DNP 815 Week 7 Individual Patient Care discussions

DNP 815 Week 7 Individual Patient Care discussions

DNP 815 Week 7 Individual Patient Care discussions

DNP 815 Week 7 Discussions

DQ 1

How can the DNP-prepared nurse apply the concepts of a complex adaptive system to individual patient care? Provide examples.

DQ 2

Research change theories in scholarly literature and on the Internet. Develop a scenario and describe application of a change theory from the perspective of an advanced practice nurse leader.

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Background

The recent failure to reduce the duration of tuberculosis (TB) treatment from 6 to 4 months using fluoroquinolones in three major phase III trials [13] should prompt a review of how decisions are made to move novel regimens to pivotal phase III trials in the drug development pathway.

TB was declared a global emergency by the World Health Organization (WHO) as far back as 2003, with 9.0 million new cases and 1.5 million deaths worldwide from TB in 2013 [4]. It is widely recognized that new treatment regimens are urgently needed to end the TB epidemic [5]. New drugs and regimens are in the pipeline for drug-sensitive TB and multi-drug-resistant TB (MDR-TB) with a number of phase III trials for novel regimens starting over the next few years. Although there is a modest association between late culture conversion and poor outcomes for individual patients on standard treatment [67], this relationship is unknown for other regimens. A better understanding of how the available microbiological markers measured during treatment relate to long-term clinical outcomes will enable improved decision-making for both individual patient care and moving regimens into time-consuming expensive pivotal phase III trials.

A surrogate endpoint is defined as “a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint. … Changes induced by a therapy on a surrogate endpoint are expected to reflect changes in a clinically meaningful endpoint” [8]. Although not usually a perfect surrogate, the primary efficacy endpoint of a phase II trial is chosen so that differences between interventions in the endpoint are expected to reflect differences between interventions in a more clinically meaningful phase III endpoint, irrespective of the interventions being compared. This is often described as trial-level surrogacy in contrast to individual-level surrogacy, which relates to the degree to which the results of an early outcome are predictive of the long-term clinical outcome in individual patients undergoing the same treatment.

Culture positivity on LJ solid media at either 2 or 3 months is not an acceptable surrogate endpoint for long-term clinical outcome [911], although it is the only marker that has undergone rigorous evaluation. The inherent lower statistical power of a dichotomous compared to a continuous endpoint means TB phase II trials are now rarely designed with these endpoints. Rather, time to culture conversion [12] or the slope of quantitative cultures on solid or liquid media over time [1314] are more commonly used as they permit smaller trials and are thought to be more reliable for comparing regimens by capturing an element of time on treatment. As an example, bedaquiline received accelerated approval by the US Food and Drug Administration (FDA) based on time to culture conversion as the primary efficacy measure [15]. Despite this, the place of these markers in regimen development has not yet been formally evaluated, mainly due to the paucity of data collected in the majority of previous TB phase III trials [16]. The REMoxTB trial was designed with weekly cultures during the first 8 weeks and monthly cultures to the end of treatment to allow for the evaluation of the role of various measures of bacillary clearance in response to treatment as individual-level and trial-level surrogates for long-term clinical outcome.

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