Información personalizada mantenida por el paciente para la atención habitual de pacientes con enfermedades mentales graves
Resumen
Antecedentes
Es importante buscar métodos efectivos en función de los costos para mejorar la atención y el resultado de los pacientes con enfermedades mentales graves. Actualmente las historias clínicas mantenidas por el paciente, quien tiene toda o parte de la información personal sobre el curso y el cuidado de su enfermedad, son habituales en algunos ámbitos clínicos. No se conoce su valor en los pacientes con enfermedades mentales graves.
Objetivos
Evaluar los efectos de la información clínica personalizada y accesible mantenida por el paciente en quienes presentan enfermedades mentales graves (definidas como enfermedades psicóticas).
Métodos de búsqueda
Se actualizaron las búsquedas anteriores mediante búsquedas en el Registro de Ensayos del Grupo Cochrane de Esquizofrenia (Cochrane Schizophrenia Group) en agosto de 2011. Este registro se compila mediante búsquedas sistemáticas en las principales bases de datos, búsquedas manuales de revistas y actas de congresos.
Criterios de selección
Se incluyeron todos los ensayos controlados aleatorios (ECA) pertinentes que:
i. hubieran incluido participantes adultos con diagnóstico de enfermedades mentales graves (específicamente enfermedades psicóticas y trastornos graves del estado de ánimo como trastorno bipolar y depresión con características psicóticas); y
ii. compararan cualquier información clínica personalizada y accesible conservada por el paciente más allá de la atención estándar con la información estándar conservada sistemáticamente, como fichas de citas e información genérica sobre el diagnóstico, el tratamiento o los servicios disponibles.
Obtención y análisis de los datos
Dos revisores realizaron de forma independiente la selección de los estudios y la extracción de los datos, y un tercer revisor las confirmó y verificó. Se estableció contacto con los autores de los ensayos para obtener datos adicionales y faltantes. De ser posible se calcularon los cocientes de riesgos (CR) y los intervalos de confianza (IC) del 95%. Se utilizó un modelo de efectos aleatorios. Se evaluó el riesgo de sesgo de los estudios incluidos y se creó una tabla "Resumen de los hallazgos" con el enfoque GRADE.
Resultados principales
Cuatro ECA (n = 607) de historias clínicas conservadas por el paciente versus tratamiento habitual cumplieron los criterios de inclusión. Cuando el efecto de las historias clínicas conservadas por el paciente sobre los ingresos en hospitales psiquiátricos se comparó con el tratamiento habitual en cuatro estudios, el efecto agrupado del tratamiento no mostró efectos significativos de la intervención y fue de magnitud muy baja (n = 597, cuatro ECA, CR 0,99; IC: 0,71 a 1,38; pruebas de calidad moderada). De manera similar, no hubo efectos significativos de la intervención en tres estudios que investigaron los ingresos obligatorios en hospitales psiquiátricos (n = 507, cuatro ECA, CR 0,64; IC: 0,37 a 1,10; pruebas de calidad moderada). Se investigaron otros resultados incluida la satisfacción y el estado mental, aunque no fue posible obtener las estimaciones agrupadas debido a que los datos fueron asimétricos o se informaron de forma deficiente, o solo se investigaron en un estudio. En los estudios incluidos no se investigaron dos resultados (violencia y muerte). Dos estudios aleatorios importantes están en curso.
Conclusiones de los autores
Aún hay brechas en las pruebas con respecto a la información clínica personalizada y accesible mantenida por el paciente en quienes presentan enfermedades psicóticas con respecto a muchos de los resultados de interés. Sin embargo, esta revisión indica a partir de pruebas de calidad moderada que la intervención no tiene efectos sobre el uso de citas en hospitales o clínicas ambulatorias en los pacientes con trastornos psicóticos. Sin embargo, el número de estudios es escaso y se necesitan más pruebas para evaluar si estos resultados están mediados por el tipo de intervención, como la participación de un equipo clínico o el tipo de información incluida.
PICO
Resumen en términos sencillos
Información clínica en manos del paciente para pacientes con enfermedades psicóticas
La información en manos del paciente implica que el paciente conserva información personal acerca de la atención de su enfermedad. Dichas historias clínicas se han vuelto habituales en muchos ámbitos y son cada vez más aceptadas por los pacientes. Esta aceptación se observa especialmente cuando el paciente afectado no está hospitalizado y recibe atención por parte de más de un profesional. Se cree que la provisión de información a los pacientes acerca de su atención aumenta su sensación de participación en el tratamiento y tiene como objetivo aumentar la satisfacción y la participación del paciente con los servicios, asegurar el tratamiento temprano y prevenir el ingreso hospitalario.
Sin embargo, no se conoce el valor de la información personal conservada por el paciente en quienes presentan enfermedades mentales graves, y son poco frecuentes los estudios de investigación que evalúan la efectividad. Algunos estudios de investigación indican que aunque muchos pacientes rechazan la oferta de una historia clínica conservada por el paciente, la mayoría de los que conservan sus historias clínicas informa que es de utilidad.
Según una búsqueda realizada en 2011, esta revisión incluye cuatro ensayos con 607 pacientes y evalúa los efectos de la información conservada por el paciente en quienes presentan enfermedades mentales graves. En general, el número de estudios relevantes es escaso y el informe de algunos resultados es deficiente. Según pruebas de calidad moderada, la revisión encontró que la información conservada por el paciente no redujo los ingresos hospitalarios, y no disminuyó los ingresos obligatorios ni estimuló a los pacientes con enfermedades mentales graves a asistir a las citas (en comparación con el tratamiento habitual). Otros resultados importantes como la satisfacción con la atención, los costos y el efecto sobre la salud mental, no estuvieron disponibles debido a la calidad limitada de los cuatro estudios. Por lo tanto, hay una brecha en el conocimiento y las pruebas con respecto a la información conservada por el paciente en quienes presentan problemas graves de salud mental. También se necesitan pruebas adicionales sobre los diferentes tipos de información conservada por el paciente (por ejemplo, si incluye al equipo de salud mental y qué tipo de información contiene la historia clínica). Se necesitan estudios a gran escala, bien realizados y bien informados con el objetivo de evaluar los efectos de la información conservada por el paciente en quienes presentan enfermedades mentales. Actualmente se realizan dos estudios aleatorios importantes. Por ahora, a pesar de la brecha en las pruebas, la información conservada por el paciente es de bajo costo y aceptable para los pacientes, por lo que es probable que aumente su uso. Sin embargo, no se puede suponer que la información conservada por el paciente tenga efectos beneficiosos para los pacientes y sea efectiva en función de los costos sin la realización de ensayos adicionales a gran escala, bien realizados y bien informados.
Este resumen en términos sencillos ha sido redactado por un consumidor, Benjamin Gray: Rethink Mental Illness. E‐mail: [email protected]
Authors' conclusions
Summary of findings
| User‐held information versus Sstandard Information for routine care of people with severe mental illness | ||||||
| Patient or population: patients with routine care of people with severe mental illness | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | USER‐HELD INFORMATION versus STANDARD INFORMATION | |||||
| Psychiatric hospital admission: psychiatric admission | Low1 | RR 0.99 | 597 | ⊕⊕⊕⊝ | ||
| 50 per 1000 | 49 per 1000 | |||||
| High1 | ||||||
| 440 per 1000 | 436 per 1000 | |||||
| Psychiatric hospital admission: compulsory admission | Low1 | RR 0.64 | 507 | ⊕⊕⊕⊝ | ||
| 40 per 1000 | 26 per 1000 | |||||
| High1 | ||||||
| 260 per 1000 | 166 per 1000 | |||||
| Death: causes other than suicide ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No study reported this outcome |
| Violence ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No study reported this outcome |
| Mental state: psychopathology | See comment | See comment | Not estimable | 0 | See comment | Data not pooled: studies used inconsistent/incompatible measures of psychopathology and/or data are skewed. No indication of differences between groups |
| Satisfaction with health care | See comment | See comment | Not estimable | 0 | See comment | Data not pooled: studies used inconsistent/incompatible measures of satisfaction and/or data are skewed. No indication of differences between groups |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Assumed risk: the low and high risk values correspond to the lowest and highest rates of admissions in the control groups from the included studies. | ||||||
Background
It is important to seek cost‐effective methods of improving the care and outcome of those with serious mental illnesses. User‐held records, where the person with the illness holds all or some personal information relating to the course and care of their illness, are now the norm in some clinical settings (Kaelber 2008). This is particularly the case where the person concerned is not in hospital and receives care from more than one professional. User‐held notes are becoming popular for obstetric care (Brown 2004; Phipps 2001) both in developed and developing countries (Shah 1993). Parent‐held records are widely used in paediatric care (Bourgeois 2009; Ghossein 1998; Hampshire 2004). The management of people with chronic disabilities such as stroke or cancer can also involve user‐held records (Banet 1997; Finlay 1999; Ko 2010; Williams 2001).
