Development of a clinical prediction model to calculate patient life expectancy: the measure of actuarial life expectancy (MALE).

OBJECTIVES: To develop a clinical prediction model enabling the calculation of an individual patient's life expectancy (LE) and survival probability based on age, sex, and comorbidity for use in the joint decision-making process regarding medical treatment. METHODS: A computer software program was developed with a team of 3 clinicians, 2 professional actuaries, and 2 professional computer programmers. This incorporated statistical spreadsheet and database access design methods. Data sources included life insurance industry actuarial rating factor tables (public and private domain), Government Actuary Department UK life tables, professional actuarial sources, and evidence-based medical literature. The main outcome measures were numerical and graphical display of comorbidity-adjusted LE; 5-, 10-, and 15-year survival probability; in addition to generic UK population LE. RESULTS: Nineteen medical conditions, which impacted significantly on LE in actuarial terms and were commonly encountered in clinical practice, were incorporated in the final model. Numerical and graphical representations of statistical predictions of LE and survival probability were successfully generated for patients with either no comorbidity or a combination of the 19 medical conditions included. Validation and testing, including actuarial peer review, confirmed consistency with the data sources utilized. CONCLUSIONS: The evidence-based actuarial data utilized in this computer program design represent a valuable resource for use in the clinical decision-making process, where an accurate objective assessment of patient LE can so often make the difference between patients being offered or denied medical and surgical treatment. Ongoing development to incorporate additional comorbidities and enable Web-based access will enhance its use further.

Proxy assessment of quality of life in patients with prostate cancer: how accurate are partners and urologists?

OBJECTIVES: To assess the ability of partners and clinicians to make proxy judgements on behalf of patients with prostate cancer relating to selection of life priorities and quality of life (QoL). DESIGN: 47 consecutive patients with histologically proven adenocarcinoma, and their partners, were recruited. The partners were asked to assess, by proxy, the QoL of the patient by completion of a series of interview-led questionnaires assessing global QoL (SEIQoL-DW), health-related QoL (FACT-P) and overall QoL (visual analogue score [VAS]). The patients' clinicians were asked to complete the SEIQoL-DW and VAS by proxy as soon as possible after a consultation with the patient. SETTING: Patients with histologically proven adenocarcinoma, their partners and their clinicians. MAIN OUTCOME MEASURES: Proxy scores for SEIQoL-DW, FACT-P and VAS, as provided by partners and clinicians. RESULTS: 25 partners made a proxy assessment of the patients. The results showed that partners were able to select similar QoL cues to those of the patients (Spearman-Rank correlation 0.89). Comparison of the QoL scores obtained from patients and partners in proxy using the questionnaires showed no statistically significant difference (paired t-test). Urologists were poor predictors of areas of life (cues) that were important to their patients. The doctors overemphasized the importance of survival, postoperative complications, urinary symptoms, sexual ability, activities of daily living and finance, but underestimated the importance of wife, family, home and religion. Comparison of the QoL scores obtained from patients and urologists by proxy showed a significantly lower score when assessed by urologists using the SEIQoL-DW questionnaire. CONCLUSIONS: Partners are able to accurately assess, by proxy, the areas of life that are of importance to patients. Clinicians, however, who are charged with making decisions on behalf of patients, are very poor judges of their patients' life priorities and QoL. This illustrates that conventional views held by most doctors regarding the priorities patients set themselves when planning treatment should be called into question and consequently suggests that the way in which doctors and patients arrive at treatment decisions must be reviewed.

Analysis of consultant decision-making in the management of prostate cancer.

The purpose of this study was to assess the consistency of decision-making among consultant urologists in the management of early prostate cancer. Thirty-two UK urology consultants completed a questionnaire containing 70 paper scenarios representing patients with early prostate cancer. Within these were 13 repeat cases to allow assessment of reliability of decision-making. Consultants demonstrated low reliability (on average 56-79%) when formulating decisions. None of the consultants used all of the available patient information when formulating treatment plans. The cue 'patient choice' was not used significantly by any of the consultants and the cue 'patient co-morbidity' was rarely used despite being crucial components of decision-making. These results are surprising and in general represent poor clinical practice. They also justify the increasing use of the multidisciplinary team and protocol-driven pathways to standardize and thus improve patient care.

