Safety, Quality, and Acceptability of Contraceptive Subdermal Implant Provision by Community Health Extension Workers Versus Nurses and Midwives in Nigeria: Protocol for a Quasi-Experimental, Noninferiority Study.

BACKGROUND: As part of its Family Planning 2020 commitment, the Nigerian government is aiming for a contraceptive prevalence rate of 36% by 2018, and in 2014, approved a policy to allow community health extension workers (CHEWs), in addition to doctors, nurses, and midwives, to provide contraceptive subdermal implants. There is a lack of rigorous evidence on the safety of long-acting reversible contraceptive provision, such as implants, among lower cadres of health providers. OBJECTIVE: This study aimed to compare implant provision by CHEWs versus nurses and midwives up to 14 days post insertion. METHODS: The quasi-experimental, noninferiority study will take place in public sector facilities in Kaduna and Ondo States. In each state, we will select 60 facilities, and from these, we will select a total of 30 nurses and midwives and 30 CHEWs to participate. Selected providers will be trained to provide implant services. Once trained, providers will recruit a minimum of 8125 women aged between 18 and 49 years who request and are eligible for an implant, following comprehensive family planning counseling. During implant insertion, providers will record data about the process and any adverse events, and 14 days post insertion, providers will ask 4410 clients about adverse events arising from the implant. Supervisors will observe 792 implant insertions to assess service provision quality and ask clients about their satisfaction with the procedure. We will conclude noninferiority if the CI for the difference in the proportion of adverse events between CHEWs and nurses and midwives on the day of insertion or 14 days post insertion lies to the right of -2%. RESULTS: In September and October 2015, we trained 60 CHEWs and a total of 60 nurses and midwives from 12 local government areas (LGAs) in Kaduna and 23 LGAs in Ondo. Recruitment took place between November 2015 and December 2016. Data analysis is being finalized, and results are expected in March 2018. CONCLUSIONS: The strength of this study is having a standard care (nurse and midwife provision) group with which CHEW provision can be compared. The intervention builds on existing training and supervision procedures, which increases the sustainability and scalability of CHEW implant provision. Important limitations include the lack of randomization due to nurses and midwives in Nigeria working in separate types of health care facilities compared with CHEWs, and that providers self-assess their own practices. It is unfeasible to observe all procedures independently, and observation may change practice. Although providers will be trained to conduct implant removals, the study time will be too short to reach the sample size required to make noninferiority comparisons for removals. TRIAL REGISTRATION: ClinicalTrials.gov NCT03088722; https://clinicaltrials.gov/ct2/show/NCT03088722 (Archived by WebCite at http://www.webcitation.org/6xIHImWvu).

Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial.

PURPOSE: Radiotherapy with concomitant and adjuvant temozolomide is the standard of care for newly diagnosed glioblastoma (GBM). O(6)-methylguanine-DNA methyltransferase (MGMT) methylation status may be an important determinant of treatment response. Dose-dense (DD) temozolomide results in prolonged depletion of MGMT in blood mononuclear cells and possibly in tumor. This trial tested whether DD temozolomide improves overall survival (OS) or progression-free survival (PFS) in patients with newly diagnosed GBM. PATIENTS AND METHODS: This phase III trial enrolled patients older than age 18 years with a Karnofsky performance score of ≥ 60 with adequate tissue. Stratification included clinical factors and tumor MGMT methylation status. Patients were randomly assigned to standard temozolomide (arm 1) or DD temozolomide (arm 2) for 6 to 12 cycles. The primary end point was OS. Secondary analyses evaluated the impact of MGMT status. RESULTS: A total of 833 patients were randomly assigned to either arm 1 or arm 2 (1,173 registered). No statistically significant difference was observed between arms for median OS (16.6 v 14.9 months, respectively; hazard ratio [HR], 1.03; P = .63) or median PFS (5.5 v 6.7 months; HR, 0.87; P = .06). Efficacy did not differ by methylation status. MGMT methylation was associated with improved OS (21.2 v 14 months; HR, 1.74; P < .001), PFS (8.7 v 5.7 months; HR, 1.63; P < .001), and response (P = .012). There was increased grade ≥ 3 toxicity in arm 2 (34% v 53%; P < .001), mostly lymphopenia and fatigue. CONCLUSION: This study did not demonstrate improved efficacy for DD temozolomide for newly diagnosed GBM, regardless of methylation status. However, it did confirm the prognostic significance of MGMT methylation. Feasibility of large-scale accrual, prospective tumor collection, and molecular stratification was demonstrated.

