Psychosocial outcomes after varying risk management strategies in women at increased familial breast cancer risk: a mixed methods study of patient and partner outcomes.

INTRODUCTION: Female carriers of BRCA1/2 genes have an increased lifetime risk of breast cancer. Options for managing risk include imaging surveillance or risk-reducing surgery (RRS). This mixed methods study aimed to identify factors affecting risk-management decisions and the psychosocial outcomes of these decisions for high-risk women and their partners. METHODS: Semi-structured qualitative interviews were performed with women at high breast cancer risk who had faced these choices. Partners were also interviewed. Analysis used a framework approach. A bespoke questionnaire was developed to quantify and explore associations. RESULTS: A total of 32 women were interviewed. Of these, 27 had partners of whom 7 (26%) agreed to be interviewed. Four main themes arose: perception of risk and impact of increased risk; risk-management strategy decision-making; impact of risk-management strategy; support needs and partner relationship issues. The questionnaire response rate was 36/157 (23%). Decision satisfaction was high in both surveillance and RRS groups. Relationship changes were common but not universal. Common causes of distress following RRS included adverse body image changes. Both groups experienced generalised and cancer-specific anxiety. Drivers for surgery included having children, deaths of close family from breast cancer and higher levels of cancer anxiety. CONCLUSIONS: Levels of psychosocial and decision satisfaction were high for women choosing both RRS and surveillance but, for a minority, risk-reducing measures result in long-term psychosocial morbidity. Efforts to recognise women at increased risk of psychological morbidity may allow targeted support.

A Randomised Clinical Feasibility Trial of a Breast Immobilisation Device: The SuPPORT 4 All Bra.

AIMS: Despite the breast being a mobile organ, there is currently no standard suitable immobilisation device to optimise radiotherapy for women with larger breasts treated after a wide local excision. The SuPPORT 4 All (S4A) bra was co-designed with patients and radiotherapy professionals. The purpose of this study was to test the feasibility of using the S4A bra in the existing breast cancer radiotherapy pathway. MATERIALS AND METHODS: A randomised feasibility trial was conducted in a single institution; the primary feasibility endpoint was the recruitment of 50 participants. Efficacy endpoints were also tested, including assessment of skin reactions, dose to organs at risk and patient comfort. Fifty women were randomised to receive either standard radiotherapy with no immobilisation (control) or radiotherapy with the S4A bra (intervention). A separate planning study was undertaken on the cases randomised to receive the S4A bra. Participants in the intervention arm (S4A bra) underwent two planning computed tomography scans, one with the bra on and one without the bra; allowing direct comparison of organs at risk data for S4A bra versus no bra. RESULTS: All women who started radiotherapy wearing the S4A bra completed treatment with the bra; patient comfort did not change across the 3 weeks of treatment. Positional accuracy using the bra was comparable with existing published accuracy for methods without immobilisation. The mean ipsilateral lung doses showed some improvement when positioning with the S4A bra was compared with the no bra set-up (3.72 Gy versus 4.85 Gy for right-sided cases, 3.23 Gy versus 3.62 Gy for left-sided cases). CONCLUSIONS: The S4A bra is feasible to use in the radiotherapy pathway with good patient adherence. The S4A bra has potential to reduce dose to organs at risk (specifically ipsilateral lung dose) while maintaining good breast tissue coverage, and improved patient dignity, warranting further investigation on a larger scale.

A machine-learning assisted review of the use of habit formation in medication adherence interventions for long-term conditions.

Adherence to medication in long-term conditions is around 50%. The key components of successful interventions to improve medication adherence remain unclear, particularly when examined over prolonged follow-up periods. Behaviour change theories are increasingly interested in the utility of habit formation for the maintenance of health behaviour change, but there is no documentation on how habit has been conceptualised in the medication adherence intervention literature, or what effect the key technique identified in habit formation theory (context dependent repetition) has in these studies. To examine this, a machine-learning assisted review was conducted. Searches of MEDLINE, EMBASE and PSYCInfo and the reference list of a comprehensive systematic review of medication adherence interventions yielded 5973 articles. Machine learning-assisted title and abstract screening identified 15 independent RCTs published between 1976 and 2021, including 18 intervention comparisons of interest. Key findings indicate that conceptualisations of habit in the medication adherence literature are varied and behaviour change technique coding identified only six studies which explicitly described using habit formation. Future work should aim to develop this evidence base, drawing on contemporary habit theory and with explicit demonstration of what techniques have been used to promote habit formation.

Volume-outcome relationships in open and endovascular repair of abdominal aortic aneurysm: administrative data 2006-2018.

