anurajms/meta_analysis huggingface dataset:
primary outcome:
Interventions for preventing and reducing the use of physical restraints of older people in general hospital settings
Number or proportion of participants who were physically restrained at least once, assessed either by direct observation or from the clinical documentation.Adverse events, including injuries related to PR use.
primary outcome:
Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia
Change in cognitive function between baseline and final follow‐up using validated cognitive assessment measures.Incident dementia of any cause as defined by internationally accepted diagnostic criteria.Bleeding, including new intracranial haemorrhagic events (intracerebral, subdural, subarachnoid and extradural) or major extracranial haemorrhagic events.
primary outcome:
Algorithm‐based pain management for people with dementia in nursing homes
Pain‐related outcomes, e.g. the number of participants with pain, mean change in pain intensity, number of participants with at least 50% improvement in pain intensityChallenging behaviourNumber of people with serious adverse events
primary outcome:
Early pharmacological interventions for universal prevention of post‐traumatic stress disorder (PTSD)
PTSD severity (continuous): using the mean score on a validated rating scale such as the Clinician‐Administered PTSD Scale (CAPS) (Blake 1995), or the Posttraumatic Stress Disorder Checklist (PCL) (Weathers 2001), the Comprehensive International Diagnostic Interview (CIDI) (WHO 1997), or any other validated rating scale to assess symptom severity.Dropouts due to adverse events (dichotomous): we considered the number of participants who left the assigned arms early due to side effects, out of the number of randomised individuals.
primary outcome:
Non‐pharmacological interventions for preventing delirium in hospitalised non‐ICU patients
Incidence of delirium during hospital admission, using a validated diagnostic method. (Studies using only a positive screening test in the absence of a formal diagnosis were excluded.)Mortality as an inpatient, between one and three months, six and 12 months, and beyond 12 months from randomisation.New diagnosis of dementia, made between one and three months, six and 12 months, and beyond 12 months from randomisation.
primary outcome:
Multi‐domain interventions for the prevention of dementia and cognitive decline
Eligible studies had to have a clearly defined outcome measure assessing cognitive function or incidence of dementia. Such outcome measures could be cognitive screening instruments, multi‐domain cognitive assessment scales, neuropsychological test batteries, or dementia diagnosis according to any of the validated criteria current at the time of the study.
primary outcome:
Ketamine and other glutamate receptor modulators for depression in adults with bipolar disorder
Efficacy outcome (dichotomous): number of participants who respond to treatment, where treatment response is defined as (1) a reduction of at least 50% compared to baseline on the Hamilton Rating Scale for Depression (HRSD) (Hamilton 1960), Montgomery‐Åsberg Depression Rating Scale (MADRS) (Montgomery 1979), or any other depression scale, depending on the study authors' definition or (2) 'much or very much improved' (score 1 or 2) on the Clinical Global Impression‐Improvement (CGI‐I) scale (Guy 1976). Where both scales were provided, we preferred the former criteria for judging response. We used the response rate instead of a continuous symptom score for the primary efficacy analysis to make the interpretation of results easier for clinicians (Guyatt 1998). To avoid possible outcome reporting bias, we did not use the original authors' definitions of response or remission, if different from above, in this review (Furukawa 2007a).Adverse events outcome (dichotomous): We evaluated adverse events using the following outcome measures.Total number of participants experiencing at least one side effect.Total number of participants experiencing the following specific side effects:agitation/anxiety;constipation;delusions;diarrhoea;dissociative symptoms;dizziness;dry mouth;hallucinations;headache;hypo/hypertension;insomnia;mania/hypomania;nausea;seizure;sleepiness/drowsiness;urination problems;vomiting;tremor.
primary outcome:
Lamotrigine in the maintenance treatment of bipolar disorder
Recurrence of any episode at one year:hospitalization for any mood episodes;Young Mania Rating Scale (YMRS) total score ≥15 for manic episode (Young 1978);Montgomery‐Asberg Depression Rating Scale (MADRS) total score ≥ 15 for depressive episode (Montgomery 1979); Hamilton Depression Rating Scale (HDRS) total score ≥ 14 for depressive episode (Hamilton 1960);clinical worsening with the need for additional treatment (e.g. mood stabilizers, antidepressants, antipsychotics or benzodiazepines);active suicidal behavior.Withdrawal from treatment due to any reason:short term, up to 12 weeks after treatment initiation (range: 7 to 16 weeks);long term, at least six months after treatment initiation (range: 6 to 16 months).Adverse effects:short term, up to 12 weeks after treatment initiation (range: 7 to 16 weeks);long term, at 6 to 12 months after treatment initiation (range: 6 to 16 months).
primary outcome:
Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder
Efficacy outcome (dichotomous): number of participants who respond to treatment, where treatment response is defined as (1) a reduction of at least 50% compared to baseline on the Hamilton Rating Scale for Depression (HRSD) (Hamilton 1960), Montgomery‐Åsberg Depression Rating Scale (MADRS) (Montgomery 1979), or any other depression scale, depending on the study authors' definition, or (2) 'much or very much improved' (score 1 or 2) on the Clinical Global Impression‐Improvement scale (CGI‐S) (Guy 1976). Where both scales were provided we preferred the former criteria for judging response. We used the response rate instead of a continuous symptom score for the primary efficacy analysis in order to make the interpretation of results easier for clinicians (Guyatt 1998). To avoid possible outcome reporting bias, we did not use the original authors' definitions of response or remission, if different from above (Furukawa 2007a).Adverse events outcome (dichotomous): We evaluated adverse events using the following outcome measures.Total number of participants experiencing at least one side effect.Total number of participants experiencing the following specific side effects:agitation/anxiety;constipation;delusions;diarrhoea;dissociative symptoms;dizziness;dry mouth;hallucinations;headache;hypo/hypertension;insomnia;mania/hypomania;nausea;seizure;sleepiness/drowsiness;urination problems;vomiting;tremor.
