Question
Outcome Control event rate (X) Experimental event rate (Y) Relative risk (Y/X) Relative risk reduction 1 - (RR) Absolute risk reduction (X-Y) Number need to
Outcome | Control event rate (X) | Experimental event rate (Y) | Relative risk (Y/X) | Relative risk reduction 1 - (RR) | Absolute risk reduction (X-Y) | Number need to treat (1/ARR) |
List your outcome of interest here | ||||||
- Describe the overall results over the study.Use the data from the table above to assist in your description of the results (i.e. use RRR and NNT)
How to explain CER,EVR ,RSR,ARR,ANT. in the data im very confused.
how do i find the data to calculate the data above with the formula provided in the table below, please show me the real calculation thankyou for it,
INFORMATION NEEDED :
This study was initiated on November 25, 2014 and the last follow-up occurred on December 2, 2018. Of the 292 participants randomized, 264 entered into the trial. Table 1 provides baseline demographic information and tobacco use history of trial-entered participants across groups. Over half of the participants were White (53.4%), with 49.2% female and a median age of 47.0 (range 19-74) years. The median number of CPD was 15 (range 5-40), the median FTND score was 3.0 (range 0-8), and the median TNE concentration was 62.7 nmol/mg creatinine (range 5.4-236.6). There was a significant difference in dropout rates across groups following study entry (p = .041), with the highest dropout rates observed in the complete substitution groups, particularly in the NRT group (see Supplementary Figure 1). Supplementary Figure 1 shows reasons for dropping out after entry into the clinical trial.
Table 2.
Extent of Reduction in Cigarettes and Biomarker Levels by Week with Baseline as a Reference Point
Visit | AD-E | CS-E | CS-NRT | UB | ||||
---|---|---|---|---|---|---|---|---|
Cigarettes/day (n, estimated ratio, 95% CI) | ||||||||
Baseline | n=76 | 1.00 | n=76 | 1.00 | n=76 | 1.00 | n=36 | 1.00 |
1 | n=70 | 0.81 (0.75, 0.87)** | n=65 | 0.30 (0.25, 0.38)** | n=69 | 0.45 (0.37, 0.55)** | n=35 | 0.94 (0.89, 0.99)+ |
2 | n=71 | 0.80 (0.73, 0.88)** | n=64 | 0.23 (0.16, 0.32)** | n=62 | 0.35 (0.26, 0.46)** | n=33 | 0.94 (0.89, 0.99)+ |
4 | n=69 | 0.76 (0.69, 0.84)** | n=61 | 0.25 (0.17, 0.36)** | n=60 | 0.35 (0.25, 0.48)** | n=33 | 0.96 (0.90, 1.04) |
6 | n=65 | 0.78 (0.70, 0.85)** | n=60 | 0.21 (0.14, 0.33)** | n=54 | 0.28 (0.20, 0.38)** | n=33 | 0.92 (0.84, 1.00) |
8 | n=65 | 0.73 (0.65, 0.82)** | n=58 | 0.25 (0.17, 0.37)** | n=53 | 0.29 (0.21, 0.39)** | n=32 | 0.93 (0.84, 1.02) |
Demographics and Smoking History Overall and by Study Groups
Variable | All arms (N=264) | AD-E (N=76) | CS-E (N=76) | CS-NRT (N=76) | Usual brand (N=36) | p + |
---|---|---|---|---|---|---|
Study site, (n, %) | ||||||
UMN | 126 (47.7) | 36 (47.4) | 37 (48.7) | 36 (47.4) | 17 (47.2) | .947 |
OSU/APP | 102 (38.6) | 31 (40.8) | 30 (39.5) | 29 (38.2) | 12 (33.3) | |
Roswell | 36 (13.6) | 9 (11.8) | 9 (11.8) | 11 (14.5) | 7 (19.4) | |
Age, median [min/max] | 47.0 [19/74] | 48.0 [19/68] | 45.0 [20/71] | 50.5 [21/74] | 46.5 [21/64] | .626 |
Sex, female (n, %) | 130 (49.2) | 38 (50.0) | 36 (47.4) | 39 (51.3) | 17 (47.2) | .957 |
Race, three-category (n, %) | ||||||
