Human-Comparable Sensitivity of Large Language Models in Identifying Eligible Studies Through Title and Abstract Screening: 3-Layer Strategy Using GPT-3.5 and GPT-4 for Systematic Reviews.

BACKGROUND: The screening process for systematic reviews is resource-intensive. Although previous machine learning solutions have reported reductions in workload, they risked excluding relevant papers. OBJECTIVE: We evaluated the performance of a 3-layer screening method using GPT-3.5 and GPT-4 to streamline the title and abstract-screening process for systematic reviews. Our goal is to develop a screening method that maximizes sensitivity for identifying relevant records. METHODS: We conducted screenings on 2 of our previous systematic reviews related to the treatment of bipolar disorder, with 1381 records from the first review and 3146 from the second. Screenings were conducted using GPT-3.5 (gpt-3.5-turbo-0125) and GPT-4 (gpt-4-0125-preview) across three layers: (1) research design, (2) target patients, and (3) interventions and controls. The 3-layer screening was conducted using prompts tailored to each study. During this process, information extraction according to each study's inclusion criteria and optimization for screening were carried out using a GPT-4-based flow without manual adjustments. Records were evaluated at each layer, and those meeting the inclusion criteria at all layers were subsequently judged as included. RESULTS: On each layer, both GPT-3.5 and GPT-4 were able to process about 110 records per minute, and the total time required for screening the first and second studies was approximately 1 hour and 2 hours, respectively. In the first study, the sensitivities/specificities of the GPT-3.5 and GPT-4 were 0.900/0.709 and 0.806/0.996, respectively. Both screenings by GPT-3.5 and GPT-4 judged all 6 records used for the meta-analysis as included. In the second study, the sensitivities/specificities of the GPT-3.5 and GPT-4 were 0.958/0.116 and 0.875/0.855, respectively. The sensitivities for the relevant records align with those of human evaluators: 0.867-1.000 for the first study and 0.776-0.979 for the second study. Both screenings by GPT-3.5 and GPT-4 judged all 9 records used for the meta-analysis as included. After accounting for justifiably excluded records by GPT-4, the sensitivities/specificities of the GPT-4 screening were 0.962/0.996 in the first study and 0.943/0.855 in the second study. Further investigation indicated that the cases incorrectly excluded by GPT-3.5 were due to a lack of domain knowledge, while the cases incorrectly excluded by GPT-4 were due to misinterpretations of the inclusion criteria. CONCLUSIONS: Our 3-layer screening method with GPT-4 demonstrated acceptable level of sensitivity and specificity that supports its practical application in systematic review screenings. Future research should aim to generalize this approach and explore its effectiveness in diverse settings, both medical and nonmedical, to fully establish its use and operational feasibility.

How Does Standing Anteroposterior Stability Limits Correlate to Foot/ankle Functions in Bilateral Spastic Cerebral Palsy?

PURPOSE: To determine whether foot and ankle functions are correlated with the limits of stability (LoS) while standing in individuals with bilateral spastic cerebral palsy (BSCP). METHODS: Eighteen people who could walk and with BSCP and 18 people without disability participated. Anteroposterior LoS was measured using a force platform. To quantify ankle and foot functions, spasticity, isometric muscle strength, passive range of motion, and plantar light touch-pressure sensation were assessed. RESULTS: In the BSCP group, anteroposterior LoS was significantly decreased, and anterior LoS reduction was correlated with decreases in plantar flexor and toe flexor strength and in sensitivity of the forefoot to light touch-pressure sensation, whereas the posterior LoS reduction was correlated with reduced dorsiflexor strength. CONCLUSIONS: The present findings suggest that improvement in these foot and ankle functions in BSCP may increase LoS while standing.

Treatment strategies for insomnia in Japanese primary care physicians' practice: A Web-based questionnaire survey.

