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Anna Hart

Publications and source records attributed to Anna Hart.

12 recordsLinked to original sources

Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review.

Good quality clinical trials are essential to inform the best cystic fibrosis (CF) management and care, by determining and comparing the effectiveness of new and existing therapies and drug delivery systems. The formal inclusion of quality of life (QoL) as an outcome measure in CF clinical trials is becoming more common. Both an appropriate QoL measure and sound methodology are required in order to draw valid inferences about treatments and QoL. A review was undertaken of randomised controlled trials in cystic fibrosis where QoL was measured. EMBASE, MEDLINE and ISI Web of Science were searched to locate all full papers in the English language reporting randomised controlled trials in cystic fibrosis, published between January 1991 and December 2004. All Cochrane reviews published before December 2004 were hand searched. Papers were included if the authors had reported that they had measured QoL or well being in the trial. 16 trials were identified. The interventions investigated were: antibiotics (4); home versus hospital administration of antibiotics (1); steroids (1); mucolytic therapies (6); exercise (3) and pancreatic enzymes (1). Not one trial evaluated in this review provided conclusive results concerning QoL. This review highlights many of the pitfalls of QoL measurement in CF clinical trials and provides constructive information concerning the design and reporting of trials measuring QoL.

Cystic Fibrosis↗

Measuring health in quantitative studies.

For quantitative studies it is essential to select (and sometimes even construct) outcome measures, which are appropriate for measuring the specific aspect of health you are interested in. The measures should be valid, repeatable, and sensitive to change. It is complex and time-consuming to develop outcome measures afresh, so choose existing measures whenever possible and use them in the way they were intended. Measures may be generic or specific and should match the subjects involved. Objective measures, though accurate, may be less relevant to patients than subjective measures, particularly for CAM therapies. Findings made with one measure are more credible if they are supported by a second, as are results produced with the same measures used to measure outcomes in conventional medical studies. Careful planning of the analysis will help reveal any problems with measures.

Adolescent↗

Associations between clinical variables and quality of life in adults with cystic fibrosis.

BACKGROUND: The disease progression of cystic fibrosis (CF) is marked by an increase in clinical conditions and therapeutic interventions, which have the potential to affect health-related quality of life (HRQoL). This cross-sectional study explored associations between clinical variables and HRQoL. METHODS: HRQoL was measured using the Cystic Fibrosis Quality of Life (CFQoL) questionnaire, which consists of nine domains: physical, social, treatment, chest symptoms, emotional functioning, concerns for the future, relationships, body image, and career concerns. The CFQoL was completed by 223 adults with CF. Clinical and demographic data collected were: age, gender, FEV1% predicted, BMI, Burkholderia cepacia status, lung transplant status, diabetic status, level of nutritional intervention, and presence of an intravenous access device. Multiple regression using forward selection was used to construct models relating these variables to each HRQoL domain. RESULTS: Despite many of the variables being inter-related, some variables were associated with CFQoL domains even in the presence of other important clinical factors. FEV1% predicted was weakly positively associated with all nine domains. Strong evidence emerged that patients who had received a lung transplant reported a higher HRQoL in physical and social functioning, chest symptoms, and treatment issues. Females tended to report a lower quality of life for chest symptoms and career issues, but higher values for body image. Patients with an access device expressed more career concerns. There was no evidence of an association between B. cepacia and any of the nine CFQoL domains. The model for the body image domain explained a high percentage of the variance (R2=30%): negative body image was associated with lower BMI, having an access device, diabetes, and enteral feeding. CONCLUSIONS: While important associations were identified, much of the variance in HRQoL remains unexplained. Other clinical and psychosocial variables merit investigation. A longitudinal study is required to investigate how the disease trajectory and associated treatments affect an individual's quality of life.

Adult↗

Progress of first stage of labour for multiparous women: an observational study.

