Marys Medicine

Bjp-2014-158931 1.6

The British Journal of Psychiatry1–6. doi: 10.1192/bjp.bp.114.158931 Shared treatment decision-making andempowerment-related outcomes in psychosis:systematic review and meta-analysisDiana Stovell, Anthony P. Morrison, Margarita Panayiotou and Paul Hutton BackgroundIn the UK almost 60% of people with a diagnosis of shared decision-making were found on indices of treatment- schizophrenia who use mental health services say they are related empowerment (6 RCTs; g = 0.30, 95% CI 0.09–0.51), not involved in decisions about their treatment. Guidelines although the effect was smaller if trials with 425% missing and policy documents recommend that shared decision- data were excluded. There was a trend towards shared making should be implemented, yet whether it leads to decision-making for future care leading to reduced use of greater treatment-related empowerment for this group has compulsory treatment over 15–18 months (3 RCTs; RR = 0.59, not been systematically assessed.
95% CI 0.35–1.02), with a number needed to treat ofapproximately 10 (95% CI 5–?). No clear effect on treatment decision-making ability (3 RCTs) or the quality of the To examine the effects of shared decision-making on indices therapeutic relationship (8 RCTs) was found, but data were of treatment-related empowerment of people with psychosis.
MethodWe conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) of shared decision-making For people with psychosis the implementation of shared concerning current or future treatment for psychosis treatment decision-making appears to have small beneficial (PROSPERO registration CRD42013006161). Primary outcomes effects on indices of treatment-related empowerment, but were indices of treatment-related empowerment and more direct evidence is required.
objective coercion (compulsory treatment). Secondaryoutcomes were treatment decision-making ability and the Declaration of interest quality of the therapeutic relationship.
Copyright and usage We identified 11 RCTs. Small beneficial effects of increased B The Royal College of Psychiatrists 2016.
The Schizophrenia Commission has stated that: ‘shared decision- enhancing shared decision-making can improve treatment-related making on medication choices is essential to improving outcomes empowerment in this group, as judged by participants and [ . . ]. This means practitioners discussing medication options indicated by objective measures. The effects on secondary fully with service users [and] providing them with quality outcomes – quality of patient–provider relationship (patient- or information so that informed decisions can be made.'1 observer-rated) and decision-making abilities and knowledge Shared decision-making in healthcare has been described as (clinician-rated) – were also evaluated.
a process of supportive collaboration between patients* andclinicians, drawing on evidence and the patient's preferences and values to reach a consensus about treatment or care.2,3 It isseen as falling midway on a continuum between paternalistic The electronic databases Medline (from 1946), PsycINFO (from 1806), EMBASE (from 1980), CINAHL (from 1937) and the informed decision-making by patients.4–7 Although benefits have Cochrane Central Register of Controlled Trials (CENTRAL) were been reported for shared decision-making in physical healthcare,8 searched by two authors (D.S. and M.P.) in August 2013 and research and practice on this topic in relation to people with January 2015 respectively, along with the references of two mental health problems are still at a formative stage.9 Shared previous reviews of shared decision-making interventions in decision-making may be particularly relevant in psychosis, where mental healthcare.4,5 Titles, abstracts and keywords were searched increasing treatment-related empowerment and reducing use of using the terms ‘shared decision making', ‘psychosis' and coercion have been identified by patients as outcomes of intrinsic ‘randomised controlled trial', with related terms in each case.
value.10–13 If clinical trials of this approach show it to be effective The full search strategy is given in online supplement DS1. The at improving these outcomes, then this would support existing search was not limited by date or publication status, but only English-language studies were included. Initial screening and data implemented with this group.1,14 extraction were carried out by D.S. and studies published between We conducted a systematic review and meta-analysis of 2013 and 2015 were screened and extracted by M.P. Supervision randomised controlled trials (RCTs) of shared decision-making of screening and extraction, and arbitration in the event of in psychosis, with the overall aim of finding out whether uncertainty, were provided by P.H.
Inclusion and exclusion criteria *The literature reviewed refers to people with psychosis variously as ‘patients',‘service users' and ‘clients'; ‘patients' is used here for consistency and in Trials were included if they compared a psychosocial intervention accordance with BJPsych house style.
designed to enhance shared decision-making in the planning of Shared decision-making and empowerment treatment for psychosis with usual care or a non-specific control values, regression coefficients, P values and sample size were used treatment. Shared decision-making was defined as a process of to estimate the standardised mean difference (SMD) using supportive collaboration between patients and clinicians, drawing equations specified in the Cochrane Handbook.15 In the absence on evidence and the patient's preferences and values to reach a of available continuous data, proportions were converted to SMDs consensus about treatment or care.2,3 Interventions to enhance using the Campbell Collaboration's Practical Meta-Analysis Effect it could be delivered either individually or in a group format, and could involve either current or future treatment decisions input.php). Numbers randomised were used where appropriate (e.g. joint crisis planning), but they had to share a focus on methods for imputing missing data were reported, but limitation promoting shared decision-making as defined above and they to use of n reported for the analysis was expected where this was had to involve direct contact with patients or clinicians. Thus, not the case. Missing data were assessed as part of the risk of bias studies of advance statements or care planning not involving assessment, but no test of robustness of estimates to changing promotion of shared decision-making were excluded, as were assumptions around missing data was planned or performed.
studies providing interventions to family members or carers. We For the binary outcome of compulsory admission, we assumed included trials where assessing the effects of promoting shared those randomised but unaccounted for had an unchanged decision-making was either a primary or a secondary aim of the outcome from randomisation.
Continuous data were extracted and combined using MetaXL We included studies in which at least half of the participants had a version 2.0 (epigear.com) to derive the SMD and 95% confidence diagnosis of a schizophrenia spectrum disorder. Studies where intervals, with Hedges' g employed to adjust for small sample more than half of participants had a diagnosis of bipolar disorder sizes. Statistical significance was inferred with P values of or learning disability, or where psychosis was predominantly 50.05, using two-tailed hypotheses. Analyses employed a random substance-induced or organic in origin, were excluded. We did effects model although a fixed effect analysis was also performed not include participants at risk of developing psychosis, and we where the I2 statistic indicated less than moderate heterogeneity did not exclude participants on the basis of age or stage of (defined a priori as 40%).15 Cohen's proposed criteria for interpretation of effect sizes (small 0.2, moderate 0.5, large 0.8)were used in the absence of more specific criteria for judging clinical significance of SMDs.16 For the binary outcome ofobjective coercion (compulsory admission) we computed the Two primary outcomes were chosen: first, subjective empowerment, pooled relative risk of the unfavourable outcome, the risk and second, reduced objective coercion. For the first outcome a difference and number needed to treat, each with 95% confidence scoping review of the literature suggested that few studies measured subjective empowerment directly; however, severalmeasured aspects of empowerment or closely related concepts.
In order to include as many studies as possible a conceptual Sensitivity analyses hierarchy was developed to specify in advance the order of Sensitivity analyses were used to assess the effect of excluding preference for the data that would be extracted and analysed, studies with more than 25% attrition.