BACKGROUND: It is unclear how primary care physicians manage insomnia after the introduction of novel hypnotics such as orexin receptor antagonists and melatonin receptor agonists. This Web-based questionnaire survey aimed to examine treatment strategies for insomnia in Japanese primary care practice. METHODS: One-hundred-and-seventeen primary care physicians were surveyed on the familiarity of each management option for insomnia on a binary response scale (0 = "unfamiliar"; 1 = "familiar") and how they managed insomnia using a nine-point Likert scale (1 = "I never prescribe/perform it"; 9 = "I often prescribe/perform it"). Physicians who were unfamiliar with a management option were deemed to have never prescribed or performed it. RESULTS: Regarding medication, most physicians were familiar with novel hypnotics. Suvorexant was the most used hypnotic, followed by lemborexant and ramelteon. These novel hypnotics averaged 4.8-5.4 points and 4.0-4.7 points for sleep onset and sleep maintenance insomnia, respectively. By contrast, most benzodiazepines were seldom used below two points. Regarding psychotherapy, only approximately 40% of the physicians were familiar with cognitive behavioral therapy for insomnia (CBT-I) and they rarely implemented it, at an average of 1.5-1.6 points. More physicians were familiar with single-component psychotherapies (i.e., relaxation, sleep restriction therapy, and stimulus control) compared to CBT-I, and 48-74% of them implemented it slightly more often, with scores ranging from 2.6 to 3.4 points. CONCLUSION: This study suggests that Japanese primary care physicians seldom use CBT-I to treat insomnia. In addition, they use novel sleep medications more frequently than benzodiazepines in terms of pharmacotherapy. The use and availability of CBT-I in Japanese primary care might be facilitated by: educating primary care physicians, implementing brief or digital CBT-I, and/or developing collaborations between primary care physicians and CBT-I specialists.

A psychometric analysis of the Japanese version of the clinically useful depression outcome scale supplemented with questions for the DSM-5 anxious distress specifier (CUDOS-A).

AIM: The aim of the study was to identify the clinical significance of anxiety in those with depression, the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) defined criteria for an anxious distress specifier for major depressive disorder (MDD). The Clinically Useful Depression Outcome Scale (CUDOS) supplemented with questions for the DSM-5 anxious distress specifier (CUDOS-A) is a self-report instrument to assess the clinical significance of anxiety in addition to assess symptoms and the severity of depression. This study aimed to evaluate the psychometric properties of the Japanese version of the CUDOS-A. METHODS: An observational, prospective study was conducted with 131 MDD outpatients and 200 healthy controls. The Japanese version of the CUDOS-A, along with other measures, was administered to assess depressive symptoms, anxiety, social function, and biological rhythm. Reliability and validity analyses were performed, including internal consistency, test-retest reliability, convergent validity, and contrasted-groups validity. RESULTS: The Japanese version of the CUDOS-A demonstrated excellent internal consistency (Cronbach's alpha = 0.96) and test-retest reliability (ICC = 0.78). Significant positive correlations were found between the CUDOS-A and measures of depression, anxiety, social function, and biological rhythm (all, p < 0.001), supporting its convergent validity. The CUDOS-A effectively differentiated between patients with MDD and healthy controls (p < 0.001), indicating good contrasted-groups validity. CONCLUSIONS: The Japanese version of the CUDOS-A is a useful measure for research and for clinical practice, enabling the efficient assessment of anxious distress in individuals with depression.

Assessing the Quick Inventory of Depressive Symptomatology Self-Report scores to predict continuous employment in mood disorder patients.

Objective: Depression significantly impacts the job performance and attendance of workers, leading to increased absenteeism. Predicting occupational engagement for individuals with depression is of paramount importance. This study aims to determine the cut-off score which predicts continuous employment for patients with mood disorders using the Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR). Methods: In a prospective observational trial conducted in Tokyo, 111 outpatients diagnosed with either major depressive disorder or bipolar depression were enrolled. Their employment statuses of these participants were tracked over a six-month period after their QIDS-SR scores were recorded. Based on their employment trajectories, participants were categorized into either continuous or non-continuous employment groups. Binary logistic regression was applied to examine the relationship between the QIDS-SR scores and employment outcomes, with adjustments for age, gender, and psychiatric diagnoses. Receiver operating characteristic curves were utilized to identify the optimal QIDS-SR cut-off values for predicting continuous employment. Findings: Binary logistic regression demonstrated that a lower score on the QIDS-SR was linked to an elevated likelihood of continuous employment (adjusted odds ratio 1.15, 95% CI: 1.06-1.26, p=0.001). The optimal cut-off point, determined by the Youden Index, was 10/11, showcasing a 63% sensitivity and 71% specificity. Conclusion: The results emphasize the potential of the QIDS-SR as a prognostic instrument for predicting employment outcomes among individuals with depressive disorders. These findings further underscore the importance of managing depressive symptoms to mild or lower intensities to ensure ongoing employment.

