## 10.1 Protocols

If the RQ is well-constructed, all terms are clearly defined, and the research design is clear and well explained, then collecting the data should be reasonably easy to implement. However, data collection may be time-consuming, tedious and expensive so getting the data collection correct first time is important.

Before collecting the data, a plan should be established and documented that explains exactly how the data will be obtained; Unforeseen complications are not unusual, so often a pilot study (or a practice run) is conducted before the real data collection takes place, to see if the planned procedure is practical and optimal. This plan is a draft protocol.

A pilot study allows the researcher to:

• Determine the feasibility of the data collection protocol.
• Identify unforeseen challenges.
• Obtain data that might help with sample size calculations.
• Potentially save time and money.

Definition 10.1 (Protocol) A protocol is a procedure documenting the details of the design and implementation of studies, and for data collection.
Definition 10.2 (Pilot study) A pilot study is a small test run of the study protocol, used to check that the protocol seems appropriate and practical, and to identify possible problems with the design or protocol.

After the pilot study, the planned protocol may need to be refined. Once the protocol has been finalised, then the data can be collected.

Protocols ensure repeatability of the study (to ensure successful replication of results by others) to enable others to confirm or compare results, and others can understand exactly what was done, and how:

…scientific reports must describe experiments in sufficient detail to allow other researchers to reproduce them.

(p. 3081)

Protocols should clearly indicate how design aspects (such as blinding the individuals, random allocation of treatments, etc.) will happen. This final record is the final protocol. Someone else should be able to read the protocol and approximately repeat the study (this is part of ethical research practice: Sect. 4). Diagrams can be useful to aid explanations. All studies should have a well-established protocol for describing how the study was done.

Example 10.1 (Protocol) A study examined the forward-leaning angle from which people could recover and not fall, to determine if this angle was different (on average) for younger and older people. The paper goes into great detail to explain the protocol (almost 1.5 pages, plus a diagram).

Example 10.2 (Protocol) Consider this partial protocol, which shows ethics and honesty in describing a protocol:

Fresh cow dung was obtained from free-ranging, grass fed, and antibiotic-free Milking Shorthorn cows (Bos taurus) in the Tilden Regional Park in Berkeley, CA. Resting cows were approached with caution and startled by loud shouting, whereupon the cows rapidly stood up, defecated, and moved away from the source of the annoyance. Dung was collected in ZipLoc bags (1 gallon), snap-frozen and stored at $$-80$$ C.

, p. 10

A study examined three different types of male catheters, to compare ‘withdrawal friction force.’ The paper goes into great detail to explain the protocols (almost a whole page, plus a (painful-looking) diagram).

In addition, the exclusion criterion are given as:

Subjects with experience of recurrent urinary tract infections, known congenital urogenital abnormalities or known urethral strictures were excluded from participation.

, p. 979

One approach to documenting the data collection process is to use the STAR method:

• S (Structured): The protocol is organised logically, with attention to detail.
• T (Transparent): All the necessary information is provided: the protocol is transparent, comprehensive and accurate.
• A (Accessible): The protocol is easy to access, easy to follow, and easy to comprehend.
• R (Reporting):
The protocol is reported in whole and in detail, so it could be replicated.

### References

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Mendes P. Reproducible research using biomodels. Bulletin of Mathematical Biology. Springer; 2018;80(12):3081–7.
Stensballe J, Looms D, Nielsen PN, Tvede M. Hydrophilic-coated catheters for intermittent catheterisation reduce urethral microtrauma: A prospective, randomised, participant-blinded, crossover study of three different types of catheter. European Urology. 2005;48:978–83.
Wojcik LA, Thelen DG, Schultz AB, Ashton-Miller JA, Alexander NB. Age and gender differences in single-step recovery from a forward fall. Journal of Gerentology. 1999;54A(1):M44–50.