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Michael J Campbell

Publications and source records attributed to Michael J Campbell.

At least 19 recordsLinked to original sources
PubMed2006

Implementing referral guidelines: lessons from a negative outcome cluster randomised factorial trial in general practice.

BACKGROUND: Few patients with lower bowel symptoms who consult their general practitioner need a specialist opinion. However data from referred patients suggest that those who are referred would benefit from detailed assessment before referral. METHODS: A cluster randomised factorial trial. 44 general practices in North Trent, UK. Practices were offered either an electronic interactive referral pro forma, an educational outreach visit by a local colorectal surgeon, both or neither. The main outcome measure was the proportion of cases with severe diverticular disease, cancer or precancerous lesions and inflammatory bowel disease in those referred by each group. A secondary outcome was a referral letter quality score. Semi-structured interviews were conducted to identify key themes relating to the use of the software RESULTS: From 150 invitations, 44 practices were recruited with a total list size of 265,707. There were 716 consecutive referrals recorded over a six-month period, for which a diagnosis was available for 514. In the combined software arms 14% (37/261) had significant pathology, compared with 19% (49/253) in the non-software arms, relative risk 0.73 (95% CI: 0.46 to 1.15). In the combined educational outreach arms 15% (38/258) had significant pathology compared with 19% (48/256) in the non-educational arms, relative risk 0.79 (95% CI: 0.50 to 1.24). Pro forma practices documented better assessment of patients at referral. CONCLUSION: There was a lack of evidence that either intervention increased the proportion of patients with organic pathology among those referred. The interactive software did improve the amount of information relayed in referral letters although we were unable to confirm if this made a significant difference to patients or their health care providers. The potential value of either intervention may have been diminished by their limited uptake within the context of a cluster randomised clinical trial. A number of lessons were learned in this trial of novel innovations.

Colonic Diseases↗
PubMed2006

Breast cancer growth prevention by statins.

Statins are cholesterol-lowering drugs with pleiotropic activities including inhibition of isoprenylation reactions and reduction of signals driving cell proliferation and survival responses. The objectives of this study were to examine the effects of statins on breast cancer cells, both in vitro and in vivo, and to begin to determine their mechanism of action. We evaluated the effects of statins on breast cancer cell growth, phosphoprotein signaling intermediates, survival/apoptosis regulators, cell cycle regulators, and activated transcription factors. We also examined the in vivo effect of statin administration in a mouse ErbB2(+) breast cancer model. Only lipophilic statins had direct anticancer activity in vitro. Breast cancer cells with activated Ras or ErbB2 pathways seemed to be more sensitive than those overexpressing estrogen receptor, and this correlated with endogenous levels of activated nuclear factor kappaB (NF-kappaB). Key intermediates regulating cell survival by NF-kappaB activation, as well as cell proliferation by the mitogen activated protein kinase cascade, were among the earliest phosphoproteins influenced by statin treatment. These early effects were followed by declines in activator protein-1 and NF-kappaB activation and concordant changes in other mediators of proliferation and apoptosis. In vivo results showed that oral dosing of statins significantly inhibited the growth of a mouse mammary carcinoma. Lipophilic statins can exert direct anticancer activity in vitro by reducing proliferation and survival signals in susceptible breast cancer phenotypes. Tumor growth inhibition in vivo using a clinically relevant statin dose also seems to be associated with reduced tumor cell proliferation and survival. These findings provide supporting rationale for future statin trials in breast cancer patients.

Antineoplastic Agents↗
PubMed2006

Health Related Quality of Life in Malaysian children with thalassaemia.

BACKGROUND: Health Related Quality of Life (HRQoL) studies on children with chronic illness such as thalassaemia are limited. We conducted the first study to investigate if children with thalassaemia have a lower quality of life in the four dimensions as measured using the PedsQL 4.0 generic Scale Score: physical, emotional, social and role (school) functioning compared to the healthy controls allowing for age, gender, ethnicity and household income. METHODS: The PedsQL 4.0 was administered to children receiving blood transfusions and treatments at Hospital Kuala Lumpur, Malaysia using PedsQL 4.0 generic Scale Score. Accordingly, the questionnaire was also administered to a control group of healthy school children. Socio-demographic data were also collected from patients and controls using an interview schedule designed for the study. RESULTS: Of the 96 thalassaemia patients approached, 78 gave consent to be interviewed giving a response rate of 81.3%. Out of 235 healthy controls approached, all agreed to participate giving a response rate of 100%. The mean age for the patients and schoolchildren is 11.9 and 13.2 years respectively. The age range for the patients and the schoolchildren is between 5 to 18 years and 7 to 18 years respectively. After controlling for age and demographic background, the thalassaemia patients reported having significantly lower quality of life than the healthy controls. CONCLUSION: Thalassaemia has a negative impact on perceived physical, emotional, social and school functioning in thalassaemia patients which was also found to be worse than the children's healthy counterparts. Continuing support of free desferal from the Ministry of Health should be given to these patients. More understanding and support especially from health authorities, school authorities and the society is essential to enhance their quality of life.

