Mixed Protocol Research Articles

Educational needs and preferences of adult patients with acute or chronic pain: a mixed methods systematic review protocol.

This review will aim to synthesize the available quantitative and qualitative evidence on the educational needs and preferences of adult patients with acute or chronic pain. Acute and chronic pain are prevalent problems and are associated with significant individual and societal consequences. Education is a critical component of pain management. However, the impact of educational interventions on pain outcomes remains limited. The lack of patient input--what patients want to know and how they want to be informed--is one of the main problems underlying intervention design. We will include qualitative, quantitative, and mixed methods studies describing the educational needs and preferences of adult patients with acute or chronic pain. This review will follow the JBI guidelines for mixed methods systematic reviews. We will search MEDLINE (PubMed), Embase (Ovid), PsycINFO (Ovid), CINAHL (EBSCO), the Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science, and ProQuest Dissertations & Theses. The search strategy will commence from the year 1990 onward and there will be no language restrictions. The retrieved titles, abstracts, and full-text reports will be screened by pairs of independent reviewers. These pairs of reviewers will also independently extract data using the JBI tools for mixed methods systematic reviews. Methodological quality will be assessed using the Mixed Methods Appraisal Tool. A convergent integrated approach to synthesis and integration of the quantitative and qualitative data will be used. PROSPERO CRD42022303834.

First Nations populations' perceptions, knowledge, attitudes, beliefs, and myths about prevention and bereavement in stillbirth: a mixed methods systematic review protocol.

The objective of this review is to investigate First Nations populations' perceptions, knowledge, attitudes, beliefs, and myths about stillbirth. First Nations populations experience disproportionate rates of stillbirth compared with non-First Nations populations. There has been a surge of interventions aimed at reducing stillbirth and providing better bereavement care, but these are not necessarily appropriate for First Nations populations. As a first step toward developing appropriate interventions for these populations, this review will examine current perceptions, knowledge, attitudes, beliefs, and myths about stillbirth held by First Nations people from the United States, Canada, Aotearoa/New Zealand, and Australia. The review will consider studies that include individuals of any age (bereaved or non-bereaved) who identify as belonging to First Nations populations. Eligible studies will include the perceptions, knowledge, attitudes, beliefs, and myths about stillbirth among First Nations populations. This review will follow the JBI methodology for convergent mixed methods systematic reviews. The review is supported by an advisory panel of Aboriginal elders, lived-experience stillbirth researchers, Aboriginal researchers, and clinicians. PubMed, MEDLINE (Ovid), CINAHL (EBSCOhost), Embase (Ovid), Emcare (Ovid), PsycINFO (EBSCOhost), Indigenous Health InfoNet, Trove, Informit, and ProQuest Dissertations and Theses will be searched for relevant information. Titles and abstracts of potential studies will be screened and examined for eligibility. After critical appraisal, quantitative and qualitative data will be extracted from included studies, with the former 'qualitized' and the data undergoing a convergent integrated approach. PROSPERO CRD42023379627.

Exploring diabetes status and social determinants of health influencing diabetes-related complications in a Northwestern community, Ontario, Canada: A mixed method study protocol.

Diabetes is a common chronic condition affecting the many spheres of individuals' lives. It can also lead to severe complications without continuous management. Accordingly, this paper describes a study protocol aimed at 1) determining the status and prevalence of diabetes complications in a Northwestern Ontario community; 2) exploring the internal (e.g., demographic and clinical variables) and external factors (e.g., access to services and resources) affecting diabetes outcomes (e.g., complications, emergency room visits, hospitalizations); 3) critically exploring how the social determinants of health affect self-management for individuals living with diabetes; and 4) identifying individuals' needs, concerns, and challenges to monitor and regulate diabetes. The study uses a cross-sectional design and a social constructivist approach based on qualitative data collection. The proposed study will include patients with type 1 and type 2 diabetes with or without diabetes complications who have been attending the Centre for Complex Diabetes Care (CCDC) in Thunder Bay, Ontario, Canada, since January 2019. Quantitative data related to diabetes complications and other outcomes, diabetes management, and demographic and clinical status will be retrieved from patients' charts using a data extraction form. Analyses of the quantitative data will include the prevalence of diabetes complications, rate of hospitalizations, and their associations with diabetes management, access to services, and social determinants of health. Additionally, interviews will occur with at least 10 participants with or without diabetes complications to understand their needs, concerns, and struggle to self-manage diabetes daily. The results of this study will generate evidence to support future research and policy on the development and implementation of an educational program to improve self-care management and outcomes for individuals living with diabetes and its complications in Northwestern Ontario.