As there is no universal definition of 'normal' labour, diagnosing prolonged labour is inherently difficult. Simple charts (partograms) are used to aid this process; however, there are little empirical data on which to base such charts. Therefore, we monitored 403 multiparous women, in the first stage of labour with uncomplicated term pregnancies, in a midwife-led unit. They had vaginal examinations every 2 hours, and we modelled rates of cervical dilatation for all women, either to the end of the first stage of labour or to the point of transfer for intervention. Overall, the median rate of dilatation was 1.9 cm/hour and the 5th percentile was 0.5 cm/hour. There was a weak positive correlation between initial dilatation and rate of dilatation (r= 0.2). Individualised computer-based partograms incorporating some of the factors that affect progress might prove useful in the future.

Adult↗

Mortality study of policies on insured lives with diabetes mellitus known at time of issue.

BACKGROUND: This is an Impairment Study Capture System (ISCS) study of contemporary diabetes mellitus mortality among insured lives. Because the diagnosis and treatment of diabetes has changed during the last 15 years, many applicants may be expected to exhibit more favorable outcomes than in the past. The study covers policy-years durational experience extending to only 10 years. METHODS: We analyzed the total mortality experience of 41,972 insurance policies. The policies were issued at standard or substandard premium rates between 1989 and 2002 policy anniversaries. The number of policies terminated by death (actual deaths) is compared with expected deaths using the 2001 Valuation Basic Table (2001 VBT). Main outcome measures are expressed as mortality ratios (MR %) and excess death rates/1000 (EDR/M). Poisson confidence intervals are used to test the statistical significance of mortality ratios at the 95% confidence limit. RESULTS: The total experience is based on 103,104 policy-years exposure: males 57,888 policy-years (56%) and females 45,216 policy-years (44%). There were 495 policy-deaths 284 male and 211 female. Substandard risks represented the majority of the total exposure, 76,658 policy-years in both sexes combined (male 56%, female 44%). The mean duration of substandard exposure was 2.3 years. Total mortality for all insured age-groups and risk categories combined was 187%. The mortality ratios for policies rated standard had confidence intervals that were consistent with 100% of the 2001 VBT. The mortality ratios for policies rated substandard had confidence intervals that were above 100% of the 2001 VBT. Mortality ratios varied with the type of treatment. They were lowest in those treated with diet alone and highest in individuals treated with diet plus insulin. CONCLUSION: A clinical diagnosis of diabetes continues to demonstrate evidence of increased, but improving, mortality in insured individuals. The underwriting risk appraisal process effectively categorizes the risk, especially for the substandard classes where the ratings assigned to policies were consistent with the mortality results. The lack of significant differences in the mortality ratios between males and females as well as between nonsmokers and smokers indicate that the early duration variations by gender and smoking status in the 2001 VBT account for these differences in early duration diabetes mortality. Subsequent follow-up studies containing longer durations may show these differences emerging. Results must be interpreted with caution because of the small data set, limited number of ISCS participating companies, and durational experience extending to only 10 policy years.

Adolescent↗

Randomised controlled trial of magnetic bracelets for relieving pain in osteoarthritis of the hip and knee.

OBJECTIVE: To determine the effectiveness of commercially available magnetic bracelets for pain control in osteoarthritis of the hip and knee. DESIGN: Randomised, placebo controlled trial with three parallel groups. SETTING: Five rural general practices. PARTICIPANTS: 194 men and women aged 45-80 years with osteoarthritis of the hip or knee. INTERVENTION: Wearing a standard strength static bipolar magnetic bracelet, a weak magnetic bracelet, or a non-magnetic (dummy) bracelet for 12 weeks. MAIN OUTCOME MEASURES: Change in the Western Ontario and McMaster Universities osteoarthritis lower limb pain scale (WOMAC A) after 12 weeks, with the primary comparison between the standard and dummy groups. Secondary outcomes included changes in WOMAC B and C scales and a visual analogue scale for pain. RESULTS: Mean pain scores were reduced more in the standard magnet group than in the dummy group (mean difference 1.3 points, 95% confidence interval 0.05 to 2.55). Self reported blinding status did not affect the results. The scores for secondary outcome measures were consistent with the WOMAC A scores. CONCLUSION: Pain from osteoarthritis of the hip and knee decreases when wearing magnetic bracelets. It is uncertain whether this response is due to specific or non-specific (placebo) effects.

