***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Pilot studies for phase III trials - which are comparative r and omized trials design ed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas . Also commonly know as " feasibility " or " vanguard " studies , they are design ed to assess the safety of treatment or interventions ; to assess recruitment potential ; to assess the feasibility of international collaboration or coordination for multicentre trials ; to increase clinical experience with the study medication or intervention for the phase III trials . They are the best way to assess feasibility of a large , expensive full-scale study , and in fact are an almost essential pre-requisite . Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies . The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including : 1 ) the general reasons for conducting a pilot study ; 2 ) the relationships between pilot studies , proof-of-concept studies , and adaptive design s ; 3 ) the challenges of and misconceptions about pilot studies ; 4 ) the criteria for evaluating the success of a pilot study ; 5 ) frequently asked questions about pilot studies ; 7 ) some ethical aspects related to pilot studies ; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format Background Falls among hospitalised patients impose a considerable burden on health systems globally and prevention is a priority . Some patient-level interventions have been effective in reducing falls , but others have not . An alternative and promising approach to reducing inpatient falls is through the modification of the hospital physical environment and the night lighting of hospital wards is a leading c and i date for investigation . In this pilot trial , we will determine the feasibility of conducting a main trial to evaluate the effects of modified night lighting on inpatient ward level fall rates . We will test also the feasibility of collecting novel forms of patient level data through a concurrent observational sub- study . Methods / design A stepped wedge , cluster r and omised controlled trial will be conducted in six inpatient wards over 14 months in a metropolitan teaching hospital in Brisbane ( Australia ) . The intervention will consist of supplementary night lighting installed across all patient rooms within study wards . The planned placement of luminaires , configurations and spectral characteristics are based on prior published research and pre-trial testing and modification . We will collect data on rates of falls on study wards ( falls per 1000 patient days ) , the proportion of patients who fall once or more , and average length of stay . We will recruit two patients per ward per month to a concurrent observational sub- study aim ed at underst and ing potential impacts on a range of patient sleep and mobility behaviour . The effect on the environment will be monitored with sensors to detect variation in light levels and night-time room activity . We will also collect data on possible patient-level confounders including demographics , pre-admission sleep quality , reported vision , hearing impairment and functional status . Discussion This pragmatic pilot trial will assess the feasibility of conducting a main trial to investigate the effects of modified night lighting on inpatient fall rates using several new methods previously untested in the context of environmental modifications and patient safety . Pilot data collected through both parts of the trial will be utilised to inform sample size calculations , trial design and final data collection methods for a subsequent main trial . Trial registration Australian New Zeal and Clinical Trials Register ( ANZCTR ) : ACTRN12614000615684 ( cluster RCT ) and ACTRN12614000616673 ( observational sub- study ) . Date Registered : 10 June 2014 ( both studies ) . Protocol version : 1.2 ( Date d : 01 June 2014)Anticipated completion : September 2015Role of Trial Sponsor : The named sponsor for this investigator-initiated trial was the Director of the Royal Brisbane and Women ’s Hospital ( RBWH ) Safety and Quality Unit ( Therese Lee , Phone : + 61 7 3646 8111 ) . The principal investigators , SC and MA , are employed by the RBWH Safety and Quality Unit . The trial sponsor has no involvement in any aspects of study design , conduct or decision to su bmi t the report for publication . AM and MD are employed by other departments in the same organisation BACKGROUND A crucial part in the development of any intervention is the preliminary work carried out prior to a large-scale definitive trial . However , the definitions of these terms are not clear cut and many authors redefine them . Because of this , the terms feasibility and pilot are often misused . AIM To provide an introduction to the topic area of pilot and feasibility trials and draw together the work of others in the area on defining what is a pilot or feasibility study . METHODS This study used a review of definitions and advice from the published literature and from funders ' websites . Examples are used to show evidence of good practice and poor practice . RESULTS We found that research ers use different terms to describe the various stages of the research process . Some define the terms feasibility and pilot as being different whereas others argue that these terms are synonymous . All reflective papers agree that feasibility/pilot studies should not test treatment comparisons nor estimate feasible effect