Zanga Josue, Wumba Roger

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Malaria and schistosomiasis remain life-threatening public health problems in sub-Saharan Africa. The infection pattern related to age indicates that preschool and school-age children are at the highest risk of malaria and schistosomiasis. Both parasitic infections, separately or combined, may have negative impacts on the haemoglobin concentration levels. The existing data revealed that artemisinin derivatives commonly used to cure malaria present also in antischistosomal activities. The current study investigated the impact of Artesunate-Amodiaquine (AS-AQ) on schistosomiasis when administered to treat malaria in rural area of Lemfu, DRC. A prospective longitudinal study including 171 coinfected children screened for anaemia, Schistosoma mansoni, and Plasmodium falciparum infections. The egg reduction rate and haemoglobin concentration were assessed four weeks after the treatment with AS-AQ, of all coinfected children of this series. One hundred and twenty-five (74.4%) out of 168 coinfected children treated and present during the assessment were found stool negative for S. mansoni eggs. Out of 43 (25.6%) children who remained positives, 37 (22%) showed a partial reduction of eggs amount, and no reduction was noted in 3.6% of coinfected. The mean of haemoglobin concentration and the prevalence of anaemia were, respectively, 10.74±1.5g/dl , 11.2±1.3g/dl, and 64.8%, 51.8%, respectively, before and after treatment, p<0.001. The AS-AQ commonly used against Plasmodium allowed curing S. mansoni in coinfected children and increasing the Hb level. For the future, the randomized and multicentric clinical trials are needed for a better understanding of the effectiveness of AS-AQ against Schistosoma spp. The trial registration number was 3487183.

Keywords: paludisme, schistosomiase, as-aq, enfants lemfu

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Authors: Svetlana Missina, Anatoliy Shipilov, Alexandr Vavaev

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The purpose of the present study was to investigate the relationship between sprint and vertical jump performance in elite female football players. Twenty four professional female football players (age, 18.6±3.1 years; height, 168.3±6.3 cm, body mass 61.6±7.4 kg; mean±SD) were tested for 30-m sprint time, 10-m sprint time and vertical countermovement (CMJ) and squat (SJ) jumps height. Participants performed three countermovement jumps and three squat jumps for maximal height on a force platform. Mean values of three trials were used in statistical analysis. The displacement of center of mass (COM) during flight phase (e.g. jump height) was calculated using the vertical velocity of the COM at the moment of take-off. 30-m and 10-m sprint time were measured using OptoGait optical system. The best of three trials were used for analysis. A significant negative correlation was found between 30-m sprint time and CMJ, SJ height (r = -0.85, r = -0.79 respectively), between 10-m sprint time and CMJ, SJ height (r = -0.73, r = -0.8 respectively), and step frequency was significantly related to CMJ peak power (r = -0.57). Our study indicates that there is strong correlation between sprint and jump performance in elite female football players, thus vertical jump test can be considered as a good sprint and agility predictor in female football.

Keywords: agility, female football players, sprint performance, vertical jump height

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Authors: Sheikh Omar Sillah

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Introduction: Monitoring is an important means of ensuring the smooth implementation and quality of clinical trials. For many years, traditional site monitoring approaches have been critical in detecting data errors but not optimal in identifying fabricated and implanted data as well as non-random data distributions that may significantly invalidate study results. The objective of this paper was to provide recommendations based on best statistical monitoring practices for detecting data-integrity issues suggestive of fabrication and implantation early in the study conduct to allow implementation of meaningful corrective and preventive actions. Methodology: Electronic bibliographic databases (Medline, Embase, PubMed, Scopus, and Web of Science) were used for the literature search, and both qualitative and quantitative studies were sought. Search results were uploaded into Eppi-Reviewer Software, and only publications written in the English language from 2012 were included in the review. Gray literature not considered to present reproducible methods was excluded. Results: A total of 18 peer-reviewed publications were included in the review. The publications demonstrated that traditional site monitoring techniques are not efficient in detecting data anomalies. By specifying project-specific parameters such as laboratory reference range values, visit schedules, etc., with appropriate interactive data monitoring, statistical monitoring can offer early signals of data anomalies to study teams. The review further revealed that statistical monitoring is useful to identify unusual data patterns that might be revealing issues that could impact data integrity or may potentially impact study participants' safety. However, subjective measures may not be good candidates for statistical monitoring. Conclusion: The statistical monitoring approach requires a combination of education, training, and experience sufficient to implement its principles in detecting data anomalies for the statistical aspects of a clinical trial.