BACKGROUND: The aim of this study was to use recent evidence to investigate and update volume-outcome relationships after open surgical repair (OSR) and endovascular repair (EVAR) of abdominal aortic aneurysm in England. METHODS: Hospital Episode Statistics (HES) data from April 2006 to March 2018 were obtained. The primary outcome was in-hospital death. Other outcomes included duration of hospital stay, readmissions within 30 days, and critical care requirements. Case-mix adjustment included age, sex, HES year, deprivation index, weekend admission, mode of admission, type of procedure and co-morbidities. RESULTS: Annual volume of all repairs combined appeared to be an appropriate measure of volume. After case-mix adjustment, a significant relationship between volume and in-hospital mortality was seen for OSR (P < 0·001) but not for EVAR (P = 0·169 for emergency and P = 0·363 for elective). The effect appeared to extend beyond 60 repairs per year to volumes above 100 repairs per year. There was no significant relationship between volume and duration of hospital stay or 30-day readmissions. In patients receiving emergency OSR, higher volume was associated with longer stay in critical care. CONCLUSION: Higher annual all-procedure volumes were associated with significantly lower in-hospital mortality for OSR, but such a relationship was not significant for EVAR. There was not enough evidence for a volume effect on other outcomes.

Bridging the age gap in breast cancer: impact of omission of breast cancer surgery in older women with oestrogen receptor-positive early breast cancer on quality-of-life outcomes.

BACKGROUND: Primary endocrine therapy may be an alternative treatment for less fit women with oestrogen receptor (ER)-positive breast cancer. This study compared quality-of-life (QoL) outcomes in older women treated with surgery or primary endocrine therapy. METHODS: This was a multicentre, prospective, observational cohort study of surgery or primary endocrine therapy in women aged over 70 years with operable breast cancer. QoL was assessed using European Organisation for Research and Treatment of cancer QoL questionnaires QLQ-C30, -BR23, and -ELD14, and the EuroQol Five Dimensions 5L score at baseline, 6 weeks, and 6, 12, 18, and 24 months. Propensity score matching was used to adjust for baseline variation in health, fitness, and tumour stage. RESULTS: The study recruited 3416 women (median age 77 (range 69-102) years) from 56 breast units. Of these, 2979 (87.2 per cent) had ER-positive breast cancer; 2354 women had surgery and 500 received primary endocrine therapy (125 were excluded from analysis due to inadequate data or non-standard therapy). Median follow-up was 52 months. The primary endocrine therapy group was older and less fit. Baseline QoL differed between the groups; the mean(s.d.) QLQ-C30 global health status score was 66.2(21.1) in patients who received primary endocrine therapy versus 77.1(17.8) among those who had surgery plus endocrine therapy. In the unmatched analysis, changes in QoL between 6 weeks and baseline were noted in several domains, but by 24 months most scores had returned to baseline levels. In the matched analysis, major surgery (mastectomy or axillary clearance) had a more pronounced adverse impact than primary endocrine therapy in several domains. CONCLUSION: Adverse effects on QoL are seen in the first few months after surgery, but by 24 months these have largely resolved. Women considering surgery should be informed of these effects.

Bridging the age gap in breast cancer: cluster randomized trial of two decision support interventions for older women with operable breast cancer on quality of life, survival, decision quality, and treatment choices.

BACKGROUND: Rates of surgery and adjuvant therapy for breast cancer vary widely between breast units. This may contribute to differences in survival. This cluster RCT evaluated the impact of decision support interventions (DESIs) for older women with breast cancer, to ascertain whether DESIs influenced quality of life, survival, decision quality, and treatment choice. METHODS: A multicentre cluster RCT compared the use of two DESIs against usual care in treatment decision-making in older women (aged at least ≥70 years) with breast cancer. Each DESI comprised an online algorithm, booklet, and brief decision aid to inform choices between surgery plus adjuvant endocrine therapy versus primary endocrine therapy, and adjuvant chemotherapy versus no chemotherapy. The primary outcome was quality of life. Secondary outcomes included decision quality measures, survival, and treatment choice. RESULTS: A total of 46 breast units were randomized (21 intervention, 25 usual care), recruiting 1339 women (670 intervention, 669 usual care). There was no significant difference in global quality of life at 6 months after the baseline assessment on intention-to-treat analysis (difference -0.20, 95 per cent confidence interval (C.I.) -2.69 to 2.29; P = 0.900). In women offered a choice of primary endocrine therapy versus surgery plus endocrine therapy, knowledge about treatments was greater in the intervention arm (94 versus 74 per cent; P = 0.003). Treatment choice was altered, with a primary endocrine therapy rate among women with oestrogen receptor-positive disease of 21.0 per cent in the intervention versus 15.4 per cent in usual-care sites (difference 5.5 (95 per cent C.I. 1.1 to 10.0) per cent; P = 0.029). The chemotherapy rate was 10.3 per cent at intervention versus 14.8 per cent at usual-care sites (difference -4.5 (C.I. -8.0 to 0) per cent; P = 0.013). Survival was similar in both arms. CONCLUSION: The use of DESIs in older women increases knowledge of breast cancer treatment options, facilitates shared decision-making, and alters treatment selection. Trial registration numbers: EudraCT 2015-004220-61 (https://eudract.ema.europa.eu/), ISRCTN46099296 (http://www.controlled-trials.com).

Analytic and numerical solutions to the seismic wave equation in continuous media.

