Conectar
This study aims to reduce potentially inappropriate prescribing (PIP) of statins and foster healthy lifestyle promotion in cardiovascular disease (CVD) primary prevention in low-risk patients. To this end, we will compare the effectiveness and feasibility of several de-implementation strategies developed following the structured design process of the Behaviour Change Wheel targeting key determinants of the clinical decision-making process in CVD prevention.
A cluster randomised implementation trial, with an additional control group, will be launched, involving family physicians (FPs) from 13 Integrated Healthcare Organisations (IHOs) of Osakidetza-Basque Health Service with non-zero incidence rates of PIP of statins in 2021. All FPs will be exposed to a non-reflective decision assistance strategy based on reminders and decision support tools. Additionally, FPs from two of the IHOs will be randomly assigned to one of two increasingly intensive de-implementation strategies: adding a decision information strategy based on knowledge dissemination and a reflective decision structure strategy through audit/feedback. The target population comprises women aged 45–74 years and men aged 40–74 years with moderately elevated cholesterol levels but no diagnosed CVD and low cardiovascular risk (REGICOR
The study was approved by the Basque Country Clinical Research Ethics Committee and was registered in ClinicalTrials.gov (NCT04022850). Results will be disseminated in scientific peer-reviewed journals.
Clinical pharmacy services often involve multifaceted pharmacist-led interventions. However, current pharmacy practice models vary across different countries. Despite the documented benefits of clinical pharmacy services, the characteristics of pharmacist-led interventions in different countries have not yet been adequately explored and described. Therefore, this protocol outlines the methodology for a proposed scoping review aiming to investigate various types of multifaceted pharmacist-led interventions and the outcomes used to evaluate their effectiveness within secondary care settings. Additionally, the scoping review will map the current evidence surrounding the characteristics of interventions and outcomes reported across various countries of socioeconomic status.
The scoping review will be conducted according to the JBI Methodology for Scoping Reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Extension for Scoping Reviews. We will systematically search the following electronic databases: MEDLINE (Ovid), CINAHL (EbscoHost), Embase (embase.com), Scopus (scopus.com), Cochrane Library (cochranelibrary.com) and APA PsycInfo (Ovid). Additionally, the reference lists of identified reviews and included full texts will be searched for relevant papers. Grey literature sources, such as International Pharmaceutical Abstracts and the International Pharmaceutical Federation (FIP) website, will be searched. We will include primary studies published in the English language from January 2013 to December 2023, involving secondary care multifaceted pharmacist-led interventions. Two independent reviewers will screen studies against eligibility criteria and use a piloted data extraction form to extract relevant information. We will extract relevant data, complete a tabular summary from each included publication and analyse it.
Ethical approval is not required as we will be using data from publicly available literature sources. Findings will be disseminated in publications and presentations with relevant stakeholders. We aim to map available evidence across the breadth of studies that have reported multifaceted pharmacist-led interventions and their outcomes.
Nurses' vigor at work profoundly impacts the quality of patient care. However, the determinants of nurses' vigor remain underexplored in the current nursing literature, and the mechanism through which these determinants exert their effects remains unclear.
This study aimed to elucidate the mediating role of psychological ownership in linking decent work to nurses' vigor at work.
A two-wave, time-lagged study was conducted to collect data from 289 nurses working across three hospitals in Port Said, Egypt, between March and June 2023. Data were collected using the Decent Work Scale, the Psychological Ownership Scale, the Shirom–Melamed Vigor Measure, on an Introductory Information Form. Mediation testing was performed using structural equation modeling.
Decent work was significantly associated with psychological ownership and vigor at work. Psychological ownership partially mediated the relationship between decent work and nurses' vigor at work.
Decent work practices are critical in fostering nurses' vigor while working, and psychological ownership plays a mediating role in this relationship.
Hospital administrators should value decent work practices, which could enhance psychological ownership, resulting in a potential improvement in nurses' vigor at work.
The American Nurses Credentialing Center's (ANCC's) Practice Transition Accreditation Program (PTAP) establishes standards for nurse residency programs to elevate and optimize the skills, knowledge, and attitudes of new nurses participating in nurse residency programs. Evidence-based practice (EBP) is foundational to providing safe nursing care. One of the National Academy of Medicine's (NAM's) 2020 goals stated that 90% of clinical decisions would be supported by the best available evidence to attain the best patient outcomes. Nurse residency programs can benefit from evidence-based strategies to develop EBP competencies in new nurses.
