Assessing and addressing cognitive impairment in bipolar disorder: the International Society for Bipolar Disorders Targeting Cognition Task Force recommendations for clinicians.

OBJECTIVES: Cognition is a new treatment target to aid functional recovery and enhance quality of life for patients with bipolar disorder. The International Society for Bipolar Disorders (ISBD) Targeting Cognition Task Force aimed to develop consensus-based clinical recommendations on whether, when and how to assess and address cognitive impairment. METHODS: The task force, consisting of 19 international experts from nine countries, discussed the challenges and recommendations in a face-to-face meeting, telephone conference call and email exchanges. Consensus-based recommendations were achieved through these exchanges with no need for formal consensus methods. RESULTS: The identified questions were: (I) Should cognitive screening assessments be routinely conducted in clinical settings? (II) What are the most feasible screening tools? (III) What are the implications if cognitive impairment is detected? (IV) What are the treatment perspectives? Key recommendations are that clinicians: (I) formally screen cognition in partially or fully remitted patients whenever possible, (II) use brief, easy-to-administer tools such as the Screen for Cognitive Impairment in Psychiatry and Cognitive Complaints in Bipolar Disorder Rating Assessment, and (III) evaluate the impact of medication and comorbidity, refer patients for comprehensive neuropsychological evaluation when clinically indicated, and encourage patients to build cognitive reserve. Regarding question (IV), there is limited evidence for current evidence-based treatments but intense research efforts are underway to identify new pharmacological and/or psychological cognition treatments. CONCLUSIONS: This task force paper provides the first consensus-based recommendations for clinicians on whether, when, and how to assess and address cognition, which may aid patients' functional recovery and improve their quality of life.

Methodological recommendations for cognition trials in bipolar disorder by the International Society for Bipolar Disorders Targeting Cognition Task Force.

OBJECTIVES: To aid the development of treatment for cognitive impairment in bipolar disorder, the International Society for Bipolar Disorders (ISBD) convened a task force to create a consensus-based guidance paper for the methodology and design of cognition trials in bipolar disorder. METHODS: The task force was launched in September 2016, consisting of 18 international experts from nine countries. A series of methodological issues were identified based on literature review and expert opinion. The issues were discussed and expanded upon in an initial face-to-face meeting, telephone conference call and email exchanges. Based upon these exchanges, recommendations were achieved. RESULTS: Key methodological challenges are: lack of consensus on how to screen for entry into cognitive treatment trials, define cognitive impairment, track efficacy, assess functional implications, and manage mood symptoms and concomitant medication. Task force recommendations are to: (i) enrich trials with objectively measured cognitively impaired patients; (ii) generally select a broad cognitive composite score as the primary outcome and a functional measure as a key secondary outcome; and (iii) include remitted or partly remitted patients. It is strongly encouraged that trials exclude patients with current substance or alcohol use disorders, neurological disease or unstable medical illness, and keep non-study medications stable. Additional methodological considerations include neuroimaging assessments, targeting of treatments to illness stage and using a multimodal approach. CONCLUSIONS: This ISBD task force guidance paper provides the first consensus-based recommendations for cognition trials in bipolar disorder. Adherence to these recommendations will likely improve the sensitivity in detecting treatment efficacy in future trials and increase comparability between studies.

Elevated triglycerides are associated with decreased executive function among adolescents with bipolar disorder.

OBJECTIVE: Cardiovascular risk factors that comprise metabolic syndrome (MetS) have been linked with cognition in adults with bipolar disorder (BD). This study examines the association between MetS components and executive function in adolescents with BD. METHODS: A total of 34 adolescents with BD and 35 healthy control (HC) adolescents were enrolled. MetS components included triglycerides, high-density lipoprotein, glucose, waist circumference, and systolic and diastolic blood pressure. Executive functioning was measured using the intra-extra-dimensional (IED) set-shifting task from the Cambridge Neuropsychological Tests Automated Battery. RESULTS: Adolescents with BD were more likely to have ≥1 MetS components (64.7%) as compared to HC participants (22.9%, χ(2) = 12.29, P = <0.001). Adolescents with BD also had poorer IED task performance compared to HC adolescents (composite Z-score: 0.21 ± 0.52 vs. 0.49 ± 0.51, P = 0.011). Within the BD group, IED composite Z-scores were correlated with diastolic blood pressure and triglyceride levels (ρ = -0.358, P = 0.041 and ρ = -0.396, P = 0.020 respectively). The association of triglycerides with executive function remained significant after controlling for age, IQ, and current use of second-generation antipsychotics. CONCLUSION: Elevated triglycerides are associated with poorer executive function among adolescents with BD. Studies of behavioural and pharmacological interventions targeting MetS components for the purpose of improving executive function among adolescents with BD are warranted.