This paper presents two approaches to mathematical modelling of a synthetic seismic pulse, and a comparison between them. First, a new analytical model is developed in two-dimensional Cartesian coordinates. Combined with an initial condition of sufficient symmetry, this provides a valuable check for the validity of the numerical method that follows. A particular initial condition is found which allows for a new closed-form solution. A numerical scheme is then presented which combines a spectral (Fourier) representation for displacement components and wave-speed parameters, a fourth-order Runge-Kutta integration method, and an absorbing boundary layer. The resulting large system of differential equations is solved in parallel on suitable enhanced performance desktop hardware in a new software implementation. This provides an alternative approach to forward modelling of waves within isotropic media which is efficient, and tailored to rapid and flexible developments in modelling seismic structure, for example, shallow depth environmental applications. Visual comparisons of the analytic solution and the numerical scheme are presented.

Breast cancer surgery in older women: outcomes of the Bridging Age Gap in Breast Cancer study.

BACKGROUND: Breast cancer surgery in older women is variable and sometimes non-standard owing to concerns about morbidity. Bridging the Age Gap in Breast Cancer is a prospective multicentre cohort study aiming to determine factors influencing treatment selection and outcomes from surgery for older patients with breast cancer. METHODS: Women aged at least 70 years with operable breast cancer were recruited from 57 UK breast units between 2013 and 2018. Associations between patient and tumour characteristics and type of surgery in the breast and axilla were evaluated using univariable and multivariable analyses. Oncological outcomes, adverse events and quality-of-life (QoL) outcomes were monitored for 2 years. RESULTS: Among 3375 women recruited, surgery was performed in 2816 patients, of whom 24 with inadequate data were excluded. Sixty-two women had bilateral tumours, giving a total of 2854 surgical events. Median age was 76 (range 70-95) years. Breast surgery comprised mastectomy in 1138 and breast-conserving surgery in 1716 procedures. Axillary surgery comprised axillary lymph node dissection in 575 and sentinel node biopsy in 2203; 76 had no axillary surgery. Age, frailty, dementia and co-morbidities were predictors of mastectomy (multivariable odds ratio (OR) for age 1·06, 95 per cent c.i. 1·05 to 1·08). Age, frailty and co-morbidity were significant predictors of no axillary surgery (OR for age 0·91, 0·87 to 0·96). The rate of adverse events was moderate (551 of 2854, 19·3 per cent), with no 30-day mortality. Long-term QoL and functional independence were adversely affected by surgery. CONCLUSION: Breast cancer surgery is safe in women aged 70 years or more, with serious adverse events being rare and no mortality. Age, ill health and frailty all influence surgical decision-making. Surgery has a negative impact on QoL and independence, which must be considered when counselling patients about choices.

ANTECEDENTES: La cirugía del cáncer de mama en mujeres mayores es variable y, a veces, no estandarizada debido a las reservas que origina la morbilidad quirúrgica. Bridging the Age Gap in Breast Cancer es un estudio de cohortes, prospectivo, multicéntrico cuyo objetivo fue determinar los factores que influyen en la selección del tratamiento y en los resultados de la cirugía en pacientes mayores con cáncer de mama. MÉTODOS: Se reclutaron mujeres de > 70 años de edad con cáncer de mama operable atendidas en 56 unidades de mama del Reino Unido entre 2013-2018. Los datos sobre las características de la paciente y del tumor se correlacionaron con el tipo de cirugía en la mama y en la axila mediante análisis univariable y multivariable. Se controlaron los resultados oncológicos, los eventos adversos y los resultados en cuanto a la calidad de vida durante 2 años. RESULTADOS: De 3.375 mujeres reclutadas, se realizó una intervención quirúrgica en 2.816 pacientes. Hubo 62 tumores bilaterales, por lo que se analizan 2.854 procedimientos. La mediana de edad fue de 76 años (rango 70-95). En 1.138 pacientes se realizó una mastectomía y en 1.798 cirugía conservadora de la mama. En cuanto a la cirugía de la axila, en 575 pacientes se realizó una linfadenectomía, en 2.203 una biopsia de ganglio centinela y en 76 no se realizó ningún procedimiento. Los factores predictores de mastectomía fueron la edad, la fragilidad, la demencia y las comorbilidades (riesgo relativo, RR 1,06; i.c. del 95% 1,05-1,08), mientras que para la cirugía axilar los factores predictores fueron la fragilidad y las comorbilidades (RR 0,91; i.c. del 95% 0,87-0,96). La tasa de efectos adversos fue moderada (551/2854; 19,3%), sin mortalidad a los 30 días. La calidad de vida a largo plazo y la independencia funcional se vieron negativamente afectadas por la cirugía. CONCLUSIÓN: La cirugía de cáncer de mama es segura, con escasos efectos adversos graves y sin mortalidad. La edad, las comorbilidades y la fragilidad tienen impacto en la toma de decisiones quirúrgicas. La cirugía tiene una repercusión negativa en la calidad de vida e independencia funcional, hechos que deben ser tenidos en cuenta al aconsejar a las pacientes sobre las opciones terapéuticas.

Probing human sperm metabolism using 13C-magnetic resonance spectroscopy.

