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L M Bouter

Publications and source records attributed to L M Bouter.

At least 55 records · Page 3Linked to original sources
PubMed1998

[Straying in the methodology. I. Introduction].

In recent decades clinical studies with patients have gained qualitative and quantitative importance. This has led to growing interest in methodological quality. At present, doctors need more methodological knowledge. Sophisticated software enables almost everyone to carry out the most exotic of statistical and epidemiological analyses, but the methodological implications are too often incompletely understood. In a series of column-like short articles methodological items will be discussed, in order to point out frequent errors, fallacies and practical problems.

Clinical Medicine↗
PubMed1998

Lumbar supports and education for the prevention of low back pain in industry: a randomized controlled trial.

CONTEXT: Low back pain is a frequent and costly health problem. Prevention of low back pain is important both for the individual patient and from an economic perspective. OBJECTIVE: To assess the efficacy of lumbar supports and education in the prevention of low back pain in industry. DESIGN: A randomized controlled trial with a factorial design. SETTING: The cargo department of an airline company in the Netherlands. PARTICIPANTS: A total of 312 workers were randomized, of whom 282 were available for the 6-month follow-up. INTERVENTIONS: Subjects were randomly assigned to 4 groups: (1) education (lifting instructions) and lumbar support, (2) education, (3) lumbar support, and (4) no intervention. Education consisted of 3 group sessions on lifting techniques with a total duration of 5 hours. Lumbar supports were recommended to be used during working hours for 6 months. MAIN OUTCOME MEASURES: Low back pain incidence and sick leave because of back pain during the 6-month intervention period. RESULTS: Compliance with wearing the lumbar support at least half the time was 43%. In the 282 subjects for whom data were available, no statistically significant differences in back pain incidence (48 [36%] of 134 with lumbar support vs 51 [34%] of 148 without, P=.81) or in sick leave because of low back pain (mean, 0.4 days per month with lumbar support vs 0.4 days without, P=.52) were found among the intervention groups. In a subgroup of subjects with low back pain at baseline, lumbar supports reduced the number of days with low back pain per month (median, 1.2 vs 6.5 days per month; P=.03). CONCLUSIONS: Overall, lumbar supports or education did not lead to a reduction in low back pain incidence or sick leave. The results of the subgroup analysis need to be confirmed by future research. Based on our results, the use of education or lumbar supports cannot be recommended in the prevention of low back pain in industry.

Absenteeism↗
PubMed1998

Insulin and risk of cardiovascular disease: a meta-analysis.

BACKGROUND: Our purposes were to estimate the strength of the longitudinal relationship between hyperinsulinemia and cardiovascular diseases (CVD) from the available literature and to identify study characteristics that modify this relationship. METHODS AND RESULTS: Articles were identified by means of a MEDLINE and Embase search and citation tracking. Eligible studies were prospective population-based cohort studies and nested case-control studies on the relationship between, on the one hand, fasting or nonfasting insulin levels and, on the other hand, myocardial infarction, death from coronary heart disease, and/or ECG abnormalities. Data were extracted pertaining to insulin measurements, type of outcome studied, adjustment for confounding, sex, mean age of the study population, follow-up period, insulin assay, and ethnic background (white or nonwhite). Associations of insulin and CVD were reexpressed in a uniform manner, an estimate of relative risk (RR) and 95% CI, to be used in meta-regression analyses. Twelve of 17 potentially eligible articles provided sufficient information. Overall, a weak positive association was found. The meta-analysis resulted in an estimated summary RR (95% CI) of 1.18 (1.08 to 1.29) for differences in insulin level, equivalent to the difference between the 75th and the 25th percentiles of the general population in The Netherlands. Ethnic background and type of insulin assay modified the relationship between insulin and CVD with borderline significance. CONCLUSIONS: Hyperinsulinemia is a weak risk indicator for the occurrence of CVD. The relationship between hyperinsulinemia and CVD was modified by ethnic background and by the type of insulin assay involved.