primary outcome:
Enteral tube feeding for people with severe dementia
survival time (measured by the time‐to‐event post‐intervention);quality of life (measured by a recognised and validated quality of life scale or tool, such as the quality of life in late‐stage dementia (QUALID) scale (Weiner 2000), or the Dementia Quality of Life scale (Dem‐QoL) (Smith 2007));pressure ulcers.
primary outcome:
Magnetic seizure therapy for treatment‐resistant depression
Symptom severityThe primary outcome measure for assessing benefit was symptom severity, determined from the following validated psychometric scalesContinuous symptom scales, such as the Hamilton Rating Scale for Depression (HAMD) (Hamilton 1960), the Montgomery–Äsberg Depression Rating Scale (MADRS) (Montgomery 1979), the Clinical Global Inventory (CGI) (Guy 1976; Spearing 1997), and the Beck Depression Inventory (BDI) (Beck 1961), which were analysed as continuous variablesGlobal state: clinically significant response in depressive symptoms (i.e. response or non‐response) as defined by studies (short term). For trials in which dichotomous outcome data were available, we summarised these as the number of people who experienced those outcomes in each comparison group and the total number in each group, and we analysed them as dichotomous variablesCognitive functionThe primary outcome measure for assessing harm was cognitive function. Outcome measures of interest were changes in test scores and in rate of cognitive recovery by means of validated neuropsychological tests from baseline to follow‐up periods after completion of treatment. These included (but were not limited to):Montreal Cognitive Assessment (MoCA);Repeatable Battery for Assessment of Neuropsychological Status (RBANS); andCogstate computerised cognitive tests.
primary outcome:
Pharmacological treatment of hypertension in people without prior cerebrovascular disease for the prevention of cognitive impairment and dementia
Incidence of dementia. For the diagnosis of dementia, we accepted standard criteria, such as the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders (DSM) (APA 1987), International Classification of Diseases‐10 (ICD‐10) (WHO 1992); National Institute of Neurological and Communicative Disorders and Stroke ‐ Alzheimer's Disease and Related Disorders Association (NINCDS‐ADRDA) (McKhann 1984), or acceptable equivalents (Dubois 2007, McKhann 2011).Cognitive change from baseline. We required cognitive function to have been formally assessed using, for example, the Mini‐Mental State Examination (MMSE) or acceptable alternative.
primary outcome:
Approaches for discontinuation versus continuation of long‐term antidepressant use for depressive and anxiety disorders in adults
Successful discontinuation rate: the proportion (%) of participants who successfully stopped antidepressants at the end of the trial. We defined successful discontinuation rate as:no antidepressant use;absence of depressive or anxiety symptoms or diagnosis, or both; andno dropout before the end of the trialRelapse rate: the proportion (%) of participants who did not successfully stop antidepressants at the end of the trial due to relapse or recurrence of depressive and/or anxiety symptoms and/or diagnosis. We defined relapse rate as:relapse of depressive and/or anxiety symptoms and/or diagnosis after continuation;relapse of antidepressant use after discontinuation due to the presence of depressive and/or anxiety symptoms and/or diagnosis;relapse of depressive and/or anxiety symptoms after discontinuation; ordropout from the trial due to relapse to depressive and/or anxiety symptoms and/or diagnosis. We used the definition of relapse as defined by study authorsPresence of withdrawal symptoms (measured by Discontinuation‐Emergent Signs and Symptoms (DESS) Scale (Rosenbaum 1988), symptoms assessment form, Unified Parkinson Disease Rating Scale, or any relevant instrument)Any adverse events attributable to continuation of antidepressant use
primary outcome:
Cholinesterase inhibitors for vascular dementia and other vascular cognitive impairments: a network meta‐analysis
Cognitive function (e.g. the cognitive part of the Alzheimer's Disease Assessment Scale, ADAS‐Cog; Syndrom‐Kurz test)Clinical global impression (e.g. Clinician's Interview‐Based Impression of Change scale, CIBIC‐Plus; Clinical Global Impression of Change, CGIC; Clinical Global Impression, CGI (which measures of symptom severity, treatment response, and treatment efficacy); Sandoz Clinical Assessment Geriatric Scale, SCAG)Functional performance in activities of daily living (e.g. Alzheimer's Disease Cooperative Study‐Activities of Daily Living, ADCS‐ADL; Behavioural Rating Scale for Geriatric Patients, BGP)Number of adverse events (including nausea and/or vomiting, diarrhoea, dizziness, loss of appetite and/or anorexia, headache and hypertension). If the number of adverse events was not presented, we used the number of participants with any adverse events (one or more) in a study. We accepted adverse events as defined in the included studies.
