Invasive Placebos, Patient Burdens, and Community Advocacy

2018 ◽  
pp. 88-121
Author(s):  
Donna L. Snyder ◽  
Catherine S. Lee ◽  
Robert M. Nelson
Keyword(s):  
Central Venous Access ◽  
Venous Access ◽  
Institutional Review Boards ◽  
Minimal Risk ◽  
Time Line ◽  
Institutional Review ◽  
Clinical Investigations ◽  
Panel Review ◽  
A Minor ◽  
Venous Access Device

The “Additional Safeguards for Children in FDA-Regulated Clinical Investigations,” 21 CFR 50 subpart D, places limits on the risk to which a child can be exposed in a study. Absent a prospect of direct clinical benefit, institutional review boards (IRBs) cannot approve an intervention or procedure that exceeds “a minor increase over minimal risk.” If there is an ethical justification for the study to proceed, the IRB may refer the protocol for review by a federal panel under 21 CFR 50.54. A study allowing use of a totally implantable central venous access device (TICVAD) to provide placebo was referred for federal panel review; the committee voted unanimously in favor of a TICVAD. A determination by the Food and Drug Administration commissioner was issued within 10 weeks of the initial referral, an unprecedented time line. The Duchenne Muscular Dystrophy community was instrumental in initiating the referral and informing the panel’s decision.

Pediatric Participation in Non-Therapeutic Research

2012 ◽  
Vol 40 (3) ◽  
pp. 665-672 ◽  
Author(s):  
Marilyn C. Morris
Keyword(s):  
Medical Condition ◽  
Human Subjects ◽  
National Commission ◽  
Institutional Review Boards ◽  
Minimal Risk ◽  
Research Risks ◽  
Institutional Review ◽  
Protection Of Human Subjects ◽  
A Minor ◽  
Therapeutic Research

Pediatric participation in non-therapeutic research that poses greater than minimal risk has been the subject of considerable thought-provoking debate in the research ethics literature. While the need for more pediatric research has been called morally imperative, and concerted efforts have been made to increase pediatric medical research, the importance of protecting children from undue research risks remains paramount.United States research regulations are derived largely from the deliberations and report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The authors of this report specifically designated children as a vulnerable population and suggested additional protections, most of which became U.S. law. One of the more contested sets of regulations surrounds non-therapeutic research, e.g., research that does not offer the potential for direct benefit to participants. Federal regulations allow local Institutional Review Boards (IRBs) to approve non-therapeutic research posing a minor increase above minimal risk when it involves children who have the disease or medical condition that the research addresses (Table 1).

Interpretation of the Subjects' Condition Requirement: A Legal Perspective

2010 ◽  
Vol 38 (2) ◽  
pp. 365-373 ◽  
Author(s):  
Seema Shah ◽  
David Wendler
Keyword(s):  
Ethical Concern ◽  
Institutional Review Boards ◽  
Minimal Risk ◽  
Federal Regulations ◽  
Direct Benefit ◽  
Institutional Review ◽  
Research With Children ◽  
Legal Perspective ◽  
A Minor ◽  
The U.S

Clinical research with children generates special ethical concern, raising the need for additional protections beyond those for research with competent adults. Most guidelines permit research with children when it offers a prospect of direct benefit, or poses minimal risk. Unlike many other guidelines, the U.S. federal regulations also allow institutional review boards (IRBs) to approve pediatric research that does not offer a prospect of direct benefit when the risks are no greater than a minor increase over minimal risk. To approve research in this category, IRBs must find that two additional conditions obtain:1). The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; and 2). The intervention or procedure is likely to yield generalizable knowledge about the subjects disorder or condition which is of vital importance for the understanding or amelioration of the subjects disorder or condition.

