Patient Involvement in the Design of a Patient-Centered Clinical Trial to Promote Adherence to Supplemental Oxygen Therapy in COPD.

BACKGROUND: Patients are increasingly viewed as key stakeholders who can contribute in meaningful ways to clinical research and are emphasized in research funded by the Patient-Centered Outcomes Research Institute (PCORI). We are not aware of other peer-reviewed publications that report methods and outcomes of patient engagement to refine study design for a PCORI-sponsored clinical effectiveness trial. OBJECTIVE: The aim of this report was to describe the process and outcomes of involving patients in the design of a clinical trial to promote adherence to supplemental oxygen therapy among patients with chronic obstructive pulmonary disease. METHODS: In-person focus groups and individual discussions via telephone and email were used to elicit feedback to refine the intervention and clarify outcomes of highest importance to patients. RESULTS: A total of 25 patients and five caregivers provided feedback. Their feedback has informed decisions regarding the length of intervention sessions (20 min and in some cases longer was acceptable), the importance of including caregivers, and discussion topics (e.g., social discomfort about using oxygen in public, identifying personally relevant reasons to use oxygen, pulmonary rehabilitation). Multiple outcomes were rated as highly important to patients (physical function, fatigue, sleep, anxiety, depression, and ability to participate in social roles and activities), and the outcome that was ranked as most important varied by individual. Therefore, multiple patient-reported outcomes will be used as endpoints for the clinical trial. CONCLUSIONS: Patient involvement led to refinements of the intervention and clinical trial endpoints to better address the expressed needs and concerns of patients and caregivers.

Clinical care pathway for head and neck cancer: a valuable tool for decreasing resource utilization.

OBJECTIVE: To evaluate the durability over time of the reduction of resource utilization after implementing a clinical care pathway (CCP) for head and neck cancer surgery. DESIGN: Cohort study. SETTING: A tertiary care academic medical center. PATIENTS: We studied control subjects from 1995 (pre-CCP) (n = 87), a cohort from July 1, 1996, through July 31, 1997 (the first year after CCP implementation) (n = 43), and a cohort from 1999 (n = 82) after major resection and tracheostomy for upper aerodigestive tract cancer. INTERVENTIONS: Starting July 1, 1996, all patients undergoing major resection for head and neck cancer were treated using a CCP, which delineates daily interventions and goals. MAIN OUTCOME MEASURES: Length of stay (LOS), readmission and complication rates, and hospital charges. RESULTS: Median total LOS and LOS exclusive of the intensive care unit decreased in the first year and remained stable at 3 years (from 13.0 to 8.0 days and from 10.5 to 6.4 days, respectively). The intensive care unit LOS decreased across 3 years from 2.2 to 1.1 days (P=.001). Median total charges declined from 105,410 US dollars pre-CCP to 65,919 US dollars at 3 years. Incidence of postoperative pneumonia decreased from 12% to 1% (P=.02), and readmission rate decreased from 18% to 11% (P=.37) across 3 years. CONCLUSIONS: The CCP for head and neck cancer maintained the improvement in LOS and charges seen in the first year of implementation and continues to decrease resource utilization while enhancing quality of care.