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Impact of supplementation with iron-folic acid (IFA) and vitamin D3 compared with IFA alone on haemoglobin levels in elderly people with mild-to-moderate anaemia: protocol for the double-blind, randomised, placebo-controlled Iron and vitamin D trial in El

Por: Ahamed · F. · Jaiswal · A. · Sahoo · S. · Ghosh · T. · Kaur · A. · Rehman · T. · Goswami · K.
Introduction

Anaemia in the elderly is often difficult to treat with iron supplementation alone as prevalence of anaemia of chronic disease (ACD) alone or mixed with iron-deficiency anaemia (IDA) is high in this age group. Hepcidin remains high in ACD, preventing utilisation of iron for heme synthesis. Vitamin D3 has shown hepcidin suppression activity in both in vitro and in vivo studies. As there is no study assessing the effect of iron–folic acid (IFA) with vitamin D3 on haemoglobin levels in the elderly in India, we want to conduct this study to estimate the impact of supplementation of a therapeutic package of IFA and vitamin D3 on haemoglobin levels in the elderly with mild-to-moderate anaemia in comparison with IFA only. The study will also assess the impact of the proposed intervention on ferritin, hepcidin, 25-hydroxyvitamin D, C reactive protein (CRP) and parathyroid hormone (PTH) levels.

Methods and analysis

This study is a community-based, double-blind, placebo-controlled, randomised trial. The study will be done in the Kalyani municipality area. Individuals aged ≥60 years with mild-to-moderate anaemia and normal vitamin D3 levels will be randomised into the intervention (IFA and vitamin D3 supplementation) group or the control group (IFA and olive oil as placebo). All medications will be self-administered. Follow-up will be done on a weekly basis for 12 weeks. The calculated sample size is 150 in each arm. Block randomisation will be done. The primary outcome is change in haemoglobin levels from baseline to 12 weeks. Secondary outcome is change in serum ferritin, 25-hydroxyvitamin D, hepcidin, CRP and PTH levels from baseline to 12 weeks.

Ethics and dissemination

Ethical approval from the Institutional Ethics Committee of All India Institute of Medical Sciences Kalyani has been obtained (IEC/AIIMS/Kalyani/Meeting/2022/03). Written informed consent will be obtained from each study participant. The trial results will be reported through publication in a reputable journal and disseminated through health talks within the communities.

Trial registration number

CTRI/2022/05/042775.

Protocol version

Version 1.0.

THromboprophylaxis In Sickle Cell Disease with central venous catheters (THIS): an internal pilot randomised controlled trial protocol

Por: Abdulrehman · J. · Forte · S. · Tomlinson · G. · Solh · Z. · Bolster · L. · Sun · H. · Bartolucci · P. · Kuo · K. H. M.
Introduction

Individuals with sickle cell disease (SCD) and central venous catheters (CVC) are at high risk for venous thromboembolism (VTE). Minimal data exist regarding the use of anticoagulation as thromboprophylaxis of VTE in this demographic, and as a result, clinical equipoise exists. Prophylactic dose rivaroxaban, a direct oral anticoagulant, is efficacious and safe as thromboprophylaxis in other demographics, and may be an optimal agent in SCD with CVC. Prior to conducting a full clinical trial to assess rivaroxaban as thromboprophylaxis in SCD with CVC, a pilot study is needed to gauge its feasibility.

Methods and analysis

THromboprophylaxis In Sickle Cell Disease pilot trial is an investigator-initiated, multicentre, double-blinded, randomised controlled trial (RCT) assessing if it is feasible and safe to conduct an adequately powered RCT comparing rivaroxaban to matching placebo as thromboprophylaxis in those with SCD and CVC. Fifty adult patients with SCD and CVC will be randomised to receive either rivaroxaban 10 mg daily or matching placebo for the duration of the CVC in situ for up to 1 year. After randomisation, follow-up visits will occur every 3 months. The primary outcomes pertain to the feasibility of a full trial and include numbers of eligible and recruited participants. Exploratory outcomes include overall incidence of VTE and bleeding complications, as well as quality of life. If the full trial is feasible, blinding will be maintained and patients in the pilot study will be included in the full trial.

Ethics and dissemination

The trial was initially approved by the University Health Network Research Ethics Board (REB) in Toronto, Canada. All sites will obtain approval from their respective REB prior to commencement of study activities. Study results will be disseminated through presentations at medical conferences and peer-reviewed publications.