Estimating the contribution of a service delivery organisation to the national modern contraceptive prevalence rate: Marie Stopes International's Impact 2 model.

BACKGROUND: Individual family planning service delivery organisations currently rely on service provision data and couple-years of protection as health impact measures. Due to the substitution effect and the continuation of users of long-term methods, these metrics cannot estimate an organisation's contribution to the national modern contraceptive prevalence rate (CPR), the standard metric for measuring family planning programme impacts. Increasing CPR is essential for addressing the unmet need for family planning, a recognized global health priority. Current health impact estimation models cannot isolate the impact of an organisation in these efforts. Marie Stopes International designed the Impact 2 model to measure an organisation's contribution to increases in national CPR, as well as resulting health and demographic impacts. This paper aims to describe the methodology for modelling increasing national-level CPR as well as to discuss its benefits and limitations. METHODS: Impact 2 converts service provision data into estimates of the number of family planning users, accounting for continuation among users of long-term methods and addressing the challenges of converting commodity distribution data of short-term methods into user numbers. These estimates, combined with the client profile and data on the organisation's previous year's CPR contribution, enable Impact 2 to estimate which clients maintain an organisation's baseline contribution, which ones fulfil population growth offsets, and ultimately, which ones increase CPR. RESULTS: Illustrative results from Marie Stopes Madagascar show how Impact 2 can be used to estimate an organisation's contribution to national changes in the CPR. CONCLUSIONS: Impact 2 is a useful tool for service delivery organisations to move beyond cruder output measures to a better understanding of their role in meeting the global unmet need for family planning. By considering health impact from the perspective of an individual organisation, Impact 2 addresses gaps not met by other models for family planning service outcomes. Further, the model helps organisations improve service delivery by demonstrating that increases in the national CPR are not simply about expanding user numbers; rather, the type of user (e.g. adopters, provider changers) must be considered. Impact 2 can be downloaded at http://www.mariestopes.org/impact-2.

Subcutaneous heparin does not increase postoperative complications in neurosurgical patients: An institutional experience.

INTRODUCTION: Prophylaxis for venous thromboembolic disease continues to pose a challenging management problem in postoperative neurosurgical patients, particularly those in the intensive care unit (ICU). This study evaluates neurosurgical patients admitted to the surgical ICU (SICU) at a tertiary hospital and compared those who had received subcutaneous unfractionated heparin (SQUFH) to those who did not. This study was conducted to better evaluate if the administration of SQUFH to neurosurgical patients is safe and whether the administration of SQUFH is an independent risk factor for bleeding in this patient population. METHODS: Retrospective analysis was performed on prospectively collected data on all postoperative neurosurgical patients admitted over the course of 11 years to the SICU at Long Island Jewish Medical Center. This study included neurosurgical patients who received SQUFH and those who did not. Data acquired included demographic information, hemodynamic monitoring, pharmacologic interventions, laboratory results, and survival outcomes as well as occurrences of heparin-induced thrombocytopenia and pulmonary embolism. Subcutaneous unfractionated heparin for venous thromboembolic prophylaxis were dosed according to previously established literature based hospital protocols. Data were analyzed by χ(2), Fisher exact test, Mann-Whitney U test, or the product limit method, where appropriate. RESULTS: Five hundred twenty-two neurosurgical patients were included in the study. Two hundred thirteen patients (40.8%) with mean age of 58 years received SQUFH (133 patients received SQUFH within 24 hours of surgery and 80 patients received SQUFH 24 hours postoperatively). Once SQUFH was initiated, it was continued until discharge from the hospital. Three hundred nine patients (59.2%) with mean age 57.8 years received no anticoagulation. In the SQUFH patient population, 72 patients (33.8%) had a diagnosis of subarachnoid hemorrhage compared with 125 patients (40.5%) from the group who had not received anticoagulation. There was no significant difference in ICU length of stay between the groups, 5.8 ± 5.4 (no deep vein thrombosis prophylaxis), and those receiving SQUFH, 6.7 ± 6.1 (over 24 hours) and 5.9 ± 4.8 (over 24 hours). No postoperative hemorrhages were observed (confirmed by computed tomography of the brain) in any of the neurosurgical patients with subarachnoid hemorrhage, intracerebral hemorrhage, or subdural or epidural hemorrhage. No instances of heparin-induced thrombocytopenia (HIT) or pulmonary embolism (PE) were observed. CONCLUSIONS: Administration of SQUFH dosed according to the risk for thromboembolism does not appear to contribute to postoperative hemorrhage in neurosurgical patients. This study supports the concept that the administration of SQUFH is safe in postoperative neurosurgical population.