Design and analysis of pilot studies: recommendations for good practice

Pilot studies play an important role in health research, but they can be misused, mistreated and misrepresented. In this paper we focus on pilot studies that are used specifically to plan a randomized controlled trial (RCT). Citing examples from the literature, we provide a methodological framework in which to work, and discuss reasons why a pilot study might be undertaken. A well-conducted pilot study, giving a clear list of aims and objectives within a formal framework will encourage methodological rigour, ensure that the work is scientifically valid and publishable, and will lead to higher quality RCTs. It will also safeguard against pilot studies being conducted simply because of small numbers of available patients.     

我国临床药师工作现状与分析

本文分析探讨了临床药师制度试点工作开展两年以来我国临床药师的工作现状,以期对临床药学发展有所启示。本研究采用问卷调查的形式调研我国44所试点医院,深入访谈典型医院,并对结果进行统计分析。研究发现临床药师的临床药学工作较为充实,医生对其评价也很高,均为有帮助。但是,目前临床药师的临床药学工作还不能完全满足临床的需求。我国临床药学处于Hutchinson模型中回顾性评估药物治疗方法阶段,临床药师在数量和质量方面有待提高。     

事故后飞行员个性特征对心理干预需求影响因素的研究

目的探讨事故后飞行员个性特征对心理干预需求的影响因素。方法对两个事故后飞行团72名飞行员采用进行MHI人格特征测量、心理干预需求问卷及心身相关疾病疾病评价因子调查。结果事故后飞行员具有＂反应过激型＂的个性特征者在疾病症状量表分〉2分的占56.8%。并与心理干预需求密切相关。结论事故后飞行员个性特征对其心理干预需求有较大的影响。     

Pilot Randomized Clinical Trial of an SSRI vs Bupropion: Effects on Suicidal Behavior,Ideation, and Mood in Major Depression

Randomized controlled trials in depressed patients selected for elevated suicidal risk are rare. The resultant lack of data leaves uncertainty about treatment in this population. This study compared a serotonin reuptake inhibitor with a noradrenergic/dopaminergic antidepressant in major depression with elevated suicidal risk factors. We conducted a double-blind, randomized, clinical pilot trial of paroxetine (N=36) or bupropion (N=38) in DSM IV major depression with a suicide attempt history or current suicidal ideation. The effects during acute (8 weeks) and continuation treatment (up to 16 weeks) were measured. Main outcomes were suicidal behavior and ideation. The secondary outcome was modified 17-item Hamilton Depression Rating Scale score subtracting the suicide item (mHDRS-17). Treatment was not associated with time to a suicidal event and no treatment main effect or treatment × time interaction on suicidal ideation or mHDRS-17 was found. Exploratory model selection showed modest advantages for paroxetine on: (1) mHDRS-17 (p=0.02); and (2) in a separate model adjusted for baseline depression, for suicidal ideation measured with the Beck Scale for Suicidal Ideation (p=0.03), with benefit increasing with baseline severity. Depressed patients with greater baseline suicidal ideation treated with paroxetine compared with bupropion appeared to experience greater acute improvement in suicidal ideation, after adjusting for global depression. Given the lack of evidence-based pharmacotherapy guidelines for suicidal, depressed patients—an important public health population—this preliminary finding merits further study.     

Uncoupling the functions of a multifunctional protein: the isolation of a DNA pilot protein mutant that affects particle morphogenesis

Defective øX174 H protein-mediated DNA piloting indirectly influences the entire viral lifecycle. Faulty piloting can mask the H protein's other functions or inefficient penetration may be used to explain defects in post-piloting phenomena. For example, optimal synthesis of other viral proteins requires de novo H protein biosynthesis. As low protein concentrations affect morphogenesis, protein H's assembly functions remain obscure. An H protein mutant was isolated that allowed morphogenetic effects to be characterized independent of its other functions. The mutant protein aggregates assembly intermediates. Although excess internal scaffolding protein restores capsid assembly, the resulting mutant H protein-containing particles are less infectious. In addition, nonviable phenotypes of am(H) mutants in Su⁺ hosts, which insert non-wild-type amino acids, do not always correlate with a lack of missense protein function. Phenotypes are highly influenced by host and phage physiology. This phenomenon was unique to am(H) mutants, not observed with amber mutants in other genes.     