The purpose of this scoping review was to synthesize the literature around strategies for incorporating EBP into nurse residency programs across the United States.
This scoping review was informed by the JBI (formerly known as the Joanna Briggs Institute) methodology for scoping reviews. Searches were conducted by a health science librarian in PubMed and CINAHL with Full Text. Keywords and their synonyms, Medical Subject Headings (MeSH; PubMed), and Subject Headings (CINAHL with Full Text) were used. Covidence, a literature review management program, was used to organize the literature and manage the review. Title, abstract, and full-text reviews were completed within Covidence using three teams of two independent reviewers.
Four hundred and thirty-eight citations were imported into Covidence. Ten articles were retained for the final review. Three strategies for incorporating EBP into nurse residency programs emerged from the literature: (1) exposure of nurse residents to existing organizational resources, (2) completion of online EBP modules, and (3) completion of an EBP project.
The incorporation of EBP competencies in nurse residency programs aligns with NAM's and ANCC's goals, yet a paucity of evidence exists to guide curriculum development in nurse residency programs. This scoping review corroborates the need for further research to inform best practices for implementing EBP into nurse residency programs.
To explore parents' experiences of unsettled babies and medical labels.
Qualitative systematic review, thematic synthesis and development of a conceptual model.
Systematic review and thematic synthesis of primary, qualitative research into parents' experiences of unsettled babies <12 months of age. ‘Unsettled’ was defined as perception of excessive crying with additional feature(s) such as vomiting, skin or stool problems. The Critical Appraisal Skills Programme (CASP) checklist was used to assess trustworthiness.
Structured searches completed in CINAHL, Medline, Embase, PsychINFO and CochraneCT on 23 March 2022 and rerun on 14 April 2023.
Ten eligible studies were included across eight countries contributing data from 103 mothers and 24 fathers. Two analytical themes and eight descriptive themes were developed.
Firstly, parents expressed fearing judgement, feeling guilty and out of control as a result of babies' unsettled symptoms and seeking strategies to construct an ‘Identity as a “Good Parent”’.
This desire for positive parenting identity underpinned the second analytical theme ‘Searching for an explanation’ which included seeking external (medical) causes for babies' unsettled behaviours.
Parents can become trapped in a cycle of ‘searching for an explanation’ for their baby's unsettled behaviours, experiencing considerable distress which is exacerbated by feelings of guilt and failure.
Insight gained from this review could inform interventions to support parents, reducing inaccurate medicalization.
Health visiting teams supporting parents with unsettled baby behaviour could focus on supporting a positive parenting identity by managing expectations, normalizing the continuum of infant behaviours, reducing feelings of guilt or uncertainty and helping parents regain a feeling of control.
ENTREQ guidelines were adhered to in the reporting of this review.
Parent input was crucial in the design phase; shaping the language used (e.g., ‘unsettled babies’) and in the analysis sense-checking findings.
Quantify disparities and identify correlates and predictors of ‘wellness’ supplement use among nurses during the first year of the pandemic.
Longitudinal secondary analysis of Nurses' Health Studies 2 and 3 and Growing Up Today Study data.
Sample included 36,518 total participants, 12,044 of which were nurses, who completed surveys during the first year of the COVID-19 pandemic (April 2020 to April 2021). Analyses were conducted in March 2023. Modified Poisson models were used to estimate disparities in ‘wellness’ supplement use between nurses and non-healthcare workers and, among nurses only, to quantify associations with workplace-related predictors (occupational discrimination, PPE access, workplace setting) and psychosocial predictors (depression/anxiety, county-level COVID-19 mortality). Models included race/ethnicity, gender identity, age and cohort as covariates.
Nurses were significantly more likely to use all types of supplements than non-healthcare workers. Lacking personal protective equipment and experiencing occupational discrimination were significantly associated with new immune supplement use. Depression increased the risk of using weight loss, energy and immune supplements.
Nurses' disproportionate use of ‘wellness’ supplements during the COVID-19 pandemic may be related to workplace and psychosocial stressors. Given well-documented risks of harm from the use of ‘wellness’ supplements, the use of these products by nurses is of concern.
‘Wellness’ supplements promoting weight loss, increased energy, boosted immunity and cleansing of organs are omnipresent in today's health-focused culture, though their use has been associated with harm. This is of added concern among nurses given their risk of COVID-19 infection at work. Our study highlighted the risk factors associated with use of these products (lacking PPE and experiencing occupational discrimination). Findings support prior research suggesting a need for greater public health policy and education around the use of ‘wellness’ supplements.
