Practical Examples

Example 1:

Topic:

• Wound healing (surgical site infection)

Participants:

• 18 patients undergoing primary elective bilateral mammary surgery and 18 patients undergoing skin lesions removals

• Randomly assigned into the 2 groups and were blinded as to which type of suture was used on which breast/incision half and lesion half: Antibacterial-coated sutures on either the right or left breast/lesion and uncoated sutures were used on the contralateral breast/lesion.

• Risk factors for poor wound healing and the development of surgical site infection were recorded

Groups:

• Intervention: Antibacterial-coated (coated monofilament absorbable suture treated with Chlorhexidine)

• Control: uncoated sutures

Study/Outcome:

• Evaluated for complications (skin swelling, erythema, hematoma, seromas, wound dehiscence, infection) and for scar results (through Vancouver scale, which assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation).

• Signs of surgical site infections - in accordance with the Centres for Disease Control and Prevention criteria

• Follow-up was at 1 and 3 weeks and at 1, 3, 6 and 12 months after surgery

• No significant differences between participants regarding age, sex, type of wound, and other risk factors for surgical site infections (except for 3 smokers among patients undergoing MS and 1 smoker among patients undergoing SS)

• Findings:

1. No statistical significant differences on scar evaluation in terms of pliability, pigmentation vascularity and height

2. Less large wounds in the 44% of those from the intervention group compared to those in the control group 3. no wound infections in both groups

• Moving forward:

1. Chlorhexidine-coated sutures should be considered in case of inflamed lesions removal

2. Larger and more numerous RCTs needed

(Carella et al., 2019)

Example 2:

Topic:

• Mobile app-based interactive diabetes management model

Participants:

• 276 adults aged 18-65 with either type 1 or type 2 diabetes

• Inclusion: HbA1c >8% within 3 months of enrolment and under the American Diabetes Association criteria; must have a smartphone and be willing to perform daily self-monitoring of glucose and be willing to visit a physician at 3 and 6 months

• Exclusion: insulin pump users, pregnant and plan to be pregnant, excessive drinking or drug use, use of drugs that may affect blood sugar within 3 months of enrolment, psychotic and receiving treatment, severe complications of systemic diseases, experiences cardio or CVA events, severe hearing or visual impairments, unable to access the Web, unsuitable for study according to judgement of researchers

Groups: 3 treatment groups

• Intervention:

  1. A: Individuals were requested to download the mobile app with diabetes-related knowledge and skills, including glycemic control, diet, exercise, medication, and use of insulin. Only 1 clinician was involved

  2. B: The mobile self-management app included interactive management online (service for stable glucose x180 days). Included the services of 1 dietician and health manager who interacted with the patient through the platform to assist in glycemic management

• Control:

  1. C: usual glycemic management without a mobile-based app. All knowledge and skills were acquired through self-learning and summarizing

Study/Outcome:

• The primary outcome/variable that was measured was a change in HbA1c level at the 3rd and 6th month mark

• Findings:

  1. In every treatment group, there was a significant decrease in HbA1c levels

  2. Multivariate line regression analyses with interactive app management is associated with a larger reduction in HbA1c

  3. There is no significant difference in HbA1c reduction between self management Group A and the control group. Indicates that self-management is not sufficient when managing long-term glycemic control

  4. While there is a significant improvement in HbA1c levels at the first 3-month mark, there was no significant reduction at the 6-month check in. The effects appear to hit a plateau or "platform period" with the app achieving quick and effective improvement.

• Moving forward:

  1. Utilizing the mobile app for self-management is not superior to routine self-management

  2. The combination of interactive diabetes management with a mobile app can improve and sustain glycemic control.

(Zhang et al., 2019)

Example 3:

Topic:

• Clinical management and prevention of dental caries in athletes

Participants:

• 54 participants were randomized into test and control groups

• Participants were athletes from sports club who participated in five or more hours of endurance training per week

• The inclusion criteria were: participants who were older than 18 years, gave written informed consent, declared that they performed endurance sports with a cumulative weekly training time of five or more hours, and were in good general health and not restricted in practicing oral hygiene

• The exclusion criteria were: participants who were under the age of 18, gave no written informed consent, performed a cumulative weekly training of less than five hours, were restricted in practicing oral hygiene, were pregnant or nursing, had been or were still taking part in another clinical study within the last 30 days, took antibiotics within the last 30 days, were dental students or dental staff members

Groups:

• The participants were randomized by block randomization into either test or control group

• The test group used special stannous fluoride products including mouth rinses and toothpaste

• The participants in the control group did not get any products with the exception of the instruction to use fluoridated toothpaste with their conventional oral hygiene products at home

Study/Outcome:

• The primary endpoint dental caries was assessed by the ICDAS-II-System and analyzed both by a linear mixed model for repeated measures and a generalized linear mixed model

• Findings:

  1. The time of examination had significant influence on the increase of sound enamel surfaces and on the decrease of surfaces with carious lesions

  2. stannous-fluoride test products did not show an additional effect on caries development

  3. Due to biannual dental examinations, professional tooth cleaning and restorative treatment the number of caries-free surfaces increased and the odds of a new surface to be afflicted with caries media decreased 25-fold.

• Moving forward:

Use of stannous fluoride products has no significant impacts on caries prevention

(Frese et al., 2018)