“Limb Salvage and Amputation in Survivors of Pediatric Lower-Extremity Bone Tumors: What Are the Long-Term Implications?” by Rajaram Nagarajan, Joseph P. Neglia, Denis R. Clohisy, and Leslie L. Robison.
This review article suggests that long-term outcomes are not substantially different with regard to quality of life when comparing limb salvage and amputation in pediatric survivors of lower-extremity bone tumors.
The results of studies show that survival is equivalent between amputation and limb salvage, although complications occur more frequently with limb salvage. The article compares the major surgical approaches to lower-limb bone tumors and their impact on the physical function and general well-being of affected children.
Primary malignant bone tumors represent approximately 6% of all cancers in children younger than age 20. The two predominant primary bone malignancies are osteosarcoma (60%) and Ewing's sarcoma (34%), which frequently affect the long bones in the lower extremities.
Options for achieving local control include amputation and limb salvage, both of which have benefits and drawbacks, which are magnified in the pediatric population due to skeletal and psychological immaturity.
The article reviews amputation, including rotationplasty, and lower extremity limb-sparing techniques, such as arthrodesis, osteoarticular and intercalary allograft bone, composite endoprosthetic implants and allografts, and expanding endoprosthetic implants. The rationale for each of these techniques is discussed and potential complications are described.
The types and frequencies of immediate and late complications following limb-sparing techniques and amputations vary depending on the site and type of procedure performed. Direct comparisons are often difficult because of differences in defining and classifying complications, varying lengths of follow-up, varying surgical techniques, and reporting bias.
Although complications from amputations are less frequent than those from limb-salvage procedures, the risk is often offset by perceived improvement in functionality and cosmetic appearance with limb salvage. However, complications following limb-sparing procedures will have a direct impact on future functionality and quality of life, making it imperative that patients have realistic expectations about the prosthesis and the need for further future surgeries.
Overall, there are few data to support the position that quality of life after limb salvage is substantially superior to that after amputation. However, limb-sparing tumor resection remains the current practice at most centers, despite its higher complication rate and questionable long-term durability, especially in children and adults. The authors believe this may be in part due to patient and family perception that saving the limb is the first priority.
J Clin Oncol 2002; 20:4493–4501.
“Reporting of Ethical Issues in Publications of Medical Research” by Franklin G. Miller and Donald L. Rosenstein.
Clinical reports usually include a statement that the research protocol was approved by an ethics committee, and that informed consent was obtained from the participants. However, these reports rarely describe the rationale for ethically controversial components of study design, such as placebo controls, symptom provocation, or participant deception.
The authors recommend that medical journals include a description of ethical issues, in the same way that such publications include a methods section in clinical trial reports, thus allowing readers to evaluate the research's ethical adequacy.
Additionally, investigators seldom describe the safeguards that protect participants from excessive risks or how they ensured informed consent.
The authors of this article say that heightened regulation of clinical research could improve ethical conduct and design, thereby protecting patients while improving researcher accountability and promoting public trust.
The authors recommend that medical journals include a description of pertinent ethical issues, in the same way that medical journals have a methods section in clinical trial reports. The methods section allows readers to assess the validity and reliability of the research. Similarly, a description of pertinent ethical issues would allow readers to evaluate the ethical adequacy of the research.
Whenever the design of a study has morally controversial features, justification should be provided. For example, a placebo-controlled study should include adequate justification for using a placebo control, the methodological limitations of an active-controlled trial alternative, and the safeguards in place to protect the patient.
Also, researchers should be required to describe how they assessed the ability of the participants to give informed consent and how consent was obtained if participants were decision-making impaired or were vulnerable to exploitation.
Medical journals that provide instructions to investigators concerning which pertinent ethical issues require attention and that utilize peer reviewers to assess manuscripts with these guidelines would benefit clinical research, according to the authors.
These potential benefits include encouraging consideration of controversial ethical issues by investigators and readers, improving attention to ethical issues in analysis by researchers, and possibly avoiding unwarranted ethical criticism of valuable research.
Lancet 2002; 360:1326–1328.