Assessment of response rates and yields for Two opportunistic Tools for Early detection of Non-diabetic hyperglycaemia and Diabetes (ATTEND). A randomised controlled trial and cost-effectiveness analysis.

AIMS: To assess the opportunistic use in primary care of a computer risk score versus a self-assessment risk score for undiagnosed type 2 diabetes. METHODS: We conducted a randomised controlled trial in 11 primary care practices in the UK. 577 patients aged 40-75years with no current diagnosis of type 2 diabetes were recruited to a computer based risk score (Leicester Practice Computer Risk Score (LPCRS)) or a patient self-assessment score (Leicester Self-Assessment Score (LSAS)). RESULTS: The rate of self-referral blood tests was significantly higher for the LPCRS compared to the LSAS, 118.98 (95% CI: 102.85, 137.64) per 1000 high-risk patient years of follow-up compared to 92.14 (95% CI: 78.25, 108.49), p=0.022. Combined rate of diagnosis of type 2 diabetes and those at risk of developing the disease (i.e. impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)) was similar between the two arms, 15.12 (95% CI: 9.11, 25.08) per 1000 high-risk patient years for LPCRS compared to 14.72 (95% CI: 9.59, 22.57) for the LSAS, p=0.699. For the base case scenario the cost per new case of type 2 diabetes diagnosed was lower for the LPCRS compared to the LSAS, £168 (95% Credible Interval (CrI): 76, 364), and £352 (95% CrI: 109, 1148), respectively. CONCLUSIONS: Compared to a self-assessment risk score, a computer based risk score resulted in greater attendance to an initial blood test and is potentially more cost-effective.

Self-monitoring of blood glucose versus self-monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes receiving structured education: a cluster randomized controlled trial.

AIMS: To compare the effectiveness and acceptability of self-monitoring of blood glucose with self-monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes. METHODS: We conducted a multi-site cluster randomized controlled trial with practice-level randomization. Participants attended a structured group education programme, which included a module on self-monitoring using blood glucose or urine glucose monitoring. HbA1c and other biomedical measures as well as psychosocial data were collected at 6, 12 and 18 months. A total of 292 participants with Type 2 diabetes were recruited from 75 practices. RESULTS: HbA1c levels were significantly lower at 18 months than at baseline in both the blood monitoring group [mean (se) -12 (2) mmol/mol; -1.1 (0.2) %] and the urine monitoring group [mean (se) -13 (2) mmol/mol; -1.2 (0.2)%], with no difference between groups [mean difference adjusted for cluster effect and baseline value = -1 mmol/mol (95% CI -3, 2); -0.1% (95% CI -0.3, 0.2)]. Similar improvements were observed for the other biomedical outcomes, with no differences between groups. Both groups showed improvements in total treatment satisfaction, generic well-being, and diabetes-specific well-being, and had a less threatening view of diabetes, with no differences between groups at 18 months. Approximately one in five participants in the urine monitoring arm switched to blood monitoring, while those in the blood monitoring arm rarely switched (18 vs 1% at 18 months; P < 0.001). CONCLUSIONS: Participants with newly diagnosed Type 2 diabetes who attended structured education showed similar improvements in HbA1c levels at 18 months, regardless of whether they were assigned to blood or urine self-monitoring.

Stability and predictive utility, over 3 years, of the illness beliefs of individuals recently diagnosed with Type 2 diabetes mellitus.

AIM: To determine the stability of beliefs of patients with Type 2 diabetes about their diabetes over 3 years, following diagnosis. METHODS: Data were collected as part of a multicentre cluster randomized controlled trial of a 6-h self-management programme, across 207 general practices in the UK. Participants in the original trial were eligible for follow-up with biomedical data (HbA1c levels, blood pressure, weight, blood lipid levels) collected at the practice, and questionnaire data collected by postal distribution and return. Psychological outcome measures were depression (Hospital Anxiety and Depression Scale) and diabetes distress (Problem Areas in Diabetes scale). Illness beliefs were assessed using the Illness Perceptions Questionnaire-Revised and the Diabetes Illness Representations Questionnaire scales. RESULTS: At 3-year follow-up, all post-intervention differences in illness beliefs between the intervention and the control group remained significant, with perceptions of the duration of diabetes, seriousness of diabetes and perceived impact of diabetes unchanged over the course of the 3-year follow-up. The control group reported a greater understanding of diabetes during the follow-up, and the intervention group reported decreased responsibility for diabetes outcomes during the follow-up. After controlling for 4-month levels of distress and depression, the perceived impact of diabetes at 4 months remained a significant predictor of distress and depression at 3-year follow-up. CONCLUSIONS: Peoples' beliefs about diabetes are formed quickly after diagnosis, and thereafter seem to be relatively stable over extended follow-up. These early illness beliefs are predictive of later psychological distress, and emphasize the importance of initial context and provision of diabetes care in shaping participants' future well-being.

