Computerised analysis of intrapartum fetal heart rate patterns and adverse outcomes in the INFANT trial.

OBJECTIVE: To assess if a computerised decision support system reliably identified abnormal fetal heart rate (FHR) patterns in fetuses with adverse neonatal outcomes in the INFANT trial, and whether its use reduced substandard care. DESIGN: Prospective cohort study within a randomised controlled trial. SETTING: Twenty-four maternity units in the UK and Ireland. POPULATION OR SAMPLE: A total of 46 614 labours between January 6 2010 and August 31 2013 in the INFANT trial. METHODS: Panel review of intrapartum and neonatal care in infants with adverse outcome, and an assessment of the effectiveness of computerised interpretation of fetal heart rate in reducing substandard care. Descriptive analysis of other factors associated with adverse outcome. MAIN OUTCOME MEASURES: Incidence and detection rate of abnormal fetal heart rate patterns, other characteristics associated with perinatal adverse outcome, and frequency of substandard care. RESULTS: Computer interpretation of FHR patterns was deemed to be completely valid in only 24 of 71 (33.8%) cases of adverse outcome. On a scale of 0-10 (completely invalid to completely valid), 28 cases (39.4%) had a score of 6 or less, mainly due to lack of recognition of decelerations (15 cases), or reduced variability (seven cases), or failure to recognise tachysystole (five cases). There were multiple associated factors that modified the clinical assessment of FHR patterns. There was substandard care in 45/71 cases (63%). CONCLUSION: A significant proportion of abnormal fetal heart rate patterns were not detected accurately by computer analysis, and its use did not reduce the incidence of substandard care. FUNDING: UK National Institute for Health Research Health Technology Assessment Programme (project number 06.38.01). TWEETABLE ABSTRACT: Improved recognition of abnormal fetal heart rate patterns is insufficient to reduce the incidence of substandard care.

Perinatal and maternal outcomes in planned home and obstetric unit births in women at 'higher risk' of complications: secondary analysis of the Birthplace national prospective cohort study.

OBJECTIVE: To explore and compare perinatal and maternal outcomes in women at 'higher risk' of complications planning home versus obstetric unit (OU) birth. DESIGN: Prospective cohort study. SETTING: OUs and planned home births in England. POPULATION: 8180 'higher risk' women in the Birthplace cohort. METHODS: We used Poisson regression to calculate relative risks adjusted for maternal characteristics. Sensitivity analyses explored possible effects of differences in risk between groups and alternative outcome measures. MAIN OUTCOME MEASURES: Composite perinatal outcome measure encompassing 'intrapartum related mortality and morbidity' (intrapartum stillbirth, early neonatal death, neonatal encephalopathy, meconium aspiration syndrome, brachial plexus injury, fractured humerus or clavicle) and neonatal admission within 48 hours for more than 48 hours. Two composite maternal outcome measures capturing intrapartum interventions/adverse maternal outcomes and straightforward birth. RESULTS: The risk of 'intrapartum related mortality and morbidity' or neonatal admission for more than 48 hours was lower in planned home births than planned OU births [adjusted relative risks (RR) 0.50, 95% CI 0.31-0.81]. Adjustment for clinical risk factors did not materially affect this finding. The direction of effect was reversed for the more restricted outcome measure 'intrapartum related mortality and morbidity' (RR adjusted for parity 1.92, 95% CI 0.97-3.80). Maternal interventions were lower in planned home births. CONCLUSIONS: The babies of 'higher risk' women who plan birth in an OU appear more likely to be admitted to neonatal care than those whose mothers plan birth at home, but it is unclear if this reflects a real difference in morbidity. Rates of intrapartum related morbidity and mortality did not differ statistically significantly between settings at the 5% level but a larger study would be required to rule out a clinically important difference between the groups.

The impact of maternal obesity on intrapartum outcomes in otherwise low risk women: secondary analysis of the Birthplace national prospective cohort study.