STUDY QUESTION: Can 13C-Magnetic Resonance Spectroscopy (MRS) of selected metabolites provide useful information about human sperm metabolism and how glycolysis or oxidative phosphorylation are used by different sperm populations? SUMMARY ANSWER: Sperm populations, prepared by density gradient centrifugation (DGC) and incubated with either 13Cu-glucose, 13Cu-fructose or 13C1-pyruvate, showed consistent evidence of metabolism generating principally lactate and more intermittently bicarbonate, and significantly more lactate was produced from 13Cu-glucose by vital or motile sperm recovered from the 40/80% interface compared to those from the pellet, which could not be accounted for by differences in the non-sperm cells present. WHAT IS KNOWN ALREADY: Previous studies have focused on CO2 or other specific metabolite production by human sperm and there remains considerable debate about whether glycolysis and/or oxidative phosphorylation is the more important pathway for ATP production in sperm. STUDY DESIGN, SIZE, DURATION: Sperm populations were prepared by DGC and subjected to 13C-MRS to answer the following questions. (i) Is it possible to detect human sperm metabolism of 13C substrates implicated in energy generation? (ii) What are the kinetics of such reactions? (iii) Do different sperm populations (e.g. '80%' pellet sperm and '40%' interface sperm) utilise substrates in the same way? Semen samples from 97 men were used in these experiments; 52 were used in parallel for aims (i) and (ii) and 45 were used for aim (iii). PARTICIPANTS/MATERIALS, SETTING, METHODS: Sperm populations were prepared from ejaculates of healthy men using a Percoll/Phosphate Buffered Saline (PBS) DGC and then incubated with a range of 13C-labelled substrates (13Cu-glucose, 13Cu-fructose, 13C1-pyruvate, 13C1-butyrate, 13C3-lactate, 13C2,4-D-3-hydroxybutyrate, 13C5-l-glutamate, 13C1,2-glycine or 13Cu-galactose) along with penicillin/streptomycin antibiotic at 37°C for 4 h, 24 h or over 48 h for an estimated rate constant. Sperm concentration, vitality and motility were measured and, for a subset of experiments, non-sperm cell concentration was determined. A 9.4 T magnetic resonance spectrometer was used to acquire 1D 13C, inverse gated 1H decoupled, MRS spectra. Spectrum processing was carried out using spectrometer software and Matlab scripts to determine peak integrals for each spectrum. MAIN RESULTS AND THE ROLE OF CHANCE: 13Cu-glucose, 13Cu-fructose and 13C1-pyruvate were consistently converted into lactate and, to a lesser extent, bicarbonate. There was a significant correlation between sperm concentration and lactate peak size for 13Cu-glucose and 13Cu-fructose, which was not observed for 13C1-pyruvate. The lactate peak did not correlate with the non-sperm cell concentration up to 6.9 × 106/ml. The concentration of 13Cu-glucose, 13Cu-fructose or 13C1-pyruvate (1.8, 3.6, 7.2 or 14.4 mM) had no influence on the size of the observed lactate peak over a 4 h incubation. The rate of conversion of 13C1-pyruvate to lactate was approximately three times faster than for 13Cu-glucose or 13Cu-fructose which were not significantly different from each other. After incubating for 4 h, the utilisation of 13Cu-glucose, 13Cu-fructose or 13C1-pyruvate by sperm from the '40%' interface of the DGC was no different from those from the pellet when normalised to total sperm concentration. However, after normalising by either the vital or motile sperm concentration, there was a significant increase in conversion of 13Cu-glucose to lactate by '40%' interface sperm compared to pellet sperm (Vital = 3.3 ± 0.30 × 106 vs 2.0 ± 0.21 × 106; P = 0.0049; Motile = 7.0 ± 0.75 × 106 vs 4.8 ± 0.13 × 106; P = 0.0032. Mann-Whitney test P < 0.0055 taken as statistically significant). No significant differences were observed for 13Cu-fructose or 13C1-pyruvate. LARGE SCALE DATA: Not applicable. LIMITATIONS, REASONS FOR CAUTION: Only 13C labelled metabolites that accumulate to a sufficiently high concentration can be observed by 13C MRS. For this reason, intermediary molecules in the metabolic chain are difficult to observe without trapping the molecule at a particular step using inhibitors. Non-sperm cell concentration was typical of the general population and no link was found between these cells and the magnitude of the 13C-lactate peak. However, it is possible that higher concentrations than the maximum observed (6.9 × 106/ml) may contribute to exogenous substrate metabolism in other experiments. WIDER IMPLICATIONS OF THE FINDINGS: 13C-MRS can provide information on the underlying metabolism of multiple pathways in live sperm. Dysfunction in sperm metabolism, as a result of either impaired enzymes of lack of metabolisable substrate, could be detected in sperm by a non-destructive assay, potentially offering new treatment options to improve overall sperm quality and outcomes for reproduction. STUDY FUNDING AND COMPETING INTERESTS: This work was supported by the Medical Research Council Grant MR/M010473/1. The authors declare no conflicts of interest.

What influences healthcare professionals' treatment preferences for older women with operable breast cancer? An application of the discrete choice experiment.