Current smoking is associated with worse cognitive and adaptive functioning in serious mental illness.

OBJECTIVE: Cigarette smoking is highly prevalent among people with bipolar disorder or schizophrenia. Few studies have examined whether smoking history is associated with adaptive functioning among individuals diagnosed with these serious mental illnesses. METHOD: In a large relatively homogenous cohort of patients with either bipolar disorder (n=363) or schizophrenia (n=400), we investigated the association between cigarette smoking status, intensity, and cumulative exposure and performance on a comprehensive battery of neurocognitive, functional capacity, and informant-rated functional measures. The associations were adjusted for variation in sociodemographic indicators, psychopathologic symptoms, and substance use. RESULTS: There was an average of 12 pack years of smoking across the sample. People with schizophrenia reported double the rate of current smoking compared to patients with bipolar disorder. Adjusting for demographic covariates, current smokers had worse composite cognitive functioning and poorer functional outcome than past or never smokers. There were no significant differences between never and past smokers, and these effects were evident in both bipolar disorder and schizophrenia. CONCLUSION: Current smokers with either schizophrenia or bipolar disorder evidence worse cognitive and adaptive functioning functional outcome, even when demographic covariates are considered.

Painting a picture of trans-Tasman mortality.

OBJECTIVES: The determinants of health and mortality inequalities in New Zealand and Australia have been subjected to research, with the influence of a range of socio-economic and demographic influences (deprivation, social class, ethnicity) receiving notable attention. Both countries are considered privileged, positioned amongst the world leaders in rankings of mortality and life expectancy. This paper reports on observed rates of mortality and views how the countries have fared over time with respect to one another. STUDY DESIGN, OBSERVATIONAL, METHODS: This study derives comparable rates of mortality for both New Zealand and Australia, disaggregated by age and sex for the time period 1948-2008. The age-standardised rates are visualised using the Lexis mapping software program, showing the relative differences between the countries over time whilst simultaneously highlighting age, period and cohort effects. RESULTS: Relative to Australia, New Zealand had advantageous rates of mortality across almost all age groups between the years 1948 and 1980 (approximately). For both sexes, a dramatic reversal of fortunes in New Zealand has followed relative to Australia. For example, for younger males in New Zealand, the reversal is startling. Over the time period observed, males aged 10-20 years in New Zealand have moved from an advantageous position of having a mortality rate 20% lower than Australia to a relative position of 50% higher. CONCLUSIONS: The social and economic forces in both New Zealand and Australia which may have driven the divergence require further scrutiny. It is argued here, that the changing fortunes of the populations are linked to the process of selective migration and the large-scale population movements between the countries facilitated by the Trans-Tasman Travel Arrangement. These findings have important implications for policy formation and service planning, if the inequality in mortality between the areas of study is to be addressed.

Is access to alcohol associated with alcohol/substance abuse among people diagnosed with anxiety/mood disorder?

OBJECTIVES: To investigate the relationship between access to off-license alcohol outlets and areas with dual treatment for alcohol/drug abuse and anxiety/mood disorder compared to areas with anxiety/mood disorder only in an urban setting in New Zealand. STUDY DESIGN: Ecologic study. METHODS: Within small areas (2840 meshblocks, mean size 0.05 km(2)) in the city of Auckland, New Zealand, counts of adults receiving anxiety/mood disorder treatment (2008-9) were identified and the proportions of these individuals also receiving treatment for alcohol/drug abuse were generated. Access to off-license alcohol outlets were defined as: 1) shortest road distance from the population-weighted centroid of each small area to an outlet; 2) count of outlets within a 3 km road network buffer; and 3) relative density of outlets across Auckland (determined through kernel density estimates). To test for the relationship between access to alcohol outlets and dual diagnosis, meshblocks without any cases of anxiety/mood disorder were excluded from analyses. Remaining meshblocks were dichotomized into any or no dual diagnosis. Logistic regression was used to estimate the association between access to alcohol outlets and treatment for the dual conditions. RESULTS: Neighbourhoods with dual diagnosis were generally similar to those with anxiety/mood disorder only, in terms of ethnic and gender/age composition. Regression analyses indicated statistically significant decreased risk of dual diagnosis for those areas with the lowest density (using a buffer) of alcohol outlets (OR = 0.75, P-value = 0.027) compared with areas with the highest density, after adjustment for deprivation and population density. All access measures also indicated significant linear trends where dual diagnosis was more likely in areas with greater access. CONCLUSIONS: Generally, decreased access to alcohol outlets was associated with decreased odds of dual diagnosis of alcohol/drug abuse and anxiety/mood disorder. Measures to control access to alcohol outlets may be an important area for alcohol/substance abuse intervention, particularly for vulnerable sub-populations.

