1. Karnieli, E., Baeres, F. M. M., Dzida, G., Ji, Q., Lighthelm, R., Ross, S., . . . Yale, J.-F. (2013, February 1). Observational study of once-daily insulin detemir in people with type 2 diabetes aged 75 years or older: A sub-analysis of data from the Study of Once-Daily LeVEmir (SOLVE). Drugs Aging, 30, 167-175.
Type of Study: The article analyzed is a quantitative research because the authors have quantified the data from the Study of Once-Daily LeVEmir (SOLVE) and generalized those results from the sample to the population of interest (National Service-Learning Clearinghouse, n.d.).
Location/Setting: The location for the study is, so to say, multinational since it involves “3,219 investigators and 2,817 project sites from ten countries” (Karnieli et al., 2013, p. 167).
Concepts/Variables: The scholars analyze both dependent and independent variables in order to reach their objective. The latter is focused on investigation the connection between once-daily insulin detemir for the 75-year-old patients or older and the evaluation of these indexes in comparison with the results of younger diabetics.
Independent Variable (if quantitative study): The independent variable is insulin detemir treatment for diabetics of 75 years and older and its consequences. Specifically, in this position, the study is centered on assessment if insulin detemir treatment leads to severe drug reactions and complications, such as hypoglycemia, in elderly populations suffering from diabetes mellitus.
Dependent Variable (if quantitative study): The dependent variable, in this case, is identified as “managing people with type 2 diabetes mellitus (T2DM) as glycemic targets” (Karnieli et al., 2013, p. 168).
Framework or Theory (if any): The researchers have not specified any theoretical framework to which their observational study could be related.
Study Design: Karnieli et al. (2013) have not done any experiments for their research by themselves and their article is titled as “observational study.” The paper is of experimental design since respondents whose condition has been traced during certain period (24 weeks) were “treated with one or more oral antidiabetic drugs” (Karnieli et al, 2013, p. 168). Therefore, the results for comparison and analysis have been influenced from the outside.
Sample: Sample for the research, namely population of interest, have been people suffering from T2DM aged 75 and older, as well as younger persons suffering from this disease.
Sample Size: The number of respondents involved 17,374 patients.
Sampling Methods: In order to make a research, Karnieli et al. (2013) have applied particular methods:
- SOLVE, which results have become the basis for the exploration, was a “multinational, open-label observational study of patients with T2DM treated with one or more oral antidiabetic drugs” (Karnieli et al., 2013, p. 168).
- Various health indicators, like insulin dose, weight and so on have been measured and recorded.
- Eligibility criteria varied from one country to another.
- Statistical methods, such as mean and standard deviation, have been used as well.
Sample Characteristics: The group for comparison included people aged 75 and older versus patients of younger than 75 suffering from T2DM. The study provided detailed information regarding the sample in various aspects: patients’ age, country of origin, gender, ethnicity, health complications apart from T2DM, weight, antidiabetic drugs prescribed among others. Moreover, they used charts demonstrating how patients’ condition changed at pre-insulin stage and to the end of research.
Data Sources: As it has been mentioned above, the major source of data for the study was the results of SOLVE.
Data Collection Measures: Data collected have been represented through definite medical indexes reflecting the specified health condition of the examined group of patients: for example, a blood glucose measurement, body mass index, blood pressure, etc.
Data Collection Methods: Karnieli et al. (2013) claim that all necessary data for the research has been obtained from “patients’ recall, clinical notes, and self-monitored blood glucose diaries” (p. 169).
Procedures: During investigation, researchers have recorded and collected multi-aspect data about patients from ten countries; classified the information and reflected their findings in comparative tables, graphs, and charts; discussed the results obtained; emphasized limitations and findings.
Data Analysis: Data analysis has been held in accordance with the specific characteristics required to clarify if there is a connection between independent and dependent variables. Specifically, particular indicators fluctuations have been traced in terms of (a) changes in glycated hemoglobin, fasting plasma glucose and hypoglycemia; (b) changes in oral antidiabetic drug and insulin use, etc.
Statistical Tests: During analysis, such statistics methods as paired t test, the Wilcoxon as well as McNenar tests, and two-sided testing have been used.
Results/Findings/Recommendations (i.e., future studies, practice, theory): As a result, it has been concluded that insulin detemir treatment in 75-year-old diabetics and older is both effective and safe. Moreover, this aspect should be taken into account by those managing people with T2DM in order to be “preappraised for quality and used in practice” (Polit & Beck, 2012, p. 31).
Strengths: SOLVE is the largest observational study, and it provided researchers with a possibility to study the aforementioned issue for elderly populations within ten countries. What is more, the data analysis proved that the indicated treatment – once-daily insulin detemir – does not cause excess weight or hypoglycemia in the population of interest. Therefore, this series of medication is found to be of little risk in terms of the aforementioned severe complications for both 75-yer-old younger and older T2DM patients.