based on its closeness to the concept of empowerment. Thehierarchy was structured as follows: self-reported subjective Registration of review protocol empowerment4treatment decision-making self-efficacy4health-related locus of control4patient-perceived involvement in The review protocol was registered in advance with the Inter- national Prospective Register of Systematic Reviews (PROSPERO) provider interaction4reduced perceived coercion. The second number CRD42013006161.17 primary outcome was reduced objective coercion as indicated byfewer admissions under mental health legislation: the Mental Risk of bias and study quality Health Act 1983 for studies in England & Wales or corresponding Risk of bias was assessed for each study using the Cochrane legislation within the country concerned for studies that had taken Collaboration risk of bias tool.18 Assessment of outcome quality place elsewhere. We originally planned to analyse days spent in was performed using the GRADE approach.19 Risk of performance hospital under compulsory care for this outcome, but skewed or bias was not used as a criterion for downgrading the quality of the unavailable data meant we decided to analyse admission rates evidence, since it is essentially unavoidable in trials of psychosocial instead. Secondary outcomes were quality of patient–provider interventions, and to downgrade on this basis was judged to be relationship (patient- or observer-rated) and decision-making overly conservative. Assessment of risk of publication bias using abilities and knowledge (clinician-rated). For all outcomes we funnel plots was planned if there were at least ten studies.20 included data derived from both validated and non-validated GRADE ratings were used to determine overall confidence in scales, although use of the latter was considered when assessing the reliability of individual outcomes. Full details of the the quality of the individual outcome.
assessment methods are provided in online supplements DS2and DS3.
Summary data (means and standard deviations) were extracted where possible from relevant studies using a spreadsheet.
Information on study characteristics was also collated. Authors The titles and abstracts of 4676 papers were screened for eligibility were contacted where information was missing. When means (Fig. 1). Of these, full-text reports were sought for 38. Three and standard deviations were not reported and the authors were studies were not included because they were ongoing or could unable to supply this information, other parameters such as F not be traced. A further 25 studies were excluded because they delivered and baseline demography of the participants are given Records identified Records identified in online Table DS1; reasons for exclusions are summarised in online Tables DS2 and DS3.
Bias and quality assessment Table 1 provides a summary of the results for each outcome andthe GRADE ratings of outcome quality. The full risk of bias and Irrelevant or duplicate quality ratings are provided in online Tables DS4 and DS5.
records excluded on Funding of the included studies is summarised in online Table basis of title or abstract: DS6. Most (k = 8) studies had at least one judgement of unclear risk of selection bias.21,22,25,26,28–32 Risk of performance bias washigh across all studies owing to the nature of the interventions,which precluded masking (blinding). Insufficient information inreporting Full-text reports studies,21,22,25–27,29,30,32 and one RCT stated no attempt to mask Styles excluded: 28 assessors was made.31 Risk of attrition bias was high or unclear Ongoing studies: 2 Untraced reports: 1 on some post-intervention measures in just over half of the studies No usable outcomes: 5 (k = 6).24–27,31,32 Risk of selective reporting bias was largely Not treatment SDM: 11 unclear, although there was an indication that three RCTs Not RCT: 6450% data missing: 1 did not report all their outcomes.21,25,32 There was unclear risk 450% participants of other sources of bias in four trials, namely risk of recruitment Randomised controlled bias due to cluster randomised design,26,29,31 and risk of cross- Not English language: 1 contamination due to in-patient research setting.30 Study selection process.
RCT, randomised controlled trial; SDM, shared decision-making.
A small effect of shared decision-making interventions on indicesof subjective empowerment (Fig. 2) was observed (k = 6, g = 0.30,95% CI 0.09 to 0.51; low-quality evidence). Six trials (n = 843) did not report outcomes we could use (k = 5), did not evaluate a provided data on this outcome.24,26,28–30 The quality of the treatment-related shared decision-making intervention (k = 11), evidence was downgraded owing to its indirectness, with no study were not RCTs (k = 6), had an attrition rate of 450% (k = 1), measuring subjective empowerment specifically, and its imprecision, had less than 50% participants with non-affective psychosis given that the 95% confidence interval included both trivial and (k = 1) or were not published in English (k = 1). A total of 11 RCTs moderate effects. There was, however, no evidence of undue were therefore included. Of these, four evaluated interventions de- heterogeneity (I 2 = 35%). Two small studies provided follow-up signed to support shared decision-making in relation to future data. One did not find a significant effect at hospital discharge treatment (joint crisis planning or facilitated advance direc- (g = 0.16, 95% CI 70.27 to 0.60), but data were missing for more tives).21–25 The remaining seven RCTs examined interventions de- than a quarter of participants.26 For the other, ratings on an signed to support shared decision-making in relation to current idiosyncratic measure of patient-perceived involvement were treatment. Of these, four examined the effects of paper-based or reported at 6-month follow-up, and suggested a large effect was web-based decision or communication aids;26–29 one evaluated a maintained (g = 1.09, 95% CI 0.49 to1.69).30 group intervention;30 another evaluated the effects of trainingclinicians in a shared decision-making approach to medicines Compulsory treatment management;31 and another evaluated the effects of patient- Data from three studies (n = 872) suggested a trend towards case management where treatment-related shared decision-making for future treatment (crisis planning) decision-making was emphasised.32 Details of interventions reducing the likelihood of future compulsory in-patient treatment Summary of results Outcome (number of trials) Indices of subjective empowerment (k = 6) g = 0.30 (0.09, 0.51) Risk of compulsory treatment (k = 3) RR = 0.59 (0.35, 1.02) RD = 70.10 (70.19, 0) Relationship with clinician (k = 8) g = 0.14 (70.05, 0.34) Relationship with clinician, g = 0.21 (0.07, 0.35) excluding Hamann et al (2011)31 (k = 7) Clinician-rated decision-making abilities g = 0.27 (70.24, 0.79) and knowledge (k = 3) C, control; I, intervention; NNT, number needed to treat; RD, risk difference; RR, relative risk.
Shared decision-making and empowerment SDM Control Total Hamann et al (2006)26 Perceived involvement 0.50 (0.03, 0.96) Hamann et al (2011)30 Decision self-efficacy 0.04 (70.45, 0.54) 13.02 Steinwachs et al (2011)28 Reduced clinician verbal dominance 0.60 (0.04, 1.16) Thornicroft et al (2013)24 Reduced perceived coercion 0.13 (70.05, 0.32) 35.56 Woltmann et al (2011)29 Perceived involvement 0.18 (70.26, 0.62) 15.67 O'Donnell et al (1999)32 ‘Have more say' 0.74 (0.17, 1.31) 0.30 (0.09, 0.51) Effect of shared decision-making (SDM) on indices of subjective empowerment.
over the subsequent 15–18 months (Fig. 3), but the estimate was in physician' rather than ‘alliance' or ‘quality of communication'.
imprecise and inconsistent and did not exclude the possibility of Omitting these data suggested a small, statistically significant effect no effect (RR = 0.59, 95% CI 0.35 to 1.02; risk difference 70.10, (g = 0.21, 95% CI 0.07 to 0.35; moderate-quality evidence) favouring 95% CI 70.19 to 0; NNT = 10, 95% CI 5 to ?).23–25 shared decision-making, with a reduction in heterogeneity to 20%.
Sensitivity analysis Clinician-rated decision-making abilities Excluding the two studies with more than 25% missing data from Pooled data from three studies (n = 520) did not support the the empowerment analysis resulted in a smaller effect size (k = 4, hypothesis that shared decision-making interventions can enhance g = 0.17, 95% CI 0.01 to 0.32),26,32 as did using a fixed effect participant decision-making ability as rated by clinicians (k = 3, analysis instead of random effects (k = 8, g = 0.23, 95% CI 0.09 g = 0.27, 95% CI 70.24 to 0.79, very low-quality evidence); see Fig. DS2.21,26,30 heterogeneity was (I 2 = 83%), as was imprecision, with a 95% confidence interval Secondary outcomes including both small negative and large positive estimates, and Relationship with clinician only one of the studies used a validated measure of decisional Overall, no significant effect of shared decision-making inter- ventions on patient or observer-rated relationship with clinicianwas found (k = 8, g = 0.14, 95% CI -0.05 to 0.34); see online Sensitivity analyses Fig. DS1. Eight studies (n = 1200) contributed to this out- Excluding four studies with more than 25% missing data from the come.22,24,25,27,28,30–32 High heterogeneity (I 2 = 60%) together analysis of patient–provider relationship reduced the overall effect with wide 95% confidence intervals (including both marginal size to 0.07 (95% CI 70.29 to 0.42; k = 4) but increased negative effects and small positive effects) meant we rated the heterogeneity (I 2 = 73%).24,25,31,32 Also removing the Hamann evidence as low quality. A moderate negative effect in the study study from this analysis increased the pooled effect size to 0.25 by Hamann et al (g = 70.62, 95% CI 71.13 to 70.11) contributed (95% CI 0.08 to 0.41; k = 3) and reduced heterogeneity to 0%.30 particularly to the high heterogeneity.31 This study of a group Excluding one study with more than 25% missing data from the in-patient intervention differed from the others in measuring ‘trust analysis of decision-making ability reduced the effect size to Cases/SDM Control/control Total Henderson et al (2004)23 0.48 (0.34, 0.96) Thornicroft et al (2013)24 0.87 (0.62, 1.23) Ruchlewska et al (2014)23 Admission, Court Order 0.38 (0.17, 0.86) 0.59 (0.36, 1.02) Effect of shared decision-making (SDM) on risk of compulsory treatment.