Contrasting cardiovascular risk profiles and prescribed cardio-protective therapies in newly-diagnosed type 2 diabetes identified through screening and standard practice.

AIMS: Screening for Type 2 diabetes mellitus (T2DM) may improve long-term outcomes by managing cardiovascular risk at an earlier stage of the disease. The cardiovascular risk profile of screen-detected (SD) T2DM is ill defined and has not been compared to conventional newly diagnosed (CD) cases. METHODS: Baseline data from SD (n=337) and CD (n=824) cohorts were compared. SD adopted mixed approaches to screening, population based (n=214) and cardiovascular-risk factor targeted (n=123). CD reflected UK primary care practice with cases referred within four weeks of diagnosis. RESULTS: People with SD T2DM were leaner, had a lower HbA1c(%) and lower triglyceride but were more hypertensive compared to people with CD T2DM. Fewer SD were on blood pressure lowering (46% vs. 60%, p<0.0001), statin (30% vs. 41%, p<0.0001) or anti-platelet (15% vs. 27%, p<0.0001) therapies. Modelled 10 year cardiovascular disease (CVD) risk was actually greater in the SD group compared to CD (CVD: 20.8 vs. 17.2, p=0.0001). CONCLUSION: Individuals with SD T2DM are at high risk of CVD as a result of untreated hyperglycaemia, hypertension and dyslipidaemia. Those prescribed antihypertensive or lipid-lowering therapies frequently still had inadequate control. Identifying vascular risk by screening for latent glucose disease provides therapeutic opportunities for earlier intervention.

Comparison of illness representations dimensions and illness representation clusters in predicting outcomes in the first year following diagnosis of type 2 diabetes: results from the DESMOND trial.

This article explores the utility of cluster analysis of illness representations, in comparison to analysing each dimension of the individual's illness representation, to predict an individual's response to diagnosis of type 2 diabetes. Participants in a large multi-centre randomised controlled trial of a self-management education intervention for people with type 2 diabetes, completed measures of illness beliefs (coherence, timeline, impact, seriousness, personal responsibility) and depression along with HbA1c and body mass index (BMI), at baseline 4, 8 and 12 months. The results of the cluster analysis were compared with an independent qualitative study of participants' responses to diagnosis and participation in the study. The quantitative analysis of 564 participants for whom complete data were available, identified four clusters of illness representations as the most parsimonious description of the data. The mean profiles of these clusters were comparable with groups identified by the independent qualitative analysis, and predicted the trajectory of illness outcomes over the 1-year follow-up. Combining illness beliefs into discrete clusters may be more useful in understanding patterns of responding to illness than using analysis of illness beliefs dimensions independently.

Delivering the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cost effectiveness analysis.

