Family Practice Advance Access published online on April 28, 2008
Family Practice, doi:10.1093/fampra/cmn016
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Routine glutamic acid decarboxylase autoantibody (GADA) testing: patients' perspective
Centre for Health Information, Research and Evaluation (CHIRAL), The School of Medicine, Swansea University, The Grove Building, Singleton Park, Swansea SA2 8PP, UK
Correspondence to H Davies, Centre for Health Information, Research and Evaluation (CHIRAL), The School of Medicine, Swansea University, The Grove Building, Singleton Park, Swansea SA2 8PP, UK; Email: h.davies{at}swansea.ac.uk
Received 24 July 2007; Revised 9 March 2008; Accepted 31 March 2008.
 |
Abstract |
|---|
 Top Abstract IntroductionMethodsFindingsDiscussionConclusionsDeclarationReferences |
|---|
Background. Latent autoimmune diabetes in adults (LADA) is a form of type 1 diabetes which in the UK is often diagnosed and treated as type 2 diabetes (T2D). People with LADA show slow progression to insulin dependence and can be distinguished from T2D by blood tests for glutamic acid decarboxylase autoantibodies (GADA).
Aims. This study explores the views and experiences of patients who are newly diagnosed with LADA, with particular reference to (i) routine GADA testing; (ii) whether this diagnosis has any influence on the self-management of their diabetes; and (iii) the information needs of patients newly diagnosed with LADA.
Methods. Ten consecutive patients newly diagnosed with LADA (GADA positive) were invited to participate in individual qualitative semi-structured interviews. Their views and experiences were analysed into codes and categories, using a constant comparative method.
Findings. Participants supported routine GADA testing in all patients with diabetes because the provision of a correct diagnosis has an empowering effect on patients, as it encourages the consideration of treatment options early on in the condition. Participants preferred to rely on future Hba1c levels and their doctor's opinion to determine a change in treatment to insulin. Some participants had difficulty distinguishing between the different types of diabetes, including LADA. Others needed to ask questions about LADA in addition to written information.
Conclusions. Participants were supportive of routine GADA testing, would prefer not to start insulin immediately following a diagnosis of LADA and needed to discuss treatment options with health professionals who were knowledgeable on LADA.
Keywords. Latent autoimmune diabetes in adults, qualitative, patient views.
|
Introduction |
|---|
|
TopAbstractIntroductionMethodsFindingsDiscussionConclusionsDeclarationReferences |
|---|
Latent autoimmune diabetes in adults (LADA) is a type 1 diabetes (T1D)1 which shows slow progression to insulin dependency. LADA is often treated as type 2 diabetes (T2D). This is because a person with LADA is not dependent on insulin, at diagnosis. However, such individuals are at risk of becoming insulin dependent.2,3 Most patients with LADA do require insulin within 6 years of diagnosis and early initiation of insulin may protect the beta cells.3
Studies have suggested that 10–13% of patients diagnosed with T2D may have LADA,4 but despite this frequency there are no universal recommendations for antibody testing in adult onset diabetes5 and no testing is routinely available in the UK at present. The decision to test a person for autoantibodies is generally based on body weight alone.6 Certain studies have observed no differences between the body mass index of patients with LADA and T2D7 indicating that a significant proportion of patients with LADA would not be tested for antibodies and be treated as T2D.
A Cochrane review8 investigating the interventions for people with LADA concluded that sulphonylurea is not recommended for people with LADA, as progression to insulin dependence is faster than with other glucose lowering agents.3
Identifying patients with LADA is of public health interest for the correct classification of diabetes and consequently diagnosis, treatment and the provision of appropriate patient information.
