Challenges in collecting clinical samples for research from pregnant women of South Asian origin: evidence from a UK study.

Objective: To recruit South Asian pregnant women, living in the UK, into a clinicoepidemiological study for the collection of lifestyle survey data and antenatal blood and to retain the women for the later collection of cord blood and meconium samples from their babies for biochemical analysis. Design: A longitudinal study recruiting pregnant women of South Asian and Caucasian origin living in the UK. Setting: Recruitment of the participants, collection of clinical samples and survey data took place at the 2 sites within a single UK Northern Hospital Trust. Participants: Pregnant women of South Asian origin (study group, n=98) and of Caucasian origin (comparison group, n=38) living in Leeds, UK. Results: Among the participants approached, 81% agreed to take part in the study while a ‘direct approach’ method was followed. The retention rate of the participants was a remarkable 93.4%. The main challenges in recruiting the ethnic minority participants were their cultural and religious conservativeness, language barrier, lack of interest and feeling of extra ‘stress’ in taking part in research. The chief investigator developed an innovative participant retention method, associated with the women’s cultural and religious practices. The method proved useful in retaining the participants for about 5 months and in enabling successful collection of clinical samples from the same mother–baby pairs. The collection of clinical samples and lifestyle data exceeded the calculated sample size required to give the study sufficient power. The numbers of samples obtained were: maternal blood (n=171), cord blood (n=38), meconium (n=176), lifestyle questionnaire data (n=136) and postnatal records (n=136). Conclusions: Recruitment and retention of participants, according to the calculated sample size, ensured sufficient power and success for a clinicoepidemiological study. Results suggest that development of trust and confidence between the participant and the researcher is the key to the success of a clinical and epidemiological study involving ethnic minorities

Research priorities for non-pharmacological therapies for common musculoskeletal problems: nationally and internationally agreed recommendations

<p>Abstract</p> <p>Background</p> <p>Musculoskeletal problems such as low back pain, neck, knee and shoulder pain are leading causes of disability and activity limitation in adults and are most frequently managed within primary care. There is a clear trend towards large, high quality trials testing the effectiveness of common non-pharmacological interventions for these conditions showing, at best, small to moderate benefits. This paper summarises the main lessons learnt from recent trials of the effectiveness of non-pharmacological therapies for common musculoskeletal conditions in primary care and provides agreed research priorities for future clinical trials.</p> <p>Methods</p> <p>Consensus development using nominal group techniques through national (UK) and international workshops. During a national Clinical Trials Thinktank workshop in April 2007 in the UK, a group of 30 senior researchers experienced in clinical trials for musculoskeletal conditions and 2 patient representatives debated the possible explanations for the findings of recent high quality trials of non-pharmacological interventions. Using the qualitative method of nominal group technique, these experts developed and ranked a set of priorities for future research, guided by the evidence from recent trials of treatments for common musculoskeletal problems. The recommendations from the national workshop were presented and further ranked at an international symposium (hosted in Canada) in June 2007.</p> <p>Results</p> <p>22 recommended research priorities were developed, of which 12 reached consensus as priorities for future research from the UK workshop. The 12 recommendations were reduced to 7 agreed priorities at the international symposium. These were: to increase the focus on implementation (research into practice); to develop national musculoskeletal research networks in which large trials can be sited and smaller trials supported; to use more innovative trial designs such as those based on stepped care and subgrouping for targeted treatment models; to routinely incorporate health economic analysis into future trials; to include more patient-centred outcome measures; to develop a core set of outcomes for new trials of interventions for musculoskeletal problems; and to focus on studies that advance methodological approaches for clinical trials in this field.</p> <p>Conclusion</p> <p>A set of research priorities for future trials of non-pharmacological therapies for common musculoskeletal conditions has been developed and agreed through national (UK) and international consensus processes. These priorities provide useful direction for researchers and research funders alike and impetus for improvement in the quality and methodology of clinical trials in this field.</p

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory

Chronic non-specific low back pain - sub-groups or a single mechanism?