A-308 The Molecular Diagnosis of Varicella Zoster Virus (VZV): A Validation of a Real-Time PCR (qPCR) Assay for the Qualitative Detection

Abstract Background Varicella zoster virus (VZV) is the etiological agent of chicken pox and herpes zoster. After the primary infection, which usually occurs in childhood, VZV remains latent in sensory nerve roots for life. When reactivation occurs, especially in immunocompromised patients, the virus migrates to the skin and causes painful rashes that can evolute to a dermatome. Even after the end of the viral acute infection, some individuals may experience continued pain. Furthermore, VZV reactivation can lead to a wide spectrum of clinical manifestations such as self-limited radicular pain and central nervous system involvement. During acute illness, 90% of patients experience pain and 12% have symptoms similar to influenza infection (influenza-like). Immunocompromised patients may have an unfavorable course with disseminated infection, pneumonitis, hepatitis, and encephalitis. The cerebrospinal fluid polymerase chain reaction (PCR) test is indicated for suspected involvement of the central nervous system and complications of ocular or periocular lesions. Compared to other diagnostic methods, real-time PCR has great advantages as its high throughput, efficiency, and sensitivity. Therefore, the detection of VZV by real-time PCR presents great importance for the diagnosis and monitoring of the disease due to its precision and agility. Thus, we intended to validate a qualitative method for VZV detection by real-time PCR. Methods We evaluated the performance of the inventoried TaqMan assay (Vi06439647_s1) (Thermo Fisher Scientific). For this validation, we used 64 samples - whole blood (n = 31), cerebrospinal fluid (n = 32), vaginal lesion scraping (n = 1) - from the Genetics sector of the Pardini Group, previously tested by in-house PCR for the qualitative detection of VZV. Samples were extracted using the MagNA Pure 24 System platform (Roche Diagnostics) with the MagNA Pure 24 Total NA Isolation Kit, according to the manufacturer's instructions. All assays were performed using Taqman Universal Master Mix (Thermo Fisher Scientific). The inventoried B-actin Assay (assay ID: Hs01060665_g1) (Thermo Fisher Scientific) was used as endogenous control. Assay verification tests, evaluation of reaction efficiency, and determination of the detection limit (LOD) were performed using a synthetic control of known concentrations and a pool of negative samples (healthy volunteers). At the end of the tests, were made a comparison of the previous results with the results obtained in the ThermoFisher Real-Time PCR Assay. Results The Inventoriad Taqman Assay (VZV) had a limit of detection of 10 copies/µL and the Cq > 35 was defined as a cut-off to consider a sample as positive. Whole blood samples had higher Cts than cerebrospinal fluid samples, indicating lower viremia. Whitin all evaluated samples, 11 samples had positive results detected by in-house PCR (9 from whole blood and 2 from cerebrospinal fluid). Of these, 10 had a result detected in Real-time PCR and the agreement with the positive results between compared methodologies was 91.0%. The divergent sample was whole blood and can be related to DNA degradation. The 47 negative samples evaluated were concordant in both methods. Conclusion The inventoried TaqMan Assay with Taqman Universal Master Mix protocol evaluated was sensitive, fast, and applicable as a tool for the qualitative detection of VZV.

Comparison of binocular visual quality in six treatment protocols for bilateral cataract surgery with presbyopia correction: a prospective two-center single-blinded cohort study