STROBE guidelines were followed throughout manuscript.
No patient or public contribution was involved.
To use a community-based participatory research (CBPR) design to explore local community behaviours and stakeholders’ challenges in engaging communities in dengue prevention behaviours in Hulu Langat, Selangor, Malaysia.
This CBPR design in implementation comprised in-depth interviews (IDIs) and focus group discussions (FGDs). Themes were identified from the data with inductive and deductive thematic analysis.
FGDs were conducted in local community areas and IDIs were conducted in the local authority (LA) office and the Hulu Langat district health office.
All FGD and IDI participants consented to the study, and included health authorities (n=4), LAs (n=7), community leader (n=1), faith leader (n=1), patients diagnosed with dengue (IDIs, n=2) and permanent residents of Hulu Langat who had been exposed to dengue infectious disease (FGDs, n=27).
The main themes were categorised into community behaviour and stakeholder challenges. The community behaviour-related themes were awareness of dengue disease and Aedes mosquitoes, perception of risk and severity, and involvement of authorities. The themes related to stakeholder challenges were resource constraints and capacity issues, jurisdictional constraints and coordination, and educational dissemination and vandalism.
The actions of the authorities shape community and stakeholder behaviours. Effective communication, including clear and aesthetically pleasing messages, motivates individuals to take appropriate actions. It is crucial for the authorities to engage in inclusive communication and consider diverse perspectives, such as those of residents and individuals exposed to dengue infection. Authorities that provide accurate and unbiased information foster transparency and enable informed decision-making by all stakeholders.
To assess the effects of COVID-19 pandemic on clinical variables as part of the routine clinical monitoring of patients with chronic diseases in primary care.
A prospective longitudinal study was conducted in primary care centres of the Andalusian Health Service.
Data were recorded before the pandemic (T1), during the declaration of the state of emergency (T2) and in the transition phase (T3). The Barthel index and the Short Portable Mental Status Questionnaire (SPMSQ) were used to analyse functional and cognitive changes at the three time points. HbA1c, systolic and diastolic blood pressure, heart rate, BMI and lipid levels were assessed as clinical variables. Descriptive statistics and non-parametric chi-square test were used for analysis. STROBE checklist was used for the preparation of this paper.
A total fo148 patients with chronic conditions were included in the analysis. Data analysis revealed in T2 only significant reductions in BMI, total levels of cholesterol and HDL during the onset of the pandemic. Barthel Index, SPMSQ, blood pressure and triglycerides and LDL levels worsened in T2, and the negative effects were maintained in T3. Compared to pre-pandemic values, HbA1c levels improved in T3, but HDL levels worsened.
COVID-19 has drastically disrupted several functional, cognitive and biological variables. These results may be useful in identifying clinical parameters that deserve closer attention in the case of a new health crisis. Further studies are needed to assess the potential impacts of each specific chronic condition.
Cognitive and functional status, blood pressure and triglycerides and LDL levels worsen in short term, maintaining the negative effects in medium-term.
To evaluate the impact of nurse care changes in implementing a blood pressure management protocol on achieving rapid, intensive and sustained blood pressure reduction in acute intracerebral haemorrhage patients.
Retrospective cohort study of prospectively collected data over 6 years.
Intracerebral haemorrhage patients within 6 h and systolic blood pressure ≥ 150 mmHg followed a rapid (starting treatment at computed tomography suite with a target achievement goal of ≤60 min), intensive (target systolic blood pressure < 140 mmHg) and sustained (maintaining target stability for 24 h) blood pressure management plan. We differentiated six periods: P1, stroke nurse at computed tomography suite (baseline period); P2, antihypertensive titration by stroke nurse; P3, retraining by neurologists; P4, integration of a stroke advanced practice nurse; P5, after COVID-19 impact; and P6, retraining by stroke advanced practice nurse. Outcomes included first-hour target achievement (primary outcome), tomography-to-treatment and treatment-to-target times, first-hour maximum dose of antihypertensive treatment and 6-h and 24-h systolic blood pressure variability.
