Considerations in determining sample size for pilot studies.
ABSTRACT There is little published guidance concerning how large a pilot study should be. General guidelines, for example using 10% of the sample required for a full study, may be inadequate for aims such as assessment of the adequacy of instrumentation or providing statistical estimates for a larger study. This article illustrates how confidence intervals constructed around a desired or anticipated value can help determine the sample size needed. Samples ranging in size from 10 to 40 per group are evaluated for their adequacy in providing estimates precise enough to meet a variety of possible aims. General sample size guidelines by type of aim are offered.
- SourceAvailable from: Jane Turner
Dataset: Protocol. Trials
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ABSTRACT: Despite the use of evidence-based preventive measures, delirium affects about 40% of patients following cardiac surgery with the potential for serious clinical complications and anxiety for caregivers. There is some evidence that family involvement as a core component of delirium management may be beneficial since familiarity helps patients stay in contact with reality, however, this merits further investigation. There is also currently a gap in the scientific literature regarding objective indicators that could enhance early detection and monitoring of delirium. Therefore, this randomized pilot trial examines the acceptability, feasibility, and preliminary efficacy of an experimental nursing intervention to help family caregivers manage post-cardiac surgery delirium in their relatives. It also explores the validity of a new and innovative measure that has potential as an indicator for delirium.Methods/design: In this two-group randomized pilot study (n = 30), the control group will receive usual care and the intervention group will receive the experimental intervention aimed at reducing delirium severity. The intervention nurse's objective will be to foster the family caregiver's self-efficacy in behaving in a supportive manner during delirium episodes. Data will be collected from standard delirium assessment scales and a novel measure of delirium, i.e., cerebral oximetry obtained using near infrared spectroscopy, as well as medical records and participants' responses to questionnaires.Trials. 07/2014; 15(1):306.
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ABSTRACT: Purpose: This study explored the expectations of patients with chronic obstructive pulmonary disease (COPD) and family members about a family-based pulmonary rehabilitation (PR) programme; developed and implemented a family-based PR programme and explored the impacts of the intervention on patients and family members. Method: Patients with COPD and family members were interviewed. A family-based PR programme was designed. Patients' breathlessness, muscle strength, exercise tolerance, functional balance and health-related quality of life were collected pre/post-programme. Family coping and adjustment to illness were measured in patients and family members. Focus groups were conducted after the programme. Results: Patients (n = 35; 69 ± 10 years; FEV1 62 ± 15% predicted) and family members (n = 35; 57 ± 12 years) had similar expectations/needs about a PR programme. Nine dyads participated. Patients' quadriceps strength, exercise tolerance and functional balance improved significantly (all p values < 0.023). Patients and family members seem to use more positive coping behaviours (p = 0.026; p = 0.011). Patients (n = 7; 78%) and family members (n = 8; 89%) considered having more knowledge about COPD and its management. Patients felt more functional (n = 9; 100%) and reported their family members to be more active (n = 3; 38%). In family members' perspective, their relationship with the care receiver was enhanced (n = 2; 22%). Conclusions: PR programmes, if inclusive of family members, may enhance the skills of the whole family to manage COPD.Disability and Rehabilitation 09/2014; · 1.54 Impact Factor