Patient-Reported Outcomes after Monitoring, Surgery, or Radiotherapy for Prostate Cancer.

BACKGROUND: Robust data on patient-reported outcome measures comparing treatments for clinically localized prostate cancer are lacking. We investigated the effects of active monitoring, radical prostatectomy, and radical radiotherapy with hormones on patient-reported outcomes. METHODS: We compared patient-reported outcomes among 1643 men in the Prostate Testing for Cancer and Treatment (ProtecT) trial who completed questionnaires before diagnosis, at 6 and 12 months after randomization, and annually thereafter. Patients completed validated measures that assessed urinary, bowel, and sexual function and specific effects on quality of life, anxiety and depression, and general health. Cancer-related quality of life was assessed at 5 years. Complete 6-year data were analyzed according to the intention-to-treat principle. RESULTS: The rate of questionnaire completion during follow-up was higher than 85% for most measures. Of the three treatments, prostatectomy had the greatest negative effect on sexual function and urinary continence, and although there was some recovery, these outcomes remained worse in the prostatectomy group than in the other groups throughout the trial. The negative effect of radiotherapy on sexual function was greatest at 6 months, but sexual function then recovered somewhat and was stable thereafter; radiotherapy had little effect on urinary continence. Sexual and urinary function declined gradually in the active-monitoring group. Bowel function was worse in the radiotherapy group at 6 months than in the other groups but then recovered somewhat, except for the increasing frequency of bloody stools; bowel function was unchanged in the other groups. Urinary voiding and nocturia were worse in the radiotherapy group at 6 months but then mostly recovered and were similar to the other groups after 12 months. Effects on quality of life mirrored the reported changes in function. No significant differences were observed among the groups in measures of anxiety, depression, or general health-related or cancer-related quality of life. CONCLUSIONS: In this analysis of patient-reported outcomes after treatment for localized prostate cancer, patterns of severity, recovery, and decline in urinary, bowel, and sexual function and associated quality of life differed among the three groups. (Funded by the U.K. National Institute for Health Research Health Technology Assessment Program; ProtecT Current Controlled Trials number, ISRCTN20141297 ; ClinicalTrials.gov number, NCT02044172 .).

Fatigue Intervention by Nurses Evaluation--the FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610].

BACKGROUND: Chronic fatigue syndrome, also known as ME (CFS/ME), is a condition characterised primarily by severe, disabling fatigue, of unknown origin, which has a poor prognosis and serious personal and economic consequences. Evidence for the effectiveness of any treatment for CFS/ME in primary care, where most patients are seen, is sparse. Recently, a brief, pragmatic treatment for CFS/ME, based on a physiological dysregulation model of the condition, was shown to be successful in improving fatigue and physical functioning in patients in secondary care. The treatment involves providing patients with a readily understandable explanation of their symptoms, from which flows the rationale for a graded rehabilitative plan, developed collaboratively with the therapist. The present trial will test the effectiveness and cost-effectiveness of pragmatic rehabilitation when delivered by specially trained general nurses in primary care. We selected a client-centred counselling intervention, called supportive listening, as a comparison treatment. Counselling has been shown to be as effective as cognitive behaviour therapy for treating fatigue in primary care, is more readily available, and controls for supportive therapist contact time. Our control condition is treatment as usual by the general practitioner (GP). METHODS AND DESIGN: This study protocol describes the design of an ongoing, single-blind, pragmatic randomized controlled trial of a brief (18 week) self-help treatment, pragmatic rehabilitation, delivered by specially trained nurse-therapists in patients' homes, compared with nurse-therapist delivered supportive listening and treatment as usual by the GP. An economic evaluation, taking a societal viewpoint, is being carried out alongside the clinical trial. Three adult general nurses were trained over a six month period to deliver the two interventions. Patients aged over 18 and fulfilling the Oxford criteria for CFS are assessed at baseline, after the intervention, and again one year later. Primary outcomes are self-reported physical functioning and fatigue at one year, and will be analysed on an intention-to-treat basis. A qualitative study will examine the interventions' mechanisms of change, and also GPs' drivers and barriers towards referral.

Can earnings decline cause a retirement flight of physicians? Financial compensation and the decision to stay in practice.