primary outcome:
Antidepressant treatment for postnatal depression
Response or remission of depression, using dichotomous response or remission measures as reported in the individual studies and defined by the study authors. Response is typically measured by the number of women with a reduction of at least 50% on the total score of a standardised depression scale. Remission is typically measured by the number of women whose scores fall below a predefined threshold on a standardised depression scale. We report the study authors’ definitions in this review.Adverse events (or side effects) experienced by:mother;nursing baby.
primary outcome:
Withdrawal or continuation of cholinesterase inhibitors or memantine or both, in people with dementia
Cognitive, neuropsychiatric and functional outcomes, measured with validated scalesRates of institutionalisationAdverse effectsDropouts from the trial, including total number of dropouts and number of dropouts due to deterioration or lack of efficacy
primary outcome:
Pharmacological interventions for self‐harm in adults
The primary outcome measure in this review was the occurrence of repeated SH over a maximum follow‐up period of two years. Repetition of SH was identified through self‐report, collateral report, clinical records, or research monitoring systems. As we wished to incorporate the maximum data from each trial, we included both self‐reported and hospital records of SH, where available. Preference was given to clinical records over self‐report where a study reported both measures. We also reported proportions of participants repeating SH, frequency of repeat episodes, and time to SH repetition (where available).
primary outcome:
Remotely delivered information, training and support for informal caregivers of people with dementia
Caregiver burden, measured by validated questionnaires such as the Zarit Burden Interview (ZBI) or the Sense of Competence Questionnaire (SCQ 27).Caregiver mood or psychosocial well‐being, measured by validated questionnaires such as the Center for Epidemiologic Studies Depression Scale (CES‐D), the Hospital Anxiety and Depression Scale (HADS), or the General Health Questionnaire (GHQ).Caregiver health‐related quality of life (HRQoL), measured by the EuroQoL Group's instrument (EUROQOL), the 36‐Item Short Form Health Survey (SF‐36) or the World Health Organization (WHO) Quality of Life assessment tool (WHOQOL).Acceptability of the intervention: we used dropouts for any reason as a surrogate for the acceptability of interventions.
primary outcome:
Personally tailored activities for improving psychosocial outcomes for people with dementia in community settings
Challenging behaviour, assessed by e.g. the Cohen‐Mansfield Agitation Inventory (CMAI).Quality of life, assessed by e.g. Dementia Care Mapping, EuroQol (EQ‐5D).
primary outcome:
Behavioural activation therapy for depression in adults with non‐communicable diseases
Treatment efficacy for depression: the number of participants who responded to treatment, as determined by changes in scores for Beck Depression Inventory (BDI; Beck 1961), Hamilton Rating Scale for Depression (HAM‐D/HRSD; Hamilton 1960), or Montgomery‐Asberg Depression Rating Scale (MADRS; Montgomery 1979), or in scores from any other validated depression scale. We used HAM‐D, and, if this was not available, we used MADRS, and if MADRS was not available, then we used BDI. If BDI was not available, we used the measure most frequently used across trials. Many trials define response as 50% or greater reduction on BDI, HAM‐D, etc., with some trials defining response using Jacobson's Reliable Change Index (Jacobson 1992); we accepted the trial authors' original definition and preferred Jacobson's Reliable Change Index if this was used in addition to other response outcomes.Treatment acceptability: the number of participants who dropped out of the study after being randomised and allocated to a study arm.
primary outcome:
Avatar Therapy for people with schizophrenia or related disorders
We divided all outcomes into short term (less than six months), medium term (six to 12 months) and long term (over 12 months).We sought to report binary outcomes recording clear and clinically meaningful degrees of change (e.g. global impression of much improved, or more than 50% improvement on a rating scale defined within the trials). Thereafter, we listed other binary outcomes and then those that were continuous. See Differences between protocol and review.
primary outcome:
Aspirin and other non‐steroidal anti‐inflammatory drugs for the prevention of dementia
Incidence of dementia, diagnosed according to standard diagnostic criteria at the time the study was undertaken. We included data on any dementia pathological subtype, but, because NSAIDs may have specific effects in the pathological processes underlying AD, we favoured estimates of AD as our primary outcome where reported.Adverse events, for example, cardiovascular (specifically MI and stroke), gastrointestinal or renal events.Mortality.
primary outcome:
Simulated presence therapy for dementia
Any behavioural and psychological symptoms as measured using scales such as the Neuropsychiatric Inventory (NPI) or Brief Psychiatric Rating Scale (BPRS) (multidomain scales), Cohen‐Mansfield Agitation Inventory (CMAI) (scale specific to agitation), or Cornell Scale for Depression in Dementia (CSDD) (scale specific to depression).Quality of life.
primary outcome:
Computerised cognitive training for 12 or more weeks for maintaining cognitive function in cognitively healthy people in late life
Global cognitive functioning: measured using validated tests, for example (but not limited to):Mini Mental State Examination (MMSE);Alzheimer's Disease Assessment Scale (ADAS‐Cog);Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); andCambridge Cognition Examination (CAMCOG).
primary outcome:
Cognitive training interventions for dementia and mild cognitive impairment in Parkinson’s disease
Measures of cognitive function: global cognition, executive function, attention, memory (specifically verbal memory), and visual processing.