Aged↗
PubMed1998

Determinants of specific serum insulin concentrations in a general Caucasian population aged 50 to 74 years (the Hoorn Study).

The aim of this study was to investigate anthropometric and life-style determinants of insulinaemia. Specific fasting serum insulin (FI) was analysed in a general Caucasian population aged 50-74 years, not known to have diabetes mellitus (n = 2226, sample 1). The analysis was repeated some weeks later in a subgroup of sample 1 in which two individual measurements of FI were available (n = 540, sub-sample 2). Specific serum insulin 2 h after ingestion of 75 g glucose (2hI), also measured on two occasions, was analysed in this same subgroup after excluding 59 subjects with fasting plasma glucose >7 mmol l(-1) (n = 481, sub-sample 3). Multiple regression analyses were performed, stratified for sex, with 10log insulin as the dependent variable. All determinants were adjusted for each other. FI was positively associated with BMI and waist-hip ratio (men and women) and inversely associated with intake of fibre (women), moderate alcohol use (men), and current smoking (women). 2hI was positively associated with BMI and waist-hip ratio (men and women), and intake of fat (women). 2hI was inversely associated with physical activity and moderate alcohol use (men and women), and current smoking (men). Family history of diabetes was not associated with insulinaemia. In conclusion, various life-style factors are related to insulinaemia, independent of obesity.

Aged↗
PubMed1998

Microalbuminuria is strongly associated with NIDDM and hypertension, but not with the insulin resistance syndrome: the Hoorn Study.

Microalbuminuria is a strong predictor of cardiovascular disease. The aim of this study was to investigate whether microalbuminuria is part of a cluster of risk factors, the insulin resistance syndrome (IRS), or whether it is only associated with, and presumably a complication of, hypertension and non-insulin-dependent diabetes mellitus (NIDDM). An age-, sex- and glucose tolerance-stratified random sample from a 50-75 year old general population (n = 622) was investigated. The urinary albumin-to-creatinine ratio was measured in an early morning spot urine sample. Microalbuminuria was defined as an albumin-to-creatinine ratio greater than 2.0 mg/ mmol. We considered, as IRS-related variables, fasting hyperinsulinaemia, insulin resistance (IR; calculated from the formula of the homeostasis model assessment), dyslipidaemia, glucose intolerance, hypertension and waist-to-hip ratio (WHR). Dyslipidaemia was defined as levels of HDL-cholesterol in the lowest and/or levels of triglyceride in the highest tertile. Fasting insulin levels, IR and WHR were divided into tertiles; the highest tertiles were compared to the lowest tertiles. Age-, sex- and glucose tolerance-adjusted analyses showed microalbuminuria to be significantly associated with hypertension, NIDDM and WHR. In multiple logistic regression analyses, microalbuminuria showed independent associations with hypertension, NIDDM and WHR, with odds ratios (ORs [95% confidence interval]) of 3.33 (1.86-5.96), 2.26 (1.14-4.48) and 2.49 (1.09-5.70), respectively. No associations were found with impaired glucose tolerance, hyperinsulinaemia, IR or dyslipidaemia. Multiple logistic regression analyses in diabetic and non-diabetic subjects separately showed that microalbuminuria was independently associated only with hypertension (ORs 4.31 and 2.69). In this Caucasian population, microalbuminuria was associated with hypertension, NIDDM and WHR and not with other variables of the IRS. It is therefore likely that microalbuminuria is a complication of hypertension and NIDDM, and not an integral part of the IRS.

Age Factors↗
PubMed1998

The influence of physical activity and fractures on ultrasound parameters in elderly people.

