EAL

DM: Carbohydrate Management Strategies (2014)

Citation:

Rankin D, Cooke DD, Elliott J, Heller SR, Lawton J; UK NIHR DAFNE Study Group. Supporting self-management after attending a structured education programme: A qualitative longitudinal investigation of type 1 diabetes patients' experiences and views. BMC Public Health. 2012; 12: 652.

PubMed ID: 22891794

Study Design:

Prospective Cohort Study

Class:

B - Click here for explanation of classification scheme.

Quality Rating:

NEUTRAL: See Quality Criteria Checklist below.

Research Purpose:

To inform development of future support provisions for patients following participation in structured education programs such as Dose Adjusted for Normal Eating (DAFNE).

Inclusion Criteria:

Provided written informed consent
Expressed willingness to participate.

Exclusion Criteria:

Not described.

Description of Study Protocol:

Recruitment

Participants were recruited from six DAFNE courses hosted in five DAFNE centers across the United Kingdom.

Design

Prospective cohort study.

Intervention

Subjects had all attended Dose Adjustment for Normal Eating (DAFNE) courses in the United Kingdom.

Statistical Analysis

The method of constant comparison was used to develop a framework of themes for coding and further analyzing the data
The data were examined for contradictory evidence to counteract the possibility of researcher bias
Regular team meetings were held to compare interpretations, resolve any differences in understanding and to reach consensus on recurrent themes
A coding framework was devised after agreement on key themes was reached
Data were coded by DR using a qualitative software program that facilitated additional coding and data retrieval to permit further examination of specific datasets
A subset of transcripts was independently coded by one of the researchers to ensure consistency and any disagreements were resolved by discussion
Data collection stopped when no new themes arose from the data.

Data Collection Summary:

Timing of Measurements

Semi-structured interviews were conducted with patients between July 2008 and February 2011. Interviews took place after attending the Dose Adjustment for Normal Eating (DAFNE) courses and six months and 12 months later.

Dependent Variables

Support needs of patients with type 1 diabetes were measured by repeated, in-depth interviews
The first round of interviews took place face-to-face and in patients' homes in the week following DAFNE course attendance, with follow-up interviews conducted by telephone
The first round of interviews explored patients' accounts of support received prior to the course and the support they envisaged might be necessary to sustain effective use of a flexible intensive insulin regimen
Follow-up interviews examined patients' perceptions of support sought and received post-course, their views on future support requirements and their unmet support needs.

Independent Variables

Subjects had all attended Dose Adjustment for Normal Eating (DAFNE) courses.

Description of Actual Data Sample:

Initial N: A total of 30 subjects were interviewed during the first round (16 females, 14 males)
Attrition (final N): A total of 28 subjects were interviewed after six months and 27 after 12 months
Age: Mean age 36.1±11.6 years, with a range of 18 to 56 years
Other relevant demographics: Diabetes duration at recruitment was 16.5±10.3 years, with a range of one to 45
Location: Five different DAFNE centers across the United Kingdom.

Summary of Results:

Key Findings

The flexible intensive insulin treatment approach taught on DAFNE courses was seen as a logical and effective way of managing one's diabetes. It was also considered more technically complex than other insulin regimens.
To sustain effective disease self-management using flexible intensive insulin treatment over time, patients often expected and needed ongoing input and support from health care professionals trained in the approach. This included help determining insulin dose adjustments, reassurance and opportunities to troubleshoot issues of concern.
While some benefits were identified to receiving follow-up support in a group setting, most patients stated a preference or need for tailored and individualized support from appropriately trained clinicians, accessible on an “as and when needed” basis
DAFNE resulted in a reduction of HbA1C from 8.8±1.9% (range 5.4% to 12.7%) at baseline to 8.2±2.0% (range 6.0% to 14.1%) at 12 months.

Author Conclusion:

To maintain the clinical benefits of structured education for patients with type 1 diabetes over time, course graduates may benefit from and prefer ongoing, one-to-one support from health care professionals trained in the program’s practices and principles. This support should be tailored and personalized to reflect patients' specific and unique experiences of applying their education and training in the context of their everyday lives, and could be the subject of future research.

Funding Source:

Government:

National Institute for Health Research RP-PG-0506-1184

Reviewer Comments:

A relatively small sample size
Inclusion and exclusion criteria was not well described
The cohort was only followed for one year
The authors noted that the group-based approach employed was well received by all patients.
Some benefits can be gained from attending follow-up sessions in a group, but most subjects indicated a preference and need for one-to-one support.
Several patients expressed dissatisfaction with reviews of blood glucose readings at six-week follow-up sessions.
Patients expressed a preference for individualized and tailored support provided by specialists.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		No
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	No
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	Yes
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	N/A
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	N/A
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	No
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	N/A
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	Yes
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	Yes
	6.6.	Were extra or unplanned treatments described?	Yes
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		???
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	???
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	Yes
	7.7.	Were the measurements conducted consistently across groups?	N/A
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	N/A
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	N/A
	8.6.	Was clinical significance as well as statistical significance reported?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes