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Biomedical subjects

J L Donovan

Publications and source records attributed to J L Donovan.

At least 55 records · Page 3Linked to original sources
PubMed1999

Use of symptom questionnaires in the assessment and follow-up of men with benign prostatic disease.

The assessment of lower urinary tract symptoms is an essential component of the evaluation of men with benign prostatic disease in clinical practice and research. Symptom evaluation is necessary for the formal evaluation of the effectiveness of treatments in randomized controlled trials and in the assessment of outcome in individuals, and can also be useful in determining the numbers of individuals in the community who might potentially require or benefit most from treatment. Increasingly, symptom assessments are being undertaken using a small number of questionnaires that are self-completed by patients and have been tested for validity and reliability.

Follow-Up Studies↗
PubMed1999

Urinary symptoms and incontinence in women: relationships between occurrence, age, and perceived impact.

BACKGROUND: The prevalence of urinary symptoms that impact on quality-of-life will be important in determining resource allocation in primary care groups. AIM: To determine the prevalence of urinary symptoms and their perceived impact in a community population of women. METHOD: A postal survey using a validated self-completed questionnaire among all women aged over 18 years and registered with one general practice in a major British city. The prevalence rates and perceived impact of a wide range of urinary symptoms and their relationship with age was determined. Data were analysed using the chi-squared test and the chi-squared test for trend. Spearman's rank correlation was used to assess the relationship between symptom severity and perceived impact. RESULTS: The number of completed questionnaires returned was 2075, giving an 80% response rate. Of these, the number of women who reported some degree of incontinence in the previous month was 1414 (69%), although only 578 (30%) indicated that it had social or hygienic impact. Other lower urinary tract symptoms reported included nocturia (19%), poor stream (19%), urgency (61%), and dysuria (23%). The most troublesome symptoms were incontinence for no obvious reason, nocturnal incontinence, and nocturia, with 73%, 69%, and 63% of sufferers, respectively, finding these symptoms troublesome. CONCLUSIONS: Incontinence and other urinary symptoms are more common than previously thought. These symptoms are not always perceived as bothersome or as having a social or hygienic impact, and therefore many women who report urinary leakage do not require treatment. Nocturnal symptoms in women are commoner than might have been supposed and are extremely troublesome to sufferers.

Adult↗
PubMed1998

Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial.

OBJECTIVES: To explore trial participants' understandings of randomisation. DESIGN: In this exploratory study, which used qualitative research methods, in-depth, semistructured interviews were carried out with 20 participants from the CLasP randomised controlled trial. Interviews were recorded on audio tape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes, using a grounded theory approach. SETTING: The CLasP study comprises three linked multicentre, pragmatic randomised controlled trials evaluating the effectiveness and cost effectiveness of laser therapy, standard surgery, and conservative management for men with lower urinary tract symptoms or urinary retention, or both, related to benign prostatic disease. SUBJECTS: 20 participants in the CLasP study were interviewed. Sampling was purposeful: men were included from each of the treatment arms, the two major centres, and at different points in the trial. INTERVENTIONS AND OUTCOME MEASURES: Interviews used a checklist of topics to encourage participants to describe their experiences. Narratives concerning randomisation were compared to identify common themes, retaining the context of the discussion to allow detailed interpretation. RESULTS: Most participants recalled and described aspects of randomisation, such as the involvement of chance, comparison, and concealed allocation. Many found the concept of randomisation difficult, however, and developed alternative lay explanations to make sense of their experiences. Inaccurate patient information and lay interpretations of common trial terms caused confusion. CONCLUSIONS: The provision of clear and accurate patient information is important, but this alone will not ensure consistent interpretation of concepts such as randomisation. Patients may need to discuss the purposes of randomisation in order to understand them fully enough to give truly informed consent.

Attitude to Health↗
PubMed1998

Randomised trial of effectiveness of second eye cataract surgery.

BACKGROUND: The effectiveness of cataract surgery on one eye is well established, but concerns over health-care expenditure have called into question the value of cataract surgery on the second eye. We examined the effects of second eye surgery in terms of patient perceptions as well as through visual acuity, contrast sensitivity, and stereoacuity tests. METHODS: 208 otherwise healthy patients awaiting second eye cataract surgery were recruited into our randomised trial. At randomisation participants were allocated expedited surgery (planned to take place within 6 weeks) or routine surgery (routine waiting time, 7-12 months). Assessments were made at randomisation and again at review after about 6 months. Eight primary trial outcomes consisted of four questionnaire items and four visual function tests, done with both eyes open. FINDINGS: Traditional clinical tests of success in cataract surgery (visual acuity and contrast sensitivity) showed only slight differences in binocular vision in favour of the expedited-surgery group. There were major benefits for the expedited-surgery group in terms of reported visual symptoms and effects on quality of life. At review, differences in self-reported vision related difficulties between the two groups ranged from 11% (95% CI 4.4-17%, activities) to 30% (19-41%, reading). Stereoacuity was better in the expedited surgery group, the difference between the groups for the proportions with stereoacuity of 3000 s of arc or worse was 58% (47-69%). INTERPRETATION: This trial has shown that there is a clear benefit from second eye cataract surgery.

Adult↗
PubMed1998

Relationships between lower urinary tract symptoms and bladder outlet obstruction: results from the ICS-"BPH" study.

Despite the lack of evidence in the literature for close relationships between lower urinary tract symptoms and bladder outlet obstruction, the majority of urologists rely on symptomatology when selecting patients for prostatic surgery. We investigated the relationships between a wide range of lower urinary tract symptoms from the ICSmale questionnaire and the results of urodynamic pressure and flow studies. We evaluated 933 patients with lower urinary tract symptoms suggestive for bladder outlet obstruction from 12 countries who participated in the ICS-"BPH" study with the ICSmale questionnaire and urodynamic pressure and flow studies. Spearman rank correlation coefficients were obtained between symptoms and measures of bladder outlet obstruction. There was little or no correlation between a wide range of symptoms and the results of free uroflowmetry and pressure and flow studies. From symptoms alone, it is not possible to diagnose bladder outlet obstruction. Pressure and flow studies and symptom profiles measure different aspects of the clinical condition that should be viewed separately in the evaluation and treatment decision of the patient presenting with lower urinary tract symptoms.

Humans↗
PubMed1998

Sexual dysfunction in men with lower urinary tract symptoms.

The conventional view that sexual function is not adversely affected by lower urinary tract symptoms (LUTS), assumed to be caused by enlargement secondary to benign prostatic hyperplasia (BPH), was investigated in this study of 423 men aged 40 years and over in a community population in the UK and 1271 urology clinic attenders aged 45 years and over in 12 countries, using the ICSmale and ICSsex questionnaires. Sexual dysfunction was found to be common: in the community, age standardized prevalences of reduced rigidity of erections were 53%, reduced ejaculation 47%, and pain on ejaculation 5%; in clinic men, age standardized prevalences of reduced rigidity of erections were 60%, reduced ejaculation 62%, and pain on ejaculation 17%. Sex lives were reported to be spoiled by LUTS in 8% of community men and 46% in the clinic. There were negative trends for age in the extent to which clinic men were bothered by these symptoms, although older men were still very concerned. Significantly raised odds ratios of sexual dysfunction were found in those with LUTS, especially storage symptoms associated with incontinence. Urinary flow rates were not associated with sexual symptoms. Sexual dysfunction is, therefore, strongly associated with LUTS, is a matter of concern to the men affected, and should be taken into account when managing patients with LUTS.

Adult↗
PubMed1998

The ICS-'BPH' Study: uroflowmetry, lower urinary tract symptoms and bladder outlet obstruction.

