Evaluating If Anaemia And Haemoglobin Are Co-Related? Research Proposal Example

Abstract

Background: Hemoglobin A1c (HbA1c) is considered as a major indictor to evaluate a patient’s glycemic status. Iron deficiency has increased exponentially in the US leading to various co-morbid disorders, especially diabetes. There is a direct correlation between altered HbA1c levels and iron deficiency (anaemia). However, current evidence does not provide a clear picture on the relation between these two medical entities. Most researchers predict that there is high risk of altered HbA1c levels in patients with diabetes.
Study Objectives: To evaluate if there is a correlation between HbA1c levels and iron deficiency based on the current literature. The main objective of the paper is also to evaluate if the prevalence of altered HbA1c levels is high in diabetic patients with iron deficiency. Is there a link between HbA1c levels and iron deficiency?
Study Design: This would be a meta-analysis that would comprise of literature published after 1990. The meta-analysis would be based on a scientific and evidence-based data collection followed by synthesis of the data using SPSS software, forest plot, and sensitivity analysis. The meta-analysis would be free from publication bias.
Research approval: Since there are no direct studies that involve humans or animals, the need for approval from the IRB is not required. The approval of the final paper would be solely based on the decision of the university management.

Introduction

Hemoglobin A1c (HbA1c) is considered as a major indictor to evaluate a patient’s glycemic status in the past three months. The HbA1 fraction of haemoglobin consists of different haemoglobins, HbA1c and glycated haemoglobins. One of the major constituents found in HbA1 fractions is the HbA1c which is also the predominant haemoglobin. In order to prevent the development of any complications (microvascular) in diabetic patients, the American Diabetes Association recommends that the HbA1c levels should be maintained below 7%. It is often misunderstood that blood glucose levels alone affect the levels of HbA1c in the body. Moreover, these levels change in acute and chronic blood loss, haemolytic anaemia, uremia, pregnancy, and hemoglobinopathies. In some cases, iron deficiency (anaemia), folate, and vitamin B12 also affect HbA1c levels in the body. In the US, iron deficiency is the most common anaemia. Sinha, Nitin et al. revealed the relationship between HbA1c levels and iron deficiency. They also tried to explain that HbA1c levels were affected in cases of anaemia by modifying the structure of haemoglobins. The modification was associated with the change in HbA1c levels in both new and old red blood cells. However, some researchers contradict the above statements. A few studies also stated that there was no link between HbA1c levels and iron deficiency. These researchers found no difference in HbA1c levels in patients with anaemia by comparing patients with altered anaemia who did not have anaemia. The hypothesis by these researchers was confirmed through affinity chromatography, ion exchange chromatography, and colorimetric assays. The number of studies confirming the link between haemoglobin and iron deficiency is high. It is important to understand the mechanism associated with the iron deficiency and altered HbA1c levels. Since the current evidence does not provide a clear picture of the correlation and most studies are vague with conflicting conclusions, it was decided to conduct a research study to evaluate the link between anaemia (iron deficiency) and HbA1c levels.
Study objectives and hypothesis: To evaluate the correlation between anaemia and altered haemoglobin (HbA1c) levels in the body. The study also aims to understand the underlying mechanism between altered HbA1c levels in patients with anaemia. Is there a link between HbA1c levels and iron deficiency?
Literature review: Adeoye, S, et al. report a direct correlation between haemoglobin and anaemia (iron deficiency). There is significant therapeutic benefit of controlling anaemia and controlling HbA1c levels. The therapeutic benefits is based on the reference range of HbA1c levels. In a similar study, L. Christy, Alap et al. confirmed the correlation between Hba1c levels and iron deficiency. The study was conducted on diabetic women with a fasting glucose range of 100-126 mg/dl. In such patients, there was significant correlation by the presence of altered HbA1c levels and iron deficiency. To confirm the correlation of HbA1c and iron deficiency, Ford, S, et al. reported the absence of altered HbA1c levels in non-iron-deficiency anemia and non-diabetic patients. However, there was significant changes in HbA1c levels in diabetic patients who were anemic.
Methodology: This would be a meta-analysis of research studies that took place in the past 10 years. Studies would be selected by a two reviewers who would use PUBMED, CINHAL, EMBASE, and Google Scholar are the primary source for published data. A meta-analysis is considered as a statistical analysis of pooled information from various scientific sources to provide a precise and reliable conclusion. A meta-analysis is considered as the most supreme research method since it involves the analysis of large studies and bring about a conclusion based on the combined findings from these studies. A diagrammatic representation of a meta-analysis has been shared here below:
Tools to design/sample collection: SPSS software (2013 version) would be used to statistically analyse the data. Most research-based meta-analysis are conducted through advanced statistical tools or software in order to get precise and consistent results. The design of the meta-analysis was based on the review of the evidence-based medicine journal (What is meta-analysis? by Iain K Crombie.
The process of data collection: PUBMED, EMBSAE, and Google Scholar would be used for the primary literature search. The scholars would use the following key words: Haemoglobin levels, iron deficiency, diabetes, HbA1c levels, anaemia, and correlation. Only articles published after 1990 would be selected and reviewed. Only peer-reviewed and articles from legitimate sources would be selected for the meta-analysis. Some of the major types of studies that would be selected are Randomized-control, post-hoc analysis, cohort, reviews, and long-term observational reports. Case reports or short-term studies would be excluded at the time of literature search.
Sampling bias: The review of the literature search and analysis of the data was reviewed by two scholars. Studies or sample population that might have been missed by the first scholar would be included or deleted by the second scholar. The same key words for the primary literature search was used by both experts. Advanced statistical tools such as citation manager would be used in order to avoid duplication of a research study.
Independent variables: Some of the most predictable independent variables that may come across include knowledge of the reviewer, data collection techniques, method for synthesis of data, quality of analysis, and criteria for sample size for the meta-analysis.
Dependent variables: Some of the most predictable variable for the meta-analysis can include author review, selection of studies by the author, publication bias, and reliability of the selected research study.
Control and placebo group: Since this a meta-analysis, no control or placebo group would be present, However, the collection and synthesis of data is of prime importance. Evaluation of sensitivity analysis is the key strength to any evidence or research meta-analysis.
Reliability and validity of the study: The data collection, review, and synthesis of data for the entire study would be based on the expertise of 5 scholars in the same field. Only articles from peer-reviewed and international journals would be selected for this study. Since all studies would be of supreme quality in terms of data selection and synthesis, there is 99% chance of obtaining a valid and reliable conclusion. Only advanced statistical software would be used for the actual software to avoid human error and increase the chances of an error-free and valid conclusion.
Maximizing reliability: In order for the meta-analysis to be precise and reliable so that it could be reviewed in the future, the best statistical analysis and calculative techniques would be utilized. Some of the key factors that would include in the statistical analysis to increase the reliability of the study are as follows: mean difference, standardized mean difference, and their confidence intervals. Standard mean difference is the best and most simple method to perform a meta-analysis. The scholars would also avoid key factors that limit the reliability of a meta-analysis such as publication bias, quality of selected studies, search strategy, combined size effect, and heterogeneity. If required, meta-regression would also be applied.
Precise data collection technique and analysis: Only articles published after 1990 would be included in the paper. The data and sample collection would be done by a team of experts (2 scholars) along with 2 reviewers. The data collection process would be free from publication bias and include complete transparency. Forest plot and sensitivity analysis would ensure that the data synthesized and conclusions made are precise and of international standards.
Ethical considerations: All ethical issues pertaining to the study would be addressed to the sponsor (if any) or to the university and organization. In case the research would require frequent travelling or inclusion of experts other than the guide or university personnel, written permission would be taken to avoid future issues. If an external editor would be involved, it should be disclosed at the start of the study. Financial agreements between an individual or an organization would be reported at the earliest.
Research approval (IRB): Since there are no direct studies that involve humans or animals, the need for the application/approval from the IRB is not required. The method for data collection and synthesis should be reported to the concerned authorities for review and feedback on the overall process.
Process for approval: The approval of the final paper would be solely based on the decision of the university management. Revisions (if any) should be completed at the earliest.

Reference

Sinha, Nitin et al. “Effect of Iron Deficiency Anemia on Hemoglobin A1c Levels.” Annals of Laboratory Medicine 32.1 (2012): 17–22. PMC. Web. 14 Apr. 2015.
Ford ES, Cowie CC, Li C, Handelsman Y, Bloomgarden ZT. Iron-deficiency anemia, non-iron-deficiency anemia and HbA1c among adults in the US. J Diabetes. 2011 Mar;3(1):67-73.
L. Christy, Alap et al. “Influence of Iron Deficiency Anemia on Hemoglobin A1C Levels in Diabetic Individuals with Controlled Plasma Glucose Levels.” Iranian Biomedical Journal 18.2 (2014): 88–93. PMC. Web. 14 Apr. 2015.
Adeoye. S, ET AL. Anemia and Hemoglobin A1c level: Is there a case for redefining reference ranges and therapeutic goals? British Journal of Medical Practitioners. 7 (1). Mar.2014.