Adolescent↗
PubMed2006

Applications for protein sequence-function evolution data: mRNA/protein expression analysis and coding SNP scoring tools.

The vast amount of protein sequence data now available, together with accumulating experimental knowledge of protein function, enables modeling of protein sequence and function evolution. The PANTHER database was designed to model evolutionary sequence-function relationships on a large scale. There are a number of applications for these data, and we have implemented web services that address three of them. The first is a protein classification service. Proteins can be classified, using only their amino acid sequences, to evolutionary groups at both the family and subfamily levels. Specific subfamilies, and often families, are further classified when possible according to their functions, including molecular function and the biological processes and pathways they participate in. The second application, then, is an expression data analysis service, where functional classification information can help find biological patterns in the data obtained from genome-wide experiments. The third application is a coding single-nucleotide polymorphism scoring service. In this case, information about evolutionarily related proteins is used to assess the likelihood of a deleterious effect on protein function arising from a single substitution at a specific amino acid position in the protein. All three web services are available at http://www.pantherdb.org/tools.

Amino Acid Substitution↗
PubMed2006

Language ability after early detection of permanent childhood hearing impairment.

BACKGROUND: Children with bilateral permanent hearing impairment often have impaired language and speech abilities. However, the effects of universal newborn screening for permanent bilateral childhood hearing impairment and the effects of confirmation of hearing impairment by nine months of age on subsequent verbal abilities are uncertain. METHODS: We studied 120 children with bilateral permanent hearing impairment identified from a large birth cohort in southern England, at a mean of 7.9 years of age. Of the 120 children, 61 were born during periods with universal newborn screening and 57 had hearing impairment that was confirmed by nine months of age. The primary outcomes were language as compared with nonverbal ability and speech expressed as z scores (the number of standard deviations by which the score differed from the mean score among 63 age-matched children with normal hearing), adjusted for the severity of the hearing impairment and for maternal education. RESULTS: Confirmation of hearing impairment by nine months of age was associated with higher adjusted mean z scores for language as compared with nonverbal ability (adjusted mean difference for receptive language, 0.82; 95 percent confidence interval, 0.31 to 1.33; and adjusted mean difference for expressive language, 0.70; 95 percent confidence interval, 0.13 to 1.26). Birth during periods with universal newborn screening was also associated with higher adjusted z scores for receptive language as compared with nonverbal ability (adjusted mean difference, 0.60; 95 percent confidence interval, 0.07 to 1.13), although the z scores for expressive language as compared with nonverbal ability were not significantly higher. Speech scores did not differ significantly between those who were exposed to newborn screening or early confirmation and those who were not. CONCLUSIONS: Early detection of childhood hearing impairment was associated with higher scores for language but not for speech in midchildhood.

Child↗
PubMed2006

A protocol for investigation of the effects of outdoor air pollution on stroke incidence, phenotypes and survival using the South London Stroke Register.

