Checking the assumptions of a negative binomial model involved two steps: examining whether the data violated any independence assumption and verifying that the observed outcomes were a reasonable fit to a negative binomial distribution. To verify whether the assumption of independence was violated, binomial proportions, along with Clopper- Pearson exact 95% confidence intervals for each stick attempt were examined and compared under the assumption that there may be some common underlying probability of success that is irrespective of attempt. Clopper-Pearson exact confidence intervals were selected because a standard, conservative, exact test was desired that was readily available in standard software [10].
To verify that the observed data values were similar to the expected values under a negative binomial model, the current data was examined using a Goodness-of-Fit test as outlined by Morel and Neerchal [11]. Fitting the data to an intercept only negative binomial regression model, observed and expected counts were output and compared using Goodness of Fit criteria. Since negative binomial models include the possibility of observing a success on the zero count, a small change in the way the data was counted was necessary in order to truly compare the observations to the expectation [5]. For the process of IV insertion, at least one attempt to start an IV must be made. Therefore, rather than counting the actual number of the attempt, the data was modeled on the number of additional stick attempts beyond the first. Thus, those patients who experienced a successful IV placement on the first stick were represented as a success with zero additional stick attempts, or zero failures. For thoroughness, the data was fit under zero-inflated negative binomial and Poisson models as well.
After exploring the assumptions and utility of modeling the data under the negative binomial model, the results of the analysis indicated that the data itself should be modeled using the negative binomial distribution directly. Therefore, the GLM interpretation was be used to fit a negative binomial regression model. Those results were be compared to ordinary least squares (OLS) output in terms of inferences and model fit. It is worth noting that the use of negative binomial models is a fairly recent innovation and historically this type of count data would be modeled using OLS methods. It seems obvious that should an individual decide to model the data under a GLM, that the negative binomial would provide a more natural fit than other models, such as the Poisson. A seemingly appropriate question of interest is whether there are gains by modeling this data as a GLM in terms of model fit and general clinical inferences. Negative binomial regression uses a log-link function, making it difficult to directly compare parameter estimates with an OLS model. Hence, direct comparison to OLS parameters is not recommended. Instead, comparing the model based adjusted means (based on maximum likelihood estimates) for each factor was be preferable. Such comparison will indicated the impact for the factor, having adjusted for the contribution of other variables in the model. Comparisons of model fit were be made by examination of Akaike's Information Criterion (AIC) with smaller values purporting a better fitting model to the observed data [12]. All statistical analyses and simulations were performed using SAS® version 9.4 [13]. Data cleaning and quality control evaluations were performed using JMP® Pro 11 [14] software.