primary outcome:
Enhanced rehabilitation and care models for adults with dementia following hip fracture surgery
Health‐related quality of life assessed using validated outcome measures such as the 36‐item Short Form Health Survey (SF‐36) (Ware 1992), Bath Assessment of Subjective Quality of Life in Dementia (BASQID) (Trigg 2007), DEMQOL (Smith 2005), 12‐item Short Form Health Survey (SF‐12) (Ware 1996), EuroQol (EQ)‐5D (EuroQol Group 1990), and Health Utility Index instruments (Feeny 2002).Activities of daily living and functional performance assessed by validated outcome measures such as the Barthel Index (Mahoney 1965), Nottingham Extended Activities of Daily Living Scale (Nouri 1987), Oxford Hip Score (Dawson 1996), the Bristol Activities of Daily Living Score (BADLS) (Bucks 1996), or a timed walk test.
primary outcome:
Psychosocial interventions for people with both severe mental illness and substance misuse
We intended to group data into short‐, medium‐ and long‐term outcomes. However, this would have resulted in much data loss as outcome periods varied and therefore, we reported for the following time periods: 3, 6, 9, 12, 18, 24 and 36 months (where applicable).We endeavoured to report binary outcomes, recording clear and clinically meaningful degrees of change (e.g. global impression of much improved, or more than 50% improvement on a rating scale ‐ as defined within the trials) before any others. Thereafter we listed other binary outcomes and then those that are continuous*.We only extracted data from valid scales (see Data collection and analysis).For outcomes measured and scales used by included studies see (Included studies).
primary outcome:
Couple and family therapies for post‐traumatic stress disorder (PTSD)
Severity of PTSD symptoms for the primary presenting patient, ascertained using self‐reports or clinician reports on measurement scales such as the PTSD Checklist (Weathers 1993), the PTSD symptom scale (Foa 1993), as well as the Clinician Administered PTSD Scale (Blake 1995). The last is considered a 'gold standard' measure in many contexts (Weathers 2001).Dyadic adjustment, ascertained using self‐report, family member reports or clinician reports on measures of relationship satisfaction or distress, like the Dyadic Adjustment Scale or the Marital Adjustment Test (Locke 1959; Spanier 1976).
primary outcome:
Present‐centered therapy (PCT) for post‐traumatic stress disorder (PTSD) in adults
Efficacy outcomesReduced severity of PTSD symptoms as determined by a clinician‐administered standardized measure (e.g. the Clinician Administered PTSD Symptom Scale (CAPS; Weathers 2001)).Non‐inferiority outcomes: the goal of non‐inferiority research is to determine whether a new treatment has comparable efficacy to an existing treatment, such that the new treatment results in differences that are no worse than a prespecified margin. Conclusions of non‐inferiority are determined based on whether the confidence interval (CI) exceeds this prespecified minimally important difference (MID).Reduced PTSD severity as assessed by the CAPS, with the 95% CI excluding the MID value. We also calculated standardized mean differences to include studies that did not use the CAPS to confirm the direction of the effect and provide an estimate of the effect size. Based on existing guidelines (Berliner 2019), any effect size < 0.2 was considered not clinically meaningful.Adverse events outcomesRates of dropout at post‐treatment for any reason
primary outcome:
Cerebrolysin for vascular dementia
(1) Cognitive function (measured by multidomain tools such as MMSE).(2) Global function (measured by tools such as Clinician Interview Based Impression of Change (CIBIC)).(3) All‐cause death.
primary outcome:
Pharmacological interventions for the treatment of delirium in critically ill adults
Duration of delirium (defined as the time from which delirium was identified or the patient was randomized until resolution (i.e. screened negative as defined by study authors)), measured in days
primary outcome:
Multiple session early psychological interventions for the prevention of post‐traumatic stress disorder
Rates of PTSD among those exposed to trauma as measured by a standard classificatory system, assessed using a standardised measure such as the Clinician‐Administered PTSD Scale (CAPS; Blake 1995).Dropout from treatment.
primary outcome:
Benzodiazepines for catatonia in people with schizophrenia or other serious mental illnesses
We would have divided all outcomes into short term (up to 12 weeks), medium term (13 to 26 weeks) and long term (over 26 weeks). Short‐term studies would also be distinguished according to whether they were single injection, one day or longer studies.
primary outcome:
Antidepressants plus benzodiazepines for adults with major depression
Depressive severity: studies had to include at least one measure of depressive severity. The symptom severity could have been measured by either observer‐rating (our preference) or self‐report. The primary outcome for depressive severity was based on the observer‐rated scale, preferably the Hamilton Rating Scale for Depression (HRSD) (Hamilton 1960). We combined data on observer‐rated and self‐report outcomes, while prioritising data from observer‐rating scales in case of available data from both observer‐rating scales and self‐report questionnaire.Acceptability of treatment: as measured by leaving study early for any reason.
primary outcome:
Psychological therapies for preventing seasonal affective disorder
The primary outcome for benefit was the incidence of SAD, measured as the proportion of participants with a Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders (SIGH‐SAD; Williams 2012) score of 20 or higher.The primary outcome for harm was the overall rate of adverse events (e.g. increased suicidal ideation, worsening of symptoms) related to preventive interventions. We intended to include all information on adverse events, irrespective of the way it was assessed in the study (targeted, structured or spontaneously reported).
primary outcome:
Interventions for preventing delirium in older people in institutional long‐term care
Prevalence and incidence of delirium, using a validated diagnostic method (see Types of studies).Severity of delirium, using a validated diagnostic method (e.g. DRS; Trzepacz 1988)).Mortality.