Stroke is a major cause of death and disability. About 5.3 million people die every year from stroke worldwide with over 9 million people surviving at any one time after suffering a stroke. About 1 in 4 men and 1 in 5 women aged 45 years will suffer a stroke if they live to their 85th year. It is estimated that by 2023 there will be an absolute increase in the number of people experiencing a first ever stroke of about 30% compared with 1983. In the UK, stroke is the third commonest cause of death and the most common cause of adult physical disability and consumes 5% of the health and social services budget. Stroke is assuming strategic public health importance because of increased awareness in society, an ageing population and emerging new treatments. It is an NHS health service and research priority, being identified as a target in Our Healthier Nation and the NSF for Older People for prevention and risk factor control and in the NHS Plan as a disease requiring intermediate care planning and reduction in inequalities of care. Whilst a number of risk factors for stroke are well known (e.g. increasing age, ethnicity, socioeconomic deprivation, hypertension), the potential importance of outdoor air pollution as a modifiable risk factor is much less well recognised. This is because studies to date are inconclusive or have methodological limitations. In Sheffield, we estimated that 11% of stroke deaths may be linked to current levels of outdoor air pollution and this high figure is explained by the fact that so many people are exposed to air pollution.We plan to study the effects of outdoor air pollution on stroke using a series of epidemiological (i.e. population based) studies. The purpose of this project is: to examine if short term increases in pollution can trigger a stroke in susceptible individuals, to investigate if the occurrence of stroke is higher amongst people living in more polluted areas (which would be explained by a combination of exposure to short term increases and longer term exposure to higher pollution levels), and to see if people living in more polluted areas have reduced survival following their stroke. We will use geographical information systems, robust statistical methods and powerful grid computing facilities to link and analyse the data. The datasets we will use are the South London Stroke Register database, daily monitored pollution data from national monitoring networks and modelled pollution data for London from the Greater London Authority. The South London Stroke Register records information on all patients who suffer a stroke ("incident" cases) living within a defined area. This stroke incidence dataset offers major advantages over previous studies examining the effects of pollution on hospital admissions and mortality, as not all patients with stroke are admitted or die and there may be a delay between the onset of stroke and admission or death. In addition, it contains other useful information, particularly the type of stroke people have suffered. Air pollution is a potentially modifiable risk factor for stroke. This study will provide robust population level evidence regarding the effects of outdoor air pollution on stroke. If it confirms the link, it will suggest to policy-makers at national and international levels that targeting policy interventions at high pollution areas may be a feasible option for stroke prevention.

Adult↗
PubMed2006

The effect of helium and oxygen on exercise performance in chronic obstructive pulmonary disease: a randomized crossover trial.

RATIONALE: Breathing supplemental oxygen reduces breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD). Replacing nitrogen with helium reduces expiratory flow resistance and may improve lung emptying. Combining these treatments should be independently effective. OBJECTIVES: Study the effect of changing oxygen or helium concentration in inspired gas during exercise in patients with stable COPD. METHODS: In 82 patients (mean age, 69.7 yr; mean FEV(1), 42.6% predicted), we measured endurance shuttle walking distance, resting and exercise oxygen saturation, and end-exercise dyspnea (Borg scale) while patients breathed Heliox28 (72% He/28% O(2)), Heliox21 (79% He/21% O(2)), Oxygen28 (72% N(2)/28% O(2)), or medical air (79% N(2)/21% O(2)). Gases were administered using a randomized, blinded, crossover design via a face mask and an inspiratory demand valve. RESULTS: Breathing Heliox28 increased walking distance (mean+/-SD, 147+/-150 m) and reduced Borg score (-1.28+/-1.30) more than any other gas mixture. Heliox21 significantly increased walking distance (99+/-101 m) and reduced dyspnea (Borg score, -0.76+/-0.77) compared with medical air. These changes were similar to those breathing Oxygen28. The effects of helium and oxygen in Heliox28 were independent. The increase in walking distance while breathing Heliox28 was inversely related to baseline FEV(1) breathing air. CONCLUSION: Reducing inspired gas density can improve exercise performance in COPD as much as increasing inspired oxygen. These effects can be combined as Heliox28 and are most evident in patients with more severe airflow obstruction.

Aged↗
PubMed2006

Diarylureas are small-molecule inhibitors of insulin-like growth factor I receptor signaling and breast cancer cell growth.

In breast and certain other cancers, receptor tyrosine kinases, including the insulin-like growth factor I receptor (IGF-IR), play an important role in promoting the oncogenic process. The IGF-IR is therefore an important target for developing new anti-breast cancer therapies. An initial screening of a chemical library against the IGF-IR in breast cancer cells identified a diaryl urea compound as a potent inhibitor of IGF-IR signaling. This class of compounds has not been studied as inhibitors of the IGF-IR. We studied the effectiveness of one diaryl urea compound, PQ401, at antagonizing IGF-IR signaling and inhibiting breast cancer cell growth in culture and in vivo. PQ401 inhibited autophosphorylation of the IGF-IR in cultured human MCF-7 cells with an IC50 of 12 micromol/L and autophosphorylation of the isolated kinase domain of the IGF-IR with an IC50 <1 micromol/L. In addition, PQ401 inhibited the growth of cultured breast cancer cells in serum at 10 micromol/L. PQ401 was even more effective at inhibiting IGF-I-stimulated growth of MCF-7 cells (IC50, 6 micromol/L). Treatment of MCF-7 cells with PQ401 was associated with a decrease in IGF-I-mediated signaling through the Akt antiapoptotic pathway. Twenty-four hours of treatment with 15 micromol/L PQ401 induced caspase-mediated apoptosis. In vivo, treatment with PQ401 (i.p. injection thrice a week) reduced the growth rate of MCNeuA cells implanted into mice. These studies indicate that diaryl urea compounds are potential new agents to test in the treatment of breast and other IGF-I-sensitive cancers.