OBJECTIVES: To evaluate the impact of maternal BMI on intrapartum interventions and adverse outcomes that may influence choice of planned birth setting in healthy women without additional risk factors. DESIGN: Prospective cohort study. SETTING: Stratified random sample of English obstetric units. SAMPLE: 17,230 women without medical or obstetric risk factors other than obesity. METHODS: Multivariable log Poisson regression was used to evaluate the effect of BMI on risk of intrapartum interventions and adverse maternal and perinatal outcomes adjusted for maternal characteristics. MAIN OUTCOME MEASURES: Maternal intervention or adverse outcomes requiring obstetric care (composite of: augmentation, instrumental delivery, intrapartum caesarean section, general anaesthesia, blood transfusion, 3rd/4th degree perineal tear); neonatal unit admission or perinatal death. RESULTS: In otherwise healthy women, obesity was associated with an increased risk of augmentation, intrapartum caesarean section and some adverse maternal outcomes but when interventions and outcomes requiring obstetric care were considered together, the magnitude of the increased risk was modest (adjusted RR 1.12, 95% CI 1.02-1.23, for BMI > 35 kg/m(2) relative to low risk women of normal weight). Nulliparous low risk women of normal weight had higher absolute risks and were more likely to require obstetric intervention or care than otherwise healthy multiparous women with BMI > 35 kg/m(2) (maternal composite outcome: 53% versus 21%). The perinatal composite outcome exhibited a similar pattern. CONCLUSIONS: Otherwise healthy multiparous obese women may have lower intrapartum risks than previously appreciated. BMI should be considered in conjunction with parity when assessing the potential risks associated with birth in non-obstetric unit settings.

A promoting early presentation intervention increases breast cancer awareness in older women after 2 years: a randomised controlled trial.

BACKGROUND: We have developed the Promoting Early Presentation (PEP) Intervention to equip older women with the knowledge, skills, confidence and motivation to present promptly with breast symptoms, and thereby improve survival from breast cancer. The PEP Intervention consists of a 10-min interaction between a radiographer and an older woman, supported by a booklet. Our previous report showed that at 1 year, the PEP intervention increased the proportion who were breast cancer aware compared with usual care. METHODS: We randomised 867 women aged 67-70 years attending for their final routine appointment on the National Health Service Breast Screening Programme to receive the PEP Intervention, a booklet alone or usual care. The primary outcome was breast cancer awareness measured using a validated questionnaire asking about knowledge of breast cancer symptoms, knowledge that the risk of breast cancer increases with age and breast checking behaviour. RESULTS: At 2 years, the PEP Intervention increased the proportion who were breast cancer aware compared with usual care (21 vs 6%; odds ratio 8.1, 95% confidence interval 2.7-25.0). CONCLUSIONS: The uniquely large and sustained effect of the PEP Intervention on breast cancer awareness increases the likelihood that a woman will present promptly should she develop breast cancer symptoms up to many years later.

A randomised controlled trial of an intervention to promote early presentation of breast cancer in older women: effect on breast cancer awareness.

BACKGROUND: There is virtually no evidence for the effectiveness of interventions to promote early presentation in breast cancer. We aimed to test the efficacy of an intervention to equip older women with the knowledge, skills, confidence and motivation to detect symptoms and seek help promptly, with the aim of promoting early presentation with breast cancer symptoms. METHODS: We randomised 867 women aged 67-70 years attending for their final routine appointment on the UK NHS Breast Screening Programme to receive: a scripted 10-min interaction with a radiographer plus a booklet, a booklet alone or usual care. The primary outcome was whether or not a woman was breast cancer aware based on knowledge of breast cancer symptoms and age-related risk, and reported breast checking. RESULTS: At 1 month, the intervention increased the proportion who were breast cancer aware compared with usual care (interaction arm: 32.8% vs 4.1%; odds ratio (OR): 24.0, 95% confidence interval (CI): 7.7-73.7; booklet arm: 12.7% vs 4.1%; OR: 4.4, 95% CI: 1.6-12.0). At 1 year, the effects of the interaction plus booklet, and the booklet, on breast cancer awareness were largely sustained, although the interaction plus booklet remained much more effective. CONCLUSIONS: An intervention to equip older women with the knowledge, skills, confidence and motivation to detect breast cancer symptoms and seek help promptly increases breast cancer awareness at 1 year. Future research will evaluate whether the intervention promotes early presentation and reduces breast cancer mortality.