Objective To compare the postoperative binocular visual quality in six treatment protocols for bilateral age-related cataract surgery with presbyopia correction for clinical decisions. Materials and methods In this prospective two-center single-blinded cohort study, participants from North or South China who underwent bilateral phacoemulsification and intraocular lens implantation were divided into six protocols: monovision, diffractive bifocal, mixed, refractive bifocal, trifocal, and micro-monovision extended range of vision (EROV). Binocular visual quality was evaluated at 3 months postoperatively, including binocular uncorrected full-range visual acuity, binocular defocus curves (depth of focus [DoF] and area under the curve [AUC]), binocular visual function (fusion function and stereopsis), binocular subjective spectacle independence rates, visual analog scale (VAS) of overall satisfaction, 25-item visual function questionnaire (VFQ-25), and binocular dysphotopsia symptoms. Results Of the 300 enrolled patients, 272 (90.7%; 544 eyes) were analyzed. The trifocal protocol showed excellent binocular full-range visual acuity and the best performance for most DoFs and AUCs. The monovision protocol presented the worst binocular visual quality in most perspectives, especially in convergence, distance, and near stereopsis (p < 0.001). The full-range subjective spectacle independence rates were sorted from highest to lowest as follows: trifocal (84.8%), refractive bifocal (80.9%), EROV (80.0%), mixed (73.3%), diffractive bifocal (65.2%), and monovision (32.6%) protocols, with no statistically significant differences between the former five protocols (p > 0.05). The EROV protocol achieved the highest VAS and VFQ-25 scores. The incidence of postoperative binocular dysphotopsia symptoms was comparable in all protocols. Conclusions The trifocal protocol showed the best performance, and the monovision protocol presented the worst performance in most perspectives of binocular visual quality for presbyopia correction. The refractive bifocal, mixed, or EROV protocols can provide an approximate performance as a trifocal protocol. Ophthalmologists can customize therapies using different protocols.

SofitMix: A Secure Offchain-Supported Bitcoin-Compatible Mixing Protocol

Privacy preservation is highly expected in the Bitcoin Network. However, only applying pseudonyms cannot completely ensure anonymity/unlinkability between payers and payees. Current approaches mainly depend on a mixer service, which obfuscates payer-payee relationships of transactions. While the mixer service improves transaction privacy, it still suffers from some severe security threats (e.g., DoS attack and collusion attack), and does not support effective and reliable off-chain payment in a parallel mode. In this paper, we propose a mixing protocol for the Bitcoin Network based on zero-knowledge proof, called SofitMix. It is the first mixing protocol that can effectively resist both the DoS attack and the collusion attack. It can also support a set of parallel off-chain payments in a reliable way no matter whether some payers abort a transaction. We analyze and prove SofitMix security following the Universal Composability model with regard to fair exchange, unlinkability, collusion-resistance, DoS-resistance and Sybil-resistance. Through a proof-of-concept implementation, we demonstrate its validity and fairness. We also show its advance on off-chain payment reliability and DoS attack resistance, compared to TumbleBit.

A pre-hospital mixed methods systematic review protocol.

Mixed methods research, a methodology entailing the integration of qualitative and quantitative data within a single study, offers researchers the ability to investigate complex processes and systems in health and healthcare. The collective strength gained through the data combination can provide an enhanced understanding of research problems, providing an ideal solution to understanding complex clinical issues in a range of settings. In pre-hospital practice, where often uncontrollable variables and environmental considerations increase healthcare complexity, mixed methods has emerged as a valuable approach to research. Given the exponential growth of pre-hospital mixed methods research since the publication of our first systematic review in 2014, we aim to provide an update. Our review will explore how mixed methods is utilised in pre-hospital research and identify what standards of reporting are achieved. This systematic review update will search MEDLINE, CINAHL Complete, Embase and Scopus bibliographic databases from 1 January 2012 to 15 March 2023, using an updated pre-hospital search strategy. Study screening will be performed in duplicate. Articles reported in English, explicitly stating the use of 'mixed methods' in the pre-hospital ambulance setting, including helicopter emergency medical services and community first-responder services, will be included. Data related to underpinning philosophy or theoretical framework, rationale for utilising mixed methods, background of the corresponding author, mode of data integration, model of publication and adherence to reporting standards, utilising the good reporting of a mixed methods study (GRAMMS) guidelines, will be extracted and analysed. All extracted data from study articles will be summarised in a table, allowing analysis of included studies against specified criteria.

Ultrasensitive Ionophore-Based Liquid Sensors for Colorimetric Ion Measurements in Blood.

