Optimising informed consent for participants in a randomised controlled trial in rural Uganda: a comparative prospective cohort mixed-methods study.

BACKGROUND: Poor participant understanding of research information can be a problem in community interventional studies with rural African women, whose levels of illiteracy are high. This study aimed to improve the informed consent process for women living in rural eastern Uganda. We assessed the impact of alternative consent models on participants' understanding of clinical trial information and their contribution to the informed consent process in rural Uganda. METHODS: The study applied a parallel mixed-methods design for a prospective comparative cohort, nested within a pilot study on the community distribution of an alcohol-based hand rub to prevent neonatal sepsis (BabyGel pilot trial). Women of at least 34 weeks' pregnancy, suitable for inclusion in the BabyGel pilot trial, were recruited into this study from their homes in 13 villages in Mbale District. As part of the informed consent process, information about the trial was presented using one of three consent methods: standard researcher-read information, a slide show using illustrated text on a flip chart or a video showing the patient information being read as if by a newsreader in either English or the local language. In addition, all women received the patient information sheet in their preferred language. Each information-giving method was used in recruitment for 1 week. Two days after recruitment, women's understanding of the clinical trial was evaluated using the modified Quality of Informed Consent (QuIC) tool. They were also shown the other two methods and their preference assessed using a 5-point Likert scale. Semi-structured interviews were administered to each participant. The interviews were audio-recorded, transcribed and translated verbatim, and thematically analysed. RESULTS: A total of 30 pregnant women in their homes participated in this study. Their recall of the trial information within the planned 48 h was assessed for the majority (90%, 27/30). For all three consent models, women demonstrated a high understanding of the study. There was no statistically significant difference between the slide-show message (mean 4.7; standard deviation, SD 0.47; range 4-5), video message (mean 4.9; SD 0.33; range 4-5) and standard method (mean 4.5; SD 0.53; range 4-5; all one-way ANOVA, p = 0.190). The slide-show message resulted in the most objective understanding of question items with the highest average QuIC score of 100 points. For women who had been recruited using any of the three models, the slide show was the most popular method, with a mean score for all items of not less than 4.2 (mean 4.8; SD 0.6; range 4-5). Most women (63%, 19/30) preferred the slide-show message, compared with 17% (5/30) and 20% (6/30) for the standard and video messages, respectively. The reasons given included the benefits of having pictures to aid understanding and the logical progression of the information. CONCLUSION: Our results from this small study suggest that slide-show messages may be an effective and popular alternative way of presenting trial information to women in rural Uganda, many of whom have little or no literacy. TRIAL REGISTRATION: ISRCTN, ISRCTN67852437 . Registered on 18 March 2018.

Preventing neonatal sepsis in rural Uganda: a cross-over study comparing the tolerance and acceptability of three alcohol-based hand rub formulations.

BACKGROUND: Neonatal sepsis causes 0.5 million deaths annually, mostly in low resource settings. Babies born in African rural homes without running water or toilet facilities are especially vulnerable. Alcohol-based hand rub (ABHR) may be used by mothers and carers as an alternative to hand washing with soap to prevent neonatal infection. However, no definite study has established the preferred formulation of hand rub for the mothers. This study aimed to assess the effects of addition of bitterants and perfume towards the acceptability of the alcohol-based hand rubs by the mothers in their homes after childbirth. METHODS: This was a 3-way blinded cross-over study design. Mothers with children aged ≤3 months were recruited from immunisation clinics at 3 local health facilities in rural eastern Uganda and received 3-different ABHR formulations (in the order plain, bitterant and perfumed) packed in 100 ml bottles. Each ABHR was used for 5 consecutive days followed by a 2-day 'washout' period (evaluation period). Overall satisfaction with each hand rub was evaluated at the end of each week using a 7-point Likert scale. RESULTS: A total of 43 women were recruited, whose ages ranged from 16 to 45 years (mean 26.2 years old). None of the participants normally used a hand protective lotion/cream. The three formulations were used for a mean of 5 (range 3-7) days. A significantly greater volume of the "bitterant" and "perfumed" formulations (mean 91 and 83 ml respectively) were used in comparison to the "plain" formulation (mean 64 ml). Overall satisfaction was high with all the hand rubs, but the perfumed formulation had a significantly higher overall satisfaction score [mean 6.7, range 4-7] compared with the plain [6.4, 3-7] and bitterant [6.2, 2-7] formulations. CONCLUSIONS: All the 3 ABHR formulations were well accepted with little to choose between them. The ABHR with added perfume scored highest on overall satisfaction and was used significantly more often than plain ABHR. ABHR with bitterant additive did, however, score highly and may be a preferable choice to those with concern over alcohol misuse. TRIAL REGISTRATION: ISRCTN67852437 , prospectively registered on 18/03/2018.

