The Christmas BMJ article

This year in the aim of collaborative SOuRCe working, we would like to submit a paper for the Christmas BMJ titled:

MOET Medics: Does the use of a teaspoon help maintain champagne's fizziness?

Dates:

• Protocol design: 15th January 2019
• Feasibility trial:
• Data collection:
• Submission to BMJ: June 2019

Collaborative working

To acheive the publication in true collaborative fashion, we will need assistance in certain elements of the protocol development, feasibility trial, data collection and analysis. Please can you put yourself forward to a role:

Protocol development: We have a very rough first draft attached below. please comment on it in the google drive version so we can track comments and any changes.

CRF development: We have created an example of the primary outcome measure Case Report Form. Again comment within the google drive document so we can track this.

Statistical Analysis Plan: Any budding statisticians if you could come up with a proposed SAP (one to two paragraphs)

Literature review: when ready for publication we will need to discuss previous work. Any one who wouldnt mind

Anybody who contributes will put as an author as part of the SOuRCe Christmas BMJ submission in June 2019.

Summary of protocol

Research title

To evaluate the effectiveness of a teaspoon at maintaining champagne fizziness?

Research Question

Does the insertion of a teaspoon maintain the fizziness of champagne compared to standard practice?

Hypothesis

The use of a teaspoon increases the fizziness of chamagne at multiple time-points following opening.

Type of trial:

MOET Medics is a single -centre, assessor-blinded, two-armed, parallel group, randomised controlled clinical trial assessing the effectiveness of a teaspoon at maintaining fizziness of a 201… bottle of MOET. This trial is being designed and coordinated by the Surgical Outcomes Research Centre with the assistance of the Surgical Interventions and Trials unit.

Trial design and methods:

This is a phase III single-centre randomised controlled trial evaluating the effectiveness of a teaspoon at maintaining the fizziness of a 201… bottle of MOET.

Moet bottles will be screen for recruitment prior to the trial. Those meeting the inclusion criteria will be recruited to participate in the trial before randomisation into either a standard practice arm or intervention arm.

All Moet randomised to either the standard practise or intervention arm will be maintained at a temperature of …… for a minimum of 24 hours before opening.

Trial arms:

Following screening and recruitment to the trial, MOET bottle will be randomised (1:1) into either an intervention or standard care (control) group.

Standard care arm (Control):

MOET bottles randomised to the standard care arm will be managed as per Following opening the bottles will be maintained at a temperature of …

Intervention arm:

Moet bottles allocated to the intervention arm will receive the same management as the standard care arm, as well as the insertion of standard ….mm NHS teaspoon acquired from the hospital canteen. We are unable to ascertain the metallurgic composition of the teaspoon.

Trial Participant participation

Talk about the visits and protocol of opening all the bottles at the same time and then inserting all into fridge at specific times so that all bottles are opened at same point for testing.

• Spit out ??????
• Water in-between.

Primary outcomes

Fizziness will be assessed at multiple time points through a 100mm visual analogue scale.

• The sensation of fizziness on the tongue.

Secondary outcome

• Visual Analogue Scale: Bubble size
• Visual Analogue Scale: Consumer satisfaction

Trial duration per participant:

The time between opening and consumption. Maximum duration 24 hours.

Estimated total trial duration:

24 hours.

Planned trial sites:

• Single-centre study

Total number of participants planned:

Local feasibility data for the primary outcome measure was obtained by the Surgical Outcomes Research Centre at Univeristy College London Hospitl.

A total of … observers provided visual analogue scale scores for a single bottle of 201... Moet immediately following opening. The bottle had been maintained at a controlled temperature of …. For the preceding twenty-four hours. These observer scores would represent the control arm in the randomised controlled trial.

A sample size of …. Observers was calculated to detect a …mm difference between the control and intervention arms at 5% significance with 90% power.

This was calculated using a standard deviation of …. , obtained from a local feasibility study collating scores of …. Observers. We did not adjust the sample size to account for standard medical research attrition as we felt this was highly unlikely to occur.

The sample size calculation was performed by the trial statistician Dr ……. . We have not powered for subgroup analysis in the initial sample size calculation.

Main inclusion/exclusion criteria:

The main inclusion criteria are:

• Vintage 2017

Bottles will be excluded from the trial if:

• There is visible external bottle damage or damage to the cork

Assessors will be excluded from the trial if:

• Starting (baseline) level of inebriation exceeds the ability to perform assessment.
• 
  

Statistical methodology and analysis:

We will analyse using an intention-to-treat approach. Our primary analysis will compare mean observer fizziness scores at 24 hours following opening. Comparison between trial arms will be performed through a …….

Additional analyses will compare fizziness at 0,1,2,4,8 and 24 hours after surgery.