The IOM stated that survivorship care plans "have strong face validity and can reasonably be assumed to improve care unless and until evidence accumulates to the
Table 5. Examples of Key Quality of Care Research Questions for Cancer Survivors
• Basic science studies to elucidate the mechanisms of late effects
• Observational studies to assess the incidence and predictors of late effects
• Clinical trials of interventions (medical, psychological, risk behaviors) to prevent or reduce the severity of physical or psychological late effects
• Evaluation of the effectiveness of different surveillance strategies on survival, quality of life, and cost
• Examining whether disparities exist in the quality of care provided to survivors of different ages, racial and ethnic groups, sexes, socioeconomic status, and diagnoses
• Exploring the effect of cancer on a survivor's family and caregivers
• Development and validation of instruments able to capture important outcomes specific to the survivor population
• Observational studies to determine survivors' knowledge of the content of the survivorship care plan (i.e., their diagnosis, previous treatment, plan for surveillance and monitoring, resources available and who to turn to for different problems, etc.)
• Assessing variation in practice patterns and outcomes by geography, patient and provider characteristics, organizational and insurance structure, etc., and whether disparities in the quality of follow-up care exist
• Determining the current and optimal levels of involvement of different specialists and PCPs in cancer follow-up and ongoing care
• Evaluating ways to optimize portability of medical records (smart cards, web-based data) for the increasingly mobile survivor population
• Determining the cost-effectiveness of different survivorship care plan strategies
• Creating and validating quality measures related to survivorship care plans contrary" and calls for research to assess both the effectiveness and cost-effectiveness of survivorship care plans, as well as their acceptance by both cancer survivors and health care providers. Table 5 provides examples of quality of care research questions important for the management of the growing survivor population. Survivorship research presents several methodological challenges, however, especially when looking at interventions such as surveillance that may affect survival outcomes. Randomized trials are required because nonrandomized studies are susceptible to lead-time and length-time biases. Randomized trials are logistically difficult and expensive to carry out, however, because they have to be very large to detect usually very small differences. Furthermore, what is tested is generally a complex strategy, and so the chosen components, frequency, and duration of surveillance are open to question. Moreover, overall survival outcomes may be confounded by ever improving treatment for relapsed disease. Recent changes in privacy laws can be a barrier to population-based survivorship research by preventing researchers from identifying and contacting former patients. Despite these problems, investment in survivorship research must continue. The evolution of cancer therapies means that late effects we see now may be replaced by new unanticipated concerns for our current patients in years to come. Consequently, information is needed ranging from basic science studies to delineate mechanisms of late effects, to health services research to ensure that outcomes are optimized with good value for the money.
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