Brief types of user‐held information are available for use in emergencies such as anaphylaxis and post‐splenectomy infection (Freeman 1998; Wharry 1996; Williams 1996). This type of information tends not to be comprehensive and the aims vary with setting and condition. Nevertheless, as with the full notes, the aim of these truncated personal record systems is to promote patient participation in care, increase consumer satisfaction with services, facilitate early treatment and help avoid hospital admission.
Both long and short forms of user‐held information are now being used for people with mental health problems (Backlar 1996; Essex 1990; Henderson 2004; Lester 2003; Pickersgill 1998; Reuler 1991; Stafford 1997; Sutherby 1999; Swanson 2006a; Wolf 1996). In certain countries legislation obligates the provision of a copy of the treatment outline and professionals' contact details to those in receipt of specialist mental health services (DoH 1990). This information is not specifically designed to be something patients might wish to carry, nor to be of use in a crisis, but it may in itself have an effect, so evaluation is justified. Another form of personal information has recently emerged. Advance Statements can be defined as statements regarding service user preferences for future treatment (Henderson 2008). These are typically devised and held by the service user and include such interventions as Psychiatric Advance Directives, Joint Crisis Plans (Sutherby 1999) and Wellness Recovery Actions Plans (Cook 2009).
Attempts at evaluation of the effects of user‐held records for those with long term mental illness are rare. There are several audit and case series studies of the use of user‐held records (Essex 1990; Pickersgill 1998; Reuler 1991; Stafford 1997; Wolf 1996). These suggest that while many people refuse the offer of a user‐held record, the majority of those who carry their records report this activity to be useful (Stafford 1997). In the USA, Psychiatric Advance Directives (PADs) have been shown to be popular with service users and their carers (Backlar 2001) and some professional groups (Atkinson 2004). However, there are some concerns regarding the implementation of wishes contained in PADs during crises from both service users and clinicians (Atkinson 2004; Backlar 2001); the ability of the service user to generate a valid PAD (Amering 2007; Atkinson 2004; Elbogen 2007); and questions regarding their impact on or relationship to outcome (Backlar 2001). Additionally, clinicians often express concern regarding the possibility of service users requesting unreasonable treatments or indeed refusing treatment altogether (Atkinson 2004; Backlar 2001; Elbogen 2006; Swartz 2005; Van Dorn 2006). However, an analysis of the content of PADs developed by 106 outpatients in the US (Srebnik 2005) showed that in 95% of cases the PADs were rated as clinically useful and consistent with clinical practice standards. Another type of advance statement, the Wellness Recovery Action Plan (WRAP) is a structured self‐management intervention that assists users both manage symptoms and consider broader life issues. A recent assessment of WRAPs for mental illness (Cook 2009) suggests that it may generate improvements in a range of areas including symptoms, hopefulness and feelings of empowerment. Furthermore, a case series study of the Joint Crisis Plan intervention (Sutherby 1999) in which patients develop their personalised plan for use in a crisis or possible relapse, suggests that hospital use may be reduced in those who develop such a plan. The increased input in determining future treatment was suggested to be an important factor in determining the perceived coerciveness of the treatment experience (Lidz 1995). It certainly seems plausible that those who have little knowledge of the patient or no access to their notes, such as a junior psychiatrist in a hospital emergency department, would find such information useful in making an appropriate disposition, and further that actions carried out which have been previously negotiated are less likely to require compulsory interventions.
Description of the condition
For the purpose of this review, we defined severe mental illness (SMI) as psychotic disorders and severe mood disorders such as bipolar disorder and depression with psychotic features. Psychosis is a collective term used to describe a range of conditions including schizophrenia, delusional disorder, and schizoaffective disorder. Individuals with psychotic disorders may experience a range of symptoms including unusual thoughts or 'delusions', hallucinations, and mood disturbance such as emotional flatness and withdrawal. Recent studies of schizophrenia globally suggest that about seven individuals per 1000 will be affected and individuals with schizophrenia have a two to threefold increased risk of dying compared to the general population (McGrath 2008). The economic burden associated with schizophrenia is substantial, with recent estimates suggesting it represents between 1.5% and 3% of total healthcare expenditures (Knapp 2004).
Description of the intervention
'User‐held records' may be defined as information, held by the individual with the illness, which contains all or some personal information relating to the course and care of his or her illness. User‐held records may include notes made by professionals at appointments and kept by the patient, advance directives and crisis cards (personal information held for use in the event of a crisis or relapse).
How the intervention might work
The main aim of providing individual patients with personalised information about their illness and treatment is to improve the individual's sense of control and empowerment. Providing patients with information is thought to increase their feelings of involvement in their treatment, reducing the perceived coerciveness of the treatment experience (Lidz 1995); it may also facilitate early help‐seeking.
Why it is important to do this review
This is an update of a Cochrane review first published in 1999 (Henderson 1999). The previous review found no studies meeting the criteria for inclusion, but found two ongoing trials (Lester 2003; Papageorgiou 2002). Since the publication of the original Cochrane review, there have been a number of published and relevant clinical trials undertaken. Additionally, current national treatment guidelines in the United Kingdom (NICE 2009) recommend involving mental health service users in decisions about their treatment and providing opportunities for service users to make advance statements and advance decisions to refuse treatment. Valid advance decisions are now legally binding under the UK's Mental Capacity Act 2005. User‐held records potentially provide a cost‐effective methodology for facilitating such involvement. Several of the authors of this updated review are affiliated with an ongoing trial of user‐held records (CRIMSON) (Thornicroft 2010). Another randomised evaluation of user‐held records for those with serious mental illnesses (Ruchlewska 2009) is known to be ongoing.
Objectives
To evaluate the effects of personalised, accessible, user‐held clinical information for people with a severe mental illness (defined as psychotic illnesses).
Methods
Criteria for considering studies for this review
Types of studies
All relevant randomised, controlled trials (RCTs).
Types of participants
Adults with SMI. For the purposes of the review we defined SMI as a diagnosis of a psychotic illness, including other psychoses such as bipolar disorder and depression with psychotic features. In studies where there was a mixture of diagnostic groups, only those studies where the majority of participants (that is, more than 50%) had psychotic diagnosis were included. We did not include studies where the sole diagnosis was bipolar disorder or depression. People whose main problem and primary diagnosis was one of deliberate self harm were also not the focus of this review.
Types of interventions
1. User‐held information: any personalised and accessible clinical information held by the patient beyond standard care.
This includes both user‐held records (notes made by professionals at appointments and kept by the patient) and crisis cards (personal information held for use in the event of a crisis or relapse). Generic information on diagnosis, treatment or services available was excluded.
2. Standard information: any information routinely held such as appointment cards and generic information on diagnosis, treatment or services available.
In certain settings standard information may include a copy of the treatment plan with contact details for the key carers (DoH 1990).
Types of outcome measures
Outcomes were not part of the criteria for including studies in the review. Outcomes of interest are listed below. We divided outcomes into very short term (less than three months), short term (less than six months), medium term (seven to 12 months) and long term (over one year).
