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Table 3 Overview of guideline development methods (N = 40)

From: Guidelines for randomized clinical trial protocol content: a systematic review

Characteristic

N (%)

  Methods described (any)

 

   Yes

8 (20)

   None reported

19 (48)

   Unclear*

13 (33)

  Consensus process

6 (15)

   Formal (for example, Delphi)

0 (0)

   Informal consensus and/or consensus meeting(s)

4 (10)

  Pilot testing

2 (5)

  Validation

 

   Formal validation

1 (3)

   Informal validation - shared with a broader circle of experts (for example, for face validity)

5 (13)

   Future plans to validate

1 (3)

  Search for existing guidance/evidence to inform guideline recommendations

 

   Yes

2 (5)

     Search for previous guidelines

2 (5)

        Systematic

0 (0)

     Search for empirical evidence

1 (3)

        Systematic

0 (0)

   None reported

34 (85)

   At least one empirical study referenced to support at least one guideline item - methods of searching not reported

3 (8)

   Unclear

1 (3)

  Number of authors/stated contributors - median (IQR); range

2 (1, 3); 1 to 88

   Not stated

11 (28)

  Time frame for guideline development (years) [n = 4 guidelines] - median (IQR); range

4 (2, 4); 1 to 5

  1. * If no methods were described, institutional guidelines were inferred to have some form of consensus and were labeled as unclear.