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1.  Ultra-radical (extensive) surgery versus standard surgery for the primary cytoreduction of advanced epithelial ovarian cancer 
Ovarian cancer is the sixth most common cancer among women and the leading cause of death in women with gynaecological malignancies. Opinions differ regarding the role of ultra-radical (extensive) cytoreductive surgery in ovarian cancer treatment.
To evaluate the effectiveness and morbidity associated with ultra-radical/extensive surgery in the management of advanced stage ovarian cancer.
Search methods
We searched the Cochrane Gynaecological Cancer Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 4), MEDLINE and EMBASE (up to November 2010). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field.
Selection criteria
Randomised controlled trials (RCTs) or non-randomised studies, analysed using multivariate methods, that compared ultra-radical/extensive and standard surgery in adult women with advanced primary epithelial ovarian cancer.
Data collection and analysis
Two review authors independently assessed whether potentially relevant studies met the inclusion criteria, abstracted data and assessed the risk of bias. One non-randomised study was identified so no meta-analyses were performed.
Main results
One non-randomised study met our inclusion criteria. It analysed retrospective data for 194 women with stage IIIC advanced epithelial ovarian cancer who underwent either ultra-radical (extensive) or standard surgery and reported disease specific overall survival and perioperative mortality. Multivariate analysis, adjusted for prognostic factors, identified better disease specific survival among women receiving ultra-radical surgery, although this was not statistically significant (Hazard ratio (HR) = 0.64, 95% confidence interval (CI): 0.40 to 1.04). In a subset of 144 women with carcinomatosis, those who underwent ultra-radical surgery had significantly better disease specific survival than women who underwent standard surgery (adjusted HR = 0.64, 95% CI 0.41 to 0.98). Progression-free survival and quality of life (QoL) were not reported and adverse events were incompletely documented. The study was at high risk of bias.
Authors’ conclusions
We found only low quality evidence comparing ultra-radical and standard surgery in women with advanced ovarian cancer and carcinomatosis. The evidence suggested that ultra-radical surgery may result in better survival. It was unclear whether there were any differences in progression-free survival, QoL and morbidity between the two groups. The cost-effectiveness of this intervention has not been investigated. We are, therefore, unable to reach definite conclusions about the relative benefits and adverse effects of the two types of surgery.
In order to determine the role of ultra-radical surgery in the management of advanced stage ovarian cancer, a sufficiently powered randomised controlled trial comparing ultra-radical and standard surgery or well-designed non-randomised studies would be required.
PMCID: PMC4028614  PMID: 21491400
2.  Centralisation of services for gynaecological cancer 
Gynaecological cancers are the second most common cancers among women. It has been suggested that centralised care improves outcomes but consensus is lacking.
To assess the effectiveness of centralisation of care for patients with gynaecological cancer.
Search methods
We searched the Cochrane Gynaecological Cancer Group Trials Register, CENTRAL (The Cochrane Library, Issue 4, 2010), MEDLINE, and EMBASE up to November 2010. We also searched registers of clinical trials, abstracts of scientific meetings, and reference lists of included studies.
Selection criteria
We included randomised controlled trials (RCTs), quasi-RCTs, controlled before-and-after studies, interrupted time series studies, and observational studies that examined centralisation of services for gynaecological cancer, and used multivariable analysis to adjust for baseline case mix.
Data collection and analysis
Three review authors independently extracted data, and two assessed risk of bias. Where possible, we synthesised the data on survival in a meta-analysis.
Main results
Five studies met our inclusion criteria; all were retrospective observational studies and therefore at high risk of bias.
Meta-analysis of three studies assessing over 9000 women suggested that institutions with gynaecologic oncologists on site may prolong survival in women with ovarian cancer, compared to community or general hospitals: hazard ratio (HR) of death was 0.90 (95% confidence interval (CI) 0.82 to 0.99). Similarly, another meta-analysis of three studies assessing over 50,000 women, found that teaching centres or regional cancer centres may prolong survival in women with any gynaecological cancer compared to community or general hospitals (HR 0.91; 95% CI 0.84 to 0.99). The largest of these studies included all gynaecological malignancies and assessed 48,981 women, so the findings extend beyond ovarian cancer. One study compared community hospitals with semi-specialised gynaecologists versus general hospitals and reported non-significantly better disease-specific survival in women with ovarian cancer (HR 0.89; 95% CI 0.78 to 1.01). The findings of included studies were highly consistent. Adverse event data were not reported in any of the studies.