White | 141 (53.4) | 38 (60.0) | 48 (63.2) | 37 (48.7) | 18 (50.0) | .363++ |
Black | 100 (37.9) | 28 (36.8) | 24 (31.6) | 31 (40.8) | 17 (47.2) | |
Other | 23 (8.7) | 10 (13.2) | 4 (5.3) | 8 (10.5) | 1 (2.8) | |
Education (n, %) | ||||||
Eighth grade or less | 1 (0.4) | 1 (1.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
Some high school | 24 (9.1) | 7 (9.2) | 7 (9.2) | 7 (9.2) | 3 (8.3) | |
High school | 85 (32.2) | 27 (35.5) | 22 (29.0) | 27 (35.5) | 9 (25.0) | |
Some college | 126 (47.7) | 32 (42.1) | 40 (52.6) | 35 (46.1) | 19 (52.8) | |
College grad | 21 (8.0) | 6 (7.9) | 5 (6.6) | 6 (7.9) | 4 (11.1) | |
Grad./Prof. degree | 7 (2.7) | 3 (4.0) | 2 (2.6) | 1 (1.3) | 1 (2.8) | |
Education, two-category (N, %) | ||||||
High school grade or less | 110 (41.7) | 35 (46.1) | 29 (38.2) | 34 (44.7) | 12 (33.3) | .511 |
Some college or more | 154 (58.3) | 41 (54.0) | 47 (61.8) | 42 (55.3) | 24 (66.7) | |
Income (n, %) | ||||||
Less than $30 000 | 180 (68.2) | 53 (69.7) | 48 (63.2) | 53 (69.7) | 26 (72.2) | .723 |
More than $30 000 | 84 (31.8) | 23 (30.3) | 28 (36.8) | 23 (30.3) | 10 (27.8) | |
Current employment | ||||||
Full/part-time (n, %) | 90 (34.1) | 28 (36.8) | 28 (36.8) | 23 (30.3) | 11 (30.6) | .751 |
Cigarettes per day (CPD)* Median [min/max] | 15.0 [5/40] | 13.0 [5/40] | 16.5 6/35] | 15.0 [5/40] | 14.5 [7/25] | .266 |
Baseline TNE nmol/mg creatinine Median [min/max] | 62.7 [5.4/236.6] | 59.6 [8.9/126.5] | 62.5 [6.6/182.5] | 78.0 [9.9/236.6] | 60.1 [5.4/148.1] | .071 |
Usual brand cigarette type** | ||||||
Menthol | 148 (56.3) | 43 (56.6) | 38 (50.0) | 44 (58.7) | 23 (63.9) | .524 |
Tobacco | 115 (43.7) | 33 (43.4) | 38 (50.0) | 31 (41.3) | 13 (36.1) | |
FTND total score Median [min/max] | 3.0 [0/8] | 3.0 [0/7] | 4.0 [1/8] | 3.0 [0/7] | 3.0 [1/7] | .118 |
CES-D (depression) Median [min/max] | 6.0 [0/31] | 7.0 [0/29] | 6.5 [0/31] | 6.0 [0/25] | 7.0 [0/20] | .729 |
Study dropouts | 56/264 (21.2) | 11/76 (14.5) | 18/76 (23.7) | 23/76 (30.3) | 4/36 (11.1) | .041 |
Open in a separate window
AD-E = ad libitum e-cigarette; CS-E = complete substitution e-cigarette; CS-NRT = complete substitution nicotine replacement therapies; UMN = University of Minnesota; OSU/APP = The Ohio State Universality/Appalachia; TNE = total nicotine equivalents; FTND = Fagerstrm Test for Nicotine Dependence; CES-D = Center for Epidemiological StudiesDepression.
+The p-values were derived from the chi-square test or the Kruskal-Wallis test.
++This p-value compares Whites and Blacks only.
*CPD from the Tobacco History Questionnaire.
**One person in CS-NRT said "no usual type."
Cigarettes per Day
Average self-reported CPD by groups and by weeks is shown in Figure 1. Significant group (p<.001), week (changes over time; p<.001), and group by week interaction (p<.001) effects were observed using an unadjusted model. Because of the significant interaction effect, the four groups were analyzed separately for trends over study visits using the adjusted model and baseline as the reference point (see Table 2). For the AD-E, CS-E, and CS-NRT groups, significant reductions in CPD was observed for each intervention week (ps < .001). For the UB group, slight but significant reductions were observed for CPD only at week 1 (p = .013) and week 2 (p = .03).