Future perspective of psychiatric home-visit nursing provided by nursing stations in Japan.

Psychiatric home-visit nursing supports the lives of people with mental disorders in the community and plays an important role in the "community-based integrated care system" which is rapidly being implemented in Japan. Although the number of responsive home-visit nursing stations (HVNS) is increasing, the current situation of service provision has not yet been clarified. This study aimed to investigate the characteristics and difficulties of psychiatric home-visit nursing provided by HVNS. We further discussed future care provisions and service improvements. We conducted a questionnaire survey of 7,869 member stations of the National Association for Visiting Nurse Service; of this number 2,782 facilities (35.4%) responded. Of the 2,782 facilities, 1,613 (58.0%) provided psychiatric home-visit nursing. The HVNS that provided psychiatric home-visit nursing were diverse, and the percentage of users with mental disorders ranged widely. Majority of the HVNS reported having "difficulty in caring for users/families who refuse care" (56.3%), "difficulty in care for psychiatric symptoms" (54.0%), and "difficulty in assessment of psychiatric symptoms" (49.1%), with differences in difficulty depending on the percentage of psychiatric users. As user needs and HVNS characteristics diversify, it is necessary to take advantage of the characteristics of each station to develop consultation and training systems and collaborative network platforms within each community for future sustainable service provision.

Development and acceptability testing of a decision aid for considering whether to reduce antipsychotics in individuals with stable schizophrenia.

AIM: Continued antipsychotic treatment is the key to preventing relapse. Maintenance antipsychotic monotherapy and optimal dose use are recommended for individuals with stable schizophrenia because of their undesirable effects. Decision aids (DAs) are clinical conversation tools that facilitate shared decision-making (SDM) between patients and health-care providers. This study aimed to describe the development process and results of acceptability testing of a DA for individuals with stable schizophrenia, considering (i) whether to continue high-dose antipsychotics or reduce to the standard dose and (ii) whether to continue two antipsychotics or shift to monotherapy. METHODS: A DA was developed according to the guidelines for the appropriate use of psychotropic medications and International Patient Decision Aid Standards (IPDAS). First, a DA prototype was developed based on a previous systematic review and meta-analysis conducted for identifying the effects of continuing or reducing antipsychotic treatment. Second, mixed-method survey was performed among individuals with schizophrenia and health-care providers to modify and finalize the DA. RESULTS: The DA consisted of an explanation of schizophrenia, options to continue high-dose antipsychotics or reduce to the standard dose, options to continue two antipsychotics or shift to monotherapy, pros and cons of each option, and a value-clarification worksheet for each option. The patients (n = 20) reported acceptable language use (75%), adequate information (75%), and well-balanced presentation (79%). Health-care providers (n = 20) also provided favorable overall feedback. The final DA covered six IPDAS qualifying criteria. CONCLUSION: A DA was successfully developed for schizophrenia, considering whether to reduce antipsychotics, which can be used in the SDM process.

Development and acceptability of a decision aid for anxiety disorder considering discontinuation of benzodiazepine anxiolytic.

Aim: We aimed to develop a decision aid (DA) for individuals with anxiety disorders who consider tapering benzodiazepine (BZD) anxiolytics, and if tapering, tapering BZD anxiolytics with or without cognitive behavioral therapy (CBT) for anxiety. We also assessed its acceptability among stakeholders. Methods: First, we conducted a literature review regarding anxiety disorders to determine treatment options. We cited the results of the systematic review and meta-analysis, which we conducted previously, to describe the related outcomes of two options: tapering BZD anxiolytics with CBT and tapering BZD anxiolytics without CBT. Second, we developed a DA prototype in accordance with the International Patient Decision Aid Standards. We carried out a mixed methods survey to assess the acceptability among stakeholders including those with anxiety disorders and healthcare providers. Results: Our DA provided information such as explanation of anxiety disorders, options of tapering or not tapering BZD anxiolytics (if tapering, the options of tapering BZD anxiolytics with or without CBT) for anxiety disorder, benefits and risks of each option, and a worksheet for value clarification. For patients (n = 21), the DA appeared to be acceptable language (86%), adequate information (81%), and well-balanced presentation (86%). The developed DA was also acceptable for healthcare providers (n = 10). Conclusion: We successfully created a DA for individuals with anxiety disorders who consider tapering BZD anxiolytics, which was acceptable for both patients and healthcare providers. Our DA was designed to assist patients and healthcare providers to involve decision-making about whether to taper BZD anxiolytics or not.