sizes . However , this is not universally observed in practice . SUMMARY We believe that the term ' feasibility ' should be used as an overarching term for preliminary studies and the term ' pilot ' refers to a specific type of study which resembles the intended trial in aspects such as , having a control group and r and omisation . However , studies labelled ' pilot ' should have different aims and objectives to main trials and also should include an intention for future work . Research ers should not use the title ' pilot ' for a trial which evaluates a treatment effect OBJECTIVES To determine the advantages and disadvantages of a stepped wedge design for a specific clinical application . STUDY DESIGN AND SETTING The clinical application was a pragmatic cluster r and omized surgical trial intending to find an increased percentage of curable recurrences in patients in follow-up after colorectal cancer . Advantages and disadvantages of the stepped wedge design were evaluated , and for this application , new advantages and disadvantages were presented . RESULTS A main advantage of the stepped wedge design was that the intervention rolls out to all participants , motivating patients and doctors , and a large number of patients who were included in this study . The stepped wedge design increased the complexity of the data analysis , and there were concerns regarding the informed consent procedure . The repeated measurements may bring burden to patients in terms of quality of life , satisfaction , and costs . CONCLUSION The stepped wedge design is a strong alternative for pragmatic cluster r and omized trials . The known advantages hold , whereas most of the disadvantages were not applicable to this application . The main advantage was that we were able to include a large number of patients . Main disadvantages were that the informed consent procedure can be problematic and that the analysis of the data can be complex Background A pragmatic , stepped wedge trial design can be an appealing design to evaluate complex interventions in real-life setting s. However , there are certain pitfalls that need to be considered . This paper reports on the experiences and lessons learned from the conduct of a cluster r and omized , stepped wedge trial evaluating the effect of the Hospital Elder Life Program ( HELP ) in a Dutch hospital setting to prevent older patients from developing delirium . Methods We evaluated our trial which was conducted in eight departments in two hospitals in hospitalized patients aged 70 years or older who were at risk for delirium by reflecting on the assumptions that we had and on what we intended to accomplish when we started , as compared to what we actually realized in the different phases of our study . Lessons learned on the design , the timeline , the enrollment of eligible patients and the use of routinely collected data are provided accompanied by recommendations to address challenges . Results The start of the trial was delayed which caused subsequent time schedule problems . The requirement for individual informed consent for a quality improvement project made the inclusion more prone to selection bias . Most units experienced major difficulties in including patients , leading to excluding two of the eight units from participation . This result ed in failing to include a similar number of patients in the control condition versus the intervention condition . Data on outcomes routinely collected in the electronic patient records were not accessible during the study , and appeared to be often missing during analyses . Conclusions The stepped wedge , cluster r and omized trial poses specific risks in the design and execution of research in real-life setting s of which research ers should be aware to prevent negative consequences impacting the validity of their results . Valid conclusions on the effectiveness of the HELP in the Dutch hospital setting are hampered by the limited quantity and quality of routine clinical data in our pragmatic trial . Executing a stepped wedge design in a daily practice setting using routinely collected data requires specific attention to ethical review , flexibility , a spacious time schedule , the availability of substantial capacity in the research team and early checks on the data availability and quality .Trial registration Netherl and s Trial Register , identifier : NTR3842 . Registered on 24 January 2013 Research ers should consider five questions before starting a stepped wedge trial . Why are you planning one ? Research ers sometimes think that stepped wedge trials are useful when there is little doubt about the benefit of the intervention being tested . However , if the primary reason for an intervention is to measure its effect , without equipoise there is no ethical justification for delaying implementation in some clusters . By contrast , if you are undertaking pragmatic research , where the primary reason for rolling out the intervention is for it to exert its benefits , and if phased implementation is inevitable , a stepped wedge trial is a valid option and provides better evidence than most non-r and omized evaluations . What design will you use ? Two common stepped wedge design s are based on the recruitment of a closed or open cohort . In both , individuals may experience both control and intervention conditions and you should be concerned about carry-over effects . In a third , continuous-recruitment , short-exposure