In this cross-sectional study we investigated the relationship between ultrasound measurements in the calcaneus versus daily physical activity and fractures sustained in the past in elderly subjects. Ultrasound measurements were performed at both heels, which enabled us to examine determinants of differences between contralateral heels. Participants were 132 men and 578 women, aged 70 years and over (mean age and standard deviation (SD): 83 +/- 6 years), living in homes for the elderly (n = 343) or apartment houses for the elderly (n = 367). Broadband ultrasound attenuation (BUA) and speed of sound (SOS) were measured in the right and left calcaneus. The median difference (and interquartile range) between the two heels for BUA and SOS, expressed as a percentage of the mean value for each individual, was 9.6% (4.2-15.7%) and 1.0% (0.4-1.7%), corresponding to 25% and 40% of the study population SD, respectively. Greater differences in BUA between the two heels were associated with variables indicating poorer functional status, such as past fractures at the lower extremities. The level of daily physical activity was obtained by means of a questionnaire regarding household and leisure activities. Subsequently sumscores were calculated for daily physical activity and a subscore indicating weight-bearing physical activity. After adjustment for age, gender, residence, and body weight, physical activity scores were positively linearly related to both BUA and SOS. Each 5 point increase on the weight-bearing physical activity score, corresponding to, for example, walking for 2.5 h per week, was associated with a difference in BUA of 4.7 dB/MHz and in SOS of 5.1 m/s, which is similar to the differences associated with 10 kg higher body weight, or 10 years younger age. After the age of 50 years, 47 subjects had fractured a hip, 61 subjects had sustained another lower extremity fracture, 104 subjects a wrist fracture, and 62 subjects another upper extremity fracture. After adjusting for age, gender and residence, odds ratios for all fracture types in the lowest terciles of BUA and SOS versus the highest terciles ranged from 1.9 to 3.8. This study showed significant differences in ultrasound measurements between the left and the right heel, indicating that measurements at both sides are necessary for optimal evaluation of bone strength. Furthermore, after careful adjustments, ultrasound parameters had higher values with higher daily physical activity in elderly subjects and discriminated subjects with a history of fracture from those without.

Aged↗
PubMed1998

Dissimilar association of conventional immuno-reactive versus specific insulin with cardiovascular risk factors: a consequence of proinsulinaemia?

In this study involving 365 non-diabetic elderly Caucasians, we examined the relationship of immuno-specific insulin (ISI), total immuno-reactive insulin (IRI), proinsulin (PI) and proinsulin-insulin ratio (PI:ISI) to serum high-density lipoprotein cholesterol (HDL-C), triglyceride (TG), systolic blood pressure (SBP) and diastolic blood pressure (DBP), mean blood pressure (MBP) and pulse pressure. In a multiple regression analysis, adjusted for age, sex and obesity, a 1.3-fold stronger inverse association with HDL-C levels was found for IRI than for ISI, with a 1.6-fold better fit of the regression equation. The positive association of insulin with TG was 1.6-fold stronger for IRI compared to ISI, with a 2.5-fold better fit. In contrast, the positive association of IRI with the various blood pressure parameters was 1.5-1.9-fold weaker than for ISI, with a 2.1-3.8-fold worse fit. Both PI:ISI ratio and PI were independently associated with TG levels, but not with HDL-C. The PI:ISI ratio but not PI, was associated with blood pressure, but dependent on glycaemia. In conclusion, compared to ISI, IRI overestimates the association of insulin with serum lipids and underestimates the association of insulin with blood pressure. The use of non-specific insulin assays may explain the inconsistencies in the findings of previous epidemiological studies.

Aged↗
PubMed1998

The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by Delphi consensus.

Most systematic reviews rely substantially on the assessment of the methodological quality of the individual trials. The aim of this study was to obtain consensus among experts about a set of generic core items for quality assessment of randomized clinical trials (RCTs). The invited participants were experts in the field of quality assessment of RCTs. The initial item pool contained all items from existing criteria lists. Subsequently, we reduced the number of items by using the Delphi consensus technique. Each Delphi round comprised a questionnaire, an analysis, and a feedback report. The feedback report included staff team decisions made on the basis of the analysis and their justification. A total of 33 international experts agreed to participate, of whom 21 completed all questionnaires. The initial item pool of 206 items was reduced to 9 items in three Delphi rounds. The final criteria list (the Delphi list) was satisfactory to all participants. It is a starting point on the way to a minimum reference standard for RCTs on many different research topics. This list is not intended to replace, but rather to be used alongside, existing criteria lists.

