Impact of counselling on quality of life and sleep in cancer patients

It has been acknowledged that poor quality of sleep significantly correlates with poor quality of life; evidence suggests that counselling has a positive impact not only on the cancer patient's quality of life, but also on family members and friends. The aim of this service evaluation was to determine if there was an improvement in clients’ quality of life and sleep patterns following counselling as offered by a local cancer charity. A total of 60 matched pre- and post-counselling questionnaires were completed and subjected to statistical analysis. When considering quality of life, in the domains of Role Emotional, Mental Health and Mental Component Summary Score, it can be concluded that counselling has a positive effect on emotional health and mental wellbeing. The mean total number of hours sleep per night significantly increased from 6 hours sleep per night at baseline to 6.8 hours sleep per night at the completion of counselling (p=0.005) showing clients gained an extra 48 minutes sleep per night. The improved emotional and mental wellbeing alongside the extra 48 minutes sleep per night provides evidence that there is a positive outcome for those patients and families who use counselling services. Nurses and other members of the multidisciplinary team should be encouraged to discuss supportive therapies with patients and those affected by cancer at all stages of the cancer trajectory, regardless of social status, gender or cancer type.

Impact of a play-based curriculum in the first two years of primary school: literacy and numeracy outcomes over seven years

In 2000–2002 an innovative early years curriculum, the Enriched Curriculum (EC), was introduced
into 120 volunteer schools across Northern Ireland, replacing a traditional curriculum similar to
others across the UK at that time. It was intended by the designers to be developmentally appropriate
and play-based with the primary goal of preventing the experience of persistent early failure in
children. The EC was not intended to be a literacy and numeracy intervention, yet it did considerably
alter pedagogy in these domains, particularly the age at which formal reading and mathematics
instruction began. As part of a multi-method evaluation running from 2000–2008, the research
team followed the primary school careers of the first two successive cohorts of EC children, comparing
them with year-ahead controls attending the same 24 schools. Compared to the year-ahead control
group, the findings show that the EC children’s reading and mathematics scores fell behind in
the first two years but the majority of EC children caught up by the end of their fourth year. Thereafter,
the performance of the first EC cohort fell away slightly, while that of the second continued to
match that of controls. Overall, the play-based curriculum had no statistically significant positive
effects on reading and mathematics in the medium term. At best, the EC children’s scores matched
those of controls.

First steps: study protocol for a randomized controlled trial of the effectiveness of the Group Family Nurse Partnership (gFNP) program compared to routine care in improving outcomes for high-risk mothers and their children and preventing abuse

Background: Evidence from the USA suggests that the home-based Family Nurse Partnership program (FNP), extending from early pregnancy until infants are 24 months, can reduce the risk of child abuse and neglect throughout childhood. FNP is now widely available in the UK. A new variant, Group Family Nurse Partnership (gFNP) offers similar content but in a group context and for a shorter time, until infants are 12 months old. Each group comprises 8 to 12 women with similar expected delivery dates and their partners. Its implementation has been established but there is no evidence of its effectiveness.

Methods/Design: The study comprises a multi-site randomized controlled trial designed to identify the benefits of gFNP compared to standard care. Participants (not eligible for FNP) must be either aged <20 years at their last menstrual period (LMP) with one or more previous live births, or aged 20 to 24 at LMP with low educational qualifications and no previous live births. 'Low educational qualifications' is defined as not having both Maths and English Language GCSE at grade C or higher or, if they have both, no more than four in total at grade C or higher. Exclusions are: under 20 years and previously received home-based FNP and, in either age group, severe psychotic mental illness or not able to communicate in English. Consenting women are randomly allocated (minimized by site and maternal age group) when between 10 and 16 weeks pregnant to either to the 44 session gFNP program or to standard care after the collection of baseline information. Researchers are blind to group assignment. The primary outcomes at 12 months are child abuse potential based on the revised Adult-Adolescent Parenting Inventory and parent/infant interaction coded using the CARE Index based on a video-taped interaction. Secondary outcomes are maternal depression, parenting stress, health related quality of life, social support, and use of services.

Discussion: This is the first study of the effectiveness of gFNP in the UK. Results should inform decision-making about its delivery alongside universal services, potentially enabling a wider range of families to benefit from the FNP curriculum and approach to supporting parenting.

