Integrated Project Delivery (IPD) and Lean Project Delivery (LPD) are innovative approaches that are capturing the attention of the construction industry. However, there is a confusion about the ...definitions of these approaches and how they integrate a project delivery process. This confusion negatively affects the learning process, which could create a barrier to advancing them. Based on a structured literature review and two case illustrations, this study aims to clarify the similarities and differences between IPD and LPD. This paper presents a comparative analysis of these approaches through a structured analysis of the project organizations, contractual relationships, and operational systems. The results showed that the operational system is perhaps the most relevant difference between these approaches for their definition as a project delivery system. The core of both approaches is to encourage the use of integrated project organizations, relational contracting, and integrated process as mechanisms to integrate a project delivery system.
•IPD and LPD systems have the same perspective with regards to project organization.•The nature of IPD and LPD agreements is relational.•The main difference between IPD and LPD delivery systems stems from the operational system.
Many building projects do not meet owners' performance expectations. Integrated project delivery (IPD) has emerged as a new delivery system with the potential to provide better performance through ...more supply chain integration. However, there is a knowledge gap surrounding how project delivery systems, IPD in particular, affect supply chain relationships and potential project performance. To fill this gap, we applied a simulation method, General Performance Model (GPM), to assess the interactions between numerous project delivery variables and compare potential performance between delivery systems. This study presents a GPM analysis of a complex hospital project and based upon cross-impact assessments by owners, architects, constructors, and specialty contractors from the building industry. The results found the most influential drivers of project delivery performance to be communication, alignment of interest and objectives, team working, trust, and gain/pain sharing. The performance of the supply chain was found to drive the project delivery performance.
•The performance of the supply chain was found to drive the project delivery performance.•The owner’s strategy decisions impact the management of the supply chain relationships.•IPD has emerged as a new system with the potential to provide better performance through more supply chain integration.
Public projects continually face multiple difficulties for their satisfactory completion. One of the most complex challenges is early contract termination (ECT), which delays social goods delivery ...and exhausts public resources. This study aimed to determine the root causes of the critical factors that lead to ECT in public building projects. We studied 20 kindergarten construction projects in Chile through a multi-case study. It addressed a pattern-matching analysis of symptoms associated with risks of design–build (DB) contracts and a five whys analysis to determine the root causes of the symptoms identified in the units of analysis. The results show that ECT projects’ most common symptoms are labor force shortage, materials shortage, and non-payment claims. In addition, the root-cause analysis exposed that the main causes of ECT’s symptoms were deficiencies in the bidding evaluation process, which led to an inadequate selection of the general contractor, lack of experience of the owner, and regulatory limitations of the legal framework for public projects. The construction projects faced ECT and cost and time overruns associated with poor risk management due to the owner’s and general contractor’s lack of experience in DB contracts.
The supply chain relationship is an essential factor in the performance of Integrated Project Delivery (IPD). The IPD system encourages the early involvement of key participants in the design stage. ...Consequently, this early involvement requires a new configuration of the supply chain relationship in the IPD system. However, there is a lack of knowledge in understanding the performance of the supply chain relationship in the IPD system. To fill this gap, we applied a simulation model, Virtual Design Team (VDT), to explore the dynamics of the supply chain integration in terms of project organization and project delivery process in design. This study presents a conceptual and qualitative analysis of the VDT model applied in two IPD projects. The results explored different behaviors of integration at inter-organizational and project levels throughout project organization, contractual and technological mechanisms of coordination. The project organization characteristics influence the performance of the construction supply chain.
The popularity of Integrated Project Delivery (IPD) in the construction industry has grown significantly in recent years. While IPD systems are proposed as a response to poor project performance in ...the design and construction industry, there is a knowledge gap surrounding how and why IPD systems impact project performance in terms of their project organization, contractual relationship and operational system. This study addresses the following research question: How does the IPD system operate in terms of project organization, contractual relationship and operational system? To address this question, I explore the general behavior of the project delivery system and internal dynamics of the supply chain in IPD projects. I then create a series of simulation models that compare different project delivery systems. Two primary modeling methods support this modeling: General Performance Model (GPM) and Virtual Design Team (VDT). Lastly, I address a conceptual dilemma between IPD and Lean Project Delivery (LPD). This dissertation presents a GPM analysis of a complex hospital project that is based upon cross-impact assessments by experienced professionals from the building industry. A conceptual and qualitative analysis of the VDT model is applied to two IPD projects. Finally, a comparative analysis between IPD and LPD is made through a structured analysis of the organizational, contractual, and operational strategy. The GPM results showed that the performance of the supply chain relationship drives the project delivery performance and the most influential supply chain drivers in terms of project performance are communication, alignment of interest and objectives, team working, trust and gain/pain sharing. The VDT results showed that an IPD system can be structured in different ways. These differences can be from organizational and operational points of view and the manner in which key participants are organized influences the project integration at inter-organizational and project levels. The comparison between IPD and LPD systems showed that, while these approaches are based on relational contracting and require multi-party contracting, LPD has additional requirements. LPD system incorporates lean principles to design the legal framework. LPD system also fundamentally requires a lean operational system, whereas the IPD system does not require any specific operational system.
