Common use of P Value Clause in Contracts

P Value. NOTE. Data are presented as means SD or medians (range, min to max). All data presented are assessments completed by the clinician at the baseline face-to-face appointment. An independent sample t test was used to compare the 2 groups. Abbreviation: BMI, body mass index. * P<.05. y nZ16 completers and nZ19 noncompleters. z nZ17 completers and nZ18 noncompleters. push-up posture (as per men, but with the lower legs together in contact with the ground and ankles plantar flexed), according to a standardized protocol.13 A marker (standard sized can of food) was placed on its end below the head of the participant to mark the range of motion required for each push-up. Prior to the test, participants completed up to 3 repetitions to ensure correct technique and then rested for 1 minute before completing the test. Participants then completed the maximum number of push- ups possible with good technique, consecutively without rest. Participants were given an exercise matc and instructed to use a can of equal size to complete their home-based test. Statistical analysis Data analyses was performed using SPSS 25.d Data were verified for normal distribution via the ▇▇▇▇▇▇▇-▇▇▇▇▇ test, the Kolmogorov-Smirnov test, and visualization of Q-Q plots. Patient characteristic data were compared between those who did and did not complete the home assessments using an independent t test (numerical data) or chi-square test (categorical data). A 1-sample t test was conducted to determine whether there were statistically significant differences between the clinician-measured assessments and participant home assessment for each clinical and functional test variable, with a test value of 0. Agreement between clinician and study participant assessments was determined according to ▇▇▇▇▇-▇▇▇▇▇▇ plots. The ▇▇▇▇▇- ▇▇▇▇▇▇ plots show mean difference and limits of agree- ment between the 2 methods, with limits of agreement calculated as mean difference 1.96 standard deviation. ▇▇▇▇▇-▇▇▇▇▇▇ analyses are reported as mean difference (95% confidence interval) and limits of agreement (lower limit of agreement [LoA]-upper LoA). The mean difference was calculated as clinician measurement minus participant measurement, and thus a positive mean difference indicated that the participant-measured value was lower than the clinician-measured value. Systematic bias was assessed by the 1-sample t test to determine if the mean difference was significantly different from 0 and/or if the line of equality (yZ0) was outside the 95% confidence in- terval of the mean difference. Proportional bias was assessed by linear regression to determine whether the average of the measures (independent variable) was significantly related to the difference between the clinician and participant measures (dependent variable). The extent to which measurements can be replicated between the clinician and the participant was further assessed via intraclass correlation coefficients (ICCs) using a 2-way mixed model with absolute agreement. ICCs were interpreted as poor (<0.5), moderate (0.5-0.74), good (0.75-0.9), and excellent (>0.9).14 With 2 observations per participant (ie, the clinician assessment and the participant assessment), a minimum sample size of nZ13 would be required to achieve the statistical significance, based on ICCs of 0.70, for an alpha value set at 0.05 and a minimum power of 90%.15 Determining clinically meaningful agreement In addition to the statistical approaches, minimal clinically important differences (MCIDs) were used to interpret the level of clinically meaningful reliability and agreement for each assessment. Differences between clinician-measured and participant-measured scores below the MCID were judged as representing an acceptable level of agreement. As recommended by ▇▇▇▇▇▇▇ et al,16 multiple methods (anchor and distribution methods) were used to determine the MCID for each measure, in particular where existing literature was sparse. Accordingly, for this study, a clini- cally meaningful agreement (ie, a difference lower than the a priori MCID) for each variable was defined as a dif- ▇▇▇▇▇▇▇ less than weight ≤3%, waist ≤2%, SBP ≤10 mmHg, Clinician vs patient assessment reliability Table 2 Statistical, anchoring, and distribution methods to determine agreement between clinician-measured and participant-measured outcome assessments [—127.3 to 142.4] female adults.22 OutcomeMeasures (units) Clinician Measures Participant Measures Mean Diff (95% CI) [Lower LoA-Upper LoA] P Value* ICC (95% CI) Anchor Method for MCID Distribution Method for MCID Acceptable Limit for MCID n (%) Within Acceptable MCID Weight (kg) 78.6 20.3 77.9 20.3 0.7 (0.01-1.4) [—2.17 to 3.57] .59 0.998 (0.995- 0.999) <3% considered not clinically meaningful 1/2 SD: <0.75 kg SEM: <0.07 kg ≤3% 16/18 (89) Waist (cm) 96 15 96 14 0.4 (—1.2 to 2.0) [—5.86 to 6.57] .56 0.989 (0.970- 0.996) change17 Intertester reliability should be <2%.13,18 MCIDZ5% and WC maintenanceZ3%.19 Mean coefficient of 1/2 SD: <1.6 cm SEM: <0.33 cm ≤2% 12/18 (67) SBP (mmHg) 137 (102- 164.5) 129 (100- 156) 7.7 (0.6-14.7) [—19.35 to 34.85] .04 0.768 (0.348- 0.917) variation in measure between health professionalsZ1.5%20 SBP should be retested if readings differ >10 1/2 SD: <6.85 mmHg ≤10 mmHg 11/17 (65) DBP (mmHg) 84 9 81 13 2.4 (—1.4 to 6.2) [—12.16 to 16.97] .20 0.872 (0.657- 0.953) mmHg.13 DBP should be retested if readings differ SEM: <6.60 mmHg 1/2 SD: 3.7 mmHg SEM: <2.65 mmHg ≤5 mmHg 8/17 (47) STST (s) 10 (8-16) 10 (5-16) 0.5 (—0.8 to 1.7) [—4.31 to 5.29] .42 0.733 (0.269- 0.903) >6mmHg.13 MCIDZ1.7 s in patients with COPD.21 MCIDZ2.5 s (95% LoA Z 1/2 SD: <1.2 s SEM: <1.24 s £1.5 s 6/17 (35) 6MWT (m) 466 80 459 98 7.5 (—29.1 to 44.1) .67 0.934 (0.521- —2.6 to 2.6s) in older MCIDZ36 m in patients 1/2 SD: < 34.45 m ≤30 m 6/16 (38) with chronic heart failure.23 MCIDZ43.1 (16.8) m and 95% CI, 31.8-54.4 m in patients with chronic heart failure.24 MCIDZ25 m in patients with coronary artery disease.25 SEM: <17.7 m (continued on next page) n (%) Within Acceptable MCID 12/17 (71) ≤ ≤ ≤ DBP 5 mmHg, 6MWT 30 m, push-ups 2, and STST Acceptable Limit for MCID ≤2 push-ups ≤