Primary outcomes
1. Psychiatric hospital admission
1.1 Admitted or not
1.2 Compulsory admission
1.3 Number of days spent in hospital
1.4 Discharged or not
2. Death from causes other than suicide
3. Violence
3.1 To self
3.1.1 Non‐fatal
3.1.2 Fatal
3.2 To others
3.2.1 Major (homicide, sex attacks, attempted or actual serious assault)
3.2.2 Non‐major (incidents requiring attendance of police or on‐ward seclusion or special civil law admissions to a place of safety)
Secondary outcomes
1. Rates of criminal charges
2. Mental state
2.1 Relapse of psychotic illness
2.2 Mental state score
3. Satisfaction with health care
3.1. Patient satisfaction
3.2. Carer satisfaction
4. Perceived coercion on hospital admission
5. Acceptability of management
5.1 As measured by loss to follow‐up within the study
6. Compliance with treatment other than the intervention
7. Social functioning
7.1 Homelessness
7.2 Employment
7.3 Average change in social functioning
8. Economic costs of all care and health care
9. Other relevant measures
10. Summary of findings table
We used the GRADE approach to interpret findings (Schünemann 2008) and used the GRADE profiler (GRADEPRO) to import data from RevMan 5.1 (Review Manager) to create 'Summary of findings' tables. These tables provided outcome‐specific information concerning the overall quality of evidence from each included study in the comparison, the magnitude of effect of the interventions examined, and the sum of available data on all outcomes we rated as important to patient care and decision making. We aimed to select the following main outcomes for inclusion in the 'Summary of findings' table.
-
Psychiatric hospital admission: general admission ‐ medium and long term
-
Psychiatric hospital admissions: compulsory admission ‐ medium and long term
-
Death: causes other than suicide
-
Violence
-
Mental state: psychopathology ‐ medium and long term
-
Satisfaction with health care ‐ medium and long term
Search methods for identification of studies
Electronic searches
We searched the Cochrane Schizophrenia Group Trials Register (August 2011) using the phrase:
[((*consumer?h?ld* or *consumer?particip* or *client?h?ld* or *client?particip* or *user?h?ld* or *user?particip? or *patient?h?ld* or *patient particip* or (*Cris?s* AND *plan*) in the title, abstract and index terms in REFERENCE) and ((patient particip* or patient info* or *decision* or medical record* or *crisis plan*) in interventions field in STUDY)]
This register is compiled by systematic searches of major databases, handsearches of journals and conference proceedings (see Group Module). For previous searches please see Appendix 1.
Searching other resources
1. Reference lists
All references of included articles were searched for further relevant trials.
Data collection and analysis
Methods used in data collection and analysis for this update are below, for previous methods please see Appendix 2.
Selection of studies
SF and GB independently inspected all citations from the searches and identified relevant abstracts. Where disputes arose, the full report was acquired for more detailed scrutiny and was independently assessed. All included citations were then discussed with CH. Where it was not possible to resolve a disagreement by discussion, we contacted the authors of the study for clarification. If citations met the inclusion criteria, we obtained full reports of the papers for more detailed inspection. Full reports were then inspected by SF and GB, and discussed with CH.
Data extraction and management
1. Extraction
Review author SF extracted data from all included studies. In addition, to ensure reliability, GB independently extracted data from all studies. Any disagreement was discussed with CF (statistician) and the decisions documented and, if necessary, authors of studies were contacted for clarification. CH provided advice and final decisions were documented. We attempted to contact authors through an open‐ended request in order to obtain missing information or for clarification whenever necessary. If studies were multi‐centre, where possible, we extracted data relevant to each component centre separately.
2. Management
2.1 Forms
We extracted data onto standard, simple forms.
2.2 Scale‐derived data
We included continuous data from rating scales only if:
a. the psychometric properties of the measuring instrument have been described in a peer‐reviewed journal (Marshall 2000); and
b. the measuring instrument has not been written or modified by one of the trialists for that particular trial.
Ideally the measuring instrument should either be: i. a self‐report, or ii. completed by an independent rater or relative (for example, not the therapist). We acknowledge that this is often not reported clearly and noted if this was the case or not in the 'Description of studies' section.
2.3 Endpoint versus change data
There are advantages of both endpoint and change data. Change data can remove a component of between‐person variability from the analysis. On the other hand the calculation of change needs two assessments (baseline and endpoint), which can be problematic in unstable and difficult to measure conditions such as schizophrenia. We decided to primarily use endpoint data, and only use change data if the former were not available. If we had found both, we would have combined endpoint and change data in the analysis and used mean differences (MD) rather than standardised mean differences throughout (Higgins 2011).
2.4 Skewed data
Many of our targeted outcomes tend to be skewed, for example, duration of admission and duration of compulsory admission. For this reason the authors of included studies have provided non‐parametric summary measures and tests, that is, the median and range, and tested with the Mann‐Whitney U test. Since it is not possible to combine non‐parametric data in a meta‐analysis, and there were so few studies that met the inclusion criteria and provided these data, we report these data in 'Other data' tables.
2.5 Common measure
To facilitate comparison between trials, we converted variables reported in different metrics, such as days in hospital (mean days per year, per week or per month), to a common metric (for example, mean days per month).
2.6 Conversion of continuous to binary
Where possible we tried to maintain continuous measures to avoid losing information and power in the analyses.
2.7 Direction of graphs
Where possible, we entered data in such a way that the area to the left of the line of no effect indicated a favourable outcome for user‐held records. Where keeping to this made it impossible to avoid outcome titles with clumsy double‐negatives we reported data where the left of the line indicates an unfavourable outcome. This was noted in the relevant graphs.
Assessment of risk of bias in included studies
SF and GB worked independently to assess risk of bias by using the criteria described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) to assess trial quality. This set of criteria is based on evidence of associations between overestimation of effect and high risk of bias of the article, such as sequence generation, allocation concealment, blinding, incomplete outcome data and selective reporting.
If the raters disagreed, the final rating was made by consensus, with advice from CH. Where inadequate details of randomisation and other characteristics of trials were provided, the authors of the studies were contacted in order to obtain further information. Non‐concurrence in quality assessment was reported, but if disputes arose as to which category a trial was to be allocated, again, resolution was be made by discussion.
Measures of treatment effect
1. Binary data
For binary outcomes we calculated a standard estimation of the risk ratio (RR) and its 95% confidence interval (CI). It has been shown that RR is more intuitive (Boissel 1999) than odds ratios and that odds ratios tend to be interpreted as RR by clinicians (Deeks 2000). For statistically significant results we had planned to calculate the number needed to treat to provide benefit/to induce harm statistic (NNTB/H), and its 95% confidence interval (CI) using Visual Rx (http://www.nntonline.net/) taking account of the event rate in the control group. This, however, has been superseded by the summary of findings Table for the main comparison and calculations therein.
2. Continuous data
We had too few studies to combine continuous outcomes. Furthermore, outcomes common to more than one study were assessed by different measures therefore precluding any combined estimate of effect. However, if we had found sufficient studies we would have estimated the mean difference (MD) between groups. Data from included studies were often skewed, in these circumstances we have presented the data as reported by the original authors in 'Other data' tables.
Unit of analysis issues
1. Cluster trials
Studies increasingly employ 'cluster randomisation' (such as randomisation by clinician or practice) but analysis and pooling of clustered data poses problems. Firstly, authors often fail to account for intra‐class correlation in clustered studies, leading to a 'unit of analysis' error (Divine 1992) whereby P values are spuriously low, confidence intervals unduly narrow and statistical significance overestimated. This causes type I errors (Bland 1997; Gulliford 1999).
For relevant cluster trials that did not account for clustering in the primary studies (Warner 2000), we have presented data in a table marked with a (*) symbol to indicate the presence of a probable unit of analysis error. We have sought statistical advice and were advised that the binary data as presented in a report should be divided by a 'design effect'. This is calculated using the mean number of participants per cluster (m) and the intra‐class correlation coefficient (ICC) (design effect = 1 + (m ‐ 1)*ICC) (Donner 2002). If the ICC was not reported it was assumed to be 0.1 (Ukoumunne 1999).