Aged↗

Study of policies on insured lives with elevated blood pressure known at time of issue.

BACKGROUND: The mortality results of policies on insured lives with elevated blood pressure have been the subject of several studies since the early 20th century. This study, which began with issues of 1989, utilizes data from the Impairment Study Capture System (ISCS). Data are also compiled for impairments other than elevated blood pressure in the ISCS for the same study period. A comparison of these 2 sets of data shows the relative severity of elevated blood pressure compared to all other impairments combined. The determination of elevated blood pressure was made on the basis of risk classification due to lack of specific blood pressure readings. METHODS: Mortality results are actual to expected ratios based on the SOA 1990-95 Select Basic Table. The companies participating in this study have completed 3 steps: (1) agreement to have individual reports to the MIB included in the ISCS file; (2) submission of additional policy information, not on the MIB report; and (3) update of in-force status annually. Reports do not include personal identifying information. RESULTS: Based on the limited amount of data contributed by relatively few companies, there has been considerable improvement since earlier studies in mortality among insureds with elevated blood pressure. Some possible reasons for this include: (1) fewer smokers--there were fewer smokers in the population and hence applying for insurance during the period covered by this study as compared to earlier studies; (2) improved treatment, patient awareness and adherence to regimen--a wider variety of medications and current treatment practices compared to treatment in the 1970s and early 1980s may have influenced results. Compared to prior studies, it is likely that more insureds with elevated blood pressure first noted on the insurance examination subsequently have received treatment. In addition, those with elevated blood pressure have become more aware of the importance of adhering to their medication regimen and improving other adverse risk factors; (3) improvement in the treatment of related medical conditions. CONCLUSION: The results of this study must be interpreted with caution. The volume of data is not substantial, and the results may not be representative of non-contributing companies. Going forward, it is hoped that more companies will agree to participate such that future studies will produce data and results of greater utility.

Actuarial Analysis↗

Randomised controlled trial of reflexology for menopausal symptoms.

OBJECTIVE: Clinical experience suggests that reflexology may have beneficial effects on the symptoms occurring in menopausal women, particularly psychological symptoms. This study aims to examine that effect rigorously. DESIGN: Randomised controlled trial with two parallel arms. SETTING: School of Complementary Health in Exeter, Devon, UK. SAMPLE: Seventy-six women, aged between 45 and 60 years, reporting menopausal symptoms. METHODS: Women were randomised to receive nine sessions of either reflexology or nonspecific foot massage (control) by four qualified reflexologists given over a period of 19 weeks. MAIN OUTCOME MEASURES: The Women's Health Questionnaire (WHQ), the primary measures being the subscores for anxiety and depression. Severity (visual analogue scale, VAS) and frequency of flushes and night sweats. RESULTS: Mean (SD) scores for anxiety fell from 0.43 (0.29) to 0.22 (0.25) in the reflexology group and from 0.37 (0.27) to 0.27 (0.29) in the control group over the course of treatment. Mean (SD) scores for depression fell from 0.37 (0.25) to 0.20 (0.24) in the reflexology group and from 0.36 (0.23) to 0.20 (0.21) in the control (foot massage) group over the same period. For both scores there was strong evidence of a time effect (P < 0.001) but no evidence of a time-group interaction (P > 0.2). Similar changes were found for severity of hot flushes and night sweats. In the control group, 14/37 believed they had not received true reflexology. CONCLUSION: Foot reflexology was not shown to be more effective than non-specific foot massage in the treatment of psychological symptoms occurring during the menopause.

Aged↗