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Testing Of Hypothesis

Q1. Describe desirable properties of the odds ratio A1.The odds ratio is easy to estimate for a 2x2 table. One of best properties of the odds ratio is that we can use it to estimate the population odds ratio using data from cross-sectional, cohort or case-control studies. That is not the case with other estimators, like the risk ratio. Thus from this perspective (and also again after learning about logistic regression) we can answer a prospective question (estimating population odds ratio) even using retrospective data with the odds ratio.

Q2. Open the q2.sas7bdat dataset in SAS Enterprise and answer the following questions Here in the q2 dataset, agegrp represents 3 age groups you have already slyly created in SAS. Trt is the treatment group variable (Trt=treatment, zControl=control). Died = Y for passed away at 1 year into this study and = zN for alive at 1 year. Count = frequency counts of the particular age group, treatment group and mortality combinations. 2a. What is the overall 1 year mortality rate of thse in the treatment group What is the overall 1 year mortality rate of those in the control group

A 2a.We can get the group mortality rates in Enterprise by going to Describe->Table Analysis using count as the Frequency count, and trt, died as Table variables: Which gives:

Frequency Percent Row Pct Col Pct

Table of trt by died trt Y Trt 612 26.10 64.35 34.44 1165 49.68 83.57 65.56 1777 75.78 died zN 339 14.46 35.65 59.68 229 9.77 16.43 40.32 568 24.22 951 40.55 Total

zControl

1394 59.45

Total

2345 100.00

The mortality rates are given by the Row %s in the y column for died:

Treatment group: Control group:

612 0.6435 64% 951

1165 0.8357 84% 1394

Thus the treatment group had about a 20% lower mortality rate.

2b. What is the relative risk (risk ratio) of death for treatment vs. control Estimate the 95% confidence interval around this estimate .Interpret the estimate of relative risk A 2b. We can get this in Enterprise by re-running the same 2x2 table but checking the Relative risk for 2x2 tables option under Measures of Association in the Table Statistics-> Association menu to get an appropriate risk ratio and confidence interval

Doing so gives:

Frequency Row Pct Trt

Table of trt by died died Y Trt 612 64.35 1165 83.57 1777 zN 339 35.65 229 16.43 568 951 Total

zControl

1394

Total

2345

Statistics for Table of trt by died Estimates of the Relative Risk (Row1/Row2) Type of Study Case-Control (Odds Ratio) Cohort (Col1 Risk) Cohort (Col2 Risk) Value 0.3549 0.7700 2.1699 95% Confidence Limits 0.2923 0.7305 1.8752 0.4309 0.8117 2.5110

Sample Size = 2345

Thus the RR = 0.7700 with a 95% CI = (0.7305, 0.8117). Thus the risk of death was reduced by 23% in the treatment group compared to control. 2c. Estimate the overall odds ratio with a 95% confidence interval. Interpret the odds ratio (is there evidence of treatment effect? A 2c.The odds ratio was given in the last output and was OR=0.3549 (95% CI = [0.2923, 0.4309]). Thus, the odds of death was reduced by about 65% in the treatment group compared to control.

2d. Give the age group specific odds ratios for treatment vs. control along with their 95% confidence intervals. Which age groups possibly show a more beneficial treatment effect? A 2d.We can run separate 2x2 tables for each age group and estimate their ORs and 95% CIs by going to a Table Analysis again but now using agegrp as a variable for Group analysis by. Doing so gives the following relevant output: agegrp=18-30 Frequency Row Pct trt Y Trt 153 64.56 378 79.75 531 Table of trt by died died zN 84 35.44 96 20.25 180 237 Total

zControl

474

Total

711

Statistics for Table of trt by died Estimates of the Relative Risk (Row1/Row2) Type of Study Case-Control (Odds Ratio) Cohort (Col1 Risk) Cohort (Col2 Risk) Value 0.4626 0.8095 1.7500 95% Confidence Limits 0.3267 0.7291 1.3658 0.6550 0.8989 2.2422

Sample Size = 71

agegrp=31-45 Frequency Row Pct trt Y Trt 207 63.69 386 83.91 593 Table of trt by died died zN 118 36.31 74 16.09 192 325 Total

zControl

460

Total

785

Statistics for Table of trt by died

Estimates of the Relative Risk (Row1/Row2) Type of Study Case-Control (Odds Ratio) Cohort (Col1 Risk) Cohort (Col2 Risk) Sample Size = 785 agegrp=46-70 Frequency Row Pct trt Y Trt 252 64.78 401 87.17 653 Table of trt by died died zN 137 35.22 59 12.83 196 389 Total Value 0.3363 0.7590 2.2570 95% Confidence Limits 0.2403 0.6928 1.7515 0.4707 0.8316 2.9084

zControl

460

Total

849

Statistics for Table of trt by died Estimates of the Relative Risk (Row1/Row2) Type of Study Case-Control (Odds Ratio) Cohort (Col1 Risk) Cohort (Col2 Risk) Sample Size = 849 Value 0.2706 0.7431 2.7458 95% Confidence Limits 0.1920 0.6852 2.0883 0.3816 0.8060 3.6104

Thus, Age = 18-30: OR=0.4626, 95% CI = (0.3267, 0.6550) Age = 31-45: OR=0.3363, 95% CI = (0.2403, 0.4707) Age = 46-70: OR=0.2706, 95% CI = (0.1920, 0.3816)

It appears that older age groups show a slightly more beneficial treatment effect. 2e. Conduct a stratified analysis of treatment and mortality, stratifying by age groups (12 points). Determine the appropriate statistics to report, with justification (3 points). Does it appear that controlling for age group matters? (2 points) Does the direction of the effect change by age group? (1 point) Is there a treatment effect on 1 year mortality? (1 point) We can conduct a stratified analysis on the 2x2x2 table formed by age group x treatment x death using the CMH approach. We first check the directions and magnitudes of the OR Crude , OR Age=18-30 , OR Age=31-45 , OR Age=46-70 and OR MH . We also conduct a formal test of the homogeneity of the age-group specific ORs using a Breslow-Day test.

We already computed

OR Crude , OR Age=18-30 , OR Age=31-45 , OR Age=46-70 in parts 2c) and 2d).

We can compute the CMH test, ORMH and the Breslow Day test in Enterprise by adding agegrp rd as a 3 and last variable into the Table Analysis as a Table variable under Task roles and then as rd the 3 variable in Tables. Then, we can get the CMH analysis by choosing CMH statistics under Table Statistics->Association menu. Doing so gives the following output: Summary Statistics for trt by died Controlling for agegrp Cochran-Mantel-Haenszel Statistics (Based on Table Scores) Statistic 1 2 3 Alternative Hypothesis Nonzero Correlation Row Mean Scores Differ General Association DF 1 1 1 Value 117.2836 117.2836 117.2836 Prob <.0001 <.0001 <.0001

Estimates of the Common Relative Risk (Row1/Row2) Type of Study Case-Control (Odds Ratio) Cohort (Col1 Risk) Cohort (Col2 Risk) Method Mantel-Haenszel Logit Mantel-Haenszel Logit Mantel-Haenszel Logit Value 0.3446 0.3469 0.7664 0.7646 2.2234 2.1821 95% Confidence Limits 0.2831 0.2847 0.7271 0.7255 1.9157 1.8804 0.4194 0.4227 0.8078 0.8059 2.5805 2.5321

Breslow-Day Test for Homogeneity of the Odds Ratios Chi-Square 4.6855

Breslow-Day Test for Homogeneity of the Odds Ratios DF Pr > ChiSq Total Sample Size = 2345 2 0.0961

Which can be summarized by:

OR Crude 0.3549 OR Age=18-30 0.4626 OR Age=31-45 0.3363 OR Age=46-70 0.2706 OR MH 0.3446


and that the Breslow-Day test p-value = 0.0961. Here, the age-group specific odds ratios do appear to be somewhat different (>10% change) from the crude OR. Thus age group could be a potential confounder or effect modifier of treatment group and mortality. Since the Breslow-Day test was not significant we could report the ORMH=0.34, which adjusts for age group, and where the CMH Chi-square test statistic = 117.2836 with p-value<0.0001. Here, the p-value of this test implies there is a significant association of treatment group and mortality, after adjusting for age group. However the age-group specific odds ratios appear to be different from each other such that age group could be considered an effect modifier. Thus if in addition our substantive considerations dictate that these ORs are meaningfully different from one another we should report the three separate odds ratios for each age group and their associated Chi-square tests. All three individual Chi-square tests were significant with p-value < 0.0001 (output not shown), indicating a significant association of treatment group and mortality within the given age group. Concluding either of these with justified reasoning was acceptable.

Q3. In a study of the effective of a drug for curing high blood pressure, five hospitals were selected as study sites. A total of 600 patients were recruited and each was randomly assigned to either the treatment or the control group. The outcome is dichotomized as reduction in blood pressure or no reduction of blood pressure. The researcher decided to perform an outcome by treatment by site analysis. In the 2x2x5 CMH analysis, it is reported that the Breslow-Day test gave a p-value of 0.076 for hospital, and the CMH Chisquare test gave a p-value <0.0001. What does that mean in plain language? A3.This means that barring no flipping of the direction of the site-specific ORs that there was not evidence against homogeneity of the ORs (Breslow-Day p=0.076). Thus, in an analysis adjusting for site there was a significant association of treatment and outcome (CMH Chi-square p<0.0001) in the study of 600 patients in 5 sites. Without seeing the odds ratios is hard to comment further on the direction of this effect for treatment vs. control.

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