As part of a study examining the prevalence and characterization of LADA,9 we set out to explore the views of patients who are newly diagnosed with LADA including: routine glutamic acid decarboxylase autoantibody (GADA) testing, whether this diagnosis had any influence on the self-management of their diabetes and the information needs of patients with LADA. This study provides the first data, collected directly with patients who have been tested for GADA.
|
Methods |
|---|
|
TopAbstractIntroductionMethodsFindingsDiscussionConclusionsDeclarationReferences |
|---|
Sampling population
This is a consecutive sample. The first 10 patients who tested positive for GADA were invited for an interview, and all patients invited agreed to do so. GADA were measured in radio-binding assays in the Department of Clinical Science at North Bristol, University of Bristol, UK.10
Study participants
Patients (n = 667) diagnosed with apparent T2D in 30 general practices within the previous 24 months were tested for GADA. Of these, 28 patients were GADA positive (LADA). The researcher wrote to the patients GP to inform them of a positive GADA result and included two LADA information booklets (one for the GPs’ reference and one for the patient when diagnosing them with LADA). Patients were asked by their GP whether they agreed to be contacted by the researcher. An interview was then scheduled by the researcher. Demographic data were also collected as part of the main study to help characterize people with LADA, including age, gender and ethnicity.
Design
This explorative study used qualitative semi-structured interviews which were conducted on a one to one basis. Open-ended questions were used to explore patients’ experience of GADA testing and subsequent diagnosis of LADA. One researcher (HD) facilitated the interview process and another researcher (SBM) provided technical support (audio taped) and recorded non-verbal information, including body language.
Interviews were carried out between August 2005 and August 2006, at a setting of the patient's choice. Each interview lasted between 30 and 90 minutes and was transcribed by an independent person. Each participant received a LADA booklet prior to the interview, of which the LADA website is signposted http://www.locallada.swan.ac.uk/. Areas explored within the interviews are illustrated in Table 1.
|
Analysis
This study used a constant comparative method to facilitate the analysis process.11 The analysis took place in two stages: The first two interview transcripts were read by both researchers separately in order to enter the interviewees’ frame of reference.12 After the first two interviews, researchers met and agreed on the codes which were done. The codes were done independently, by hand, by the two researchers to assess the reliability of the coding. Following open coding, axial coding was used to identify categories with code words.13 At this stage, the researchers’ initial thoughts were recorded to help explain the thinking that underpins the coding process.
Data collection and analysis ran concurrently for the remaining interviews. The same procedure of analysis was applied to each subsequent interview.
Ethical considerations
Participants in this study were told they have a T1D and not a T2D and are likely to be on insulin eventually. This may potentially be upsetting.
|
Findings |
|---|
|
TopAbstractIntroductionMethodsFindingsDiscussionConclusionsDeclarationReferences |
|---|
Study participants
The number of participants (n = 10) was determined by the point when no new themes emerged, and this was after the eighth interview. Two more interviews were conducted to identify whether any new themes arose and data saturation had been reached.
Mean age of the participants was 56 years (range 22–73 years), 7 were female and all were White Caucasian. All patients were newly diagnosed with apparent T2D and had a GADA-positive test of >32 U/ml14 [mean 424 U (SD 333 U) range 57.7–969.2 U].
The findings presented here focus on the main categories that were highlighted from the analysis. Six categories were identified: (i) diabetes knowledge; (ii) emotional response; (iii) health professionals and information; (iv) time to insulin; (v) test or not to test; and (vi) seeking information.
Experience of a LADA diagnosis
Diabetes knowledge.
Some participants (n = 6) in this study identified themselves as having T1D as opposed to T2D. Others (n = 4) were unable to distinguish between T1D and T2D and perceived diabetes as one condition. The following dialogue illustrates this misconception, ‘I didn't know there were so many different types of diabetes to be honest .... I thought diabetes was diabetes’ (n1p2). Being diagnosed with LADA did affect the emotional responses of participants.
Emotional response. Many participants (n = 7) were anxious and confused regarding the future treatment of their diabetes following a LADA diagnosis. In particular, whether they would choose to start insulin or remain on their current regime. One participant said, ‘I am getting confused now. I thought when you were told that you had diabetes you were on insulin straightaway. Then I found you can go on tablets, and then you can go on insulin. And now I find you can go on insulin strait away and no tablets’ (n1p4/5).