Achalasia: A review of clinical diagnosis, epidemiology, treatment and outcomes

Achalasia is a neurodegenerative motility disorder of the oesophagus resulting in deranged oesophageal peristalsis and loss of lower oesophageal sphincter function. Historically, annual achalasia incidence rates were believed to be low, approximately 0.5-1.2 per 100000. More recent reports suggest that annual incidence rates have risen to 1.6 per 100000 in some populations. The aetiology of achalasia is still unclear but is likely to be multi-factorial. Suggested causes include environmental or viral exposures resulting in inflammation of the oesophageal myenteric plexus, which elicits an autoimmune response. Risk of achalasia may be elevated in a sub-group of genetically susceptible people. Improvement in the diagnosis of achalasia, through the introduction of high resolution manometry with pressure topography plotting, has resulted in the development of a novel classification system for achalasia. This classification system can evaluate patient prognosis and predict responsiveness to treatment. There is currently much debate over whether pneumatic dilatation is a superior method compared to the Heller's myotomy procedure in the treatment of achalasia. A recent comparative study found equal efficacy, suggesting that patient preference and local expertise should guide the choice. Although achalasia is a relatively rare condition, it carries a risk of complications, including aspiration pneumonia and oesophageal cancer. The risk of both squamous cell carcinoma and adenocarcinoma of the oesophagus is believed to be significantly increased in patients with achalasia, however the absolute excess risk is small. Therefore, it is currently unknown whether a surveillance programme in achalasia patients would be effective or cost-effective.

Inclusion of chemotherapy in addition to anthracycline in the treatment of acute promyelocytic leukaemia does not improve outcomes:results of the MRC AML15 trial

Two hundred eighty-five patients, median age 42, with PML-RARa-positive acute promyelocytic leukaemia were randomised to Ara-C-containing 'Medical Research Council (MRC) Chemotherapy'+ATRA (All-trans-retinoic acid) or anthracycline+ATRA (modified 'Spanish') therapy. MRC treatment comprised four courses with ATRA in courses 1-2. Spanish treatment comprised four anthracycline-based courses with ATRA in courses 1-3. In course 3 patients were randomised to gemtuzumab ozogamicin (GO) or not. The Spanish arm received 24-month maintenance. Patients were sequentially molecularly monitored. Quality of life was assessed at baseline, 3, 6, 9, 12, 24 months. Remission rates were similar in both arms (93%): cumulative incidence of haematological relapse (CIHR) was 6% at 5 years; 5 patients relapsed molecularly. Survival post relapse was 80%. There were more deaths in remission in the MRC arm (4% vs 10%: P=0.2). The overall 5-year relapse-free and overall survival was similar between arms (81% vs 82% and 84% vs 83%, respectively). More supportive care and hospitalisation (81.8 vs 63 days, P10 × 10(9)/l) was not prognostic overall, or within treatment arms. Both approaches deliver similar results with minor differences in quality of life. MRC treatment required more hospitalisation. This suggests that additional chemotherapy, Ara-C in particular, is not required.

Prostate stereotactic ablative body radiotherapy using a standard linear accelerator:toxicity, biochemical, and pathological outcomes

Biological dose escalation through stereotactic ablative radiotherapy (SABR) holds promise of improved patient convenience, system capacity and tumor control with decreased cost and side effects. The objectives are to report the toxicities, biochemical and pathologic outcomes of this prospective study.

Investigating the Potential Impact of Four-dimensional Computed Tomography (4DCT) on Toxicity, Outcomes and Dose Escalation for Radical Lung Cancer Radiotherapy

AIMS: To investigate the potential dosimetric and clinical benefits predicted by using four-dimensional computed tomography (4DCT) compared with 3DCT in the planning of radical radiotherapy for non-small cell lung cancer.

MATERIALS AND METHODS:
Twenty patients were planned using free breathing 4DCT then retrospectively delineated on three-dimensional helical scan sets (3DCT). Beam arrangement and total dose (55 Gy in 20 fractions) were matched for 3D and 4D plans. Plans were compared for differences in planning target volume (PTV) geometrics and normal tissue complication probability (NTCP) for organs at risk using dose volume histograms. Tumour control probability and NTCP were modelled using the Lyman-Kutcher-Burman (LKB) model. This was compared with a predictive clinical algorithm (Maastro), which is based on patient characteristics, including: age, performance status, smoking history, lung function, tumour staging and concomitant chemotherapy, to predict survival and toxicity outcomes. Potential therapeutic gains were investigated by applying isotoxic dose escalation to both plans using constraints for mean lung dose (18 Gy), oesophageal maximum (70 Gy) and spinal cord maximum (48 Gy).

