Substance use disorders and psychological trauma

AIMS AND METHOD The Impact of Events Scale was administered to 104 in-patients detoxing 
from alcohol or opiates to determine the prevalence of psychological trauma, 
the severity of its symptoms and the types of trauma responsible for 
symptoms. RESULTS Out of the 104 in-patients undergoing detoxification, 75 had symptoms of 
psychological trauma; in 60 patients the symptoms were in the treatable range. 
Patients with alcohol-dependence were more severely affected. ‘Life 
events’ traumatised a higher proportion of individuals than ‘
traumatic events’. CLINICAL IMPLICATIONS Psychological trauma requiring treatment is commonly found in substance 
misusers. This is rarely addressed despite the cormorbid disorder running a 
complicated clinical course. There are conflicting opinions about best 
practice, but consideration should be given to providing patients with 
accessible treatments for psychological trauma.


Discussion
We know that home treatment is an effective intervention 2 and reduces hospital admission rates by about 23% for 24-hour services. 3 Additionally, home treatment is generally preferred by patients. 2 Similarly, we know that certain carefully selected individuals with severe mental illness improve more quickly in a day hospital than if cared for as an in-patient 4 and that acute day hospitals provide greater patient satisfaction than in-patient care, at least in the short-term. 5 One of Marshall's 6 proposals for developing day hospital care was to combine it with outreach services for people who fail to attend. Our model has started from the same 'structures' but our philosophical approach has been to tailor the care to what patients value most. Working as one team, the crisis and home treatment team and the acute day hospital are able to design flexible care plans, switching easily between modalities of care with minimal bureaucracy, creating a whole much larger than the sum of its parts.
From a service management point of view, the team is now fulfilling its service level agreement; increased efficiency has also facilitated a reduction of in-patient beds. Early polling suggests high user satisfaction and the team is committed to collecting continuous feedback through market research-style questionnaires; these will be used to inform future improvements. One of the areas we are currently working on is improving the interface with other services.
Losing participants before the trial ends erodes credibility of findings

AIMS AND METHOD
To estimate the proportion of attrition at which results of drug trials for people with schizophrenia lose enough credibility to become mistrusted by relevant groups of stakeholders. A piloted questionnaire was sent to 128 local clinicians, 100 relevant researchers and 104 service users and carers.

RESULTS
We received the biggest number of responses from the service user and carer group (n=81, 76%); 43% of clinicians and 32% of researchers responded. All three groups suggested that the follow-up rate for a 12-week schizophrenia drug trial should be around 70-75% for the trial to be credible.

CLINICAL IMPLICATIONS
This survey suggests that relevant stakeholders, including researchers, fundamentally mistrust results of the majority of drug trials in schizophrenia. Adopting a more pragmatic trial design can help address this.
Although some complete information may still be obtained from routine data, this loss to follow-up does mean that many scale-derived outcomes reflect the condition of only a proportion of participants. As scale data are so commonly the primary outcomes in trials relevant to mental healthcare, 2 this leaves these studies vulnerable to the many biases introduced by not undertaking an intention-to-treat analysis. 3 Statistical techniques have evolved to rebuild a semblance of the complete data-set but all such devices are imperfect and are based on assumptions that are difficult or impossible to substantiate. 4,5 We aimed to gauge the attrition level at which results of drug trials for people with schizophrenia lose enough credibility to be mistrusted by three relevant groups of stakeholders.

Method
A protocol was written and power calculations undertaken, suggesting that for what we thought would be a meaningful difference (20%) about 100 people in each of the groups would be necessary (a=0.05, power 80%). The questionnaire was drawn up and piloted in groups of clinicians, researchers and mental health service users (this led to refinement of the accompanying background information and of the final questionnaire question; see the online supplement to this paper). In March 2007, three groups of stakeholders were targeted. First, email contacts of all 128 general adult psychiatrists within the Yorkshire Deanery were obtained (the clinicians). Then a list of the first 100 most recently published email contacts from within the Cochrane Schizophrenia Group's Register of trials was generated (the researchers). Finally, 104 carers/service users from Rethink's regional groups across England were contacted (Rethink is a leading UK mental health membership charity, www.rethink.org). The trial gained approval from Leeds East Research Ethics Committee and one follow-up email was allowed should there be no response on first contact. On 23 March 2007, the question (see online supplement) was sent to the clinicians and researchers via email and followed up 2 months later. During this period, questionnaires were also sent out to carers and service users who attend Rethink's regional governance meetings.

Results
Response rates from clinicians and researchers were poor but all three stakeholder groups estimated the proportion of follow-up sample necessary at 12 weeks to original papers Xia et al Losing participants before the trial ends generate a basic level of trust in the outcomes in drug trials relevant to schizophrenia to be about 70-80% (Table 2).

