Visual functioning and quality of life in the SubFoveal Radiotherapy Study (SFRADS): SFRADS report 2.

AIMS: To determine whether or not self reported visual functioning and quality of life in patients with choroidal neovascularisation caused by age related macular degeneration (AMD) is better in those treated with 12 Gy external beam radiotherapy in comparison with untreated subjects. METHODS: A multicentre single masked randomised controlled trial of 12 Gy of external beam radiation therapy (EBRT) delivered as 6 x 2 Gy fractions to the macula of an affected eye versus observation. Patients with AMD, aged 60 years or over, in three UK hospital units, who had subfoveal CNV and a visual acuity equal to or better than 6/60 (logMAR 1.0). METHODS: Data from 199 eligible participants who were randomly assigned to 12 Gy teletherapy or observation were available for analysis. Visual function assessment, ophthalmic examination, and fundus fluorescein angiography were undertaken at baseline and at 3, 6, 12, and 24 months after study entry. To assess patient centred outcomes, subjects were asked to complete the Daily Living Tasks Dependent on Vision (DLTV) and the SF-36 questionnaires at baseline, 6, 12, and 24 months after enrolment to the study. Cross sectional and longitudinal analyses were conducted using arm of study as grouping variable. Regression analysis was employed to adjust for the effect of baseline co-variates on outcome at 12 months and 24 months. RESULTS: Both control and treated subjects had significant losses in visual functioning as seen by a progressive decline in mean scores in the four dimensions of the DLTV. There were no statistically significant differences between treatment and control subjects in any of dimensions of the DLTV at 12 months or 24 months after study entry. Regression analysis confirmed that treatment status had no effect on the change in DLTV dimensional scores. CONCLUSIONS: The small benefits noted in clinical measures of vision in treated eyes did not translate into better self reported visual functioning in patients who received treatment when compared with the control arm. These findings have implications for the design of future clinical trials and studies.

Visual outcomes in the subfoveal radiotherapy study: a randomized controlled trial of teletherapy for age-related macular degeneration.

OBJECTIVE: To determine whether teletherapy with 6-mV photons can reduce visual loss in patients with subfoveal choroidal neovascularization in age-related macular degeneration. DESIGN: A multicenter, single-masked, randomized controlled trial of 12 Gy of external beam radiation therapy delivered to the macula of an affected eye vs observation only. SETTING: Three United Kingdom-based hospital units. PARTICIPANTS: Patients with age-related macular degeneration, aged 60 years and older, who had subfoveal choroidal neovascularization and a visual acuity of 20/200 (logMAR 1.0) or better. METHODS: Two hundred three patients were randomly assigned to radiotherapy or observation. Treatment was undertaken at designated radiotherapy centers, and patients assigned to the treatment group received a total dosage of 12 Gy of 6-mV photons in 6 fractions. Follow-up was scheduled at 3, 6, 12, and 24 months. After excluding protocol violators, the data from 199 patients were analyzed. MAIN OUTCOME MEASURES: The primary outcome measure was mean loss of distance visual acuity in the study eye at 12 and 24 months. Other outcome variables analyzed were near visual acuity and contrast sensitivity. The proportions of patients losing 3 or more or 6 or more lines of distance and near acuity and 0.3 or more or 0.6 or more log units of contrast sensitivity at each follow-up were also analyzed. RESULTS: At all time points, mean distance visual acuity was better in the radiotherapy-treated group than in the control group, but the differences did not reach statistical significance. At 24 months, analysis of the proportions of patients with loss of 3 or more (moderate) (P =.08) or 6 or more (severe) (P =.29) lines of distance vision showed that fewer treated patients had severe losses, but there was no statistically significant difference between groups. For near visual acuity, although there was no evidence of treatment benefit at 12 and 24 months, a significant difference in favor of treatment was present at 6 months (P =.048). When analyzed by the proportions of patients losing 3 lines of contrast sensitivity, there was a significant difference in favor of treatment at 24 months (P =.02). No adverse retinal effects were observed during the study, but transient disturbance of the precorneal tear film was noted in treated patients. CONCLUSION: The results of the present trial do not support the routine clinical use of external beam radiation therapy in subjects with subfoveal choroidal neovascularization in age-related macular degeneration.

Influence of hospital and clinician workload on survival from colorectal cancer: cohort study.