Treatment strategy for insomnia disorder: Japanese expert consensus.

Purpose: There is a lack of evidence regarding answers for clinical questions about treating insomnia disorder. This study aimed to answer the following clinical questions: (1) how to use each hypnotic and non-pharmacological treatment differently depending on clinical situations and (2) how to reduce or stop benzodiazepine hypnotics using alternative pharmacological and non-pharmacological treatments. Methods: Experts were asked to evaluate treatment choices based on 10 clinical questions about insomnia disorder using a nine-point Likert scale (1 = "disagree" to 9 = "agree"). The responses of 196 experts were collected, and the answers were categorized into first-, second-, and third-line recommendations. Results: The primary pharmacological treatment, lemborexant (7.3 ± 2.0), was categorized as a first-line recommendation for sleep initiation insomnia, and lemborexant (7.3 ± 1.8) and suvorexant (6.8 ± 1.8) were categorized as the first-line recommendations for sleep maintenance insomnia. Regarding non-pharmacological treatments for primary treatment, sleep hygiene education was categorized as the first-line recommendation for both sleep initiation (8.4 ± 1.1) and maintenance insomnia (8.1 ± 1.5), while multicomponent cognitive behavioral therapy for insomnia was categorized as the second-line treatment for both sleep initiation (5.6 ± 2.3) and maintenance insomnia (5.7 ± 2.4). When reducing or discontinuing benzodiazepine hypnotics by switching to other medications, lemborexant (7.5 ± 1.8) and suvorexant (6.9 ± 1.9) were categorized as first-line recommendations. Conclusion: Expert consensus indicates that orexin receptor antagonists and sleep hygiene education are recommended as first-line treatments in most clinical situations to treat insomnia disorder.

A Comparison between Perceptions of Psychiatric Outpatients and Psychiatrists Regarding Benzodiazepine Use and Decision Making for Its Discontinuation: A Cross-Sectional Survey in Japan.

BACKGROUND: Although long-term use of benzodiazepines and z-drugs (BZDs) is not recommended, little is known about the stakeholders' perceptions. This study aimed to assess and compare the perceptions of BZD use and decision making regarding its discontinuation between psychiatric outpatients and psychiatrists. METHODS: A cross-sectional survey was conducted. RESULTS: Of 104 outpatients, 92% were taking hypnotics and 96% were taking anxiolytics for ≥a year, while 49% were willing to taper hypnotic/anxiolytics within a year of starting. Most psychiatrists felt that "patient and psychiatrist make the decision together on an equal basis" compared to patients (p < 0.001), while more patients felt that "the decision is (was) made considering the psychiatrists' opinion" compared to psychiatrists (p < 0.001). Of 543 psychiatrists, 79% reported "patients were not willing to discontinue hypnotic/anxiolytic" whereas a certain number of patients conveyed "psychiatrists did not explain in enough detail about hypnotic/anxiolytic discontinuation such as procedure (18.3%), timing (19.2%), and appropriate condition (14.4%)". CONCLUSION: The results suggest that the majority of psychiatric outpatients were taking hypnotic/anxiolytics for a long time against their will. There might be a difference in perceptions toward hypnotic/anxiolytic use and decision making for its discontinuation between psychiatric outpatients and psychiatrists. Further research is necessary to fill this gap.

Physicians' attitudes toward hypnotics for insomnia: A questionnaire-based study.

Introduction: Benzodiazepines and non-benzodiazepines are still widely prescribed despite safety concerns and the introduction of novel hypnotics (orexin receptor antagonists [ORA] and melatonin receptor agonists [MRA]), which may be influenced by physicians' attitudes toward hypnotics. Methods: A questionnaire survey was administered to 962 physicians between October 2021 and February 2022, investigating frequently prescribed hypnotics and the reasons for their selection. Results: ORA were the most frequently prescribed at 84.3%, followed by non-benzodiazepines (75.4%), MRA (57.1%), and benzodiazepines (54.3%). Compared to non-frequent prescribers of hypnotics, a logistic regression analysis showed that frequent ORA prescribers were more concerned with efficacy (odds ratio [OR]: 1.60, 95% confidence interval [CI]: 1.01-2.54, p = 0.044) and safety (OR: 4.52, 95% CI: 2.99-6.84, p < 0.001), frequent MRA prescribers were more concerned with safety (OR: 2.48, 95% CI: 1.77-3.46, p < 0.001), frequent non-benzodiazepine prescribers were more concerned with efficacy (OR: 4.19, 95% CI: 2.91-6.04, p < 0.001), and frequent benzodiazepine prescribers were more concerned with efficacy (OR: 4.19, 95% CI: 2.91-6.04, p < 0.001) but less concerned with safety (OR: 0.25, 95% CI: 0.16-0.39, p < 0.001). Discussion: This study suggested that physicians believed ORA to be an effective and safe hypnotic and were compelled to prescribe benzodiazepine and non-benzodiazepine frequently, choosing efficacy over safety.

