Stellar idea, though I would advise not to start with an expensive, randomized, double-blind, multicenter, international study - at the next PNWFF rondi, a preliminary Phase I proof-of-concept study could be performed:
Study DEOBOCF-001:
Study Title: The Effect of Bananas of the Catching of Fish, a Phase I Exploratory Study
Synopsis
Methodology:
This study is a Phase I, open-label, single-site, dose-escalation, cross-over study to explore the effect of bananas on the catching of fish. The study will consist of 3 banana doses with 3 participants in each cohort:
Cohort 1: 3 participants; 0 bananas each
Cohort 2: 3 participants; 1 banana each
Cohort 3: 3 participants: 2 bananas each
Day 1: Each participant will leave camp and enter the lake at dawn, paddle to their designated fishing spot (ie, Spot 1, 2, or 3), and commence fishing. To avoid any banana-proximity effect, all participants in a single cohort will fish within the same designated spot. Cohorts/spots will be separated by the greatest distance the Rondi lake will allow. At the end of the first 2-hour fishing period, cohorts will exchange fishing spots (ie, Cohort 1 will move to Spot 2, Cohort 2 to Spot 3, and Cohort 3 to Spot 1). At the end of the second 2-hour fishing period, cohorts will again exchange fishing spots (ie, Cohort 1 will move to Spot 3, Cohort 2 to Spot 1, and Cohort 3 to Spot 2). At the end of the third fishing period, participants will return to the Rondi campsite, register their catch number and photographs as detailed in the full protocol, open favorite beverage, and exchange fish stories.
Day 2: The process from Day 1 will be repeated with a crossover such that Cohort 1 will now have 1 banana each, Cohort 2 will have 2 bananas each, and Cohort 3 will have 0 bananas each.
Day 3: The process will again be repeated with a second crossover such that Cohort 1 will now have 2 bananas each, Cohort 2 will have 0 bananas each, and Cohort 3 will have 1 banana each.
Note: The number of participants within each cohort may be expanded to 6 participants with the approval of the PNWFF moderators.
To minimize potential bias, all participants will use the same fishing technique (ie, dry fly, nymph, streamer, etc) as determined by the Fish Adjudication Committee (FAC). The same fly and same fly line (sinking or floating), including weight and color will also be used by each participant. Participants will be asked to wear attire that is as close to identical as conditions and individual style preferences allow (tweed apparel being the recommended choice). All fish caught will be measured for length and photographed with time stamp for verification and estimation of weight. The FAC, in a blinded fashion (ie, without knowledge of the banana dose group), will determine the final weight of each fish through the examination of photographs annotated with fish length. The FAC decision on fish weight is final and will not be influenced by fish stories told around the evening campfire.
Objectives and Endpoints:
Primary Objective: The primary objective of the study is to explore the effect of bananas on fish caught.
Primary Endpoint: Number of fish caught within each banana dose group
Secondary Objective: To explore the effect of bananas on total fish biomass caught
Secondary Endpoint 1: Total estimated fish weight within each banana dose group
Secondary Endpoint 2: Total length of fish caught within each banana dose group
Exploratory Objective: To explore the effect of bananas on species of fish caught
Exploratory Endpoint 1: Number of different species caught within each banana dose group
Exploratory Endpoint 2: Total number by species within each banana dose group
Study Population
The study will include participants who are active and supportive of PNWFF. The PNWFF moderators will have final approval of participants. Prospective approval of protocol deviations to recruitment and enrollment criteria, otherwise known as protocol waivers or exemptions, is not permitted.
Key Inclusion Criteria:
- Male and female participants 10 years of age and older are eligible for inclusion
- Participants must be available to fish for 3 consecutive days at a sanctioned PNWFF Rondi
- Participants must be elitist fly fishers
- Only fly fishing equipment and tactics are permitted (Note: The use of bobbers is strictly forbidden)
- Participants must use (wear) a sanctioned personal flotation device while fishing from any floating platform
Key Exclusion Criteria:
- Individuals who are not members of PNWFF are not eligible for inclusion
- The use of bait is not allowed
- Individuals who wish to use tackle other than standard fly fishing equipment will not be eligible (see Inclusion criterion # 4)
- The use of fish finders is prohibited
Refer to the full study protocol for full inclusion and exclusion criteria and details of prohibited fishing tactics.
Statistical Considerations:
A detailed and comprehensive Statistical Analysis Plan (SAP) will be written and approved prior to database lock.
The results of this study will be reported using summary tables, figures, and data listings as appropriate. The following descriptive statistics will be used as applicable to summarize the study data, unless otherwise specified:
- Continuous variables: Number of observations (N), mean, standard deviation (SD), 90% confidence intervals (CIs), median, minimum, and maximum
- Categorical/discrete variables: Absolute frequencies and percentages.
All CIs will be 2-sided 90% CIs. All analyses are exploratory, no statistical tests will be employed.
Statistical analyses will be performed using SAS Version 9.4 or higher. Any deviation from the SAP will be reported in the final Study Report, which in accordance with EU CTR Annex IV will be released within 1 year of the end of the study.
Special Committees:
A FAC will be employed to determine the mode of fly fishing (dry, nymph, streamer) based upon Rondi conditions and their personal
idiosyncrasies. The FAC will also be responsible for determining fish weight from submitted, time-stamped, annotated photographs. Fish weight determination will ideally be performed prior to serious alcohol consumption. The FAC will be appointed by the PNWFF moderators or their designates. Additional details of membership and rules will be outlined in the FAC Charter.
