2.1.5 Pre-specification - Revision history

ChristophEmmerich at 13:03, 24 March 2021

2021-03-24T13:03:18Z

Bjoerngerlach at 17:11, 5 September 2020

2020-09-05T17:11:46Z

Bjoerngerlach at 13:48, 2 September 2020

2020-09-02T13:48:07Z

Bjoerngerlach: Created page with "== A. Background & Definitions == Pre-specification is a protective measure against so called "rationalization" („making excuses“), a defense mechanism in which..."

2020-09-02T13:47:35Z

Created page with "== A. Background & Definitions == Pre-specification is a protective measure against so called "rationalization" („making excuses“), a defense mechanism in which..."

New page

== A. Background & Definitions ==

Pre-specification is a protective measure against so called "rationalization" („making excuses“), a defense mechanism in which controversial or questionable behaviors or feelings are justified and explained in a seemingly rational or logical manner to avoid the true explanation, and are made consciously tolerable - or even admirable and superior - by plausible means (e.g. "I didn't get the job that I applied for, but I really didn't want it in the first place").

An example of a situation when rationalization mechanisms can get engaged:
* You are running an experiment and there is a sudden noise, vibration or some other factor
* You get angry but cannot do anything other than recording in your lab journal that such event occurred at this particular time point
* When analyzing the data, you notice that one of the subjects / data points behaves strange and it is exactly when that disturbing interference occurred
* If including or excluding this subject or data point makes the results appear differently, what do you do?

Pre-specification aims to protect scientists from giving a wrong answer to the question above and, thereby, supports generation of unbiased results.

Pre-specification is mechanistically similar to precommitment or self-binding when we make the decision before being in the tempting situation (e.g. take a limited amount of money with you to curtail spending; have only healthy foods at home to avoid the temptation to go astray).

Thus, pre-specification is about a strategy that we may use to restrict the number of choices available to us at a future time.

== B. Guidance & Expectations ==

EQIPD advises to pre-specify key study and analysis details irrespective of the purpose of research.

For knowledge-claiming research ([[Purpose of research]]), pre-specification is mandatory and should cover all key study and analysis details as well as the key decisions, e.g.:
* study hypothesis
* data analysis plan (including statistical methods to be applied)
* inclusion and exclusion criteria (including criteria for "outliers")
* primary outcome measure
* if applicable, interpretation of the study results dependent on performance of the control groups or treatments (e.g. is the study declared "failed study" if a positive control fails)
* if applicable, decisions to be made if the primary outcome is met or not met

It is recommended that pre-specification is documented by the same scientist who prepares and documents the [[Study (experimental) plan]].

Pre-specification requires no special training and can be completed as a free-text summarizing the study and analysis details that are to be pre-specified.

Information about pre-specified study design and analysis details should be saved in a manner that:
* identifies the author and time of creation
* is protected against deletion and unauthorized modification
* is retrievable and readable

The most optimal way of performing pre-specification is by storing pre-specified information in a laboratory notebook (e.g. electronic) as part of a [[Study (experimental) plan]].

Pre-specification may also be conducted by means of [[Preregistration]] of the study plans.

Any amendments to pre-specified study design and analysis details should be properly documented (dated, signed, etc.).

'''PLEASE DO NOT FORGET'''

To check whether the means chosen for pre-specification ensure safe and secure storage of pre-specified information
To consider adding this subject to an awarenss training program for new employees or refresher training

== C. Resources ==

Precommitment (Wikipedia article) - link

-------------------

back to [[Toolbox]]

Next item: [[2.1.6 Sample size and power analysis]]

@@ Line 31: / Line 31: @@
 * if applicable, decisions to be made if the primary outcome is met or not met
-It is recommended that pre-specification is documented by the same scientist who prepares and documents the [[2.1.1 Study (experimental) plan]].
+It is recommended that pre-specification is documented by the same scientist who prepares and documents the [[2.1.1 Study protocol]].
 Pre-specification requires no special training and can be completed as a free-text summarizing the study and analysis details that are to be pre-specified.
@@ Line 40: / Line 40: @@
 * is retrievable and readable
-The most optimal way of performing pre-specification is by storing pre-specified information in a laboratory notebook (e.g. electronic) as part of a [[2.1.1 Study (experimental) plan]].
+The most optimal way of performing pre-specification is by storing pre-specified information in a laboratory notebook (e.g. electronic) as part of a [[2.1.1 Study protocol]].
 Pre-specification may also be conducted by means of [[2.1.11 Preregistration]] of the study plans.

← Older revision		Revision as of 13:48, 2 September 2020
Line 55:		Line 55:


−	Precommitment (Wikipedia article) ~~- link~~	+	Precommitment (Wikipedia article) [https://en.wikipedia.org/wiki/Precommitment]

@@ Line 23: / Line 23: @@
 EQIPD advises to pre-specify key study and analysis details irrespective of the purpose of research.
-For knowledge-claiming research ([[Purpose of research]]), pre-specification is mandatory and should cover all key study and analysis details as well as the key decisions, e.g.:
+For knowledge-claiming research ([[2.1.4 Purpose of research]]), pre-specification is mandatory and should cover all key study and analysis details as well as the key decisions, e.g.:
 * study hypothesis
 * data analysis plan (including statistical methods to be applied)
@@ Line 31: / Line 31: @@
 * if applicable, decisions to be made if the primary outcome is met or not met
-It is recommended that pre-specification is documented by the same scientist who prepares and documents the [[Study (experimental) plan]].
+It is recommended that pre-specification is documented by the same scientist who prepares and documents the [[2.1.1 Study (experimental) plan]].
 Pre-specification requires no special training and can be completed as a free-text summarizing the study and analysis details that are to be pre-specified.
@@ Line 40: / Line 40: @@
 * is retrievable and readable
-The most optimal way of performing pre-specification is by storing pre-specified information in a laboratory notebook (e.g. electronic) as part of a [[Study (experimental) plan]].
+The most optimal way of performing pre-specification is by storing pre-specified information in a laboratory notebook (e.g. electronic) as part of a [[2.1.1 Study (experimental) plan]].
-Pre-specification may also be conducted by means of [[Preregistration]] of the study plans.
+Pre-specification may also be conducted by means of [[2.1.11 Preregistration]] of the study plans.
 Any amendments to pre-specified study design and analysis details should be properly documented (dated, signed, etc.).
 '''PLEASE DO NOT FORGET'''
@@ Line 53: / Line 54: @@
 == C. Resources ==
 Precommitment (Wikipedia article) [https://en.wikipedia.org/wiki/Precommitment]

2.1.5 Pre-specification - Revision history

ChristophEmmerich at 13:03, 24 March 2021

Bjoerngerlach at 17:11, 5 September 2020

Bjoerngerlach at 13:48, 2 September 2020

Bjoerngerlach: Created page with "== ​​​A. Background & Definitions == Pre-specification is a protective measure against so called "rationalization" („making excuses“), a defense mechanism in which..."

Bjoerngerlach: Created page with "== A. Background & Definitions == Pre-specification is a protective measure against so called "rationalization" („making excuses“), a defense mechanism in which..."