Helena Harder

Randomised controlled trials of yoga interventions for women with breast cancer: a systematic literature review

PurposeYoga is increasingly used as a complementary therapy to manage disease and treatment-related side effects in patients with cancer and has resulted in an increase in the number of studies exploring the effectiveness of yoga interventions. This systematic review examines whether yoga interventions provide any measurable benefit, both physically and psychologically, for women with breast cancer. The results will inform future research in this field and advance the development of yoga programmes.MethodsWe performed electronic searches of MEDLINE, PsychINFO, the Cochrane Library, Embase, CINAHL, AMED, Web of Science and Scopus for articles published up to June 2012. Only randomised controlled trials (RCTs) were included and methodological quality rating scores were determined using the PEDro (Physiotherapy Evidence Database) Scale.ResultsOne hundred thirty-two studies were identified through a systematic search of eight electronic databases. Only published manuscripts that employed a RCT design were included (n = 18). The sample sizes for these studies varied widely from 18 to 164 participants and the associated PEDro scores ranged from 1 (poor) to 8 (good). All 18 studies reported positive effects for treatment-related side effects in favour of the yoga interventions, with the greatest impact on global quality of life (QoL) scores and emotional well-being.ConclusionResults from the few RCTs suggest there is moderate to good evidence that yoga may be a useful practice for women recovering from breast cancer treatments. Large-scale RCTs using objective measures and patient-reported outcomes with long-term follow-up are needed to substantiate whether the benefits are true and sustainable.

Predictors of Anxiety after Stroke: A Systematic Review of Observational Studies

BACKGROUND Anxiety disorders or symptoms are relatively common after stroke. A better understanding of the predictors of anxiety in stroke patients may improve the management of these disorders. The current review was conducted to determine the predictors of anxiety after stroke. METHODS Relevant articles concerning population, hospital, or rehabilitation-based studies were identified by searching 10 electronic databases up to May 2014. Methodological quality appraisal, including the validity of prognostic models and data extraction were conducted by 3 reviewers. RESULTS A total of 18 studies were identified. Data from 3 population-based studies including 8130 patients, 8 hospital-based studies including 1199 patients, and 7 rehabilitation-based studies including 1103 patients were evaluated. Prestroke depression, stroke severity, early anxiety, and dementia or cognitive impairment after stroke were the main predictors of poststroke anxiety. Older age, physical disability or impairment, and use of antidepressant drugs were not associated with the presence of anxiety. Limitations of studies included wide variation in screening tools and cutoff scores, variability in the time frame of screening for anxiety, use of extensive exclusion criteria, and questionable statistical internal and external validity of the models. CONCLUSIONS Lack of methodological and statistical rigor affects the validity of proposed models to predict anxiety after stroke. Future research should focus on testing proposed models on both internal and external samples to ultimately inform future clinical practice.

Intravenous versus Subcutaneous Drug Administration. Which Do Patients Prefer? A Systematic Review

BackgroundIntravenous (IV) drug delivery is commonly used for its rapid administration and immediate drug effect. Most studies compare IV to subcutaneous (SC) delivery in terms of safety and efficacy, but little is known about what patients prefer.MethodsA systematic review was conducted by searching seven electronic databases for articles published up to February 2014. Included studies were randomized controlled trials (RCTs) and/or crossover designs investigating patient preference for SC versus IV administration. The risk of bias in the RCTs was determined using the Cochrane Collaboration tool. Reviewers independently extracted data and assessed the risk of bias. Any discrepancies were resolved by consensus.ResultsThe search identified 115 publications, but few (6/115) met the inclusion criteria. Patient populations and drugs investigated were diverse. Four of six studies demonstrated a clear patient preference for SC administration. Main factors associated with SC preference were time saving and the ability to have treatment at home. Only three studies used study-specific instruments to measure preference.ConclusionsResults suggest that patients prefer SC over IV delivery. Patient preference has clearly been neglected in clinical research, but it is important in medical decision making when choosing treatment methods as it has implications for adherence and quality of life. If the safety and efficacy of both administration routes are equivalent, then the most important factor should be patient preference as this will ensure optimal treatment adherence and ultimately improve patient experience or satisfaction. Future drug efficacy and safety studies should include contemporaneous, actual patient preference where possible, utilizing appropriate measures.