An open-label, randomized, flexible-dose, crossover study to assess the comparative efficacy and safety of sildenafil citrate and apomorphine hydrochloride in men with erectile dysfunction.

OBJECTIVE: To compare the efficacy and safety of sildenafil and apomorphine in the treatment of men with erectile dysfunction (ED). PATIENTS AND METHODS: In all, 139 men with ED who were naïve to treatment were entered into an open-label crossover trial with two treatment periods, each of 8 weeks, separated by a 2-week washout period. Men were randomized to receive either sildenafil then apomorphine or apomorphine then sildenafil, and were allowed to titrate the dose on both drugs. The primary endpoint was the erectile function (EF) domain of the International Index of Erectile Function (IIEF), and other endpoints included diary data, the other domains of the IIEF, overall assessment questions and the Erectile Dysfunction Index of Treatment Satisfaction (EDITS) questionnaire. RESULTS: The EF domain score after treatment was 25.2 for sildenafil and 15.9 for apomorphine. The treatment difference of the adjusted means was 9.3 points (95% confidence interval 7.6-11.1; P < 0.001). After sildenafil the successful intercourse rate was 75%, vs 35% for apomorphine (P < 0.001), and the EDITS scores were 82.5 for sildenafil and 46.8 for apomorphine (P < 0.001). Of the men, 96% expressed a preference for sildenafil as a treatment for their ED. The side-effect profiles for both drugs were in keeping with published data. CONCLUSION: By all measurable endpoints sildenafil was superior to apomorphine in this open-label crossover study of men with ED who were naïve to therapy

The ED-EQoL: the development of a new quality of life measure for patients with erectile dysfunction.

PURPOSE: To identify the important issues which have an impact on the quality of life (QoL) of men suffering from erectile dysfunction (ED) and to generate a new ED-specific QoL questionnaire ready to undergo further psychometric testing. METHODS: QoL issues relating to ED were generated through in-depth qualitative interviews of 29 patients, literature review and consultation with other healthcare professionals. The issues were formulated into a questionnaire, which was piloted using 40 patients with ED and subsequently refined using well-established principles of questionnaire development. RESULTS: The qualitative interviews revealed numerous psychosocial problems associated with ED, which were operationalised into a 40-item questionnaire. Pilot testing allowed the questionnaire to be reduced to a manageable 15-item final questionnaire while maintaining face and content validity and the potential to discriminate between men with varying degrees of affected QoL. This questionnaire had a Cronbach's alpha of 0.94. CONCLUSIONS: A new ED-specific QoL measure has been developed using appropriate methodology. Qualitative techniques identified a range of psychosocial morbidity in men with ED, leading to a simple but robust instrument with face and content validity. This questionnaire, Erectile Dysfunction-Effect on quality of life (ED-EQoL), has now undergone psychometric testing for validity and reliability.

Prospective vs retrospective assessment of lower urinary tract symptoms in patients with advanced prostate cancer: the effect of 'response shift'.

OBJECTIVE: To compare prospectively obtained symptom scores (pre-tests) with retrospective assessment (then-tests) in patients with newly diagnosed advanced prostate cancer. PATIENTS AND METHODS: Patients with newly diagnosed locally advanced or metastatic prostate cancer were recruited. They completed the International Prostate Symptom Score (IPSS) and Symptom Problem Index (SPI) before starting treatment. At 3 and 6 months after diagnosis they again completed these questionnaires, but also retrospectively reassessed their initial symptom level. Healthy age-matched controls were recruited from primary care and completed the same questionnaires; in all, 76 patients and 17 controls participated. RESULTS: The IPSS and SPI scores decreased significantly over the 6 months of the study. Patients retrospectively rated their level of symptoms and symptom bother as higher than their contemporaneous assessments. This was not the case in the control group. CONCLUSION: These results question the assumption that contemporaneously collected pre-test scores are interchangeable with retrospectively assessed then-tests. This suggests that caution is required when comparing the results of studies that use these two alternative techniques of data collection. The difference between then-test and pre-test scores may represent an example of a phenomenon termed 'response shift', in which, by adapting to their disease, patients changed the internal standards by which they assessed their symptoms.