Clustering was appropriately incorporated into the analysis of one of the cluster studies (Lester 2003) but not in the second (Warner 2000). Therefore we have reported the original data as if from a non‐cluster randomised study (Analysis 1.1) and, in addition, have provided a cluster‐adjusted outcome where frequencies have been divided by the design effect (Analysis 1.8).
2. Cross‐over trials
A major concern of cross‐over trials is the carry‐over effect. It occurs if an effect (for example, pharmacological, physiological or psychological) of the treatment in the first phase is carried over to the second phase. As a consequence, on entry to the second phase the participants can differ systematically from their initial state despite a wash‐out phase. For the same reason cross‐over trials are not appropriate if the condition of interest is unstable (Elbourne 2002). We did not find any cross‐over trials in our search.
3. Studies with multiple treatment groups
We did not find any multiple treatment group studies, but we would have presented the additional treatment arms in comparisons. If data were binary we would have added and combined the data within the two‐by‐two table. If data were continuous we would have combined data following the formula in section 7.7.3.8 (Combining groups) of the Cochrane Handbook for Systematic Reviews of Interventions. Where the additional treatment arms were not relevant, we would not have reproduced these data.
Dealing with missing data
1. Overall loss of credibility
At some degree of loss of follow‐up data must lose credibility (Xia 2009). We chose that, for any particular outcome, should more than 50% of data be unaccounted for we would not reproduce these data or use them within analyses. If, however, more than 50% of those in one arm of a study were lost, but the total loss was less than 50%, we would have marked such data with (*) to indicate that such a result may well be prone to bias. However, this did not occur for any of the included studies.
2. Binary
The included studies had low attrition on the primary outcomes. However, had we found higher attrition rates we would have followed the following procedure. Where attrition for a binary outcome was between 0% and 50% and where these data were not clearly described, we would have presented data on a 'once randomised always analyse' basis (an intention‐to‐treat analysis). We would have assumed that data were missing at random, and that those leaving the study early would be similar to those remaining and have the same rates of negative outcome as those who completed the study.
3. Continuous
3.1 Attrition
If attrition for a continuous outcome had been between 0% and 50% and completer‐only data were reported, we would have reproduced these. However, this was not the case.
3.2 Standard deviations
The continuous outcome measures in our studies were skewed and authors reported the median as a summary measure rather than the mean. In the case of skewed data the standard deviation is not a useful measure and so we did not seek to obtain it. Had the mean values been reported but not the standard deviations we would have first tried to obtain the missing values from the authors. If not available, we would have calculated the standard deviation, where possible, from the data provided, that is, from confidence intervals and statistical tests.
3.3 Last observation carried forward
We did not find any studies that used the last observation carried forward (LOCF) for missing data. If this had been used in a trial for less than 50% of the data, we would have reproduced these data and indicated that they were the product of LOCF assumptions.
Assessment of heterogeneity
1. Clinical heterogeneity
We considered all included studies initially, without seeing comparison data, to judge clinical heterogeneity. We simply inspected all studies for clearly outlying people or situations which we had not predicted would arise. When such situations or participant groups arose, these were discussed.
2. Methodological heterogeneity
We considered all included studies initially, without seeing comparison data, to judge methodological heterogeneity. We simply inspected all studies for clearly outlying methods which we had not predicted would arise. When such methodological outliers arose these were fully discussed.
3. Statistical heterogeneity
3.1 Visual inspection
We visually inspected graphs to investigate the possibility of statistical heterogeneity.
3.2 Employing the I2 statistic
Heterogeneity between studies was investigated by considering the I2 statistic method alongside the Chi2 P value. The I2 provides an estimate of the percentage of total variance due to study heterogeneity (beyond inconsistency thought to be due to chance) (Higgins 2003). The importance of the observed value of I2 depends on: i. magnitude and direction of effects, and ii. strength of evidence for heterogeneity (for example, P value from Chi2 test, or a confidence interval for I2). An I2 estimate greater than or equal to around 50%, accompanied by a statistically significant Chi2 statistic, was interpreted as evidence of substantial levels of heterogeneity (Higgins 2011). When substantial levels of heterogeneity were found in the primary outcome, we explored reasons for heterogeneity (Subgroup analysis and investigation of heterogeneity).
Assessment of reporting biases
Reporting biases arise when the dissemination of research findings is influenced by the nature and direction of results (Egger 1997). These are described in Section 10 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We are aware that funnel plots may be useful in investigating reporting biases but are of limited power to detect small‐study effects. As we had less than 10 studies, we did not use funnel plots.
Data synthesis
We understand that there is no closed argument for preference for use of fixed‐effect or random‐effects models. The random‐effects method incorporates an assumption that the different studies are estimating different, yet related, intervention effects. This often seems to be true to us and the random‐effects model takes into account differences between studies even if there is no statistically significant heterogeneity. There is, however, a disadvantage to the random‐effects model. It adds an extra weight to all studies, making the weights more evenly spread and giving small studies relatively more weight compared to the fixed‐effect model analysis. The small studies are often the most biased ones and, depending on the direction of effect, these studies can either inflate or deflate the effect size. We chose the random‐effects model for all analyses as the studies were all of similar size. The reader is, however, able to choose to inspect the data using the fixed‐effect method.
Subgroup analysis and investigation of heterogeneity
1. Subgroup analyses ‐ only primary outcomes
We proposed to undertake this review and provide an overview of the effects of user‐held records for people with schizophrenia, and therefore we did not perform any subgroup analyses.
2. Investigation of heterogeneity
If inconsistency was high, this was reported. First we investigated whether the data had been entered correctly. Second, if data were correct, the graph was visually inspected and studies outside the company of the rest were successively removed to see if homogeneity was restored. For this review we decided that should this occur with data contributing to the summary finding of no more than around 10% of the total weighting, the data were presented. If not, the data were not pooled and issues were discussed. We know of no supporting research for this 10% cut off but are investigating use of prediction intervals as an alternative to this unsatisfactory state.
When unanticipated clinical or methodological heterogeneity was obvious, we simply stated that hypotheses regarding these for future reviews or versions of this review would be generated. We did not undertake analyses relating to these.
Sensitivity analysis
1. Implication of randomisation
We planned to include trials in a sensitivity analysis if they were described in some way as to imply randomisation. For the primary outcomes we included these studies and if there was no substantive difference when the implied randomised studies were added to those with a better description of randomisation, then all data were employed from these studies.
2. Assumptions for lost binary data
There was low attrition in the included studies and therefore it was not necessary to perform a sensitivity analysis.
3. Risk of bias
We analysed the effects of excluding trials that were judged to be at high risk of bias across one or more of the domains of randomisation (implied as randomised with no further details available), allocation concealment, blinding and outcome reporting for the meta‐analysis of the primary outcome. If the exclusion of trials at high risk of bias did not substantially alter the direction of effect or the precision of the effect estimates, then data from these trials were included in the analysis.
4. Imputed values
We also undertook a sensitivity analysis to assess the effects of including data from trials where we used imputed values for ICC in calculating the design effect in cluster randomised trials.
If substantial differences were noted in the direction or precision of effect estimates in any of the sensitivity analyses listed above, we did not pool data from the excluded trials with the other trials contributing to the outcome but presented them separately.
5. Fixed and random effects
We assessed the differences between using a fixed‐effect model and a random‐effects model on our primary outcomes of interest.
Results
Description of studies
Results of the search
Electronic searches identified 237 references. Seventy‐five potentially relevant records were obtained and scrutinised, and 70 of these reports did not meet the inclusion criteria (see Characteristics of excluded studies). Two references were protocols for ongoing trials for which no data were available at the time of review (Figure 1).
Study flow diagram.