The self-monitoring of electrolytes using a small volume of capillary blood is needed for the management of many chronic diseases. Herein, we report an ionophore-based colorimetric sensor for electrolyte measurements in a few microliters of blood. The sensor is a pipet microtip preloaded with a segment of oil (plasticizer) containing a pH-sensitive chromoionophore, a cation exchanger, and an ionophore. The analyte is extracted from the sample into the oil via a mixing protocol controlled by a stepper motor. The oil with an optimized ratio of sensing chemicals shows an unprecedentedly large color response for electrolytes in a very narrow concentration range that is clinically relevant. This ultrahigh sensitivity is based on an exhaustive response mode with a novel mechanism for defining the lower and higher limits of detection. Compared to previous optodes and molecular probes for ions, the proposed platform is especially suitable for at-home blood electrolyte measurements because (1) the oil sensor is interrogated independent of the sample and therefore works for whole blood without requiring plasma separation; (2) the sensor does not need individual calibration as the consistency between liquid sensors is high compared to solid sensors, such as ion-selective electrodes and optodes; and (3) the sensing system consisting of a disposable oil sensor, a programmed stepper motor, and a smartphone is portable, cost-effective, and user-friendly. The accuracy and precision of Ca2+ sensors are validated in 51 blood samples with varying concentrations of total plasma Ca2+. Oil sensors with an ultrasensitive response can also be obtained for other ions, such as K+.

Investigation of the dispersion of reduced graphene oxide in cementitious composites under different mixing strategies

The use of reduced graphene oxide (rGO) to enhance the strength, durability, and electromagnetic properties of cementitious composites has received extensive attention in recent years. However, the agglomeration behavior of rGO in alkaline environment greatly reduces its reinforcement effect on cement-based materials. This study aims to develop a practical and feasible dispersion scheme to facilitate the practical application of rGO in cement systems. To achieve this goal, four different mixing protocols were evaluated, including the typical combination of superplasticizer and ultrasound (Methods 1), and three preparation methods involving direct dry mixing of cement clinker with rGO (Methods 2), dry mixing of sand with rGO (Methods 3), and dry mixing of sand with rGO solution (Methods 4).The mechanical and durability properties of the cement mortar samples were analyzed under different mixing protocols to determine the effects of rGO on the performance of the composite. Furthermore, the microstructure and hydration product of the cementitious composite were investigated using scanning electron microscopy (SEM) and thermogravimetric analysis (TGA) to assess the dispersion of rGO in the cement matrix. The test results indicated that the direct dry mixing of sand with rGO (Method 3) was the most effective dispersion scheme among the evaluated mixing protocols. The flexural and compressive strengths of the cement mortar samples produced using Method 3 were increased by 26.01% and 39.8%, respectively, after 28 days as compared to the control samples. This enhancement can be attributed to the shear effect of the sand grains, which effectively reduces the aggregation of rGO in the cement matrix, leading to stronger nucleation effects occurring in the cement hydration. In addition, well-dispersed rGO improves the pore structure of the composite and increases its erosion resistance. The results of this study may provide valuable insights for the large-scale production of rGO-cement composites with enhanced properties and contribute to the development of sustainable and high-performance construction materials.

Understanding health-related quality of life trajectories among older adults with diabetes mellitus: Mixed methods research.

To examine health-related quality of life trajectories among older adults with diabetes mellitus (DM). A sequential explanatory mixed method study protocol. In the quantitative phase, health-related quality of life trajectory over 5 years, from 2009 to 2013, of a national representative sample (N = 440) of older adults with DM was analysed using group-based modelling. Next, a qualitative multiple case study (N = 10) was conducted between November 2017 and April 2018. In the mixed phase, by linking the quantitative and qualitative data, similarities and differences among the four trajectories were identified. Four distinctive health-related quality of life trajectories could be distinguished: high then decrease, high stable, medium stable and low then increase. These differed in attitude towards DM, self-management of DM-related tasks, comorbidity-related health-related quality of life, coping with DM and financial concerns about medical needs. Our results help illuminate the heterogeneity of health-related quality of life trajectories in older adults with DM. This research may help healthcare providers understand the need to assess the HR-QoL comprehensively and promote HR-QoL for older adults with DM.

Exploring regional healthcare utilisation and quality of care for endometriosis in rural areas in Hesse, Germany: a mixed methods study protocol

IntroductionThe need of a regional healthcare monitoring in order to evaluate quality and utilisation of health services in smaller scale is internationally and in Germany well established. Little is known...

Human Dendritic Cell Enrichment and Their Activation of T Cells.

