“Illness and Treatment Perceptions are Associated to ...



“Illness and Treatment Perceptions are Associated to Adherence to Medications, Diet and Exercise in Diabetic Patients,” Elizabeth Broadbent, Liesje Donkin, and Julia C. Stroh. Diabetes Care, Vol. 34, Feb. 2011, pp. 338-340..

RESULTS—Patients rated medication more important than diet and exercise, and reponed higher adherence to medications. Insulin was perceived as more helpful for diabetes, while antihypertensives and cholesterol medication were perceived more helpful for preventing heart problems_ Perceptions were associated with adherence to insulin, cholesterol and antihypertensive

medications, exercise, and diet_ Blood glucose control in type I diabetic patients was associated with insulin adherence and perceived personal control, and in type 2 diabetic patients to being prescribed insulin or antihypertensives, and perceived personal control.

Illness perceptions have been associated with adherence. They cite this article: (338)

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Also:

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Patients rated insulin more helpful that exercise which was rated more helpful than diet management. 338

Pts who reported that they were adherent to taking drugs had lower ratings of consequences of diabetes, fewer symptoms and lower distress. 339. For cholesterol pills, no difference in perceptions for adherent and nonadherent.

Those who exercised thought it would do them more good than those that didn’t. 339.

The importance of health belief models in determining self-care behaviour in diabetes

J. N. Harvey and V. L. Lawson Diabetic Med. 26, 5–13 (2009)

Abstract

Patients’ self-care behaviours have a major role in diabetes management. Diabetes education provides the required knowledge, but despite this, self-care is often suboptimal. The degree to which patients follow advice as regards the various self-care behaviours is determined by their health beliefs (Illness Representations or Personal Models) of diabetes. Psychometric studies have tried to categorize and measure the beliefs about illness that influence patients to adhere to treatment recommendations in diabetes. Various models have been proposed to explain the relationship between beliefs and behaviour. Leventhal’s Self-Regulatory Model, which takes account of the emotional as well as the objective rational response to illness, currently seems to offer the best system for identifying the determinants of patient self-care behaviour. A review of interventions indicates those based on psychological theory offer professionals the best chance of maximizing their patients’ contribution to diabetes self-management and achieving improved outcomes, both glycaemic and psychosocial. Studies designed specifically to modify illness representations are now being undertaken. This brief review aims to summarize developments in this area of psychological theory over the last 20 years and the implications for promoting better self-care behaviour in diabetes.

Is There a Glycemic Threshold for

Mortality Risk?Diabetes Care 22:696–699, 1999

BEVERLEY BALKAU, PHD SANDRINE BERTRAIS, MSC PIERRE DUCIMETIERE, PHD EVELINE ESCHWEGE, MD

“However, we challenge the concept that micro v a s c u l a r complications are the most important criteria. We believe that perhaps the ultimate criteria should be longevity, although we do not dispute the importance of the associated quality of life of diabetic patients with m i c ro v a s c u l a r, or even macro v a s c u l a r, disease.” 696

“Overall, there were 1,924 deaths, of which 347 were from CHD. The observ e d all-cause mortality was lowest for subjects with fasting glucose of 5.25–5.75 mmol/l, and for subjects with 2-h glucose of 4.75–5.25 mmol/l (Fig. 1).” 697

A subject with a fasting glucose level of 7.8 mmol/l (previously the fasting glucose level for defining diabetes) had a risk of death 40% gre a t e r than a subject with a fasting glucose level of 6.0 mmol/l (the upper limit of norm a l , a c cording to the ADA criteria [1]) (Table 2). When other risk factors were taken into account, the relationship was no longer curvilinear for fasting glucose (x2 = 2.7, df = 1, P,0.1), but fasting glucose re m a i n e d a significant predictor of mortality (x2 = 5.0, df = 1, P , 0.03). For 2-h glucose, a concentration of 11.1 mmol/l carried a 55% higher risk than 7.7 mmol/l (Table 2). 697-8.

7.8 vs. 6.0 1.40 All causes: Adjusted for age (1.22–1.61) Adjusted for age and risk factors 1.31 (1.02–1.36) CHD Death Adjusted for age 1.42 (1.15–1.82) Adjusted for age and risk factors 1.04 (0.81–1.33)

Other figures for 2h glucose, noticeably higher, with CHD adjusted for risk factors & age 1.31 (1.11–1.53) (11.1 vs. 7.7) 698

The modeled re l a t i o n s h i p between fasting glucose concentration and CHD mortality was linear, although a higher death rate was observed in the lowest fasting glucose class; the number of CHD deaths may have been too low to show a significant curvilinear re l a t i o n s h i p . 698

“In the Paris Prospective Study, there was no clear concentration of either fasting

or 2-h plasma glucose above which the risk of death or death by CHD sharply

i n c reased. These results do not challenge the existing diagnostic criteria for diabetes

of 7.0 mmol/l for fasting and 11.1 mmol/l for 2-h glucose concentrations, which were

based on data that showed a sharp incre a s e in retinopathy incidence and prevalence.” 699

[pic]Other graphs are provided. P. 697.