Included studies
Four studies met our inclusion criteria (Henderson 2004; Lester 2003; Papageorgiou 2002; Warner 2000) and are summarised in the 'Characteristics of included studies' table. One study met our inclusion criteria, however we were unable to include it as the required summary statistics and results were not provided in the report. We have classified this study (Swanson 2006) as 'awaiting classification' in the event we should obtain the relevant results from the study authors in the future.
1. Study design
All studies were randomised controlled trials. Warner 2000 and Lester 2003 used cluster randomisation and the remaining trials used individual level randomisation. Both cluster trials acknowledged and investigated clustering effects within their reported data. The Lester 2003 study reported that the random‐effects model did not alter the results of their analysis and so reported the original figures, which we use in our report. The Warner 2000 study did not specifically report a cluster‐adjusted analysis, but provided a design effect based on the intra‐class correlation coefficient of 1.53. We have reported the results with the original data and have additionally provided a cluster‐adjusted result where the Warner 2000 frequencies have been divided by the design effect.
2. Study sizes
The total number of participants included in the four studies was N = 607. The average among the studies was n = 152 and the range was 90 to 201.
3. Study setting
All studies were conducted in the United Kingdom. Warner 2000 and Lester 2003 were conducted in a 'shared care' setting, that is, care that was jointly provided by primary and secondary care. Lester 2003 was conducted between six community mental health teams in Birmingham (UK); Papageorgiou 2002 was delivered in an inpatient setting, whereas all other trials involved participants who were treated in community settings. Participants in Henderson 2004 were from eight community mental health teams in South London and Kent (UK).
4. Participants
With the exception of Lester 2003, which included only those people with a diagnosis of schizophrenia, all studies had a mixture of diagnoses. Henderson 2004 recruited individuals with psychosis and bipolar disorders (proportions not reported). Papageorgiou 2002 had 63% with psychosis and 28% with depression and bipolar. Warner 2000 had 42% schizophrenia and 12% bipolar (the remaining diagnoses included 22% depression and 14% 'other') and thereby reached our inclusion criterion (at least 50%). In terms of gender profile, there were 338 male participants and 269 female participants across the studies, with the studies having a majority male sample (range 53% to 68%). The average age in the studies was very similar, with inclusion criteria ranging from 18 to 66 years, and a mean age of 39 years.
5. Interventions
Two of the studies (Henderson 2004; Papageorgiou 2002) tested a form of advance statement (Henderson 2008); that is, personal information and treatment preferences held for use in the event of a crisis or relapse. In these two studies, the user developed the user‐held record with the help of a researcher or 'facilitator', and in the Henderson 2004 study the clinical team involved in delivering routine care was also involved. The content of these interventions was similar and broadly included the users' views on relapse indicators, wishes for future treatment, contact details for themselves, their clinicians and family and carers. They may also have included an indication of treatments that they did not want, that is, a refusal of medication.
The other two studies (Lester 2003; Warner 2000) tested a form of medical record which included aspects such as contact details, clinical notes, future appointments and medication. Lester 2003 also included an indication of relapse indicators and a diary section. For Lester 2003 and Warner 2000, these records were given to the user after randomisation.
All studies compared the active intervention to 'treatment as usual' in primary or secondary care. In addition, Henderson 2004 provided control participants with information leaflets regarding local services, treatments, and relevant legislation and policies (Henderson 2004).
6. Outcomes (rating scales)
A range of outcomes were investigated in the included studies. However, only four outcomes were investigated by more than one study: psychiatric hospital admissions; psychopathology; satisfaction; and outpatient attendance. All outcomes investigated by the studies are listed below.
6.1 Psychiatric admissions
Each included study compared the effect of user‐held records to treatment as usual on the rate and length of psychiatric admission.
6.2 Compulsory psychiatric admissions
Henderson 2004, Lester 2003 and Papageorgiou 2002 also examined the rates of compulsory psychiatric hospital admissions under a section of the UK's Mental Health Act. Henderson 2004 and Papageorgiou 2002 additionally looked at number of days spent under a section of the Mental Health Act.
6.3 Psychopathology
Psychopathology was examined by three of the four studies (Lester 2003; Papageorgiou 2002; Warner 2000).
6.3.1 Brief Psychiatric Rating Scale (BPRS) (Overall 1962)
Warner 2000 used the BPRS, which is a rating scale designed to assess psychopathology across 16 dimensions: somatic concern; anxiety; emotional withdrawal; conceptual disorganisation; guilt feelings; tension; mannerisms and posturing; grandiosity; depressive mood; hostility; suspiciousness; hallucinatory behaviour; motor retardation; uncooperativeness; unusual thought content; and blunted affect. The BPRS is usually rated by an experienced researcher or clinician, with each item rated on a seven‐point scale, varying from 0 = 'not present' to 7 = 'extremely severe', with high scores indicating more severe symptoms.
6.3.2 Behavior and Symptom Identification Scale (BASIS‐32) (Eisen 1994)
Papageorgiou 2002 and Warner 2000 used the BASIS‐32 scale, which is a self‐report measure completed by patients. The BASIS‐32 has five subscales: relation to self and others; daily living and role functioning; depression and anxiety; impulsive and addictive behaviour; and psychosis. Thirty‐two items are rated between 0 (= no problem) and 4 (= severe problem).
6.3.3 Krawiecka and Goldberg (K & G) scale (Krawiecka 1977)
Additionally, Lester 2003 used the K & G scale, which is a five‐point rating scale assessing psychopathology across the following domains: depressed; anxious; coherently expressed delusions; hallucinations; incoherence and irrelevance of speech; poverty of speech; flattened incongruous affect; psychomotor agitation; and side effects of medication (tremor, rigidity, dystonic reactions, akathisia, difficulties with vision, other). A score of 0 represents the absence of an item, where a score of 4 may indicate severe psychopathology.
6.4 Satisfaction
6.4.1 Verona Service Satisfaction Scale (VSSS) (Ruggieri 1993)
Three studies examined the effect of the intervention on patient satisfaction. Lester 2003 and Papageorgiou 2002 used the Verona Service Satisfaction Scale (VSSS), however Papageorgiou 2002 used an 'adapted brief version'. The full VSSS‐54 contains 54 items rating questions over seven dimensions: overall aspects; professionals' skills and behaviour; information; access; efficacy; types of intervention; and relative's involvement. This is a five‐point Likert scale, with a score of 1 = 'terrible' and 5 = 'excellent'.
6.4.2 Client Satisfaction Questionnaire (CSQ) (Larsen 1979)
Warner 2000 used the Client Satisfaction Questionnaire (CSQ), which is an eight‐item self‐report measure covering: quality of service; needs addressed; amount of assistance; effect of assistance; recommendable; and overall satisfaction. Each item is rated on a one to four scale, with a lower score indicating a worse outcome.
6.5 Outpatient visits
Lester 2003 and Warner 2000 both examined outpatient visits in terms of attendance.
6.6 Economic costs
The Henderson 2004 study published a secondary economic evaluation paper comparing the costs of service use between those who received the intervention and the control group over the 15‐month study period. They used a modified version of the client service receipt inventory to collect information about use of services. Hospital use was collected from patient medical records and the Mental Health Act office.
6.7 Other outcomes
Several other outcomes were investigated by individual studies including: self efficacy (no summary statistics so unable to include) (Papageorgiou 2002); and use of home treatment and non‐mental health referrals (Lester 2003).
Excluded studies
Of the 75 potentially relevant references identified in the updated search, 17 were duplicate studies or secondary references, and 49 were excluded as they did not meet the inclusion criteria described in the 'Types of studies’, ‘Types of participants’, and ‘Types of interventions’. The most common reason for exclusion was that the intervention did not involve a user‐held information component. Four further references were excluded after contacting the authors (n = 3) or having materials translated (n = 1). Hamann 2006 was a trial of shared decision making compared with standard treatment for 113 individuals with psychotic disorders treated in an inpatient setting in Germany. The intervention involved patients working through a decision aid booklet and noting their preferences for care, and using that as a prompt for discussion with their treating doctor; however, the patients did not hold the a record after this consultation. Similarly, Van Os 2004 examined the effect of patients completing a checklist (2‐COM) to identify care needs prior to routine consultations with their doctor, however the patients did not hold a record of the consultation or treatment plan. Likewise, Borell 1995 examined a psycho‐education initiative that involved some personalised information, but the patients did not hold the records after the sessions. Finally, Swanson 2008 was excluded as it was a secondary paper from the Swanson 2006 study that examined coercive events within the intervention group who received a Facilitated Psychiatric Advance Directive, that is, there was no comparison group.
