Rural Clinical School - Research Publications
Now showing items 1-12 of 220
The need for a large-scale trial of fibrate therapy in diabetes: the rationale and design of the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. [ISRCTN64783481]
BACKGROUND: Fibrates correct the typical lipid abnormalities of type 2 diabetes mellitus, yet no study, to date, has specifically set out to evaluate the role of fibrate therapy in preventing cardiovascular events in this setting. METHODS: Subjects with type 2 diabetes, aged 50-75 years, were screened for eligibility to participate in a long-term trial of comicronized fenofibrate 200 mg daily compared with matching placebo to assess benefits of treatment on the occurrence of coronary and other vascular events. People with total cholesterol levels 3.0-6.5 mmol/L plus either a total-to-HDLc ratio > 4.0 or triglyceride level > 1.0 mmol/L with no clear indication for lipid-modifying therapy were eligible. RESULTS: A total of 9795 people were randomized into the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial. All received dietary advice, followed by a 6-week single-blind placebo run-in, then a 6-week active run-in period before randomization. Participants are being followed up every 6 months for outcome events and safety assessments. The study is designed to yield at least 500 coronary events (primary endpoint: first nonfatal myocardial infarction or coronary death) over 5 years, to have 80% power to identify as statistically significant at 2P = 0.05 a 22% reduction in such events, using intention-to-treat methods. CONCLUSIONS: Type 2 diabetes is the most common endocrine disorder worldwide, and its prevalence is increasing. The current evidence about use of fibrates in type 2 diabetes, from around 2000 people treated, will increase with FIELD to evidence from around 12000. FIELD will establish the role of fenofibrate treatment in reducing cardiovascular risk in people with type 2 diabetes. The main results are expected to be available in late 2005.
Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study: baseline characteristics and short-term effects of fenofibrate [ISRCTN64783481]
OBJECTIVE: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study is examining the effects of long-term fibrate therapy on coronary heart disease (CHD) event rates in patients with diabetes mellitus. This article describes the trial's run-in phase and patients' baseline characteristics. RESEARCH DESIGN AND METHODS: FIELD is a double-blind, placebo-controlled trial in 63 centres in 3 countries evaluating the effects of fenofibrate versus placebo on CHD morbidity and mortality in 9795 patients with type 2 diabetes mellitus. Patients were to have no indication for lipid-lowering therapy on randomization, but could start these or other drugs at any time after randomization. Follow-up in the study was to be for a median duration of not less than 5 years and until 500 major coronary events (fatal coronary heart disease plus nonfatal myocardial infarction) had occurred. RESULTS: About 2100 patients (22%) had some manifestation of cardiovascular disease (CVD) at baseline and thus high risk status. Less than 25% of patients without CVD had a (UKPDS determined) calculated 5-year CHD risk of <5%, but nearly all had a 5-year stroke risk of <10%. Despite this, half of the cohort were obese (BMI > 30), most were men, two-thirds were aged over 60 years, and substantial proportions had NCEP ATP III features of the metabolic syndrome independent of their diabetes, including low HDL (60%), high blood pressure measurement (41%), high waist measurement (65%), and raised triglycerides (52%). After a 6-week run-in period before randomisation with all participants receiving 200 mg comicronized fenofibrate, there were declines in total and LDL cholesterol (10%) and triglycerides (26%) and an increase in HDL cholesterol (6.5%). CONCLUSION: The study will show the effect of PPAR-alpha agonist action on CHD and other vascular outcomes in patients with type 2 diabetes including substantial numbers with low to moderate CVD risk but with the various components of the metabolic syndrome. The main results of the study will be reported in late 2005.
"There's no place like home" a pilot study of perspectives of international health and social care professionals working in the UK.