OBJECTIVES: To assess the long term clinical and cost effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) intervention compared with usual care in people with newly diagnosed type 2 diabetes. DESIGN: We undertook a cost-utility analysis that used data from a 12 month, multicentre, cluster randomised controlled trial and, using the Sheffield type 2 diabetes model, modelled long term outcomes in terms of use of therapies, incidence of complications, mortality, and associated effect on costs and health related quality of life. A further cost-utility analysis was also conducted using current "real world" costs of delivering the intervention estimated for a hypothetical primary care trust. SETTING: Primary care trusts in the United Kingdom. PARTICIPANTS: Patients with newly diagnosed type 2 diabetes. INTERVENTION: A six hour structured group education programme delivered in the community by two professional healthcare educators. MAIN OUTCOME MEASURES: Incremental costs and quality adjusted life years (QALYs) gained. RESULTS: On the basis of the data in the trial, the estimated mean incremental lifetime cost per person receiving the DESMOND intervention is pound209 (95% confidence interval - pound704 to pound1137; euro251, -euro844 to euro1363; $326, -$1098 to $1773), the incremental gain in QALYs per person is 0.0392 (-0.0813 to 0.1786), and the mean incremental cost per QALY is pound5387. Using "real world" intervention costs, the lifetime incremental cost of the DESMOND intervention is pound82 (- pound831 to pound1010) and the mean incremental cost per QALY gained is pound2092. A probabilistic sensitivity analysis indicated that the likelihood that the DESMOND programme is cost effective at a threshold of pound20 000 per QALY is 66% using trial based intervention costs and 70% using "real world" costs. Results from a one way sensitivity analysis suggest that the DESMOND intervention is cost effective even under more modest assumptions that include the effects of the intervention being lost after one year. CONCLUSION: Our results suggest that the DESMOND intervention is likely to be cost effective compared with usual care, especially with respect to the real world cost of the intervention to primary care trusts, with reductions in weight and smoking being the main benefits delivered.

Depressive symptoms in the first year from diagnosis of Type 2 diabetes: results from the DESMOND trial.

AIMS: To describe the course of depressive symptoms during the first year after diagnosis of Type 2 diabetes. METHODS: Post hoc analysis of data from a randomized controlled trial of self-management education for 824 individuals newly diagnosed with Type 2 diabetes. Participants completed the Depression scale of the Hospital Anxiety and Depression Scale after diagnosis and at 4, 8 and 12 months follow-up. Participants also completed the Problem Areas in Diabetes scale at 8 and 12 months follow-up. We present descriptive statistics on prevalence and persistence of depressive symptoms. Logistic regression is used to predict possible depression cases, and multiple regression to predict depressive symptomatology. RESULTS: The prevalence of depressive symptoms in individuals recently diagnosed with diabetes (18-22% over the year) was not significantly different from normative data for the general population (12%) in the UK. Over 20% of participants indicated some degrees of depressive symptoms over the first year of living with Type 2 diabetes; these were mostly transient episodes, with 5% (1% severe) reporting having depressive symptoms throughout the year. At 12 months post diagnosis, after controlling for baseline depressive symptoms, diabetes-specific emotional distress was predictive of depressive symptomatology. CONCLUSIONS: The increased prevalence of depressive symptoms in diabetes is not manifest until at least 1 year post diagnosis in this cohort. However, there are a significant number of people with persistent depressive symptoms in the early stages of diabetes, and diabetes-specific distress may be contributing to subsequent development of depressive symptoms in people with Type 2 diabetes.

Biomedical, lifestyle and psychosocial characteristics of people newly diagnosed with Type 2 diabetes: baseline data from the DESMOND randomized controlled trial.

AIMS: To describe the characteristics of newly diagnosed people with Type 2 diabetes (T2DM) and compare these with published studies. METHODS: Baseline data of participants recruited to the DESMOND randomized controlled trial conducted in 13 sites across England and Scotland were used. Biomedical measures and questionnaires on psychological characteristics were collected within 4 weeks of diagnosis. RESULTS: Of 1109 participants referred, 824 consented to participate (74.3%). Mean (+/- sd) age was 59.5 +/- 12 years and 54.9% were male. Mean HbA(1c) was 8.1 +/- 2.1% and did not differ by gender. Mean body mass index (BMI) was significantly higher in women (33.7 vs. 31.3 kg/m2; P < 0.001); 69% of women and 54% of men were obese (BMI > 30 kg/m2). Total cholesterol was significantly higher in women (5.6 vs. 5.2 mmol/l; P < 0.001). Overall, 14.7% reported smoking. Percentages reporting recommended levels of vigorous activity (> or = 3 times/week) and moderate activity (> or = 5 times/week) were 10.6 and 16.0%, respectively, and were lower in women. Specific illness beliefs included 73% being unclear about symptoms and only 54% believing diabetes is a serious condition. Symptoms indicative of depression were reported by significantly more women than men (16.1% vs. 8.2%; P = 0.001). CONCLUSION: Data from this large and representative cohort of newly diagnosed people with T2DM show that many have modifiable cardiovascular risk factors. Comparison with the literature suggests that the profile of the newly diagnosed may be changing, with lower HbA1c and higher prevalence of obesity. Many expressed beliefs about and poor understanding of their diabetes that need to be addressed in order for them to engage in effective self-management.