Other participants felt surprised and shocked when told they had LADA, as illustrated in the following quote, ‘It was a bit of a surprise when my results (GADA) came back, somebody was saying that I was virtually a level 1 not a level 2, and without this test I wouldn't have known, and I would have been treated as type 2’ (n4p4).
Observational notes were kept on each participant during the interview, and many participants showed signs of anxiety, i.e. fidgeting and restlessness and many participants needed reassurance (repeating questions) about the future treatment of their diabetes. The observations were clarified with each participant for accuracy, at the end of the interview.
The majority of participants (9 of 10) stated they were happy to have had the test, despite the emotional responses associated with being informed they now have a slowly progressive T1D, not a T2D. The following category explores how participants perceived health professionals' roles and behaviour within the process of being diagnosed with LADA.
Health professionals and information. Six participants were given the LADA diagnosis by either their GP or nurse, and one participant received a letter from their GP. The remaining three participants were not given a specific LADA diagnosis by health professionals, rather general advice and information on diabetes care. One participant suggested that she had information overload regarding her LADA diagnosis and felt she was just coming to terms with being newly diagnosed with diabetes. However, another felt she was happy with the information received at diagnosis on treatment options from her GP. In general, participants felt they had received limited information from their primary health care team at the time of their LADA diagnosis. One participant said, ‘Looking back at it, well perhaps I should have been more informed about it’ (LADA) (n8p38). The following category discusses some of the decisions participants made about managing their diabetes following a LADA diagnosis.
Time to insulin. The majority of participants managed their diabetes with diet/oral hypoglycaemic agents (n = 8) and preferred this method of treatment because it can be taken orally, and most people in this study were ‘already taking other tablets’. Two participants were on insulin by the time of the interview and found the transition to insulin therapy, ‘a small price to pay for health’ and had more ‘flexibility with the diet’ since taking insulin (n7p8).
Most participants on diet/oral hypoglycaemic agents (n = 7/8), if given the choice would prefer to go on insulin later rather than sooner. The main reason for this included (i) reliance on what the doctor thought best, one participant implied, ‘If the doc says to me well I think you would be wise to do so then I wouldn't hesitate, but I would prefer to go on tablets rather than to give myself injections’ (n5p14); (ii) future blood glucose control (Hbalc levels), one participant commented, ‘I'd like to give it at least some time to see how it goes, and if the tablets keep controlling it then I'd like to do it that way’ (n2p6); and (iii) time in relation to own lifespan, another implied, ‘I am not going to worry about three or five years time because I will be seventy’ (n9p4).
Unanimously, participants felt that ‘time’ was a factor needed to enable them to adjust to the diagnosis of LADA and the often inevitability of using insulin for glycaemic control.
For the majority of participants, the decision to remain on diet and/or oral hypoglycaemic agents was also influenced by the perceived challenges to insulin therapy. This is illustrated in Table 2.
|
To test or not to test. The majority of participants (9 of 10) were glad upon reflection to have been tested for GADA and would support the test in primary care for other newly diagnosed people with diabetes. One participant felt empowered and suggested that, ‘If the sugars start to rise, I am going to have to see about this and get in touch with doctor and say look, what about this LADA business’ (n10p53). Another participant thought the test was convenient, saying, ‘You might as well do it (GADA test) because you are going to the hospital in any case, to do the normal tests’ (n4p10). One participant who was symptomatic and unwell at the onset of his diabetes stated, ‘If the test had been available, I would have probably been on insulin a lot earlier and that would have stabilised me ... it would have been a shock but I would have rather taken the test and known straight away ... and it would have removed the uncertainty and the doubt away’ (n6p5/6).
All participants felt it important to have a correct diagnosis at the onset of their condition. One participant implied: ‘Everybody should be able to have this ... I can't see why everybody isn't having this test. You know, if you are getting diagnosed with a type 2 and you are actually type 1, it is going to be bad for you in the long run ... they are not treating you right’ (n7p6). Other participants had genetic concerns, and one participant said, ‘My son is not very happy in case I pass it on to him, and it could have been passed on to me through my parents’ (n10p6).
