Analyzing Age in Clinical Trials: NSAIDs & Osteoarthritis (OA)

This assignment focuses on analyzing the age of participants in randomized clinical trials (RCTs) evaluating non-steroidal anti-inflammatory drugs (NSAIDs) for osteoarthritis (OA). It begins by estimating the prevalence of hip osteoarthritis from 2000 to 2009 using US census data and prevalence percentages by age group. The analysis includes creating a graph to visualize the age-specific prevalence of osteoarthritis. The assignment then discusses the importance of including patients with a higher risk of complications (older individuals) in RCTs to avoid bias. Further analysis involves examining data from trials conducted between 1985 and 2008, focusing on trial study size and participant mean age, and categorizing RCTs by their focus (efficacy, safety) across different time periods. The assignment also calculates the mean number of participants and mean age of patients across different time periods and discusses the trend of increased participant involvement over time. Finally, the assignment involves creating a graph to visualize the mean age in relation to RCT results.

Question 1
Using the estimated percentages of prevalence per age group, we come up with the number of
prevalence. The values obtained are recorded in table 1.
Age
Prevalence estimates from 2001 to 2009
2001 2002 2003 2004 2005 2006 2007 2008 2009
.35 to 39 years 430366
42248
2
40401
9
39661
8
39517
4
39788
3
39831
4
39553
2
38964
8
.40 to 44 years 472878
47913
3
48069
1
48143
8
47684
5
46835
4
45847
9
44887
5
44058
0
.45 to 49 years 626805
64166
8
67340
3
68402
3
69493
2
70417
4
70679
3
70745
0
70873
0
.50 to 54 years 551163
57930
6
59201
6
60650
5
62244
1
63769
7
65534
6
67082
4
68215
0
.55 to 59 years 447676
46097
6
52188
0
54803
7
57760
6
60709
6
60900
7
62088
1
63626
0
.60 to 64 years 358483
36749
9
40241
5
41903
8
43356
3
44659
7
48423
1
50630
2
53212
5
.65 to 69 years 476195
47811
2
49154
0
50367
1
51393
1
52766
0
54851
2
57971
7
60461
9
.70 to 74 years 443001
44109
7
43350
6
42970
5
43015
4
43249
1
43642
5
44556
7
45703
6
.75 to 79 years 357054
35786
0
35989
6
35814
7
35825
3
35745
8
35521
7
35259
6
35016
3
.80 to 84 years 239258
24663
4
25913
3
26536
8
26933
7
27111
0
27298
0
27505
7
27493
0
85 and over 204599
20700
0
21437
6
21820
2
22527
8
23356
5
24189
8
24940
0
25763
0
Table 1: Data of osteoarthritis prevalence
This data produces the graph below;

.35 to
39 .40 to
44 .45 to
49 .50 to
54 .55 to
59 .60 to
64 .65 to
69 .70 to
74 .75 to
79 .80 to
84 85
and
over
0
100000
200000
300000
400000
500000
600000
700000
800000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Years
Estimated number of prevalences
Figure 1: Age-specific prevalence of osteoarthritis in 2001-2009
From the graph, we see a sharp increase in prevalence for people with 35 to 49 years. The
number steadily decreases between 50 to 60 years. There was a sharp decrease in the estimated
number of prevalence for people aged 65 years and above. With comparison with the number of
people in different age groups, people aged 60 years recorded the highest percentage.
Question 2
RCT should use patients with the higher risk of the complication. This means that many of the
patients who will undergo the process will be those with 60 years and above. In order to remove
biasness and allow direct comparison, a real representation of how the medication will react with
the wider population in terms of age differences after distribution will be adopted (Turner, 2012).
Question 3
From the data provided for trials conducted between 1985 and 2008, the following graph was
obtained.

1985
1993
1995
1996
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2005
2006
2007
0
2000
4000
6000
8000
10000
12000
14000
16000
18000
20000
0
10
20
30
40
50
60
70
80
Trial_Study_size
Participants_Mean_age
Year
Trial study size
Participants mean age
Question 4
1985-1992: RCTs done between 1985 to 1992 was focused on investigating efficacy and safety
of the medication.
1993-2000: RCTs done between 1993 and 2000 was aimed at efficacy and safety of the
medication.
2001 – 2008: RCTs done between 2001 to 2005 was focused on the efficacy and safety of the
medication.
2006 trials were done to determine efficacy of the medication.
Trials conducted in 2007 and 2008 were investigating the safety of the medication.
Combined line and bar graph were the best for this type of data because of the different type of
information recorded and their wide range (Mastenbroek, 2011).
Question 5

Mean=∑ x
n
See excel file for the calculations.
Mean number of participants ,1985−1992=873 people
Mean number of participants ,1993 ¿ 2000=1203 people
Mean number of participants ,2001 ¿ 2008=2076 people
overall average=1585 people
A histogram was the best graph for the evolution of number of participants. It clearly
demonstrated the increase and decrease of participants between successive years (Yalman,
2014).
Question 6
i)
Mean age of patients , 1985−1992=62.7 years
Mean age of patients , 1993−2000=63.3 years
Mean age of patients , 2001−2008=61.8 years
ii) Mean age of patient
the entire period=62.6 years
Question 7
The trend showed that more people were involved in the trials as year’s progress. This showed
an increased involvement during evolution. The response was in line with the expected
outcomes.
The mean age of participants conforms with the highest percentage of prevalence. The age group
with high risk of prevalence were highly involved in the trials (Guan, 2016).
Question 8
The data and graph are shown in the attached excel file.
The graph obtained is shown below;

1985
1987
1989
1991
1993
1995
1997
1999
2001
2003
2005
2007
0.00
10.00
20.00
30.00
40.00
50.00
60.00
70.00
80.00
Mean age
RCTs results
Year
Mean age

References
Guan, Y., Shi, H., Chen, Y., Liu, S., Li, W., Jiang, Z., Wang, H., He, J., Zhou, Z. and Ge, Y.,
2016. Whole-lesion histogram analysis of apparent diffusion coefficient for the assessment of
cervical cancer. Journal of computer assisted tomography, 40(2), pp.212-217.
Mastenbroek, S., Twisk, M., van der Veen, F. and Repping, S., 2011. Preimplantation genetic
screening: a systematic review and meta-analysis of RCTs. Human reproduction update, 17(4),
pp.454-466.
Turner, L., Shamseer, L., Altman, D.G., Weeks, L., Peters, J., Kober, T., Dias, S., Schulz, K.F.,
Plint, A.C. and Moher, D., 2012. Consolidated standards of reporting trials (CONSORT) and the
completeness of reporting of randomised controlled trials (RCTs) published in medical journals.
Cochrane Database of Systematic Reviews, (11), pp. 7-14.
Yalman, Y., 2014. Histogram based perceptual quality assessment method for color images.
Computer Standards & Interfaces, 36(6), pp.899-908.