(Springer Science and Business Media LLC, 2005-10-27)
BACKGROUND: Many countries are reporting health workforce shortages across a range of professions at a time of relatively high workforce mobility. Utilising the global market to supply shortage health skills is now a common recruitment strategy in many developed countries. At the same time a number of countries report a 'brain drain' resulting from professional people leaving home to work overseas. Many health and social care professionals make their way to the UK from other countries. This pilot study utilises a novel 'e-survey' approach to explore the motives, experiences and perspectives of non-UK health and social care professionals who were working or had worked in the UK. The study aims to understand the contributions of international health and social care workers to the UK and their 'home' countries. The purpose of the pilot study is also in part to test the appropriateness of this methodology for undertaking a wider study. RESULTS: A 24-item questionnaire with open-ended and multiple choice questions was circulated via email to 10 contacts who were from a country outside the UK, had trained outside the UK and had email access. These contacts were requested to forward the email to other contacts who met these criteria (and so on). The email was circulated over a one month pilot period to 34 contacts. Responses were from physiotherapists (n = 11), speech therapists (n = 4), social workers (n = 10), an occupational therapist (n = 1), podiatrists (n = 5), and others (n = 3). Participants were from Australia (n = 20), South Africa (n = 10), New Zealand (n = 3) and the Republic of Ireland (n = 1). Motives for relocating to the UK included travel, money and career opportunities. Participants identified a number of advantages and disadvantages of working in the UK compared to working in their home country health system. Respondents generally reported that by working in the UK, they had accumulated skills and knowledge that would allow them to contribute more to their profession and health system on their return home. CONCLUSION: This pilot study highlights a range of issues and future research questions for international learning and comparison for the health and social care professions as a result of international workforce mobility. The study also highlights the usefulness of an e-survey technique for capturing information from a geographically diverse and mobile group of professionals.
Evaluation of the Edinburgh Post Natal Depression Scale using Rasch analysis
BACKGROUND: The Edinburgh Postnatal Depression Scale (EPDS) is a 10 item self-rating post-natal depression scale which has seen widespread use in epidemiological and clinical studies. Concern has been raised over the validity of the EPDS as a single summed scale, with suggestions that it measures two separate aspects, one of depressive feelings, the other of anxiety. METHODS: As part of a larger cross-sectional study conducted in Melbourne, Australia, a community sample (324 women, ranging in age from 18 to 44 years: mean = 32 yrs, SD = 4.6), was obtained by inviting primiparous women to participate voluntarily in this study. Data from the EPDS were fitted to the Rasch measurement model and tested for appropriate category ordering, for item bias through Differential Item Functioning (DIF) analysis, and for unidimensionality through tests of the assumption of local independence. RESULTS: Rasch analysis of the data from the ten item scale initially demonstrated a lack of fit to the model with a significant Item-Trait Interaction total chi-square (chi Square = 82.8, df = 40; p < .001). Removal of two items (items 7 and 8) resulted in a non-significant Item-Trait Interaction total chi-square with a residual mean value for items of -0.467 with a standard deviation of 0.850, showing fit to the model. No DIF existed in the final 8-item scale (EPDS-8) and all items showed fit to model expectations. Principal Components Analysis of the residuals supported the local independence assumption, and unidimensionality of the revised EPDS-8 scale. Revised cut points were identified for EPDS-8 to maintain the case identification of the original scale. CONCLUSION: The results of this study suggest that EPDS, in its original 10 item form, is not a viable scale for the unidimensional measurement of depression. Rasch analysis suggests that a revised eight item version (EPDS-8) would provide a more psychometrically robust scale. The revised cut points of 7/8 and 9/10 for the EPDS-8 show high levels of agreement with the original case identification for the EPDS-10.
Anxiety and stress in the postpartum: Is there more to postnatal distress than depression?