Ruxolitinib, a potent Janus kinase 1/2 inhibitor, resulted in rapid and durable improvements in splenomegaly and disease-related symptoms in the 2 phase III COMFORT studies. In addition, ruxolitinib ...was associated with prolonged survival compared with placebo (COMFORT-I) and best available therapy (COMFORT-II). We present a pooled analysis of overall survival in the COMFORT studies using an intent-to-treat analysis and an analysis correcting for crossover in the control arms. Overall, 301 patients received ruxolitinib (COMFORT-I, n=155; COMFORT-II, n=146) and 227 patients received placebo (n=154) or best available therapy (n=73). After a median three years of follow up, intent-to-treat analysis showed that patients who received ruxolitinib had prolonged survival compared with patients who received placebo or best available therapy hazard ratio=0.65; 95% confidence interval (95%CI): 0.46-0.90; P=0.01; the crossover-corrected hazard ratio was 0.29 (95%CI: 0.13-0.63). Both patients with intermediate-2- or high-risk disease showed prolonged survival, and patients with high-risk disease in the ruxolitinib group had survival similar to that of patients with intermediate-2-risk disease in the control group. The Kaplan-Meier estimate of overall survival at week 144 was 78% in the ruxolitinib arm, 61% in the intent-to-treat control arm, and 31% in the crossover-adjusted control arm. While larger spleen size at baseline was prognostic for shortened survival, reductions in spleen size with ruxolitinib treatment correlated with longer survival. These findings are consistent with previous reports and support that ruxolitinib offers a survival benefit for patients with myelofibrosis compared with conventional therapies. (clinicaltrials.gov identifiers: COMFORT-I, NCT00952289; COMFORT-II, NCT00934544).
Myelofibrosis is a BCR-ABL1–negative myeloproliferative neoplasm characterized by anemia, progressive splenomegaly, extramedullary hematopoiesis, bone marrow fibrosis, constitutional symptoms, ...leukemic progression, and shortened survival. Constitutive activation of the Janus kinase/signal transducers and activators of transcription (JAK-STAT) pathway, and other cellular pathways downstream, leads to myeloproliferation, proinflammatory cytokine expression, and bone marrow remodeling. Transplant is the only curative option for myelofibrosis, but high rates of morbidity and mortality limit eligibility. Several prognostic models have been developed to facilitate treatment decisions. Until the recent approval of fedratinib, a JAK2 inhibitor, ruxolitinib was the only available JAK inhibitor for treatment of intermediate- or high-risk myelofibrosis. Ruxolitinib reduces splenomegaly to some degree in almost all treated patients; however, many patients cannot tolerate ruxolitinib due to dose-dependent drug-related cytopenias, and even patients with a good initial response often develop resistance to ruxolitinib after 2–3 years of therapy. Currently, there is no consensus definition of ruxolitinib
failure
. Until fedratinib approval, strategies to overcome ruxolitinib resistance or intolerance were mainly different approaches to continued ruxolitinib therapy, including dosing modifications and ruxolitinib rechallenge. Fedratinib and two other JAK2 inhibitors in later stages of clinical development, pacritinib and momelotinib, have been shown to induce clinical responses and improve symptoms in patients previously treated with ruxolitinib. Fedratinib induces robust spleen responses, and pacritinib and momelotinib may have preferential activity in patients with severe cytopenias. Reviewed here are strategies to ameliorate ruxolitinib resistance or intolerance, and outcomes of clinical trials in patients with myelofibrosis receiving second-line JAK inhibitors after ruxolitinib treatment.
Symptomatic burden in myeloproliferative neoplasms is present in most patients and compromises quality of life. We sought to validate a broadly applicable 18-item instrument (Myeloproliferative ...Neoplasm Symptom Assessment Form MPN-SAF, coadministered with the Brief Fatigue Inventory) to assess symptoms of myelofibrosis, essential thrombocythemia, and polycythemia vera among prospective cohorts in the United States, Sweden, and Italy. A total of 402 MPN-SAF surveys were administered (English 25%, Italian 46%, and Swedish 28%) in 161 patients with essential thrombocythemia, 145 patients with polycythemia vera, and 96 patients with myelofibrosis. Responses among the 3 administered languages showed great consistency after controlling for MPN subtype. Strong correlations existed between individual items and key symptomatic elements represented on both the MPN-SAF and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30. Enrolling physicians' blinded opinion of patient symptoms (6 symptoms assessed) were highly correlated with corresponding patients' responses. Serial administration of the English MPN-SAF among 53 patients showed that most MPN-SAF items are well correlated (r > 0.5, P < .001) and highly reproducible (intraclass correlation coefficient > 0.7). The MPN-SAF is a comprehensive and reliable instrument that is available in multiple languages to evaluate symptoms associated with all types of MPNs in clinical trials globally.
