Results: At 14 months, the X-PERT group showed significant improvement in HbA1C levels, body weight, BMI, waist circumference, physical activity levels, foot care, and fruit & vegetable intake.
Conclusions of the study: Participation in the X-PERT programme led to improvements in health and self management skills over longer periods.
Figure 1 – The Research Report Summary adapted from Lanoe, 2002
Why was it done?
Previous studies provided evidence that self-management programmes had a positive affect on glycaemic control. However these effects did not seem to last and a meta analysis (Norris, 2002) on this issue illustrated that the positive effects diminished between 1 and 3 months. This study set out to establish that long term improvements to health could be made by attending an intensive, group-based self management programme.
How was it done?
314 participants were randomised into two groups. The control group were given individual appointments with a dietician (lasting 30 minutes), a practice nurse (lasting 15 minutes) and a GP (lasting 10 minutes). The Intervention group attended six weekly group sessions lasting 2 hours each. In these sessions they were taught about the disease itself and how to self monitor the condition. They were given information on weight management via exercise and healthy eating, and discussed the complications of diabetes and ways to prevent them. In addition, each participant was given a resource manual which provided background reading, and could be used to set goals and monitor progress.
Did the study address a clearly focused issue?
Detailed information was provided on the circumstances of all participants and to ensure generalisations could be made, the study used patients from various cultural and demographic backgrounds as well as a large population of “314 people”. The study also used minimal exclusion criteria, so that only those with “reduced cognitive abilities” (due to being unable to understand) or those who were “immobile” (due to being unable to attend) were excluded. This increased the possibility for generalisation even further.
The type of intervention used was also made clear by the author and was based on the “X-PERT programme”; six, 2 hour group sessions of patient education. This was compared with the control group who experienced “routine care” plus one individual appointment with a dietician, a practice nurse and a GP. The study was designed to test an intensive programme against routine care, and hypothesised that the X-PERT group would achieve and maintain greater reduced glycated haemoglobin over a period longer than four months compared with the control group. However, one minor flaw to be mentioned is that although the type intervention used was made clear, the author admits that not even they were sure which aspect of the intervention contributed to the results, stating: “it is difficult to define the active ingredients”. It should also be noted that, although the study provides a brief description of what’s included in the six individual sessions, a comprehensive guide is not. This questions the reliability of the study and whether or not it can be delivered in a homogenous way (Cochrane, 2007) every time it is replicated.
Another flaw of this study is that the outcomes can become overwhelming for the reader. This is because although the primary outcome is clearly stated as the level of glycated haemoglobin; numerous other outcomes are also mentioned including: clinical, lifestyle, and psychosocial outcomes.
Cont’d
A large proportion of the results and discussion are dedicated to these secondary outcomes detracting the reader from the original aim. Furthermore, those who are not familiar with normal levels of and “significant differences” in glycated haemoglobin may find it difficult to interpret the results of the study.
One important aspect of this study to consider is the way in which the outcomes were measured. Apart from glycated haemoglobin levels and physical outcomes, all other measurements were recording via the use of a questionnaire. The problem with this method is that participants become subject to social desirability bias; where they want to be seen in the best light and do not provide truthful answers in the hope of achieving this (Davey, 2004). For example the participants may have recorded that they had eaten more fruit and vegetables than they actually had, thinking this was a more satisfactory answer.
The level of participants’ perception must also be considered when using questionnaires. Some outcomes in the study were rated via the use of scales; for example -9 to +9. We must remember that people see things differently, and although one person may rate a particular situation with a low score; another person may rate the exact same situation with a higher score.
Was the assignment of the participants randomised?
All participants were randomized using permuted blocks, a computerised method that ensures participants are distributed equally between comparison groups. For example, in a study like this one, if two participants had had diabetes for 6 years; then one participant would be allocated to each group. If eight participants had had diabetes for 6 years, then four would be allocated to each group (Cochrane, 2007).
Were the groups similar at the start of the trial?