primary outcome:
Benzodiazepines versus placebo for panic disorder in adults
Rate of response, i.e. substantial improvement from baseline as defined by the original investigators. Examples would be 'very much or much improved' according to the Clinical Global Impression Change Scale; more than 40% reduction in the Panic Disorder Severity Scale score (which is considered as equivalent to 'very much or much improved' on the Clinical Global Impression of Improvement Scale (CGI‐I)) (Furukawa 2009); and more than 50% reduction in the Fear Questionnaire Agoraphobia Subscale (which is considered as an appropriate rate of response according to Bandelow 2006).Total number of dropouts for any reason as a proxy measure of treatment acceptability.
primary outcome:
Cognitive training for people with mild to moderate dementia
We considered outcomes within the following broad categories as relevant for this review.Although it is acknowledged that surrogate and economic outcomes are important, we determined them to be beyond the scope of the current review; therefore we selected the main primary and secondary outcomes from the top four categories, as further outlined below.
primary outcome:
Memantine for dementia
The primary outcomes of interest included the following.We also sought data on the following pragmatic outcomes.
primary outcome:
Electroconvulsive therapy for treatment‐resistant schizophrenia
If possible, we divided all outcomes into short term (less than six weeks), medium term (six weeks to six months), and long term (over six months).
primary outcome:
Second‐generation antidepressants for preventing seasonal affective disorder in adults
The primary outcome for benefit was incidence of SAD, measured as the proportion of participants with a SIGH‐SAD (Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders (Williams 2002)) of 20 or higher.The primary outcome for harms was the overall rate of adverse events related to preventive interventions.
primary outcome:
Computerised cognitive training for preventing dementia in people with mild cognitive impairment
Incidence of all‐cause dementia (measured as a dichotomous outcome).Global cognitive function (measured as a continuous outcome).Alzheimer's Disease Assessment Scale ‐ Cognitive subscale (ADAS‐Cog);Mini Mental State Examination (MMSE);Repeatable Battery for Assessment of Neuropsychological Status (RBANS); andCambridge Cognition Examination (CAMCOG).
primary outcome:
Computerised cognitive training for maintaining cognitive function in cognitively healthy people in midlife
Global cognitive functioning: measured using validated tests, for example (but not limited to)Mini Mental State Examination (MMSE)Alzheimer's Disease Assessment Scale (ADAS‐Cog)Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)Cambridge Cognition Examination (CAMCOG)
primary outcome:
Cognitive behavioural therapy plus standard care versus standard care for people with schizophrenia
Outcomes could be categorised as being short‐, medium‐ or long‐term. A short‐term outcome was defined as occurring within the period typically associated with active treatment. The National Institute for Health and Care Excellence (NICE) asserts that "for it to make a difference, [the patient] should have CBT treatment for more than 16 planned sessions" (NICE 2014). Accordingly, in this review, we have grouped outcomes into those measured in the short term (within 24 weeks of the onset of therapy), medium term (within 24 to 52 weeks of the onset of therapy) and long term (over 52 weeks since the onset of therapy).We aimed to report binary outcomes recording clear and clinically meaningful degrees of change (e.g. global impression of much improved, or more than 50% improvement on a rating scale ‐ as defined within the trials) before any others. Thereafter, we listed other binary outcomes and then those that were continuous.* see Differences between protocol and review.
primary outcome:
Interventions for preventing intensive care unit delirium in adults
The event rate of ICU delirium (assessed using the Confusion Assessment Method for the ICU (CAM‐ICU) (dichotomous yes/no), the Intensive Care Delirium Screening Checklist (ICDSC) (dichotomous yes/no), or as scores (from 0 to 8) with scores of 4 and higher indicating delirium (Van Den Boogard 2018), the Diagnostic and Statistical Manual of Mental Disorders (DSM‐IV) criteria (dichotomous yes/no), or the Neelon and Champagne Confusion Scale (NEECHAM) (dichotomous yes/no) assessed within the time frames defined in the included studies (see Differences between protocol and review).In‐hospital mortality, at 30 days or at the longest follow‐up, or both, in the included trials.
primary outcome:
Cognitive behavioural therapy plus standard care versus standard care plus other psychosocial treatments for people with schizophrenia
Outcomes can be categorised as being of short‐, medium‐ or long duration. A short‐term outcome is defined as occurring within the period typically associated with active treatment. The National Institute for Health and Care Excellence (NICE) asserts that "for it to make a difference, [the patient] should have CBT treatment for more than 16 planned sessions" (NICE 2014). Accordingly, in this review, we have grouped outcomes into those measured in the short term (within 24 weeks of the onset of therapy), medium term (within 24 to 52 weeks of the onset of therapy) and long term (over 52 weeks since the onset of therapy).Outcomes can also be grouped into broad areas (Table 1).We aimed to report binary outcomes recording clear and clinically meaningful degrees of change (e.g. global impression of much improved, or more than 50% improvement on a rating scale ‐ as defined within the trials) before any others. Thereafter, we listed other binary outcomes and then those that are continuous.* see Differences between protocol and review.
primary outcome:
Valproate preparations for agitation in dementia
Agitation, or one or more aspects of agitation as measured by a scale that specifically measured agitation, either exclusively or as one of its components. The scales included but were not limited to:Cohen‐Mansfield Agitation Inventory (CMAI; Cohen‐Mansfield 1986);Social Dysfunction and Agitation Scale (SDAS; Wistedt 1990);Clinical Global Impression Scale for Aggression (CGI; Guy 1976);"Nurse Observation" scale (Colenda 1991);Behavior Observation Scale of Intramural Psychogeriatric Patients (GIP; Verstraten 1988);Brief Psychiatric Rating Scale (BPRS; Overall 1962; Overall 1988);Overt Aggression Scale (OAS; Yudofsky 1986).