Significant differences were observed across the four groups when examining median changes in CPD at weeks 4 and 8 minus baseline (ps < .001; see Supplementary Table 3). Pairwise comparisons for the three planned comparisons showed significantly greater CPD reductions at both weeks for CS-E versus AD-E (ps < .001, respectively) and AD-E versus UB (ps < .001, respectively) but no differences between CS-E versus CS-NRT (p = .122 at week 4, p = .185 at week 8).
E-Cigarettes and NRT
The flavor choices for e-cigarettes (n, %) were the following: AD-Etobacco (13, 17.3%), menthol (22, 29.3%), mint (18, 24.0%), berry (21, 28.0%), other (1, 1.3%, own brand) and for CS-Etobacco (16, 21.1%), menthol (18, 23.7%), mint (16, 21.1%), and berry (26, 34.2%). Average estimated puffs per day between AD-E and CS-E are shown in Figure 1. Significantly lower levels of e-cigarette use were reported in the AD-E group for each intervention week compared to the CS-E group (ps < .001). For the entire study period, AD-E demonstrated fewer number of puffs per day compared to the CS-E group (ratio = 0.42, 95% CI 0.27 to 0.66, p < .001). The median (range) number of nicotine gum or lozenge used varied from a minimum of 3.9 (0-44) to a maximum of 4.4 (0-21) for all visits.
Smoke-Free Days
Significant overall difference (p < .001) was found for the median (range) percent of smoke-free days: AD-E (0% [0-96]), CS-E (59.6% [0-100]), CS-NRT (24.3% [0-100]), UB (0% [0-68]), but only AD-E versus CS-E reached significance (p < .001). A total of 193 visits had self-reported smoke-free days since the previous visit with 7 in AD-E, 104 in CS-E, 80 in NRT, and 2 in UB; in 163 out of the 193 visits (84.5%), abstinence was verified based on CO of not more than 6 ppm. Significantly more participants experienced CO-verified end-of-treatment 7-day point prevalence abstinence in the CS-E (25/76, 32.9%) versus CS-NRT (13/76, 17.1%, p = .039).
Biomarkers of Exposure
Pairwise Comparisons Between Groups for Changes From Baseline
Significant differences in the magnitude of the change in biomarker levels from baseline were observed for some of the biomarkers at weeks 4 and 8, predominantly between AD-E versus CS-E (Supplementary Table 3). At week 4, GMRs (week 4/baseline) of CO (p<.001), total NNAL (p<.001), PheT (p=.007), CEMA (p<.001), 3-HPMA (p<.001), and HMPMA (p<.001) were significantly lower for CS-E versus AD-E. Significant median differences were observed at week 4 for CS-NRT versus CS-E for TNE, with an increase in TNE in the CS-NRT group (p=.005; perhaps due to higher smoking rates in CS-NRT); no differences in GMRs were observed between CS-E versus CS-NRT for all other biomarkers (p>.017) except HMPMA for which CS-E had lower GMR than CS-NRT (p<.003). No significant week 4 differences were observed for AD-E versus UB.
At week 8, GMRs (week 8/baseline) for CO (p<.001), PheT (p=.008), CEMA (p=.001), and HMPMA (p=.006) were significantly lower for CS-E versus AD-E. No significant differences in GMRs were observed between CS-E versus CS-NRT and AD-E versus UB for any of the biomarkers at week 8.
Adverse Events
The most frequent adverse events (occurred in three or more people) that were considered definitely related, possibly related, or unknown relationship to e-cigarettes were cough (n=15), headache, non-migraine (n=8), sore/itchy burning throat (n=8), nausea (n=5), and dizziness/lightheadedness (n=3). For NRT, the adverse events included nausea (n=11), vomiting (n=3), diarrhea (n=3), sore/itchy/burning throat (n=3), indigestion (n=3), and dizziness/lightheadedness (n=3).
Selection of Products by UB Group
Following completion of the 8-week trial, 11/32 completers in the UB group chose to use e-cigarettes and 2 to use NRT for the following 8 weeks. None achieved 7-day point prevalence abstinence at the end of the 8 weeks of follow-up.
Go to:
Reference for my table and data,
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443587/
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