Authors’ conclusions
We found low quality, but consistent evidence to suggest that women with gynaecological cancer who received treatment in specialised centres had longer survival than those managed elsewhere. The evidence was stronger for ovarian cancer than for other gynaecological cancers.
Further studies of survival are needed, with more robust designs than retrospective observational studies. Research should also assess the quality of life associated with centralisation of gynaecological cancer care. Most of the available evidence addresses ovarian cancer in developed countries; future studies should be extended to other gynaecological cancers within different healthcare systems.
PMCID: PMC4020155  PMID: 22419327
3.  Association Between Participation in Life Situations of Children With Cerebral Palsy and Their Physical, Social, and Attitudinal Environment: A Cross-Sectional Multicenter European Study 
Archives of physical medicine and rehabilitation  2012;93(12):10.1016/j.apmr.2012.07.011.
To evaluate how participation of children with cerebral palsy (CP) varied with their environment.
Home visits to children. Administration of Assessment of Life Habits and European Child Environment Questionnaires. Structural equation modeling of putative associations between specific domains of participation and environment, while allowing for severity of child’s impairments and pain.
European regions with population-based registries of children with CP.
Children (n=1174) aged 8 to 12 years were randomly selected from 8 population-based registries of children with CP in 6 European countries. Of these, 743 (63%) agreed to participate; 1 further region recruited 75 children from multiple sources. Thus, there were 818 children in the study.
Not applicable.
Main Outcome Measure
Participation in life situations.
For the hypothesized associations, the models confirmed that higher participation was associated with better availability of environmental items. Higher participation in daily activities—mealtimes, health hygiene, personal care, and home life—was significantly associated with a better physical environment at home (P<.01). Mobility was associated with transport and physical environment in the community. Participation in social roles (responsibilities, relationships, recreation) was associated with attitudes of classmates and social support at home. School participation was associated with attitudes of teachers and therapists. Environment explained between 14% and 52% of the variation in participation.
The findings confirmed the social model of disability. The physical, social, and attitudinal environment of disabled children influences their participation in everyday activities and social roles.
PMCID: PMC3826325  PMID: 22846455
Cerebral palsy; Child; Environment; Models, statistical; Rehabilitation; Social participation
4.  Predictors of drop-out in a multi-centre longitudinal study of participation and quality of life of children with cerebral palsy 
BMC Research Notes  2012;5:300.
SPARCLE is a study across nine European regions which examines the predictors of participation and quality of life of children with cerebral palsy. Children and their families were initially interviewed in 2004/2005 when the children were aged 8–12 years (SPARCLE1); they were approached again in 2009/2010 at age 13–17 years (SPARCLE2). The objective of this report is to assess potential for bias due to family non-response in SPARCLE2. Logistic regression was used to assess whether socio-demographic factors, parental stress and child impairment were related to non-response, both overall and by category (failure to trace families, death of child, traced families declining to participate).
Of the 818 families who participated in SPARCLE1, 224/818 (27%) did not participate in SPARCLE2. 51/818 (6%) were not traced. Among the 767 traced families, 32/767 (4%) children with cerebral palsy had died, seven children had been incorrectly diagnosed as having cerebral palsy, thirteen families had moved out of the region and one family had language problems. Of the remaining 714 families, 120/714 (17%) declined to participate. Drop-out between SPARCLE1 and SPARCLE2 varied significantly between regions; families were more difficult to trace and more likely to decline to participate if the parents’ educational qualifications, as recorded in SPARCLE1, were lower; they were also more likely to decline to participate if SPARCLE1 recorded that they were more stressed or if they had not completed a SPARCLE1 stress questionnaire.
To reduce the risk of bias, all SPARCLE2 analyses should allow for factors (region and walking ability) which determined the sampling strategy, either by adjusting for these factors or by using sampling weights. Further analyses should be performed, adjusting for additional factors that were associated with non-response: parents' educational qualifications, family structure and parental stress. To allow for differential non-response in studies which sample from population registers, such registers should routinely record socio-demographic information.