Seeking information. All participants received a LADA booklet prior to the interview, and it was described by people as, ‘good’, ‘informative’ and ‘straight to the point ... it told you what you needed to know’ (n7p4). However, all participants needed to be able to ask questions in addition to reading the LADA booklet. If written information is given in conjunction with a verbal message, then its effectiveness can be increased and supported.15
The LADA website was signposted in the LADA booklet. Only one person accessed the website prior to the interview. Reasons given by others for not accessing the website included a lack of computer skills and no access to a computer. However, some implied they may access the website in the future, through family or friends. According to participants in this study, the best method of information giving appears to be written information and the opportunity to ask questions face to face.
Following each interview, people had the opportunity to ask questions about their condition and the future care of their diabetes, which fell into two distinct categories: (i) LADA/diabetes in general; and (ii) insulin (see Table 3).
|
Asking questions following the interview reinforces the importance of offering people newly diagnosed with LADA face-to-face contact in order to discuss LADA in general and the practicalities and challenges of insulin therapy.
|
Discussion |
|---|
|
TopAbstractIntroductionMethodsFindingsDiscussionConclusionsDeclarationReferences |
|---|
In this exploratory study, using qualitative semi-structured interviews, we have been able to highlight some important issues that need to be considered when testing people for GADA.
Communication between health professionals and participants in relation to treatment options for people with LADA seems limited. Based on the findings, the first challenge appears to be the provision of adequate information to patients when diagnosing LADA? However, the literature suggests that diagnosing a chronic illness is an emotional time for patients16 and patients report feelings of shock, despair and anxiety in various degrees.17 Also, people who are anxious may not absorb or retain all the verbal information they are given.18 Participants in this study felt confused and anxious and also reported feelings of shock when told they had LADA. Unfortunately, this situation is further exacerbated due to the limited amount of clinical evidence available to guide health professionals as to the best treatments for patients with LADA. Therefore, it is not surprising that participants had little knowledge about LADA and felt they had received limited information on LADA from health professionals and continued to seek further information and reassurance about their diabetes.
The ease and convenience of taking oral medication, age of a person, doctor's opinion, time to adjust to having LADA and the challenges of insulin therapy appeared to influence participants to not want to start insulin immediately following a diagnosis of LADA. The challenges of initiating insulin therapy are not unique to this study.19 However, a recent study20 suggests that bringing in GADA testing will mean positive patients will be put on insulin sooner than they currently would be without testing. Therefore, the act of GADA testing will influence when a patient starts insulin.
Despite feelings of anxiety and the need for reassurance following a diagnosis of LADA, support for GADA testing is strong. Participants want it to be made routinely available for all patients newly diagnosed with diabetes because it is convenient and can be carried out with other routine blood tests for diabetes; GADA testing appears to empower patients by reassuring them and by providing a correct diagnosis. People who know they have LADA are more informed and willing to participate in shared decision making in relation to treatment options, early on in their condition.
Study limitations
In this study, people who were GADA negative were not interviewed for their opinion on routine GADA testing, which would have been useful to explore.
|
Conclusions |
|---|
|
TopAbstractIntroductionMethodsFindingsDiscussionConclusionsDeclarationReferences |
|---|
To conclude (i) participants were supportive of routine GADA testing in primary care and see it as an integral part of their diabetes care but (ii) were reluctant to change their medication regime immediately following a diagnosis of LADA and (iii) need appropriate information at diagnosis (verbal and written) and have the opportunity to be able to ask questions about LADA.
|
Declaration |
|---|
|
TopAbstractIntroductionMethodsFindingsDiscussionConclusionsDeclarationReferences |
|---|
Funding: Bupa Foundation (680/G14A).
Ethics approval: Obtained from the Multi-Research Ethics Committees for Wales, number MREC 04/MRE09/02.