INTRODUCTION: Primary endocrine therapy (PET) is used variably in the UK as an alternative to surgery for older women with operable breast cancer. Guidelines state that only patients with "significant comorbidity" or "reduced life expectancy" should be treated this way and age should not be a factor. METHODS: A Discrete Choice Experiment (DCE) was used to determine the impact of key variables (patient age, comorbidity, cognition, functional status, cancer stage, cancer biology) on healthcare professionals' (HCP) treatment preferences for operable breast cancer among older women. Multinomial logistic regression was used to identify associations. RESULTS: 40% (258/641) of questionnaires were returned. Five variables (age, co-morbidity, cognition, functional status and cancer size) independently demonstrated a significant association with treatment preference (p < 0.05). Functional status was omitted from the multivariable model due to collinearity, with all other variables correlating with a preference for operative treatment over no preference (p < 0.05). Only co-morbidity, cognition and cancer size correlated with a preference for PET over no preference (p < 0.05). CONCLUSION: The majority of respondents selected treatment in accordance with current guidelines, however in some scenarios, opinion was divided, and age did appear to be an independent factor that HCPs considered when making a treatment decision in this population.

Diagnostic accuracy of DXA compared to conventional spine radiographs for the detection of vertebral fractures in children.

OBJECTIVES: In children, radiography is performed to diagnose vertebral fractures and dual energy x-ray absorptiometry (DXA) to assess bone density. In adults, DXA assesses both. We aimed to establish whether DXA can replace spine radiographs in assessment of paediatric vertebral fractures. METHODS: Prospectively, lateral spine radiographs and lateral spine DXA of 250 children performed on the same day were independently scored by three radiologists using the simplified algorithm-based qualitative technique and blinded to results of the other modality. Consensus radiograph read and second read of 100 random images were performed. Diagnostic accuracy, inter/intraobserver and intermodality agreements, patient/carer experience and radiation dose were assessed. RESULTS: Average sensitivity and specificity (95 % confidence interval) in diagnosing one or more vertebral fractures requiring treatment was 70 % (58-82 %) and 97 % (94-100 %) respectively for DXA and 74 % (55-93 %) and 96 % (95-98 %) for radiographs. Fleiss' kappa for interobserver and average kappa for intraobserver reliability were 0.371 and 0.631 respectively for DXA and 0.418 and 0.621 for radiographs. Average effective dose was 41.9 µSv for DXA and 232.7 µSv for radiographs. Image quality was similar. CONCLUSION: Given comparable image quality and non-inferior diagnostic accuracy, lateral spine DXA should replace conventional radiographs for assessment of vertebral fractures in children. KEY POINTS: • Vertebral fracture diagnostic accuracy of lateral spine DXA is non-inferior to radiographs. • The rate of unreadable vertebrae for DXA is lower than for radiographs. • Effective dose of DXA is significantly lower than radiographs. • Children prefer DXA to radiographs. • Given the above, DXA should replace radiographs for paediatric vertebral fracture assessment.

Diagnosis of vertebral fractures in children: is a simplified algorithm-based qualitative technique reliable?

BACKGROUND: Identification of osteoporotic vertebral fractures allows treatment opportunity reducing future risk. There is no agreed standardised method for diagnosing paediatric vertebral fractures. OBJECTIVE: To evaluate the precision of a modified adult algorithm-based qualitative (ABQ) technique, applicable to children with primary or secondary osteoporosis. MATERIALS AND METHODS: Three radiologists independently assessed lateral spine radiographs of 50 children with suspected reduction in bone mineral density using a modified ABQ scoring system and following simplification to include only clinically relevant parameters, a simplified ABQ score. A final consensus of all observers using simplified ABQ was performed as a reference standard for fracture characterisation. Kappa was calculated for interobserver agreement of the components of both scoring systems and intraobserver agreement of simplified ABQ based on a second read of 29 randomly selected images. RESULTS: Interobserver Kappa for modified ABQ scoring for fracture detection, severity and shape ranged from 0.34 to 0.49 Kappa for abnormal endplate and position assessment was 0.27 to 0.38. Inter- and intraobserver Kappa for simplified ABQ scoring for fracture detection and grade ranged from 0.37 to 0.46 and 0.45 to 0.56, respectively. Inter- and intraobserver Kappa for affected endplate ranged from 0.31 to 0.41 and 0.45 to 0.51, respectively. Subjectively, observers' felt simplified ABQ was easier and less time-consuming. CONCLUSION: Observer reliability of modified and simplified ABQ was similar, with slight to moderate agreement for fracture detection and grade/severity. Due to subjective preference for simplified ABQ, we suggest its use as a semi-objective measure of diagnosing paediatric vertebral fractures.

Prioritising public health guidance topics in the National Institute for Health and Care Excellence using the Analytic Hierarchy Process.

OBJECTIVES: The Centre for Public Health (CPH), at the United Kingdom's National Institute for Health and Care Excellence (NICE) is responsible for producing national guidance relating to the promotion of good health and the prevention and treatment of disease. Given the challenges of developing guidance in this area, choosing the most appropriate topics for further study is of fundamental importance. This paper explores the current prioritisation process and describes how the Analytic Hierarchy Process (AHP), a multi criteria decision analysis (MCDA) technique, might be used to do so. STUDY DESIGN: A proposed approach is outlined, which was tested in a proof of concept pilot. This consisted of eight participants with experience of related NICE committees building scores for each topic together in a 'decision conference' setting. METHODS: Criteria were identified and subsequently weighted to indicate the relative importance of each. Participants then collaboratively estimated the performance of each topic on each criterion. RESULTS: Total scores for each topic were calculated, which could be ranked and used as the basis for better informed discussion for prioritising topics to recommend to the Minister for future guidance. Sensitivity analyses of the dataset found it to be robust. CONCLUSIONS: Choosing the right topics for guidance at the earliest possible time is of fundamental importance to public health guidance, and judgement is likely to play an important part in doing so. MCDA techniques offer a potentially useful approach to structuring the problem in a rational and transparent way. NICE should consider carefully whether such an approach might be worth pursuing in the future.