PMCID: PMC3502092  PMID: 22704327
Attrition; Longitudinal study; Cerebral palsy
5.  Study protocol: Determinants of participation and quality of life of adolescents with cerebral palsy: a longitudinal study (SPARCLE2) 
BMC Public Health  2010;10:280.
Children and adults with impairments such as cerebral palsy have lower participation in life situations than able-bodied people. Less is known about their subjective perception of their lives, called their quality of life.
During adolescence, rapid physical and psychological changes occur; although these may be more difficult for disabled than for able-bodied adolescents, little research has examined the lives of disabled adolescents.
In 2003-4 a European Union funded project, SPARCLE, visited 818 children aged 8-12 years with cerebral palsy, sampled from population-based registers in nine European regions. The quality of life reported by these disabled children was similar to that of the general population but their participation was lower; levels of participation varied between countries even for children with similar severity of cerebral palsy.
We are currently following up these children, now aged 13-17 years, to identify (i) to what extent contemporaneous factors (pain, impairment, psychological health and parental stress) predict their participation and quality of life, (ii) what factors modify how participation and quality of life at age 8-12 years are associated with participation and quality of life in adolescence, and (iii) whether differences between European countries in participation and quality of life can be explained by variations in environmental factors.
Trained researchers will visit families to administer questionnaires to capture the adolescents' type and severity of impairment, socio-demographic characteristics, participation, quality of life, psychological health, pain, environmental access and parental stress. We will use multivariable models (linear, logistic or ordinal) to assess how adolescent participation, quality of life, psychological health, pain, environmental access and parental stress, vary with impairment and socio-demographic characteristics and, where possible, how these outcomes compare with general population data. For participation and quality of life, longitudinal analyses will assess to what extent these are predicted by corresponding levels in childhood and what factors modify this relationship. Structural equation modelling will be used to identify indirect relationships mediated by other factors.
PMCID: PMC2885989  PMID: 20504349
6.  Statistical considerations in a systematic review of proxy measures of clinical behaviour 
Studies included in a related systematic review used a variety of statistical methods to summarise clinical behaviour and to compare proxy (or indirect) and direct (observed) methods of measuring it. The objective of the present review was to assess the validity of these statistical methods and make appropriate recommendations.
Electronic bibliographic databases were searched to identify studies meeting specified inclusion criteria. Potentially relevant studies were screened for inclusion independently by two reviewers. This was followed by systematic abstraction and categorization of statistical methods, as well as critical assessment of these methods.
Fifteen reports (of 11 studies) met the inclusion criteria. Thirteen analysed individual clinical actions separately and presented a variety of summary statistics: sensitivity was available in eight reports and specificity in six, but four reports treated different actions interchangeably. Seven reports combined several actions into summary measures of behaviour: five reports compared means on direct and proxy measures using analysis of variance or t-tests; four reported the Pearson correlation; none compared direct and proxy measures over the range of their values. Four reports comparing individual items used appropriate statistical methods, but reports that compared summary scores did not.
We recommend sensitivity and positive predictive value as statistics to assess agreement of direct and proxy measures of individual clinical actions. Summary measures should be reliable, repeatable, capture a single underlying aspect of behaviour, and map that construct onto a valid measurement scale. The relationship between the direct and proxy measures should be evaluated over the entire range of the direct measure and describe not only the mean of the proxy measure for any specific value of the direct measure, but also the range of variability of the proxy measure. The evidence about the relationship between direct and proxy methods of assessing clinical behaviour is weak.
PMCID: PMC2846869  PMID: 20187923
7.  Response rates in postal surveys of healthcare professionals between 1996 and 2005: An observational study 
Postal surveys are a frequently used method of data collection in health services research. Low response rates increase the potential for bias and threaten study validity. The objectives of this study were to estimate current response rates, to assess whether response rates are falling, to explore factors that might enhance response rates and to examine the potential for non-response bias in surveys mailed to healthcare professionals.
A random sample of postal or electronic surveys of healthcare workers (1996-2005) was identified from Medline, Embase or Psycinfo databases or Biomed Central. Outcome measures were survey response rate and non response analysis. Multilevel, multivariable logistic regression examined the relationship between response rate and publication type, healthcare profession, country and number of survey participants, questionnaire length and use of reminders.