Keywords: statistical monitoring, data anomalies, clinical trials, traditional monitoring

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Authors: Johnson C. Y. Pang, Amy S. N. Fu, Ryan K. L. Lee, Allan C. L. Fu

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Dry needling (DN) is one of the puncturing methods that involves the insertion of needles into the tender spots of the human body without the injection of any substance. DN has long been used to treat the patient with knee pain caused by knee osteoarthritis (KOA) and patellofemoral pain syndrome (PFPS), but the effectiveness is still inconsistent. This study aimed to conduct a systematic review and meta-analysis to assess the intervention methods and effects of DN with and without ultrasound guidance for treating pain and dysfunctions in people with KOA and PFPS. Design: This systematic review adhered to the PRISMA reporting guidelines. The registration number of the study protocol published in the PROSPERO database was CRD42021221419. Six electronic databases were searched manually through CINAHL Complete (1976-2020), Cochrane Library (1996-2020), EMBASE (1947-2020), Medline (1946-2020), PubMed (1966-2020), and Psychinfo (1806-2020) in November 2020. Randomized controlled trials (RCTs) and controlled clinical trials were included to examine the effects of DN on knee pain, including KOA and PFPS. The key concepts included were: DN, acupuncture, ultrasound guidance, KOA, and PFPS. Risk of bias assessment and qualitative analysis were conducted by two independent reviewers using the PEDro score. Results: Fourteen articles met the inclusion criteria, and eight of them were high-quality papers in accordance with the PEDro score. There were variations in the techniques of DN. These included the direction, depth of insertion, number of needles, duration of stay, needle manipulation, and the number of treatment sessions. Meta-analysis was conducted on eight articles. DN group showed positive short-term effects (from immediate after DN to less than 3 months) on pain reduction for both KOA and PFPS with the overall standardized mean difference (SMD) of -1.549 (95% CI=-0.588 to -2.511); with great heterogeneity (P=0.002, I²=96.3%). In subgroup analysis, DN demonstrated significant effects in pain reduction on PFPS (p < 0.001) that could not be found in subjects with KOA (P=0.302). At 3-month post-intervention, DN also induced significant pain reduction in both subjects with KOA and PFPS with an overall SMD of -0.916 (95% CI=-0.133 to -1.699, and great heterogeneity (P=0.022, I²=95.63%). Besides, DN induced significant short-term improvement in function with the overall SMD=6.069; 95% CI=8.595 to 3.544; with great heterogeneity (P<0.001, I²=98.56%) when analyzed was conducted on both KOA and PFPS groups. In subgroup analysis, only PFPS showed a positive result with SMD=6.089, P<0.001; while KOA showed statistically insignificant with P=0.198 in short-term effect. Similarly, at 3-month post-intervention, significant improvement in function after DN was found when the analysis was conducted in both groups with the overall SMD=5.840; 95% CI=9.252 to 2.428; with great heterogeneity (P<0.001, I²=99.1%), but only PFPS showed significant improvement in sub-group analysis (P=0.002, I²=99.1%). Conclusions: The application of DN in KOA and PFPS patients varies among practitioners. DN is effective in reducing pain and dysfunction at short-term and 3-month post-intervention in individuals with PFPS. To our best knowledge, no study has reported the effects of DN with ultrasound guidance on KOA and PFPS. The longer-term effects of DN on KOA and PFPS are waiting for further study.