Bridging the age gap in breast cancer: evaluation of decision support interventions for older women with operable breast cancer: protocol for a cluster randomised controlled trial

Introduction While breast cancer outcomes are improving steadily in younger women due to advances in screening and improved therapies, there has been little change in outcomes among the older age group. It is inevitable that comorbidities/frailty rates are higher, which may increase the risks of some breast cancer treatments such as surgery and chemotherapy, many older women are healthy and may benefit from their use. Adjusting treatment regimens appropriately for age/comorbidity/frailty is variable and largely non-evidence based, specifically with regard to rates of surgery for operable oestrogen receptor-positive disease and rates of chemotherapy for high-risk disease. Methods and analysis This multicentre, parallel group, pragmatic cluster randomised controlled trial (RCT) (2015-18) reported here is nested within a larger ongoing ‘Age Gap Cohort Study’ (2012-18RP-PG-1209-10071), aims to evaluate the effectiveness of a complex intervention of decision support interventions to assist in the treatment decision making for early breast cancer in older women. The interventions include two patient decision aids (primary endocrine therapy vs surgery/antioestrogen therapy and chemotherapy vs no chemotherapy) and a clinical treatment outcomes algorithm for clinicians. Ethics and dissemination National and local ethics committee approval was obtained for all UK participating sites. Results from the trial will be submitted for publication in international peer-reviewed scientific journals. IRAS reference 115550. Trial registration number European Union Drug Regulating Authorities Clinical Trials (EudraCT) number 2015-004220-61;Pre-results. Sponsors Protocol Code Number Sheffield Teaching Hospitals STH17086. ISRCTN 32447*.

A study of the validity and the reliability of the Geriatric Anxiety Inventory in screening for anxiety after stroke in older inpatients

Objectives: To investigate the validity and reliability of the Geriatric Anxiety Inventory in screening for anxiety in older inpatients post-stroke. Design: Longitudinal. Subjects: A total of 81 inpatients with stroke aged 65 years or older were recruited at four centres in England. Main measures: At phase 1 the Geriatric Anxiety Inventory and the Hospital Anxiety and Depression Scale were administered and then the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders 4th edition (phase 2). The Geriatric Anxiety Inventory was repeated a median of seven days later (phase 3). Results: Internal reliability of the Geriatric Anxiety Inventory was high (α = 0.95) and test–retest reliability acceptable (τB = 0.53). Construct validity was evident relative to the Hospital Anxiety and Depression Scale – Anxiety subscale (τB = 0.61). At a cut off of 6/7, sensitivity of the Geriatric Anxiety Inventory was 0.88, specificity 0.84, with respect to the Structured Clinical Interview anxiety diagnosis. Hospital Anxiety and Depressions Scale – Anxiety subscale sensitivity was 0.88, specificity 0.54 at the optimum cut off of 5/6. A comparison of the areas under the curve of the Receiver Operating Characteristics for the two instruments indicated that the area under the curve of the Geriatric Anxiety Inventory was significantly larger than that of the Hospital Anxiety and Depressions Scale – Anxiety subscale, supporting its superiority. Conclusions: The Geriatric Anxiety Inventory is an internally consistent, reliable (stable) and valid instrument with acceptable sensitivity and specificity to screen for anxiety in older inpatients with stroke.

A pilot study to examine the experiences and attitudes of women with breast cancer towards one versus two-step axillary surgery

PURPOSE To elicit the views, experiences and preferences of women with clinically node negative breast cancer towards intra-operative sentinel lymph node biopsy (SLNB) analysis. METHODS Focus groups with 14 women with breast cancer from two UK centres; one group had undergone the standard practice of waiting two weeks for results of their axillary surgery, the other had experienced the intra-operative SLNB analysis. RESULTS Women generally were unaware about their lymph nodes, what their function is and how they are removed. Preference was indicated for intra-operative sentinel lymph node biopsy (SLNB) analysis provided clear descriptions were given about the risk of experiencing false negative and false positive results. DISCUSSION Adopting an intra-operative analysis technique of axillary nodes was viewed as an excellent option by women from both centres. The immediacy of knowing the results was seen as a great advantage for their physical and psychological well being and more cost effective.

The effects of breast cancer treatment on cognition

There is growing concern among patients with early-stage breast cancer about self-perceived or objective cognitive changes following their diagnosis and treatment. Symptoms include difficulties with multi-tasking, short-term memory, attention and concentration and word-finding, which may have a detrimental effect on quality of life. The severity of symptoms varies widely, when assessed objectively, the problems are generally subtle. Early clinical observational studies accumulated evidence that suggested cognitive problems could be attributed to the direct neurotoxic effects of chemotherapy. However, observations of cognitive deficits before the start of any treatment question the singular role of chemotherapy. Additionally, results from studies examining the effect of endocrine therapies on cognitive function are mixed.

P084 Feasibility study to examine underlying mechanisms for “Chemo Fog”

P084 Feasibility study to examine underlying mechanisms for “Chemo Fog” V. Jenkins *, H. Harder, M. Cercingani, H. Whiteley-Jones, R. Thwaites, L. Mullen, N. Harrison, K. Davies, C. Zammit, S. Sacre. SHORE-C Brighton & Sussex Medical School, University of Sussex, Brighton, United Kingdom, CISC Brighton & Sussex Medical School, University of Sussex, Brighton, United Kingdom, Brighton & Sussex Medical School, University of Sussex, Brighton, United Kingdom, Breast Surgery, Brighton & Sussex University Hospitals, Brighton, United Kingdom