Compared to P1, antihypertensive titration by stroke nurses (P2) reduced treatment-to-target time and increased the rate of first-hour target achievement, retraining of stroke nurses by neurologists (P3) maintained a higher rate of first-hour target achievement and the integration of a stroke advanced practice nurse (P4) reduced both 6-h and 24-h systolic blood pressure variability. However, 6-h systolic blood pressure variability increased from P4 to P5 following the impact of the COVID-19 pandemic. Finally, compared to P1, retraining of stroke nurses by stroke advanced practice nurse (P6) reduced tomography-to-treatment time and increased the first-hour maximum dose of antihypertensive treatment.
Changes in nursing care and continuous education can significantly enhance the time metrics and blood pressure outcomes in acute intracerebral haemorrhage patients.
STROBE guidelines.
No Patient or Public Contribution.
The utility and uptake of pain management interventions across intensive care settings is inconsistent. A rapid realist review was conducted to synthesise the evidence for the purpose of theory building and refinement.
A five-step iterative process was employed to develop project scope/ research questions, collate evidence, appraise literature, synthesise evidence and interpret information from data sources.
Realist synthesis method was employed to systematically review literature for developing a programme theory.
Initial searches were undertaken in three electronic databases: MEDLINE, CINHAL and OVID. The review was supplemented with key articles from bibliographic search of identified articles. The first 200 hits from Google Scholar were screened.
Three action-oriented themes emerged as integral to successful implementation of pain management interventions. These included health facility actions, unit/team leader actions and individual nurses' actions.
Pain assessment interventions are influenced by a constellation of factors which trigger mechanisms yielding effective implementation outcomes.
The results have implications on policy makers, health organisations, nursing teams and nurses concerned with optimising the successful implementation of pain management interventions.
The review enabled formation of a programme theory concerned with explaining how to effectively implement pain management interventions in intensive care.
This review was informed by RAMESES publication standards for realist synthesis.
No patient or public contribution.
The study protocol was registered in Open Science Framework.
Burn survivors experience profound physiological changes following injury, which may have lasting implications for cardiovascular health. This study aims to investigate the cardiovascular risk profile among burn survivors treated at a burn center in northern Iran. This observational study was conducted from 2022 to 2023 at the burn centre affiliated with Guilan University of Medical Sciences, Rasht, Iran. This study assessed a cohort study of 210 burn survivors, focusing on individuals with ≥20% TBSA burn injuries who had recovered and returned to their daily lives. This study assessed patients' lipid profiles, Framingham General Cardiovascular Risk Score (FGCRS) and risk factors, including demographics, clinical variables and physical activity. Statistical analysis employed descriptive and inferential statistics. The mean age was 49.23 years, and the mean TBSA burned was 37.06%. The risk of cardiovascular disease in 66% of the study population was less than 10%, and in 13%, it was more than 20%. Significant associations were identified between CVD risk and sex, diabetes, hypertension, BMI, TBSA burned, years after burn, physical activity level and LDL. Of the lipid profile measures, LDL, triglycerides and TC/HDL exceeded the desirable levels. This research highlights the heightened cardiovascular risk in burn survivors, emphasizing the necessity for targeted interventions and regular monitoring. Identifying modifiable risk factors enables healthcare practitioners to develop tailored strategies, enhancing cardiovascular health in this vulnerable population and improving overall outcomes and quality of life.
In the ongoing challenge to reduce burn-associated mortality rates, this study explores the predictive capacity of clinical factors in burn patients, focusing on vitamin D, calcium, and serum albumin levels during hospitalisation in cases with Pseudomonas aeruginosa infection. Our research involves a comprehensive analysis of 100 burn patients, encompassing crucial clinical parameters such as the burn severity index, serum albumin, vitamin D, and calcium levels at admission. Data were meticulously entered into IBM Statistics SPSS software version 28 and subjected to statistical analysis. The study reveals an average patient age of 39.75 years and a notable 34% mortality rate. Additionally, the average lengths of hospital and intensive care unit (ICU) stays are determined to be 11.33 and 7.79 days, respectively. Significantly, a correlation between calcium and albumin variables and treatment outcomes is established, showcasing their potential to predict variable changes in patient mortality rates. Furthermore, a noteworthy association is observed between serum calcium levels and the duration of ICU hospitalisation. In conclusion, albumin and calcium variables emerge as sensitive and specific indicators for predicting outcomes in burn patients. Importantly, the independence of these factors from the physician's experience and diagnosis reduces human error and thus increases the accuracy of mortality prediction in this patient population.
To explore parents' perceptions/experiences of help-seeking for unsettled baby behaviours, including views and experiences of obtaining advice from primary healthcare professionals.