Dendritic cells (DCs) enable the immune system to mount and modulate precisely targeted responses to various threats across the organism by bridging innate and adaptive immunity. Historically, DCs have been classified as conventional (cDC) and plasmacytoid (pDC). More recently, cDCs were acknowledged as a heterogenous population composed of several subsets. Examining the functional diversity of cDCs in healthy homeostasis and pathology requires a robust experimental pipeline, beginning with an efficient enrichment protocol in preparation for cell sorting. Unfortunately, several commercial DC enrichment kits were developed before the discovery of the more recently described DC populations. Here, we detail two approaches to enrich human blood DCs or certain DC subsets and an in vitro protocol to examine DC stimulation of naïve T cells. The methods employed here overcome many hurdles encountered while enriching human DC subsets. Basic Protocol 1 describes a method that will enrich pDC, Axl Siglec6-DC (AS-DC), cDC1, DC2, DC3, monocytes, and human HLA+ cells by crosslinking unwanted cells to erythrocytes. Basic Protocol 2 describes the enrichment of pDC, AS-DC, cDC1, and DC2 but not DC3 via a highly efficient negative magnetic selection that is valuable in circumstances where DC3 is not required. Finally, Basic Protocol 3 describes a conventional protocol to perform a Mixed leucocyte Reaction (MLR) following the isolation of these DC subsets. These methods detail the advantages and pitfalls when isolating a heterogeneous population of cells. © 2023 The Authors. Current Protocols published by Wiley Periodicals LLC. Basic Protocol 1: Human peripheral mononuclear phagocyte enrichment Basic Protocol 2: DC enrichment of pDC, cDC1, AS-DC, and DC2 but not DC3 Basic Protocol 3: Basic mixed lymphocyte reaction protocol with sorted human DC subsets.

Costs and Causes of Oncology Drug Attrition With the Example of Insulin-Like Growth Factor-1 Receptor Inhibitors

The development of oncology drugs is expensive and beset by a high attrition rate. Analysis of the costs and causes of translational failure may help to reduce attrition and permit the more appropriate use of resources to reduce mortality from cancer. To analyze the causes of failure and expenses incurred in clinical trials of novel oncology drugs, with the example of insulin-like growth factor-1 receptor (IGF-1R) inhibitors, none of which was approved for use in oncology practice. In this cross-sectional study, inhibitors of the IGF-1R and their clinical trials for use in oncology practice between January 1, 2000, and July 31, 2021, were identified by searching PubMed and ClinicalTrials.gov. A proprietary commercial database was interrogated to provide expenses incurred in these trials. If data were not available, estimates were made of expenses using mean values from the proprietary database. A search revealed studies of the effects of IGF-1R inhibitors in preclinical in vivo assays, permitting calculation of the percentage of tumor growth inhibition. Archival data on the clinical trials of IGF-1R inhibitors and proprietary estimates of their expenses were examined, together with an analysis of preclinical data on IGF-1R inhibitors obtained from the published literature. Expenses associated with research and development of IGF-1R inhibitors. Sixteen inhibitors of IGF-1R studied in 183 clinical trials were found. None of the trials, in a wide range of tumor types, showed efficacy permitting drug approval. More than 12 000 patients entered trials of IGF-1R inhibitors in oncology indications in 2003 to 2021. These trials incurred aggregate research and development expenses estimated at between $1.6 billion and $2.3 billion. Analysis of the results of preclinical in vivo assays of IGF-1R inhibitors that supported subsequent clinical investigations showed mixed activity and protocols that poorly reflected the treatment of advanced metastatic tumors in humans. Failed drug development in oncology incurs substantial expense. At an industry level, an estimated $50 billion to $60 billion is spent annually on failed oncology trials. Improved target validation and more appropriate preclinical models are required to reduce attrition, with more attention to decision-making before launching clinical trials. A more appropriate use of resources may better reduce cancer mortality.

Probiotic Formulations Containing Fixed and Essential Oils Ameliorates SIBO-Induced Gut Dysbiosis in Rats.