Informational needs of patients with melanoma and their views on the utility of investigative tests.

BACKGROUND: The aim of the study was to identify the informational needs of patients with melanoma on disease status and prognosis, and to ascertain their views on the utility of positron emission tomography (PET) and sentinel node biopsy (SNB). PATIENTS AND METHODS: Patients attending the weekly melanoma outpatient clinic at St Thomas' Hospital London UK between February and August 2007 participated in this cross-sectional survey. Views of 106 melanoma patients were elicited using a face-to face semi-structured questionnaire. RESULTS: The majority of participants wanted to know everything about their disease (88%). Prognostic information (> 85%) and information on palliative care input (97%) were highly valued. More than 50% expected the doctor to impart this information without negotiation. Nearly 70% of the responders who had previously had a PET scan felt they should decide if and when the scans should be performed. Fifty three percentage had undergone the SNB because the doctor had suggested it. CONCLUSIONS: Patients with melanoma want detailed and prompt information about their disease including prognosis. Regular PET scans provide reassurance. The role of SNB is not clear to all patients.

Mortality in British military participants in human experimental research into chemical warfare agents at Porton Down: cohort study.

OBJECTIVE: To investigate any long term effects on mortality in participants in experimental research related to chemical warfare agents from 1941 to 1989. DESIGN: Historical cohort study. Data sources Archive of UK government research facility at Porton Down, UK military personnel records, and national death and cancer records. Participants 18,276 male members of the UK armed forces who had spent one or more short periods (median 4 days between first and last test) at Porton Down and a comparison group of 17,600 non-Porton Down veterans followed to 31 December 2004. MAIN OUTCOME MEASURES: Mortality rate ratio of Porton Down compared with non-Porton Down veterans and standardised mortality ratio of each veteran group compared with the general population. Both ratios adjusted for age group and calendar period. RESULTS: Porton Down veterans were similar to non-Porton Down veterans in year of enlistment (median 1951) but had longer military service (median 6.2 v 5.0 years). After a median follow-up of 43 years, 40% (7306) of Porton Down and 39% (6900) of non-Porton Down veterans had died. All cause mortality was slightly greater in Porton Down veterans (rate ratio 1.06, 95% confidence interval 1.03 to 1.10, P<0.001), more so for deaths outside the UK (1.26, 1.09 to 1.46). Of 12 cause specific groups examined, rate ratios in Porton Down veterans were increased for deaths attributed to infectious and parasitic (1.57, 1.07 to 2.29), genitourinary (1.46, 1.04 to 2.04), circulatory (1.07, 1.01 to 1.12), and external (non-medical) (1.17, 1.00 to 1.37) causes and decreased for deaths attributed to in situ, benign, and unspecified neoplasms (0.60, 0.37 to 0.99). There was no clear relation between type of chemical exposure and cause specific mortality. The mortality in both groups of veterans was lower than that in the general population (standardised mortality ratio 0.88, 0.85 to 0.90; 0.82, 0.80 to 0.84). CONCLUSIONS: Mortality was slightly higher in Porton Down than non-Porton Down veterans. With lack of information on other important factors, such as smoking or service overseas, it is not possible to attribute the small excess mortality to chemical exposures at Porton Down.

Cancer morbidity in British military veterans included in chemical warfare agent experiments at Porton Down: cohort study.

OBJECTIVE: To determine cancer morbidity in members of the armed forces who took part in tests of chemical warfare agents from 1941 to 1989. DESIGN: Historical cohort study, with cohort members followed up to December 2004. DATA SOURCE: Archive of UK government research facility at Porton Down, UK military personnel records, and national death and cancer records. PARTICIPANTS: All veterans included in the cohort study of mortality, excluding those known to have died or been lost to follow-up before 1 January 1971 when the UK cancer registration system commenced: 17,013 male members of the UK armed forces who took part in tests (Porton Down veterans) and a similar group of 16,520 men who did not (non-Porton Down veterans). MAIN OUTCOME MEASURES: Cancer morbidity in each group of veterans; rate ratios, with 95% confidence intervals, adjusted for age group and calendar period. RESULTS: 3457 cancers were reported in the Porton Down veterans compared with 3380 cancers in the non-Porton Down veterans. While overall cancer morbidity was the same in both groups (rate ratio 1.00, 95% confidence interval 0.95 to 1.05), Porton Down veterans had higher rates of ill defined malignant neoplasms (1.12, 1.02 to 1.22), in situ neoplasms (1.45, 1.06 to 2.00), and those of uncertain or unknown behaviour (1.32, 1.01 to 1.73). CONCLUSION: Overall cancer morbidity in Porton Down veterans was no different from that in non-Porton Down veterans.