Because of the permuted blocks method (mentioned above), both the control and intervention groups were similar at the start of the trial. This was further demonstrated by a table located within the study; that provided information on both the control and intervention groups’ age, level of education, employment history and martial status. No significant differences were found confirming similarities between the two groups.
Were all the participants properly accounted for?
Although not all of the participants completed the study, all of them were accounted for. An “intention to treat” analysis was performed, whereby all the participants who were eligible for the study were analysed irrespective of whether or not they took part in it (Cochrane, 2007). The analysis revealed that overall attrition rates, for both groups, was less than 8%, an insignificant loss; giving integrity to the study. Furthermore, a flow chart following participants through the study was provided. It detailed the reason behind the loss of every patient, further increasing credibility.
Were the participants and study personnel “blind” to the treatment?
Although the participants were blinded to the intervention (“an intensive education programme” versus “routine care”) they were informed that the study’s objective was to compare group education with individual education. From this, the X-PERT group may have interpreted the specialist training they received as an indication that they were supposed to do better than the other group. This could have led to the patients displaying demand characteristics; where they make sense of the research and act accordingly to either help or hinder the researcher (Davey, 2004). In this instance the participants may have demonstrated greater improvement in glycated haemoglobin due to the fact that they knew that was what was required of them. Additionally, it was not possible to blind the study personnel, which could have led to differences in the levels of motivation shown by the educators.
Were the groups treated equally?
It is hard to say whether both groups were treated equally as the people delivering the intervention were not blind to the treatment and may have been subject to experimenter bias. However, one specific “diabetes research dietician” was used to deliver the X-PERT programme and the same GP, dietician and practice nurse consulted with the control group; therefore standardised the treatment within the two groups was maintained.
Biomedical Results
The biomedical results showed that X-PERT participants displayed a greater reduction in glycated haemoglobin (HbA1C) which was reduced by 0.6% in the intervention group compared with an increase of 0.1% in the control group. There was also a greater reduction in cholesterol by 0.3mmol/l in the intervention group compared with 0.2mmol/l in the control. The participants of the X-PERT group also managed to lose weight, with a mean loss of 0.65kg. This was compared with a mean increase of 1.1kg within the control group. There was a greater reduction in waist circumference; and the intervention group demonstrated a mean reduction of 4cm in women and 2cm in men compared with only 1cm in women and no reduction in men from the control group.
Medication Levels
Additionally, the intervention group also demonstrated a greater decrease in the number of patients on reduced medication. At the end of the study, 24 out of 157 X-PERT patients had managed to reduce their level of medication compared with 1 out of 157 in the control. This meant that for every 7 patients who participated in the X-PERT programme 1 could expect to lower their level of diabetes medication making the number needed to treat (NNT) 7.
Lifestyle Outcomes
Improved lifestyle outcomes were also demonstrated by the X-PERT group members. Diabetes knowledge increased and was scored at 9.3 versus 7.81 in the control group. Levels of exercise and healthy diet were also increased with the X-PERT group completing a mean of 2.6 activities per week compared 1.7 in the control, and increasing the intake of fruit and vegetables to 5.2 versus 3.1 portions per day.
Psychosocial Outcomes
The psychosocial outcomes showed that X-PERT patients had a higher level of satisfaction regarding their treatment and scored it with a rating of 9.5 versus 5.82 in the questionnaire. They also showed a greater enjoyment of food with a rating of -1.8 versus -2.83; and felt an increased freedom to drink with a rating of -1.7 versus -3.23.
- What do the results mean?
How significant were the results?
With regards to the main aim of the study, the difference in the level of glycated haemoglobin is very small in terms of the relative effectiveness; and is only reduced from 7.7% to 7.1%. Considering that the normal range is 4%-6% (Walsh, 2002); a difference of 0.6% could be considered as inconsequential.
However, when the statistical significance is considered, the results (which are demonstrated in the table below), however small; are due to the X-PERT programme and not just chance, supporting its function.