Dysbiosis of the gut microbiota is associated with the pathogenesis of intestinal diseases such as inflammatory bowel disease, irritable bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO), and metabolic disease states such as allergies, cardiovascular diseases, obesity, and diabetes. SIBO is a condition characterized by an increased number (>1 × 103 CFU) of abnormal bacterial species in the small intestine. Interest in SIBO has gained importance due to increased awareness of the human microbiome and its potential relationships with human health and disease, which has encouraged new work in this area. In recent years, standard antibiotic regimens (rifaximin and metronidazole) have been used to treat SIBO, but solo antibiotics or their derivatives are insufficient. In this study, the therapeutic effects of the probiotic form, which contains coconut oil and traces of peppermint-lemon-patchouli essential oil, were evaluated on the Dysbiosis-Based Rat SIBO Model. There are significant differences between sick and healthy rats (p = 0.014), between sick rats and rats treated with the oil mix plus probiotic mix protocol (p = 0.026), and between rats treated with only the probiotic and only oil protocols (p = 0.030) in the evaluation of TNF-α levels. Histologically, villi distortion and loss of crypts, epithelial shedding and necrotic changes in the apical regions of the villi, and inflammatory cell infiltrations extending to the lamina propria and submucosa were observed in sick rats. Mitotic figures in villus epithelium and crypts were observed in rats treated with 9.2 × 109 CFU/1000 mg/coconut oil + trace amounts of peppermint-lemon-patchouli essential oil and a probiotic mixture (oil + probiotic mix protocol). A regression of inflammatory reactions and an increase in goblet cells were observed. A decrease was observed in inflammation markers in sick rats. On the other hand, the oil plus probiotic mix protocol recovered digestive system defects in the animals caused by dysbiosis. In the future, these treatment approaches can be effective in the treatment of SIBO.

Effective service provision and partnerships in service providers for children and young people with special educational needs and disabilities: a mixed methods systematic review protocol

It is widely recognized that provision of services for children and young people (CYP) with Special Educational Needs and Disabilities (SEND) are enhanced when services such as healthcare, social care, and education collaborate and interact effectively, rather than separately. In the UK, while there have been significant changes to policy and provision which support and improve collaboration, professionals responsible for implementing these changes face multiple challenges, including a lack of specific implementation guidance and a logic model or framework to illustrate how effective multi-agency working could, or should, work. This systematic review aims to identify the ‘key ingredients’ for effective multi-agency working in services for CYP with SEND; and the most effective forms of partnership working in this setting. In addition, the review will highlight interventions that lead to improved service outcomes; and the conditions in the local area (organisational or geographical) that support and encourage success. This protocol has been written following the Preferred Reporting Items for Systematic Review and Meta-Analyses Protocols guidelines. Searches will be conducted on several health, care, education and applied social science databases from the year 2012 onwards. Citation chaining will be undertaken, as will broader grey literature searching to enrich the findings. Qualitative, quantitative, and mixed methods studies will be included, assessed independently and critically appraised or assessed for risk of bias using appropriate tools based on study design. Data will be extracted using a standardized, pre-piloted data extraction form. A convergent segregated approach to synthesis and integration will be used in which the quantitative and qualitative data will be synthesized independently, and then integrated using a joint display integration matrix. Results will be of interest to educators and health and social care professionals that provide services to those with SEND. These will also be used to develop policy recommendations for how UK healthcare, social care, and education services for CYP with SEND aged 0–25 can most effectively collaborate and improve service outcomes. The review will also identify any gaps in the literature to recommend areas for future research. Funding for this review was provided by the Department for Education.PROSPERO registration: CRD42022352194.

Developing and testing a clinical care bundle incorporating caffeine citrate to manage apnoea of prematurity in a resource-constrained setting: a mixed methods clinical feasibility study protocol