BACKGROUND: Postnatal depression has received considerable research and clinical attention, however anxiety and stress in the postpartum has been relatively ignored. Along with the widespread use of the Edinburgh Postnatal Depression Scale (EPDS), depression has become the marker for postnatal maladjustment. Symptoms of anxiety tend to be subsumed within diagnoses of depression, which can result in anxiety being minimized or overlooked in the absence of depression. Some researchers have identified the need to distinguish between postnatal depression and anxiety, and to discern cases where depression and anxiety co-exist. The aim of this study was to assess the prevalence of postnatal distress using the EPDS and the Depression Anxiety Stress Scales (DASS-21). METHOD: As part of a larger cross-sectional study, the EPDS and DASS-21 were administered to a convenience sample of 325 primiparous mothers, who ranged in age from 18 to 44 years (M = 32 years). Recruited through mother's groups and health centres in Melbourne Australia, inclusion was limited to mothers whose babies were aged between 6 weeks and 6 months. Analyses included comparisons between the classifications of women according to the EPDS and the DASS-21, and an exploration of the extent to which the EPDS identified anxious-depressed women. RESULTS: The EPDS identified 80 women (25%) as possibly depressed (using a cut-off of over 9), of which the DASS-21 corroborated 58%. In the total sample, 61 women (19%) were classified by the DASS-21 to be depressed. Using broader criteria for distress, it was revealed by the DASS-21 that a further 33 women (10%) showed symptoms of anxiety and stress without depression. A total of 41 women (13%) had symptoms of anxiety either in isolation or in combination with depression. The DASS-21 identified 7% of the sample as being both anxious and depressed. This at-risk sub-group had higher mean EPDS and DASS-depression scores than their depressed-only counterparts. CONCLUSION: The prevalence of anxiety and stress in the present study points to the importance of assessing postnatal women for broader indicators of psychological morbidity than that of depression alone. The DASS-21 appears to be a useful instrument for this purpose.
Measuring the impact and distress of health problems from the individual's perspective: development of the Perceived Impact of Problem Profile (PIPP)
BACKGROUND: The aim of this study was to develop and conduct preliminary validation of the Perceived Impact of Problem Profile (PIPP). Based on the biopsychosocial model of health and functioning, the PIPP was intended as a generic research and clinical measurement tool to assess the impact and distress of health conditions from the individuals' perspective. The ICF classification system was used to guide the structure of the PIPP with subscales included to assess impact on self-care, mobility, participation, relationships and psychological well-being. While the ICF focuses on the classification of objective health and health related status, the PIPP broadens this focus to address the individuals' subjective experience of their health condition. METHODS: An item pool of 23 items assessing both impact and distress on five key domains was generated. These were administered to 169 adults with mobility impairment. Rasch analysis using RUMM2020 was conducted to assess the psychometric properties of each set of items. Preliminary construct validation of the PIPP was performed using the EQ5D. RESULTS: For both the Impact and Distress scales of the PIPP, the five subscales (Self-care, Mobility, Participation, Relationships, and Psychological Well-being) showed adequate psychometric properties, demonstrating fit to the Rasch model. All subscales showed adequate person separation reliability and no evidence of differential item functioning for sex, age, educational level or rural vs urban residence. Preliminary validity testing using the EQ5D items provided support for the subscales. CONCLUSION: This preliminary study, using a sample of adults with mobility impairment, provides support for the psychometric properties of the PIPP as a potential clinical and research measurement tool. The PIPP provides a brief, but comprehensive means to assess the key ICF components, focusing on the individuals' perspective of the impact and distress caused by their health condition. Further validation of its use across different health conditions and varying cultural settings is required.
Impact, distress and HRQoL among Malaysian men and women with a mobility impairment
BACKGROUND: Although non-communicable and chronic disease now accounts for 47% of the global burden of disease, little is known of the everyday experiences and social aspects of disability and disablement in middle and low income countries. This article aims to address this gap by exploring the subjective experience of mobility impairment in Malaysia. Specifically, it examines health-related quality of life and the impact and distress related to impaired mobility, and investigates any gender differences in relation to the experience of disability. METHODS: The data were collected as part of an interdisciplinary, multi-country study known as RESILIENCE (Research into Social Inclusion, Locomotive Impairment and Empowerment through Networking, Collaboration and Education). Cluster sampling was used to administer the EQ-5D and the Perceived Impact of Problems Profile (PIPP) to 210 adults from Selangor state, west coast Peninsular Malaysia. RESULTS: The participants consisted of 94 males and 116 females, aged between 18-90 years (mean 60 years), with the majority being Malay. The majority of participants were also married, from rural areas and had primary education only. Very few participants lived alone. In addition, males were more likely to attribute their impaired mobility to an accident. The majority of participants with mobility impairment experienced a moderate to high level of pain/discomfort (79%) and anxiety/depression (72%), and at least some problems with performing usual activities (71%), as measured by the EQ-5D. In addition, using the Perceived Impact of Problems Profile (PIPP), participants also reported high levels of impact and distress related to participation in community life. In general, males reported higher impact and distress across several items, most significantly in regard to participation in community activities, moving around the neighbourhood, ability to live independently, and ability to assist their family members. CONCLUSION: This paper provides preliminary data regarding the health-related quality of life among Malaysians with impaired mobility, and highlights the multifaceted impact of disability and the importance of acknowledging the diverse cultural contexts in which disability can occur. It also raises questions regarding gender differences in the subjective experience of disability in Malaysia.