Keywords: dry needling, knee osteoarthritis, patellofemoral pain syndrome, ultrasound guidance

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Authors: Sopana Wongtawee

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Purpose: Adequate bowel cleansing is essential for a high quality, effective and safe colonoscopy. The aims of this study were to compare the efficacy of bowel preparation based on a low-residue diet before 8:00 followed by a clear-liquid diet, and a low-residue diet until 16:00 one day before colonoscopy using sodium phosphate solution (Xubil ®), the side effects of the two protocols and the patient satisfaction with them. Method: This was an endoscopist-blinded, prospective, randomized, controlled trial. A total of 224 patients (112 in each group) scheduled for outpatient colonoscopy met the criteria.They were randomized to either a low-residue diet consisting of white rice porridge with either fish, chicken or eggs before 8:00 followed by a clear-liquid diet (Group 1) or a low-residue diet consisting of the same food and drink, until 16:00 the day before colonoscopy(Group 2). All of them received 45 ml of sodium phosphate solution (Xubil ®) and three glasses of water (300 ml/glass) the evening before and the morning of the procedure. The cleansing efficacy of bowel preparation was rated according to the modified Rajawithi hospital bowel preparation score scale, patient satisfaction with bowel preparation was rated using Likert scale, and side effects of the 2 protocols was assessed using a patient questionnaire. Results: The cleansing efficacy between the two groups was significantly different (p=0.02). Satisfaction with bowel preparation and side effects were not different, except for the feeling of hunger in the first group (p=0.001). Conclusion: The low-residue diet consisting of white rice porridge with fish, chicken or eggs until 16:00 one day before colonoscopy achieved a better bowel-cleansing efficacy than the protocol consisting of clear liquid all day and rice porridge only before 8:00 one day before colonoscopy.

Keywords: bowel preparation, colonoscopy, sodium phosphate solution, nursing management

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Authors: Ali Faisal Saleem, Farheen Quadri, Mach Ondrej, Anita Zaidi

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Purpose: Pakistan is the final frontier for a polio-free world. Chronic malnutrition is associated with lack of effective gut immunity, and possibly associated with poliomyelitis in children received multiple OPV. We evaluate IPV dose administered together with OPV results in higher immunogenicity and mucosal immunity compared to OPV alone in chronically malnourished infants. Methods AND Materials: A community-based, unblinded-randomized-trial, conducted in 5 peri-urban, low-middle-income households of Karachi, in infants 9-12 months. Two study groups were non-malnourished (HAZ= -2 or more) and chronic malnourished (HAZ <-2SD), with 2-arms each i) OPV and ii) OPV and IPV. Two blood specimens (2ml) at baseline and at day 28 and two stool specimens (6 gm.) at day 29 and after 7 days. All infants received a bOPV challenge dose after first stool specimen. Calculates sample size was 210 in each arm. Serological (baseline compared to 28 days post-vaccine) and mucosal immunity after one week of bOPV challenge dose were study outcomes. Results: Baseline seroprevalence in malnourished infants were low compared to non-malnourished (P1, P2 and P3 (p=<0.001). There is significant rise in antibody titer and P1 seroprevalence in Mal A and B after receiving study vaccine; much higher in Mal B. Infants randomized to bOPV + IPV study vaccine showed incremental immune response against P1 (Mal B, 92.2%; Nor B, 98.4%), P2 (Mal B, 90.4%; Nor B, 94.7%), and P3 (Mal B, 85.6% and Nor B, 93.5%) was observed. A significant proportion of infants in malnourished (P1, 13%; P2, 24%; P3, 26%) and normally nourished group (P1, 5%; P2, 11%; P3, 14%) were found to be seronegative at baseline. Infants who received BOPV + IPV as their study vaccine showed a very high seroconversion response after vaccine (p=<0.001 for P1, P2 and P3). Majority of the specimens were negative at baseline (Mal A, 2%, Mal B, 1%; Nor A, 2%; Nor B, 1%), and remains negative after bOPV challenge dose (Mal A, 8%, Mal B, 6%; Nor A, 11%; Nor B, 10%). Conclusion: Malnourished-infants have low poliovirus-seroprevalence that increased remarkably after IPV. There is less viral shedding after IPV in infants.