OBJECTIVE: To explore the relationship between uroflow variables and lower urinary tract symptoms (LUTS): to define performance statistics (sensitivity, specificity, positive and negative predictive values) for maximum urinary flow rate (Qmax) with respect to bladder outlet obstruction (BOO) at various threshold values; and to investigate the diagnostic value of low-volume voids. PATIENTS AND METHODS: The study comprised 1271 men aged between 45 and 88 years recruited from 12 centres in Europe, Australia, Canada, Taiwan and Japan over a 2-year period. Symptom questionnaires, voiding diaries, uroflowmetry and pressure-flow data were recorded. The relationship between uroflow variables and symptoms, Qmax and BOO, and the diagnostic performance of low volume voids were analysed. RESULTS: The relationship between symptoms and uroflow variables was poor. The mean difference between home-recorded and clinic-recorded voided volumes was -48 mL. Qmax was significantly lower in those with BOO (9.7 mL/s for void 1) than in those with no obstruction (12.6mL/s; P<0.001) and Qmax was negatively correlated with obstruction grade (Spearman's correlation coefficient -0.3, P<0.001), even when controlling for the negative correlation between age and Qmax (Spearman's partial correlation coefficient -0.29, P<0.001). A threshold value of Qmax of 10 mL/s had a specificity of 70%, a positive predictive value (PPV) of 70% and a sensitivity of 47% for BOO. The specificity using a threshold Qmax of 15 mL/s was 38%, the PPV 67% and the sensitivity 82%. Those voiding <150 mL (n=225) had a 72% chance of BOO (overall prevalence of BOO 60%). In those voiding >150 mL the likelihood of BOO was 56%. The addition of a specific threshold of 10 mL/s to these higher volume voiders improved the PPV for BOO to 69%. CONCLUSION: While uroflowmetry cannot replace pressure-flow studies in the diagnosis of BOO. it can provide a valuable improvement over symptoms alone in the diagnosis of the cause of lower urinary tract dysfunction in men presenting with LUTS. This study provides performance statistics for Qmax with respect to BOO: such statistics may be used to define more accurately the presence or absence of BOO in men presenting with LUTS, so avoiding the need for formal pressure-flow studies in everyday clinical practice, while improving the likelihood of a successful outcome from prostatectomy. This study also shows that low-volume uroflowmetry can provide useful diagnostic information and that, as such, the data from such voids should not be discarded.

Aged↗
PubMed1998

Development of a questionnaire for measurement of vision-related quality of life.

PURPOSE: To define vision-related quality of life, to outline the development of a vision-specific quality of life instrument and to present the characteristics of a 10-item 'core' questionnaire. METHOD: A standard method included: 1. Generation of relevant issues by individual interviews with 38 visually impaired adults, consultation with 37 professionals and support workers and literature review. 2. Operationalisation, involving 58 ophthalmic patients. 3. Pre-testing, to maximise face validity and content validity, involving 184 individuals with a variety of different visual problems and social backgrounds. 4. Adoption of a modular approach to item selection. 5. Formal piloting in 92 individuals to establish reliability and construct validity. RESULTS: More than 232 items were tested of which 139 were considered suitable for a final question pool or 'parent' questionnaire (the VQOL). From this parent questionnaire individual items or groups of items can be selected. Ten broadly applicable items referring to physical, social and psychological issues were selected for the core questionnaire (the VCM1). The VCM1 has high reliability (alpha = 0.93) and validity. CONCLUSIONS: Any self-reported problem relating to vision may constitute a quality of life issue. A modular approach to item selection may provide the flexibility to investigate vision-related quality of life in a wide range of clinical settings, allowing detailed assessment of specific problems and also cross-study comparisons where appropriate.

Adult↗
PubMed1997

The International Continence Society "Benign Prostatic Hyperplasia" Study: international differences in lower urinary tract symptoms and related bother.