MHA, Mental Health Act; RR, relative risk.
0.02 (95% CI 70.60 to 0.65) but did not reduce heterogeneity indirect indices of empowerment instead. We think the conceptual overlap of the different data we extracted is sufficient to ensure thepooled estimate is meaningful and interpretable. Nonetheless, our findings should be interpreted with caution and, if we wish tounderstand how to reduce disempowerment in schizophrenia, Collaborative decision-making around psychiatric treatment, with future RCTs need to use valid and reliable measures of this greater consideration of patient preferences and values, may help construct. Shared decision-making is often assessed by its ability people receiving treatment for psychosis experience greater to improve treatment satisfaction, but clearly this is not the same empowerment and reduced coercion in relation to their care.
thing as empowerment, since empowerment might involve feeling We examined whether and to what extent this hypothesis is able to express dissatisfaction.
supported by findings from clinical trials. Although we did not In interpreting our findings it should also be noted that not find any study that measured treatment-related empowerment everyone diagnosed with schizophrenia wishes to be involved in directly, our analysis of data from six RCTs (n = 843) found that treatment decisions.6,38 People who believe their decision-making interventions that shared a focus on increasing shared decision- ability is not good enough, or lack clear goals, may prefer to adopt making were associated with a small overall increase in indices a more passive role in their meetings with prescribers. We would patients' subjective sense argue that shared decision-making should be implemented in a involvement in treatment, self-efficacy and autonomy. There was thoughtful way, and that clinical judgement and case formulation also trend-level evidence from three RCTs (n = 872) that applying will always be required when deciding what approach to take with a shared decision-making approach to decisions about future particular individuals. Coercing unwilling patients to engage with treatment may reduce by approximately 40% the risk of patients treatment decision-making may be as much a threat to their experiencing compulsory care over a 15–18 month period, with autonomy as excluding them without consultation.
an NNT of approximately 10. Both primary outcomes were heavily The interventions we included in our meta-analysis were influenced by the null results of a large multicentre study;24 varied. However, they all shared a focus on increasing the use of however, the ability of this trial to detect benefits attributable to shared decision-making, and we assumed they were successful in shared decision-making may have been compromised by what this regard. Our interest lay not in finding out which interventions appeared to be poor implementation of shared decision-making were best placed to increase shared decision-making, but rather in by participating clinicians.24,33 finding out whether doing so led to improvements in empower- What is the clinical significance of a standardised mean ment. Our assumption that interventions were successful in difference of 0.3? If we accept the results of the 2014 National increasing shared decision-making is challenged by the study Audit of Schizophrenia that 59% of people with a diagnosis of reported by Thornicroft et al,24 where the particular context may schizophrenia using mental health services in the UK do not feel have moderated uptake of shared decision-making by clinicians.33 involved in treatment decision-making,34 then the observed effect It could also be argued that our definition of shared decision- size of 0.3 would translate to an NNT of 9 (95% CI 6–26).35 making was overly broad, and that pooling results from trials of That is, shared decision-making would need to be implemented shared decision-making and trials of joint crisis planning is with approximately nine people for one to experience greater misleading, since these interventions might have different aims.
empowerment. Given that up to half of clinicians do not regularly However, we argue the only real distinction between these inter- practice shared decision-making when treating people with ventions is the time frame of the decision to be made. Supporting psychosis,34,36 this is an important finding.
this, in the most recent report of the largest trial of joint crisis We did not find clear evidence that shared decision-making planning to date, that by Thornicroft et al,24 the authors have can improve treatment-related decision-making ability of patients, also described their approach as shared decision-making about but the data were heterogeneous and imprecise. This is future treatment.33 unfortunate, because impaired treatment decisional ability has There was some evidence that excluding trials missing more been identified by clinicians as a barrier to implementation of than a quarter of outcome data led to smaller estimates of benefit.
shared decision-making in psychosis, and it may also increase We did not test whether the overall results were robust to making the risk of involuntary treatment. We tried to examine the different assumptions about the outcomes of those who left early, hypothesis that shared decision-making might actually help but the overall rates of missing data were generally low and better increase decisional ability, but the very low quality of our findings than for other interventions in psychosis.39,40 The limited number prevented us from doing so. More rigorous studies investigating of studies for the primary outcome (six) also contributed to this question as a primary outcome would be welcome.
increased imprecision in our estimate. Although this is not Eight trials provided usable data on the effect of shared uncommon for healthcare interventions – for example, the decision-making on the patient–provider relationship, but the median number of trials in Cochrane reviews across medicine is pooled results were also heterogeneous. A significant negative six – more trials are required to reduce uncertainty regarding finding from Hamann et al seemed to account for this,30 and the true effect.41 excluding it resulted in an overall small positive finding for theremaining trials. Hamann et al used the Trust in Physician scale,37 Implications of the study which conceptualises trust as agreement with statements such as,‘If my doctor tells me something is so, then it must be true'. It Finally, it may be argued that empowerment has value only in so may be that shared decision-making can cause small improve- far as it facilitates other established outcomes, such as symptom ments in working alliance and communication, while also reduction, lower cost or improved social outcomes. However, stimulating greater questioning of clinician authority.
there is considerable evidence that people using mental healthservices regard greater treatment-related empowerment not justas a means to some further end, but also as having value in its Study limitations own right.13,42,43 Indeed, some 80% of people with experience Our findings are limited by the absence of studies using direct of psychosis believe that knowing a great deal about treatment measures of empowerment, and we were forced to consider more options is an essential part of what it means to experience recovery.13 Shared decision-making and empowerment 22 Swanson JW, Swartz MS, Elbogen EB, van Dorn RA, Ferron J, Wagner HR, Diana Stovell, ClinPsyD, Anthony P. Morrison, ClinPsyD, Division of Clinical et al. Facilitated psychiatric advance directives: a randomized trial of an Psychology, School of Psychological Sciences, University of Manchester, Manchester; intervention to foster advance treatment planning among persons with Margarita Panayiotou, PhD, Paul Hutton, ClinPsyD, Section of Clinical Psychology, severe mental illness. Am J Psychiatry 2006; 163: 1943–51.
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We would like to thank all the original authors who helped answer our various queries, andwe are also grateful to anonymous reviewers for their useful comments and suggestions.
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Shared decision-making in psychosis: Supplementary material Data supplement to Stovel et al. Shared decision-making and empowerment-related outcomes in psychosis: systematic review and meta-analysis. Br J Psychiatry doi: 10.1192/bjp.bp.114.158931
Supplement DS1