RESULTS:
4DCT based plans had lower PTV volumes, a lower dose to organs at risk and lower predicted NTCP rates on LKB modelling (P < 0.006). The clinical algorithm showed no difference for predicted 2-year survival and dyspnoea rates between the groups, but did predict for lower oesophageal toxicity with 4DCT plans (P = 0.001). There was no correlation between LKB modelling and the clinical algorithm for lung toxicity or survival. Dose escalation was possible in 15/20 cases, with a mean increase in dose by a factor of 1.19 (10.45 Gy) using 4DCT compared with 3DCT plans.

CONCLUSIONS:
4DCT can theoretically improve therapeutic ratio and dose escalation based on dosimetric parameters and mathematical modelling. However, when individual characteristics are incorporated, this gain may be less evident in terms of survival and dyspnoea rates. 4DCT allows potential for isotoxic dose escalation, which may lead to improved local control and better overall survival.

Prevalence and Causes of Prescribing ErrorsL The PRescribing Outcomes for Trainee Doctors Engaged in Clinical Training (PROTECT) Study

Objectives: Study objectives were to investigate the prevalence and causes of prescribing errors amongst foundation doctors (i.e. junior doctors in their first (F1) or second (F2) year of post-graduate training), describe their knowledge and experience of prescribing errors, and explore their self-efficacy (i.e. confidence) in prescribing.

Method: A three-part mixed-methods design was used, comprising: prospective observational study; semi-structured interviews and cross-sectional survey. All doctors prescribing in eight purposively selected hospitals in Scotland participated. All foundation doctors throughout Scotland participated in the survey. The number of prescribing errors per patient, doctor, ward and hospital, perceived causes of errors and a measure of doctors’ self-efficacy were established.

Results: 4710 patient charts and 44,726 prescribed medicines were reviewed. There were 3364 errors, affecting 1700 (36.1%) charts (overall error rate: 7.5%; F1:7.4%; F2:8.6%; consultants:6.3%). Higher error rates were associated with : teaching hospitals (p,0.001), surgical (p = ,0.001) or mixed wards (0.008) rather thanmedical ward, higher patient turnover wards (p,0.001), a greater number of prescribed medicines (p,0.001) and the months December and June (p,0.001). One hundred errors were discussed in 40 interviews. Error causation was multi-factorial; work environment and team factors were particularly noted. Of 548 completed questionnaires (national response rate of 35.4%), 508 (92.7% of respondents) reported errors, most of which (328 (64.6%) did not reach the patient. Pressure from other staff, workload and interruptions were cited as the main causes of errors. Foundation year 2 doctors reported greater confidence than year 1 doctors in deciding the most appropriate medication regimen.

Conclusions: Prescribing errors are frequent and of complex causation. Foundation doctors made more errors than other doctors, but undertook the majority of prescribing, making them a key target for intervention. Contributing causes included work environment, team, task, individual and patient factors. Further work is needed to develop and assess interventions that address these.

Variation of clinical outcomes used in glaucoma randomised controlled trials:a systematic review

Purpose: In randomised clinical trials (RCTs) the selection of appropriate outcomes is crucial to the assessment of whether one intervention is better than another. The purpose of this review is to identify different clinical outcomes reported in glaucoma trials.

Methods We conducted a systematic review of glaucoma RCTs. A sample or selection of glaucoma trials were included bounded by a time frame (between 2006 and March 2012). Only studies in English language were considered. All clinical measured and reported outcomes were included. The possible variations of clinical outcomes were defined prior to data analysis. Information on reported clinical outcomes was tabulated and analysed using descriptive statistics. Other data recorded included type of intervention and glaucoma, duration of the study, defined primary outcomes, and outcomes used for sample size calculation, if nominated.

Results The search strategy identified 4323 potentially relevant abstracts. There were 315 publications retrieved, of which 233 RCTs were included. A total of 967 clinical measures were reported. There were large variations in the definitions used to describe different outcomes and their measures. Intraocular pressure was the most commonly reported outcome (used in 201 RCTs, 86%) with a total of 422 measures (44%). Safety outcomes were commonly reported in 145 RCTs (62%) whereas visual field outcomes were used in 38 RCTs (16%).

Conclusions There is a large variation in the reporting of clinical outcomes in glaucoma RCTs. This lack of standardisation may impair the ability to evaluate the evidence of glaucoma interventions.

Abstinence from alcohol may indeed be the best policy: 32 month longitudinal outcomes among adolescents in the United Kingdom.