Trial registration number

NCT05033314.

Are pharmacists on the front lines of the opioid epidemic? A cross-sectional study of the practices and competencies of community and hospital pharmacists in Punjab, Pakistan

Por: Mubarak · N. · Zahid · T. · Rana · F. R. · Ijaz · U.-E.-B. · Shabbir · A. · Manzoor · M. · Khan · N. · Arif · M. · Naeem · M. M. · Kanwal · S. · Saif-ur-Rehman · N. · Zin · C. S. · Mahmood · K. · Asgher · J. · Elnaem · M. H.
Introduction

Countries are grappling with a rapidly worsening upsurge in the opioid-related overdose deaths, misuse and abuse. There is a dearth of data in Pakistan regarding the practices and competencies of pharmacists in handling opioid-related issues.

Study design

A cross-sectional study, conducted across Punjab, Pakistan.

Method

The study deployed a validated survey to evaluate the competencies and practices of the community and hospital pharmacists.

Results

504 community pharmacists and 279 hospital pharmacists participated in the survey with an overall response rate of 85.5%. Almost half of the respondents ‘never’ or ‘sometimes’ made clinical notes in a journal or dispensing software to monitor ongoing opioid use. Generally, pharmacists were reluctant to collaborate with physicians or notify police regarding the abuse/misuse of opioids. Hospital pharmacists achieved significantly higher mean competency scores than chain and independent community pharmacists (p

Conclusion

Both community and hospital pharmacists hold significant positions and potential to contribute meaningfully to the mitigation of harms and risks associated with opioids. Nevertheless, this study underscores notable deficiencies in the competence of pharmacists, whether in hospital or community settings in Punjab, concerning various aspects related to the dispensing and utilisation of opioids. It also highlights the pressing need for the development of strategies aimed at improving several practice areas including the documentation, the quality of patient counselling, the effectiveness of reporting mechanisms for opioid abuse and the stringent enforcement of regulatory policies to curtail opioid misuse. Thus, to mitigate the opioid epidemic in Pakistan, it is imperative to institute opioid stewardship initiatives aimed at rectifying the competency and procedural deficiencies within the pharmacist workforce.

How well does the virtual format of oncology multidisciplinary team meetings work? An assessment of participants’ perspectives and limitations: A scoping review

by Muhammad Abdul Rehman, Unaiza Naeem, Anooja Rani, Umm E. Salma Shabbar Banatwala, Afia Salman, Muhammad Abdullah Khalid, Areeba Ikram, Erfa Tahir

Background

Virtual multidisciplinary team meetings (VMDTM) provide a standard of care that is not limited by physical distance or social restrictions. And so, when the COVID-19 pandemic imposed irrefutable social restrictions and made in-person meetings impossible, many hospitals switched to the VMDTMs. Although the pandemic might have highlighted the ease of VMDTMs, these virtual meetings have existed over the past decade, albeit less in importance. Despite their recent importance, no review has previously assessed the feasibility of VMDTMs through the eyes of the participants, the barriers participants face, nor their comparison with the in-person format. We undertook this scoping review to map existing literature and assess the perspectives of VMDTM participants.

Material and methods

We searched MEDLINE, Embase, CINAHL, and Google Scholar from inception till July 1st, 2023 to select studies that evaluated the perspectives of participants of VMDTMs regarding the core components that make up a VMDMT. Four authors, independently, extracted data from all included studies. Two authors separated data into major themes and sub-themes.

Results

We identified six core, intrinsic aspects of a VMDTM that are essential to its structure: (1) organization, (2) case discussion and decision-making, (3) teamwork and communication, (4) training and education, (5) technology, and (6) patient-related aspect. VMDTMs have a high overall satisfaction rating amongst participants. The preference, however, is for a hybrid model of multidisciplinary teams. VMDTMs offer support to isolated physicians, help address complex cases, and offer information that may not be available elsewhere. The periodical nature of VMDTMs is appropriate for their consideration as CMEs. Adequate technology is paramount to the sustenance of the format.

Conclusion

VMDTMs are efficient and offer a multidisciplinary consensus without geographical limitations. Despite certain technical and social limitations, VMDTM participants are highly satisfied with the format, although the preference lies with a hybrid model.

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