PURPOSE: We investigated the international differences in the reporting of lower urinary tract symptoms and related bother in patients with symptoms suggestive of bladder outlet obstruction. MATERIALS AND METHODS: Multiple logistic regression analysis was used to evaluate international differences in the reporting of lower urinary tract symptoms and related bother in 1,271 patients from 12 countries who participated in the International Continence Society "benign prostatic hyperplasia" study. RESULTS: Country of origin was significantly associated with the prevalence of a large number of lower urinary tract symptoms (10 of 20), even after adjusting for potentially confounding variables, including physical and socio-demographic factors. Country of origin was also significantly associated with the reporting of bother but for a much smaller number of symptoms (2). CONCLUSIONS: In different countries lower urinary tract symptoms may be reported to different extents. Therefore, the results of studies in particular countries may not be generally applicable to other countries. It is likely that symptom scores will conceal this variation, necessitating consideration of individual symptoms (as in the International Continence Society "benign prostatic hyperplasia" study) or the development of country specific scoring systems. An alternative would be to focus on bother, which appeared to be much less sensitive to international differences.

Aged↗
PubMed1997

International Continence Society "Benign Prostatic Hyperplasia" Study: background, aims, and methodology.

The International Continence Society Benign Prostatic Hyperplasia Study (ICS-BPH) was devised in response to the perceived underutilization of urodynamics in the diagnosis of benign prostatic obstruction (BPO), together with the apparent reliance on symptoms alone when selecting patients for invasive therapies, despite evidence that lower urinary tract symptoms (LUTS) had poor diagnostic specificity for BPO. The ICS-BPH Study is an international multicenter study employing a wide-ranging patient-completed questionnaire, with questions on symptoms, bothersomeness, quality of life, and sexual function. In addition, each patient underwent multiple urine flow studies and standardized urodynamic investigations (phase I). Phase II was an observational assessment of outcome following a range of treatments: conservative, medical, and surgical. Phase III included data from randomized controlled trials involving a wide range of therapies. One thousand, two hundred and seventy-one patients (mean age, 66 years) were included in phase I from 12 countries: 18% of patients were unobstructed, 22% mildly obstructed, and 60% obstructed on pressure flow studies; 83% of patients performed at least two flow studies. The ICS-BPH Study will allow definitive statements to be made concerning the diagnostic potential of a wide range of LUTS, and will define the place of urine flow studies, describe patients who will need pressure flow studies prior to invasive treatment, and identify those likely to experience an adverse outcome. Although an aim of the study is to produce a diagnostic symptom score, there is considerable doubt as to whether this can be achieved where aging and a variety of lower urinary tract dysfunctions often coexist.

Aged↗
PubMed1997

The International Continence Society "Benign Prostatic Hyperplasia" Study: the botherosomeness of urinary symptoms.

PURPOSE: We assessed the bothersomeness of lower urinary tract symptoms as reported by men, and investigated relationships among occurrence, degree of problem caused and age. MATERIALS AND METHODS: Questionnaire data from 1,271 men presenting with lower urinary tract symptoms in 12 countries were analyzed. Statistical methods included distributions, cross tabulations, chi-square analysis and Spearman's rank correlation coefficients. RESULTS: Although prevalence and bothersomeness were moderately positively related, voiding symptoms were the most prevalent whereas the most bothersome were predominantly storage symptoms, including incontinence. While prevalence showed a broadly decreasing trend with age, bothersomeness was relatively unrelated to age. CONCLUSIONS: These findings suggest that symptom occurrence alone does not necessarily reflect the degree to which patients are bothered by lower urinary tract symptoms. Therefore, when deciding on treatment it is important not only to consider the presence and frequency of lower urinary tract symptoms but also the bother that they cause.

Aged↗
PubMed1997

Using the ICSOoL to measure the impact of lower urinary tract symptoms on quality of life: evidence from the ICS-'BPH' Study. International Continence Society--Benign Prostatic Hyperplasia.

