Guideline Development Process
The work on the evidence based clinical guideline started in 2011 with formation of a guideline development committee of five members and an advisor. The aim is to outline the research questions and guide subsequent literature review and discussion.
A comprehensive literature review was undertaken. Related research studies, journal articles, guidelines, and other documents relating to subcutaneous insulin injection and best practice guidelines in insulin injection published by professional organizations between 1980 to 2012 were included. Many studies before 1980 were performed with injection tools no longer in use in Hong Kong and were excluded from the result, with one exception (Koivisto & Felig 1978) that had studied skin bacteria (as alcohol swab is still in use). The reviewed publications are listed in the reference section.
Each guideline development committee member was held responsible for examining one to two research question(s), studying relevant literature to develop recommendations. The members as a whole reviewed the recommendations, discussed gaps, available evidence, and came to consensus in a first draft guideline by 2012.
The draft was then discussed and refined in 8 meetings where the research questions, recommendations and their substantiating evidence were considered and modified based on consensus.
Description of the guideline
Evidence was graded according to the grading method proposed by Frid et al (2010)27. The method includes a ‘I II III’ scale for scientific support and a ‘ABC’ scale for the strength of recommendations.
Scientific support scale:
I At least one randomized controlled trials (RCTs)
II At least one non-randomized (or non-controlled
or epidemiologic) study
III Consensus expert opinion (including e.g. case reports, case series) based on extensive patient experience
The content of the guideline was confirmed by the Committee by February 2013, and together with supporting literature, was presented for review to a panel of fifteen local diabetes nurses experts; all of whom are experienced clinicians from various hospitals/ clinics. The panel was asked to review the recommendations and the literature provided within one month. A worksheet was also designed to facilitate discussion. A series of three hearing meetings were then held in March and April 2013, for an iterative process of discussion, debate and validation. Each recommendation was modified if necessary. Recommendations were considered legitimate based on ≥80% panel consensus. The level of evidence and its strength were assessed by all panel members together to ensure reproducibility. The guideline was finalized after consensus approval reached by the board of experts.
The evidence-based clinical guideline put forth in this document is the result of the process. Evidence was graded according to a grading method (see next section). The grade for each of the guideline statements is indicated at the end of each statement together with respective citations.
Strength of recommendation scale:
A. Strongly recommended B. Recommended
C. Unresolved issue
Thus, each guideline statement is followed by both a number and a letter (e.g. IIA). The number indicates the degree of rigor of scientific evidence in the literature as support by the expert panel, and the letter indicates the weight of significance of the recommendation to be applied to local practice.