The effect of erectile dysfunction on the quality of life of men after radical prostatectomy.

OBJECTIVE: To report on the first use of a quality-of-life (QoL) measure specific for erectile dysfunction (ED), the 'ED effect on QoL' (ED-EQoL), to assess the effect of ED on QoL after radical prostatectomy (RP). PATIENTS AND METHODS: We retrospectively identified 89 patients who had undergone RP at one institution. Each was sent the ED-EQoL and a second questionnaire asking whether they had been counselled before RP about possible ED afterward. RESULTS: The response rate was 91% and the median time since RP 92 months; 76% of those who were potent before RP were impotent afterward. The overall results showed that the QoL of 72% of patients was moderately or severely affected. For each question, on average a third of the patients reported that their QoL was affected either 'quite a lot' or 'a great deal'. CONCLUSIONS: This study shows that ED after RP has a profound effect on QoL; it is therefore important when assessing ED to use an ED-specific QoL questionnaire such as the ED-EQoL to measure the psychosocial effect of ED, in addition to using an instrument such as the International Index of Erectile Function to measure the functional aspects of ED.

Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure.

PURPOSE: We developed the ureteral stent symptom questionnaire (USSQ), a psychometrically valid measure to evaluate symptoms and impact on quality of life of ureteral stents. MATERIALS AND METHODS: A total of 309 patients were asked to participate during different phases of our study. In phase 1 a structured literature search, 9 patient interviews and studies of 90 patients using existing instruments formed the foundation for the initial draft of our new questionnaire. In phase 2 the USSQ was pilot tested, reviewed by experts and field tested in 40 patients to produce a final 38-item draft. In phase 3 formal validation studies were performed in 55 patients to assess validity, reliability and sensitivity to change. Discriminant validation was performed by administering the questionnaire to 3 groups of patients without stents. RESULTS: The final draft addressed various domains of health (6 sections and 38 items) affected by stents covering urinary symptoms, pain, general health, work performance, sexual matters and additional problems. The validation studies showed the questionnaire to be internally consistent (Cronbach's alpha > 0.7) with good test-retest reliability (Pearson's coefficient > 0.84). The questionnaire demonstrated good construct validity and sensitivity to change shown by significant changes in the score with and after removal of stents. The new USSQ discriminated patients with stents from healthy controls (p < 0.001) and patients with urinary calculi without stents and lower urinary tract symptoms. CONCLUSIONS: Indwelling ureteral stents have a significant impact on health related quality of life. The new USSQ is a valid and reliable instrument that is expected to become a standard outcome measure to evaluate the impact and compare different types of stents.

Indwelling ureteral stents: evaluation of symptoms, quality of life and utility.

PURPOSE: We report the prevalence of symptoms associated with ureteral stents, their impact on health related quality of life and utility analysis based on the validation studies of the new ureteral stent symptom questionnaire (USSQ). MATERIALS AND METHODS: A total of 85 consecutive adult patients with unilateral indwelling ureteral stents who were asked to participate during the validation phases of the USSQ were considered for this analysis. They were asked to complete the USSQ and the EuroQol, a weighted utility instrument, 4 weeks after stent insertion and removal. In addition, 40 patients were asked to complete these questionnaires 1 week after stent insertion to assess the prevalence of symptoms and utility values at different times. RESULTS: Of the 85 patients 62 (73%) with a mean age of 50 years completed the necessary questionnaires. Urinary symptoms and pain that affected work performance and general health were important stent related problems. Of the patients 78% reported bothersome urinary symptoms that included storage symptoms, incontinence and hematuria. More than 80% of patients experienced stent related pain affecting daily activities, 32% reported sexual dysfunction, and 58% reported reduced work capacity and negative economic impact. The mean EuroQol utility values, which indicate patient satisfaction with treatment, were significantly reduced following stent insertion. CONCLUSION: Urinary symptoms and pain associated with indwelling ureteral stents interfere with daily activities and result in reduced quality of life in up to 80% of patients. Stents are associated with negative functional capacity and reduced utility values. The results have implications in terms of routine clinical practice, patient counseling and future stent research.