The analysis included 350 studies. Average response rate in doctors was 57.5% (95%CI: 55.2% to 59.8%) and significantly lower than the estimate for the prior 10 year period. Response rates were higher when reminders were sent (adjusted OR 1.3; 95%CI 1.1-1.6) but only half the studies did this. Response rates were also higher in studies with fewer than 1000 participants and in countries other than US, Canada, Australia and New Zealand. They were not significantly affected by publication type or healthcare profession (p > 0.05). Only 17% of studies attempted assessment of possible non-response bias.
Response rates to postal surveys of healthcare professionals are low and probably declining, almost certainly leading to unknown levels of bias. To improve the informativeness of postal survey findings, researchers should routinely consider the use of reminders and assess potential for non-response bias.
PMCID: PMC2758861  PMID: 19751504
8.  Are there valid proxy measures of clinical behaviour? a systematic review 
Accurate measures of health professionals' clinical practice are critically important to guide health policy decisions, as well as for professional self-evaluation and for research-based investigation of clinical practice and process of care. It is often not feasible or ethical to measure behaviour through direct observation, and rigorous behavioural measures are difficult and costly to use. The aim of this review was to identify the current evidence relating to the relationships between proxy measures and direct measures of clinical behaviour. In particular, the accuracy of medical record review, clinician self-reported and patient-reported behaviour was assessed relative to directly observed behaviour.
We searched: PsycINFO; MEDLINE; EMBASE; CINAHL; Cochrane Central Register of Controlled Trials; science/social science citation index; Current contents (social & behavioural med/clinical med); ISI conference proceedings; and Index to Theses. Inclusion criteria: empirical, quantitative studies; and examining clinical behaviours. An independent, direct measure of behaviour (by standardised patient, other trained observer or by video/audio recording) was considered the 'gold standard' for comparison. Proxy measures of behaviour included: retrospective self-report; patient-report; or chart-review. All titles, abstracts, and full text articles retrieved by electronic searching were screened for inclusion and abstracted independently by two reviewers. Disagreements were resolved by discussion with a third reviewer where necessary.
Fifteen reports originating from 11 studies met the inclusion criteria. The method of direct measurement was by standardised patient in six reports, trained observer in three reports, and audio/video recording in six reports. Multiple proxy measures of behaviour were compared in five of 15 reports. Only four of 15 reports used appropriate statistical methods to compare measures. Some direct measures failed to meet our validity criteria. The accuracy of patient report and chart review as proxy measures varied considerably across a wide range of clinical actions. The evidence for clinician self-report was inconclusive.
Valid measures of clinical behaviour are of fundamental importance to accurately identify gaps in care delivery, improve quality of care, and ultimately to improve patient care. However, the evidence base for three commonly used proxy measures of clinicians' behaviour is very limited. Further research is needed to better establish the methods of development, application, and analysis for a range of both direct and proxy measures of behaviour.
PMCID: PMC2713194  PMID: 19575790
9.  Participation in life situations of 8-12 year old children with cerebral palsy: cross sectional European study 
Objectives To evaluate how involvement in life situations (participation) in children with cerebral palsy varies with type and severity of impairment and to investigate geographical variation in participation.
Design Cross sectional study. Trained interviewers visited parents of children with cerebral palsy; multilevel multivariable regression related participation to impairments, pain, and sociodemographic characteristics.
Setting Eight European regions with population registers of children with cerebral palsy; one further region recruited children from multiple sources.
Participants 1174 children aged 8-12 with cerebral palsy randomly selected from the population registers, 743 (63%) joined in the study; the further region recruited 75 children.
Main outcome measure Children’s participation assessed by the Life-H questionnaire covering 10 main areas of daily life. Scoring ignored adaptations or assistance required for participation.
Results Children with pain and those with more severely impaired walking, fine motor skills, communication, and intellectual abilities had lower participation across most domains. Type of cerebral palsy and problems with feeding and vision were associated with lower participation for specific domains, but the sociodemographic factors examined were not. Impairment and pain accounted for up to a sixth of the variation in participation. Participation on all domains varied substantially between regions: children in east Denmark had consistently higher participation than children in other regions. For most participation domains, about a third of the unexplained variation could be ascribed to variation between regions and about two thirds to variation between individuals.