Keywords: chronic malnutrition, infants, IPV, OPV

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Authors: Ayon Mukherjee

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Covariate-adjusted response-adaptive (CARA) designs use the available responses to skew the treatment allocation in a clinical trial in towards treatment found at an interim stage to be best for a given patient's covariate profile. Extensive research has been done on various aspects of CARA designs with the patient responses assumed to follow a parametric model. However, ranges of application for such designs are limited in real-life clinical trials where the responses infrequently fit a certain parametric form. On the other hand, robust estimates for the covariate-adjusted treatment effects are obtained from the parametric assumption. To balance these two requirements, designs are developed which are free from distributional assumptions about the survival responses, relying only on the assumption of proportional hazards for the two treatment arms. The proposed designs are developed by deriving two types of optimum allocation designs, and also by using a distribution function to link the past allocation, covariate and response histories to the present allocation. The optimal designs are based on biased coin procedures, with a bias towards the better treatment arm. These are the doubly-adaptive biased coin design (DBCD) and the efficient randomized adaptive design (ERADE). The treatment allocation proportions for these designs converge to the expected target values, which are functions of the Cox regression coefficients that are estimated sequentially. These expected target values are derived based on constrained optimization problems and are updated as information accrues with sequential arrival of patients. The design based on the link function is derived using the distribution function of a probit model whose parameters are adjusted based on the covariate profile of the incoming patient. To apply such designs, the treatment allocation probabilities are sequentially modified based on the treatment allocation history, response history, previous patients’ covariates and also the covariates of the incoming patient. Given these information, an expression is obtained for the conditional probability of a patient allocation to a treatment arm. Based on simulation studies, it is found that the ERADE is preferable to the DBCD when the main aim is to minimize the variance of the observed allocation proportion and to maximize the power of the Wald test for a treatment difference. However, the former procedure being discrete tends to be slower in converging towards the expected target allocation proportion. The link function based design achieves the highest skewness of patient allocation to the best treatment arm and thus ethically is the best design. Other comparative merits of the proposed designs have been highlighted and their preferred areas of application are discussed. It is concluded that the proposed CARA designs can be considered as suitable alternatives to the traditional balanced randomization designs in survival trials in terms of the power of the Wald test, provided that response data are available during the recruitment phase of the trial to enable adaptations to the designs. Moreover, the proposed designs enable more patients to get treated with the better treatment during the trial thus making the designs more ethically attractive to the patients. An existing clinical trial has been redesigned using these methods.

Keywords: censored response, Cox regression, efficiency, ethics, optimal allocation, power, variability

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Authors: Opara Monica, Suriani Ismail, Ahmad Iqmer Nashriq Mohd Nazan

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The true magnitude of the mortality and morbidity attributable to malaria worldwide is, at best, a scientific guess, although it is not disputable that the greatest burden is in sub-Saharan Africa. Those at highest risk are children younger than 5 years and pregnant women, particularly primigravidae. Nationally, malaria remains the third leading cause of death and is still considered a major public health problem. Therefore, this study is aimed to assess the effectiveness of health education intervention on insecticide-treated net use and its practices among pregnant women attending antenatal clinics. Materials and Methods: This study will be an intervention study with two arms double parallel randomized controlled trial (blinded) to be conducted in 3 stages. The first stage will develop health belief model (HBM) program, while in the second stage, pregnant women will be recruited, assessed (baseline data), randomized into two arms of the study, and follow-up for six months. The third stage will evaluate the impact of the intervention on HBM and disseminate the findings. Data will be collected with the use of a structured questionnaire which will contain validated tools. The main outcome measurement will be the treatment effect using HBM, while data will be analysed using SPSS, version 22. Discussion: The study will contribute to the existing knowledge on hospital-based care programs for pregnant women in developing countries where the literature is scanty. It will generally give insight into the importance of HBM measurement in interventional studies on malaria and other related infectious diseases in this setting.

Keywords: malaria, health education, insecticide-treated nets, sub-Saharan Africa

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