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Where patients are willing, two additional questions are asked to those that decline to participate in the trial to capture their treatment preference and expectations with respect to acupuncture and an advice & exercise treatment package.
The "Collecting health outcomes and economic data on hospitalized Community Acquired Pneumonia (CHO-CAP) – a prospective cohort study" is executed alongside the Community Acquired Pneumonia Immunization Trial with Adults (CAPiTA trial) to capture health outcomes and economic data of elderly hospitalized with CAP and matched controls without CAP.
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Unfortunately, given the need for longer trials to capture the preventive nature of CAIM, trial participants are generally only followed for one year or less [ 20].
The HUI may also be preferable if the purpose of the trial is to capture elements of HRQL that are restricted to 'within the skin' phenomena.
Side effects were classified using the Common Terminology Criteria for Adverse Events (CTC-AE) version 4, with further data captured using a validated neurotoxicity questionnaire and pre/post trial questionnaires to capture demographics and concerns regarding curcumin consumption.
22– 27, 27, 41 The effect of statins on clinical outcomes is modeled based on their effects on plasma lipid levels (primarily the total cholesterol to HDL-C ratio) and other pleiotropic effects, calibrated against trial results to capture additional benefits of treatment beyond those resulting directly from lipid biomarker changes.
Further, recent improvements in the treatment of cardiovascular disease have changed the scope of relevant outcomes that prevention trials seek to capture.
A growing emphasis is placed on "pragmatic" trials designed to capture the overall impact of acupuncture as a whole system vis-à-vis the fragmented "drug model" of trials [ 71].
11 Investigators have evaluated the use of pegylated liposomal doxorubicin (PLD) in several phase II clinical trials, trying to capture the efficacy of doxorubicin while minimizing the side effects like cardiac toxicity and myelosuppression.
Where general practitioner visits are expected to vary significantly between intervention and control groups we recommend that administrative data be included in the trial to accurately capture resources for an economic evaluation.
This is the first large study in the context of a phase III HIV prevention trial to systematically capture detailed prospective information about the role of the male partner in women's study participation and product use.
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