Pilot Guidelines
Athenasby Regalado
The rule for operating unmanned aircraft systems (UAS) or drones under 55 pounds in the National Airspace System (NAS) is 14 CFR Part 107, referred to as the Small UAS Rule. However, if you want to fly a drone for purely recreational purposes, there is a limited statutory exception ("carve out") that provides a basic set of requirements.
Many people assume that a recreational flight simply means not flying for a business or being compensated. But, that's not always the case. Compensation, or the lack of it, is not what determines if a flight was recreational or not. Before you fly your drone, you need to know which regulations apply to your flight.
The Exception for Limited Recreational Operations of Unmanned Aircraft (USC 44809) is the law that describes how, when, and where you can fly drones for recreational purposes. Following these rules helps keep people, your drone and our airspace safe:
Fly at or below 400 feet in Class G (uncontrolled) airspace.
Note: Anyone flying a drone in the U.S. National Airspace System (NAS) is responsible for flying within the FAA guidelines and regulations. That means it is up to you as a drone pilot to know the rules: Where Can I Fly?
Have a current FAA registration, mark (PDF) your drones on the outside with the registration number, and carry proof of registration with you when flying.
Note: Beginning September 16, 2023, if your drone requires an FAA registration number it will also be required to broadcast Remote ID information (unless flown within a FRIA). For more information on drone registration, visit How to Register Your Drone.
These publications have focused on guidelines for reporting randomised pilot and feasibility trials, but as the number of manuscript submissions to the journal continues to increase (by 200% from 2015 to 2018), there has arisen a need for some guidance on the reporting of non-randomised pilot and feasibility studies. Many non-randomised studies are undertaken before a randomised pilot or feasibility trial takes place and may comprise a wide spectrum of study designs. In this editorial, we discuss the most common types of non-randomised studies seen in the journal and give guidance on how they should be reported. In most cases, we recommend referring to the CONSORT extension to pilot and feasibility trials [2, 3] as many of the items (excluding items that are specific to the randomisation nature of the study) will be relevant for reporting other types of pilot and feasibility studies, and the guideline provides helpful examples and commentary for each of the 26 items. Many other guidelines exist on the Equator (Enhancing the QUAlity and Transparency Of health Research) website ( -network.org/), and with minor amendments, some can be adapted for reporting certain types of non-randomised studies.
In the journal Pilot and Feasibility Studies, aided by the CONSORT extension to pilot and feasibility trials, authors are encouraged to report the purpose of a feasibility or pilot study in the context of the planned future study. Many types of non-randomised feasibility studies are at an earlier stage of preparation to that of a randomised pilot or feasibility trial. The proposed methodology and procedures for the main randomised controlled trial (RCT) may still be under development and not yet ready to fully pilot test. These studies usually focus on one or more related but substantive areas of development along the RCT preparatory pathway (e.g. intervention development, development of patient-reported outcome measures (PROMS), piloting of several components of the main trial and piloting the feasibility of implementation).
Moreover, not all pilot and feasibility studies relate to trials or interventional studies; some concern testing out design features of future large-scale cohort studies, such as the feasibility of roll-out across a wide area or being able to obtain buy-in from different stakeholders. Other researchers may want to test the feasibility of preliminary hypotheses of associations between variables that may be important to inform future research before any kind of intervention is developed or future study planned.
Studies that describe intervention development typically adopt mainly qualitative methods. The Template for Intervention Description and Replication (TIDieR) guideline exists for reporting intervention description [8]. Intervention development studies often describe a theoretical model that underpins the reasoning behind the intervention and through literature review or focus group work develop a feasible intervention model. This new intervention is then tried out on a small number of patients and adopted or modified as necessary.
PROM development, or development of any questionnaire-based outcome measure, has some methodological similarities to the previous section in terms of selection of the proposed items for the PROM. Items generally stem from an underlying theoretical model and literature review, aided by focus group work with some preliminary testing. The PROM is then assessed for its preliminary reliability and validity in certain patient populations related to its intended use. In our second thematic series of the journal, guest editor, Professor Georgina Jones, presents seven papers that represent the types of pilot work that might take place in PROM development, including issues of translation and back-translation for use in another language [17], time and cost of administration [18], technology-based assessment [19] and the use of e-PROMS [20]. In another study, the authors follow the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework [21] to pilot and evaluate use at clinic of an adolescent needs assessment tool for type 1 diabetes [22].
The CONSORT Patient-Reported Outcomes (PRO) guideline for the reporting of PROMs in main RCTs [23] may provide some further help but it should be adapted in line with the CONSORT extension to pilot and feasibility trials. The COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) guideline for systematic reviews of PROMs [24] is a comprehensive document to also be aware of especially when reporting aspects of preliminary reliability and validity and when considering the design of a future large-scale validation study.
Again, we would recommend using the CONSORT extension to pilot and feasibility trials as the basis for reporting such studies with suitable adaptation of items where necessary. The one published paper from the call to date describes the implementation into nutritional rehabilitation units in Malawi of the Kusamala Program, an interactive counselling programme for primary caregivers of children with severe acute malnutrition [27]. In the GLA:D Back (Good Life with osteoArthritis in Denmark) before-after study, physiotherapists and chiropractors were trained in intervention delivery of standardised care following national guidelines for low back pain to plan a future implementation-effectiveness study [28]. Another example seeks to improve the implementation of evidence-based practices by teaching the Generation Parent Management Training Oregon (GenerationPMTO) model, a parenting intervention, in a university graduate curriculum [29]. The RE-AIM framework has also been used in this context [21, 22].
While the majority of studies submitted to the journal are in preparation for a main future RCT, the journal is also open to submission of articles related to pilot and feasibility work for cohort studies or other large-scale observational studies. The STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guideline [30] provides a checklist of items that should be included in these types of reports, and most items are applicable to pilot and feasibility studies. However, care should be taken to state clearly the aims and feasibility objectives for the pilot work which should differ from those of the main future study. For this reason, it is recommended that the STROBE checklist is used alongside the CONSORT extension to pilot and feasibility trials to ensure that all items relate or are adapted to issues of feasibility.
Examples of feasibility cohort studies that have been published in the journal to date have concerned the feasibility of recruiting and following up children with respiratory tract infections in the community, including collecting microbiological, symptom severity and duration data [31], and determining the feasibility of recruiting practices and patients with apparent treatment-resistant hypertension for data collection and follow-up of outcomes [32].
Sometimes, it is necessary to test preliminary hypotheses of associations between variables which if found to be promising may lead to intervention development or other preliminary work. In other cases, the associations may be in preparation for a trial. These studies are in the minority in the journal, but there are several examples to draw upon. Some adopt observational study designs and some are non-randomised experiments. We again recommend the use of the STROBE guideline alongside the CONSORT extension to pilot and feasibility trials with suitable adaptation of items as necessary.
The two examples in Table 1 look at associations between delirium and electroencephalography (EEG) frequency band connectivity readings as potential future therapeutic and diagnostic biomarkers [33] and whether sound stimulation in the womb is associated with mouth movements in the foetus [34]. If these associations are observed, then further future research can be planned.
We have provided guidance for reporting non-randomised pilot and feasibility studies. In most cases, existing guidelines can be adapted and utilised for this purpose, and we have taken some sample guidelines from the Equator website. While we have categorised studies into several common types, as can be seen from the published examples, there is overlap in the types of studies discussed with some examples fitting under more than one sub-heading.
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