Evidence-based medicine and randomized double-blind clinical trials: a study of flawed implementation.

The randomized double-blind clinical trial (RDBCT) is a key source of information for evidence-based medicine. However, anomalous and unexplainable results have prompted suggestions that 'unknown and unidentifiable biases' may exist. This paper identifies that a possible flaw in the implementation of RDBCTs may account for these biases. The flaw relates to the breaking of the double blind through the generation of beliefs and expectations in experimenters. These, in turn, may lead to unconscious biases in assessment and cues to patients. It is then uncertain how much of an observed effect is due to such expectations or the treatment itself. Therefore, any RDBCT in which the maintenance of blinding is not monitored throughout its course is at risk of its conclusions being compromised. It is not sufficient to assert that blinding must have been maintained through arguments based on design features. The burden of proof is on the researchers to demonstrate, through data, that blinding has been maintained. The need to address social psychological issues in implementing RDBCTs is discussed and it is recommended that to avoid this confound, methods of monitoring and accounting for experimenter beliefs and expectations should be routinely included in future RDBCTs.

Characteristics of children and adolescents presenting to accident and emergency departments with deliberate self harm.

OBJECTIVES: The aim of this study was to provide a description of the characteristics of children and adolescents presenting to the accident and emergency (A&E) department with deliberate self harm. METHODS: Descriptive analysis of data collected by reviewing the notes of all children and adolescents aged 16 years and under, presenting during the period of study (1 January to 31 December) with a history of deliberate self harm. RESULTS: A total of 100 children (18 boys, 82 girls) were responsible for 117 episodes of deliberate self harm. Nine repeaters were responsible for 22% of the attendances; 38% had made use of emergency ambulance service and 6% were referred by their general practitioner (GP). Sixty nine per cent were accompanied by immediate family and 21% children presented alone. Seventy four per cent presented within three hours of the attempt and 37% presented between 6 pm and midnight; 77% presented during weekdays and 30% of attempts had occurred during spring. Ninety two per cent had used a pharmaceutical drug. Sixty five per cent had made the attempt at home and 12% in a public place. Twenty five per cent had prior or current contact with the child psychiatric services and a similar proportion had prior or current contact with social services. CONCLUSIONS: Few of the children and adolescents presenting with deliberate self harm to the A&E department have been referred by their GP. They frequently present alone or are accompanied by people who are not family members making assessment and treatment difficult. Many already have other services involved in their care and thus the gathering and dissemination of information can become quite lengthy. The time of presentation is usually out of hours, further complicating this process. A small number of young people present with repeated self harm, who are known to be most vulnerable for completing suicide.

The nature of mother and toddler problems. (ii) Patterns of disturbance and disadvantage.

Prevalence estimates for psychiatric disturbance in mothers and their 2 1/2 year old children and the variations in prevalence associated with marriage quality, social class and the child's developmental level are presented. It was found that both the mother's psychiatric disturbance, and more specifically, depression were associated most strongly with child disturbance, poor marriage quality and low child developmental level. For toddler disturbance, the strong associations were with type and severity of disturbance in mother, social class, marriage quality and low developmental quotient.

Predicting the short-term outcome of first episodes and recurrences of clinical depression: a prospective study of life events, difficulties, and social support networks.

BACKGROUND: The study employed interview-based, investigator-rated measures of symptoms and psychosocial adversity in a panel survey to predict clinical course of depression. METHOD: 130 men and women attending psychiatric hospitals for episodes of depressive disorders were interviewed with the Present State Examination and Life Events and Difficulties Schedule. After a mean 4-month interval, 119 were successfully reassessed to test the hypothesis that recovery from clinical depression is related to rates of life event stress and difficulties (termed psychosocial adversity) in the 6 to 12 months preceding initial evaluation. RESULTS: The severity (p < .01) and the duration (p < .01) of the episode of depression up until the initial evaluation emerged as the only significant background predictors of episode severity at later follow-up. High levels of adversity were significantly (p < .05) related to a poor clinical course, due to failure to recover from first-onset and from second episodes. Recovery from all but first episodes was predicted by higher levels of social support rated at initial attendance. There was no evidence for the buffering of the harmful effects of adversity by larger, more connected social support networks. CONCLUSION: Both life event stress and support network characteristics are associated with the short-term outcome of depressive episodes. The findings for social support in particular confirm growing evidence of the importance of distinguishing between early and later relapsing episodes in causal investigations of depression. They reveal a progressive vulnerability to deficits in social circumstances with advancing course of disorder.

A study of expressed emotion in the parental primary carers of adolescents with intellectual impairment.

Expressed emotion (EE) was measured in the parental primary carer (carer) of 92 adolescents with intellectual impairment to examine its associated characteristics. High EE was mainly a result of high levels of emotional overinvolvement. High EE was associated with psychological illhealth, poor-quality marriage and poor practical social support of the carer, and psychiatric disorder in the adolescent with intellectual impairment. This suggests that EE may be a useful indicator of coping difficulties in these families. The subgroup of high EE emotional overinvolvement was associated with a carer with more psychological illhealth, a worse-quality marriage, less practical social support, greater professional support and an insecure style of respite care usage for an adolescent of greater intellectual impairment. The subgroup of criticism have an adolescent of less severe intellectual impairment, more behavioural disturbance and yet the carer has less professional support. Appreciation of the quality of the relationship of the carer with their dependent family member may enable greater understanding of how to improve the quality of life for both the carer and the cared for.

Subtyping of panic disorder by symptom profile.

During Phase II of the Cross-National Panic Study, descriptions of the patient's last severe panic attack were collected for 1168 patients. Statistical analysis indicated that patients could be divided into two groups, characterised by the presence or absence of prominent respiratory symptoms. The two groups did not differ on demographic variables or coexisting diagnoses, but they did differ on psychopathology on entry to the study and treatment outcome. The group with prominent respiratory symptoms suffered more spontaneous panic attacks and responded to imipramine, whereas the group without prominent respiratory symptoms suffered more situational panic attacks and responded more to alprazolam. It is important to distinguish spontaneous and situational panic attacks, to aid choice of treatment.

Hostel-based respite care for adolescents with developmental retardation: the need for "normalized" respite resources.

Hostel respite care for adolescents with developmental retardation is the most readily available organized support for their families. This comparison of users and non-users shows that hostel-care usage relates to some measures of family functioning rather than to qualities of the adolescent. These family measures reflect less good organization and support rather than current stress. Consumer opinion indicates that hostel care is not meeting the carers' perceived needs for relief. A greater range of "normalized" and family-orientated respite care resources might be more effective for relieving stress and providing support to improve family-based community care.

The nature of mother and toddler problems--I. Development of a multiple criterion screen.

A multicriterion screen made up of the General Health Questionnaire, the Behaviour Checklist and a health visitor questionnaire was given in a community project. This paper describes the usefulness of the screen and compares it with others which might be used in similar situations.

Controlled comparison of three interventions for mother and toddler problems: preliminary communication.

This paper summarizes the preliminary thinking, the hypotheses and design and some preliminary results of a large community-based intervention project which is currently underway in the North East of England.