Semi-structured qualitative interviews.
Recruitment occurred via social media, general practice and health visiting teams. Remote semi-structured interviews were conducted with parents of babies. Babies were under 12 months old at time of interview, and parents had perceived unsettled baby behaviours in their first 4 months of life. Interviews were transcribed and data analysed using reflexive thematic analysis.
Based on interviews with 25 mothers, four main themes were developed. ‘The need for answers’ highlighted parental uncertainty about what constitutes normal baby behaviour, leading to help-seeking from multiple sources. ‘The importance of health professionals’ and ‘Experiencing health professional support’ identified perceptions about limited access, communication, mixed advice and how these influenced parental perception/management of behaviours. ‘Foundations to help-seeking’ highlighted important roles of social support and online help for valued shared experiences, emotional and practical support.
Health professional access and advice are important to parents, despite the increasing role of online help and importance of social support. More support and improved access to reliable sources of information is needed for parents.
Findings will inform future research and clinical practice to address parental uncertainties. Qualitative research with front-line health professionals is necessary.
Findings can inform the development of resources to support professionals/families managing unsettled babies.
Standards for Reporting Qualitative Research.
A public contributor was involved throughout all stages of the research. Emerging findings were discussed at a parent group.
Addressing parental uncertainties is important; about what is normal, non-pharmacological approaches and when pharmacological intervention is required. A digital information/self-management intervention may be useful for parents/clinicians.
The pandemic has ensued challenges across all sections of the human population such as livelihood and educational changes, which involve the abrupt shift to online learning, immensely affecting the students’ well-being. Negative health consequences of e-learning among students stem from the increased demand for new technological skills, productivity, information overload and restriction of students to spend time with their peers.
To explore the experiences of the students from the University of Santo Tomas—College of Rehabilitation Sciences (UST-CRS) who participated in the online well-being programme.
A phenomenological design will be used to determine the participants’ perceptions and experiences. Purposive sampling will be used to recruit 8–10 undergraduate students from UST-CRS ages 18–22 years, who participated in the well-being programme, and completed the study’s quantitative counterpart. Semistructured, in-depth questions will be used to conduct a focus group discussion. The transcripts will be analysed using thematic analysis via the NVivo V.12 software.
The study protocol is approved by the UST-CRS Ethical Review Committee (Protocol Number: SI-2022–034 (V.4)). It will be implemented in accordance with the Declaration of Helsinki and the National Ethical Guidelines for Health and Health-Related Research, and Data Privacy Act. Findings will be published in accredited journals and presented in related scientific fora.
PHRR230214-005419; Philippine Health Research Registry.
The COVID-19 pandemic has shown the importance of resilient, modern, and well-equipped public health administrations from national to communal levels. In Germany, the surveillance, contact tracing, and local adaptions went through local health offices, revealing both their important role and also their lack of equipment and general preparation for health crises. Research on the mode of operation of the public health service (PHS), especially in a time of crisis, is rare. The present study aims to qualitatively and quantitatively assess problem areas, conflict potentials, and challenges that have become apparent for the PHS of Saxony-Anhalt during the pandemic. It focuses on the individual insight of employees of the PHS of Saxony-Anhalt and its 14 health offices to derive concrete needs and fields of action for increasing pandemic preparedness. Furthermore, the prospective personnel and resource-based requirements as well as the necessary structural and organisational changes of the public health departments are to be considered.
The study will follow a sequential mixed-methods approach. Introductory expert interviews (n=12) with leading staff of Saxony-Anhalt’s PHS will be conducted, followed by focus group interviews (n=4) with personnel from all departments involved in the pandemic response. Thereafter, a quantitative survey will be carried out to validate and complement the results of the qualitative phase.
Ethical approval was obtained by the Martin-Luther-Universität Halle-Wittenberg ethics commission (Ref number 2023-102). The authors will submit the results of the study to relevant peer-reviewed journals and give national and international oral presentations to researchers, members of the PHS, and policymakers.
by Afsoon Dadvar, Melika Jameie, Mehdi Azizmohammad Looha, Mohammadamin Parsaei, Meysam Zeynali Bujani, Mobina Amanollahi, Mahsa Babaei, Alireza Khosravi, Hamed Amirifard
ObjectivesCaffeine’s potential benefits on multiple sclerosis (MS), as well as on the ambulatory performance of non-MS populations, prompted us to evaluate its potential effects on balance, mobility, and health-related quality of life (HR-QoL) of persons with MS (PwMS).