design , individuals are recruited as they become eligible and experience either control or intervention condition , but not both . How will you conduct the primary analysis ? In stepped wedge trials , control of confounding factors through secular variation is essential . ‘ Vertical ’ approaches preserve r and omization and compare outcomes between r and omized groups within periods . ‘ Horizontal ’ approaches compare outcomes before and after crossover to the intervention condition . Most analysis models used in practice combine both types of comparison . The appropriate analytic strategy should be considered on a case-by-case basis . How large will your trial be ? St and ard sample size calculations for cluster r and omized trials do not accommo date the specific features of stepped wedge trials . Methods exist for many stepped wedge design s , but simulation-based calculations provide the greatest flexibility . In some scenarios , such as when the intracluster correlation coefficient is moderate or high , or the cluster size is large , a stepped wedge trial may require fewer clusters than a parallel cluster trial . How will you report your trial ? Stepped wedge trials are currently challenging to report using CONSORT principles . Research ers should consider how to demonstrate balance achieved by r and omization and how to describe trends for outcomes in both intervention and control clusters Background : Shared decision making is important to ensure that patients receive therapies aligned with their goals and values . Based upon a detailed needs assessment with diverse stakeholders , pamphlet and video decision aids for destination therapy left ventricular assist devices ( DT LVAD ) were developed to help patients and their caregivers think through , forecast , and deliberate their options . These decision aids are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients and their Caregivers Offered Destination  Therapy for  End-Stage Heart Failure ( DECIDE-LVAD ) study , a multicenter , r and omized trial aim ed at underst and ing the effectiveness and implementation of a shared decision support intervention for patients considering DT LVAD .  Methods / Design : A stepped-wedge r and omized controlled trial was design ed , guided by the RE- AIM framework and modeled after an effectiveness-implementation hybrid type II design . Six DT LVAD programs from across the United States will participate . Primary outcomes include knowledge and values-treatment concordance .  Patients with advanced heart failure who are being considered for DT LVAD and their caregivers are eligible with a target enrollment of 168 dyads . From August 2014 to January 2015 , an acceptability and feasibility pilot study was performed , which clarified opportunities and challenges around decision support for DT LVAD and result ed in significant modifications to the DECIDE-LVAD study . Discussion : Study findings will provide a foundation for implementing decision support interventions , including decision aids , with patients who have chronic progressive illness facing end-of-life decisions involving invasive , preference-sensitive therapy options We describe a framework for defining  pilot and feasibility studies  focusing on studies conducted in preparation for a r and omised controlled trial . To develop the framework , we undertook a Delphi survey ; ran an open meeting at a trial methodology conference ; conducted a review of definitions outside the health research context ; consulted experts at an international consensus meeting ; and review ed 27 empirical pilot or feasibility studies . We initially adopted mutually exclusive definitions of pilot and feasibility studies . However , some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions . Their viewpoint was supported by definitions outside the health research context , the use of the terms ‘ pilot ’ and ‘ feasibility ’ in the literature , and participants at the international consensus meeting . In our framework , pilot studies are a subset of feasibility studies , rather than the two being mutually exclusive . A feasibility study asks whether something can be done , should we proceed with it , and if so , how . A pilot study asks the same questions but also has a specific design feature : in a pilot study a future study , or part of a future study , is conducted on a smaller scale . We suggest that to facilitate their identification , these studies should be clearly identified using the terms ‘ feasibility ’ or ‘ pilot ’ as appropriate . This should include feasibility studies that are largely qualitative ; we found these difficult to identify in electronic search es because research ers rarely used the term ‘ feasibility ’ in the title or abstract of such studies . Investigators should also report appropriate objectives and methods related to feasibility ; and give clear confirmation that their study is in preparation for a future r and omised controlled trial design ed to assess the effect of an intervention The Consoli date d St and ards of Reporting Trials ( CONSORT ) statement is a guideline design ed to improve the transparency and quality of the reporting of r and omised controlled trials ( RCTs ) 
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Conclusion Published feasibility studies for SW-CRTs are scarce and those that are being reported do not investigate issues specific to the complexities of the trial design .