Clinical Research in Head and Neck Reconstruction

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Reconstructive head and neck surgery is not unlike other surgical fields in its paucity of clinical research. Difficulties exist in the design and execution of surgical studies, and there are many challenges and limitations that must be addressed. In this article, the types of studies that make up head and neck reconstructive literature are reviewed, as well as the evolution toward the use of quality-of-life scales, which measure patients' satisfaction with their state of health and function.

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Methodologic challenges in surgical trials

  • 1.

    Surgeons learn how to do things better with time. Given that a learning curve exists for surgical procedures, the number of procedures performed by a surgeon needs to be considered before beginning a randomized controlled trial.

  • 2.

    Surgical skills differ among surgeons. There are implications of differences between surgeons in their expertise in performing different surgeries. It may be that only the best surgeons should be involved in a trial comparing procedures, and they should be allowed to

Study designs

In simplistic terms, the two main groups of epidemiologic studies are observational and interventions. In both groups, studies can be descriptive or analytic. The main difference is that observation studies identify associations, while analytical studies explore causal relationships. Table 1 depicts the study types that fall within this framework.

True randomized prospective trials (Level I evidence, also termed randomized, controlled trials or RCT) are infrequent in head and neck surgery, and

Cohort studies

Numerous series have been published reviewing surgical options and the outcomes of reconstructive procedures for soft tissue and bony defects in the head and neck after ablation. Some series deal with the retrospective, cross-sectional review of certain types of defects and reconstruction [15], [16], [17], [18], [19]. For example, Said and colleagues [15] reported on the results of bilobed free osteocutaneous fibula flaps for through-and-through oromandibular defects. The limitations in this

Quality-of-life studies

Surgical treatment always aims to improve the quality of life (QOL) by improving function or form, to reduce troublesome symptoms such as pain, and to improve the overall sense of well-being. Sometimes surgery succeeds in prolonging life by eradicating a disease, but where symptoms dominate the patient's experience, the priority becomes relief of these symptoms where it can be achieved.

Head and neck cancers rank among the most debilitating maladies known, affecting key contributors to a

Quality-of-life instruments

The concept of “health-related quality of life,” although intuitive, is nevertheless elusive. What would be “good” quality of life for one person might be “poor” quality for another. Because this cannot be standardized in an absolute sense, the work in this area accepts that the individual patient defines what their own quality of life is from their own perspective. This perspective can be assessed by general or global measures that look at the patient's overall satisfaction with the state of

Problems and cautions in head and neck surgery quality-of-life studies

Progress in QOL studies in head and neck cancer surgery are hampered by a number of potential problems. The significance of this depends on the question that the study hopes to answer. For instance, for some questions, only a few patients might be required. The following is a list of limitations in head and neck surgery studies:

  • 1.

    Lack of a uniformly accepted score or system, which would describe the extent of the anatomical defect and physiologic disruption resulting from the various resections.

Possible solutions to the head and neck quality of life problems

  • 1.

    Multicenter studies may help overcome the few patients available in any one center. This will be expensive, as it requires an infrastructure to be developed for any trial. Once the pattern is established, subsequent studies should be easier. Another alternative is to provide the raw demographic and staging data, as well as QOL domain scores, in case series publications, so that meta-analysis can eventually be performed.

  • 2.

    Trials should be designed with QOL outcomes as the primary measure. The

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