Copyright 2008 Wand and O'Connell; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Background: Low back pain is a substantial health problem and has subsequently attracted a considerable amount of research. Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches. Discussion: Many clinicians challenge the results of clinical trials as they feel that this lack of effectiveness is at odds with their clinical experience of managing patients with back pain. A common explanation for this discrepancy is the perceived heterogeneity of patients with chronic non-specific low back pain. It is felt that the effects of treatment may be diluted by the application of a single intervention to a complex, heterogeneous group with diverse treatment needs. This argument presupposes that current treatment is effective when applied to the correct patient. An alternative perspective is that the clinical trials are correct and current treatments have limited efficacy. Preoccupation with sub-grouping may stifle engagement with this view and it is important that the sub-grouping paradigm is closely examined. This paper argues that there are numerous problems with the sub-grouping approach and that it may not be an important reason for the disappointing results of clinical trials. We propose instead that current treatment may be ineffective because it has been misdirected. Recent evidence that demonstrates changes within the brain in chronic low back pain sufferers raises the possibility that persistent back pain may be a problem of cortical reorganisation and degeneration. This perspective offers interesting insights into the chronic low back pain experience and suggests alternative models of intervention. Summary: The disappointing results of clinical research are commonly explained by the failure of researchers to adequately attend to sub-grouping of the chronic non-specific low back pain population. Alternatively, current approaches may be ineffective and clinicians and researchers may need to radically rethink the nature of the problem and how it should best be managed

Maternal alcohol intake up to and during pregnancy and risk of adverse birth outcomes: evidence from a British cohort

Background High maternal alcohol consumption has been linked to adverse birth outcomes such as small for gestational age and preterm birth, which in turn have been linked to increased risk of development of cardiovascular diseases and type 2 diabetes in adulthood. The UK Department of Health (DH) recommends that pregnant women and those trying to conceive should avoid alcohol and never drink more than 1GÇô2 units once or twice a week. This study aimed to investigate the association between alcohol intake before and during different stages of pregnancy with both birthweight and gestational age. Methods Data were used from the Caffeine and Reproductive Health Study (CARE), a prospective birth cohort that included 1303 low-risk pregnant women aged 18GÇô45 years, recruited from September, 2003, to June, 2006. Questionnaires administered in the first and second trimester and postpartum assessed alcohol consumption before pregnancy and for the three trimesters. Frequency of weekly alcohol consumption was analysed by categories of intake to accord with DH guidelines (Gëñ2 units per week, &gt;2 units per week, and a non-drinking category as the referent) and was related to preterm birth and size at birth, measured as grams and as customised birthweight centile, which takes into account maternal prepregnancy weight, height, parity, ethnicity, gestation, and baby's sex in multivariable linear and logistic regression models. We also adjusted for maternal age, caffeine intake, education, energy intake, and salivary cotinine as a biomarker of smoking status. Only participants with complete data for all variables were included in the analyses, which excluded just under 10% of the sample. All women provided informed consent and the study was approved by the Leeds West Local Research Ethics Committee (ref 03/054). Findings 1153, 1135, 793, and 377 women, respectively, had data available for birth outcomes and alcohol consumption before pregnancy and during the three trimesters. 74% of women before pregnancy and 53% in the first trimester reported alcohol intakes above the DH recommendation. For intakes above 2 units per week compared with non-drinkers, the adjusted differences in birth centile were GêÆ7-À7 (95% CI GêÆ12-À8 to GêÆ2-À6; ptrend=0-À009), GêÆ8-À2 (GêÆ12-À6 to GêÆ3-À7; ptrend=0-À002), and GêÆ6-À4 (GêÆ11-À8 to GêÆ1-À1, ptrend=0-À06) before pregnancy and during trimesters 1 and 2, respectively. The association with small for gestational age and preterm birth was strongest in trimester 1, with adjusted odds ratios of 2-À0 (95% CI 1-À2GÇô3-À4; ptrend=0-À03) and 3-À5 (1-À1GÇô11-À2, ptrend=0-À04), respectively. Women who adhered to the recommendations in the first trimester of 2 units or fewer per week were also at a significantly higher risk of having babies born with lower birthweight (adjusted difference GêÆ98-À5, 95% CI GêÆ170-À9 to GêÆ26-À1; ptrend=0-À007), birth centile (GêÆ5-À8, GêÆ10-À8 to GêÆ0-À7; ptrend=0-À002), and preterm birth (adjusted odds ratio 4-À6, 95% CI 1-À4GÇô14-À7; ptrend=0-À04) compared with non-drinkers. Interpretation The first trimester was the most sensitive period for the association of alcohol with restricted fetal growth. However, this finding could be explained by under-reporting of alcohol intake. Our small sample size in the third trimester did not allow us to detect a change in birthweight, and larger prospective studies that take into account timing of exposure to alcohol are needed. We showed no evident safe level of alcohol consumption in pregnancy, and the safe advice should be to abstain from alcohol when planning to conceive and during pregnancy, particularly during its early stages. Funding The CARE study was supported by a grant from the Food Standards Agency, UK (T01033

Long-term health effects of chemical warfare agents on children following a single heavy exposure.