Risk factors determining central venous access device-associated deep vein thrombosis resolution in children: a retrospective study

2021 ◽  
Author(s):  
Miguel García-Boyano ◽  
José Manuel Caballero-Caballero ◽  
Marta García Fernández de Villalta ◽  
Mar Gutiérrez Alvariño ◽  
María Jesús Blanco Bañares ◽  
...  
Keyword(s):  
Risk Factors ◽  
Deep Vein Thrombosis ◽  
Central Venous Access ◽  
Venous Access ◽  
Central Venous ◽  
Central Venous Access Device ◽  
Access Device ◽  
Vein Thrombosis ◽  
Venous Access Device ◽  
Deep Vein

Thromboembolism in Patients With Advanced Gastroesophageal Cancer Treated With Anthracycline, Platinum, and Fluoropyrimidine Combination Chemotherapy: A Report From the UK National Cancer Research Institute Upper Gastrointestinal Clinical Studies Group

2009 ◽  
Vol 27 (23) ◽  
pp. 3786-3793 ◽  
Author(s):  
Naureen Starling ◽  
Sheela Rao ◽  
David Cunningham ◽  
Timothy Iveson ◽  
Marianne Nicolson ◽  
...  
Keyword(s):  
Combination Chemotherapy ◽  
Treated Patient ◽  
Controlled Trial ◽  
Central Venous Access ◽  
Locally Advanced ◽  
Venous Access ◽  
Gastroesophageal Cancer ◽  
National Cancer Research Institute ◽  
The Uk ◽  
Venous Access Device

PurposeData concerning the prevalence of and outcomes related to thromboembolic events (TEs) in patients with advanced gastroesophageal cancer who are undergoing chemotherapy are limited.Patients and MethodsThis was a prospective, exploratory analysis of TEs in a randomized, controlled trial of 964 patients recruited between 2000 and 2005 and treated with epirubicin/platinum/fluoropyrimidine combination chemotherapy for advanced/locally advanced gastroesophageal cancer. Regimens were epirubicin (E), cisplatin (C), fluorouracil (F; ECF); E, C, capecitabine (X; ECX); E, F, oxaliplatin (O; EOF); and EOX. Continuously infused F was administered via a central venous access device (CVAD) with 1 mg of warfarin for thromboprophylaxis. The principal outcome was the incidence of TEs (venous and arterial) in the whole treated patient cohort, according to chemotherapy, associated with CVADs and TE-related prognoses.ResultsThe incidences of any, of venous, and of arterial TEs among 964 treated patients were 12.1% (95% CI, 10.7 to 14.3), 10.1% (95% CI, 8.3 to 12.3), and 2.2% (95% CI, 1.4 to 3.4) respectively. There were fewer TEs in the O compared with the cisplatin groups (EOF/EOX v ECF/ECX: 7.6% v 15.1%; P = .0003). C was identified as a risk factor for TE in multivariate analysis (hazard ratio [HR], 0.51; 95% CI, 0.34 to 0.76; P = .001). There was no difference in the incidence of TEs for the F group compared with the capecitabine groups. The incidence of CVAD-related thrombosis was 7.0% (ECF/EOF arms). Overall survival was worse for patients who experienced TEs versus no TEs (median survival, 7.4 v 10.5 months; HR, 0.8; 95% CI, 0.64 to 0.99; P = .043).ConclusionThis analysis has prospectively quantified the incidence/pattern of TEs among patients with advanced gastroesophageal cancer who were treated with four triplet regimens, has demonstrated a differential thrombogenic effect according to platinum use, and has noted a poorer outcome associated with TE during treatment. Chemotherapy-related TE should contribute to the risk/benefit assessment of treatment.

scholarly journals How I treat central venous access device–related upper extremity deep vein thrombosis

Blood ◽  
2017 ◽  
Vol 129 (20) ◽  
pp. 2727-2736 ◽  
Author(s):  
Anita Rajasekhar ◽  
Michael B. Streiff
Keyword(s):  
Central Venous Access ◽  
Vena Cava ◽  
Venous Access ◽  
Postthrombotic Syndrome ◽  
Central Venous ◽  
Central Venous Access Device ◽  
Access Device ◽  
Persistent Symptoms ◽  
Vena Cava Filters ◽  
Venous Access Device