GPs' use of problem solving therapy for depression: a qualitative study of barriers to and enablers of evidence based care
(BIOMED CENTRAL LTD, 2007-04-25)
BACKGROUND: Depression is a major health concern, predominantly treated by general practitioners (GPs). Problem solving therapy (PST) is recognised as an effective treatment for depression that is not widely used by GPs. This research aims to explore barriers and enablers that may influence GPs use of this treatment. METHOD: Qualitative methodology was used including individual and focus group interviews of GPs, PST experts and consumers. Analysis was undertaken using the Theory of Planned Behaviour (TPB) as a framework. RESULTS: A spectrum of potential influences, on GPs' use of PST emerged. Both barriers and enablers were identified. PST was perceived as being close to current practice approaches and potentially beneficial to both doctor and patient. In addition to a broadly positive attitude to PST, expressed by those with previous experience of its use, potential solutions to perceived barriers emerged. By contrast some GPs expressed fear that the use of PST would result in loss of doctor control of consultations and associated potential adverse patient outcomes. Patient expectations, which emerged as not always coinciding with GPs' perception of those expectations, were identified as a potential influence on GPs' decision concerning adoption of PST. In addition specific factors, including GP skill and confidence, consultation time constraints and technical issues related to PST were noted as potential concerns. CONCLUSION: This research contributes to our knowledge of the factors that may influence GPs' decisions regarding use of PST as a treatment for depression. It recognises both barriers and enablers. It suggests that for many GPs, PST is viewed in a positive light, providing encouragement to those seeking to increase the provision of PST by GPs. In identifying a number of potential barriers, along with associated options to address many of these barriers, it provides insights which may assist in the planning of GP training in PST.
A longitudinal evaluation of the center for epidemiologic studies-depression scale (CES-D) in a rheumatoid arthritis population using Rasch analysis
BACKGROUND: The aim of this study was to test the internal validity of the total Center for Epidemiologic Studies-Depression (CES-D) scale using Rasch analysis in a rheumatoid arthritis (RA) population. METHODS: CES-D was administered to 157 patients with RA over three time points within a 12 month period. Rasch analysis was applied using RUMM2020 software to assess the overall fit of the model, the response scale used, individual item fit, differential item functioning (DIF) and person separation. RESULTS: Pooled data across three time points was shown to fit the Rasch model with removal of seven items from the original 20-item CES-D scale. It was necessary to rescore the response format from four to three categories in order to improve the scale's fit. Two items demonstrated some DIF for age and gender but were retained within the 13-item CES-D scale. A new cut point for depression score of 9 was found to correspond to the original cut point score of 16 in the full CES-D scale. CONCLUSION: This Rasch analysis of the CES-D in a longstanding RA cohort resulted in the construction of a modified 13-item scale with good internal validity. Further validation of the modified scale is recommended particularly in relation to the new cut point for depression.
