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13

MATRIX

Matrix Document

Matrix

APA Citation:

Lassen, M. R., Gallus, A., Raskob, G. E., Pineo, G., Chen, D., & Ramirez, L. M. (2010). Apixaban versus Enoxaparin for Thromboprophylaxis after Hip Replacement. New England Journal of Medicine, 363(26), 24872498. https://doi.org/10.1056/NEJMoa1006885

Variable and key concepts

The study sought to compare the effectiveness of apixaban and enoxaparian as treatments for thromboprophylaxis following hip replacement. The hypothesis was not clearly stated, but from the background information provided, it is implicit that the researchers hypothesized that apixaban is more effective for treating venous thromboembolism (VTE) after hip replacement surgery.

Sampling

5,407 patients scheduled for hip replacement were recruited from 160 healthcare facilities in 21 countries to participate in the study. This is without a doubt a sufficient sample size. Potential subjects were singled out during a screening exercise conducted 14 days prior to scheduled surgery. Out of the 5,407 patients initially recruited, only 72% were included in the final analysis.

Design and Method

The research was designed as a double-blind randomized controlled study. An experimental design was appropriate given that the study aimed to compare the effectiveness of apixaban and enoxaparian in treating VTE after hip replacement.

Instruments/Data Collection

Data was collected following the administration of the interventions. Following surgery, subjects were assessed for symptoms of VTE, pulmonary embolism, deep vein thrombosis, bleeding, wound infections, and VTE-related death. The data was collected using a survey, which was appropriate given the objective of the study.

Results

As expected, apixaban was found to be more effective in treating VTE after hip replacement compared to enoxaparin. Also, apixaban was associated with reduced bleeding.

Strengths & Limitations

Strengths:

A sufficiently large sample was used

A low dropout rate (28%)

There were significant statistical differences between the two groups

Limitations:

No notable limitations

Critique

Overall, the study is a valuable contribution to the literature on effective regimens for thromboprophylaxis following hip replacement surgery. The researchers have clearly explained the research, making it easy for the reader to understand. The study would be a useful addition to the literature review.

APA Citation:

Lassen, M. R., Raskob, G. E., Gallus, A., Pineo, G., Chen, D., & Hornick, P. (2010). Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomized, double-blind trial. The Lancet, 375(9717), 807815. https://doi.org/10.1016/S0140-6736(09)62125-5

Variable and key concepts

This study also sought to investigate the efficacy and safety of apixaban versus enoxaparin, albeit for knee replacement surgery as opposed to hip replacement surgery. The hypothesis is not clearly stated, but it is implicit that the researchers hypothesized that apixaban is more effective and safer for thromboprophylaxis following knee replacement surgery.

Sampling

3,057 patients scheduled for knee replacement surgery were recruited from multiple healthcare centers to take part in the study: 1,528 patients in the apixaban group and 1,529 in the enoxaparin group. This is a fairly representative sample. Potential subjects were singled out during a screening exercise conducted 14 days prior to the scheduled surgery. Out of the 3,057 patients initially recruited, 1,973 were suitable for efficacy analysis, translating to a 35.5% dropout rate.

Design and Method

The study was a double-blind, randomized controlled trial (RCT). Given that the research aimed to compare the efficacy of apixaban and enoxaparin, an RCT design was appropriate.

Instruments/Data Collection

The primary outcomes were symptoms of deep vein thrombosis, pulmonary embolism, and mortality in the course of treatment. These outcomes were sufficient as they are the major events likely to occur after knee replacement surgery. A survey was used to collect data relating to these outcomes.

Results

15% of patients in the apixaban group depicted the primary outcomes compared to 24% in the enoxaparin group. Also, non-major bleeding was reported in 4% of the patients in the apixaban group and 5% in the enoxaparin group. Hence, as expected, apixaban turned out...…statistical differences

Limitations:

Variables such as VTE-related mortality were not measured.

Only two RCTs were included

Critique

Overall, the study would be a useful item for the literature review. The research is well organized and easily understandable.

APA Citation:

Yan, X., Gu, X., Zhou, L., Lin, H., & Wu, B. (2016). Cost Effectiveness of Apixaban and Enoxaparin for the Prevention of Venous Thromboembolism After Total Knee Replacement in China. Clinical Drug Investigation, 36(12), 10011010. https://doi.org/10.1007/s40261-016-0444-5

Variable and key concepts

Dissimilar to other studies in this matrix, this study sought to establish not only the benefits, but also the cost effectiveness of apixaban and enopaxarin as thrombophylaxis regimens for knee replacement. The objective of the study was clearly stated, but the hypothesis was implied.

Sampling

The study was conducted within the context of China. The researchers focused on Chinese patients who had undergone total knee replacement surgery.

Design and Method

Based on Markov model, the researchers developed a decision model to evaluate the economic costs associated with VTE treatment after knee replacement. Also, the researchers performed sensitivity analyses to test uncertainty in the arameters of the model. This design was appropriate as the study aimed to measure economic costs as opposed to clinical outcomes.

Instruments/Data Collection

Over a five year period, the researchers measured direct medical costs and quality adjusted life years associated with apixaban and enopaxarin.

Results

The researchers found that apixaban was associated with higher health benefits and higher costs compared to enopaxarin. In other words, enopaxarin was found to be more cost effective than apixaban as a regimen after knee replacement. This was quite unexpected.

Strengths & Limitations

Strengths:

Significant statistical differences between the two groups were found

Limitations:

Focused on economic costs as opposed to clinical efficacy.

Critique

Overall, though the study focuses on economic costs as opposed to clinical safety, it would be useful for the literature review. This is particularly because cost is an important variable for both patients…