Aminoquinolines↗
PubMed2005

Outdoor air pollution, mortality, and hospital admissions from coronary heart disease in Sheffield, UK: a small-area level ecological study.

AIMS: To examine the hypothesis that coronary heart disease mortality and emergency hospital admission rates are higher in areas with higher outdoor air pollution levels. METHODS AND RESULTS: Modelled nitrogen oxides (NO(x)), particulate matter (PM(10)), and carbon monoxide (CO) levels were interpolated to 1030 census enumeration districts using an ecological study design. Results, based on 6857 deaths and 11,407 admissions from 1994-98 and a population of 199,682 aged >or=45 years, were adjusted for age, sex, deprivation, and smoking prevalence. Mortality rate ratios were 1.17 (95% CI 1.06-1.29), 1.08 (95% CI 0.96-1.20), and 1.05 (95% CI 0.95-1.16) in the highest relative to the lowest NO(x), PM(10), and CO quintile categories, respectively. Corresponding admission rate ratios were 1.00 (95% CI 0.90-1.10), 1.01 (95% CI 0.90-1.14), and 0.88 (95% CI 0.79-0.98). CONCLUSION: The results are consistent with an excess risk of coronary heart disease mortality in areas with high outdoor NO(x), a proxy for traffic-related pollution, but residual confounding cannot be ruled out. If causality were assumed, 6% of coronary heart disease deaths would have been attributable to outdoor NO(x,) and targeting pollution reduction measures at high pollution areas would be an option for coronary mortality prevention.

Age Distribution↗
PubMed2005

The use of bootstrap methods for estimating sample size and analysing health-related quality of life outcomes.

Health-related quality of life (HRQoL) measures are increasingly used in trials as primary outcome measures. Investigators are now asking statisticians for advice on how to plan and analyse studies using such outcomes. HRQoL outcomes, like the SF-36, are usual measured on an ordinal scale, although most investigators assume that there exists an underlying continuous latent variable and that the actual measured outcomes (the ordered categories) reflect contiguous intervals along this continuum. The ordinal scaling of HRQoL measures means they tend to generate data that have discrete, bounded and skewed distributions. Thus, standard methods of analysis that assume Normality and constant variance may not be appropriate. For this reason, conventional statistical advice would suggest non-parametric methods be used to analyse HRQoL data. The bootstrap is one such computer intensive non-parametric method for estimating sample sizes and analysing data. We describe three methods of estimating sample sizes for two-group cross-sectional comparisons of HRQoL outcomes. We then compared the power of the three methods for a two-group cross-sectional study design using bootstrap simulation. The results showed that under the location shift alternative hypothesis, conventional methods of sample size estimation performed well, particularly Whitehead's method. Whitehead's method is recommended if the HRQoL outcome has a limited number of discrete values (<7) and/or the expected proportion of cases at either of the bounds is high. If a pilot data set is readily available then bootstrap simulation will provide a more accurate and reliable estimate, than conventional methods.Finally, we used the bootstrap for hypothesis testing and the estimation of standard errors and confidence intervals for parameters, in an example data set. We then compared and contrasted the bootstrap with standard methods of analysing HRQoL outcomes. In the data set studied, with the SF-36 outcome, the use of the bootstrap for estimating sample sizes and analysing HRQoL data produces results similar to conventional statistical methods. These results suggest that bootstrap methods are not more appropriate for analysing HRQoL outcome data than standard methods.

Adolescent↗
PubMed2005

The PANTHER database of protein families, subfamilies, functions and pathways.