The development and validation of a patient-information booklet on ureteric stents.

OBJECTIVE: To report a scientific approach incorporating patient preferences towards the development of a patient-information booklet about ureteric stents. PATIENTS AND METHODS: Phase 1 of the study included 35 adult patients with ureteric stents who were surveyed using semi-structured interviews (four patients) and a questionnaire (31 patients) to assess various issues relating to information given to patients about ureteric stents. In addition, published papers were assessed and clinicians' opinions sought. The results formed the basis for a comprehensive patient-information booklet about ureteric stents that incorporated patients' views and preferences. In phase 2, the booklet was tested and formally validated by inviting 30 patients, a panel of 20 urologists and general practitioners, and five stent manufacturers to assess the booklet for adequacy, coverage and readability of the content. RESULTS: Of the 35 patients, 30 (19 men and 11 women, mean age 49 years, range 20-78) participated in the initial survey; 80% of patients reported dissatisfaction about the information they received. Patients wanted more information about the use, adverse events and effects of stents on daily life; 85% preferred all relevant information about the stents to be in a written format with illustrative drawings. An eight-page booklet was thus developed. The validation study revealed that the booklet matched patients' experiences (approval score of 9/10, range 8-10) and was reported as satisfactory by clinicians and manufacturers. CONCLUSIONS: A validated information booklet on ureteric stents was developed, incorporating patients' expectations and views. This booklet is expected to be an effective tool for patient communication that would help patients cope better with indwelling stents and be useful in counselling patients. A similar approach could be adopted for the development of other patient-information packs.

Indwelling ureteral stents: evaluation of quality of life to aid outcome analysis.

BACKGROUND: Ureteral stents cause various side effects. We have evaluated health-related quality of life (HRQoL) in patients with stents using validated questionnaires and developed a new stent symptom (intervention)-specific questionnaire (SSQ). PATIENTS AND METHODS: Along with structured literature review and in-depth interviews, prospective sub-studies were carried out using generic (SF-36 [N = 30], EuroQol [N = 40], and Functional Status Questionnaire FSQ [N = 20]) and symptom-specific (IPSS [N = 30] and International Continence Society ICS [N = 30]) questionnaires both with a stent in situ and after removal. The results of these studies formed the foundation for a new SSQ that was pilot tested (N = 10) and field tested (N = 20) in order to develop a final draft of the questionnaire that is formally validated. RESULTS: The qualitative research identified a range of problems. Urinary symptoms, pain, work performance, and general health were the most important. Most patients (80%) experienced bothersome urinary symptoms and stent-related pain. Storage symptoms and incontinence were significant urinary symptoms affecting quality of life. As many as 40% of patients experienced sexual dysfunction. The stent had a significant impact on patients' general health. None of the existing measures evaluated the complete impact. The SSQ includes five sections covering urinary symptoms, pain, sexual matters, general health, and work performance. The preliminary results showed it to be valid, reliable (alpha > 0.7) and responsive to the change in scores (p < 0.05) after stent removal. CONCLUSIONS: Indwelling ureteral stents are associated with significant morbidity, resulting in a reduced HRQoL in 80% of patients. The SSQ is a reliable intervention-specific instrument that would be useful as an outcome measure to evaluate the impact of stents.

Bilateral superselective arterial microcoil embolisation in delayed post-traumatic high flow priapism.

High flow arteriogenic priapism is uncommon and usually occurs after trauma to the genitoperineal area. The onset of prolonged erection can be delayed and is often relatively pain free. Arteriography in this case illustrated the causative bilateral arteriocavernosal fistulae and pseudoaneurysms. Treatment consisted of staged bilateral superselective metallic microcoil embolisations, resulting in prompt detumescence. There were no complications. The patient had normal erectile function six months later. Recent concerns about erectile dysfunction with the bilateral use of permanent metallic coils appear to be unfounded.

Psychosocial morbidity in prostate cancer: I. Design of a new questionnaire.