BackgroundApnoea of prematurity (AOP) is a common condition among preterm infants. Methylxanthines, such as caffeine and aminophylline/theophylline, can help prevent and treat AOP. Due to its physiological benefits and fewer side effects, caffeine citrate is recommended for the prevention and treatment of AOP. However, caffeine citrate is not available in most resource-constrained settings (RCS) due to its high cost. Challenges in RCS using caffeine citrate to prevent AOP include identifying eligible preterm infants where gestational age is not always known and the capability for continuous monitoring of vital signs to readily identify apnoea. We aim to develop an evidence-based care bundle that includes caffeine citrate to prevent and manage AOP in tertiary healthcare facilities in Kenya.MethodsThis protocol details a prospective mixed-methods clinical feasibility study on using caffeine citrate to manage apnoea of prematurity in a single facility tertiary-care newborn unit (NBU) in Nairobi, Kenya. This study will include a 4-month formative research phase followed by the development of an AOP clinical-care-bundle prototype over 2 months. In the subsequent 4 months, implementation and improvement of the clinical-care-bundle prototype will be undertaken. The baseline data will provide contextualised insights on care practices within the NBU that will inform the development of a context-sensitive AOP clinical-care-bundle prototype. The clinical care bundle will be tested and refined further during an implementation phase of the quality improvement initiative using a PDSA framework underpinned by quantitative and qualitative clinical audits and stakeholders’ engagement.The quantitative component will include all neonates born at gestation age < 34 weeks and any neonate prescribed aminophylline or caffeine citrate admitted to the NBU during the study period.DiscussionThere is a need to develop evidence-based and context-sensitive clinical practice guidelines to standardise and improve the management of AOP in RCS. Concerns requiring resolution in implementing such guidelines include diagnosis of apnoea, optimal timing, dosing and administration of caffeine citrate, standardisation of monitoring devices and alarm limits, and discharge protocols. We aim to provide a feasible standardised clinical care bundle for managing AOP in low and middle-income settings.

The determinants of the nutritional quality of food provided to the homeless population: a mixed methods systematic review protocol

BackgroundStudies assessing the nutritional quality of food provided to the homeless population show deficiencies in micronutrients and excess fat, sugar, and salt. The availability of cheap, energy-dense and nutrient-poor food has changed the profile of people living with homelessness from primarily underweight to obese in western countries. Many factors influence the nutritional quality of food provided to the homeless population such as budget and time constraints, food donations and limited equipment. Nutrient intakes in this population are unlikely to be met outside of charitable meal programmes, making the nutritional quality of these meals crucial. This review will synthesise mixed methods literature with the overarching aim of understanding the determinants of the nutritional quality of food provided to the homeless population.MethodsThis mixed methods systematic review will include English language empirical research studies from Europe, North America and Oceania. The following electronic databases have been chosen for this review: SCOPUS, EMBASE, PsycINFO, EBSCOHost SocIndex and CINAHL. The grey literature databases OpenGrey and ProQuest will also be searched. Quality appraisal will be conducted using the Mixed-Methods Appraisal Tool. Two independent reviewers will be included in study selection, data extraction and quality appraisal. A third reviewer will resolve conflicts. Thematic synthesis will be employed.DiscussionResults will be organised based on a determinants of health model, to highlight areas where change may be effective, thereby making it more likely to be useful to practitioners and researchers. The iterative steps in the systematic review process will be the focus of this article. Findings from this review will be used to develop best-practice guidelines for stakeholders such as policy makers and service providers to improve the nutritional quality of food provided in the homeless sector.Systematic review registrationThis mixed methods systematic review protocol has been registered with the International Prospective Register of Systematic Reviews (PROSPERO): CRD42021289063.

O-186 The implementation of a novel algorithm for monitoring ovulation in an IVF mixed protocol may simplify stimulation monitoring