The authors analyze the historical correlation between annual change in the population of inactive physicians and annual change in the real net income earned by the average physician per hour of patient care. For a sample of nine census divisions across 8 years (1986-1989 and 1994-1997), two regression models conclude with 99% confidence that a fall in net income increases the outflow of physicians from active practice. Regression coefficients estimate that a $1.00 fall in hourly net income increases the population of inactive physicians by 1.46 percent after a 2-year period. Based on 1999 population data, the authors project that an earnings decline of $10.00 per patient care hour motivates 11,000 physicians to retire early. With projections of between 50,000 and 150,000 excess practitioners in the U.S. health care system, the analysis suggests that deterioration in financial compensation can erase part but not all of a physician surplus through early retirement.

Unanswered questions in screening for prostate cancer.

Prostate cancer fulfils some of the conditions required of a disease that might be managed by population screening. In a cohort of 50- to 60-year-old men, carrying out a rectal examination and prostate specific antigen (PSA) test will detect clinically suspicious areas within the prostate in approximately 5%, and approximately 10% will have a raised PSA. We are however unsure which of the prostate cancers that are known to be present in approximately 30-40% of men aged over 60 years will be detected. Eventually after such screening, around 4% of men with an otherwise normal prostate will be found to have prostate cancers. The use of rectal examination may increase the number of tumours found, but will reduce compliance. The use of free/total PSA ratios will reduce the number of unnecessary biopsies at the expense of missing some tumours. Of more concern, we remain uncertain how effective aggressive local treatment is in altering the natural history of the disease. The risk of a 50-year-old man with a 25 year life expectancy of having microscopic cancer is 42%, of having clinically evident cancer is 9.5%, and of dying of prostate cancer 2.9%. Only a small proportion of cancers known to be present become clinically evident: more men die with prostate cancer than of it. Screening will identify some men with cancer who will not benefit from treatment. It is unclear whether screening would be followed by a reduction in morbidity and mortality. Recent data suggest a screening effect has been observed in the USA with: an increase in incidence, a decrease in men with distant metastases. The small decrease in mortality recently observed (many times smaller than the increase in incidence) may be confounded by inappropriate 'attribution' of cause of death, the detection of men with better prognosis distant metastatic disease responsive to hormonal ablation and changes in social factors such as diet. Future changes may incorporate molecular markers that might aid identification of men best treated aggressively because of a risk of progression. Tests to identify genetic pre-disposition may also allow targeted screening. New treatments and early chemoprevention or dietary strategies will again shift the ground on which these arguments are being rehearsed. The most urgent evidence required concerns the effectiveness of treatment strategies.

The use of duplex ultrasound in the assessment of arterial supply to the penis in vasculogenic impotence.

Impotence may be caused by arterial disease affecting the vessels supplying the corpora cavernosa. Color duplex ultrasound was used to measure the peak systolic velocity and systolic rise time in the deep penile arteries in 22 impotent men following papaverine stimulation. The results were compared with the findings of selective internal pudendal pharmaco-arteriography. A further comparison was made using color duplex ultrasound with 37 impotent men who all responded well to papaverine. A systolic rise time of 110 msec. or more was found to be the best discriminant of disease in the arteries supplying the corpora giving a positive predictive value of 0.92. A long systolic rise time in a papaverine responder may indicate that the arterial supply is borderline or that the arterial flow is maximal and that the problem lies on the sinusoidal-venous side. It appears that in the absence of a pathological condition there is a large surplus arterial supply.

Implementing an operating room pharmacy satellite.

Implementation of an operating room (OR) pharmacy satellite is described, and its impact on cost-effectiveness and efficiency of drug distribution is analyzed. The OR satellite provided pharmacy coverage for 30-35 patients per day in 10 centralized surgical suites, 2 obstetric suites, and 1 burn-unit suite in a 401-bed teaching hospital. Objectives of the satellite were to consolidate accountability for drug distribution and control, reduce controlled substance loss and waste, reduce inventory costs, and improve recording of patient charges. Stock on the OR supply cart was reduced, controlled substances were dispensed to anesthesiologists from the satellite, and a system of standardized anesthesiology exchange trays was developed. A new billing form served as both the charging document and replacement list. Reduction in the medication cart stock resulted in smaller discrepancies in patient charges. For the five most commonly used controlled substances, accounting discrepancies were reduced. Inventory turnover increased and inventory dollar value and cost per patient were reduced. The percent of nurses who believed that a pharmacist should work in the area increased from 31% before implementation of the satellite to 95% after. The pilot OR pharmacy satellite was a financial success. Efficiency and effectiveness in drug distribution and control were improved, and communication between pharmacists and other medical personnel working in the OR areas was enhanced.