Self-assembled hierarchical nanostructures composed of novel chalcopyrite nanosheets for photovoltaic properties.

Self-assembled nanostructures of CulnGaSe2 (CIGS) comprising of nanosheets with sheet thickness of 20 nm have been developed via one-step electrochemically alloying technique. These self-assembled nanoplates exhibit highly intersecting behavior and transform from CuSe to CIGS as the reduction potential was varied. The morphological analysis indicated that the process resulted in a progression of crystallites to a series of heavy dense intersecting nanoplates. Further analyses revealed that the nanostructures keep their integrity on heat treatment. The structure confirms the inclusion of Indium and Gallium at higher reduction potentials and its transition from pseudoamorphous to polycrystalline structure. A strong correlation between reduction potential, and the composition was established. The spectroscopic and optical spectra clearly prove that the direct band gap for the as-grown and annealed thin films, and appropriate for solar cell applications. These self-assembled dense interweaved nanoplates structure have not been observed previously in CIGS semiconductor system and have potential implications forenergy applications.

Cognitive Remediation and Social Recovery in Early Psychosis (CReSt-R): protocol for a pilot randomised controlled study.

BACKGROUND: Psychosis, even in its early stages, is associated with significant disability, causing it to be ranked ahead of paraplegia and blindness in those aged 18-35 in terms of years lived with disability. Current pharmacological and psychological interventions intervention have focused primarily on the reduction of positive symptoms (hallucinations and delusions), with little benefit to domains of psychosis such as cognitive difficulties and social and occupational functioning. METHODS/DESIGN: The CReSt-R intervention trial is a single center, pilot randomised controlled study based at the National University of Ireland (NUI), Galway. The trial will recruit participants from four clinical sites with assessment and intervention completed by the primary NUI Galway team. The trial will explore the feasibility, acceptability, and effectiveness of a novel psychosocial intervention for early psychosis based on a combined cognitive remediation training and cognitive behavioural therapy approach focused on social recovery. Participants, aged 16-35 within the first 5 years of a diagnosed psychotic disorder, will be recruited from the Children and Adolescent Mental Health Service and the Adult Mental Health Services in the region. DISCUSSION: Cognitive remediation training (for improving cognition) and social recovery focused cognitive behavioural therapy, have both separately demonstrated effectiveness. This trial will evaluate the feasibility, acceptability, and explore the efficacy of a treatment approach that combines both approaches as part of an integrated, multicomponent intervention. TRIAL REGISTRATION: Cognitive Remediation & Social Recovery in Early Psychosis (CReSt-R): ClincialTrials.gov Identifier NCT04273685. Trial registered Feb 18th, 2020. Last updated April 14th, 2021.

Evidence supporting the use of a brief cognitive assessment in routine clinical assessment for psychosis.

Cognitive impairment is a core feature of psychosis. Full cognitive assessments are not often conducted in routine clinical practice as administration is time-consuming. Here, we investigated whether brief tests of cognition could be used to predict broader neurocognitive performance in a manner practical for screening use in mental health services. We carried out a principal component analysis (PCA) to obtain an estimate of general cognitive function (N = 415). We investigated whether brief tests of memory accounted for a significant percentage of variation in the PCA scores. We used discriminant function analysis to determine if measures could predict classification as lower, intermediate or higher level of cognitive function and to what extent these groups overlapped with groups based on normative data. Memory tests correctly classified 65% of cases in the highest scoring group, 35% of cases in the intermediate group, and 77% of cases in the lowest scoring group. These PCA-derived groups and groups based on normative scores for the two tests were significantly associated (χ2 = 164.00, p < 0.001). These measures accurately identified three quarters of the low performing group, the group of greatest interest from the perspective of identifying those likely to need greater supports as part of clinical care. In so doing they suggest a potentially useful approach to screening for cognitive impairment in clinical services, upon which further assessment can be built if required.

Sandpile modeling of pellet pacing in fusion plasmas.