An evaluation of patient-reported outcome measures in lower limb reconstruction surgery.

PURPOSE: To assess the measurement properties (acceptability, validity, reliability and responsiveness), of the MOS 36-Item Short-Form Health Survey (SF-36), the EQ-5D, the Short-Form McGill Pain Questionnaire (SF-MPQ) and the Musculoskeletal Functional Assessment Instrument (MFA), in patients who have undergone limb reconstruction surgery (LRS). METHODS: Four instruments measuring patient-reported outcome were completed at baseline and 12 months from surgery. RESULTS: 101 LRS patients were recruited with 95 responding at baseline and 71 at a 12-month follow-up. Response rates at baseline were over 94%. In three instruments, there was evidence of floor or ceiling effect, the exception being the EQ-5D. Cronbach's α statistics of internal consistency reliability were acceptable at ≥ 0.80 for all dimensions of the MFA, the SF-MPQ PRI(S) and seven of the SF-36 dimensions. When comparing mean changes in scores between baseline and 12 months, the most responsive measure was the SF-36 with an average Standardised Response Mean of 0.48 for those who reported their health as better. Statistically significant differences were observed between the health change groups ('worse', 'better' and 'same') for four dimensions of the SF-36, the two summary scores and the SF-6D. CONCLUSIONS: Variation and poor performance of some of the instruments resulted in a recommendation of using the SF-36 and the SF-6D for LRS patients.

Universal prevention of depression in women postnatally: cluster randomized trial evidence in primary care.

BACKGROUND: To test whether receiving care from a health visitor (HV) trained in identification and psychological intervention methods prevents depression 6-18 months postnatally in women who are not depressed 6 weeks postnatally. METHOD: The study was a prospective cluster trial, randomized by GP practice, with follow-up for 18 months in 101 primary care teams in the Trent area of England. The participants were women scoring <12 on the postal Edinburgh Postnatal Depression Scale (EPDS) at 6 weeks postnatally (1474 intervention and 767 control women). Intervention HVs (n=89, 63 clusters) were trained in identifying depressive symptoms using the EPDS and face-to-face clinical assessment and in providing psychologically orientated sessions based on cognitive behavioral or person-centered principles. The control group comprised HVs (n=49, 37 clusters) providing care as usual (CAU). The primary outcome measure was the proportion of women scoring ≥ 12 on the EPDS at 6 months postnatally. Secondary outcomes were mean EPDS score, Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) score, State-Trait Anxiety Inventory (STAI), 12-item Short Form Health Survey (SF-12) and Parenting Stress Index Short Form (PSI-SF) scores at 6, 12 and 18 months. RESULTS: After adjusting for individual-level covariates, living alone, previous postnatal depression (PND), the presence of one or more adverse life events and the 6-week EPDS score, the odds ratio (OR) for EPDS ≥ 12 at 6 months was 0.71 [95% confidence interval (CI) 0.53-0.97, p=0.031] for the intervention group (IG) women compared with the control (CAU) group women. Two subgroups were formed by baseline severity: a 'subthreshold' subgroup with a 6-week EPDS score of 6-11 (n=999) and a 'lowest severity' subgroup with a 6-week EPDS score of 0-5 (n=1242). There was no difference in psychological effectiveness by subgroup (interaction term: z=-0.28, p=0.782). CONCLUSIONS: This study provides new evidence of a universal, enduring preventive effect for depression in women who screen negative for depression postnatally.

Assessing quality of care from hospital case notes: comparison of reliability of two methods.

OBJECTIVES: To determine which of the two methods of case note review provide the most useful and reliable information for reviewing quality of care. DESIGN: Retrospective, multiple reviews of 692 case notes were undertaken using both holistic (implicit) and criterion-based (explicit) review methods. Quality measures were evidence-based review criteria and a quality of care rating scale. SETTING: Nine randomly selected acute hospitals in England. PARTICIPANTS: Sixteen doctors, 11 specialist nurses and three clinically trained audit staff, and eight non-clinical audit staff. ANALYSIS METHODS: Intrarater consistency, inter-rater reliability between pairs of staff using intraclass correlation coefficients (ICCs), completeness of criterion data capture and between-staff group comparison. RESULTS: A total of 1473 holistic reviews and 1389 criterion-based reviews were undertaken. When the three same staff types reviewed the same record, holistic scale score inter-rater reliability was moderate within each group (ICC 0.46 to 0.52). Inter-rater reliability for criterion-based scores was moderate to good (ICC 0.61 to 0.88). Comparison of holistic review score and criterion-based score of case notes reviewed by doctors and by non-clinical audit staff showed a reasonable level of agreement between the two methods. CONCLUSIONS: Using a holistic approach to review case notes, same staff groups can achieve reasonable repeatability within their professional groups. When the same clinical record was reviewed twice by the doctors, and by the non-clinical audit staff, using both holistic and criterion-based methods, there are close similarities between the quality of care scores generated by the two methods. When using retrospective review of case notes to examine quality of care, a clear view is required of the purpose and the expected outputs of the project.