Measuring the impact of health problems among adults with limited mobility in Thailand: further validation of the Perceived Impact of Problem Profile
BACKGROUND: The Perceived Impact of Problem Profile (PIPP) was developed to provide a tool for measuring the impact of a health condition from the individual's perspective, using the ICF model as a framework. One of the aims of the ICF is to enable the comparison of data across countries, however, relatively little is known about the subjective experience of disability in middle and low-income countries. The aim of this study was to assess the validity of the Perceived Impact of Problem Profile (PIPP) for use among adults with a disability in Thailand using Rasch analysis. METHODS: A total of 210 adults with mobility impairment from the urban, rural and remote areas of northeast Thailand completed the PIPP, which contains 23 items assessing both impact and distress across five key domains (Self-care, Mobility, Participation, Relationships, and Psychological Well-being). Rasch analysis, using RUMM2020, was conducted to assess the internal validity and psychometric properties of the PIPP Impact subscales. Validation of the PIPP Impact scales was conducted by comparing scores across the different response levels of the EQ5D items. RESULTS: Rasch analysis indicated that participants did not clearly differentiate between 'impact' and 'distress,' the two aspects assessed by the PIPP. Further analyses were therefore limited to the PIPP Impact subscales. These showed adequate psychometric properties, demonstrating fit to the Rasch model and good person separation reliability. Preliminary validity testing using the EQ5D items provided support for the PIPP Impact subscales. CONCLUSION: The results provide further support for the psychometric properties of the PIPP Impact scales and indicate that it is a suitable tool for use among adults with a locomotor disability in Thailand. Further research is needed to validate the PIPP across different cultural contexts and health conditions and to assess the usefulness of separate Impact and Distress subscales.
Cardiovascular disease in patients with chronic kidney disease.
(Informa UK Limited, 2009)
Patients with chronic kidney disease have a high burden of cardiovascular morbidity and mortality. The vast majority of patients with chronic kidney disease do not progress to end stage renal failure, but do have a significantly higher incidence of all cardiovascular co-morbidities. Traditional cardiovascular risk factors only partially account for this increased incidence of cardiovascular disease. In patients with kidney disease the basic biology underlying cardiovascular disease may be similar to that in patients without kidney disease, but it would seem many more risk factors are involved as a consequence of renal dysfunction. Although emphasis is placed on delaying the progression of chronic kidney disease, it must be appreciated that for many patients it is vital to address their cardiovascular risk factors at an early stage to prevent premature cardiovascular death. This review examines available epidemiological evidence, discusses common cardiovascular risk factors in patients with chronic kidney disease, and suggests possible treatment strategies. Potential areas for important research are also described.
Variability in depression prevalence in early rheumatoid arthritis: a comparison of the CES-D and HAD-D Scales
(BIOMED CENTRAL LTD, 2009-02-07)
BACKGROUND: Depression is common in rheumatoid arthritis (RA), however reported prevalence varies considerably. Two frequently used instruments to identify depression are the Center for Epidemiological Studies Depression (CES-D) scale, and the Hospital Anxiety and Depression Scale (HADS). The objectives of this study were to test if the CES-D and HADS-D (a) satisfy current modern psychometric standards for unidimensional measurement in an early RA sample; (b) measure the same construct (i.e. depression); and (c) identify similar levels of depression. METHODS: Data from the two scales completed by patients with early RA were fitted to the Rasch measurement model to show that (a) each scale satisfies the criteria of fit to the model, including strict unidimensionality; (b) that the scales can be co-calibrated onto a single underlying continuum of depression and to (c) examine the location of the cut points on the underlying continuum as indication of the prevalence of depression. RESULTS: Ninety-two patients with early RA (62% female; mean age = 56.3, SD = 13.7) gave 141 sets of paired CES-D and HAD-D data. Fit of the data from the CES-D was found to be poor, and the scale had to be reduced to 13 items to satisfy Rasch measurement criteria whereas the HADS-D met model expectations from the outset. The 20 items combined (CES-D13 and HADS-D) satisfied Rasch model expectations. The CES-D gave a much higher prevalence of depression than the HADS-D. CONCLUSION: The CES-D in its present form is unsuitable for use in patients with early RA, and needs to be reduced to a 13-item scale. The HADS-D is valid for early RA and the two scales measure the same underlying construct but their cut points lead to different estimates of the level of depression. Revised cut points on the CES-D13 provide comparative prevalence rates.