Sandpile models have been used to provide simple phenomenological models without incorporating the detailed features of a fully featured model. The Chapman sandpile model [Chapman et al., Phys. Rev. Lett. 86, 2814 (2001)PRLTAO0031-900710.1103/PhysRevLett.86.2814] has been used as an analog for the behavior of a plasma edge, with mass loss events being used as analogs for edge-localized modes (ELMs). In this work we modify the Chapman sandpile model by providing for both increased and intermittent driving. We show that the behavior of the sandpile, when continuously fuelled at very high driving, can be determined analytically by a simple algorithm. We observe that the size of the largest avalanches is better reduced by increasing constant driving than by the intermittent introduction of "pellets" of sand. Using the sandpile model as a reduced model of ELMing behavior, we conject that ELM control in a fusion plasma may similarly prove more effective with increased total fuelling than with pellet addition.

Predictors of mental health and academic outcomes in first-year university students: Identifying prevention and early-intervention targets.

BACKGROUND: Although there is growing interest in mental health problems in university students there is limited understanding of the scope of need and determinants to inform intervention efforts. AIMS: To longitudinally examine the extent and persistence of mental health symptoms and the importance of psychosocial and lifestyle factors for student mental health and academic outcomes. METHOD: Undergraduates at a Canadian university were invited to complete electronic surveys at entry and completion of their first year. The baseline survey measured important distal and proximal risk factors and the follow-up assessed mental health and well-being. Surveys were linked to academic grades. Multivariable models of risk factors and mental health and academic outcomes were fit and adjusted for confounders. RESULTS: In 1530 students surveyed at entry to university 28% and 33% screened positive for clinically significant depressive and anxiety symptoms respectively, which increased to 36% and 39% at the completion of first year. Over the academic year, 14% of students reported suicidal thoughts and 1.6% suicide attempts. Moreover, there was persistence and overlap in these mental health outcomes. Modifiable psychosocial and lifestyle factors at entry were associated with positive screens for mental health outcomes at completion of first year, while anxiety and depressive symptoms were associated with lower grades and university well-being. CONCLUSIONS: Clinically significant mental health symptoms are common and persistent among first-year university students and have a negative impact on academic performance and well-being. A comprehensive mental health strategy that includes a whole university approach to prevention and targeted early-intervention measures and associated research is justified.

Which levels of cognitive impairments and negative symptoms are related to functional deficits in schizophrenia?

BACKGROUND: Negative symptoms and cognitive impairments predict difficulties in aspects of everyday functioning in schizophrenia, with little research to date attempting to determine if there are threshold levels of impairment required to predict the severity of functional deficits. METHODS: People diagnosed with chronic schizophrenia (n = 821) were assessed with the MCCB and PANSS, and rated by high contact informants with SLOF. Negative symptoms of reduced emotional experience were specifically targeted for analysis because of their previously identified relationships with social outcomes. We identified patients with moderate negative symptoms (at least one PANSS item ≥4) versus less severe symptoms (PANSS items ≤3) and divided patients on the basis of a single latent-trait global cognition score (neuropsychologically normal vs neuropsychologically impaired; performance at or below 1.0 SD from the normative population mean, T = 40), then examined correlations between cognition, negative symptoms and everyday functioning in the groups with lower and higher negative symptoms and those with/without cognitive impairment. RESULTS: Even low levels of negative symptoms were correlated with ratings of social functioning. Cognitive performance in the neuropsychologically normal range, in contrast, was not correlated with any aspects of everyday functioning while more impaired performance predicted greater functional impairments. CONCLUSIONS: Even minimal symptoms may be a target for clinical attention in the domains of negative symptoms, consistent with previous findings regarding social deficits in populations with modest negative symptoms (e.g., schizotypal personality disorder). Cognitive rehabilitation treatments might not improve social functioning if even low levels of negative symptoms (social amotivation) are present.

Using tuberculosis suspects to identify patients eligible for antiretroviral treatment.