Exposures recorded for participants in the UK Chemical Warfare Agent Human Research Programme, 1941-1989.

OBJECTIVES: This study describes exposures to military veterans who participated between 1941 and 1989 in British research at Porton Down on the effects of exposure to chemical warfare agents and to defences against those agents. The study is part of a programme of epidemiological research initiated in response to service veterans' concerns about possible long-term health effects of their participation. METHODS: All entries in 97 books held in the Porton Down historical experimental archive covering the years 1939-1989 were reviewed. For tests between April 1941 and December 1989, data were abstracted on chemicals used, with additional detail abstracted for tests involving vesicants and nerve agents. For tests recorded during 1939-1941, similar data were abstracted for a representative sample of tests. RESULTS: Historical data were abstracted for 17 303 veterans included in the cohort study of 18,276 servicemen who took part in tests at Porton Down between 1941 and 1989. The median number of days per veteran on which tests were carried out was 2 days. The median difference between the last and first day of testing was 4 days. A large number of chemicals were tested over this period (n = 492). The type of chemical tested varied over time. Exposures were often modified by respirator use or use of protective clothing or protective equipment. It was possible to assign a quantitative measure of cumulative exposure to 73% of veterans exposed to the vesicant sulphur mustard--3491 (34%) of exposed veterans had cumulative exposures > or =10.63 mg and for 70% of veterans exposed to the nerve agent sarin--658 (29%) of exposed veterans had cumulative exposures > or =15.0 mg min m(-3). Ninety-three per cent of veterans exposed to sulphur mustard were classified to a semi-quantitative scale of dermal effect--3771 (37%) had a vesicle or necrosed area, and 69% of veterans exposed to sarin could be categorized by change in blood cholinesterase activity--1033 (31%) had a depression in cholinesterase activity of > or =30%. CONCLUSIONS: The experimental archive at Porton Down has proved to be a rich source of data on tests conducted between 1941 and 1989. It has been possible to categorize most veterans according to date of test, chemical group, chemical, type of protection and, for certain chemicals, level of exposure and/or degree of acute toxicity. These categorizations have been used to assign veterans to exposure groups for epidemiological analysis.

Breast cancer awareness among older women.

The aim of this study was to elicit the level of breast cancer awareness in older women. A cross-sectional study-specific questionnaire survey of 712 British women aged 67-73 years (response rate 83.8%), assessing knowledge of symptoms and risk and confidence to detect a change, was conducted. Over 85% of respondents were aware that a lump was a symptom of breast cancer but knowledge of non-lump symptoms was limited. Knowledge of risk was poor; 50% believed that the lifetime risk of developing breast cancer was less than 1 in 100 women and 75% were not aware that age is a risk factor. Thirty-one percent of women reported low levels of confidence to detect a breast change and 19% rarely or never checked their breasts. Those with fewer educational qualifications had poorer knowledge of symptoms, less awareness of lifetime and age-related risks, but were more likely to check their breasts than more highly educated women. This national survey demonstrates a significant lack of the prerequisite knowledge and confidence to detect a breast change. Raising breast cancer awareness and promoting early presentation among older women is important, as they are more at risk of breast cancer and more likely to delay seeking help with breast cancer symptoms than younger women.

Effectiveness of a three-day communication skills course in changing nurses' communication skills with cancer/palliative care patients: a randomised controlled trial.