Foley catheter vs. oral misoprostol to induce labour among hypertensive women in India: a cost-consequence analysis alongside a clinical trial.

OBJECTIVE: To determine the effectiveness and economic impact of two methods for induction of labour in hypertensive women, in low-resource settings. DESIGN: Cost-consequence analysis of a previously reported multicentre, parallel, open-label randomised trial. SETTING & POPULATION: A total of 602 women with a live fetus, aged ≥18 years requiring delivery for pre-eclampsia or hypertension, in two public hospitals in Nagpur, India. METHODS: We performed a formal economic evaluation alongside the INFORM clinical trial. Women were randomised to receive transcervical Foley catheterisation or oral misoprostol 25 mcg. Healthcare expenditure was calculated using a provider-side microcosting approach. MAIN OUTCOME MEASURES: Rates of vaginal this delivery within 24 hours of induction, healthcare expenditure per completed treatment episode. RESULTS: Induction with oral misoprostol resulted in a (mean difference) $20.6USD reduction in healthcare expenditure [95% CI (-) $123.59 (-) $72.49], and improved achievement of vaginal delivery within 24 hours of induction, mean difference 10% [95% CI (-2 to 17.9%), P = 0.016]. Oxytocin administration time was reduced by 135.3 minutes [95% CI (84.4-186.2 minutes), P < 0.01] and caesarean sections by 9.1% [95% CI (1.1-17%), P = 0.025] for those receiving oral misoprostol. Following probabilistic sensitivity analysis, oral misoprostol was cost-saving in 63% of 5,000 bootstrap replications and achieved superior rates of vaginal delivery, delivery within 24 hours of induction and vaginal delivery within 24 hours of induction in 98.7%, 90.7%, and 99.4% of bootstrap simulations. Based on univariate threshold analysis, the unit price of oral misoprostol 25 mcg could feasibly increase 31-fold from $0.24 to $7.50 per 25 mcg tablet and remain cost-saving. CONCLUSION: Compared to Foley catheterisation for the induction of high-risk hypertensive women, oral misoprostol improves rates of vaginal delivery within 24 hours of induction and may also reduce costs. Additional research performed in other low-resource settings is required to determine their relative cost-effectiveness. TWEETABLE ABSTRACT: Oral misoprostol less costly and more effective than Foley catheter for labour induction in hypertension.

The Griffiths Development Scales-Chinese (GDS-C): A cross-cultural comparison of developmental trajectories between Chinese and British children.

BACKGROUND: The Griffiths Mental Development Scales (GMDS) are used in many countries to assess the development of children from birth to 8 years. There is a need for accurate and culturally appropriate developmental assessment tools for Chinese children. Here, we adapted the GMDS for use in Chinese children and compare the developmental trajectories between Chinese and British children. METHODS: Children with typical development were recruited from 7 urban cities in China between 2009 and 2013. The Griffiths Mental Development Scales-Chinese (GDS-C) were adapted and used to assess the development of urban Chinese children. Developmental curves were computed for 6 subscales using learning management system methods and compare against the British curves from the Griffiths Mental Development Scales-Extended Revised (GMDS-ER). RESULTS: The GDS-C were used to assess the developmental status of 815 Chinese children. Plots of the 1st, 5th, 10th, 25th, 50th, 75th, 90th, 95th, and 99th percentiles, and full percentile tables were obtained, which showed similar trends to data from the British GMDS-ER. CONCLUSIONS: The Chinese developmental curves obtained from the GDS-C showed similarities and differences to the developmental curves from the British GMDS-ER. The development of urban Chinese children should be assessed with the culturally appropriate GDS-C.