Delphi Technique↗
PubMed1998

Serum homocysteine level and protein intake are related to risk of microalbuminuria: the Hoorn Study.

BACKGROUND: Microalbuminuria (MA) is a strong predictor of cardiovascular disease, but its causes are incompletely understood. Hyperhomocysteinemia is a recently recognized risk factor for cardiovascular disease independent of established risk factors. It is not known whether hyperhomocysteinemia is associated with MA, and thus could be a possible cause of microalbuminuria. METHODS: We studied an age-, sex- and glucose-tolerance-stratified random sample of a 50- to 75-year old general Caucasian population (N = 680). The urinary albumin-to-creatinine ratio (ACR) was measured in an early morning spot urine sample. MA was defined as an ACR > 3.0 mg/mmol. RESULTS: The prevalence of MA was 4.3% (13 of 304) in subjects with normal glucose tolerance, 9.2% (17 of 185) in impaired glucose tolerance and 18.3% (30 of 164) in non-insulin-dependent diabetes mellitus (NIDDM); it was 3.7% (15 of 402) in subjects without hypertension and 17.9% (45 of 251) in those with hypertension. After adjusting for age, sex, glucose tolerance category, hypertension, dyslipidemia and smoking, the odds ratio [OR; 95% confidence interval (95%CI)] for MA per 5 mumol/liter total homocysteine increment was 1.33 (1.08 to 1.63). Additional adjustment for HbA1c, waist-hip ratio, protein intake and serum creatinine did not attenuate the association between MA and total homocysteine. A 0.1 g/kg.day increment of protein intake was also associated with an increased risk for MA after adjustment for age, sex, classical risk factors and serum total homocysteine [OR (95% CI); 1.20 (1.08 to 1.32)]. CONCLUSION: Both hyperhomocysteinemia and protein intake are related to microalbuminuria independent of NIDDM and hypertension. Hyperhomocysteinemia may partly explain the link between MA and increased risk of cardiovascular disease.

Aged↗
PubMed1998

Chronic low back pain in primary care: a prospective study on the management and course.

BACKGROUND: There is little evidence about the management and course of chronic low back pain in primary care. OBJECTIVES: Our aim was to describe the course of chronic low back pain and the performed diagnostic and therapeutic procedures for patients with chronic low back pain in general practice. METHODS: Twenty-six GPs involved in the Registration Network Family Practices participated in this prospective follow-up study. All patients and GPs were asked to complete questionnaires at baseline and at 4, 8 and 12 months follow-up. RESULTS: The GPs provided information about diagnostic and therapeutic procedures concerning 524 patients with chronic low back pain. Diagnostic tests other than history-taking and physical examination were not frequently used. Medication, mostly NSAIDs, was the most frequently used type of treatment (21.6%). The most frequent referrals concerned physiotherapy (16.3%) and neurology or neurologic surgery (6.3%). Information about the course of their chronic low back pain was provided by 368 patients participating in our study. The course of chronic low back pain appeared to be quite stable, as there was only a slight improvement in pain intensity and physical functioning over the 12 months of follow-up. CONCLUSIONS: A variety of options for the treatment and referral of chronic low back pain patients is available for and used by GPs. Efforts should be made to establish which diagnostic and therapeutic procedures are the most effective for chronic low back pain.

Adult↗
PubMed1998

Elder abuse in the community: prevalence and consequences.