Weakness: As Karnieli et al. (2013) emphasize, “The lack of blinding and control groups is a potential source of confounding” (p. 174). Furthermore, there were some specific limitations, like missing data about the patients in some countries. In addition, there was no strict control regarding patients’ inclusion in the research: some diabetics may have been insulin-dependent before the study was conducted. Hence, such situations can be the cause of possible bias of this sub-analysis.
2. Miot, A., Ragot, S., Hammi, W., Saulnier, P.-J., Sosner, S., Piguel, X., . . . Hadjadj, S. (2012, October). Prognostic value of resisting heart rate or cardiovascular and renal outcomes in type 2 diabetic patients: A competing risk analysis in a prospective cohort. Diabetes Care, 35, 2069-2075.
Type of Study: Since the article is focused on analysis of numeric data, it is a quantitative research aimed at studying the diabetic complications in terms of cardiovascular system.
Location/Setting: The study is conducted within Poiters region, France, specifically the University Hospital of Poiters.
Concepts/Variables: The purpose of the scholars is to find the correlation between independent and dependent variables in order to understand “the genetic and environmental determinants of microvascular and macrovascular complications in T2DM” (Miot et al., 2012, p. 2069).
Independent Variable: The independent variable can be defined as exploration whether elevated resting heart rate (RHT) is associated with mortality and cardiovascular events (CV) in people suffering from T2DM (Miot et al., 2012, p. 2069).
Dependent Variable: In accordance with dependent variable, researchers tried to clarify if mortality of cardiovascular events is a potential risk for type 2 diabetics.
Framework or Theory (if any): None of the theoretical approaches has been indicated within the framework of the investigation.
Study Design: Scholars have defined their article as “a single-center, prospective analysis” (p. 2069). Moreover, it can be classified as a descriptive research of non-experiment design that does not involve “multiple waves of measurement” (National Service-Learning Clearinghouse, n.d.). Besides, it is part of a broader research – “the ongoing prospective monocentric SURDIAGENE study” (Miot et al., 2012, p. 2069).
Sample: The sample for the study includes type 2 diabetes mellitus patients from Poitiers, France.
Sample Size: 1,088 T2DM patients have been involved in the exploration.
Sampling Methods: The researchers applied a number of methods in order to reach their goal:
- Patients’ hospital records and clinical data collection;
- Interviews with general practitioners;
- Data analysis;
- Statistical methods.
Sample Characteristics: The age of the patients is not indicated. However, duration of the research project is 4.2 years. All these diabetics have been recruited and followed regularly at the University Hospital of Poitiers, France.
Data Sources: As it has been indicated previously, the data was collected at the University Hospital of Poitiers, France.
Data Collection Measures (quantitative): Data collected have been measured as health indicators: electrocardiogram traces, smoking status, diabetes duration, etc.
Data Collection Methods (qualitative): Information has been obtained through interviews, as well as through the hospital’s records among others.
Procedures: In order to understand if there is a correlation between increased mortality rates and cardiovascular events in T2DM patients, particular procedures have been followed:
- Data regarding patients’ condition during the duration of the project have been collected;
- Necessary examinations of the diabetics have been made and recorded;
- The statistical analysis has been held;
- The results of the investigation have been reflected in charts and tables;
- Conclusions have been made concerning the studied issue.
Data Analysis: The researchers have directed their study of data in a flow aimed at understanding certain aspects of the problem discussed:
- Baseline cohort characteristics;
- Incidence outcomes;
- RHR as a predictor of the cumulative incidence of CV end points/or renal outcome (Miot et al., 2012, pp. 2070-2071).
Statistical Tests (quantitative): The authors have applied such statistical tests as: Ewing test, Valsalva maneuver, SAS 9.2 and the R 2.13.1 software packages, cumulative evidence function of the primary outcome, and the Fine and Gray model.
Results/Findings/Recommendations (i.e., future studies, practice, theory): As Miot et al. (2012) assert, “The main finding of this study was that elevated RHR significantly interacted with history of CVD” (p. 2071). Thus, people suffering from type 2 diabetes mellitus are under potential risk of mortality caused by CVD. However, 5% of the sample representatives have died of non-CV causes.
Strengths: Miot et al. (2012) have provided a thorough research on the quite topical and acute issue, notwithstanding the article has certain shortcomings. Nevertheless, the data analyzed in the paper have confirmed the evidences and assumptions from previous longitudinal studies related to the problem.
Weakness: Neither limitations nor perspectives for future exploration of the issue have been outlined. Although the study was conducted on the regional level, the problem may be further researched in the national and international arena. Moreover, scholars could have specified non-cardiovascular death causes of T2DM patients: in this way, they could outline other possible risks for diabetics and directions for further studies.
3. Roumie, C. L., Hung, A. M., Greevy, R. A., Grijalva, C. G., Liu, X., Murff, H. J., . . . Griffin, M. R. (2012). Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: A cohort study. Annals of Internal Medicine, 157, 601-610.