Search strategy
The references of previous reviews of SDM in mental healthcare were searched.24,31 Medline (1946- ), PsychInfo (1806- ), EMBASE (1980- ), CINAHL (1937- ) and The Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 8 of 12, August 2013) were also searched in August 2013. Titles, abstracts and keywords were searched in the publication databases using a strategy involving the term ‘shared decision making' and related terms. These included patient-oriented terms such as ‘patient participation' and ‘patient autonomy'; process terms such as ‘decision making' and ‘empower*'; technique- related terms such as ‘decision aid*' and ‘communication training'; relational terms such as ‘communicat*' and ‘working alliance'; and advance treatment planning-related terms such as ‘joint crisis plan*' and ‘advance statement*'. The search strategy also included the term ‘psychosis' and related terms such as ‘schizophrenia' and ‘schizoaffective disorder'; and the term ‘randomized controlled trial' and related terms such as ‘randomised clinical trial' and ‘controlled trial'. The search terms are listed in full below. No limits were placed on the search with regard to date or publication status. Searches were updated in January 2015.
Shared decision-making terms

Patient-oriented terms Patient participation Consumer participation Patient autonomy Patient satisfaction Consumer satisfaction Patient involve* Consumer involve* Patient preference* Consumer preference* Patient centered Client Participation Patient Centered Care Process terms Informed decision making Decision process Self-determination Treatment preference Patient decision making Decision making, clinical Decision making, patient Decision support systems, clinical Shared decision-making in psychosis: Supplementary material Technique terms Decision support technique* Communication training Communication aid* Communication skill* Decision support system* Communication aid* Communication skill* Communication skills training
Relationship terms

