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Effectiveness of Recombinant Human Growth Hormone (rhGH) in the Treatment of Patients with Cystic Fibrosis

Slide: 9 of 37

Clinical Questions Addressed by the CER (1)

The CER reports findings synthesized from studies that examined the effects of rhGH on CF disease characteristics, as measured by many commonly used clinical assessments: pulmonary function (forced vital capacity [FVC], forced expiratory volume in 1 second [FEV1], and percent predicted FVC and FEV1); growth (e.g., height, weight, body mass index); bone mineralization; and exercise tolerance.

In addition to intermediate clinical outcomes, the effect of rhGH on health outcomes was investigated, as reported in the included studies.

The relationships of intermediate outcomes to mortality risk and health-related quality of life (HRLoQ) for patients with CF are not well understood.  Therefore, the CER included a survey of studies that tested these links by regression analysis.