OBJECTIVE: To design a questionnaire capable of measuring psychosocial morbidity in patients with prostate cancer and in their partners. METHODS: Issues to be covered in the questionnaire were determined by discussion among professionals, a literature review and semi-structured interviews with a group of seven patients and their partners. The potential issues were analysed and condensed, then re-presented to a further group of professionals, and to 10 patients and partners for comment and amendment. This process aimed to confirm the completeness and relevance of the list of issues. Questions were then constructed around the final list of issues and the questionnaire adjusted continually while testing on patients, until it was completed easily. RESULTS: The questionnaire consisted of 10 items; three items related to the general threat of cancer (concern about the diagnosis itself, fear of the future and difficulty dealing with the emotional response to the disease). Two items covered social and role functioning and there were five items to determine the severity of psychological morbidity caused by pain, urinary symptoms, treatment, physical limitation and sexual dysfunction. The questionnaire appeared to cover those areas of morbidity most consistently raised by patients and partners; it was also rapidly and easily completed by most respondents. CONCLUSION: The questionnaire constructed may be easily applied as part of routine clinical practice; it addresses aspects of psychosocial morbidity related to prostate cancer in patients and their partners. Although it appears to have content validity, further psychometric testing is required.

Psychosocial morbidity in prostate cancer: II. A comparison of patients and partners.

OBJECTIVE: To assess psychometrically a new questionnaire for measuring the psychosocial morbidity in patients with prostate cancer and in their partners, and to compare the morbidity of patients and their partners. PATIENTS AND METHODS: A sequential sample of patients with any stage of prostate cancer and attending general urology outpatient clinics was identified. The questionnaire was administered to 135 patients and their partners in their homes. The Hospital Anxiety and Depression Scale (HADS) questionnaire was also administered to permit construct validation of the new measure. Test-retest reliability was calculated by re-administering the questionnaire to 60 individuals. The hypothetical general cancer distress and social subscales of the questionnaire were also tested for internal consistency. Psychosocial morbidity scores obtained by the patients and partners were compared. RESULTS: The questionnaire had good test-retest reliability and construct validity when tested against the HADS. The general cancer distress and social subscales were internally consistent. General cancer distress was highly prevalent and significantly more severe in partners than in patients. There was some degree of general cancer distress in 47% of patients and 76% of partners, whereas severe distress was detected in 11% and 30%, respectively. Social morbidity was limited and of equal severity between the groups. Treatment-related worries and concerns about pain and physical limitation were more common among partners than patients, whereas there was no difference for worries about urinary symptoms. Sexual concerns were the least prevalent and were more of a problem for patients than partners. CONCLUSION: Psychosocial morbidity in prostate cancer is highly prevalent, not only among patients but particularly among their partners. The new questionnaire showed adequate psychometric properties for use in identifying individuals with significant psychosocial morbidity. Applying the questionnaire should permit emotional and informational support to be targeted at the most vulnerable.

The development and validation of a quality-of-life measure to assess partner morbidity in benign prostatic enlargement.

OBJECTIVE: To investigate morbidity in the partners of patients with benign prostatic enlargement (BPE) by developing and validating a disease-specific questionnaire. PATIENTS AND METHODS: Phase 1 of the study comprised preliminary interviews with 15 patients who had newly diagnosed BPE, and with their partners, to determine the relevant issues for the partners. In phase 2, using these issues, a questionnaire was produced and tested on the 15 partners. In phase 3 the questionnaire was completed by 90 further partners, 50 at interview and the next 40 by post. As part of the validation process, the partners were also asked to complete the Short-Form-36 questionnaire, and the patients the Internation Prostate Symptom Score (IPSS) and the ICSmale questionnaires. RESULTS: In phase 1 all 15 of the partners were affected by the patients' disease and nine issues were identified. In phase 2, of the 90 partners, only one had no morbidity from the patient's symptoms; 71% were worried that the patient may have cancer and 69% concerned that the patient may require an operation. Only six partners were present at the patients' urological consultation. The partners' questionnaire scores were related significantly to the Mental Health and Vitality domains of the SF36 and with the patients' IPSS. CONCLUSIONS: The study confirmed the presence of significant morbidity in the partners of patients with BPE. The degree of partner morbidity was related to the severity of the patients' symptoms. Many of the questionnaire issues can be addressed in the consulting room by open discussion with patient and partner.