OBJECTIVE: To present and describe the validity and reliability of the International Continence Society-Benign Prostatic Hyperplasia study quality-of-life (ICSQoL) instrument, a new set of questions to assess the impact of lower urinary tract symptoms (LUTS) on quality of life (QoL) in middle-aged and elderly men. PATIENTS AND METHODS: The study comprised 1271 consecutive men over the age of 45 years, attending urology departments in 12 countries, with LUTS and possible benign prostatic obstruction who were recruited to the ICS-'BPH' study (the clinic group); 423 ambulant men were recruited from a general practice in the UK to provide a community group. Each individual completed the ICS-'BPH' study questionnaire which includes six items addressing general and specific aspects of QoL (the ICSQoL). Content and construct validity were assessed by interviews with patients and by testing hypotheses within the study groups, e.g. the relationships with age, individual LUTS (as measured on the ICSmale questionnaire) and generic health status, as measured by the Short Form (SF-36) and EuroQol instruments. Reliability was assessed by measures of internal consistency and a test-retest analysis. RESULTS: The ICSQoL items were easily understood by patients, were completed with low levels of missing data, and address some (but not all) concerns about the impact of LUTS on QoL. The ICSQoL items have good construct validity, showing expected differences between community and clinic samples, and expected relationships with each other and individual LUTS. Items had good test-retest reliability, but their internal consistency was poor, confirming that ICSQoL questions should not be combined into a score. General ICSQoL items were closely related with most domains of the SF-36 and the EuroQol. CONCLUSION: ICSQoL items may be used individually or as a group in research studies or in clinical practice.

Aged↗
PubMed1996

The ICS-'BPH' Study: the psychometric validity and reliability of the ICSmale questionnaire.

OBJECTIVE: To assess the validity and reliability of the ICSmale questionnaire developed for the International Continence Society-'Benign Prostatic Hyperplasia' (ICS-'BPH') study. PATIENTS AND METHODS: Urology departments in 12 countries recruited 1271 consecutive men > 45 years old, with lower urinary tract symptoms and possible benign prostatic obstruction, to the ICS-'BPH' study (the clinical group); 423 ambulent men were recruited from a general practice in the UK to provide a community group. Each individual was asked to complete the wide-ranging ICSmale questionnaire, comprising questions concerned with urinary symptoms, the bother they cause, and issues of quality of life and sexual function. Content, construct and criterion validity of the symptom and problem questions were assessed by interviews with patients and urologists, testing hypotheses within sub-studies, and in relation to frequency-volume diaries and uroflowmetry. Reliability was assessed by measures of internal consistency and a test-retest analysis. RESULTS: The ICSmale questionnaire was easy to complete. It was clearly able to differentiate between men in clinical and community populations, and detected the expected positive age gradient for most symptoms in the community group. There was reasonable agreement between relevant parts of the questionnaire and frequency-volume charts when a relatively flexible approach was taken, but there was a very poor relationship between questions assessing strength of stream and the results of uroflowmetry. Internal consistency was high, and overall the questionnaire demonstrated good test-retest reliability. CONCLUSION: The self-completed ICSmale questionnaire had high levels of psychometric validity and reliability.

Aged↗
PubMed1995

Patient decision making. The missing ingredient in compliance research.

Medical noncompliance has been identified as a major public health problem that imposes a considerable financial burden upon modern health care systems. There is a large research record focusing on the understanding, measurement, and resolution of noncompliance, but it is consistently found that between one third and one half of patients fail to comply with medical advice and prescriptions. Critically absent from this research record has been the patient's role in medical decision making. For patients, particularly those with chronic illnesses, compliance is not an issue: they make their own reasoned decisions about treatments based on their own beliefs, personal circumstances, and the information available to them. The traditional concept of compliance is thus outmoded in modern health care systems, where chronic illness and questioning patients predominate.

Attitude to Health↗