There were 60 people with FPG over 7.8. The total sample is 7,018. p. 697. So they have a very small sample of people. Still, the higher HR turned out to be significantly higher.

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DECODE study group. [pic]

A metaanalysis which shows a J-shaped relationship between glucose and mortality from CVD and other causes.

[pic]p. 689.

[pic]p. 690.

Lots of graphs supplied. They show the J-shaped relationship.

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Shaded is fasting glucose while non-shaded is 2h glucose.

Apparently no adjusts for things like cholesterol levels.

Detail:34.1 (Jan 2011): pS1(2). (1211 words) 

Title:Introduction.(American Diabetes Association: Clinical Practice Recommendations 2011)

Pub:Diabetes Care 

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p. S5

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p. S5

Effect of intensive treatment of hyperglycaemia microvascular outcomes in type 2 of the ACCORD randomised trial Lancet Vol 376 August 7, 2010 pp. 419-430.

Results of several clinical trials aimed at reducing HbA1c concentrations have shown that intensive glycaemic control in patients with type 2 diabetes is associated with a reduction in microvascular complications (mostly in albuminuria). 419

We recruited volunteers who had type 2 diabetes mellitus, HbA1c concentrations of 7·5% or more, and were aged 40–79 years with history of cardiovascular disease or 55–79 years with anatomical evidence of signifi cant atherosclerosis, albuminuria, left ventricular hypertrophy, or at least two risk factors for cardiovascular disease (dyslipidaemia, hypertension, being a smoker, or obesity). 420.

The median ratio of albumin to creatinine was signifi cantly lower in the intensive group than it was in the standard group at both transition and study end (table 4). 422.

At study end, there was no diff erence in microvascular renal outcomes between groups, apart from microalbuminuria and macro albuminuria (fi gure 5). 422-23.

For diabetes-related eye events, three-line worsening of visual acuity was more common in the standard

group than in the intensive group at transition and at study end (fi gures 4 and 5). Cataract extraction was also signifi cantly reduced (by 21%) in the intensive group compared with standard group at study end (fi gure 5). Other diabetes-related eye outcomes did not differ significantly between the two groups. 423.

We recorded no signifi cant eff ect of intensive glycaemia therapy on the two prespecifi ed composite microvascular outcomes—1) advanced renal or eye complications, or 2) these two outcomes or peripheral neuropathy. Microvascular complications including nephropathy, retinopathy, and neuropathy are an important source of morbidity in patients with type 2 diabetes. Analysis of available epidemiological evidence suggests that hyperglycaemia is an important contributor to develop ment and progression of microvascular complications in type 2 diabetes.6 Although some clinical trials4,7,8 reported a decrease in occurrence of micro vascular endpoints with lowering of HbA1c, findings from recent trials9,13 showed less benefi t in elderly patients or those with long-term diabetes than in younger patients or those with short duration disease. P. 423.

Analysis of secondary renal endpoints shows that the risk of development of macroalbuminuria was 29%

lower with intensive therapy both at transition and at study end than with standard therapy. Macroalbuminuria is a known risk factor for renal insuffi ciency21 and cardiovascular disease.22

We noted reductions in albuminuria with intensive glycaemia therapy similar to those in the ADVANCE9 and VADT13 trials. Collectively, these fi ndings emphasise the benefi ts of glycaemic

control for reduction of abluminuria in an important group of patients with type 2 diabetes (ie, elderly

patients, and those with long-term disease or with established cardiovascular disease or high cardiovascular

risk). 423- 424.

Mean serum creatinine concentrations at baseline, transition, and end of study were similar in the two treatment groups (tables 2–4). By contrast with UKPDS,7 we did not record a clear

benefi t of intensive therapy for diabetic retinopathy on the basis of major clinical endpoints (such as necessity of photo coagulation); our result is consistent with VADT9 and ADVANCE.

The signifi cant reductions in the development of peripheral neuropathy, if further sustained, suggest that

intensive glycaemia therapy could decrease the risk of ulcers and number of future leg amputations.23 p.

424.