OBJECTIVES: (1) To assess the prevalence and the consequences of chronic verbal aggression, physical aggression, financial mistreatment, and neglect in a community-based sample; (2) to investigate the circumstances that led to the abuse and the ways in which the victims handled the problem. DESIGN: Prevalence was assessed in a population-based sample of 1797 older people living independently in Amsterdam, the Netherlands. In a follow-up study 1 year later, the victims were questioned again about the background and consequences of the abuse. RESULTS: The 1-year prevalence of elder abuse was 5.6%. The prevalence of the various types of elder abuse was: verbal aggression 3.2%, physical aggression 1.2%, financial mistreatment 1.4%, and neglect 0.2%. Most victims reported emotional reactions immediately after the abuse. Seven of 36 victims experienced physical or financial damage as a consequence of the abuse. More than 70% of the victims were able to stop the abuse, either by themselves or with the help of others. CONCLUSION: The rate of occurrence and the consequences of elder abuse in the Netherlands was established. Elder abuse is more widely spread if not only close relatives or people with whom the older person lives are considered as possible perpetrators but other familiar and trusted people are considered as well. Intervention should be focused on the roughly 40% of victims who were not able to stop the abuse.

Aged↗
PubMed1998

On the course of low back pain in general practice: a one year follow up study.

OBJECTIVES: Knowledge on the clinical course of low back pain presented in general practice is poor. Preceding studies offer a fragmentary view only, whereas further knowledge is important to enable the assessment of the prognosis. The object of this study is to investigate the course of low back pain presented in general practice to enable the assessment of the prognosis. METHODS: A one year follow up study on the clinical course of low back pain in consecutive cases receiving usual care in general practice. During a period of two years 15 general practitioners from Amsterdam and surrounding areas included consecutive patients with both chronic and recent onset low back pain. After the initial visit, each patient was monitored for a period of 12 months. The follow up consisted of monthly postal questionnaires on the course of the low back pain and the related disability. RESULTS: A total of 443 of 605 patients identified were included in the follow up, which was fully completed by 269 patients. In general, patients with less serious low back pain participated less often or did not complete the follow up. At 12 weeks 35% and at the end of the follow up 10% of the population, respectively, still suffered from low back pain. Both the pain and the disability seemed to diminish quickly after the initial visit, and both seemed to stabilise at a lower level if the low back pain did not disappear completely. About three of four patients, whose pain disappeared before the end of the follow up, endured one or more relapses within a year. The median time to a relapse was about seven weeks, and its median duration about six weeks. Both the pain and the disability turned out to be less severe during relapses. The median time to recovery for patients whose low back pain developed more than seven weeks before the initial visit, was four weeks longer than for patients with more recently developed low back pain at the initial visit. CONCLUSIONS: The clinical course of low back pain presented in general practice, for the most patients, clearly is less favourable than expected. It takes more than just a few weeks to recover, and relapses occur within a year in most cases. Fortunately, both the pain and the disability quickly diminish, even if the low back pain does not resolve within a few weeks.

Acute Disease↗
PubMed1998

The responsiveness of the Shoulder Disability Questionnaire.

OBJECTIVE: To evaluate the responsiveness of the Shoulder Disability Questionnaire (SDQ). METHODS: The study was conducted within the framework of an observational study on shoulder disorders in primary care. After first presentation of their complaints to the general practitioner and after one and six months, participants completed the SDQ, a single question on functional status (FSQ), and an ordinal 11 point scale for the severity of pain (PSS). Responsiveness of the SDQ was evaluated compared with that of the FSQ and PSS, by calculating responsiveness ratios and by plotting receiver operating characteristic (ROC) curves. Recovery according to the patient was used as an external criterion for clinically relevant improvement (complete recovery or much improved on a six point Likert scale was denoted as clinically relevant improvement). RESULTS: A total of 349 consecutive patients with shoulder disorders were enrolled in the observational study. Response rates ranged between 96% and 89%. Responsiveness ratios were slightly higher for the PSS compared with the SDQ (2.53 versus 2.22 at one month, 2.24 versus 1.89 at six months). The area under the ROC curve was 0.84 for both the SDQ and the PSS, and 0.72 for the FSQ. CONCLUSION: The results of this study confirm the responsiveness of the SDQ, making it a useful instrument to assess functional disability in longitudinal studies.