The views of older women towards mammographic screening: a qualitative and quantitative study.

BACKGROUND: Mammographic screening has improved breast cancer survival in the screened age group. This improved survival has not been seen in older women (>70 years) where screening uptake is low. This study explores the views, knowledge and attitudes of older women towards screening. METHODS: Women (>70 years) were interviewed about breast screening. Interview findings informed the development of a questionnaire that was sent to 1000 women (>70 years) to quantify their views regarding screening. RESULTS: Twenty-six women were interviewed and a questionnaire was designed. The questionnaire response rate was 48.3% (479 out of 992). Over half (52.9%, 241 out of 456) of the respondents were unaware that they could request a mammography by voluntary self-referral and were unaware how to arrange this. Most (81.5%, 383 out of 470) had not attended breast screening since turning 70 years. Most (75.6%, 343 out of 454) felt screening was beneficial and would attend if invited. Most (90.1%, 412 out of 457) felt screening should be offered to all women regardless of age or health. CONCLUSIONS: There is a lack of knowledge about screening in older women. The majority felt that invitation to screening should be extended to the older age group regardless of age or health. The current under-utilised system of voluntary self-referral is not supported by older women.

Comparison of case note review methods for evaluating quality and safety in health care.

OBJECTIVES: To determine which of two methods of case note review--holistic (implicit) and criterion-based (explicit)--provides the most useful and reliable information for quality and safety of care, and the level of agreement within and between groups of health-care professionals when they use the two methods to review the same record. To explore the process-outcome relationship between holistic and criterion-based quality-of-care measures and hospital-level outcome indicators. DATA SOURCES: Case notes of patients at randomly selected hospitals in England. REVIEW METHODS: In the first part of the study, retrospective multiple reviews of 684 case notes were undertaken at nine acute hospitals using both holistic and criterion-based review methods. Quality-of-care measures included evidence-based review criteria and a quality-of-care rating scale. Textual commentary on the quality of care was provided as a component of holistic review. Review teams comprised combinations of: doctors (n = 16), specialist nurses (n = 10) and clinically trained audit staff (n = 3) and non-clinical audit staff (n = 9). In the second part of the study, process (quality and safety) of care data were collected from the case notes of 1565 people with either chronic obstructive pulmonary disease (COPD) or heart failure in 20 hospitals. Doctors collected criterion-based data from case notes and used implicit review methods to derive textual comments on the quality of care provided and score the care overall. Data were analysed for intrarater consistency, inter-rater reliability between pairs of staff using intraclass correlation coefficients (ICCs) and completeness of criterion data capture, and comparisons were made within and between staff groups and between review methods. To explore the process-outcome relationship, a range of publicly available health-care indicator data were used as proxy outcomes in a multilevel analysis. RESULTS: Overall, 1473 holistic and 1389 criterion-based reviews were undertaken in the first part of the study. When same staff-type reviewer pairs/groups reviewed the same record, holistic scale score inter-rater reliability was moderate within each of the three staff groups [intraclass correlation coefficient (ICC) 0.46-0.52], and inter-rater reliability for criterion-based scores was moderate to good (ICC 0.61-0.88). When different staff-type pairs/groups reviewed the same record, agreement between the reviewer pairs/groups was weak to moderate for overall care (ICC 0.24-0.43). Comparison of holistic review score and criterion-based score of case notes reviewed by doctors and by non-clinical audit staff showed a reasonable level of agreement (p-values for difference 0.406 and 0.223, respectively), although results from all three staff types showed no overall level of agreement (p-value for difference 0.057). Detailed qualitative analysis of the textual data indicated that the three staff types tended to provide different forms of commentary on quality of care, although there was some overlap between some groups. In the process-outcome study there generally were high criterion-based scores for all hospitals, whereas there was more interhospital variation between the holistic review overall scale scores. Textual commentary on the quality of care verified the holistic scale scores. Differences among hospitals with regard to the relationship between mortality and quality of care were not statistically significant. CONCLUSIONS: Using the holistic approach, the three groups of staff appeared to interpret the recorded care differently when they each reviewed the same record. When the same clinical record was reviewed by doctors and non-clinical audit staff, there was no significant difference between the assessments of quality of care generated by the two groups. All three staff groups performed reasonably well when using criterion-based review, although the quality and type of information provided by doctors was of greater value. Therefore, when measuring quality of care from case notes, consideration needs to be given to the method of review, the type of staff undertaking the review, and the methods of analysis available to the review team. Review can be enhanced using a combination of both criterion-based and structured holistic methods with textual commentary, and variation in quality of care can best be identified from a combination of holistic scale scores and textual data review.

A randomised 2 x 2 trial of community versus hospital pulmonary rehabilitation, followed by telephone or conventional follow-up.