Shared decision making Working alliance Therapeutic alliance Doctor patient relation* Doctor patient communicat* Nurse patient relation* Physician patient relation* Professional patient relation* Professional client relation* Advance planning terms Joint crisis plan* Advance statement* Advance directive* Advance care planning
Psychosis terms
Schizoaffective disorder Schizoaffective psychosis Psychotic disorder
Trial terms

Randomised Controlled Trial Randomized Controlled Trial Randomised Clinical Trial Shared decision-making in psychosis: Supplementary material Randomized Clinical Trial Controlled Trial Controlled Clinical Study Controlled study Controlled Clinical Comparison Controlled Clinical Trial Shared decision-making in psychosis: Supplementary material Supplement DS2
Risk of bias assessment method
Assessment was carried out by DS and checked with PH, and vice versa, with disagreements being resolved through discussion. Risk of bias ratings are given in Table DS4. A judgement of unclear risk of selection bias was made where randomisation was referred to but described in insufficient detail to determine independent random sequence generation and allocation concealment. There was judged to be low risk of bias where these procedures were explicitly reported. Blinding of participants and personnel was not possible due to the nature of the interventions, as is the case with trials of psychosocial interventions in general. This resulted in high risk of performance bias across studies. Detection bias was judged to be high where non-blinding of assessors was stated, unclear if no information was given and low if blinding was explicitly reported. Where data for ≥25% of those randomised was missing, judgement of high risk of attrition bias was made where no account of this was taken in analysis,72 and unclear risk of attrition bias where it was appropriately accounted for e.g. by controlling for variables associated with missing data. Selective reporting bias was judged to be unclear where there was no availability of a study protocol, and high where outcomes of interest in the review were reported incompletely so as to preclude full inclusion in the meta-analysis. Risk of other sources of bias included that associated with cluster randomised design, where there might be potential for recruitment bias, and setting, where there might be possibility of cross-contamination through contact between participants in the different groups. Overview Most (k=8) studies had at least one judgement of unclear risk of selection bias.22,23,26,27,29,30– 33 Risk of performance bias was high across all studies due to nature of the interventions, which precluded blinding. Insufficient information in reporting also led to unclear detection bias in seven studies,22,23,26–28,30,31,33 and one RCT stated no attempt to blind assessors was made.32 Risk of attrition bias was high or unclear on some post-intervention measures in just over half of the studies (k=6).25–28,32,33 Risk of selective reporting bias was largely unclear, although there was an indication that three of the RCTs did not report all their outcomes.22,26,33 There was unclear risk of other sources of bias in four trials, namely risk of recruitment bias due to cluster randomised design,27,30,32 and risk of cross-contamination due to in-patient research setting.31 Shared decision-making in psychosis: Supplementary material Supplement DS3
GRADE assessment method
Assessment was carried out by DS and checked with PH, and vice versa, with disagreements being resolved through discussion. Results of the assessment are summarised in Table DS5. Outcome quality was downgraded by one point if at least one ‘high' risk rating was present for ≥50% studies contributing to an outcome within the Cochrane Risk of Bias assessment. Downgrading by two points occurred where ≥50% relevant studies had at least two ‘high' risk ratings. ‘High' risk ratings of performance bias were however excluded from the total ‘high' risk ratings for each outcome. Risk of performance bias is very commonly found in psychosocial interventions where blinding of participants and personnel is not possible. To rate down for this would be to imply reduced integrity in this body of research as a whole and, as such, was judged to be overly conservative. Furthermore downgrading occurred only where the risk of bias affected the particular outcome in question. For example, if a study had a high degree of missing data, or was at high risk of selective reporting bias, downgrading only occurred where missing data or selective reporting impacted directly the outcome in question. Indirectness was assessed by considering the relevance of the outcome data to the construct of interest for each outcome, together with that of the study population, nature of the intervention under investigation and the control condition. Because there were fewer than ten studies contributing to each outcome, assessment of publication bias using funnel plots was not undertaken.21 With regard to inconsistency, downgrading by one point occurred if the I2 statistic was ≥40%,16 indicating at least moderate heterogeneity, and by two points if the I2 statistic was ≥75%, indicating high heterogeneity. With regard to imprecision, downgrading occurred where the outcome represented by either end of the 95% confidence interval might lead to different clinical decision-making.20 Outcomes were also downgraded for imprecision where the sample size was insufficient to detect a clinically meaningful, small-moderate effect. Heterogeneity of outcome measures precluded possibility of calculating a meaningful Optimal Information Size.20 Overall quality of the evidence for each outcome was rated down one level for each factor that had been down-graded, or by two levels where there were especially serious problems with one particular factor.16 Shared decision-making in psychosis: Supplementary material Table DS1 Trial characteristics and baseline demographic details of participants
Baseline demographics
Treatment
Included
Included
Number and Age, mean Number
Number with Timing of
randomised primary
secondary
location of
schizophrenia- measures and
(n included in outcome
spectrum diagnosis available
analysis)
(measure)
(measure)
follow-up data
Hamann et al Nurse- supported In-patient – 54 (Primary Patient-perceived Clinician-rated 35.5 (11.9) 20 (37) outcome: 30, involvement based decision aid post intervention (30-60 minutes), and at discharge consultation with doctor. Training doctors involved. Hamann et al 5-session group In-patient – SDM intervention post acute efficacy (DSS) with clinician measured also at Shared decision-making in psychosis: Supplementary material cognitive training. Henderson et 2-session shared Community 7 CMHTs in 39.5 (12.1) al (2004)24 facilitation of (correspondence months post- from last author) randomisation. clinical team and previous 2 friend/advocate. written material health services, Steinwachs Tailored web- Total for both Clinician-verbal Relationship et al (2011)29 based & out-patient groups: 56 (24) dominance (ratio with clinician improve patients' Includes medical and psychosocial areas of care, and Video and written information about Shared decision-making in psychosis: Supplementary material Swanson et Research Across groups 247 1 month after al (2006)23 assistant- groups 42 groups 251 Elbogen et al administered facilitate advance Thornicroft 2-meeting joint Community Relationship 3 sites across 40.0 (11.8) 146 (51) et al (2013)25 facilitation of (MPCS: 213, coercion (MPCS) with clinician JCP. Facilitated by senior nurse. 267, WAI: 106) Objective Involved clinical team and possibly 39.6 (12.1) 138 (49) Shared decision-making in psychosis: Supplementary material Van Os et al Use of problem Community intervention and covering medical, 4-6 weeks later. consultation with doctor to enhance Woltmann et Electronic Patient-perceived None al (2011)30 decision support care planning for patients and case Care planning as Ruchlewska Clinician- 12 Assertive 40.6 (11.6) 24 (34.3) et al (2014)26 facilitated crisis (46 and 50 coercion (N with clinician Community provided WAI admitted under (WAI) data at 9 and 18 MHA) Shared decision-making in psychosis: Supplementary material Patient advocate- 40.3 (10.9) 19 (27.5) facilitated crisis data at 9 and 18 39.4 (11.6) 24 (32.9) data at 9 and 18 O'Donnell et Client-focused Patient-perceived Relationship 13 (28.8) Across groups, 105 0, 12 months al (1999)33 case management ( 32 provided involvement (N with clinician ‘had more say' satisfaction spectrum diagnoses on idiosyncratic with care advocacy (strong Harris et al Medication with clinician Manchester, training (strong Shared decision-making in psychosis: Supplementary material Waiting list for 41.4 (13.5) 30 (37%) COMRADE, Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness; DSS, Decision Self-efficacy Scale; TPS, Trust in Physician Scale; JCP, Joint Crisis Plan; MPCS, MacArthur Perceived Coercion Scale; CPA, Care Plan Approach; MHA, Mental Health Act; CMHT, Community Mental health Team; NS, not specified; NS*, not specified – no significant difference between groups; RIAS, Roter Interaction Analysis System; WAI, Working Alliance Inventory; DCAT-PAD, Decisional Competence Assessment Tool for Psychiatric Advance Shared decision-making in psychosis: Supplementary material Table DS2 Studies excluded primarily on basis of outcomes (full-text reports)†
Study