Activities of Daily Living↗
PubMed1998

Hyperhomocysteinemia is associated with an increased risk of cardiovascular disease, especially in non-insulin-dependent diabetes mellitus: a population-based study.

A high serum total homocysteine (tHcy) level is an independent risk factor for cardiovascular disease. Because it is not known whether the strength of the association between hyperhomocysteinemia and cardiovascular disease is similar for peripheral arterial, coronary artery, and cerebrovascular disease, we compared the three separate risk estimates in an age-, sex-, and glucose tolerance-stratified random sample (n=631) from a 50- to 75-year-old general white population. Furthermore, we investigated the combined effect of hyperhomocysteinemia and diabetes mellitus with regard to cardiovascular disease. The prevalence of fasting hyperhomocysteinemia (>14.0 micromol/L) was 25.8%. After adjustment for age, sex, hypertension, hypercholesterolemia, diabetes, and smoking, the odds ratios (ORs; 95% confidence intervals) per 5-micromol/L increment in tHcy were 1.44 (1.10 to 1.87) for peripheral arterial, 1.25 (1.03 to 1.51) for coronary artery, 1.24 (0.97 to 1.58) for cerebrovascular, and 1.39 (1.15 to 1.68) for any cardiovascular disease. After stratification by glucose tolerance category and adjustment for the classic risk factors and serum creatinine, the ORs per 5-micromol/L increment in tHcy for any cardiovascular disease were 1.38 (1.03 to 1.85) in normal glucose tolerance, 1.55 (1.01 to 2.38) in impaired glucose tolerance, and 2.33 (1.11 to 4.90) in non-insulin-dependent diabetes mellitus (P=.07 for interaction). We conclude that the magnitude of the association between hyperhomocysteinemia and cardiovascular disease is similar for peripheral arterial, coronary artery, and cerebrovascular disease in a 50- to 75-year-old general population. High serum tHcy may be a stronger (1.6-fold) risk factor for cardiovascular disease in subjects with non-insulin-dependent diabetes mellitus than in nondiabetic subjects.

Aged↗
PubMed1998

Predictors for falls and fractures in the Longitudinal Aging Study Amsterdam.

The objective of this study was to identify easily measurable predictors for falls, recurrent falls, and fractures using a population-based prospective cohort study of 1469 elderly, born before 1931, in three regions of the Netherlands. The baseline at-home interview was in 1992. In 1995, falls experienced in the preceding year and fractures over the preceding 38-month period were registered. In a period of 1 year, 32% of the participants fell at least once, and 15% fell two or more times. The rate of recurrent falls was similar in men and women up until the age of 75 years. The total number of fractures was 85, including 23 wrist fractures, 12 hip fractures, and 9 humerus fractures. The incidence density per 1000 person-years for any fracture was 25.1 (95% confidence interval [CI], 18.9-31.4) for women and 8.2 (95% CI, 4.5-12.0) for men, respectively. Multiple logistic regression identified urinary incontinence, impaired mobility, use of analgetics, and use of antiepileptic drugs as the predictors most strongly associated with recurrent falls. Female gender, living alone, past fractures, inactivity, body height, and use of analgetics proved to be the predictors most strongly associated with fractures. The probabilities of recurrent falls were 4.7% (95% CI, 2.9-7.5%) to 59. 2% (95% CI, 24.1-86.9%) with zero to four predictors, respectively. The probability of fractures ranged from 0.0% (95% CI, 0.0-0.4%) without any of the identified predictors to 12.9% (95% CI, 4.4-32. 2%) with all six predictors present. Our study shows that the risk of recurrent falls and of fractures can be predicted using up to, respectively, four and six easily measurable predictors. This study emphasizes the importance of impaired mobility and inactivity as predictors for falls and fractures.