In the 1980s, villages in the Kurdistan region of Iraq were exposed to chemical weapons (CWs), which killed and injured thousands of civilians. There has been no clinical assessment of the long-term effects of CWs exposure on those injured. We report the first such evaluation of CW effects on long-term health of children. Patients from the CW-exposed areas were interviewed to assess previous and current clinical history and underwent clinical examination. The status of organs known to be targets of CWs, including skin, eyes, respiratory and neuromuscular systems, was assessed. Children of similar age and social background, but with no history of CW exposure, were selected as a control population. Results showed that 70% of children in the CWs group had chronic health problems in contrast to 3.3% in the unexposed group ( p < 0.0001). Fifty-five per cent of the CW-exposed group had long-term visual impairment but none in the unexposed population. Thirty-six per cent of the CW-exposed group had chronic dermatological conditions compared with 0.8% of the unexposed group ( p < 0.0001), 31% of the CWs group had neurological sequelae compared with 0.4% of the unexposed group ( p < 0.0001) and 51% of the CWs group had long-term respiratory problems compared with 1.5% of the unexposed group ( p < 0.0001). Respiratory complaints including asthma, chronic bronchitis and bronchiectasis were particularly common. Our study suggests that CWs used were probably a combination of sulphur mustard and organophosphate nerve agents. Results also indicate that the prevalence of acute and chronic health problems following exposure to CW agents appear to be higher in children compared with reported data in adults

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

BACKGROUND: Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory.\n\nMETHODS: Adults aged 18 years and over consulting their General Practitioner (GP) with LBP and radiating leg pain of any duration at (n = 500) GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study.\n\nDISCUSSION: This prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI assessment, together with qualitative enquiries, to describe the course, health care usage, patients' experiences and prognostic indicators in an adult population presenting in primary care with LBP and leg pain with or without nerve root involvement

Clinical course, characteristics and prognostic indicators in patients presenting with back and leg pain in primary care. The ATLAS study protocol

Abstract Background Low-back related leg pain with or without nerve root involvement is associated with a poor prognosis compared to low back pain (LBP) alone. Compared to the literature investigating prognostic indicators of outcome for LBP, there is limited evidence on prognostic factors for low back-related leg pain including the group with nerve root pain. This 1 year prospective consultation-based observational cohort study will describe the clinical, imaging, demographic characteristics and health economic outcomes for the whole cohort, will investigate differences and identify prognostic indicators of outcome (i.e. change in disability at 12 months), for the whole cohort and, separately, for those classified with and without nerve root pain. In addition, nested qualitative studies will provide insights on the clinical consultation and the impact of diagnosis and treatment on patients' symptom management and illness trajectory. Methods Adults aged 18 years and over consulting their General Practitioner (GP) with LBP and radiating leg pain of any duration at (n = 500) GP practices in North Staffordshire and Stoke-on-Trent, UK will be invited to participate. All participants will receive a standardised assessment at the clinic by a study physiotherapist and will be classified according to the clinically determined presence or absence of nerve root pain/involvement. All will undergo a lumbar spine MRI scan. All participants will be managed according to their clinical need. The study outcomes will be measured at 4 and 12 months using postal self-complete questionnaires. Data will also be collected each month using brief postal questionnaires to enable detailed description of the course of low back and leg pain over time. Clinical observations and patient interviews will be used for the qualitative aspects of the study. Discussion This prospective clinical observational cohort will combine self-reported data, comprehensive clinical and MRI assessment, together with qualitative enquiries, to describe the course, health care usage, patients' experiences and prognostic indicators in an adult population presenting in primary care with LBP and leg pain with or without nerve root involvement.</p