Abstract Study question Which patients are eligible to skip ovulation monitoring before day 10 in In Vitro Fertilization (IVF) and what are the financial implications? Summary answer Thanks to our innovative gonadotropin prescription algorithm, patients with low ovarian reserve and maximum ovarian stimulation may not require monitoring until day 10 of IVF. What is known already In most fertility clinics, the standard procedure for IVF is early monitoring on day 6 of ovarian stimulation. Our focus is on personalizing the stimulation protocol by identifying the optimal dose of gonadotropin. With the aid of our unique algorithm, we aim to streamline monitoring. Frequent ultrasound examinations required for IVF can impose restrictions and create a burden for patients, resulting in increased costs for both patients and physicians. Study design, size, duration In a retrospective study conducted from April 2021 to August 2022 at the OVO clinic in Montreal (Canada), participants included all patients over 18 years old who underwent an IVF stimulation cycle utilizing an antagonist protocol and a customized mixed protocol prescription consisting of follitrophin delta and human menopausal gonadotropin, based on the patient's weight and anti-Mullerian hormone level. The sudy was approved by Veritas IRB, an independent ethic committee. Tracking number of study :2023-3189-13659-2 Participants/materials, setting, methods In the study, gonadotropin dosages were assigned either based on our algorithm (group 1) or at the physician's discretion (group 2). Ultrasound and hormonal analysis were performed on day 6. Following the physician's evaluation, adjustments to the gonadotropin dosage were made if necessary. The common trigger criteria was the presence of at least three follicles measuring between 16 and 22mm. Main results and the role of chance The study included 714 patients meeting the inclusion criteria. In group 1, there was a high percentage of patients stimulated with the maximum doses (80.3% compared to 22.5% in group 2). No dosage modifications or incidents of ovarian hyperstimulation syndrome were observed in group 1. Only 4.5% of patients (n = 16) triggered ovulation before day 10 (on day 9). In the non-maximal dose population, patients treated according to the algorithm (group A) experienced significantly fewer changes to the gonadotropin dosage at day 6 compared to patients treated based on the physician's discretion only (group B) (24.6% vs 46.9%, p &amp;lt; 0.001). The dosage of gonadotropins was notably more frequent adjusted in group B (46.9% vs 24.6%, p &amp;lt; 0.001). A higher risk of ovarian hyperstimulation syndrome was significantly more frequent in the non-maximal dose population compared to the maximal dose population (64.6% vs 27.5%, p &amp;lt; 0.01). These findings suggest that ovulation monitoring may not be necessary in the population stimulated to the maximum dose. This could result in 478 ultrasound and blood tests being avoided in the context of this study. Limitations, reasons for caution The data was obtained through a retrospective analysis. However, not monitoring before day 10 could pose a risk of delaying the cancellation of the IVF cycle, resulting in unnecessary treatment continuation. Wider implications of the findings This significant study indicates that, thanks to our algorithm, monitoring only on day 10 would be adequate for patients with low ovarian reserve who are stimulated to the maximum dose. Further validation of this strategy can be conducted through a randomized prospective study or with the use of different gonadotropins. Trial registration number non applicable

The impact of the European Association of Endoscopic Surgery research grant scheme-a mixed qualitative quantitative methodology study protocol.

The European Association of Endoscopic Surgery (EAES) is a surgical society who promotes the development and expansion of minimally invasive surgery to surgeons and surgical trainees. It does so through its activities in education, training, and research. The EAES research committee aims to promote the highest quality clinical research in endoscopic and minimally invasive surgery. They have provided grant funding since 2009 in education, surgery, and basic science. Despite the success and longevity of the scheme, the academic and non-academic impact of the research funding scheme has not been evaluated. The primary aim of this project is to assess the short, long term academic and real world impact of the EAES funding scheme. The secondary aims are to identify barriers and facilitators for achieving good impact. This will be a mixed qualitative and quantitative study. Semi-structured interviews will be performed with previous grant recipients. The questions for the interviews will be selected after a consensus is achieved amongst the members of the steering committee of this project. The responses will be transcribed and thematic analysis will be applied. The results of the thematic analysis will be used to populate a questionnaire which will be disseminated to grant recipients. This study is kindly funded by the EAES. The first question this project is expected to answer is whether the EAES research funding scheme had a significant positive impact on research output, career progression but also non-academic output such as change in clinical guidelines, healthcare quality and cost-effectiveness improvement. This project however is also expected to identify facilitators and barriers to successful completion of projects and to achieving high impact. This will inform EAES and the rest of the surgical and academic communities as to how clinicians would like to be supported when conducting research. There should also be a positive and decisive change towards removing factors that hinder the timely and successful completion of projects.

Evaluation of woman-centred care status by Iranian midwives and providing strategies to improve women-centred care: A sequential explanatory mixed method study protocol.

The present study aimed to evaluate the status of WCC provided by Iranian midwives. A sequential explanatory mixed method study protocol. The present study was conducted in three phases: quantitative, qualitative and mixed. The first phase is a cross-sectional study that will be performed on midwives working in health centres, public and private hospitals in Iranian. The second phase is a qualitative study, in which purposeful sampling will be used, meaning that the midwives who are part of the extreme cases according to the results of quantitative phase and are willing and able to express their own experiences regarding WCC will be selected. Also, pregnant and parturient women under their cover will also be interviewed. Finally, in the mixed phase, we will use a combination of two quantitative and qualitative studies, a literature review and expert opinion using a Delphi method to provide strategies to improve and promote WCC in midwives. Achieving this goal is expected to provide positive outcomes such as strengthening the midwives professional relationship with women and reducing health care costs. No Patient or Public Contribution.