The present study investigated the longitudinal relationship between alcohol consumption at age 13, and at age 16. Alcohol-specific measures were frequency of drinking, amount consumed at last use and alcohol related harms. Self-report data were gathered from 1113 high school students at T1, and 981 students at T2. Socio-demographic data were gathered, as was information on context of use, alcohol-related knowledge and attitudes, four domains of aggression and delay reward discounting. Results indicated that any consumption of alcohol, even supervised consumption, at T1 was associated with significantly poorer outcomes at T2. In other words, compared to those still abstinent at age 13, those engaging in alcohol use in any context reported significantly more frequent drinking, more alcohol-related harms and more units consumed at last use at age 16. Results also support the relationship between higher levels of physical aggression at T1 and a greater likelihood of more problematic alcohol use behaviours at T2. The findings support other evidence suggesting that abstinence in early adolescence has better longitudinal outcomes that supervised consumption of alcohol. These results suggest support for current guidance on adolescent drinking in the United Kingdom (UK).

How Outcomes Are Defined in Clinical Trials of Mechanically Ventilated Adults and Children

Systematic reviews have considerable potential to provide evidence-based data to aid clinical decision-making. However, there is growing recognition that trials involving mechanical ventilation lack consistency in the definition and measurement of ventilation outcomes, creating difficulties in combining data for meta-analyses. To address the inconsistency in outcome definitions, international standards for trial registration and clinical trial protocols published recommendations, effectively setting the “gold standard” for reporting trial outcomes. In this Critical Care Perspective, we review the problems resulting from inconsistent outcome definitions and inconsistent reporting of outcomes (outcome sets). We present data highlighting the variability of the most commonly reported ventilation outcome definitions. Ventilation outcomes reported in trials over the last 6 years typically fall into four domains: measures of ventilator dependence; adverse outcomes; mortality; and resource use. We highlight the need, first, for agreement on outcome definitions and, second, for a minimum core outcome set for trials involving mechanical ventilation. A minimum core outcome set would not restrict trialists from measuring additional outcomes, but would overcome problems of variability in outcome selection, measurement, and reporting, thereby enhancing comparisons across trials.

Outcomes and process in reading tutoring

Background: Large-scale randomised controlled trials are relatively rare in education. The present study approximates to, but is not exactly, a randomised controlled trial. It was an attempt to scale up previous small peer tutoring projects, while investing only modestly in continuing professional development for teachers.Purpose: A two-year study of peer tutoring in reading was undertaken in one local education authority in Scotland. The relative effectiveness of cross-age versus same-age tutoring, light versus intensive intervention, and reading versus reading and mathematics tutoring were investigated.Programme description (if relevant): The intervention was Paired Reading, a freely available cross-ability tutoring method applied to books of the pupils' choice but above the tutee's independent readability level. It involves Reading Together and Reading Alone, and switching from one to the other according to need.Sample: Eighty-seven primary schools of overall average socio-economic status, ability and gender in one council in Scotland. There were few ethnic minority students. Proportions of students with special needs were low. Children were eight and 10 years old as the intervention started. Macro-evaluation n = 3520. Micro-evaluation Year 1 15 schools n = 592, Year 2 a different 15 schools n = 591, compared with a comparison group of five schools n = 240.Design and methods: Almost all the primary schools in the local authority participated and were randomly allocated to condition. A macro-evaluation tested and retested over a two-year period using Performance Indicators in Primary Schools. A micro-evaluation tested and retested within each year using norm-referenced tests of reading comprehension. Macro-evaluation was with multi-level modelling, micro-evaluation with descriptive statistics and effect sizes, analysis of variance (ANOVA) and multivariate analysis of variance (MANOVA).Results: Macro-evaluation yielded significant pre-post gains in reading attainment for cross-age tutoring over both years. No other differences were significant. Micro-evaluation yielded pre-post changes in Year 1 (selected) and Year 2 (random) greater than controls, with no difference between same-age and cross-age tutoring. Light and intensive tutoring were equally effective. Tutoring reading and mathematics together was more effective than only tutoring reading. Lower socio-economic and lower reading ability students did better. Girls did better than boys. Regarding observed implementation quality, some factors were high and others low. Few implementation variables correlated with attainment gain.Conclusions: Paired Reading tutoring does lead to better reading attainment compared with students not participating. This is true in the long term (macro-evaluation) for cross-age tutoring, and in the short term (micro-evaluation) for both cross-age and same-age tutoring. Tutors and tutees benefited. Intensity had no effect but dual tutoring did have an effect. Low-socio-economic status, low-ability and female students did better. The results of the different forms of evaluation were indeed different. There are implications for practice and for future research. © 2012 Copyright Taylor and Francis Group, LLC.