RESPONSE is an open-label phase 3 study evaluating the Janus kinase 1/Janus kinase 2 inhibitor ruxolitinib versus best available therapy for efficacy/safety in hydroxyurea-resistant or intolerant ...patients with polycythemia vera. This preplanned analysis occurred when all patients completed the Week 80 visit or discontinued. Objectives included evaluating the durability of the primary response (Week 32 phlebotomy-independent hematocrit control plus ≥35% spleen volume reduction), its components, and that of complete hematologic remission; and long-term safety. Median exposure was 111 weeks; 91/110 (82.7%) patients randomized to ruxolitinib remained on treatment. No patients continued best available therapy (98/112 87.5% crossed over to ruxolitinib, most at/soon after Week 32). At Week 32, primary response was achieved by 22.7% vs. 0.9% of patients randomized to ruxolitinib and best available therapy, respectively (hematocrit control, 60.0% vs. 18.8%; spleen response, 40.0% vs. 0.9%). The probability of maintaining primary and hematocrit responses for ≥80 weeks was 92% and 89%, respectively; 43/44 spleen responses were maintained until Week 80. Complete hematologic remission at Week 32 was achieved in 23.6% of ruxolitinib-randomized patients; the probability of maintaining complete hematologic remission for ≥80 weeks was 69%. Among ruxolitinib crossover patients, 79.2% were not phlebotomized, and 18.8% achieved a ≥35% reduction from baseline in spleen volume after 32 weeks of treatment. New or worsening hematologic laboratory abnormalities in ruxolitinib-treated patients were primarily grade 1/2 decreases in hemoglobin, lymphocytes, and platelets. The thromboembolic event rate per 100 patient-years was 1.8 with randomized ruxolitinib treatment vs. 8.2 with best available therapy. These data support ruxolitinib as an effective long-term treatment option for hydroxyurea-resistant or intolerant patients with polycythemia vera. This trial was registered at clinicaltrials.gov identifier: 01243944.
Myelofibrosis (MF) is associated with a variety of burdensome symptoms and reduced survival compared with age-/sex-matched controls. This analysis evaluated the long-term survival benefit with ...ruxolitinib, a Janus kinase (JAK)1/JAK2 inhibitor, in patients with intermediate-2 (int-2) or high-risk MF.
This was an exploratory analysis of 5-year data pooled from the phase 3 COMFORT-I and -II trials. In both trials, patients could cross over to ruxolitinib from the control group (COMFORT-I, placebo; COMFORT-II, best available therapy). All continuing patients in the control groups crossed over to ruxolitinib by the 3-year follow-up. Overall survival (OS; a secondary endpoint in both trials) was evaluated using pooled intent-to-treat data from patients randomized to ruxolitinib or the control groups. OS was also evaluated in subgroups stratified by baseline anemia and transfusion status at week 24.
A total of 528 patients were included in this analysis; 301 were originally randomized to ruxolitinib (COMFORT-I, n = 155; COMFORT-II, n = 146) and 227 to control (n = 154 and n = 73, respectively). The risk of death was reduced by 30% among patients randomized to ruxolitinib compared with patients in the control group (median OS, 5.3 vs 3.8 years, respectively; hazard ratio HR, 0.70 95% CI, 0.54-0.91; P = 0.0065). After correcting for crossover using a rank-preserving structural failure time (RPSFT) method, the OS advantage was more pronounced for patients who were originally randomized to ruxolitinib compared with patients who crossed over from control to ruxolitinib (median OS, 5.3 vs 2.3 years; HR ruxolitinib vs RPSFT, 0.35 95% CI, 0.23-0.59). An analysis of OS censoring patients at the time of crossover also demonstrated that ruxolitinib prolonged OS compared with control (median OS, 5.3 vs 2.4 years; HR ruxolitinib vs censored at crossover, 0.53 95% CI, 0.36-0.78; P = 0.0013). The survival benefit with ruxolitinib was observed irrespective of baseline anemia status or transfusion requirements at week 24.
These findings support ruxolitinib treatment for patients with int-2 or high-risk MF, regardless of anemia or transfusion status. Further analyses will be important for exploring ruxolitinib earlier in the disease course to assess the effect on the natural history of MF.
ClinicalTrials.gov identifiers, NCT00952289 and NCT00934544 .
PDF