Post-acute serum eosinophil and neutrophil-associated cytokine/chemokine profile can distinguish between patients with neuromyelitis optica and multiple sclerosis; and identifies potential pathophysiological mechanisms - a pilot study.

Neuromelitis optica (NMO) is an inflammatory, demyelinating disease of the central nervous system. It is distinguished from multiple sclerosis (MS) by clinical and radiological features and the presence of aquaporin 4 antibodies in approximately 70%. Despite the discovery of these antibodies and the evidence of neutrophils and eosinophils in the CNS parenchyma, the immunopathogenesis of NMO remains poorly understood. Previous studies attempting to assess the role cytokines and chemokines in NMO have primarily been conducted in acute cerebrospinal fluid from East Asian cohorts, have assessed small numbers of mediators in isolation and have not accounted for important confounding factors including antibody status and disease severity. Therefore we conducted a study of a more extensive range of cytokines and associated mediators in post-acute serum from a UK cohort using unsupervised and multivariate analytical techniques to assess the relative concentration of mediators in concert. Our study of 29 patients (aquaporin 4 antibody positive NMO n=19, MS n=10), matched where possible, including for disease severity, has identified and confirmed some key cytokine/chemokine markers in NMO distinct from MS. Our findings shed further light on the importance of specific inflammatory mediators with predominant function in the differentiation, chemotaxis and activity of neutrophils and eosinophils, particularly CCL4, CCL11, granulocyte-colony stimulating factor and myeloperoxidase, and these may represent potential immunomodulatory targets.

A case-control study of nutritional factors associated with chronic suppurative otitis media in Yemeni children.

BACKGROUND/OBJECTIVES: Undernutrition and chronic suppurative otitis media (CSOM) in children are common in low resource settings, but there are few studies of their interactions. The aim is to evaluate nutritional factors associated with CSOM in Yemeni children. SUBJECTS/METHODS: A case-control study of 75 children with CSOM and 74 healthy controls. Assessment included dietary history, anthropometry, haemoglobin (Hb) and serum analytes zinc (Zn), copper (Cu), selenium (Se), iron, calcium, phosphate (PO(4)) and total 25-hydroxy vitamin D (25(OH)D). RESULTS: Cases had lower mean Z-scores for weight-for-age, weight-for-height, body mass index and mid-upper arm circumference (MUAC) (all P<0.05), and lower mean concentrations of serum Zn (P=0.032), Se (P<0.001) and calcium adjusted for albumin (P=0.026). Age-adjusted Hb and iron biomarkers did not differ between cases and controls. There was high prevalence of low serum Zn concentration (≥ 90%) and vitamin D deficiency in both cases (80%) and controls (96%). Duration of ear discharge was negatively correlated with total 25(OH)D (P=0.028), calcium adjusted for albumin (P<0.001), PO(4) (P=0.002), transferrin receptor/log ferritin ratio (P<0.001) and Cu (P<0.001), and positively correlated with child age and MUAC (both P<0.001). CONCLUSIONS: Children with CSOM were more undernourished than controls with lower mean serum Zn, Se and calcium concentrations. Vitamin D-deficient and iron-replete children had longer duration of infection, although this association was lost with age adjustment. Trials evaluating specific micronutrients are required in order to investigate specific nutrient-infection interactions in CSOM.

Brain biopsy in the management of neurology patients.