Management of unspecified anxiety disorder: Expert consensus.

AIMS: Treatment guidelines with respect to unspecified anxiety disorder have not been published. The aim of this study was to develop a consensus among field experts on the management of unspecified anxiety disorder. METHODS: Experts were asked to evaluate treatment choices based on eight clinical questions concerning unspecified anxiety disorder using a nine-point Likert scale (1 = "disagree" to 9 = "agree"). According to the responses from 119 experts, the choices were categorized into first-, second-, and third-line recommendations. RESULTS: Benzodiazepine anxiolytic use was not categorized as a first-line recommendation for the primary treatment of unspecified anxiety disorder, whereas multiple nonpharmacological treatment strategies, including coping strategies (7.9 ± 1.4), psychoeducation for anxiety (7.9 ± 1.4), lifestyle changes (7.8 ± 1.5), and relaxation techniques (7.4 ± 1.8), were categorized as first-line recommendations. Various treatment strategies were categorized as first-line recommendations when a benzodiazepine anxiolytic drug did not improve anxiety symptoms, that is, differential diagnosis (8.2 ± 1.4), psychoeducation for anxiety (8.0 ± 1.5), coping strategies (7.8 ± 1.5), lifestyle changes (7.8 ± 1.5), relaxation techniques (7.2 ± 1.9), and switching to selective serotonin reuptake inhibitors (SSRIs) (7.0 ± 1.8). These strategies were also highly endorsed when tapering the dosage of or discontinuing benzodiazepine anxiolytic drugs. There was no first-line recommendation regarding excusable reasons for continuing benzodiazepine anxiolytics. CONCLUSIONS: The field experts recommend that benzodiazepine anxiolytics should not be used as a first-line option for patients with unspecified anxiety disorder. Instead, several nonpharmacological interventions and switching to SSRIs were endorsed for the primary treatment of unspecified anxiety disorder and as alternatives to benzodiazepine anxiolytics.

Clinical practice for unspecified anxiety disorder in primary care.

Aim: Clinicians face difficulties in making treatment decisions for unspecified anxiety disorder due to the absence of any treatment guidelines. The objective of this study was to investigate how familiar and how often primary care physicians use pharmacological and nonpharmacological approaches to manage the disorder. Methods: A survey was conducted among 117 primary care physicians in Japan who were asked to assess the familiarity of using each treatment option for unspecified anxiety disorder on a binary response scale (0 = "unfamiliar," 1 = "familiar") and the frequency on a nine-point Likert scale (1 = "never used," 9 = "frequently used"). Results: While several benzodiazepine anxiolytics were familiar to primary care physicians, the frequencies of prescribing them, including alprazolam (4.6 ± 2.6), ethyl loflazepate (3.6 ± 2.4), and clotiazepam (3.5 ± 2.3), were low. In contrast, certain nonpharmacological options, including lifestyle changes (5.4 ± 2.3), coping strategies (5.1 ± 2.7), and psychoeducation for anxiety (5.1 ± 2.7), were more commonly utilized, but to a modest extent. When a benzodiazepine anxiolytic drug failed to be effective, primary care physicians selected the following management strategies to a relatively high degree: differential diagnosis (6.4 ± 2.4), referral to a specialist hospital (5.9 ± 2.5), lifestyle changes (5.2 ± 2.5), and switching to selective serotonin reuptake inhibitor (5.1 ± 2.4). Conclusion: Primary care physicians exercise caution when prescribing benzodiazepine anxiolytics for unspecified anxiety disorder. Nonpharmacological interventions and switching to SSRI are modestly employed as primary treatment options and alternatives to benzodiazepine anxiolytics. To ensure the safe and effective treatment of unspecified anxiety disorder in primary care, more information should be provided from field experts.