Effectiveness of the diabetes education and self management for ongoing and newly diagnosed (DESMOND) programme for people with newly diagnosed type 2 diabetes: cluster randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of a structured group education programme on biomedical, psychosocial, and lifestyle measures in people with newly diagnosed type 2 diabetes. DESIGN: Multicentre cluster randomised controlled trial in primary care with randomisation at practice level. SETTING: 207 general practices in 13 primary care sites in the United Kingdom. PARTICIPANTS: 824 adults (55% men, mean age 59.5 years). INTERVENTION: A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care. MAIN OUTCOME MEASURES: Haemoglobin A(1c) levels, blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, and emotional impact of diabetes at baseline and up to 12 months. MAIN RESULTS: Haemoglobin A(1c) levels at 12 months had decreased by 1.49% in the intervention group compared with 1.21% in the control group. After adjusting for baseline and cluster, the difference was not significant: 0.05% (95% confidence interval -0.10% to 0.20%). The intervention group showed a greater weight loss: -2.98 kg (95% confidence interval -3.54 to -2.41) compared with 1.86 kg (-2.44 to -1.28), P=0.027 at 12 months. The odds of not smoking were 3.56 (95% confidence interval 1.11 to 11.45), P=0.033 higher in the intervention group at 12 months. The intervention group showed significantly greater changes in illness belief scores (P=0.001); directions of change were positive indicating greater understanding of diabetes. The intervention group had a lower depression score at 12 months: mean difference was -0.50 (95% confidence interval -0.96 to -0.04); P=0.032. A positive association was found between change in perceived personal responsibility and weight loss at 12 months (beta=0.12; P=0.008). CONCLUSION: A structured group education programme for patients with newly diagnosed type 2 diabetes resulted in greater improvements in weight loss and smoking cessation and positive improvements in beliefs about illness but no difference in haemoglobin A(1c) levels up to 12 months after diagnosis. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17844016 [controlled-trials.com].

'Educator talk' and patient change: some insights from the DESMOND (Diabetes Education and Self Management for Ongoing and Newly Diagnosed) randomized controlled trial.

AIMS: To determine whether differences in the amount of time educators talk during a self-management education programme relate to the degree of change in participants' reported beliefs about diabetes. METHOD: Educators trained to be facilitative and non-didactic in their approach were observed delivering the DESMOND self-management programme for individuals newly diagnosed with Type 2 diabetes. Observers used 10-s event coding to estimate the amount of time educators spoke during different sessions in the programme. Facilitative as opposed to didactic delivery was indicated by targets for levels of educator talk set for each session. Targets were based on earlier pilot work. Using the revised Illness Perceptions Questionnaire (IPQ-R) and the Diabetes Illness Representations Questionnaire (DIRQ), participants completed measures of: perceived duration of diabetes (timeline IPQ-R), understanding of diabetes (coherence IPQ-R), personal responsibility for influencing diabetes (personal responsibility IPQ-R), seriousness of diabetes (seriousness DIRQ) and impact on daily life (impact DIRQ), before and after the education programme. RESULTS: Where data from the event coding indicated educators were talking less and meeting targets for being less didactic, a greater change in reported illness beliefs of participants was seen. However, educators struggled to meet targets for most sessions of the programme. CONCLUSION: The amount of time educators talk in a self-management programme may provide a practical marker for the effectiveness of the education process, with less educator talk denoting a more facilitative/less didactic approach. This finding has informed subsequent improvements to a comprehensive quality development framework, acknowledging that educators need ongoing support to facilitate change to their normal educational style.

The natural history of overactive bladder and stress urinary incontinence in older women in the community: a 3-year prospective cohort study.