The 22% relative and 0·27% per year absolute increase in all-cause mortality recorded with intensive

glycaemia therapy in ACCORD prompted the discontinuation of intensive glycaemia control and

transition of patients to standard glycaemia therapy.14 Additionally, intensive therapy led to increased bodymass index and a three-fold increase in frequency of severe hypoglycaemia.14

Furthermore, no overall cardiovascular disease benefi t had accrued, although non-fatal myocardial infarction was reduced by 24% (p=0·004).14 In subgroup analysis, there was a reduction in the primary composite cardiovascular disease outcome (but not in total mortality) in patients who entered the study with no previous history of cardiovascular disease events or with an HbA1c of 8·0% or less.14 426

Association of glycaemia with macrovascular and

microvascular complications of type 2 diabetes (UKPDS 35):

prospective observational study

Irene M Stratton, Amanda I Adler, H Andrew W Neil, David R Matthews, Susan E Manley,

Carole A Cull, David Hadden, Robert C Turner, Rury R Holman on behalf of the UK Prospective

Diabetes Study Group

BMJ VOLUME 321 12 AUGUST 2000

possible confounders at diagnosis of diabetes. Results The incidence of clinical complications was

significantly associated with glycaemia. Each 1% reduction in updated mean HbA1c was associated with

reductions in risk of 21% for any end point related to diabetes (95% confidence interval 17% to 24%,

P < 0.0001), 21% for deaths related to diabetes (15% to 27%, P < 0.0001), 14% for myocardial infarction

(8% to 21%, P < 0.0001), and 37% for microvascular complications (33% to 41%, P < 0.0001). No threshold

of risk was observed for any end point.

Conclusions In patients with type 2 diabetes the risk of diabetic complications was strongly associated with

previous hyperglycaemia. Any reduction in HbA1c is likely to reduce the risk of complications, with the lowest risk being in those with HbA1c values in the normal range ( < 6.0%). 405

These are the results that the full treatment document says shows that fair to good control is enough. This study is complementary to the previous UKPDS which showed no significant impact on cardiovascular events of intensive treatment. This study shows the various groups. They complain about no information on a lot of issues. They say:

Complementary information for estimates of the risk of complications at different levels of glycaemia can be obtained from

observational analyses of data during the study. 405

“Generally, these studies [showing increased risks of various sorts] measured glycaemia as being high or low or assessed glycaemia on a single occasion, whereas repeated measurements of glycaemia over several years would be more informative.

“The existence of thresholds of glycaemia—that is, concentrations above which the risk of complications

markedly increases—has not been studied often in patients with type 2 diabetes. The relative risk for myo­

cardial infarction seems to increase with any increase in glycaemia above the normal range,15 16 whereas the

risk for microvascular disease is thought to occur only with more extreme concentrations of glycaemia.17–19 “The diabetes control and complications trial (DCCT) research group showed an association between glycae­ mia and the progression of microvascular complica­ tions in patients with type 1 diabetes for haemoglobin A1c over the range of 6­11% after a mean of six years of follow up.20 No specific thresholds of glycaemia were identified above which patients were at greater risk of

progression of retinopathy, increased urinary albumin excretion, or nephropathy.19–21 Nor has any threshold of

fasting plasma glucose concentration been identified for cardiovascular deaths.22 23

We evaluated the relation between exposure to glycaemia over time and the development of macrovascu­ lar and microvascular complications and compared this with the results of the UKPDS trial of a policy of intensive control of blood glucose control.1p. 405

Conventional therapy mainly diet.

The 3867 patients who had fasting plasma glucose concentrations between 6.1 and 15.0 mmol/l and no symptoms of hyperglycaemia were randomised to a policy of conventional glucose control, primarily with diet, or to an intensive policy

with sulphonylurea or insulin.1 24–26 The aim in the group allocated to conventional control (n = 1138) was to obtain fasting plasma glucose concentration < 15 mmol/l, but if concentrations rose to >15 mmol/l or symptoms of hyperglycaemia developed patients were secondarily randomised to non­intensive use of these pharmacological treatments, with the aim of achieving fasting plasma glucose concentrations < 15 mmol/l without symptoms. The aim in the group allocated to

intensive control (n = 2729) was to achieve fasting plasma glucose concentration < 6 mmol/l, primarily with a single pharmacological treatment. Details of treatments and their effect on glucose control have been published elsewhere.1

p. 406

In the intensive control group it appears that an effort was made, with medications, to control hypertension. See Follow UP article starting on p. 412. Confounders were handled by randomization, but I think this means they ended up in totals presented. So I think that some, maybe many events, were from confounders. Need a list of confounders.