PANTHER is a large collection of protein families that have been subdivided into functionally related subfamilies, using human expertise. These subfamilies model the divergence of specific functions within protein families, allowing more accurate association with function (ontology terms and pathways), as well as inference of amino acids important for functional specificity. Hidden Markov models (HMMs) are built for each family and subfamily for classifying additional protein sequences. The latest version, 5.0, contains 6683 protein families, divided into 31,705 subfamilies, covering approximately 90% of mammalian protein-coding genes. PANTHER 5.0 includes a number of significant improvements over previous versions, most notably (i) representation of pathways (primarily signaling pathways) and association with subfamilies and individual protein sequences; (ii) an improved methodology for defining the PANTHER families and subfamilies, and for building the HMMs; (iii) resources for scoring sequences against PANTHER HMMs both over the web and locally; and (iv) a number of new web resources to facilitate analysis of large gene lists, including data generated from high-throughput expression experiments. Efforts are underway to add PANTHER to the InterPro suite of databases, and to make PANTHER consistent with the PIRSF database. PANTHER is now publicly available without restriction at http://panther.appliedbiosystems.com.

Animals↗
PubMed2005

In vitro anticancer activity of twelve Chinese medicinal herbs.

Aqueous extracts of 12 Chinese medicinal herbs, Anemarrhena asphodeloides, Artemisia argyi, Commiphora myrrha, Duchesnea indica, Gleditsia sinensis, Ligustrum lucidum, Rheum palmatum, Rubia cordifolia, Salvia chinensis, Scutellaria barbata, Uncaria rhychophylla and Vaccaria segetalis were evaluated for their antiproliferative activity on eight cancer cell lines as well as on normal human mammary epithelial cells. Five human and three murine cancer cell lines representing different tissues (breast, lung, pancreas and prostate) were used. All the crude aqueous extracts demonstrated growth inhibitory activity on some or all of the cancer cell lines, but only two showed activity against the normal mammary epithelial cells. Overall, the murine cell lines tended to be more sensitive to most of the extracts compared with the human cell lines. Among the human cell lines, cell type specificity was observed for two extracts. These results indicate the potential use of traditional Chinese medicinal herbs as antineoplastic agents and suggest that further studies evaluating their mechanism(s) of action and the isolation of active antitumor compounds are warranted.

Animals↗
PubMed2005

Immune dysfunction and micrometastases in women with breast cancer.

Cytokines produced by T lymphocytes are critical to the efficacy of a given immune response and dysregulation of immune responses may play a role in cancer progression. We assessed the intracellular cytokine profiles of T cells in the peripheral blood of women with breast cancer and explored the relationship of these responses with the presence of cancer in lymph nodes and bone marrow. Peripheral blood lymphocytes from 84 patients and 26 healthy volunteers were analyzed by 4-color flow cytometry for surface markers and for intracellular cytokines. Bone marrow samples from some of these patients were also collected and analyzed for the presence of epithelial cells (micrometastases) by flow cytometry. The percentages of both CD4(+) and CD8(+) cells producing type1 (IL-2, IFN-gamma or TNF-alpha) and type 2 (IL-4) were significantly lower in patients with breast cancer compared to healthy controls. These results indicate a general immune dysfunction in these patients as opposed to a shift in the balance of type1 and type2 cells. These dysregulated T cell responses did not correlate with age, stage of disease, or nodal status. However, we did observe a correlation between number of micrometastases in the bone marrow and T cell responsiveness.

Adult↗
PubMed2005

Do 'food deserts' influence fruit and vegetable consumption?--A cross-sectional study.

Lack of access to affordable healthy foods has been suggested to be a contributory factor to poor diet. This study investigated associations between diet and access to supermarkets, transport, fruit and vegetable price and deprivation, in a region divergent in geography and socio-economic indices. A postal survey of 1000 addresses (response rate 42%) gathered information on family demographics, supermarket and shop use, car ownership, mobility and previous day's fruit and vegetable intake. Postcode information was used to derive road travel distance to nearest supermarket and deprivation index. Fruit and vegetable prices were assessed using a shopping basket survey. Generalised linear regression models were used to ascertain predictors of fruit and vegetable intake. Male grocery shoppers ate less fruit than female grocery shoppers. Consumption of vegetables increased slightly with age. Deprivation, supermarket fruit and vegetable price, distance to nearest supermarket and potential difficulties with grocery shopping were not significantly associated with either fruit or vegetable consumption. These data suggest that the three key elements of a food desert, fruit and vegetable price, socio-economic deprivation and a lack of locally available supermarkets, were not factors influencing fruit or vegetable intake. We suggest that food policies aimed at improving diet should be orientated towards changing socio-cultural attitudes towards food.