Conclusions Participation in children with cerebral palsy should be assessed in clinical practice to guide intervention and assess its effect. Pain should be carefully assessed. Some European countries facilitate participation better than others, implying some countries could make better provision. Legislation and regulation should be directed to ensuring this happens.
PMCID: PMC2673343  PMID: 19395424
10.  Do self- reported intentions predict clinicians' behaviour: a systematic review 
Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice. Several interventions have been shown to be effective in changing health care professionals' behaviour, but heterogeneity within interventions, targeted behaviours, and study settings make generalisation difficult. Therefore, it is necessary to identify the 'active ingredients' in professional behaviour change strategies. Theories of human behaviour that feature an individual's "intention" to do something as the most immediate predictor of their behaviour have proved to be useful in non-clinical populations. As clinical practice is a form of human behaviour such theories may offer a basis for developing a scientific rationale for the choice of intervention to use in the implementation of new practice. The aim of this review was to explore the relationship between intention and behaviour in clinicians and how this compares to the intention-behaviour relationship in studies of non-clinicians.
We searched: PsycINFO, MEDLINE, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, Science/Social science citation index, Current contents (social & behavioural med/clinical med), ISI conference proceedings, and Index to Theses. The reference lists of all included papers were checked manually. Studies were eligible for inclusion if they had: examined a clinical behaviour within a clinical context, included measures of both intention and behaviour, measured behaviour after intention, and explored this relationship quantitatively. All titles and abstracts retrieved by electronic searching were screened independently by two reviewers, with disagreements resolved by discussion.
Ten studies were found that examined the relationship between intention and clinical behaviours in 1623 health professionals. The proportion of variance in behaviour explained by intention was of a similar magnitude to that found in the literature relating to non-health professionals. This was more consistently the case for studies in which intention-behaviour correspondence was good and behaviour was self-reported. Though firm conclusions are limited by a smaller literature, our findings are consistent with that of the non-health professional literature. This review, viewed in the context of the larger populations of studies, provides encouragement for the contention that there is a predictable relationship between the intentions of a health professional and their subsequent behaviour. However, there remain significant methodological challenges.
PMCID: PMC1664582  PMID: 17118180
11.  Methods underpinning national clinical guidelines for hypertension: describing the evidence shortfall 
To be useful, clinical practice guidelines need to be evidence based; otherwise they will not achieve the validity, reliability and credibility required for implementation.
This paper compares the methods used in gathering, analysing and linking of evidence to guideline recommendations in ten current hypertension guidelines.
It found several guidelines had failed to implement methods of searching for the relevant literature, critical analysis and linking to recommendations that minimise the risk of bias in the interpretation of research evidence. The more rigorous guidelines showed discrepancies in recommendations and grading that reflected different approaches to the use of evidence in guideline development.
Clinical practice guidelines as a methodology are clearly still an evolving health care technology.
PMCID: PMC1475569  PMID: 16597334
12.  The causes of childhood leukaemia 
BMJ : British Medical Journal  2005;330(7503):1279-1280.
PMCID: PMC558187  PMID: 15933336
14.  Cancer trends in England and Wales  
BMJ : British Medical Journal  2000;320(7239):884-885.
PMCID: PMC1117816  PMID: 10741974
15.  Risk of cardiovascular disease measured by carotid intima-media thickness at age 49-51: lifecourse study 
BMJ : British Medical Journal  2000;320(7230):273-278.
To quantify the direct and indirect effects of fetal life, childhood, and adult life on risk of cardiovascular disease at age 49-51 years.
Follow up study of the “Newcastle thousand families” birth cohort established in 1947.
154 men and 193 women who completed a health and lifestyle questionnaire and attended for clinical examination between October 1996 and December 1998.
Main outcome measures
Correlations between mean intima-media thickness of the carotid artery (carotid intima-media thickness) and family history, birth weight, and socioeconomic position around birth; socioeconomic position, growth, illness, and adverse life events in childhood; and adult socioeconomic position, lifestyle, and biological risk markers. Proportions of variance in carotid intima-media thickness that were accounted for by each stage of the lifecourse.