primary outcome:
Antidepressants for treating depression in dementia
Effect on depression (measured by rating scales, and by rates of response or remission defined according to clear criteria).
primary outcome:
Environmental and behavioural modifications for improving food and fluid intake in people with dementia
We only considered participant‐relevant outcomes. We excluded outcomes relevant only to other stakeholders (e.g. relatives or health professionals) and biomarkers.
primary outcome:
Cholinesterase inhibitors for the treatment of delirium in non‐ICU settings
Response to treatment:duration of delirium;severity of delirium measured by validated scales (e.g. Memorial Delirium Assessment Scale (MDAS) (Breitbart 1997), Delirium Rating Scale (DRS) (Trzepacz 1988), or DRS‐R‐98 (Trzepacz 2001).Adverse events
primary outcome:
Donepezil for dementia due to Alzheimer's disease
The primary outcomes of interest were as follows.We noted physiological outcomes, such as plasma levels, changes on functional imaging or electroencephalogram (EEG) changes but did not assess them, as they are not primarily measures of efficacy.
primary outcome:
Couple therapy for depression
1. Efficacy outcome. Depressive symptom level, presented as continuous (means and standard deviations) or dichotomous (persistence of depression versus remission or clinically significant improvement) data, measured through use of self‐rated questionnaires, such as Beck Depression Inventory (BDI) (Beck 1961), or clinician‐rated scales, such as the Hamilton Rating Scales for Depression (HRSD) (Hamilton 1960), and the Inventory of Depressive Symptomatology (IDS‐C30) (Rush 1996).2. Adverse events outcome. Proportion of dropouts or participants who discontinued treatment for any reason. This outcome was not considered in studies providing comparison with waitlist, because discontinuation of treatment does not make any sense in a no‐treatment condition.
primary outcome:
Processed electroencephalogram and evoked potential techniques for amelioration of postoperative delirium and cognitive dysfunction following non‐cardiac and non‐neurosurgical procedures in adults
Occurrence of postoperative delirium (POD) as assessed by any method such as the Mini‐Mental State Examination (MMSE) and Confusion Assessment Method (CAM) in the first week after operation.Occurrence of postoperative cognitive dysfunction (POCD) at one week (immediate), 12 weeks or three months (intermediate) and 52 weeks or over one year (long term) as determined by any method of assessing POCD including a battery of neuropsychological tests according to the criteria described by the ISPOCD group (Moller 1998).
primary outcome:
Antidepressants for preventing postnatal depression
1. Onset of postnatal depression. Depression was defined as measured in each trial using any of the following: clinical diagnostic interview; standard observer‐rated depression symptom scales based on a recognised diagnostic scheme (e.g. the Diagnostic and Statistical Manual of Mental Disorders (DSM‐IV) or the International Classification of Disease (ICD‐10); other standardised criteria (e.g. the Research Diagnostic Criteria (RDC) (Spitzer 1978)); or screening instruments (e.g. the Edinburgh Postnatal Depression Scale (EPDS) (Cox 1987)). Studies examining onset of depression up to six months postpartum were eligible. Time to onset was reported if examined in individual studies.2. Adverse events experienced by the mother, or the fetus/breastfed infant, or both.
primary outcome:
Gamma‐aminobutyric acid agonists for antipsychotic‐induced tardive dyskinesia
We have defined clinical efficacy as an improvement in the symptoms of TD of more than 50%, on any scale. When appropriate, we grouped the outcomes into time periods ‐ short term (less than six weeks), medium term (between six weeks and six months) and long term (more than six months).
primary outcome:
Antidepressants versus placebo for panic disorder in adults
Failure to respond, that is, lacking substantial improvement from baseline as defined by the original investigators. Examples of improvement would be “very much or much improved” according to the Clinical Global Impressions Scale, more than 40% reduction in the Panic Disorder Severity Scale score (which is considered as equivalent to "very much or much improved" on the Clinical Global Impression of Improvement Scale (Furukawa 2009), and more than 50% reduction in the Fear Questionnaire Agoraphobia Subscale (which is considered as an appropriate rate of response according to Bandelow 2006). For this outcome we calculated the number of participants who failed to meet these improvement criteria.Total number of dropouts for any reason as a proxy measure of treatment acceptability.
primary outcome:
Withdrawal versus continuation of long‐term antipsychotic drug use for behavioural and psychological symptoms in older people with dementia
Success of withdrawal from antipsychotics over short‐term (four weeks or less) and long‐term (more than four weeks) follow‐up. Success is defined as the ability to complete the study in the allocated study group, i.e. no dropout due to worsening of NPS, or no relapse to antipsychotic drug during the trial.Behavioural and psychological symptoms (especially agitation, aggression and psychotic symptoms) measured with appropriate scales (e.g. Neuropsychiatric Inventory score (NPI), Neuropsychiatric Questionnaire score (NPI‐Q)).Presence or absence of withdrawal symptoms or withdrawal syndrome in the first four weeks.Withdrawal symptoms or withdrawal syndrome include autonomic and behavioural symptoms such as nausea, vomiting, anorexia, rhinorrhoea, diarrhoea, diaphoresis, myalgia, paraesthesia, anxiety, as well as movement disorders, such as withdrawal emergent parkinsonism, withdrawal dyskinesia and covert dyskinesia.Agitation, insomnia and restlessness have also been reported during withdrawal, although it is possible these symptoms occur due to rebound phenomenon. It is impossible to discriminate between these aetiological phenomena.A withdrawal neuroleptic malignant syndrome is a very rare but extremely severe condition that can complicate abrupt antipsychotic discontinuation.Adverse events attributable to antipsychotics (e.g. falls, extrapyramidal symptoms, cardiovascular events and diabetes.