BACKGROUND AND METHODS: To evaluate the value of brain biopsy for neurology patients in our unit, we conducted a retrospective audit of neurology patients referred for brain biopsies for non-neoplastic disease from 1993 to 2007. RESULTS: 64 patients [median (range) age 51 (16-74) years] were included. The clinical presentation was diffuse encephalopathy for 40 patients, focal for 13 and multifocal for 11. The biopsy was diagnostic in 34 patients, abnormal but non-diagnostic in 21 and normal in 9. There was a statistically significant association between clinical presentation and biopsy result (p = 0.004); diagnostic biopsies were more common in patients with focal or multifocal clinical presentations. Twenty patients (31%) had alterations of management as a result of their brain biopsy, comprising specific treatment (11 patients) or prognosis/diagnosis of untreatable conditions (9 patients). Diagnoses of treatable conditions included Whipple's disease, tuberculoma, progressive multifocal leukoencephalopathy, and neurosarcoidosis. Five patients (7.8%) had complications. CONCLUSIONS: Brain biopsy is useful and relatively safe in the management of neurology patients, with a diagnostic yield of 53% in our series; some led to significant changes in management, including treatment of infections. Patients with focal or multifocal presentation are more likely to yield a diagnostic biopsy result.

Favourable one-year ART outcomes in adult Malawians with hepatitis B and C co-infection.

BACKGROUND: Few studies have investigated the impact of chronic hepatitis B and C infection on antiretroviral therapy (ART) outcomes in sub-Saharan Africa. Hepatotoxicity may be a particular concern in co-infected patients taking nevirapine-stavudine-lamivudine. METHODS: We conducted a prospective cohort study of 300 Malawian adults starting ART and describe one-year ART outcomes according to viral hepatitis status. RESULTS: At baseline, patients had advanced HIV disease (29.3% were in WHO stage 4; mean CD4 = 157 cells/microL; mean log(10)HIV-1 RNA = 5.24 copies/ml). Co-infection with hepatitis B, C and B + C were present in 6.7%, 5.7% and 1.7% respectively. At 50 weeks, all-cause mortality was 43 (14.3%). Sixteen (5.3%) had transferred to another unit. Eight (2.7%) were lost to follow up. Sixteen (5.3%) had stopped ART. 217 (72.3%) were alive on ART, of whom 82.5% had an HIV-1 RNA <400 copies/ml at week 50. During the first 50 weeks of ART, severe hepatotoxicity (liver enzyme values >5 times upper level of normal) occurred in 9%, but did not result in any ART discontinuations. Clinical hepatitis or jaundice was not observed. There were no significant differences in occurrence of hepatotoxicity, other side effects, mortality, severe morbidity, immune reconstitution or virological failure between hepatitis B and/or C co-infected patients and those who were not. Viral hepatitis co-infection was not associated with severe hepatotoxicity, mortality, severe morbidity or virological failure in multivariate analyses. CONCLUSION: Our data suggest that screening for viral hepatitis B and C and liver enzyme monitoring may not require high priority in ART programmes in sub-Saharan Africa.

Reliability of rapid testing for hepatitis B in a region of high HIV endemicity.

Hepatitis B (HBV) and HIV co-infection is common in resource-poor settings. A recent study from Malawi revealed poor correlation between hepatitis B surface antigen (HBsAg) point-of-care tests and reference tests in patients co-infected with HIV. We studied a cohort of 300 Malawian adults entering a treatment programme for HIV. Sera were tested for HBsAg first using the Determine rapid test and re-tested using a commercial enzyme immunoassay (EIA). All tests were done under optimal conditions in Liverpool, UK. Sera from all 25 patients positive for HBsAg using the rapid test and from 50 who were negative, were re-tested using the EIA, with complete concordance of results. The kappa correlation was 1, specificity 100% (93-100%) and sensitivity 100% (86-100%) compared to the reference test. Patients had advanced immune suppression (mean CD4=175 cells x 10(6)/l). In a non-field setting, the results of point-of-care Determine rapid hepatitis B tests appear reliable in patients with HIV-1 co-infection.

Placental expression of alpha2,6-linked sialic acid is upregulated in malaria.