Previously excluded studies are discussed below and reasons for exclusion are listed in the 'Characteristics of excluded studies' table.
Stafford 1997 was an audit of 45 people with long term mental illness who agreed to carry a small pocket‐sized file containing contact details, early warning signs for relapse, and notes made by professionals. Level of use was recorded by checking entries in the professionals' notes against those in the record, and the holders were surveyed on their views of the usefulness of the record as a whole and of its separate components. There was no control group. Two randomised studies concerned the use of 'green cards' to facilitate access to services for patients with a primary diagnosis of deliberate self harm (Cotgrove 1995; Morgan 1993) rather than one of a psychotic illness. Six other studies were already known of by the authors but were not identified by the search strategy. The aims of three (Essex 1990; Pickersgill 1998; Wolf 1996) were to improve shared care between professional primary care givers and specialist mental health services as well as to empower users of mental health services (Essex 1990; Reuler 1991; Wolf 1996). Pickersgill 1998 primarily focused on patient empowerment along with developing partnerships with users and carers. Each of these uncontrolled studies described the development and introduction of a personal record and then surveyed the individuals' views on its usefulness or level of use. (Sutherby 1999) described the use of crisis cards and joint crisis plans for people with severe mental illnesses who were in receipt of specialist care. 'Joint crisis plans' were drawn up once the contents had been agreed by both the team and patient at a meeting between the patient, an advocate if required, team members and a facilitator. Where the team could not agree with the patient's wishes, these were to have been written on a 'crisis card' instead. Participants were then followed up and asked their views on the plans and whether they had affected how they felt about their illness and treatment. There was no control group. The last case series (Backlar 1996) was not an intervention study but a postal survey of members of organisations for relatives of mentally ill people, to assess the level of use of advance directives for mental health treatment.
Ongoing
Two ongoing studies were found (Ruchlewska 2009; Thornicroft 2010) and are summarised in the 'Characteristics of ongoing studies' table. Both trials were due to be completed at the end of 2011 and were expected to report results in 2013.
Awaiting assessment
Swanson 2006 did not report any summary statistics of potentially relevant outcomes. We were unable to obtain further data from the authors.
Risk of bias in included studies
For summary and graphical representation of the risk of bias please see Figure 2 and Figure 3.
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Full assessment of bias was hindered by inadequate reporting in some of the trials. Authors were contacted for further information but either relevant data were not available or we received no reply from the requests for further information.
Allocation
All trials were randomised, and each provided a detailed description of methods used to reduce problems associated with allocation (Henderson 2004; Lester 2003; Papageorgiou 2002; Warner 2000).
Blinding
Due to the nature of the intervention, none of the trials were able to use double‐blinding procedures. However, three trials (Henderson 2004; Lester 2003; Papageorgiou 2002) attempted to reduce bias by using outcome raters who were blinded to allocation. The remaining study (Warner 2000) did not report on the blinding of outcome raters.
Incomplete outcome data
One study (Warner 2000) did not report missing data in sufficient detail and was therefore rated as unclear risk. The remaining studies (Henderson 2004; Lester 2003; Papageorgiou 2002) attempted to reduce bias by using outcome raters who were blinded to allocation. The remaining studies had low levels of data attrition, and where present it was spread evenly across the intervention arms. Reasons for data attrition were considered unlikely to be a result of the intervention.
Selective reporting
All data in this review came from the published reports of the trials. None of the studies had published protocols and therefore we were unable to determine if the published report covered the full range of planned comparisons.
Other potential sources of bias
We detected no other potential sources of bias.
Effects of interventions
Comparison 1: user‐held records versus treatment as usual
All pooled data are presented below. For continuous outcomes, where means and standard deviations were unavailable these have been presented in the 'Other data' tables as 'unpooled secondary outcomes', including data that was not suitable for data synthesis.
1.1 Psychiatric hospital admission
Many of the results were not provided as means and standard deviations. We have, however, presented results in our data and analysis section where other data such as medians or ranges were reported.
1.1.1 Psychiatric admission
Psychiatric hospital admission data were available for four trials involving 597 participants. We found no significant effect of the intervention in any of these studies individually. The pooled treatment effect showed no significant impact of the intervention and was of very low magnitude (n = 597, 4 RCTs, RR 0.99 CI 0.71 to 1.38, Analysis 1.1), see Figure 4 and summary of findings Table for the main comparison. There was some heterogeneity between the studies (P = 0.16; I2 = 41%), with the variance explained by between‐study differences.
Forest plot of comparison: 1. Psychiatric hospital admission: 1. general admission.
We adjusted the cluster randomised study for the design effect but found very little effect on the pooled effect estimate (n = 566, 4 RCTs, RR 0.97 CI 0.70 to 1.35, Analysis 1.8).
1.1.2 Compulsory admission
Only three studies involving 507 participants provided information on compulsory admissions to hospital. This is a low number of studies for a meta‐analysis, though we have provided a pooled estimate (see Figure 5). When pooled there was no significant effect of the intervention (n = 507, RR 0.64 CI 0.37 to 1.10, Analysis 1.1). Heterogeneity was lower in this comparison (P = 0.28; I2 = 21%), though this was very difficult to judge with only three studies considered (see summary of findings Table for the main comparison).
1.1.3 Psychiatric admission ‐ number of days spent in hospital
Summary data on the length of admissions were provided by three studies, none of which found a significant impact of the intervention. It was not possible to pool this data as the measure was skewed and so non‐parametric summary measures were provided (Analysis 1.3). There was evidence of some heterogeneity between the studies in terms of the median length of admissions, and the magnitude and direction of the treatment effect. This would suggest that the studies were not comparable on this outcome.
1.1.5 Compulsory admission ‐ number of days spent in hospital under a section of the Mental Health Act
Two trials also provided information on length of compulsory admission (that is, days under a section of the Mental Health Act). A significant effect of the intervention was stated to have been found in one study but not the other (Analysis 1.3); the results generally suggested that people who received user‐held personal information spent less time in hospital under compulsory admission. It was not possible to pool this data as the measure was heavily skewed and so non‐parametric summary measures were provided. These data should be interpreted with caution.
1.2 Mental state
1.2.1 Psychopathology
Psychopathology was examined, using three different measures, by three of the four studies (Lester 2003; Papageorgiou 2002; Warner 2000).
1.2.1.1 Brief Psychiatric Rating Scale (BPRS), high = worse, skew
The one study that reported this outcome found little effect of the user‐held information on psychopathology using the BPRS scale. These data were not included in a meta‐analysis due to the large standard deviations, and they were considered skewed. These are best inspected by viewing Analysis 1.4.
1.2.1.2 Behaviour and Symptom Identification Scale‐32 (BASIS‐32), high = worse, skew
Two trials used the self‐report measure of BASIS‐32. The Papageorgiou 2002 study presented only the data as median and range, with heavily skewed data, which are therefore presented in additional Table 5. In the Warner 2000 study, there was no effect of the intervention on self‐reported psychopathology measured by the BASIS‐32; however these data were also heavily skewed and are included in a separate table (Analysis 1.4).
1.2.1.3 Krawiecka and Goldberg (K & G), high = worse, skew
Lester 2003 reported change scores using the K & G scale rated by blinded keyworkers; there was no effect of the intervention. Because the standard deviations were large, the data were reported separately (Analysis 1.4).
1.3 Satisfaction
The three studies (Lester 2003; Papageorgiou 2002; Warner 2000) examining satisfaction found no effect.