Accidental Falls↗
PubMed1998

The 1997 American Diabetes Association criteria versus the 1985 World Health Organization criteria for the diagnosis of abnormal glucose tolerance: poor agreement in the Hoorn Study.

OBJECTIVE: Recently, the American Diabetes Association (ADA) introduced new diagnostic criteria. These new criteria are based on fasting plasma glucose levels, avoiding the burdensome oral glucose tolerance test (OGTT). We compared the 1997 ADA criteria with the 1985 World Health Organization (WHO) criteria with respect to the prevalence of diabetes and the cardiovascular risk profile in the population of the Hoorn Study RESEARCH DESIGN AND METHODS: The Hoorn Study is a population-based survey of 2,484 men and women, aged 50-75 years. An OGTT was performed and cardiovascular risk factors were determined in 2,378 subjects without known diabetes. Subjects were categorized according to both sets of diagnostic criteria. RESULTS: Although the prevalence of diabetes was similar for both sets of criteria, 47 of 120 (39.2%) subjects who were diagnosed with diabetes according to the 1997 ADA criteria were not classified as having diabetes when using the 1985 WHO criteria. Similarly, of 285 subjects diagnosed with impaired fasting glucose by the 1997 ADA criteria, 195 (68.4%) were classified as having normal glucose tolerance by the 1985 WHO criteria. The overall agreement was poor (kappa 0.33; 95% CI 0.28-0.38). Subjects who were diagnosed as having diabetes by either set of criteria had an adverse cardiovascular risk profile, which was between the cardiovascular risk profiles of concordant normal and concordant diabetic subjects. CONCLUSIONS: In this study both sets of criteria diagnosed a similar number of diabetic subjects, but many of the subjects shifted between glucose intolerance categories. With either set of criteria, a considerable number of subjects at risk of developing diabetes and subjects carrying an increased risk of cardiovascular disease, as reflected by an adverse cardiovascular risk profile, will be missed.

Blood Glucose↗
PubMed1998

Randomized study of two different target levels of glycemic control within the acceptable range in type 2 diabetes. Effects on well-being at 1 year.

OBJECTIVE: A randomized trial with 1-year follow-up was conducted in 23 general practices to study the relationship between target values for glycemic control and well-being in type 2 diabetes. RESEARCH DESIGN AND METHODS: A total of 176 patients with type 2 diabetes, aged 40-75 years, were included. General practitioners were encouraged to make decisions according to a standardized step-up regimen until the target level of glycemic control was reached. The random allocation to a strict or a less strict target level of glycemic control (fasting capillary glucose < 6.5 or < 8.5 mmol/l), change in HbA1c and fasting glucose, and initiating insulin or treatment with oral hypoglycemic agents were studied as putative determinants of scores on a type 2 diabetes symptom checklist, a profile of mood states, an affect balance scale, and general well-being. Adjustments were made for baseline scores on the outcome at issue. RESULTS: Positive affect (an odds ratio [OR] [95% CI] of 0.39 [0.19-0.83]) and perceived treatment burden (OR 0.48 [0.23-0.98]) were unfavorably altered in the group randomly allocated to stricter target levels (fasting capillary glucose < 6.5 mmol/l). Patients who had a decrease in HbA1c of 1% or more tended to have comparatively favorable mood (OR displeasure score 0.35 [0.13-0.94]) and general well-being scores at 1 year (ORs of having unfavorable scores ranged from 0.4 to 0.5, NS). CONCLUSIONS: Perceived treatment burden and positive effect are unfavorably affected by random allocation to a strict target level for glycemic control. Improved glycemic control is associated with favorable mood and possibly general well-being in type 2 diabetes.

Adult↗