This multi-centre, two-armed parallel-group pragmatic randomised controlled trial (RCT) evaluated the effectiveness of a 3-day communication skills course in changing nurses' communication skills. The primary outcome was the change in the nurses' communication skills score from pre-course to 12 weeks post-course. The main secondary outcome was the change in the nurses' level of confidence in communicating with patients. A total of 172 nurses were randomised to the course or control. The communication skills score for the intervention group increased by 3.4 points post-course but decreased in the control by 0.05 points (between-group difference in change: 3.41, 95% CI: 2.16-4.66, P < 0.001). Confidence scores increased by 18.16 points for the intervention group but decreased 0.7 points in the control (between-group difference in change: 18.86, 95% CI: 13.39-24.34, P < 0.001). This RCT contributes to the evidence base on the effectiveness of communication skills training in cancer and palliative care.

Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral.

OBJECTIVES: To estimate the national prevalence and incidence of adults consulting for a shoulder condition and to investigate patterns of diagnosis, treatment, consultation and referral 3 yr after initial presentation. METHODS: Prevalence and incidence rates were estimated for 658469 patients aged 18 and over in the year 2000 using a primary care database, the IMS Disease Analyzer-Mediplus UK. A cohort of 9215 incident cases was followed-up prospectively for 3 yr beyond the initial consultation. RESULTS: The annual prevalence and incidence of people consulting for a shoulder condition was 2.36% [95% confidence interval (CI) 2.32-2.40%] and 1.47% (95% CI 1.44-1.50%), respectively. Prevalence increased linearly with age whilst incidence peaked at around 50 yr then remained static at around 2%. Around half of the incident cases consulted once only, while 13.6% were still consulting with a shoulder problem during the third year of follow-up. During the 3 yr following initial presentation, 22.4% of patients were referred to secondary care, 30.8% were prescribed non-steroidal anti-inflammatory drugs and 10.6% were given an injection by their general practitioner (GP). GPs tended to use a limited number of generalized codes when recording a diagnosis; just five of 426 possible Read codes relating to shoulder conditions accounted for 74.6% of the diagnoses of new cases recorded by GPs. CONCLUSIONS: The prevalence of people consulting for shoulder problems in primary care is substantially lower than community-based estimates of shoulder pain. Most referrals occur within 3 months of initial presentation, but only a minority of patients are referred to orthopaedic specialists or rheumatologists. GPs may lack confidence in applying precise diagnoses to shoulder conditions.

Assessment of the Lequesne index of severity for osteoarthritis of the hip in an elderly population.

OBJECTIVE: To assess the measurement properties of the Lequesne index of severity for osteoarthritis of the hip (LISOH) together with its overall usefulness with reference to the original stated aims. METHOD: Postal questionnaire was sent to a random sample of 5500 Oxfordshire residents, aged 65 and above. Respondents with hip symptoms at baseline (but without verification of a diagnosis) were sent an identical follow-up questionnaire 12 months later. The questionnaire included a general health section, including the Short Form-36 survey, and a hip section which began with a screening question about hip pain. Respondents who reported having a prolonged episode of hip pain were asked to complete the LISOH. RESULTS: At baseline, response rate of 66.3% (3341/5039) was obtained from eligible participants; 19.2% (610/3175) of respondents reported having hip pain. Internal reliability (Cronbach's alpha) was 0.84 (95% CI: 0.81-0.86) for all 11 items of the LISOH; however, factor analysis identified two factors (sub-scales): "function and mobility" and "pain and discomfort". Rasch analysis revealed that the two factors were only unidimensional when applied to sub-groups of respondents. Convergent validity of the LISOH was questionable, as the "function and mobility" factor was more highly correlated with SF-36 bodily pain score than was the "pain and discomfort" factor. The assessment of sensitivity over time was problematic due to changing patterns of symptomatic weight-bearing joints over time. CONCLUSIONS: The current study identifies major limitations with the LISOH--particularly if used as a single composite measure.

A case-control study of sporadic Creutzfeldt-Jakob disease in the United Kingdom: analysis of clustering.