In Africa, approximately 25 million pregnant women are at risk of Plasmodium falciparum infection each year, one in four has evidence of placental involvement and up to half of these may be associated with low birth weight outcomes. In infected pregnant women, the placenta is an ideal site for the accumulation of the parasites, and this reduces in extent in subsequent pregnancies. Recent data indicate that terminal alpha2,3 sialic acid-dependent routes are central to the efficient invasion of erythrocytes with P. falciparum, however, the role in placental malaria of sialylated, or other glycoconjugates, on syncytiotrophoblast has not previously been assessed. Placental biopsies from Zambian women showed the Neu5Ac(alpha2,6)Gal/GalNAc sequences bound by the lectin from Sambucus nigra (SNA-1) to have greatly increased expression on microvillous membranes in samples with chronic P. falciparum infection showing, by electronic image analysis, a significant trend (p=0.002) compared to samples with past or no infection. This suggests a specific placental membrane response to falciparum malaria. Expression of alpha2,6-linked sialic acid, demonstrated by the binding of SNA-1, has been associated with intercellular repulsion in tissues from patients with cancer, and such repulsion resulting from increased alpha2,6 sialylation of chorionic villi could influence intervillous placental parasite density. Sialic acid expression should be examined in placental malaria to identify if this is a malaria-specific phenomenon, and to determine its relation to placental inflammation and pregnancy outcomes.

Verb schema use and input dependence in 5-year-old children with Specific Language Impairment (SLI).

BACKGROUND: It has been argued that children with Specific Language Impairment (SLI) use language in a conservative manner. For example, they are reluctant to produce word-plus-frame combinations that they have not heard in the input. In addition, there is evidence to suggest that their utterances replicate lexical and syntactic material from the immediate language environment. AIMS: This study investigated further the linguistic conservatism of children with SLI. It addressed the hypothesis that these children have difficulties using syntactic schemas in a verb-general manner. It employed a technique pioneered by Childers and Tomasello in 2001 that aims to develop verb-general representations through the presentation of appropriate exemplars. In addition, it tested the hypothesis that children with SLI present with input-dependent language use. METHODS & PROCEDURES: Twenty-four children with SLI (mean age 5;6 years) were matched to 23 typically developing children (mean age 3;5 years) on overall language abilities. The children experienced play sessions designed to simulate exemplar-based learning. Facilitative exemplars consisted of sentences that alternated between nouns and pronouns in the argument slots, e.g. 'Pooh's churning the plate. See, he's churning it'. The children were divided evenly into two groups. One group experienced facilitative exemplars, while the other group heard exemplars with no variation in the argument positions. The training effect was assessed with a procedure in which the children heard novel verbs in a non-transitive frame and were required to produce them in a transitive frame. In addition, the argument types of the children's responses (nouns versus pronouns) were analysed to investigate the issue of input dependence. OUTCOMES & RESULTS: Few of the children produced novel verbs in the transitive. This result may indicate difficulties using the transitive, although a number of methodological difficulties may be responsible for this finding. As hypothesized, the children with SLI demonstrated greater input dependence in terms of the kind of arguments they used in responses during the training sessions. CONCLUSIONS: Potential reasons for the low response rate of both groups during the testing stage are explored and a number of methodological adjustments proposed. It is argued that the greater input dependence of the children with SLI may reflect a tendency to reduce processing load within a limited capacity system. It is proposed that input dependence could be a fruitful new area for SLI research and an important issue in the design and delivery of therapy programmes.

Randomised controlled trial of cognitive-behavioural therapy in early schizophrenia: acute-phase outcomes.