AIMS: This is the first study designed to describe the natural history of stress urinary incontinence (SUI) and overactive bladder (OAB), using validated symptom syndrome severity scores developed for the purpose. METHODS: Two separate but related studies were involved, (i) a clinic sample (N = 2,052) from a randomised controlled trial (RCT) and (ii) a prospective cohort study (N = 12,750) with 3-year follow-up. Subjects in both studies were women aged 40 or more living in the community, approached using similar postal questionnaires. Severity scores using standardised urinary symptoms were derived for SUI and OAB from weightings obtained from logistic regression models of symptoms in relation to urodynamic diagnosis. Symptom severity scores were plotted for baseline and 3 years of follow-up to demonstrate the natural history of the main categories of SUI and OAB. RESULTS: Overactive bladder and SUI syndrome severity scores showed good criterion validity in relation to relevant clinical measures and good test-retest reliability. OAB severity increased progressively with age including a period of accelerated increase in the 60s. In contrast, SUI severity showed two age-related peaks around age 60 and again at age 80. SUI severity also showed a more fluctuating pattern from year to year compared to OAB. CONCLUSIONS: Contrasting patterns of natural history for OAB and SUI syndromes were identified consistent with differences in the patterns of related co-morbidities. Further studies are needed to confirm these findings.

The cost of clinically significant urinary storage symptoms for community dwelling adults in the UK.

OBJECTIVES: To estimate the cost of clinically significant urinary storage symptoms (CSUSS), including costs borne by the National Health Service (NHS) and individuals, in terms of the use of goods and services in community-dwelling adults. SUBJECTS AND METHODS: The subjects were community-dwelling adults aged >/= 40 years and living in Leicestershire. The prevalence of CSUSS was estimated using a postal questionnaire with a randomly selected sample of 23 182 respondents. The costs associated with CSUSS were estimated using home interviews with 613 cases with and 523 subjects without CSUSS. Cases were defined on the basis of urinary symptoms of leakage, urgency, frequency and nocturia. Willingness-to-pay was used to measure intangible costs as an indicator of the value of alleviating symptoms. RESULTS: The estimated total annual cost to the NHS for treating CSUSS cases in community-dwelling adults was pound 536 million at 1999/2000 prices ( pound 303 million and pound 233 million for men and women, respectively). The total value of costs borne by individuals was estimated to be pound 207 million ( pound 29 million and pound 178 million for men and women, respectively). This gives total annual costs related to the use of services of pound 743 million. There were large intangible costs borne by individuals estimated to be pound 669 million ( pound 301 and pound 368 million for men and women) for the UK in terms of willingness-to-pay. CONCLUSIONS: The costs of CSUSS in the community amounted to approximately 1.1% of overall NHS spending for 1999/2000. Personally borne and intangible costs are also large and important components of the costs of CSUSS. There are large gender differences in the proportion of costs borne by the NHS, i.e. 91% of male and 57% of female costs.

Diet as a risk factor for the development of stress urinary incontinence: a longitudinal study in women.

OBJECTIVE: To assess the association between diet and the onset of stress urinary incontinence (SUI) in women aged 40 y plus. DESIGN AND SETTING: The Leicestershire MRC Incontinence Study - a prospective longitudinal study of the prevalence, incidence and aetiology of urinary symptoms. SUBJECTS AND METHODS: A total of 5816 women aged 40 y plus and living in the community. Urinary symptoms were reported in a postal questionnaire at baseline and at 1-y follow-up. Dietary intake was assessed in a food frequency questionnaire at baseline. RESULTS: Intakes of total fat, saturated fatty acids and monounsaturated fatty acids were associated with an increased risk of SUI onset 1 y later. Of the micronutrients studied, zinc and vitamin B12 were positively associated with SUI onset. CONCLUSION: The results from this prospective study suggest there may be an aetiological association between certain components of the diet and the onset of SUI. The findings need confirming and possible mechanisms to explain these associations need further investigation.

Validity and reliability of a questionnaire to measure the impact of lower urinary tract symptoms on quality of life: the Leicester Impact Scale.

