The Gold Standard Publication Checklist (GSPC)

The full paper has extensive text and an analysis of the guidelines for authors in nine publications. Figure 1 (reformatted for this web site) is shown below. Authors should consider every point listed although not all will be relevant to every paper.

lntroduction:

Background information

  • Description of the literature concerning the topic of the paper, including a short (global) description about how the results have been achieved/obtained
  • Description of the gaps in the current knowledge concerning the topic
  • The aim or objective of the current study

The research question or hypothesis

  • Specific and focused
  • Use the PICO(T) mnemonic, if possible:
    • Patient Group or Animal species
    • Intervention (or exposure)
    • Comparison/Control Group
    • Outcome measure
    • If applicable:
    • Time (duration of intervention)

The clinical relevance or other relevance of research

  • Reasons why a specific animal model has been chosen; and
  • The specific characteristics of the animal model

Methods:

Experimental design (if possible)

 For example:

  • Completely randomised design
  • Block design
  • Factorial design
  • Repeated measures design
  • Sequential design

Experimental groups and controls

  • Quarantine and acclimatisation period after transportation to animal facility
  • Species
  • Designation of strain (exact genetic code)
  • Origin and source of animals
  • Genetic background (outbred, inbred, F1 hybrid, mutant, transgenic, congenic, consomic, etc.) and generation
  • Definition of the experimental unit (individual animal/animals in one cage)
  • Number of animals per group (and possibly power and sample size calculations)
  • Sex
  • Age (at the beginning and the end of the experiment)
  • Weight (at the start of the experiment)
  • Microbiological status
    • Conventional/specified pathogen-free (SPF)/gnotobiotic, germ-free
    • Measures to protect microbiological status (for example, open-system, closed-system (SPF), individually ventilated cage racks, isolation unit)
  • Housing: Animal room
    • Temperature * range (regulated or not)
    • Relative humidity + range (regulated or not)
    • Ventilation
    • Over-pressure or under-pressure
    • Air changes per hour
  • Lighting
    • Natural or artificial
    • Number of hours light per 24 hours
    • Light intensity
    • Time when light is switched on
    • Transitional decrease in light intensity
  • Noise (music, etc.)
  • Housing: Cages
    • Type and size
    • Number of animals per cage (and if individually housed, why?)
    • Bedding (reference; if not, type). Is batch analysis certificate available? Pretreatment?
    • Presence and type of cage-enrichment
    • Frequency of cage change
    • Frequency of handling
  • Nutrition
    • Type (natural-ingredient diets, chemically defined diets or purified diets)
    • Composition or batch number (if possible, use a reference)
    • Pretreatment
    • Feeding regimes (ad libitum, meal feeding, restricted, etc.). If not ad libitum:
      • Amount of food given
      • Frequency and time of feeding
  • Water
    • Type (analysis certificate available?)
    • Pretreatment (concentration of acidification or chlorination)
    • Water schedule
    • Quantity (ad libitum?)
    • Frequency of water supply (in case of restriction)
    • Frequency of change
    • Bottles or automatic watering system
  • Method of allocation to treatment group: i.e. randomly assigning animals to a specific group
  • Description of how the disease or intervention is defined in the animal
  • Description of the reasons to exclude animals from the experiment
  • Description of the control groups in the experiment, and an explanation of why these specific control groups are
  • important for answering the research question

Regulations and ethics

  • Description of compliance to national regulatory principles
  • Description of the ethical and qualitative assessment by an independent organisation within the institute. (e.g. Institutional Ethics Committee)

The intervention

  • Time schedule
    • Day and time of intervention within experiment
    • Time between intervention and sampling or processing
  • Type of intervention
    • Description of operation techniques or other techniques and materials used
    • Dose and/or frequency of intervention (when applicable)
    • Administration route (enteral [oral or via the anus]/parenteral/trans-dermal)
    • Drugs and dose tested (product name, manufacturer, concentration)
    • Other products used (product name, manufacturer, concentration)
    • Method and time of sampling (blood, urine, etc.)
    • Anesthesia (duration, type of drug and method)
    • Analgesia (type of drug and method)
    • Euthanasia (type of drug and method)
    • Description of general well being of the animal during and at the end of the intervention and - in the case of compromised well being - what relieving measures have been taken

Outcome

  • Description of parameters of interest, and the method of determination
    • Inclusion also of important physiological parameters and reference values to define well being of the animal
  • Description whether, or how, the staff was blinded to the treatment modality
  • Description of the statistics used

Results:

  • Description of the main results
  • Numbers and reasons of premature deaths during the experiments (short description of autopsy findings)
  • Excluded animals (numbers and reasons why they were excluded)
  • Total numbers of animals included in the statistical analyses
  • Short description/explanation of included animals with peculiarities
  • Power analysis after adjustment for diseased and excluded animals (to determine the reliability of the study)
  • Description of the most important relevant physiological parameters during intervention (like temperature, body weight, heart rate, etc.)

Discussion:

  • Discussion of principal findings
  • Discussion of the (indirect) clinical and overall scientific relevance of the outcome
  • Definition of whether or not follow up studies are necessary
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