Outcomes
1. Hamann et al (2007)45 Hospitalisations, compliance, severity of illness, changes to antipsychotic 2. Malm et al (2003)46 Global and social functioning, symptoms and consumer satisfaction. 3. Priebe (1999)47 Patients' ratings of treatment and own condition and BPRS 4. Priebe et al (2007)48 Quality of life, unmet needs and treatment 5. Van Dorn et al (2008)49 Reduction in patient-perceived PAD-related and external barriers to PAD completion BPRS, Brief Psychiatric Rating Scale; PAD, Psychiatric Advance Directive. †Studies or reports excluded on the basis of title or abstract alone are not given as there was a very large number. In general they covered conditions, interventions or outcomes other than those covered in the review, or were not RCTs. Shared decision-making in psychosis: Supplementary material Table DS3 Other excluded studies and reasons for exclusion (full-text reports)†
Study

Reason for exclusion
1. Gray et al (2006)50 Intervention more about adherence than 2. Hansson et al (2008)51 Adjunct to RCT looking at moderators. Not included review outcomes 3. Hayward et al (2009)52 Intervention more about adherence than 4. Henderson et al (2009)53 Not RCT: interview study 5. Li & Wan (2004)54 In Chinese – no funds for translation 6. Mittal et al (2009)55 Intervention more about adherence than 7. Rogers et al (2007)56 Intervention not sufficiently about treatment- 8. Sells et al (2006)57 SDM not main group difference; primary substance misuse 9. Staring et al (2010)58 Intervention more about adherence than 10. Tondora et al (2010)59 Outcome data not available (not SDM) 11. Woltmann & Whitley (2010)60 12. Farrelly et al (2014)43 13. Jørgensen et al (2014)61 14. Van Oenen et al (2013)62 15. Papageorgiou et al (2002)63 16. Martino & Strejilevich (2014)64 17. Kilbourne et al (2014)65 <50% participants with non-affective 18. Dow et al (1991)66 Not RCT (sequential allocation) 19. Van der Krieke et al (2013)67 >50% missing data 20. Priebe et al (2013)68 21. Ishii et al (2014)69 22. Rogers et al (2003)70 23. Slade et al (2015)71 †Studies or reports excluded on the basis of title or abstract alone are not given as there was a very large number. In general they covered conditions, interventions or outcomes other than those covered in the review, or were not RCTs. Shared decision-making in psychosis: Supplementary material Table DS4 Risk of bias in included studies – Cochrane Risk of Bias Tool
Study

Allocation
Performance bias Detection bias
Incomplete
Selective
Other bias (e.g.
sequence
concealment
(blinding of
(blinding of
outcome data
reporting
recruitment
generation
(selection bias)
participants and
(attrition bias)
(reporting bias)
(selection bias)
personnel)
Hamann et al Unclear:
Unclear:
High: risk of bias
Unclear: No
High: for patient-
Unclear:
Unclear: paired
with potential for information about unavailability of information about information about blinding assessors. involvement - randomisation of >25% of those matched pairs of recruitment bias. ‘Selection of the ‘Selection of the ‘. patients were wards was made wards was made sent to that ward so as to ensure so as to ensure of a pair that that there were six that there were six account taken of had free beds pairs of wards, pairs of wards, available.' member of each member of each pair being pair being Unclear: for
allocation where randomly assigned randomly assigned medication – 22% on both wards of control or to the control or to the did not complete interventional interventional condition.' condition.' account taken of Shared decision-making in psychosis: Supplementary material Table DS4 Risk of bias in included studies – Cochrane Risk of Bias Tool
Study

Allocation
Performance bias Detection bias
Incomplete
Selective
Other bias (e.g.
sequence
concealment
(blinding of
(blinding of
outcome data
reporting
recruitment
generation
(selection bias)
participants and
(attrition bias)
(reporting bias)
(selection bias)
personnel)
Hamann et al Unclear:
Low: ‘numbered
High: risk of bias
Unclear: no
Low: on post
Unclear:
Unclear:
with potential for information about unavailability of information about concealment report of missing envelopes were Reporting on only assess risk of ‘Patients were prepared before Unclear: at
one idiosyncratic recruited until the study.' measure at follow- contamination in group size was up raises questions in-patient reached and then research setting. assigned to the completed by 79% intervention or - attrition evenly control condition.' reasons given. No Shared decision-making in psychosis: Supplementary material Table DS4 Risk of bias in included studies – Cochrane Risk of Bias Tool
Study