primary outcome:
Calcium channel blockers for antipsychotic‐induced tardive dyskinesia
Tardive dyskinesia (TD)No clinically important improvement in the symptoms of individuals, defined as more than 50% improvement on any TD scale ‐ any time period.Adverse effectsNo clinically significant extrapyramidal adverse effects ‐ any time period.
primary outcome:
Cholinergic medication for antipsychotic‐induced tardive dyskinesia
When appropriate, the we grouped outcomes into time periods ‐ short term (less than six weeks), medium term (between six weeks and six months) and long term (over six months).
primary outcome:
Miscellaneous treatments for antipsychotic‐induced tardive dyskinesia
We have defined clinical efficacy as an improvement in the symptoms of TD of more than 50%, on any scale. We grouped outcomes into short term (less than six weeks), medium term (between six weeks and six months) and long term (more than six months).
primary outcome:
Selective noradrenaline reuptake inhibitors for schizophrenia
While all 16 studies included in the review utilised instruments which could produce an indication of rates of improvement in negative symptoms only one provided usable data. Shafti 2015 measured response rates at 12 weeks (defined as 20% reduction in the SANS) and reported rates of 6/25 and 19/25 in the placebo and reboxetine arms respectively indicating a significant benefit of reboxetine (1 RCT, n = 50; RR 3.17, 95% CI 1.52 to 6.58; Analysis 1.1).Kurland 1981 reported non‐specific improvement rates of 7/15 and 6/13 in the placebo and viloxazine arms respectively, showing no difference (Analysis 1.2). Nine studies measured global response using the CGI‐I or CGI‐S but none defined clinical improvement on these scales or reported dichotomous outcomes.
primary outcome:
Risperidone versus other antipsychotics for people with severe mental illness and co‐occurring substance misuse
We categorised outcomes into short‐term, medium‐term and long‐term outcomes. Short‐term outcomes included outcomes measured in the first six months, medium‐term outcomes include outcomes from six months to one year, and long‐term outcomes include outcomes beyond one year.
primary outcome:
Benzodiazepines for antipsychotic‐induced tardive dyskinesia
1. Tardive dyskinesiaNo clinically important improvement in symptoms, defined as more than 50% improvement on any TD scale at any time period.a2. Adverse effectsNo clinically significant extrapyramidal adverse effects at any time period.aThe primary outcome for previous versions of this review was 'any improvement in TD symptoms of more than 50% on any TD scale ‐ any time period.' Data provided in trials did not fit this exactly; however, we felt 'not improved to a clinically important extent' fit best with what we had hoped to find.
primary outcome:
Non‐antipsychotic catecholaminergic drugs for antipsychotic‐induced tardive dyskinesia
We have defined clinical efficacy as an improvement in the symptoms of TD of more than 50%, on any scale. We grouped outcomes into short term (less than six weeks), medium term (between six weeks and six months) and long term (more than six months).
primary outcome:
Anticholinergic medication for antipsychotic‐induced tardive dyskinesia
We have defined clinical efficacy as an improvement in the symptoms of TD of more than 50%, on any scale. We grouped outcomes into short term (less than 6 weeks), medium term (between 6 weeks and six months) and long term (more than six months).
primary outcome:
Aripiprazole (intramuscular) for psychosis‐induced aggression or agitation (rapid tranquillisation)
Outcomes grouped by time: by 30 minutes, up to two hours, up to four hours, up to 24 hours, and over 24 hours.We endeavoured to report binary outcomes recording clear and clinically meaningful degrees of change (e.g. global impression of much improved, or more than 50% improvement on a rating scale ‐ as defined within the trials) before any others. Thereafter, we listed other binary outcomes and then those that were continuous.
primary outcome:
Benzodiazepines for psychosis‐induced aggression or agitation
1. Tranquillisation or asleep1.1. Tranquil or asleep ‐ by up to 30 minutes.
1.2. Repeated need for rapid tranquillisation.
primary outcome:
Zuclopenthixol dihydrochloride for schizophrenia
All outcomes were reported for the short term (up to 12 weeks), medium term (13 to 26 weeks), and long term (more than 26 weeks). None of the included studies went beyond one year.
primary outcome:
Chlorpromazine versus penfluridol for schizophrenia
We divided outcomes into short term (less than 12 weeks), medium term (12‐52 weeks) and long term (over one year).
primary outcome:
Haloperidol for psychosis‐induced aggression or agitation (rapid tranquillisation)
All outcomes grouped by time: by 30 minutes, up to two hours, up to four hours, up to 24 hours and over 24 hours.