AIMS: To develop a condition specific quality of life measure for males and females with urinary storage symptoms of urgency, frequency, nocturia and incontinence. MATERIALS AND METHODS: A sample of community dwelling males and females aged 40 years or more who were taking part in an epidemiological study provided data for development and validation of the scale. Questions were developed from literature review and discussions with clinicians and patients. Inclusion of items was dependent on levels of missing data and principal components analysis. Validity was assessed by comparison with the Hospital Anxiety and Depression Scale, the Bradburn Negative Affect Scale and single questions concerning the problematic nature of symptoms. Construct validity was assessed by comparing cases and non-cases, and patients with different symptom patterns. Test-retest and inter-rater reliability statistics were calculated for individual items. Responsiveness to change was measured in subjects taking part in a randomised controlled trial of a nursing intervention. RESULTS: The scale showed high levels of internal consistency and measures of construct validity were as hypothesised. Test-retest and inter-rater reliability was moderate to excellent. The distribution of scores was skewed with low levels of impact but the questionnaire was responsive to conservative treatments in patients receiving a nursing intervention. CONCLUSIONS: The questionnaire proved to be a valid and reliable interviewer administered instrument for measuring impact of urinary symptoms.

Storage symptoms of the bladder: prevalence, incidence and need for services in the UK.

OBJECTIVE: To establish valid and reliable prevalence and incidence rates for urinary incontinence and storage disorder, and estimate the extent of healthcare need and requirement for the UK. SUBJECTS AND METHODS: This was a cross-sectional and longitudinal population-based study involving registrants with 108 general practices in Leicestershire and Rutland counties (UK). In all, 162 533 (prevalence study) and 39 602 (incidence study) people aged > or = 40 years were approached by postal questionnaire, with response rates of 60% and 63%, respectively; 1050 non-responders were followed up. The main measures were incontinence (involuntary leakage) storage disorder (including incontinence or urgency or frequency or nocturia above clinically defined thresholds), storage symptoms (as for storage disorder, above epidemiologically defined thresholds), professionally defined healthcare need (storage disorder, or storage symptoms with an impact on quality of life, QoL), and healthcare requirement (using services or wanting help among those with a healthcare need), all within the last year. RESULTS: The period prevalence was: moderate or greater incontinence, 16.1%; storage disorder, 28.5%; storage symptoms with impact on QoL, 30.4%; healthcare need, 37.1% and requirement 20.4%. Among those with storage disorders 81% reported effects on QoL. Annual incidence rates were: incontinence, 6.3%; storage disorder, 14.1%; healthcare need, 15.6% and requirement 8.4%. The remission rates were substantially greater in men than women. The problem becomes increasingly established and less likely to remit with age. CONCLUSIONS: In the UK over a 1-year period, over a third of people aged > or = 40 years are estimated to have a healthcare need for urinary storage symptoms (i.e. 9 million) and a fifth (i.e. 5 million) are estimated to require healthcare, with unmet requirement affecting 3 million. This represents a major public health problem. Apparent inconsistencies between prevalence, impact and uptake of services are explained.

The association of diet and other lifestyle factors with overactive bladder and stress incontinence: a longitudinal study in women.

OBJECTIVES: To investigate the role of diet and other lifestyle factors in the incidence of overactive bladder and stress incontinence in women. Studies have suggested relationships between different aspects of lifestyle and symptoms of urinary incontinence, but there is a lack of firm evidence about their role in its cause. SUBJECTS AND METHODS: A random sample of women aged >or= 40 years living at home took part in a prospective cohort study. Baseline data on urinary symptoms, diet and lifestyle were collected from 7046 women using a postal survey and food-frequency questionnaire. Follow-up data on urinary symptoms were collected from 6424 of the women in a postal survey 1 year later. Logistic regression was used to investigate the association of food and drink consumption and other lifestyle factors with the incidence of overactive bladder and stress incontinence. RESULTS: In the multivariate model for the onset of an overactive bladder, there were significantly increased risks associated with obesity, smoking and consumption of carbonated drinks, and reduced risks with higher consumption of vegetables, bread and chicken. Obesity and carbonated drinks were also significant risk factors for the onset of stress incontinence, while consumption of bread was associated with a reduced risk. CONCLUSIONS: Causal associations with obesity, smoking and carbonated drinks are confirmed for bladder disorders associated with incontinence, and additional associations with diet are suggested. Behavioural modification of lifestyle may be important for preventing and treating these disorders.

An investigation into nonresponse bias in a postal survey on urinary symptoms.