OBJECTIVES: To determine whether pulmonary rehabilitation carried out in a community setting is more effective than that carried out in a standard hospital setting and which is more cost-effective; also whether telephone follow-up is both cost-effective and useful in prolonging the beneficial effects of a pulmonary rehabilitation programme. DESIGN: A randomised trial. Participants were randomised in 2 x 2 factorial fashion to hospital or community rehabilitation and telephone or standard follow-up with review. SETTING: Hospitals or community sites in Sheffield. The community venues were selected to be close to public transport routes and have good parking and level access. The two hospital venues were the physiotherapy gym and a staff gym within the grounds of the hospital. PARTICIPANTS: Patients with chronic obstructive pulmonary disease diagnosed by respiratory physicians according to Global Initiative for Chronic Obstructive Lung Disease guidelines. INTERVENTIONS: Participants were randomised to one of four groups: hospital rehabilitation with no telephone follow-up; hospital rehabilitation with telephone follow-up; community rehabilitation with no telephone follow-up; or community rehabilitation with telephone follow-up. All were blinded to the telephone intervention arm until 1 month post rehabilitation, when only the assessment team and research participants were unblinded. MAIN OUTCOME MEASURES: The primary outcome measure was the difference in improvement in endurance shuttle walking test (ESWT) between hospital and community pulmonary rehabilitation groups post rehabilitation, and the difference in ESWT during 18 months' follow-up between those receiving telephone encouragement and those receiving standard care. A secondary measure was health-related quality of life. RESULTS: A total of 240 participants had evaluable data. Of these, 129 were randomised to hospital rehabilitation (64 with telephone follow-up and 65 with no telephone follow-up) and 111 to community rehabilitation (55 with telephone follow-up and 56 with no telephone follow-up). For the primary outcome measure, there were 162 patients with data for analysis: hospital rehabilitation with no telephone follow-up (n = 38); hospital rehabilitation with telephone follow-up (n = 48); community rehabilitation with no telephone follow-up (n = 43); and community rehabilitation with telephone follow-up (n = 33). For the acute phase post-rehabilitation outcomes, before patients had the opportunity for telephone follow-up, we compared outcomes between the 76 patients in the community rehabilitation group and the 86 patients in the hospital rehabilitation group. Patients in the hospital rehabilitation group increased the distance they could walk at the post-rehabilitation follow-up by 283 m (SD 360 m), an increase relative to baseline of 109% (SD 137%). Patients in the community rehabilitation group increased the distance they could walk at the post-rehabilitation follow-up by 216 m (SD 340 m), an increase relative to baseline of 91% (SD 133%). There was no statistically significant difference between the groups [17.8% (95% CI -24.3 to 59.9, p = 0.405)]. For longer term outcomes at 6, 12 and 18 months post rehabilitation there was no evidence of a rehabilitation group effect. After allowing for the initial post-rehabilitation baseline distance walked, time (follow-up visit) and the factorial design (telephone follow-up group), the average difference in the post-rehabilitation follow-up distance walked on the ESWT between the hospital and community rehabilitation groups was 1.5 m (95% CI -82.1 to 97.2, p = 0.971), and between the telephone and no-telephone groups it was 56.9 m (95% CI -25.2 to 139, p = 0.174). There was no difference between hospital or community groups in terms of acute effect or persistence of effect. Health economic analysis favoured neither hospital nor community settings, nor did it clearly favour telephone follow-up or routine care. CONCLUSIONS: Pulmonary rehabilitation delivered in a community setting has similar efficacy to that produced in a more traditional hospital-based setting, both settings producing significant improvements in terms of exercise capacity and quality of life acutely and after long-term follow-up. Health economic analysis showed that neither hospital nor community programmes were greatly favoured. The choice of model will depend on local factors of convenience, existing availability of resources and incremental costs. Staff characteristics may be important in gaining optimal outcome, and care should be taken in staff recruitment and training. TRIAL REGISTRATION: Current Controlled Trials ISRCTN86821773.

Follow-up care for cancer survivors: views of the younger adult.

BACKGROUND: Since the launch of the National Cancer Survivorship Initiative, there has been a surge of interest surrounding the value and organisation of long-term follow-up care after cancer treatment. We report the views of 309 adult cancer survivors (aged 18-45 years) on provision of follow-up and preferences for care. METHODS: A total of 207 survivors completed questionnaires before and after routine consultant-led follow-up appointments and 102 were recruited by post. Measures of health status (including late effects, perceived vulnerability to late effects and quality of life), reasons for attending follow-up (clinical and supportive), issues to be discussed at follow-up and preferences for different models of care were assessed. RESULTS: In all, 59% of the survivors reported experiencing one or more cancer-related health problems. Survivors rated clinical reasons for attending follow-up more highly than supportive reasons (P<0.001), although nutritional advice and counselling were considered useful (60 and 47%, respectively). Those still receiving scheduled follow-up appointments did not discuss the range of issues intended with 'late effects' and 'fertility', which were particularly under-discussed. Hospital rather than GP follow-up was more highly rated. CONCLUSION: Survivors value the clinical reassurance currently provided by consultant-led care. However, supportive needs are not systematically addressed. Multi-disciplinary services are recommended to meet supportive needs in addition to clinical care.