BACKGROUND: The authors investigated whether cases of sporadic Creutzfeldt-Jakob disease (CJD) had lived closer to one another at some time in life than individuals without sporadic CJD. Such a phenomenon would be compatible with some cases resulting from transmission. METHODS: UK sporadic CJD cases occurring from 1990 to 1998 were identified. Age-, sex- and hospital-matched controls were recruited. Lifetime residential histories were obtained by interview, usually with a proxy respondent. With use of Monte Carlo simulation, the residential proximity of cases during various time periods was compared with that expected in the absence of any clustering, using the information collected on the controls. RESULTS: Two hundred twenty sporadic CJD disease cases and 220 controls were included. Cases lived closer together than might be expected in the absence of any disease-clustering mechanism. This evidence became stronger as the critical period during which residential proximity was required to have occurred extended further into the past. CONCLUSIONS: These findings are consistent with some sporadic Creutzfeldt-Jakob disease (CJD) cases resulting from exposure to a common external factor. The rarity of sporadic CJD suggests that repeated point-source outbreaks of infection are more likely to explain our observations than direct case-to-case transmission. Identifying sources of such outbreaks many years after the event will be extremely difficult.

Epidemiology of hip and knee pain and its impact on overall health status in older adults.

OBJECTIVES: To obtain prevalence rates of hip and knee pain in elderly people and compare combinations of symptoms with overall health status. METHODS: We performed a cross-sectional postal survey of a random sample of 5500 Oxfordshire residents aged 65 yr and older. Prevalence estimates were based on the screening question: 'During the past 12 months, have you had pain in or around either of your hip/knee joints on most days for one month or longer?' Overall health status was assessed with the SF-36 questionnaire. RESULTS: The response rate was 66.3% (3341/5039 eligible people), and was highest (approximately reverse similar 72%) for the 65-74 yr age-group. The percentage reporting hip pain was 19.2% [95% confidence interval (CI) 17.9-20.6], and 32.6% (95% CI 31.0-34.3) reported knee pain. The percentage reporting hip and knee pain was 11.3%, and 40.7% reported hip or knee pain. Less than half (48%) of the symptomatic respondents had unilateral problems affecting one hip or knee joint only. SF-36 scores worsened as the number of symptomatic hip and knee joints increased (P<0.001 for physical function, physical role limitation and bodily pain). CONCLUSIONS: Patterns of hip and knee symptoms are complex in older people. Amongst the symptomatic, most have more than one hip/knee affected. This has implications for treatment and health status measurement. In the absence of hip and knee symptoms, general health status scores of elderly people are similar to those of people aged under 65 yr.

Geographical distribution of variant CJD in the UK (excluding Northern Ireland).

BACKGROUND: The agent that causes variant Creutzfeldt-Jakob disease (variant CJD) is indistinguishable from the causative agent of bovine spongiform encephalopathy (BSE). The transmission route by which human beings are infected has not been established. One hypothesis is that cases of variant CJD have resulted from exposure to the BSE agent via rendering plants involved in the production of meat and bone meal, the main vehicle of the BSE epidemic. METHODS: We identified cases of variant CJD through the National CJD Surveillance Unit, and obtained lifetime residential histories of cases by interviewing a relative. The addresses of all rendering plants in the UK (excluding Northern Ireland) in production in 1988 were available from a survey done in that year. We calculated the distance between each case's place of residence on Jan 1, 1988, and the nearest rendering plant from postcode data, and used data from the 1991 UK census to estimate the population living within various distances of rendering plants. We compared the observed number of cases of variant CJD within a particular distance of a rendering plant with the number expected if there is no association between residential proximity to a rendering plant and the risk of developing variant CJD. FINDINGS: Up to Aug 31, 1998, 26 cases of variant CJD with onset in the UK (Northern Ireland not included) had been identified. The observed and expected numbers of variant CJD cases living within a specified distance of any rendering plant up to 50 km were almost the same. Two plants in the county of Kent each had four cases within 50 km in 1988, significantly more cases than expected (plant A, 1.04 expected; plant B, 0.74 expected). Multiple significance tests were done, so some tests would be expected to appear significant by chance alone. Computer simulations suggested that the observation of four cases of variant CJD living in an area with a population of 1.5 million (the size of Kent) is not unexpected. INTERPRETATION: There is no evidence that people with variant CJD tended to live closer than the population as a whole to rendering plants in the 1980s. The reported cluster of variant CJD cases in Kent is most probably a chance finding.