OBJECTIVE: To investigate nonresponse bias in a postal survey on urinary symptoms in people aged >or= 40 years. SUBJECTS AND METHODS: Nonresponders to a postal survey on incontinence and other urinary symptoms were studied. A random sample of 1050 nonresponders (stratified for age and sex) was traced by a team of interviewers. Eligible nonresponders were asked several questions from the postal questionnaire, and their reason for not participating in the postal survey. RESULTS: Only 1% of those not responding were not traced in person or accounted for, and 12% were identified as not eligible to be in the survey sample (moved from address, deceased, residential home). Half of the eligible nonresponders (51%) did not answer the interviewer's questions, the main reason being general unwillingness or disinterest. The number in whom poor health was the reason increased with age. Comparing nonresponders who answered the interviewer's questions with a random sample of responders from the postal survey showed little difference in the reporting of urinary symptoms, although there were differences in general health and long-term health problems. Separate analyses by age showed greater reporting of some urinary symptoms and of poorer general health in the older nonresponders (>or= 70 years). CONCLUSION: Overall, for people aged >or= 40 years there was no evidence of a nonresponse bias in the reporting of urinary symptoms, providing confidence in such prevalence rates. However, poorer general health and greater reporting of some urinary symptoms by the older nonresponders (>or= 70 years) suggests prevalence rates in this age group may be underestimated.

Validity and reliability of an interviewer-administered questionnaire to measure the severity of lower urinary tract symptoms of storage abnormality: the Leicester Urinary Symptom Questionnaire.

OBJECTIVE: To develop a valid and reliable interviewer-administered questionnaire to measure the presence and severity of storage abnormality symptoms of incontinence, urgency, frequency and nocturia. SUBJECTS AND METHODS: Subjects were 930 men and women aged >/=40 years, taking part in a randomized controlled trial of a continence nurse practitioner (CNP) service. Criterion validity was tested by comparing questionnaire responses to 24-h pad test and 3-day urinary diary. Responsiveness was assessed by comparing questionnaire responses before and after treatment. Questions about urgency were investigated for construct validity in patients taking part in the trial who underwent urodynamic investigation (243). Test-retest and inter-rater reliability was measured at approximately 6 days in subjects recruited to an associated epidemiological study (104 and 102, respectively). RESULTS: The questionnaire responses showed significant associations with pad-test and diary measures. Questions about the severity of daytime incontinence performed better than those measuring night-time incontinence. The response categories of soaked, wet, damp and almost dry had better associations with the pad test than other measures of the severity of incontinence. Test-retest and inter-rater reliability was good for all questions, and all were responsive to change in symptoms, showing significant differences before and after treatment. CONCLUSION: There is a clear need for standardization of measurement using well-validated instruments. This interviewer-administered questionnaire is valid, reliable and sensitive to change in a wide range of severity of symptoms, and in both men and women aged >/=40 years. The questionnaire provides a useful assessment tool for primary and secondary care in research and clinical settings.

Prevalence of faecal incontinence in adults aged 40 years or more living in the community.

BACKGROUND: Prevalence studies of faecal incontinence in the general population are rare and the impact of faecal incontinence on quality of life has not been previously addressed. AIMS: To establish the prevalence of faecal incontinence in adults in terms of frequency of leakage, degree of soiling, and level of impact on quality of life. METHODS: In a cross sectional postal survey, 15 904 adults aged 40 years or more (excluding residents of nursing and residential homes) were selected randomly by household from the Leicestershire Health Authority patient register. Participants were asked to complete a confidential health questionnaire. Major faecal incontinence was defined as soiling of underwear or worse with a frequency of several times a month or more. Respondents were also asked if bowel symptoms had an impact on their quality of life. RESULTS: From a total sample of 10 116 respondents, 1.4% reported major faecal incontinence and 0.7% major faecal incontinence with bowel symptoms that had an impact on quality of life. Major faecal incontinence was significantly associated with a lot of impact on quality of life (odds ratio 12.4, 95% confidence interval 7.5-20.6). Incontinence was more prevalent and more severe in older people but there was no significant difference between men and women. CONCLUSIONS: This study has confirmed that faecal incontinence is a fairly common symptom, particularly in older people. Faecal incontinence in men has received little attention in the past and the results from this study indicate that it is as much of a problem in men as it is in women while the level of unmet need in this group is high. Estimates of need for health care for this symptom should be multidimensional and assess both the severity of symptoms and the impact it has on quality of life.