Cross-Sectional Studies↗
PubMed2004

Outdoor air pollution and stroke in Sheffield, United Kingdom: a small-area level geographical study.

BACKGROUND AND PURPOSE: Current evidence suggests that stroke mortality and hospital admissions should be higher in areas with elevated levels of outdoor air pollution because of the combined acute and chronic exposure effects of air pollution. We examined this hypothesis using a small-area level ecological correlation study. METHODS: We used 1030 census enumeration districts as the unit of analysis and examined stroke deaths and hospital admissions from 1994 to 1998, with census denominator counts for people > or =45 years. Modeled air pollution data for particulate matter (PM10), nitrogen oxides (NO(x)), and carbon monoxide (CO) were interpolated to census enumeration districts. We adjusted for age, sex, socioeconomic deprivation, and smoking prevalence. RESULTS: The analysis was based on 2979 deaths, 5122 admissions, and a population of 199 682. After adjustment for potential confounders, stroke mortality was 37% (95% CI, 19 to 57), 33% (95% CI, 14 to 56), and 26% (95% CI, 10 to 46) higher in the highest, relative to the lowest, NO(x), PM10, and CO quintile categories, respectively. Corresponding increases in risk for admissions were 13% (95% CI, 1 to 27), 13% (95% CI, -1 to 29), and 11% (95% CI, -1 to 25). CONCLUSIONS: The results are consistent with an excess risk of stroke mortality and, to a lesser extent, hospital admissions in areas with high outdoor air pollution levels. If causality were assumed, 11% of stroke deaths would have been attributable to outdoor air pollution. Targeting policy interventions at high pollution areas may be a feasible option for stroke prevention.

Age Factors↗
PubMed2004

A survey of statistics in three UK general practice journal.

BACKGROUND: Many medical specialities have reviewed the statistical content of their journals. To our knowledge this has not been done in general practice. Given the main role of a general practitioner as a diagnostician we thought it would be of interest to see whether the statistical methods reported reflect the diagnostic process. METHODS: Hand search of three UK journals of general practice namely the British Medical Journal (general practice section), British Journal of General Practice and Family Practice over a one-year period (1 January to 31 December 2000). RESULTS: A wide variety of statistical techniques were used. The most common methods included t-tests and Chi-squared tests. There were few articles reporting likelihood ratios and other useful diagnostic methods. There was evidence that the journals with the more thorough statistical review process reported a more complex and wider variety of statistical techniques. CONCLUSIONS: The BMJ had a wider range and greater diversity of statistical methods than the other two journals. However, in all three journals there was a dearth of papers reflecting the diagnostic process. Across all three journals there were relatively few papers describing randomised controlled trials thus recognising the difficulty of implementing this design in general practice.

Bibliometrics↗
PubMed2004

The use of bootstrap methods for analysing Health-Related Quality of Life outcomes (particularly the SF-36).

Health-Related Quality of Life (HRQoL) measures are becoming increasingly used in clinical trials as primary outcome measures. Investigators are now asking statisticians for advice on how to analyse studies that have used HRQoL outcomes.HRQoL outcomes, like the SF-36, are usually measured on an ordinal scale. However, most investigators assume that there exists an underlying continuous latent variable that measures HRQoL, and that the actual measured outcomes (the ordered categories), reflect contiguous intervals along this continuum. The ordinal scaling of HRQoL measures means they tend to generate data that have discrete, bounded and skewed distributions. Thus, standard methods of analysis such as the t-test and linear regression that assume Normality and constant variance may not be appropriate. For this reason, conventional statistical advice would suggest that non-parametric methods be used to analyse HRQoL data. The bootstrap is one such computer intensive non-parametric method for analysing data. We used the bootstrap for hypothesis testing and the estimation of standard errors and confidence intervals for parameters, in four datasets (which illustrate the different aspects of study design). We then compared and contrasted the bootstrap with standard methods of analysing HRQoL outcomes. The standard methods included t-tests, linear regression, summary measures and General Linear Models.Overall, in the datasets we studied, using the SF-36 outcome, bootstrap methods produce results similar to conventional statistical methods. This is likely because the t-test and linear regression are robust to the violations of assumptions that HRQoL data are likely to cause (i.e. non-Normality). While particular to our datasets, these findings are likely to generalise to other HRQoL outcomes, which have discrete, bounded and skewed distributions. Future research with other HRQoL outcome measures, interventions and populations, is required to confirm this conclusion.

Arthritis, Rheumatoid↗