OBJECTIVE: To determine whether clinician or hospital caseload affects mortality from colorectal cancer. DESIGN: Cohort study of cases ascertained between 1990 and 1994 by a region-wide colorectal cancer register. OUTCOME MEASURES: Mortality within a median follow up period of 54 months after diagnosis. RESULTS: Of the 3217 new patients registered over the period, 1512 (48%) died before 31 December 1996. Strong predictors of survival both in a logistic regression (fixed follow up) and in a Cox's proportional hazards model (variable follow up) were Duke's stage, the degree of tumour differentiation, whether the liver was deemed clear of cancer by the surgeon at operation, and the type of intervention (elective or emergency and curative or palliative intent). In a multilevel model, surgeon's caseload had no significant effect on mortality at 2 years. Hospital workload, however, had a significant impact on survival. The odds ratio for death within 2 years for cases managed in a hospital with a caseload of between 33 and 46 cases per year, 47 and 54 cases per year, and >/=55 cases per year (compared to one with

Complementary and alternative therapies in perinatal populations: a selected review of the current literature.

Complementary and alternative therapies have been accepted and used in perinatal nursing and midwifery practice for decades. Many authors describe a need for scientific scrutiny of these modalities to determine their efficacy and usefulness in patient care and to create some comparability among studies. The article presents a selective review of the current and readily available English literature about complementary and alternative therapies in perinatal care. Although there is a substantial amount of information published about these modalities in perinatal care, much of it is anecdotal. With the advent of definitions, descriptions, and funding in the United States and abroad, it is likely that additional research of improved design and comparability will be forthcoming.

Teletherapy for subfoveal choroidal neovascularisation of age-related macular degeneration: results of follow up in a non-randomised study.

AIM: A preliminary report indicated stable or improved vision in 12 of 19 patients with subfoveal choroidal neovascularisation treated with 12 or 15 Gy of 6 MV photons to the affected macula after an average follow up of 18 months. Here the prolonged follow up findings in this group of treated patients is reported which was further increased to 41. METHODS: Forty one patients with subfoveal choroidal neovascularisation were treated with 10, 12, or 15 Gy of 6 MV photons to the macula of the affected eye. Thirteen eyes of 12 patients were also observed as a non-randomised comparison group. RESULTS: At 12, 18, and 24 months of follow up the mean change in visual acuity in eyes treated with radiotherapy was less than 1 Bailey-Lovie line from that measured at presentation. By contrast, the eyes in the comparison group lost 3.7 lines of acuity at 12 months which increased to 4.5 at 24 months. These differences were highly significant at each of the time points. When initial visual acuity was taken into account, treated eyes lost on average 12% of baseline acuity throughout follow up, whereas eyes belonging to the untreated group lost 50% of baseline acuity at 1 year, and 75% at 2 years. There was no significant difference in visual outcome between the three dose regimens used, which may simply be a reflection of the small sample size in each group. There was no evidence of radiation induced retinopathy or optic neuropathy in any treated patients. CONCLUSIONS: Teletherapy appeared to have a treatment effect in eyes with subfoveal choroidal neovascularisation resulting in maintained visual function without significant radiation induced morbidity.

Is allopurinol beneficial in the prevention of renal ischaemia-reperfusion injury in the rat?: evaluation by near-infrared spectroscopy.

1. The role of allopurinol in the protection of kidney function following ischaemia-reperfusion injury has been investigated using the novel technique of near-infrared spectroscopy. 2. An in vivo model of rat kidney ischaemia was used, with the expected falls in blood and tissue oxygenation seen and confirmed by near-infrared spectroscopy. 3. Allopurinol infusion increased the rate of reperfusion of oxygenated blood seen in control rats (P < 0.05). 4. Allopurinol enhanced the rate of tissue oxygenation during early reperfusion (P < 0.01). 5. This study provides further evidence for the proposed benefits of allopurinol in ischaemia-reperfusion injury. Furthermore, the potential of near-infrared spectroscopy as a technique of value in interventional studies of this nature is confirmed.

Adjuvant therapy for colorectal cancer--is there a place for a Northern Ireland study?

Survival from colorectal cancer has not improved over the last four decades despite advances in surgery and anaesthesia. The answer to the question whether adjuvant chemotherapy and radiotherapy will improve survival from the disease can only come from randomised, controlled trails. In the future, immunotherapy and gene therapy may be of benefit but these are still many years from the clinical arena. We believe that current evidence suggests that patients with Dukes B and C colorectal cancer should be entered into trials of adjuvant therapy. This evidence is reviewed below among with estimates of the impact that adjuvant therapy would have on the outcome from this disease in Northern Ireland.