SETTING: A district in rural sub-Saharan Africa with a recently introduced antiretroviral (ARV) programme. The population has high human immunodeficiency virus (HIV) prevalence and high tuberculosis (TB) incidence. OBJECTIVE: To determine the prevalence of HIV and acquired immune-deficiency syndrome (AIDS) related symptoms in people presenting with chronic cough who are not diagnosed with TB. DESIGN: A cross-sectional survey of TB suspects. METHODS: Patients with chronic cough were recruited from out-patient facilities. After standard diagnostic procedures and providing informed consent, they received counselling and testing for HIV, and were interviewed and examined with respect to staging criteria for HIV/AIDS. Suspects were followed up for 3 months after the end of the recruitment period to allow for delayed diagnosis of TB. RESULTS: Of 145 suspects, 79% had not been diagnosed with TB by the end of the follow-up period. Of these, 108 (95%) agreed to HIV testing and 61 (56%) were HIV-positive. More than half of these were eligible for ARV treatment (Stage III or IV disease) under national programme criteria. CONCLUSION: Established chronic cough clinics are a useful setting for recruitment of patients to ARV clinics. Attendees should be offered HIV testing and simple clinical screening to identify those who should be referred for ARV treatment.

Six-year follow-up study of cognitive and functional status across the lifespan in schizophrenia: a comparison with Alzheimer's disease and normal aging.

OBJECTIVE: Follow-up studies of cognitive functions of poor-outcome (long-term institutionalized) elderly patients with schizophrenia have demonstrated deterioration over time, while stable cognitive functions over time have been reported for younger, better-outcome schizophrenic patients. This study examined whether cognitive changes in elderly schizophrenic patients with a history of long-term institutional stay extended to institutionalized younger patients. The rate of decline was compared to changes associated with Alzheimer's disease. METHOD: Patients with schizophrenia (N=107) age 20-80 years were followed over 6 years and assessed with the Clinical Dementia Rating and the Mini-Mental State Examination. The schizophrenic subjects age 50 and older were compared to 136 healthy comparison subjects and 118 Alzheimer's disease patients age 50 and older who were assessed over a similar follow-up period. RESULTS: There was a significant age group effect on the magnitude of cognitive decline for the schizophrenic subjects, with older subjects experiencing greater levels of decline over the follow-up. Neither the healthy individuals nor the Alzheimer's disease patients demonstrated similar age-related differences in the magnitude of cognitive change over the follow-up, with healthy comparison subjects showing no change and Alzheimer's disease patients manifesting decline regardless of age at the initiation of the follow-up. CONCLUSIONS: Institutionalized schizophrenic patients demonstrated an age-related pattern of cognitive change different from that observed for Alzheimer's disease patients and healthy individuals. The cognitive and functional status of these schizophrenic patients was fairly stable until late life, suggesting that cognitive change may not be occurring in younger patients over an interval as long as 6 years.

What is the prognosis for patients who relapse after primary radiation therapy for early-stage low-grade follicular lymphoma?

PURPOSE: To investigate the potential for long-term survival for patients who relapsed after primary radiation therapy (RT) for early-stage low-grade follicular lymphoma and to assess the relative importance of prognostic factors. METHODS AND MATERIALS: Records were reviewed for 79 patients with stage I (n = 32) and II (n = 47) follicular small cleaved cell (fsc, n = 48) and follicular mixed small cleaved cell and large-cell (fmx, n = 31) lymphoma who relapsed after radical RT at Stanford University. Most patients had received doses of 35 to 45 Gy to involved (n = 30) or extended fields (n = 39) or total/subtotal lymphoid irradiation (n = 9). RESULTS: Median time to relapse was 2 years. Most relapses were detected on history (30%) or physical examination (66%). Positive relapse investigations included lymphangiogram (n = 19), chest radiograph (n = 5), and bone marrow biopsy (n = 6). Known extent of relapsed disease was: stage I, n = 30; stage II, n = 26; stage III, n = 10; and stage IV, n = 8. Patients were managed with "watchful waiting" (37%), further RT (39%), chemotherapy [CT, (17%)], or RT + CT (5%). Actuarial survival rates after relapse at 5, 10, 15, and 20 years were 56%, 35%, 17%, and 17% respectively. Median survival was 5.3 years after relapse. Median survival for relapse stage I, II, III, and IV was 10.2, 5.5, 3.0, and 1.1 years respectively. Progression-free survival rates at 5, 10, 15, and 20 years after relapse were 44%, 22%, 22%, and 22% respectively. Factors associated with reduced survival were increasing age, increasing relapse stage, symptoms, histologic transformation and > or = 3 relapse sites. Survival was the same for initial management with "watchful waiting" or RT. CONCLUSION: Approximately 20% of patients experienced prolonged survival after relapse. Younger, asymptomatic patients with stage I-II relapsed disease had the best outcome but results were inferior to those for newly diagnosed stage I-II disease.

Finding causes of seasonal diseases using time series analysis.