primary outcome:
Vortioxetine for depression in adults
Response to treatment: the primary efficacy outcome was the number of participants who responded to acute treatment, as defined by a reduction of at least 50% on the Hamilton Depression Rating Scale (HAM‐D) scale (Hamilton 1960) or Montgomery‐Åsberg Depression Scale (MADRS; Montgomery 1979), or any other depression scale, or "much or very much improved" (score 1 or 2) on Clinical Global Impression ‐ Improvement (CGI‐I) (Guy 1970). We did not consider other definitions of response in this Cochrane Review.Total number of dropouts: primary outcome measuring acceptability was the total number of participants dropping out during the trial as a proportion of the total number of randomised participants.
primary outcome:
Antipsychotic combinations for schizophrenia
We grouped outcomes into long term (over 26 weeks, A), medium term (13 to 26 weeks, B) and short term (up to 12 weeks, C).
primary outcome:
Communication skills training for mental health professionals working with people with severe mental illness
With relation to the patients treated by the mental health professional.
primary outcome:
Assistive technology for memory support in dementia
The primary outcome measures regarding the efficacy of the AT under study related to ADL and the level of dependency of people with dementia. The secondary outcome measures related to clinical and care‐related outcomes of the AT for people with dementia, to their perceived quality of life and well‐being, and also the effects of AT on their carers — informal carers for community‐based interventions and formal carers for institutional‐based interventions. Adverse events resulting from use of AT for people with dementia and carers (informal and formal) were to be included. All reported time frames were to be included; all outcomes measures were to be listed, and their validity and reliability considered.
primary outcome:
Chlorpromazine versus clotiapine for schizophrenia
We divided outcomes into short‐term (less than six months), medium‐term (7 to 12 months), and long‐term (over one year).
primary outcome:
Chlorpromazine versus metiapine for schizophrenia
1. Global state1.1. Clinically important improvement in global state as defined by each study.2. Mental state2.1. Clinically important improvement in mental state as defined by each study.3. Adverse events3.1. Incidence of clinically important movement disorder as defined by each study.
primary outcome:
Clozapine combined with different antipsychotic drugs for treatment‐resistant schizophrenia
1. Clinical response.1.1. No clinically significant response in global state ‐ as defined by each of the studies.1.2. No clinically significant response in mental state ‐ as defined by each of the studies.2. Adverse effect.2.1. Weight gain.
primary outcome:
Compulsory community and involuntary outpatient treatment for people with severe mental disorders
1. Health service contact and utilisation.1.1. Admission/readmission to hospital.
1.2. Bed‐days spent in hospital.2. Social functioning.2.1. Specific ‐ imprisonment, police contact and arrests.
primary outcome:
Risperidone versus placebo for schizophrenia
We grouped outcomes into short term (up to 12 weeks), medium term (13 to 26 weeks), and long term (over 26 weeks).
primary outcome:
Implementation of treatment guidelines for specialist mental health care
We considered the following process outcome.1. Practitioner impact ‐ as defined by each of the studies
primary outcome:
Droperidol for psychosis‐induced aggression or agitation
We planned to divide outcomes into immediate (within two hours), short term (longer than two hours to 24 hours), medium term (longer than 24 hours to two weeks) and long term (beyond two weeks).
primary outcome:
Haloperidol for long‐term aggression in psychosis
We planned to divide, where possible, outcomes into short‐term (up to three months), medium‐term (over three and up to six months) and long‐term (over six months).
primary outcome:
Haloperidol plus promethazine for psychosis‐induced aggression
We predefined the primary outcomes of interest as tranquil or asleep, global state, and specific serious adverse effects. We grouped all outcomes by time: by 30 minutes, up to two hours, up to four hours, up to 24 hours, and over 24 hours.We knew that some of our own work was eligible for this review and that this potentially biases our choice of primary outcome. Countering this, however, is that the primary outcomes for our trials were not chosen by the trialists, but by the clinicians working in front‐line psychiatric emergency services of Rio de Janeiro, Brazil. This clinical grounding, we suggest, protects the review from a biased choice of outcomes.
primary outcome:
Valproate for schizophrenia
We aimed to group outcomes by time: short‐term (up to 12 weeks), medium‐term (13 to 26 weeks) and long‐term (over 26 weeks).
primary outcome:
Antihypertensive withdrawal for the prevention of cognitive decline
Cognitive impairment or rates of incident dementia in cognitively intact and cognitively impaired adults.Cognition in the short‐term in adults with or without established cognitive impairment.
primary outcome:
Psychological therapies versus pharmacological interventions for panic disorder with or without agoraphobia in adults
EfficacyShort‐term* 'remission', i.e. satisfactory end‐state as defined by the global judgement of the original investigators, such as 'panic free' or 'no or minimal symptoms' according to the Clinical Global Impression (CGI) Severity Scale (Guy 1976), or a Panic Disorder Severity Scale (PDSS) score of seven or below (Shear 1997), or a Fear Questionnaire Agoraphobia Subscale score of nine or below (Marks 1979). Short‐term* 'response' (a dichotomised outcome). 'Response' is intended to be a substantial improvement from baseline as defined by the global judgement of the original authors, such as 'very much' or 'much' improvement according to the CGI Change Scale, a more than 40% reduction in the PDSS, or a more than 50% reduction in the Fear Questionnaire Agoraphobia Subscale.Adverse effectsTotal number of dropouts for any reason, as a proxy measure of treatment acceptability.
primary outcome:
Bifeprunox versus placebo for schizophrenia
We planned to divide all outcomes into short term (zero to six weeks), medium term (six weeks to six months), and long term (over six months).