Dr. Penelope Nicholls is interested in exploring a possible connection between high plasma homocysteine (a toxic amino acid created by the body as it metabolizes protein) levels and cardiac hypertrophy (enlargement of the heart) in humans. Because there are many complex relationships among human characteristics, it will be difficult to answer her research question due to a significant risk that confounding factors will cloud her inferences. She wants to be sure that any differences in cardiac hypertrophy are due to high plasma homocysteine levels and not to other factors. Consequently, she needs to design her experiment carefully so that she controls lurking variables to the extent possible. Therefore, she decides to design a two-sample experiment with independent sampling: one group will be the experimental group, the other a control group. Knowing that many factors can affect the degree of cardiac hypertrophy (the response variable), Dr. Nicholls controls these factors by randomly assigning the experimental units to the experimental or control group. She hopes the randomization will result in both groups having similar characteristics.

In her preliminary literature review, Dr. Nicholls uncovered an article in which the authors hypothesized that there might be a relationship between high plasma homocysteine levels in patients with end-stage renal disease (ESRD) and cardiac hypertrophy. She has asked you, as her assistant, to review this article.

Upon reading the article, you discover that the authors used a nonrandom process to select a control group and an ESRD group. The researchers enlisted 75 stable ESRD patients into their study, all on hemodialysis for between 6 and 312 months. The control group subjects were chosen so as to eliminate any intergroup differences in terms of mean blood pressure (BP) and gender. In an effort to minimize situational contaminants, all physical and biochemical measurements were made after an overnight fast. The results for the control and ESRD groups are reproduced in the following tables:

1. Which type of sampling method, independent or dependent, was used in this experiment? Explain.
2. Using the appropriate hypothesis-testing procedure, determine whether the control and ESRD groups have equivalent population means for each of the various clinical and biochemical parameters. Dr. Nicholls requires that you indicate those parameters that have \(P\)-values less than 0.05 and those less than 0.01 .
3. Detail any assumptions and the rationale behind making them that you made while carrying out your analysis. Is there any additional information that you would like to have? Explain. Are there any additional statistical procedures that you think might be useful for analyzing these data? Explain.
4. Based on your findings, does it appear that the control and ESRD groups have similar initial clinical characteristics and biochemical findings? Does it appear that the authors of this article were successful in reducing the likelihood that a confounding effect would obscure their results?
5. Even though Dr. Nicholls does not wish to restrict her research to patients with end-stage renal disease, how might the information presented for this research assist her in designing her own experiment?
6. Submit a written report to Dr. Nicholls that outlines all your findings and recommendations.

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Clinical Characteristics (Mean Standard Deviation) Parameters Controls (n = 57) ESRD Subjects (n = 75) Parameters Biological Findings (Mean Standard Deviation) ESRD Subjects (n = 75) Controls (n = 57) Age (years) Sex (M/F ratio) Body surface area (m) Body mass index (kg/m) Systolic BP (mmHg) Diastolic BP (mmHg) 49.2 14.7 1.40.50 1.85 + 0.25 26.04.70 57.3 15.1 Total cholesterol (mmol/L) 5.28 1.04 4.91 1.06 1.4 0.50 HDL cholesterol (mmol/L) 1.38 0.39 1.07 0.38 1.67 0.20 Mean BP (mmHg) Pulse pressure (mmHg) Heart rate (beats/min) 145.0 15.5 85.0 14.8 104.5 14.2 59.4 15.5 63.08.0 23.7 3.90 148.8 29.7 Triglycerides (mmol/L) Serum albumin (g/L) Plasma fibrinogen (g/L) 1.39 0.63 1.90 1.02 44.7 2.60 39.9 3.00 3.21 0.78 4.75 1.04 80.2 14.3 Plasma creatinine (mmol/L) 0.10 0.01 0.90 0.13 103.6 17.4 68.6 24.3 Blood urea (mmol/L) 6.10 1.20 24.3 2.00 Calcium (mmol/L) 2.46 0.08 2.45 0.12 70.0 9.0 Phosphates (mmol/L) 1.03 0.21 1.88 0.38