The relationship between monthly Ischaemic Heart Disease mortality and mean monthly temperature and rainfall is examined using data for England and Wales covering the period 1968 to 1976. The statistical procedure adopted involves a time series analysis of each of the individual series employing an approach which has become increasingly popular in other sciences over the last decade. Results indicate the correlation coefficients quoted in previous studies involving monthly data are spuriously high implying that temperature is not as closely related to Ischaemic Heart Disease deaths as has often been claimed.

Sexual behaviour of young people and the risk of HIV infection.

A survey of 16-21 year old people in Somerset was undertaken to find out about their sexual behaviour prior to mounting a local education campaign on AIDS. A representative sample of 400 people, using quota sampling in 40 randomly selected electoral wards, completed a schedule structured part self administered questionnaire. Of these, 371 (92%) considered themselves heterosexual. Nearly half (47%) of the 16 year olds had engaged in sexual intercourse, rising to 89% by the age of 21. Mean frequency of sexual intercourse among the sexually active is 62 per year. The frequency of partner change decreases with increasing age for non-virgins from 2.1 for 16 year olds to 1.5 partner changes per year for 21 year olds (mean frequency 1.7 per year, ie, a new partner every 7 months). This level of sexual activity could eventually give rise to HIV prevalence rates similar to those found in Africa, i.e., 15-100 HIV antibody positive per 1000.

The fundholding fandango.

General practitioner fundholding allows flexible use of resources at the coal-face, provides incentives to alter practice such as prescribing within cash limits and forces hospitals to be more responsive to general practitioner demands. However, the additional administrative costs both in time and money, the fragmentation of purchasing power compounded by a lack of expertise and experience in contracting, and the poor information and financial systems which exist in the National Health Service are severe constraints. A suggested way forward is to delegate responsibility for running the scheme, including the contracting and billing, to district health authorities offering more flexible budgets to all practices and extending the scheme as local information systems allow. This will reduce fragmentation of purchasing power and administrative costs and re-establish local accountability. It will also give the general practitioner more time to see and treat patients, who will see the system as being fairer.

A comprehensive analysis of verbal fluency deficit in geriatric schizophrenia.

Deficits in verbal fluency are common in schizophrenia and may provide keys to some of the abnormalities in the semantic system in schizophrenia. While a number of studies have outlined the severity and implications of verbal fluency deficits in younger schizophrenia patients, these findings have not yet been extended to older patients with schizophrenia. In this study, 392 older (age >/= 50) patients with schizophrenia were administered phonological and semantic (i.e., category) fluency examinations, as well as tests of learning, memory, language, and praxic skills, and rated for clinical symptoms and functional status. When compared to normative standards, 82% of the patients were impaired in semantic fluency and 83% were impaired in phonological fluency. Both semantic and phonological fluency impairment were significantly correlated with other cognitive variables, total scores on the functional status measure, and with the social and self-care subscales. Scores were uncorrelated with the severity of psychosis, but were correlated with the severity of negative symptoms. Furthermore, the severity of poverty of speech (a clinical measure of verbal underproductivity) was moderate in magnitude and failed to enter as a predictor of verbal fluency, indicating that impaired fluency scores are not simply an artifact of general underproductivity or mutism. The findings support conclusions from studies with younger schizophrenia patients that suggest that verbal fluency impairment is a consequence of a disorganized semantic system. Verbal fluency impairment remains common and functionally relevant in schizophrenia patients in late life.

Clinicians' attitudes to recruitment to randomised trials in cancer care: a qualitative study.

OBJECTIVES: To explore attitudes to and problems experienced with recruitment into randomised trials in cancer care. METHODS: In-depth semi-structured interviews with a purposive sample of 20 hospital clinicians in the South West of England identified from 192 participants in a larger postal survey. Interviews were recorded on audiotape and fully transcribed. Data were analysed by comparing transcripts and describing emergent themes. RESULTS: Clinicians do not always find it easy to identify key randomised trials in their area of interest. Even when they identify those trials in which they would like to participate, they are not always able to recruit patients. Although recruitment can be hindered by the time and administration involved and the resources needed, the attitudes of clinicians to research in general, the design of randomised trials, clinicians' concerns regarding individual patients and patients' preferences for different treatments also present major barriers. Other factors of concern include the imposition of strict eligibility criteria and the expense and complexity of monitoring and follow-up. CONCLUSION: Barriers to recruitment depend on the clinicians' individual situations and on a complex combination of factors. Action is needed to promote awareness of randomised trials under way, to ensure that trials address issues of importance, are acceptable to patients and clinicians, and that practical support is provided for participating centres.