BACKGROUND: Cognitive-behavioural therapy (CBT) improves persistent psychotic symptoms. AIMS: To test the effectiveness of added CBT in accelerating remission from acute psychotic symptoms in early schizophrenia. METHOD: A 5-week CBT programme plus routine care was compared with supportive counselling plus routine care and routine care alone in a multi-centre trial randomising 315 people with DSM-IV schizophrenia and related disorders in their first (83%) or second acute admission. Outcome assessments were blinded. RESULTS: Linear regression over 70 days showed predicted trends towards faster improvement in the CBT group. Uncorrected univariate comparisons showed significant benefits at 4 but not 6 weeks for CBT v. routine care alone on Positive and Negative Syndrome Scale total and positive sub-scale scores and delusion score and benefits v. supportive counselling for auditory hallucinations score. CONCLUSIONS: CBT shows transient advantages over routine care alone or supportive counselling in speeding remission from acute symptoms in early schizophrenia.

Depressive symptoms in patients with Alzheimer's disease.

OBJECTIVES: A comparison was made between the depressive symptom profiles of thirty patients with Alzheimer's disease (AD) who did not have co-existing depression and thirty patients with major depression who did not have co-existing dementia. The main objective was to identify symptoms common to both disorders and those which may be able to differentiate AD from major depression. METHOD: A sample of patients suffering from either AD (n = 30) or major depression (n = 30) were recruited from a specialist old age psychiatry service. Depressive symptoms were profiled using the Hamilton Depression Rating Scale (HDRS), the Cornell Scale for Depression in Dementia (CSDD) and the Geriatric Depression Scale (GDS). RESULTS: Depressive symptoms were present in AD in the absence of coexistent major depression. Certain depressive symptoms from all the three scales such as sadness, diurnal variation in mood and early or late insomnia were able to differentiate the two disorders with almost 90% accuracy while symptoms such as irritability, retardation and weight loss were common to both and were unable to differentiate the two. CONCLUSION: Depressive symptoms occur in AD when co-existing depression is ruled out. Their recognition has implications for the diagnosis of major depression in these patients.

Psycholinguistic markers for specific language impairment (SLI).

In this study 160 children, aged 11 years with a definite history of specific language impairment (SLI), completed four tasks that could be potential positive psycholinguistic markers for this impairment: a third person singular task, a past tense task, a nonword repetition task, and a sentence repetition task. This allowed examination of more than one type of marker simultaneously, facilitating both comparisons between markers and also evaluation of combinations of markers in relation to identifying SLI. The study also provided data regarding the markers in relation to nonverbal IQ, made use of new normative data on all tasks, and examined marker accuracy in relation to current language status. The results show that markers vary in accuracy, with sentence repetition (a previously unused marker) proving to be the most useful. This psycholinguistic marker shows high levels of sensitivity (90%), specificity (85%), and overall accuracy (88%), as well as being able to identify the majority of children whose current language status falls in the normal range despite a history of SLI.

Predicting pathways of specific language impairment: what differentiates good and poor outcome?

A group of 117 children who met criteria for Specific Language Impairment (SLI) at 7 years of age were reassessed at 11 years of age. The data gathered from both stages were used to identify predictors of good and poor outcome from earlier test assessments. Results of logistic regressions indicated that measures of narrative retelling skills and expressive syntax were the strongest predictors of overall prognosis. This finding persisted when a nonverbal measure was included as a predictor alongside language measures in the regression model. There was found to be a lack of independent predictive contribution of early measures of articulation to later overall prognosis. Demographic factors (maternal education and family income) were not differently distributed across outcome groups. The theoretical and practical implications of the findings are discussed.

An educational intervention for front-line health professionals in the assessment and management of suicidal patients (The STORM Project).