Attitudes and Difficulties Associated with Benzodiazepine Discontinuation.

Long-term use of benzodiazepine receptor agonists (BZDs) may depend on clinicians' BZD discontinuation strategies. We aimed to explore differences in strategies and difficulties with BZD discontinuation between psychiatrists and non-psychiatrists and to identify factors related to difficulties with BZD discontinuation. Japanese physicians affiliated with the Japan Primary Care Association, All Japan Hospital Association, and Japanese Association of Neuro-Psychiatric Clinics were surveyed on the following items: age group, specialty (psychiatric or otherwise), preferred time to start BZD reduction after improvement in symptoms, methods used to discontinue, difficulties regarding BZD discontinuation, and reasons for the difficulties. We obtained 962 responses from physicians (390 from non-psychiatrists and 572 from psychiatrists), of which 94.0% reported difficulty discontinuing BZDs. Non-psychiatrists had more difficulty with BZD discontinuation strategies, while psychiatrists had more difficulty with symptom recurrence/relapse and withdrawal symptoms. Psychiatrists used more candidate strategies in BZD reduction than non-psychiatrists but initiated BZD discontinuation after symptom improvement. Logistic regression analysis showed that psychosocial therapy was associated with less difficulty in BZD discontinuation (odds ratio, 0.438; 95% confidence interval, 0.204-0.942; p = 0.035). Educating physicians about psychosocial therapy may alleviate physicians' difficulty in discontinuing BZDs and reduce long-term BZD prescriptions.

An increase in relative contribution of compensatory postural adjustments during voluntary movement while standing in adolescents and young adults with bilateral spastic cerebral palsy.

Previous studies have revealed several deficits in anticipatory postural adjustments (APAs) during voluntary movements while standing in individuals with bilateral spastic cerebral palsy (BSCP). However, it remains unclear whether compensatory postural adjustments (CPAs) during movement increase to compensate for APA deficits. We investigated the anticipatory and compensatory activities of postural muscles during voluntary movement while standing in adolescents and young adults with BSCP. The study included seven participants with BSCP with level II on the Gross Motor Function Classification System (GMFCS), seven with BSCP with level III on the GMFCS, and fourteen healthy controls. The participants stood on a force platform and lifted a load under two weight conditions (light and heavy). The electromyographic activities of postural muscles were analyzed at time intervals typical for APAs and CPAs. The percentage of muscle activity in the CPA time epoch against the total muscle activity during the APA and CPA time epochs was higher in the two BSCP groups than in the control group. In the control group, a load-related modulation was observed only in the APA time epoch, whereas in the BSCP-II group, the load-related increase was observed in both the APA and CPA time epochs. No load-related modulations were observed in the BSCP-III group. These findings suggest that adolescents and young adults with BSCP exhibit an increase in the relative contribution of CPAs during voluntary movement and that there exist severity-related differences in the modulation of APAs and CPAs.

Shared decision-making interventions for people with mental health conditions.