Treatment of age-related subfoveal neovascular membranes by teletherapy: a pilot study.

This investigation was designed to determine whether low dose radiation to the macular region could influence the natural course of age-related subfoveal neovascularisation. Nineteen patients with subfoveal membranes due to age-related macular degeneration (ARMD) were treated with 10 or 15 Gy of 6 MV photons and seven patients who declined treatment were followed up as controls. Six controls and all treated patients had completed follow up times of at least 12 months. Visual acuity was maintained or improved in 78% and 63% of treated patients at their 6 and 12 month follow up examinations respectively. By contrast visual acuity showed steady deterioration in six of seven controls. Significant neovascular membrane regression, as measured by image analysis, was recorded in 68% and 77% of treated patients at 6 and 12 months post-radiation, whereas the membranes in all seven control patients showed progressive enlargement. This study suggests that low doses of radiation can maintain central vision and induce regression of subfoveal neovascular membranes of ARMD in a significant proportion of patients. We now believe it appropriate to proceed to a prospective randomised study to test this hypothesis further.

The drug-exposed mother and infant: a regional center experience.

Drug-exposed mothers and infants continue to challenge maternal and infant health care resources. The woman who abuses drugs may have a complex social history and high resistance to change. Drug use may be intergenerational and long-standing. Although cocaine may be a drug of choice, there is often polydrug abuse, complicating the assessment of the newborn who may be suffering from an overall unstable intrauterine environment due to poor general health and lack of nutrition, inadequate prenatal care, and risk of exposure to contaminants from street drugs and of infection, including Hepatitis B and HIV. Infants must be thoroughly assessed and treated as any newborn at risk. Drug screening and child welfare issues are discussed. Hepatitis B immunization is recommended. Ongoing assessment of the infant and intervention techniques are described. Since many drug-exposed infants go home with their mothers, an integrated plan of care for mother and infant may contribute to a therapeutic relationship, facilitate maternal attachment behaviors, and motivate maternal rehabilitation. For nurses caring for these demanding families, burnout prevention and self-care strategies are discussed.

A randomized trial of intracavitary bleomycin and Corynebacterium parvum in the control of malignant pleural effusions.

Fifty-eight patients with malignant pleural effusions were entered into a prospectively randomized clinical trial comparing the efficacy of a local instillation of bleomycin or corynebacterium parvum (C. parvum) in controlling fluid reaccumulation after simple needle aspiration (thoracentesis). The response was assessed at 30 days by chest X-ray and clinical examination. There were 44 evaluable patients; 18 of 25 (72%) of those receiving bleomycin and 9/19 (47%) of those who had C. parvum gained a complete or partial response. This difference in response rate was not statistically significant (p = 0.13). The majority of patients had an effusion from a primary breast carcinoma and the response in this group was almost statistically significant (p = 0.06) with 74% of bleomycin patients and 43% of C. parvum patients responding. Fever following instillation was more common with C. parvum (53% of patients compared with 24% after bleomycin, p = 0.02), whereas nausea was more common after bleomycin (28% vs. 10.5%, p = 0.16). Local chest pain after aspiration occurred in 52% of the bleomycin group and 47% of the C. parvum subjects. There was no significant difference between the groups in age, sex, tumour type, presenting symptoms, volume of aspirate, systemic therapy or number of previous aspirations. Both of these agents appeared to be active in the control of malignant pleural effusions although the response rate was higher with bleomycin and overall, both have acceptable levels of toxicity.

Radiation therapy of cancer of the uterine cervix in Northern Ireland.

From 1976 to 1980, 275 patients with invasive uterine cervical cancer were treated at the Northern Ireland Radiotherapy Centre. Most patients had combined intracavitary and external radiotherapy. Only 26% presented with clinical Stage 1 disease; there were more of these patients aged 30-39.Five-year survival was 68% for Stage 1, 48% for Stage 2, 16% for Stage 3 and 0 for Stage 4. Survival was better in the age group 30-39 (63%) than in the age group 20-29 (18%) and for those histologically graded as squamous (49%) rather than poorly differentiated (35%). Twelve patients required colostomy. Comparison of these results with other centres in the United Kingdom and the USA show that there is still room for improvement particularly in the identification of early stages of the disease.