Allocation
Performance bias Detection bias
Incomplete
Selective
Other bias (e.g.
sequence
concealment
(blinding of
(blinding of
outcome data
reporting
recruitment
generation
(selection bias)
participants and
(attrition bias)
(reporting bias)
(selection bias)
personnel)
Henderson et al Low: ‘The
Low: ‘When a
High: risk of bias
Low: ‘One
Low: ‘Information Unclear:
Low: study
allocation patient was with potential for investigator (CH) on use of the unavailability of sequence was recruited, the collected follow-up Mental Health generated by using project worker data and was Act was available sources of bias. minimisation, requested blinded to for 77/80 of each stratified by team allocation by treatment group.' group (total and by severity of email, which was 154/160 = 96%).' the patients.' returned by a Low attrition rate statistician. and ITT analysis Allocation was not revealed to the investigator.' Steinwachs et al Unclear:
Unclear: no
High: risk of bias
Low: ‘The two
Low: data missing Unclear:
Low: study
with potential for coders were not unavailability of information about aware of study technical failure. hypotheses or sources of bias. ‘Patients were patients' ‘Patients were randomly assigned behaviour. intervention missing data but randomly assigned to the intervention unlikely to cause to the intervention or to a control or to a control Shared decision-making in psychosis: Supplementary material Table DS4 Risk of bias in included studies – Cochrane Risk of Bias Tool
Study

Allocation
Performance bias Detection bias
Incomplete
Selective
Other bias (e.g.
sequence
concealment
(blinding of
(blinding of
outcome data
reporting
recruitment
generation
(selection bias)
participants and
(attrition bias)
(reporting bias)
(selection bias)
personnel)
Swanson et al Unclear:
Unclear: no
High: risk of bias
Unclear: no
Low: attrition of
Unclear: for
Low: study
with potential for information about Elbogen et al information about of imputation of relationship with missing data – clinician due to sources of bias. ‘each participant unavailability of ‘each participant was randomly was randomly assigned to either attrition rate and assigned to either the facilitated even distribution High: for
the facilitated psychiatric psychiatric advance directive ability – data only advance directive intervention or the intervention or the control group.' control group.' significant effect. Shared decision-making in psychosis: Supplementary material Table DS4 Risk of bias in included studies – Cochrane Risk of Bias Tool
Study

Allocation
Performance bias Detection bias
Incomplete
Selective
Other bias (e.g.
sequence
concealment
(blinding of
(blinding of
outcome data
reporting
recruitment
generation
(selection bias)
participants and
(attrition bias)
(reporting bias)
(selection bias)
personnel)
Thornicroft et al Low: ‘we
Low: ‘The JCP
Low: For primary Low: protocol
Low: study
stratified facilitators at each risk of bias with outcomes. Missing available and participants by site were notified research assistants data: 4% for outcomes reported free of other site and randomly by an automatic (who did the sources of bias. allocated them. email from the follow-up), and 20% for perceived specified way. The allocation clinical trials unit trial statisticians sequence was of participants at generated by the their Trust who masked to Unclear: For
independent were allocated to allocation.' relationship with clinical trials unit the intervention or at the study control.' coordinating Attrition mitigated by ‘analysis done under ITT principles' and Shared decision-making in psychosis: Supplementary material Table DS4 Risk of bias in included studies – Cochrane Risk of Bias Tool
Study

Allocation
Performance bias Detection bias
Incomplete
Selective
Other bias (e.g.
sequence
concealment
(blinding of
(blinding of
outcome data
reporting
recruitment
generation
(selection bias)
participants and
(attrition bias)
(reporting bias)
(selection bias)
personnel)
Van Os et al Low: ‘Patients
Low: concealment High: risk of bias
Unclear: no
Unclear: no report Unclear:
Low: study
were randomised ensured by central with potential for unavailability of centrally by an and this is likely to protocol. independent, non- sources of bias. investigator agency using a predetermined random sequence.' Woltmann et al Unclear:
Unclear:
High: risk of bias
Unclear: no
Low: no report of
Unclear:
Unclear:
with potential for information about unavailability of information about information about randomisation of research assistants reported on other allocation of case recruitment bias ‘Case managers from three clinics ‘Case managers were randomly from three clinics assigned to the were randomly intervention group assigned to the clients unclear. or treatment as intervention group or treatment as Shared decision-making in psychosis: Supplementary material Table DS4 Risk of bias in included studies – Cochrane Risk of Bias Tool
Study

Allocation
Performance bias Detection bias
Incomplete
Selective
Other bias (e.g.
sequence
concealment
(blinding of
(blinding of
outcome data
reporting
recruitment
generation
(selection bias)
participants and
(attrition bias)
(reporting bias)
(selection bias)
personnel)
Ruchlewska et al Unclear:
Unclear:
High: risk of bias
Unclear: no
Low: minimal
High: a number of Low: study
with potential for information about missing data for N outcomes pre- information about envelopes containing 12 lots sources of bias. ‘Randomisation per team…" High: >25%
reported, including was stratified by missing data for treatment team… Locus of Control the principal investigator allocated participants randomly into one of the three conditions. " Shared decision-making in psychosis: Supplementary material Table DS4 Risk of bias in included studies – Cochrane Risk of Bias Tool
Study