1.3.1 Client Satisfaction Questionnaire (CSQ), high = better, skew
One small study used the CSQ and found no effect of intervention (1 RCT, n = 90, MD ‐0.89 CI ‐3.35 to 1.15). When entered into data synthesis, the calculated mean difference was different than that reported in the published report. We decided to use the published data and present this in an additional table (Analysis 1.5).
1.3.2 Verona Hospital Service Satisfaction Scale (VSSS), high = better, skew
As above, the data in one study were either skewed or adjusted; we therefore presented these data as reported by the authors in Table 7. Lester 2003 reported change scores on the VSSS scale; there was no effect of the intervention (Analysis 1.5). Using a brief version of the VSSS, Papageorgiou 2002 reported no effect (Analysis 1.5).
1.4 Other relevant measures
1.4.1 Service use
1.4.1.1 Outpatient attendance
Lester 2003 and Warner 2000 both examined the effect of user‐held records on outpatient attendance and found no effect (2 RCTs, n = 281, RR 1.09 CI 0.92 to 1.29, Analysis 1.6).
1.4.1.2 Home treatment use
Lester 2003 examined the use of home treatment teams, and demonstrated no difference (n = 191, 1 RCT, RR 0.72 CI 0.21 to 2.46, Analysis 1.6).
1.4.1.3 Non‐mental health referrals
Lester 2003 also examined the use of non‐mental health referrals, which again demonstrated no difference (n = 191, 1 RCT, RR 1.08 CI 0.59 to 1.98, Analysis 1.6).
1.5 Economic costs of care
1.5.1 Client service receipt inventory (cost, skew)
A secondary economic analysis (Flood 2006) of the Henderson 2004 trial suggested that while the mean difference in costs between user‐held records and treatment as usual was not significantly different, the user‐held personal information intervention (JCP) was more likely than not to be cost effective, most likely due to the reduction in compulsory admissions in the intervention group. However, due to very large standard deviations and skewed data, these results were presented in a separate table (Analysis 1.7).
Sensitivity analysis
1. Implication of randomisation
There were no studies that implied randomisation; all included studies provided details as to randomisation.
2. Assumptions for lost binary data
There was low attrition in the included studies and therefore it was not necessary to perform a sensitivity analysis.
3. Risk of bias
No studies were rated as at 'high' risk across one or more of the domains of risk of bias, therefore a sensitivity analysis was not necessary.
4. Imputed values
Adjusting for the reported ICC in the cluster randomised trial made little difference to the pooled estimate and did not change the conclusions of the analysis (Analysis 1.8).
5. Fixed‐effect and random‐effects models
Applying a fixed‐effect model analysis made little difference to the pooled effect estimates for both psychiatric admissions (fixed‐effect RR 0.96, 95% CI 0.76 to 1.22) and compulsory admissions (fixed‐effect RR 0.65, 95% CI 0.41 to 1.03). The conclusions of the analysis remained the same whether a fixed‐effect or random‐effects model analysis was used.
Discussion
Summary of main results
In this updated search, we found four studies involving 607 participants that met our inclusion criteria. As shown in the summary of findings Table for the main comparison, four studies involving 597 participants investigated the impact of user‐held records on psychiatric hospitalisation and three studies involving 507 participants investigated compulsory psychiatric hospitalisation. The evidence suggests that user‐held records do not affect the rate of either voluntary or involuntary psychiatric admissions.
There were too few investigations of other outcomes to estimate an effect size, but there is some preliminary evidence to suggest some beneficial effect on overall costs. There is no evidence of effect for psychological variables such as psychopathology and patient satisfaction.
Overall completeness and applicability of evidence
1. Completeness
With only four studies investigating the core question of the effect of user‐held records on psychiatric hospitalisation, and fewer examining other outcomes, it is too early to determine the effectiveness of user‐held records. We note with interest two ongoing trials, due to be completed in 2012, that examine our primary and secondary outcomes of interest including hospitalisation, costs and working alliance (Ruchlewska 2009; Thornicroft 2010).
2. Applicability
The only study to find a significant reduction in compulsory psychiatric admissions (Henderson 2004) investigated a form of advance statement (Henderson 2008), suggesting that both the involvement of the service user in deciding the content and inclusion of future treatment wishes or refusals in the record may have an important effect. However, one other trial (Papageorgiou 2002) also investigated a form of advance statement but found no effect on the outcomes of interest. There were several differences between Papageorgiou 2002 and Henderson 2004; firstly, the Papageorgiou 2002 study was conducted in an inpatient setting with service users who were under a section of the Mental Health Act and due for discharge. It is conceivable that service users may have felt compelled to participate in the trial or that their participation could influence their discharge from the hospital ward. By contrast, the Henderson 2004 study was conducted in the community and thus the potential for perceived pressure to participate was lessened. Secondly, and perhaps more importantly, the Henderson 2004 study had some direct or indirect involvement (see Henderson 2008) of the clinical team. This suggests that the efficacy of this type of user‐held record may be increased if clinical teams are also involved in the discussion of the contents and thus may be better placed to facilitate the service user's wishes in the event of a future relapse.
Quality of the evidence
Four studies involving 607 participants and two different types of interventions were included. The overall quality of the evidence was moderate. Each of the individual studies were methodologically quite strong, notwithstanding some gaps in reporting of randomisation and blinding procedures. However, there were too few studies addressing each outcome of interest to reach a robust conclusion regarding the effectiveness of user‐held records.
There was a great deal of heterogeneity in both the outcomes reported and their measurement, which prevented synthesis of most outcomes. Additionally, we believe the between‐study variability for the psychiatric hospital admissions and compulsory psychiatric admission outcomes resulted in wide confidence intervals for these estimations. We therefore downgraded the precision rating for these estimations in the summary of findings Table for the main comparison. Only one study (Henderson 2004) found a significant reduction in compulsory psychiatric admissions.
Potential biases in the review process
The search for studies was rigorous, using the Cochrane database, reference chaining, grey literature searching and contact with topic experts. One study was identified in a trial registry entry from the early 2000s, but neither reports of findings nor the authors could be located. It is unlikely that this trial would strongly affect our results as the primary outcomes were only of secondary interest to this review (for example, health behaviours and psychological variables such as locus of control). Study selection and data extraction were conducted separately by two authors and confirmed by a third, and thus the risk of bias in study selection and extraction is limited. Authors of included studies were contacted for information regarding gaps in the reports of methods but the information was not available. Without this information, the risk of bias is inconclusive and noted as such in the risk of bias tables.
Agreements and disagreements with other studies or reviews
We know of one other Cochrane Review in this topic area (Campbell 2010), a review of Advance Treatment Directives. This review included two studies that are also included in this review (Henderson 2004; Papageorgiou 2002). The authors shared our conclusion that there is insufficient evidence to make a robust conclusion about the impact of such interventions.
Study flow diagram.
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Forest plot of comparison: 1. Psychiatric hospital admission: 1. general admission.
Comparison 1 User‐held information versus standard information, Outcome 1 Psychiatric hospital admission: 1. Psychiatric admission.