MethodsThis single-arm pilot clinical trial consisted of a 2-week placebo run-in and a 12-week caffeine treatment (200 mg/day) stage. The changes in outcome measures during the study period (weeks 0, 2, 4, 8, and 12) were evaluated using the Generalized Estimation Equation (GEE). The outcome measures were the 12-item Multiple Sclerosis Walking Scale (MSWS-12) for self-reported ambulatory disability, Berg Balance Scale (BBS) for static and dynamic balance, Timed Up and Go (TUG) for dynamic balance and functional mobility, Multiple Sclerosis Impact Scale (MSIS-29) for patient’s perspective on MS-related QoL (MS-QoL), and Patients’ Global Impression of Change (PGIC) for subjective assessment of treatment efficacy. GEE was also used to evaluate age and sex effect on the outcome measures over time. (Iranian Registry of Clinical Trials, IRCT2017012332142N1).
ResultsThirty PwMS were included (age: 38.89 ± 9.85, female: 76.7%). Daily caffeine consumption significantly improved the objective measures of balance and functional mobility (BBS; P-value Conclusions
Caffeine may enhance balance, functional mobility, and QoL in PwMS. Being male was associated with a sharper increase in self-reported ambulatory disability over time. The effects of aging on balance get more pronounced over time.
Trial registrationThis study was registered with the Iranian Registry of Clinical Trials (Registration number: IRCT2017012332142N1), a Primary Registry in the WHO Registry Network.
by Md. Abu Raihan, Md. Saiful Islam, Shariful Islam, A. F. M. Mahmudul Islam, Khandaker Tanveer Ahmed, Tania Ahmed, Md. Nahidul Islam, Shamsunnahar Ahmed, Mysha Samiha Chowdhury, Dipto Kumar Sarker, Anika Bushra Lamisa
BackgroundEscalating antibiotic resistance presents a notable worldwide dilemma, pointing a large involvement of general population. The objective of this study was to assess knowledge, attitudes, and practices regarding the utilization of antibiotics among Bangladeshi residents.
MethodsA cross-sectional study, conducted from January 01 to April 25, 2022, included 1,947 Bangladeshi adults with a history of antibiotic use, via online surveys and face-to-face interviews using a pretested semi-structured questionnaire. Descriptive statistics, Chi-square tests, and multivariate linear regression models were employed.
ResultsMean scores for knowledge, attitudes, and practices were 6.59±1.20, 8.34±1.19, and 12.74±2.59, with correct rates of 73.22%, 92.67%, and 57.91%. Positive predictors for knowledge included being unmarried (β = 0.10, p = 0.001), higher education (College: β = 0.09, p = 0.025; Bachelor: β = 0.22, p Conclusions
Participants exhibited adequate knowledge and positive attitudes but lagged behind in proper practice of antibiotic use. Proper initiatives should be tailored to enhance prudent antibiotic use and mitigate the risk of antimicrobial resistance.
Despite the improvement in medical management, many patients with transfusion-dependent β-thalassaemia die prematurely due to transfusion-related iron overload. As per the current guidelines, the optimal chelation of iron cannot be achieved in many patients, even with two iron chelators at their maximum therapeutic doses. Here, we evaluate the efficacy and safety of triple combination treatment with deferoxamine, deferasirox and deferiprone over dual combination of deferoxamine and deferasirox on iron chelation in patients with transfusion-dependent β-thalassaemia with very high iron overload.
This is a single-centre, open-label, randomised, controlled clinical trial conducted at the Adult and Adolescent Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into intervention or control groups. The intervention arm will receive a combination of oral deferasirox, oral deferiprone and subcutaneous deferoxamine for 6 months. The control arm will receive the combination of oral deferasirox and subcutaneous deferoxamine for 6 months. Reduction in iron overload, as measured by a reduction in the serum ferritin after completion of the treatment, will be the primary outcome measure. Reduction in liver and cardiac iron content as measured by T2* MRI and the side effect profile of trial medications are the secondary outcome measures.
Ethical approval for the study has been obtained from the Ethics Committee of the Faculty of Medicine, University of Kelaniya (Ref. P/06/02/2023). The trial results will be disseminated in scientific publications in reputed journals.
The trial is registered in the Sri Lanka Clinical Trials Registry (Ref: SLCTR/2023/010).
FreshRSS 