BACKGROUND: One person in every four will suffer from a diagnosable mental health condition during their life. Such conditions can have a devastating impact on the lives of the individual and their family, as well as society.  International healthcare policy makers have increasingly advocated and enshrined partnership models of mental health care. Shared decision-making (SDM) is one such partnership approach. Shared decision-making is a form of service user-provider communication where both parties are acknowledged to bring expertise to the process and work in partnership to make a decision.  This review assesses whether SDM interventions improve a range of outcomes. This is the first update of this Cochrane Review, first published in 2010. OBJECTIVES: To assess the effects of SDM interventions for people of all ages with mental health conditions, directed at people with mental health conditions, carers, or healthcare professionals, on a range of outcomes including: clinical outcomes, participation/involvement in decision-making process (observations on the process of SDM; user-reported, SDM-specific outcomes of encounters), recovery, satisfaction, knowledge, treatment/medication continuation, health service outcomes, and adverse outcomes. SEARCH METHODS: We ran searches in January 2020 in CENTRAL, MEDLINE, Embase, and PsycINFO (2009 to January 2020). We also searched trial registers and the bibliographies of relevant papers, and contacted authors of included studies.  We updated the searches in February 2022. When we identified studies as potentially relevant, we labelled these as studies awaiting classification. SELECTION CRITERIA: Randomised controlled trials (RCTs), including cluster-randomised controlled trials, of SDM interventions in people with mental health conditions (by Diagnostic and Statistical Manual of Mental Disorders (DSM) or International Classification of Diseases (ICD) criteria). DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. Two review authors independently screened citations for inclusion, extracted data, and assessed risk of bias. We used GRADE to assess the certainty of the evidence. MAIN RESULTS: This updated review included 13 new studies, for a total of 15 RCTs. Most participants were adults with severe mental illnesses such as schizophrenia, depression, and bipolar disorder, in higher-income countries. None of the studies included children or adolescents.  Primary outcomes We are uncertain whether SDM interventions improve clinical outcomes, such as psychiatric symptoms, depression, anxiety, and readmission, compared with control due to very low-certainty evidence. For readmission, we conducted subgroup analysis between studies that used usual care and those that used cognitive training in the control group. There were no subgroup differences. Regarding participation (by the person with the mental health condition) or level of involvement in the decision-making process, we are uncertain if SDM interventions improve observations on the process of SDM compared with no intervention due to very low-certainty evidence. On the other hand, SDM interventions may improve SDM-specific user-reported outcomes from encounters immediately after intervention compared with no intervention (standardised mean difference (SMD) 0.63, 95% confidence interval (CI) 0.26 to 1.01; 3 studies, 534 participants; low-certainty evidence). However, there was insufficient evidence for sustained participation or involvement in the decision-making processes. Secondary outcomes We are uncertain whether SDM interventions improve recovery compared with no intervention due to very low-certainty evidence. We are uncertain if SDM interventions improve users' overall satisfaction. However, one study (241 participants) showed that SDM interventions probably improve some aspects of users' satisfaction with received information compared with no intervention: information given was rated as helpful (risk ratio (RR) 1.33, 95% CI 1.08 to 1.65); participants expressed a strong desire to receive information this way for other treatment decisions (RR 1.35, 95% CI 1.08 to 1.68); and strongly recommended the information be shared with others in this way (RR 1.32, 95% CI 1.11 to 1.58). The evidence was of moderate certainty for these outcomes. However, this same study reported there may be little or no effect on amount or clarity of information, while another small study reported there may be little or no change in carer satisfaction with the SDM intervention. The effects of healthcare professional satisfaction were mixed: SDM interventions may have little or no effect on healthcare professional satisfaction when measured continuously, but probably improve healthcare professional satisfaction when assessed categorically. We are uncertain whether SDM interventions improve knowledge, treatment continuation assessed through clinic visits, medication continuation, carer participation, and the relationship between users and healthcare professionals because of very low-certainty evidence. Regarding length of consultation, SDM interventions probably have little or no effect compared with no intervention (SDM 0.09, 95% CI -0.24 to 0.41; 2 studies, 282 participants; moderate-certainty evidence). On the other hand, we are uncertain whether SDM interventions improve length of hospital stay due to very low-certainty evidence. There were no adverse effects on health outcomes and no other adverse events reported. AUTHORS' CONCLUSIONS: This review update suggests that people exposed to SDM interventions may perceive greater levels of involvement immediately after an encounter compared with those in control groups. Moreover, SDM interventions probably have little or no effect on the length of consultations.  Overall we found that most evidence was of low or very low certainty, meaning there is a generally low level of certainty about the effects of SDM interventions based on the studies assembled thus far. There is a need for further research in this area.

Efficacy and safety of adjunctive therapy to lamotrigine, lithium, or valproate monotherapy in bipolar depression: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The efficacy and safety of adjunctive therapy are unclear in bipolar depression. In this systematic review and meta-analysis, we aimed to evaluate the efficacy and safety of second-generation antipsychotic, lamotrigine, lithium, or valproate therapy used in adjunction with lamotrigine, lithium, or valproate monotherapy in bipolar depression. A literature search of major electronic databases was conducted in February 2021, and all articles published until then were eligible. Two researchers independently screened relevant publications, extracted data, and evaluated methodological quality according to the Cochrane criteria. RESULTS: Five studies met the inclusion criteria. The meta-analysis revealed significant differences in the following outcomes: (i) remission rates from depressive episodes (risk ratio [RR]: 1.23, 95% confidence interval [CI] 1.01-1.50, p = 0.04), (ii) improvement in depressive symptoms (standardized mean difference [SMD]: 0.21, 95% CI 0.09-0.34, p = 0.001), (iii) improvement in quality of life (SMD: 0.22, 95% CI 0.06-0.37, p = 0.005), and (iv) rate of adverse events during the study period (RR: 1.12, 95% CI 1.03-1.22, p = 0.008). There was no significant difference between adjunctive therapy and monotherapy in the emergence of suicide-related behaviors, dropout rate during the study period, or rate of manic switching. CONCLUSIONS: Our results suggest that adjunctive second-generation antipsychotics, lamotrigine, lithium, or valproate increase both the benefits and risks in patients with bipolar depression, although there is no significant difference in severe adverse events. Adjunctive therapy should be provided through shared decision-making while considering the patients' condition in clinical settings.