Conflicts of interest: None.
|
Acknowledgments |
|---|
We would like to acknowledge the contribution of GPs and diabetes practice nurses at the participating general practices.
|
Notes |
|---|
Davies H, Mannan SB, Brophy S and Williams R. Routine glutamic acid decarboxylase antibody (GADA) testing: patients’ perspective. Family Practice 2008; xx: xxx–xxx.
|
References |
|---|
|
TopAbstractIntroductionMethodsFindingsDiscussionConclusionsDeclarationReferences |
|---|
1 Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med (1998) 15:539–553.[CrossRef][Web of Science][Medline]
2 Maruyama T, Shimada A, Kanatsuka A, et al. Multicenter prevention trial of slowly progressive type 1 diabetes with small dose of insulin (the Tokyo study): preliminary report. Ann N Y Acad Sci (2003) 1005:362–369.[CrossRef][Web of Science][Medline]
3 Kobayashi T, Maruyama T, Shimada A, et al. Insulin intervention to preserve beta cells in slowly progressive insulin-dependent (type 1) diabetes mellitus. Ann N Y Acad Sci (2002) 958:117–130.[Web of Science][Medline]
4 Brophy S, Williams R, Leslie D, on behalf of the Action LADA Group. Epidemiology of diabetes in eight centres in Europe. Diabet Med (2006) 23(suppl 4). (abstract A1845).
5 Owen KR, Stride A, Ellard S, Hattersley AT. Etiological investigation of diabetes in young adults presenting with apparent type 2 diabetes. Diabetes Care (2003) 26:2088–2093.
6 Fourlanos S, Harrison LC, Colman PG. A clinical screening tool identifies autoimmune diabetes in adults: response to davis et al. Diabetes Care (2006) 29:2560–2561.
7 Zinman B, Kahn SE, Haffner SM, O'Neill MC, Heise MA, Freed MI. Phenotypic characteristics of GAD antibody-positive recently diagnosed patients with type 2 diabetes in North America and Europe. Diabetes (2004) 53:3193–3200.
8 Brophy S, Brunt H, Davies H, Mannan S, Williams DRR. Interventions for latent autoimmune diabetes (LADA) in adults. Cochrane Database Syst Rev (2007) (3). CD006165.
9 Davies H, Mannan SB, Brophy S, et al. Prevalence of latent autoimmune diabetes in adults (LADA) in South Wales and implications for the patient: analysis of preliminary first year results. Diabet Med (2006) 23(suppl 2):126.
10 Bingley PJ, Bonifacio E, Muellar PW, Participating Laboratories. Diabetes Antibody Standardization Program: first assay proficiency evaluation. Diabetes (2003) 53:1128–1136.[Web of Science]
11 Wainwright S. Analysing data using Grounded Theory. Nurse Res (1994) 1(3):43–49.
12 Burnard P. A method of analysing interview transcripts in qualitative research. Nurse Educ Today (1991) 11:461–466.[CrossRef][Medline]
13 Corbin J, Strauss A. Grounded theory research: procedures, canons, and evaluative criteria. Qual Sociol (1990) 13(1):3–21.[CrossRef]
14 Buzzetti R, Di Pietro S, Giaccari A, et al. High titer of autoantibodies to GAD identifies a specific phenotype of adult-onset autoimmune diabetes. Diabetes Care (2007) 30:932–938.
15 Coulter A, Entwhistle V, Gilbert D. Informing Patients (1998) London: Kings Fund.
16 Faulkner A. When the News is Bad: A Guide for Health Professionals on Breaking Bad News (1998) Cheltenham, UK: Stanley Thornes.
17 Gillibrand W, Flynn M. Forced externalization of control in people qualitative exploratory study. J Adv Nurs (2001) 34:501–510.[CrossRef][Web of Science][Medline]
18 Lowry M. Knowledge that reduces anxiety; creating patient information leaflets. Prof Nurse (1995) 10:318–320.[Medline]
19 Meece J. Dispelling myths and removing barriers about insulin in type 2 diabetes. Diabetes Educ (2006) 32:9–18.[CrossRef]
20 Brophy S, Yderstraede K, Mauricio D, et al. Time to insulin initiation can not be used in defining Latent Autoimmune Diabetes in Adults [LADA]. Diabetes Care (2008) 439–441. Mar 31 (3).
CiteULike 
Connotea 
Del.icio.us What's this?
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||