SF-36测量战斗机飞行员腰椎间盘突出症患者生命质量的信度和效度研究

目的研究生命质量测评量表SF-36测量战斗机飞行员腰椎间盘突出症患者生命质量的信度和效度。方法用SF-36对108名战斗机飞行员腰椎间盘突出症患者进行调查,对结果进行统计分析。结果信度指标克朗巴赫α均〉0.75,23名患者重测信度。重测信度系数社会功能（SF）低于0.8。腰椎间盘突出症发作期患者在8个维度的得分明显低于健康飞行员。结论SF-36用于测评战斗机飞行员腰椎间盘突出症患者的生命质量时,具有可接受的信度和效度,可用于治疗结果评价。     

Effects of multi-source feedback on developmental plans for leaders of postgraduate medical education

Objectives  Multi-source feedback (MSF) is a widely used developmental tool for leaders in organisations including those dealing with health care. This study was performed to examine the effects of an MSF process on developmental plans made by leaders of postgraduate medical education (PGME) in clinical departments.
Methods  An MSF instrument was developed based on literature on the subject and previous investigations. The instrument was used by consultants responsible for PGME in clinical departments (CREs). Apart from CREs' self-ratings, MSF responses were collected from heads of departments, consultants and young doctors-in-training. The MSF process included individual feedback as well as guidance on drafting developmental plans for both the department and the CREs. Themes emerging in the developmental plans were analysed and compared with the areas in need of improvement identified by the MSF process.
Results  The MSF instrument was found to be feasible, valid and reliable (Cronbach's α = 0.98). The study included 52 CREs from various specialties and 498 MSF respondents. The response rate was 84%. Low ratings and negative gaps between others' ratings and self-ratings were identified for both management and leadership performance areas. The developmental plans mainly focused on management initiatives, whereas plans for the development of leadership performance were few. Areas rated low by all respondents were scarcely represented in CREs' developmental plans.
Conclusions  An MSF process might in itself lead to development in administrative areas. However, MSF carried through as a single stand-alone procedure was not sufficient to foster plans for the development of leadership performance.     

Case managers for frail older people: a randomised controlled pilot study

Scand J Caring Sci; 2010; 24; 755–763
Case managers for frail older people; a randomised controlled pilot study Aim: The aim was to test sampling and explore sample characteristics in a pilot study using a case management intervention for older people with functional dependency and repeated contact with the healthcare services as well as to investigate the effects of the intervention on perceived health and depressed mood after 3 months. The aim was also to explore internal consistency in the life satisfaction index Z, activities of daily living‐staircase and Geriatric Depression Scale‐20. Method: This pilot study was carried out in a randomised controlled design with repeated follow‐ups. In all, 46 people were consecutively and randomly assigned to either an intervention (n = 23) or a control (n = 23) group. Two nurses worked as case managers and carried out the intervention, which consisted of four parts. Result: No differences were found between the groups at baseline. The results showed the participants had low life satisfaction (median 14 vs. 12), several health complaints (median 11) and a high score on the Geriatric Depression Scale (median 6) at baseline, indicating the risk of depression. No significant effects were observed regarding depressed mood or perceived health between or within groups at follow‐up after 3 months. Cronbach′s alpha showed satisfactory internal consistency for group comparisons. Conclusions: The sampling procedure led to similar groups. The life satisfaction, functional dependency and symptoms of depression measures were reliable to use. No changes in perceived health and symptoms of depression were found after 3 months, indicating that it may be too early to expect effects. The low depression score is noteworthy and requires further research.     

Measuring the effect of patient comfort rounds on practice environment and patient satisfaction: A pilot study

Hourly rounding in the acute hospital setting has been proposed as an intervention to increase patient satisfaction and safety, and improve the nursing practice environment, but the innovation has not been adequately tested. A quasi-experimental pretest post-test non-randomized parallel group trial design was used to test the effect of hourly patient comfort rounds on patient satisfaction and nursing perceptions of the practice environment, and to evaluate research processes and instruments for a proposed larger study. A Patient Satisfaction Survey instrument was developed and used in conjunction with the Practice Environment Scale of the Nursing Work Index. Results on patient satisfaction showed no significant changes. Significant changes were found for three of the five practice environment subscales. Consistent with the aim of a pilot study, this research has provided important information related to design, instruments and process that will inform a larger sufficiently powered study.