Understanding how and under what circumstances decision coaching works for people making healthcare decisions: a realist review.

BACKGROUND: Decision coaching is non-directive support delivered by a trained healthcare provider to help people prepare to actively participate in making healthcare decisions. This study aimed to understand how and under what circumstances decision coaching works for people making healthcare decisions. METHODS: We followed the realist review methodology for this study. This study was built on a Cochrane systematic review of the effectiveness of decision coaching interventions for people facing healthcare decisions. It involved six iterative steps: (1) develop the initial program theory; (2) search for evidence; (3) select, appraise, and prioritize studies; (4) extract and organize data; (5) synthesize evidence; and (6) consult stakeholders and draw conclusions. RESULTS: We developed an initial program theory based on decision coaching theories and stakeholder feedback. Of the 2594 citations screened, we prioritized 27 papers for synthesis based on their relevance rating. To refine the program theory, we identified 12 context-mechanism-outcome (CMO) configurations. Essential mechanisms for decision coaching to be initiated include decision coaches', patients', and clinicians' commitments to patients' involvement in decision making and decision coaches' knowledge and skills (four CMOs). CMOs during decision coaching are related to the patient (i.e., willing to confide, perceiving their decisional needs are recognized, acquiring knowledge, feeling supported), and the patient-decision coach interaction (i.e., exchanging information, sharing a common understanding of patient's values) (five CMOs). After decision coaching, the patient's progress in making or implementing a values-based preferred decision can be facilitated by the decision coach's advocacy for the patient, and the patient's deliberation upon options (two CMOs). Leadership support enables decision coaches to have access to essential resources to fulfill their role (one CMOs). DISCUSSION: In the refined program theory, decision coaching works when there is strong leadership support and commitment from decision coaches, clinicians, and patients. Decision coaches need to be capable in coaching, encourage patients' participation, build a trusting relationship with patients, and act as a liaison between patients and clinicians to facilitate patients' progress in making or implementing an informed values-based preferred option. More empirical studies, especially qualitative and process evaluation studies, are needed to further refine the program theory.

Implementation of a shared decision-making training program for clinicians based on the major depressive disorder guidelines in Japan: A multi-center cluster randomized trial.

Background: Although shared treatment decision-making with patients requires attention, it is not widely implemented, particularly in the field of psychiatry. The aim of this study was to assess whether a shared decision-making (SDM) training program for clinicians based on the major depressive disorder (MDD) guidelines improved the perceived involvement of the decision process for patients with MDD. Methods: A multi-center cluster-randomized controlled intervention of a clinician training program based on the Japanese MDD guidelines using related decision aids compared to usual care was conducted among 56 clinicians from 23 institutions. A total of 124 patients with MDD were enrolled in this study. The primary outcomes were the scores of the Shared Decision Making-Questionnaire-9 (SDM-Q-9) and Decision Conflict Scale (DCS) after the first visit to the outpatient clinics. The secondary outcomes were patients' satisfaction, quality of life, trust in clinicians, and depressive symptoms. Additionally, we evaluated all the observed outcomes at the first and third months of follow-up. Results: The scores of the SDM-Q-9 in the SDM training program group were significantly higher than those in the control group at the first visit. However, no significant difference in the DCS scores was found between the two groups. There was no intervention effect for secondary outcomes and the outcomes at the first- and third-month follow-up visits. Conclusion: The clinician training program based on the Japanese MDD guidelines can be useful for implementation of SDM. Additional research is needed to confirm the efficacy of this SDM training program. Clinical trial registration: [https://www.umin.ac.jp/], identifier [UMIN000034397].