Table 2 – Details of the study’s statistical significance
Did the findings answer the research question?
The findings in this study did clearly answer the research question, and it was demonstrated that participants who took part in the X-PERT programme did experience positive clinical and lifestyle outcomes in the longer term (14 months). However, as previously mentioned, so many outcomes were discussed, that it could have been easy for the reader to become confused or distracted from the main aim of the study.
Were the results presented in the tables explained by the text in the results section?
The information was presented in a logical fashion, highlighting key findings, which facilitated understanding and indicated that a complete analysis of the data had been achieved.
- What were the implications of the study?
What was new?
Unlike other studies conducted (Norris, 2002); the X-PERT programme demonstrated improved glycaemic control over longer periods of time (14 months) following participation in a patient centred education programme.
What does it mean for healthcare professionals?
This type of training means that patients can sustain improved levels of self care due to developing the skills, knowledge and confidence and address their own problems alleviating the need for continuous advice, education and input by healthcare professionals.
Was the study relevant?
Both the National Diabetes Service Framework (NSF) (2001) and the National Institute for Clinical Excellence (NICE) (2003) recommend that all primary care services offer structured patient education programmes for people with type 2 diabetes, making this study relevant in guiding clinical practice.
Can the results be applied to the local population?
This study used a large sample of 314 participants and had minimum exclusion criteria. Additionally, it was conducted in the UK using people from various ethnic and demographic backgrounds. Furthermore, the study was conducted in a healthcare setting rather than a laboratory adding realism which would aid reliability and prevent participants acting out of character. All these factors indicate that the study findings could be generalised to the UK population.
It could be argued that this study only used participants from Lancashire and therefore would have no relevance in other areas of the UK. The researcher did state that they thought the effectiveness of this study was due to “peer support” and “group work”.
Cont’d
However, a report issued by the commission for integration and cohesion (2007); demonstrated that cohesion rates in Lancashire were among the lowest in England. Therefore, if group cohesion is an influencing factor; then theoretically, the results should improve if the study is replicated in other parts of the UK.
Are the benefits of the intervention worth the costs to the individual?
Unfortunately no information was provided regarding the expense of running the X-. PERT programme and a cost analysis was not possible. However the cost to the individual’s well being can be considered. The researcher did mention that there were “no significant improvements” in the “overall quality of life” in the X-PERT group. If this is the case, then participants may loose interest or become disheartened with the programme if they feel the time they have invested does not outweigh the benefits received. Additionally the study states that there was no significant difference between the two groups with respect to the frequency of monitoring blood glucose. The researcher though this was due to “increased confidence with diabetes self management”. However this could also have been due to lack of interest by participants towards the end of the trial.
On a more positive note, one important point to consider is that of empowerment and confidence. The X-PERT programme puts the patient at the centre of the decision making process helping them to feel “valued” and accepted as “experts at living with diabetes”. This is a positive approach and conforms to the governments’ strategy “Saving Lives: Our healthier Nation” (DOH, 1999) where public participation is called for to improve health. This supports and increases the reasons for implementation of the study.
What else is of interest?
Further searches into the X-PERT programme have revealed that it has now been implemented by over 100 local authorities (X-PERT, 2007) giving further credibility. Additionally, this programme has won 4 national awards from institutions such as “Diabetes UK” and the “Secretary of State” increasing the reasons for putting this programme into practice.
This paper has highlighted issues to both support and oppose this piece of research. It has shown that although the results were statistically significant, their relative effectiveness may only be small. However the study is relevant in today’s practice and conforms to the recommendations as set out by the NSF and NICE. Additionally the study has received various accolades and is already used by many primary care trusts; making this type of programme relevant for use within the local population.
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1 Based on a scale of 0 (minimum doabetes knowledge) to 14 (maximum diabetes knowledge).
2 Based on a scale of -18 (minimum treatment satisfaction) to +18 (maximum treatment satisfaction).
3 Based on a scale of -9 (maximum negative impact on life) to +9 (maximum positive impact on life).