Discussion
This is the result of a survey with variable response rate to a question that forced a binary decision in a situation that, in reality, usually involves managing degrees of discomfort with research findings. It is also feasible that a question with well-tested psychometric properties may have generated different results. Nevertheless, we know of no study in any area of healthcare that has even attempted to investigate this limit of credibility in those for whom results of trials are important. Using 70-80% follow-up at 12 weeks as a broad estimate of the limit of credibility on the data derived from trials (Table 1) shows that the evidence on many commonly used drugs falls short of this standard.
To put this finding in context, schizophrenia drug trials are often short, involve participants who are so rigorously diagnosed as to be difficult to find in everyday practice, prescribe interventions that demand rigid adherence and measure outcomes on many scales of variable quality 6 that are often reported poorly and are problematic to interpret clinically. 2 These studies, nevertheless, are the well-established gold standard means by which mental health treatments are evaluated. 7 This simple survey asked participants to put aside all other worries about the design, conduct and reporting of these studies and to focus on attrition. Investigation of this single variable undermines the credibility of outcomes in most studies.
Drug trials, however, often report several outcomes. Attrition from one outcome may be large, whereas other outcome data from within the same study are almost complete. Often data on outcomes such as 'loss to follow-up', 'hospitalised' or 'in contact with services/ police/family' are reasonably complete and it is not surprising that major trials are now beginning to use these as primary outcomes. 8 This choice of simple routine outcomes, however, is still the exception rather than the rule. Most trials in this area focus on fine-grain, scalederived outcomes. Scales, although greatly valued nonphysiological measures, are mostly ordinal rather than continuous and face problems with validity, analysis and interpretation. They are further undermined by their association with incomplete data-sets. Often, however, trials generate binary outcomes such as 'improved to an important degree', but these are based on incomplete scale data and fail to directly ask the simple single question that would cover this outcome and for which it is likely that much more complete and credible data could be acquired.

Conclusions
Currently, clinicians, policy makers and consumers of care have to come to decisions about treatments based on information that is of questionable credibility. We believe that this allows many factors, such as fashion and advertising, to take priority over good evidence when it comes to making the difficult decisions about care. The loss of people from these studies is both an enormous opportunity and waste. One method used to give a semblance of end-point ratings is to carry forward the last observation of the person before they left. Ratings, even from the first few weeks into the trial, are carried forward to the end of the study, perhaps months later, often with the (unlikely) assumption that the person has been stable since the point of departure. If this technique remains acceptable to users of the findings, there will be little motivation for improvement. Last-observationcarried-forward is a flawed technique that depends on considerable assumptions and can lead to erroneous results. 9 The study design that wastes the resource of willing people ensures that most trials in schizophrenia remain small and difficult to apply clinically. There is now accumulating evidence that using more routine data can generate high-grade data-sets even on protracted followup. 10 Simpler pragmatic/real-world design could ensure that more studies were adequately powered for the more complete data-sets of clinically meaningful outcomes.

original papers
Xia et al Losing participants before the trial ends

AIMS AND METHOD
The Impact of Events Scale was administered to 104 in-patients detoxing from alcohol or opiates to determine the prevalence of psychological trauma, the severity of its symptoms and the types of trauma responsible for symptoms.

RESULTS
Out of the 104 in-patients undergoing detoxification, 75 had symptoms of psychological trauma; in 60 patients the symptoms were in the treatable range. Patients with alcohol-dependence were more severely affected.'Life events' traumatised a higher proportion of individuals than 'traumatic events'.

CLINICAL IMPLICATIONS
Psychological trauma requiring treatment is commonly found in substance misusers. This is rarely addressed despite the cormorbid disorder running a complicated clinical course.There are conflicting opinions about best practice, but consideration should be given to providing patients with accessible treatments for psychological trauma.
There are strong associations between substance misuse and psychological trauma. According to one US study, 3% of substance misusers in the general population have post-traumatic stress disorder (PTSD). 1 Rates of PTSD in female substance misusers on in-patient units rise to 42.5% 2 and to 62% for pregnant women treated in a residential setting. 3 In the UK, rates of PTSD on in-patient substance misuse units have been reported at 38.5% for current PTSD and at 51.9% for lifetime PTSD. 4 Surveys of adolescent substance misusers report PTSD rates of up to 19.2%. 5 In civilian populations without PTSD, rates of lifetime substance misuse range from 8.1 to 24.7%, but in those with PTSD the levels rise to 21.6-43.0%. [6][7][8] Up to 75% of US and UK war veterans with PTSD meet the criteria for alcohol misuse or dependence. 9,10 Individuals with comorbid substance misuse and PTSD are more likely to have other psychiatric diagnoses, higher rates of psychosocial and physical problems, higher rates of in-patient admissions for substance misuse and higher rates of relapse compared with substance misusers without PTSD. 8,11 Within the general population, estimates of childhood sexual abuse in women are around 21-22% and in men 7-15%. 12,13 However, childhood sexual abuse levels among substance misusers on in-patient detoxification units range from 49 to 67% for women and 12-33% for men. [14][15][16] The association between substance misuse and psychological trauma is therefore important, not only because of the frequency of comorbidity and the additional complexity of the presentation, but also because of the more complicated clinical course and poorer prognosis. This paper presents the results of a survey of 104 individuals with alcohol or opiate dependence who were undergoing a detoxification at New House Drug and Alcohol Unit, Shrewsbury, Shropshire. The survey sought to identify the number of individuals who were currently affected by symptoms of psychological trauma, to assess the severity of any psychological trauma using the Impact of Events Scale (IES), 17,18 and to identify and describe the sorts of events that patients considered to be responsible for the development of their psychological trauma symptoms. Implications for the management of these individuals are discussed in the light of research findings and the National Institute for Health and Clinical Excellence (NICE) guidelines for the management of PTSD. 19

Method
All individuals who participated in this survey had given informed consent. A total of 104 in-patients with alcohol or opiate dependence undergoing detoxification were assessed for current symptoms of psychological trauma using the Impact of Events Scale (IES). This instrument was administered when patients were no longer experiencing any acute symptoms of alcohol or opiate