AbstractCentral venous access device (CVAD)-related thrombosis (CRT) is a common complication among patients requiring central venous access as part of their medical care. Complications of CRT include pulmonary embolism, recurrent deep venous thrombosis, loss of central venous access, and postthrombotic syndrome. Patient-, device-, and treatment-related factors can influence the risk of CRT. Despite numerous randomized controlled trials, the clinical benefit of pharmacologic thromboprophylaxis for the prevention of CRT remains to be established. Therefore, minimizing patient exposure to known risk factors is the best available approach to prevent CRT. Venous duplex is recommended for the diagnosis of CRT. Anticoagulation for at least 3 months or the duration of the indwelling CVAD is recommended for treatment of CRT. Thrombolysis should be considered for patients at low risk for bleeding who have limb-threatening thrombosis or whose symptoms fail to resolve with adequate anticoagulation. CVAD removal should be consider for patients with bacteremia, persistent symptoms despite anticoagulation, and if the CVAD is no longer needed. Superior vena cava filters should be avoided. Prospective studies are needed to define the optimal management of patients with or at risk for CRT.

Complications associated with central venous access device in children with haemophilia: a nationwide multicentre study in Finland

Haemophilia ◽  
2015 ◽  
Vol 21 (6) ◽  
pp. 747-753 ◽  
Author(s):  
K. Vepsäläinen ◽  
R. Lassila ◽  
M. Arola ◽  
P. Lähteenmäki ◽  
M. Möttönen ◽  
...  
Keyword(s):  
Multicentre Study ◽  
Central Venous Access ◽  
Venous Access ◽  
Haemophilia A ◽  
Central Venous ◽  
Central Venous Access Device ◽  
Access Device ◽  
Venous Access Device

Analysis of six cancer patients with persistent left superior vena cava identified during central venous access device placement via an intracavitary electrocardiogram

2021 ◽  
pp. 112972982110455
Author(s):  
Xinpeng Wang ◽  
Yong Yang ◽  
Jing Dong ◽  
Xiaozheng Wang ◽  
Yuanyuan Zheng ◽  
...  
Keyword(s):  
Body Surface ◽  
Superior Vena ◽  
Central Venous Access ◽  
Vena Cava ◽  
Venous Access ◽  
The Body ◽  
P Wave ◽  
P Waves ◽  
Venous Access Device ◽  
Surface Electrocardiogram

Persistent left superior vena cava (PLSVC) is a rare congenital anomaly. PLSVC can be associated with clinically significant atrial septal defect (ASD) or ventricular septal defect (VSD). It is usually asymptomatic and accidentally detected during invasive procedures or imaging examinations. However, whether central venous access device (CVAD) can be placed and used in patients with PLSVC is controversial. A total of six patients were diagnosed with PLSVC and confirmed by chest CT among 3391 cancer patients who underwent CVAD placement via intracavitary electrocardiogram (IC-EKG) at the Venous Access Center (VAC) from May 2019 to December 2020. The CVADs (peripherally inserted central catheter in four patients and Ports in two patients) of these six patients were left in PLSVC. We analyzed changes in the P-wave in the IC-EKG during CVAD placement and the characteristics of the body surface electrocardiogram in these patients and discussed the catheter tip position in PLSVC. All six patients showed negative P-waves in lead II via IC-EKG from the beginning of catheterization: four patients showed negative P-waves and two showed biphasic P-waves in the body surface electrocardiogram (lead III) before catheterization. CVAD function was normal and no obvious complications were observed during the treatment of these patients. The total retention time of CVADs was 1537 days. For patients with a negative P-wave in lead II via IC-EKG during catheterization, especially in those with a negative or biphasic P-wave in lead III of the body surface electrocardiogram, PLSVC should be considered. CVAD insertion in patients with type I PLSVC is safe under certain conditions, with the proper tip position in the middle to lower part of PLSVC.

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