Type of Study: This article is a quantitative research because it presents a multiple data embedded in a large number of cases regarding the issue, which is analyzed statistically, and findings are reflected in tabulations and graphs.
Location/Setting: The setting of the work is pointed out as “National Veterans Health Administration (VHA) databases linked to Medicare files” (Roumie et al., 2012, p. 601).
Concepts/Variables: The authors test independent and dependent variables to identify influences the drugs used may have on CVD or death.
Independent Variable (if quantitative study): The dependent variable concerns the consideration of usage of sulfonylureas in comparison with metformin as a possible risk factor of CVD or death outcomes in diabetics.
Dependent Variable (if quantitative study): This variable involves clarification regarding whether CVD or death of diabetic patients-veterans are pre-determinated by sulfonylureas- or metformin-use during the initial treatment of the disease.
Framework or Theory (if any): The theoretical approach is not indicated.
Study Design: Scholars define their research as “a retrospective cohort study” (Roumie et al., 2012, p. 601). In addition, this quantitative study is of non-experimental design: data necessary for the investigation have been taken from databases.
Sample: The sample is composed of the patients-veterans, excluding diabetics suffering from chronic kidney disease or other serious diseases.
Sample Size: 253,690 patients’ histories have been researched.
Sampling Methods: To achieve the goal set, Roumie et al. (2012) have applied a range of methods:
- Data collection through databases;
- Analysis of the information obtained;
- Statistical analysis.
Sample Characteristics: The patients, whose histories have been studied in retrospective, were veterans of 18 years old or older. Furthermore, they received “regular VHA care for at least the past 365 days” (Roumie et al., 2012, p. 602).
Data Sources: National Veterans Health Administration (VHA) databases linked to Medicare files.
Data Collection Measures (quantitative): Health indicators have been listed (medications, cholesterol, hemoglobin, etc.), as well as patients’ hospitalization and stay in the hospital, and morbidity conditions.
Data Collection Methods (qualitative): Data have been collected via database.
Procedures: The data necessary for the research have been obtained in databases and filtered; it has been classified, analyzed, and reflected in graphs and tables; limitations and findings have been listed.
Data Analysis: The information has been analyzed in various dimensions:
- Study population;
- Exposures;
- Outcomes: CVD and death;
- Covariates;
- Statistical analysis;
- Sensitivity and subgroup analyses (Romie et al., 2012, pp. 602-603).
Statistical Tests (quantitative): Such statistics methods have been applied as multiple sensitivity and subgroup analyses, propensity score-matched analysis amongst others.
Results/Findings/Recommendations (i.e., future studies, practice, theory): Scholars found evidence that sulfonylureas and metformin usage for diabetes initial treatment may cause CVD and death in patients.
Strengths: It has been proved that sulfonylureas in comparison with metformin, if used for the diabetes treatment at the initial stages, may become a cause of cardiovascular events or even death. Findings of this research proved controversial opinions (specifically, the negative impacts) concerning the issue and reflected in numerous studies on the topic dating back to the 1970s. The authors proposed to decrease the prescription of these medications and argued this position.
Weakness: The weakness of the study can be observed in that it is focused on the white men; therefore, multinational aspects of the problem have not been taken into account to make any generalized conclusions on findings. The other weakness scholars have asserted by themselves, “We included only baseline clinical variables and did not account for time-varying covariates” (Roumie et al., 2012, p. 608). Consequently, these factors may become key points for further in-depth analysis of the issue, which would ensure coverage of all angles of this complicated concern.
References
- Karnieli, E., Baeres, F. M. M., Dzida, G., Ji, Q., Lighthelm, R., Ross, S., . . . Yale, J.-F. (2013, February 1). Observational study of once-daily insulin detemir in people with type 2 diabetes aged 75 years or older: A sub-analysis of data from the Study of Once-Daily Levemir (SOLVE). Drugs Aging, 30, 167-175.
- Miot, A., Ragot, S., Hammi, W., Saulnier, P.-J., Sosner, S., Piguel, X., . . . Hadjadj, S. (2012, October). Prognostic value of resisting heart rate or cardiovascular and renal outcomes in type 2 diabetic patients: A competing risk analysis in a prospective cohort. Diabetes Care, 35, 2069-2075.
- National Service-Learning Clearinghouse. (n.d.). Service-learning research primer: Designing service-learning research. Retrieved from http://www.servicelearning.org/service-learning-research-primer
- Polit, D.F., & Beck, C.T. (2012). Nursing research: Generating and assessing evidence for nursing practice. (9th ed.). Philadelphia, PA: Lippincott Williams & Wilkins. ISBN: 978-1-60547-708-4.
- Roumie, C. L., Hung, A. M., Greevy, R. A., Grijalva, C. G., Liu, X., Murff, H. J., . . . Griffin, M. R. (2012). Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: A cohort study. Annals of Internal Medicine, 157, 601-610.