Comparison 1 User‐held information versus standard information, Outcome 2 Psychiatric hospital admission: 2a. Days in hospital (compulsory only, by range of days).
| Study | Intervention | Mean | Median | Range | N | Test statistic | Significance |
| any admission | |||||||
| Henderson 2004 | User‐held information | 32 | 0 | ‐ | 80 | Mann Whitney=1.52 | p=0.15 |
| Henderson 2004 | Standard care | 36 | 0 | ‐ | 80 | ||
| Lester 2003 | User‐held information | ‐ | 16.5 | 11.3 to 59.0 (IQR) | 92 | Mann Whitney= ‐1.10 | p=0.271 |
| Lester 2003 | Standard care | ‐ | 31.0 | 19.5 to 129.0 (IQR) | 99 | ||
| Warner 2000 | User‐held information | ‐ | 7 | 0 to 235 | 55 | Mann Whitney= 0.96 | p=0.33 |
| Warner 2000 | Standard care | ‐ | 0.71 | 0 to 96 | 35 | ||
| compulsory admission | |||||||
| Henderson 2004 | User‐held information | 14 | 0 | ‐ | 80 | Mann Whitney=4.13 | p=0.04 |
| Henderson 2004 | Standard care | 31 | 0 | ‐ | 80 | ||
Comparison 1 User‐held information versus standard information, Outcome 3 Psychiatric hospital admission: 2b. Days in hospital (skewed data).
| Study | Intervention | Mean | SD | Median | Range | N |
| BPRS | ||||||
| Warner 2000 | User‐held information | 16.9 | 9.8 | ‐ | ‐ | 55 |
| Warner 2000 | Standard care | 13.8 | 8.6 | ‐ | ‐ | 35 |
| BASIS‐32 | ||||||
| Papageorgiou 2002 | User‐held information | ‐ | ‐ | 0.81 | 0 to 3.34 | 59 |
| Papageorgiou 2002 | Standard care | ‐ | ‐ | 0.62 | 0 to 3.25 | 55 |
| Warner 2000 | User‐held information | 1.27 | 0.81 | ‐ | ‐ | 55 |
| Warner 2000 | Standard care | 1.20 | 0.82 | ‐ | ‐ | 35 |
| K&G | ||||||
| Lester 2003 | User‐held information | ‐1.22 | 3.1 | ‐ | ‐ | 91 |
| Lester 2003 | Standard care | ‐1.69 | 3.0 | ‐ | ‐ | 99 |
Comparison 1 User‐held information versus standard information, Outcome 4 Mental state: Scores (high=worse, skewed data).
| Study | Intervention | Mean | SD | Median | Range | N | Notes |
| hospital service satisfaction (VSSS, skewed data) | |||||||
| Lester 2003 | User‐held information | 0.025 | 0.30 | ‐ | ‐ | 92 | ‐ |
| Lester 2003 | Standard care | 0.008 | 0.30 | ‐ | ‐ | 99 | |
| Papageorgiou 2002 | User‐held information | ‐ | ‐ | 29 | 9 to 45 | 59 | ‐ |
| Papageorgiou 2002 | Standard care | ‐ | ‐ | 31 | 9 to 44 | 55 | |
| client satisfaction (CSQ, non skewed but data analysed taking clustering into account) | |||||||
| Warner 2000 | User‐held information | 22.3 | 6.5 | ‐ | ‐ | 55 | Mean Difference (IV, Fixed, 95% CI) |
| Warner 2000 | Standard care | 23.4 | 4.4 | ‐ | ‐ | 35 | ‐0.89 [‐3.38, 1.59] |
Comparison 1 User‐held information versus standard information, Outcome 5 Satisfaction: Scores (high=better).
Comparison 1 User‐held information versus standard information, Outcome 6 Service use.
| Study | Intervention | Mean (£) | Standard deviation | N |
| Henderson 2004 | User‐held information | 7,264 | 13,045 | 80 |
| Henderson 2004 | Standard care | 8,359 | 12,168 | 80 |
Comparison 1 User‐held information versus standard information, Outcome 7 Economic costs of care (£ ‐ client service receipt inventory, skew).
Comparison 1 User‐held information versus standard information, Outcome 8 Sensitivity analysis: Psychiatric hospital admission: adjusting for clustering.
| User‐held information versus Sstandard Information for routine care of people with severe mental illness | ||||||
| Patient or population: patients with routine care of people with severe mental illness | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect | No of Participants | Quality of the evidence | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control | USER‐HELD INFORMATION versus STANDARD INFORMATION | |||||
| Psychiatric hospital admission: psychiatric admission | Low1 | RR 0.99 | 597 | ⊕⊕⊕⊝ | ||
| 50 per 1000 | 49 per 1000 | |||||
| High1 | ||||||
| 440 per 1000 | 436 per 1000 | |||||
| Psychiatric hospital admission: compulsory admission | Low1 | RR 0.64 | 507 | ⊕⊕⊕⊝ | ||
| 40 per 1000 | 26 per 1000 | |||||
| High1 | ||||||
| 260 per 1000 | 166 per 1000 | |||||
| Death: causes other than suicide ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No study reported this outcome |
| Violence ‐ not reported | See comment | See comment | Not estimable | ‐ | See comment | No study reported this outcome |
| Mental state: psychopathology | See comment | See comment | Not estimable | 0 | See comment | Data not pooled: studies used inconsistent/incompatible measures of psychopathology and/or data are skewed. No indication of differences between groups |
| Satisfaction with health care | See comment | See comment | Not estimable | 0 | See comment | Data not pooled: studies used inconsistent/incompatible measures of satisfaction and/or data are skewed. No indication of differences between groups |
| *The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). | ||||||
| GRADE Working Group grades of evidence | ||||||
| 1 Assumed risk: the low and high risk values correspond to the lowest and highest rates of admissions in the control groups from the included studies. | ||||||
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
| 1 Psychiatric hospital admission: 1. Psychiatric admission Show forest plot | 4 | Risk Ratio (IV, Random, 95% CI) | Subtotals only | |
| 1.1 any admission | 4 | 597 | Risk Ratio (IV, Random, 95% CI) | 0.99 [0.71, 1.38] |
| 1.2 compulsory admission | 3 | 507 | Risk Ratio (IV, Random, 95% CI) | 0.64 [0.37, 1.10] |
| 2 Psychiatric hospital admission: 2a. Days in hospital (compulsory only, by range of days) Show forest plot | 1 | Risk Ratio (IV, Random, 95% CI) | Subtotals only | |
| 2.1 0 days | 1 | 156 | Risk Ratio (IV, Random, 95% CI) | 1.02 [0.87, 1.20] |
| 2.2 1‐100 days | 1 | 156 | Risk Ratio (IV, Random, 95% CI) | 0.70 [0.33, 1.47] |
| 2.3 101‐365 days | 1 | 156 | Risk Ratio (IV, Random, 95% CI) | 2.44 [0.49, 12.18] |
| 3 Psychiatric hospital admission: 2b. Days in hospital (skewed data) Show forest plot | Other data | No numeric data | ||
| 3.1 any admission | Other data | No numeric data | ||
| 3.2 compulsory admission | Other data | No numeric data | ||
| 4 Mental state: Scores (high=worse, skewed data) Show forest plot | Other data | No numeric data | ||
| 4.1 BPRS | Other data | No numeric data | ||
| 4.2 BASIS‐32 | Other data | No numeric data | ||
| 4.3 K&G | Other data | No numeric data | ||
| 5 Satisfaction: Scores (high=better) Show forest plot | Other data | No numeric data | ||
| 5.1 hospital service satisfaction (VSSS, skewed data) | Other data | No numeric data | ||
| 5.2 client satisfaction (CSQ, non skewed but data analysed taking clustering into account) | Other data | No numeric data | ||
| 6 Service use Show forest plot | 2 | Risk Ratio (M‐H, Random, 95% CI) | Subtotals only | |
| 6.1 outpatient attendance | 2 | 281 | Risk Ratio (M‐H, Random, 95% CI) | 1.09 [0.92, 1.29] |
| 6.2 home treatment use | 1 | 191 | Risk Ratio (M‐H, Random, 95% CI) | 0.72 [0.21, 2.46] |
| 6.3 non‐mental health referrals | 1 | 191 | Risk Ratio (M‐H, Random, 95% CI) | 1.08 [0.59, 1.98] |
| 7 Economic costs of care (£ ‐ client service receipt inventory, skew) Show forest plot | Other data | No numeric data | ||
| 8 Sensitivity analysis: Psychiatric hospital admission: adjusting for clustering Show forest plot | 4 | Risk Ratio (IV, Random, 95% CI) | Subtotals only | |
| 8.1 adjusted for cluster effects | 4 | 566 | Risk Ratio (IV, Random, 95% CI) | 0.97 [0.70, 1.35] |
| 8.2 not adjusted for cluster effects | 4 | 597 | Risk Ratio (IV, Random, 95% CI) | 0.99 [0.71, 1.38] |