This observational analysis provides an estimate of the reduction in risk that might be achieved by the

therapeutic lowering of haemoglobin A1cby 1.0%, but it is important to realise that epidemiological associations

cannot necessarily be transferred to clinical practice. Tissue damage from previous hyperglycaemia

may not promptly be overcome, but the results are not inconsistent with those achieved by the policy of intensive

glucose control in the clinical trial. 1

This suggests that the reduction in glycaemia obtained over a median 10 years of follow up of the trial, comparing

median haemoglobin A1c 7.0% with 7.9%, provided much of the benefit that could be expected from that

degree of improved glycaemic control. Our results suggest that intensive treatment with sulphonylurea or

insulin does not have an effect beyond that of lowering blood glucose concentration with respect to altering

risk. The 16% risk reduction (P = 0.052) in myocardial infarction in the clinical trial in the group allocated to

a policy of intensive blood glucose control (associated with a 0.9% difference in haemoglobin A1c) was similar

to the 14% risk reduction seen in the epidemiological analysis, which was associated with a 1% reduction in

concentration of updated mean haemoglobin A1c. The UKPDS clinical trial evaluated a policy of intensive

glucose control based primarily on single pharmacological treatments to enable evaluation of the

individual treatments. Now that the UKPDS has shown that improved glucose control reduces the risk of complications

and that the treaments used are safe in clinical practice, a larger reduction in haemoglobin A1c

might be achieved by the earlier use of combination treatments or by the use of newer treatments, which

could further reduce the risk of myocardial infarction. Pp. 409-410.

The UKPDS population was likely to be at lower risk of complications than other diabetic populations. Hence, the incidence rates we report are perhaps lower than might be observed in other diabetic populations as the cohort was newly

diagnosed with diabetes, excluded old or ill patients, and contained a small proportion (6%) of participants

with impaired fasting glycaemia. 38 None the less, the decrease in relative risk is unlikely to be different from

other diabetic populations. 410.

In reality, it is difficult to obtain and maintain near normal concentrations of haemoglobin A1c in patients with type 2

diabetes, particularly in those with a high concentration of haemoglobin A1c at diagnosis of diabetes. 37 Intensification of treatment by adding insulin to improve the relatively modest reduction in glycaemia achieved with oral hypoglycaemic treatments can be constrained by reluctance from patients and providers because, in part, of side effects such as hypoglycaemia or weight gain. These observational analyses, together with the results of the clinical trial, however, indicate that any improvement in a raised haemoglobin A1c concentration is likely to reduce the risk of diabetic

complications. P. 410.

The estimated 14% decrease in all cause mortality per 1% reduction in haemoglobin A1cconcentration was similar to that seen in other studies that have assessed glycaemia as haemoglobin A1c as a continuous variable (per 1%

change) in multivariate proportional hazards models.9 411.

Individuals with very high concentrations of glycaemia would be most likely to benefit from reduction of glycaemia as they are particularly at risk from the complications of type 2 diabetes, but the data suggest that any improvement in glycaemic control across the diabetic range is likely to reduce the risk of diabetic complications.

Association of systolic blood pressure with macrovascular

and microvascular complications of type 2 diabetes

(UKPDS 36): prospective observational study

Amanda I Adler, Irene M Stratton, H Andrew W Neil, John S Yudkin, David R Matthews,

Carole A Cull, Alex D Wright, Robert C Turner, Rury R Holman on behalf of the UK Prospective

Diabetes Study Group BMJ VOLUME 321 12 AUGUST 2000 Starts, p. 412.

There was no indication of a threshold for any of the complications examined below which risk no

longer decreased nor a level above which risk no longer increased. P. 415.

On average, each 10 mm Hg reduction in systolic blood pressure was associated with a 12% decrease in the risk of any end point related to diabetes and a 15% reduction in the risk of death related to diabetes. Myocardial infarction occurred more commonly than microvascular complications, but the relative risk reduction for a 10 mm Hg reduction in systolic

blood pressure was similar at 11% and 13%, respectively. 416.

This analysis indicates the importance of early assessment of blood pressure in the course of diabetes. Improved control of blood pressure in diabetic patients has been shown to be effective in reducing the risk of cardiovascular complications37 48 49 and nephropathy, 50 as well as providing considerable savings in healthcare costs. 51 52 418

Targeting and treating patients with the highest blood pressure will reduce individual risk the most, but targeting and treating people with moderately raised blood pressure will reduce the risk in greater numbers of people.56

The UKPDS provides an evidence base for the management of raised blood pressure and hyperglycaemia to reduce the complications of type 2 diabetes. 418.

ACCORD:

Effects of intensive glucose lowering in type 2 diabetes. By: Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT, The New England Journal Of Medicine, 1533-4406, 2008 Jun 12, Vol. 358, Issue 24

The finding of higher mortality in the intensive-therapy group led to a discontinuation of intensive therapy after a mean of 3.5 years of follow-up. P. 1533

During follow-up, the primary outcome occurred in 352 patients in the intensive-therapy group, as compared with 371 in the standard-therapy group (hazard ratio, 0.90; 95% confidence interval [CI], 0.78 to 1.04; P=0.16). At the same time, 257 patients in the intensive-therapy group died, as compared with 203 patients in the standard-therapy group (hazard ratio, 1.22; 95% CI, 1.01 to 1.46; P=0.04). Hypoglycemia requiring assistance and weight gain of more than 10 kg were more frequent in the intensive-therapy group (P ................
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