Socioeconomic position at birth and birth weight were negatively associated with carotid intima-media thickness, although only social class at birth in women was a statistically significant covariate independent of adult lifestyle. These early life variables accounted directly for 2.2% of total variance in men and 2.0% in women. More variation in carotid intima-media thickness was explained by adult socioeconomic position and lifestyle, which accounted directly and indirectly for 3.4% of variance in men (95% confidence interval 0.5% to 6.2%) and 7.6% in women (2.1% to 13.0%). Biological risk markers measured in adulthood independently accounted for a further 9.5% of variance in men (2.4% to 14.2%) and 4.9% in women (1.6% to 7.4%).
Adult lifestyle and biological risk markers were the most important determinants of the cardiovascular health of the study members of the Newcastle thousand families cohort at age 49-51 years. The limited overall effect of early life factors may reflect the postwar birth year of this cohort.
PMCID: PMC27272  PMID: 10650022
16.  Pain in young people aged 13 to 17 years with cerebral palsy: cross-sectional, multicentre European study 
Archives of Disease in Childhood  2013;98(6):434-440.
To determine the prevalence and associations of self- and parent-reported pain in young people with cerebral palsy (CP).
Design and setting
Cross-sectional questionnaire survey conducted at home visits in nine regions in seven European countries. Participants were 13 to 17-year-olds (n=667) drawn from population CP registers in eight regions and from multiple sources in one region. 429 could self-report; parent-reports were obtained for 657. Data were collected on: severity, frequency, site and circumstances of pain in previous week; severity of pain associated with therapy in previous year.
The estimated population prevalence of any pain in previous week was 74% (95% CI 69% to 79%) for self-reported pain and 77% (95% CI 73% to 81%) for parent-reported pain. 40% experienced leg pains, 34% reported headaches and 45% of those who received physiotherapy experienced pain during therapy. Girls reported more pain than boys (OR=2.1, 95% CI 1.5 to 3.0) and young people reported more pain if they had emotional difficulties (comparing highest and lowest quartiles: OR=3.1, 95% CI 1.7 to 5.6). Parents reported more pain in children with emotional difficulties (OR=4.2, 95% CI 2.7 to 6.6), or with more impaired walking ability.
Pain in young people with CP is highly prevalent. Because pain causes immediate distress and is associated with lower subjective well-being and reduced participation, clinicians should routinely assess pain. Clinical interventions to reduce pain should be implemented and evaluated. The efficacy of medical and therapeutic interventions causing pain should be re-examined to establish if their benefit justifies the pain and fear of pain that accompany them.
PMCID: PMC3664388  PMID: 23606716
Pain; Neurodisability; Adolescent Health
17.  Parenteral anticoagulation may prolong the survival of patients with limited small cell lung cancer: a Cochrane systematic review 
To determine the efficacy and safety of heparin (unfractionated heparin (UFH) or low-molecular-weight-heparin (LMWH)) and fondaparinux in improving the survival of patients with cancer.
We conducted in January 2007 a comprehensive search for relevant randomized clinical trials (RCTs). We used a standardized form to extract in duplicate data on methodological quality, participants, interventions and outcomes of interest including all cause mortality, thromboembolic events, and bleeding events. We assessed the methodological quality for each outcome by grading the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology
Of 3986 identified citations, we included 5 RCTs, none of which evaluated fondaparinux. The quality of evidence was moderate for survival, low for major and minor bleeding, and very low for DVT. Heparin therapy was associated with a statistically and clinically significant survival benefit (hazard ratio (HR) = 0.77; 95%CI = 0.65–0.91). In subgroup analyses, patients with limited small cell lung cancer experienced a clear survival benefit (HR = 0.56; 95%CI = 0.38–0.83). The survival benefit was not statistically significant for either patients with extensive small cell lung cancer (HR = 0.80; 95%CI = 0.60–1.06) or patients with advanced cancer (HR = 0.84; 95%CI = 0.68–1.03). The increased risk of bleeding with heparin was not statistically significant (relative risk (RR) = 1.78; 95%CI = 0.73–4.38).
This review suggests a survival benefit of heparin in cancer patients in general, and in patients with limited small cell lung cancer in particular.
PMCID: PMC2438335  PMID: 18577254

Results 1-17 (17)