BACKGROUND: Suicide prevention is a health priority in many countries. Improved management of suicide risk may improve suicide prevention. This study aimed to assess the feasibility of health district-wide training in the assessment and management of people at risk of suicide; and to assess the impact of training on assessment and management skills. METHODS: Staff in three health care settings, namely primary care, accident and emergency departments and mental health services (N = 359), were offered suicide risk management training in a district-wide programme, using a flexible 'facilitator' approach. The main outcomes were the rate of attendance at training, and changes in suicide risk assessment and management skills following training. RESULTS: It was possible to deliver training to 167 health professionals (47 % of those eligible) during a 6 month training period. This included 95 primary care staff (39%), 21 accident and emergency staff(42%) and 51 mental health staff (78%). Of these, 103 (69%) attended all training. A volunteer sample of 28 staff who underwent training showed improvements in skills in the assessment and management of suicide risk. Satisfaction with training was high. The expected costs of district-wide training, if it were able to produce a 2.5% reduction in the suicide rate, would be 99,747 pound sterling per suicide prevented and 3,391 pound sterling per life year gained. CONCLUSIONS: Training in the assessment and management of suicide risk can be delivered to approximately half the targeted staff in primary care, accident and emergency departments and mental health services. The current training package can improve skills and is well accepted. If it were to produce a modest fall in the suicide rate, such training would be cost-effective. However, a future training programme should develop a broader training package to reach those who will not attend.

Effects of a pharmacist's medication review in nursing homes. Randomised controlled trial.

BACKGROUND: Older people in nursing and residential homes often have complex disabilities and behavioural disturbances. Recent publicity has highlighted the dangers of medication in this group, and controls over prescribing have been suggested. AIMS: To investigate the effect of a review of medication by a pharmacist. METHOD: An 8-month prospective trial of an active medication review by a pharmacist was carried out on 330 residents in nursing homes in Manchester. RESULTS: The intervention group experienced greater deterioration in cognitive function and behavioural disturbance than the control group, but the changes in depression and quality of life were similar for both groups. The number of drugs prescribed fell in the intervention group, but not in the control group, with a corresponding saving in drug costs. The number of deaths was significantly smaller in the intervention homes during the intervention period (4 v. 14) but not overall during the study period as a whole (26 v. 28). CONCLUSION: This clinical intervention reduced the number of medicines prescribed to elderly people in nursing homes, with minimal impact on their morbidity and mortality.

Regional variation in incidence and case fatality of myocardial infarction among young women in England, Scotland and Wales.

OBJECTIVES: To examine the regional variation in incidence and case fatality of myocardial infarction among young women. DESIGN: Cross sectional survey, using population based incidence data. SETTING: England, Scotland and Wales. SUBJECTS: Subjects were women aged 16-44 with a diagnosis of myocardial infarction between 1 October 1993 and 15 October 1995. OUTCOME MEASURES: Incidence of myocardial infarction per 100,000 women years, with case fatality as a percentage of total cases. RESULTS: Incidence of myocardial infarction rose steeply from age 33 upwards, (maximum = 20.2 cases per 100,000 women years at age 44). The adjusted incidence rate for myocardial infarction was 3.7 (95% CI 3.2, 4.2) times greater in Scotland than in southern England. In contrast, case fatality was significantly lower in Scotland: 18.5% (95% CI 13.1%, 25.0%), compared with 31.0% (95% CI 25.9%, 36.0%) in southern England. CONCLUSIONS: The incidence of myocardial infarction varied widely within the United Kingdom. Case fatality variation may reflect differences in ambulance response, or in diagnostic acumen, within the regions.

Factors associated with outcome of cognitive-behavioural treatment of chronic post-traumatic stress disorder.

The study examined factors that were associated with outcome in the treatment of PTSD. A trial of cognitive therapy compared to imaginal exposure of chronic PTSD showed that although clinical improvements were obtained after treatment and at 6 month follow-up one type of treatment was not significantly superior to the other. Characteristics of the patient, the trauma and treatment and of pretreatment clinical measures were investigated as predictors of PTSD outcome. Eleven variables were significantly associated with the pre- to post-treatment change in CAPS severity scores. Of these, three (duration of therapy, gender and suicide risk) were selected into a step-wise multiple regression equation to explain 36.5% of the outcome. Similarly, nine variables were significant associated with the pretreatment to follow-up change with three variables (number of missed therapy sessions, residential status and co-morbid GAD) being selected into the equation and explaining 36.9% of the outcome. The best predictor of outcome was inconsistent attendance at therapy.