Allocation
Performance bias Detection bias
Incomplete
Selective
Other bias (e.g.
sequence
concealment
(blinding of
(blinding of
outcome data
reporting
recruitment
generation
(selection bias)
participants and
(attrition bias)
(reporting bias)
(selection bias)
personnel)
O'Donnell et al Unclear:
Unclear:
High: risk of bias
Unclear: no
High: >25%
High: 6-month
Low: study
with potential for information about missing data for data not reported. information about information about empowerment and Admission data sources of bias. "subjects who "subjects who agreed to agreed to participate in the participate in the relationship data study were study were allocated to one of allocated to one of protocol publicly Harris et al (2009)32 Unclear:
Unclear:
High: risk of bias
High: "There was High: >25%
Unclear:
Unclear: cluster
with potential for no ‘blind' missing data for unavailability of information about information about assessment of service user level outcomes. The recruitment bias. principle investigator was not ‘blind' to the allocation of experimental and control groups." Shared decision-making in psychosis: Supplementary material Table DS5 GRADE assessment of outcomes – detail of assessment
Included studies and
Imprecision
Comments
Subjective
Hamann et al (2006):27
empowerment
patient-perceived indirectness occurred due to absence of direct Hamann et al (2011):31
empowerment. Rating decision self-efficacy down for imprecision occurred due to span of Steinwachs et al:29 reduced
95% CI: trivial to verbal dominance by moderate effects. clinician (observer rated)
Thornicroft et al
:25
reduced perceived coercion
Woltmann et al
: patient-
perceived involvement
O'Donnell et al:33 N
agreeing they ‘have more say' in treatment decisions Shared decision-making in psychosis: Supplementary material Table DS5 GRADE assessment of outcomes – detail of assessment
Included studies and
Imprecision
Comments
Reduction in
Henderson et al:24
Significant heterogeneity objective
admissions under section of (albeit in context of clear coercion
direction of effect) and wide confidence intervals Thornicroft et al:25
for pooled estimate admissions under section of reduces quality of outcome
Ruchlewska et al:26
admissions under Court Shared decision-making in psychosis: Supplementary material Table DS5 GRADE assessment of outcomes – detail of assessment
Included studies and
Imprecision
Comments
Hamann et al (2011):31
with clinician
trust in physician inconsistency and imprecision due to Swanson et al:23 working
moderate negative effect in Hamann et al (2011).57
Thornicroft et al
:25
working alliance
Van Os et al
:28 patient-
rated quality of
Ruchlewska et al:26
working alliance
Steinwachs et al:29 greater
clinician engagement
O'Donnell et al:33
satisfaction with care
Harris et al:32 working
Shared decision-making in psychosis: Supplementary material Table DS5 GRADE assessment of outcomes – detail of assessment
Included studies and
Imprecision
Comments
Swanson et al:23 working
Moderate Imprecision due to 95% CI with clinician – alliance
spanning trivial to low-to- Hamann et al
moderate effects. (2011)31
Thornicroft et al:25
excluded
working alliance
Van Os et al
:28 patient-
rated quality of
Ruchlewska et al:26
working alliance
Steinwachs et al:29 greater
clinician engagement
O'Donnell et al:33
satisfaction with care
Harris et al:32
working alliance Shared decision-making in psychosis: Supplementary material Table DS5 GRADE assessment of outcomes – detail of assessment
Included studies and
Imprecision
Comments
Clinician-rated Hamann et al (2006):27
Very low Quality down-rated due to decision-
knowledge about disease risk of attrition bias in Hamann et al (2006)20 and abilities of
reporting bias in Elbogen knowledge
Hamann et al (2011):31
et al.50 High heterogeneity decisional capacity and wide 95% CI led to Elbogen et al:22 decisional
inconsistency and capacity (reasoning only) imprecision. Judgement of indirectness due to partial, selective and idiosyncratic measurement and reporting of decision-making Shared decision-making in psychosis: Supplementary material Table DS6 Funding sources of included studies
Funding source
Harris et al (2009)32 North West Regional Training Fellowship, Hamann et al (2006)27 German Ministry of Health and Social Security Hamann et al (2011)31 German-Israeli Foundation for Research and Henderson et al (2004)24 Medical Research Council O'Donnell et al (1999)33 Innovative Grants Program of the Australian National Mental Health Strategy Ruchlewska et al (2014)26 Dutch organization for health research and development (ZonMw) and BavoEuropoort. Steinwachs et al (2011)29 National Institute of Mental Health, USA Swanson et al (2006) and Elbogen et al National Institute of Mental Health, USA; MacArthur Foundation Research Network on Mandated Community Treatment Thornicroft et al (2013)25 Medical Research Council, UK Van Os et al (2004)28 Woltmann et al (2011)30 West Family Foundation; Segal Family Shared decision-making in psychosis: Supplementary material Fig. DS1 Forest plots for secondary outcomes: relationship with clinician.
ES (95% CI) % Weight N Control N Total Hamann 2011, trust in physician -0.62 ( -1.13, -0.11) 8.93 Swanson 2006, working alliance 0.22 ( 0.02, 0.42) 18.32 2013, working alliance 0.17 ( -0.06, 0.40) 17.33 Van Os 2004, quality of communication 0.38 ( 0.04, 0.71) 13.48 a 2015, working alliance -0.17 ( -0.57, 0.23) 11.56 Harris 2009, working alliance 0.20 ( -0.16, 0.56) 12.79 O'Donnell 1999, satisfacti on with care manager 0.64 ( 0.15, 1.12) 9.41 Steinwachs 2011, greater clini cian engagement 0.11 ( -0.43, 0.66) 8.18 0.14 ( -0.05, 0.34) 100.00 Q=17.34, p=0.02, I2=60% Shared decision-making in psychosis: Supplementary material Fig. DS2 Forest plots for secondary outcomes: clinician-rated treatment decision-making ability
ES (95% CI) % Weight Hamann 2006 knowledge 0.81 ( 0.37, 1.25) 31.74 Hamann 2011 capacity -0.34 ( -0.84, 0.16) 29.67 Elbogen 2007 reasoning 0.30 ( 0.10, 0.51) 38.58 0.27 ( -0.24, 0.79) 100.00 Q=11.53, p=0.00, I2=83% Shared decision-making in psychosis: Supplementary material Supplementary references
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Shared treatment decision-making and empowerment-related
outcomes in psychosis: systematic review and meta-analysis

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Steroids and Image Enhancing Drugs2014 Survey Results Jim McVeigh, Geoff Bates and Martin Chandler CPH, Faculty of Education, Health and Community, Liverpool John Moores University, Henry Cotton Campus, 15-21 Webster Street, Liverpool, L3 2ET0151 231 4511 j.mcveigh@ljmu.ac.uk www.cph.org.uk ISBN: 978-1-910725-10-8 (web) Contents