anurajms/meta_analysis huggingface dataset:
primary outcome:
Psychological therapies for children and adolescents exposed to trauma
1. Diagnosis of post‐traumatic stress disorder determined by accepted clinical diagnostic criteria such as International Classification of Diseases, Revision 10 (ICD‐10), or DSM‐IV‐TR.2. Symptoms of PTSD measured on scales based on diagnostic criteria such as ICD‐10 or DSM‐IV‐TR with published reliability and validity (e.g. Children's PTSD Inventory) (Saigh 2000).
primary outcome:
Continuation and maintenance treatments for depression in older people
The primary outcome measure for benefit was recurrence rate of depression at 12 months' follow‐up. We defined this as reaching a cut‐off on depression rating scales such as the Beck Depression Inventory (Beck 1996), Hamilton Depression Rating Scale (HDRS; Hamilton 1960), Montgomery‐Åsberg Depression Rating Scale (MADRS; Montgomery 1979), or any depression symptom rating scale used by study authors. We defined remission of a depressive illness as depressive symptoms dropping below case level and defined recovery as remission lasting for more than six months. Recurrence was return to case level symptoms during recovery (Frank 1991).The primary outcome measure for harm was number of participants who had dropped out during the trial at 12 months as a proportion of the total number of randomised participants.
primary outcome:
Topiramate for acute affective episodes in bipolar disorder in adults
For manic and mixed episodes, efficacy of treatment was measured by change in mean scores from baseline to end of treatment on symptom rating scales, for example Young Mania Rating Scale, Young 1978, and Cavanagh scale for mixed states (Cavanagh 2009).For depressive episodes, efficacy of treatment was measured by change in mean scores from baseline to end of treatment on depressive symptom rating scale, such as Hamilton Depression Rating Scale (HAMD‐17) (Hamilton 1980), Montgomery‐Åsberg Depression Rating Scale (MADRS) (Montgomery 1979).Number of participants experiencing troublesome side effects of any nature.
primary outcome:
Cognitive behavioural therapy (CBT), third‐wave CBT and interpersonal therapy (IPT) based interventions for preventing depression in children and adolescents
Prevalence of depression diagnosis at medium‐term follow‐up (i.e. between four and 12 months), measured using a recognised diagnostic system such as DSM‐IV‐TR (American Psychiatric Association 2000) or ICD‐10 (World Health Organization 2007), or tools that yield diagnoses of depressive disorder according to these systems (e.g. the Kiddie Schedule for Affective Disorders Scale (K‐SADS; Kaufman 1997)) or, where this was not available, using a predesignated cut‐off point on a continuous measure of depression symptoms likely to be correlated with the presence of a depressive disorder therefore indicating 'caseness' (e.g. the Children's Depression Inventory (CDI; Kovacs 1992).Depression symptoms at the post‐intervention assessment point assessed using a standardised, validated self‐report measure of depression symptoms (e.g. CDI; Kovacs 1992).
primary outcome:
Routine use of patient reported outcome measures (PROMs) for improving treatment of common mental health disorders in adults
Studies that met the above inclusion criteria were included regardless of whether they reported on the following outcomes.
primary outcome:
Fluphenazine (oral) versus atypical antipsychotics for schizophrenia
We divided outcomes into short term (up to 12 weeks), medium term (13 to 26 weeks) and long term (over 26 weeks).
primary outcome:
Pharmacological interventions for clozapine‐induced sinus tachycardia
The primary measure of efficacy is clinical improvement in pulse rate, measured either as a dichotomous outcome (proportions of patients with treatment response as defined by each of the studies), or as a continuous outcome (reported either as an endpoint score or change in pulse rate from baseline to endpoint).
primary outcome:
Psychosocial interventions for self‐harm in adults
The primary outcome measure in this review was the occurrence of repeated SH (defined above) over a maximum follow‐up period of two years. Repetition was identified through at least one of the following: self‐report, collateral report, clinical records, or research monitoring systems. As we wished to incorporate the maximum amount of data from each trial, we included both self‐reported and hospital records of SH where available. We also assessed frequency of repetition of SH.2.15 Repetition of SHThere was evidence of a significant treatment effect for DBT‐oriented therapy for repetition of SH by post‐treatment assessment (Analysis 2.1; 1/12 vs 8/12; OR 0.05, 95% CI 0.00 to 0.49; k = 1; N = 24). This result had low quality evidence (see summary of findings Table 2).Data on number of repeat episodes of SH, obtained by correspondence, also suggest a significant treatment effect for DBT‐oriented therapy by the post‐treatment assessment (Analysis 2.5; mean 0.75, SD 1.23, n = 12 vs mean 5.58, SD 5.28, n = 12; MD ‐4.83, 95% CI ‐7.90 to ‐1.76; k = 1; N = 24). Once again, however, a low quality of evidence was associated with this outcome (see summary of findings Table 2).
primary outcome:
Chlorpromazine versus reserpine for schizophrenia
We divided outcomes into short term (up to 6 months), medium term (7‐12 months) and long term (over 12 months). We planned to include follow‐up studies.
primary outcome:
Psychological therapies for panic disorder with or without agoraphobia in adults: a network meta‐analysis
Short‐terma remissionb of panic disorder with or without agoraphobiaShort‐term responsec of panic disorder with or without agoraphobiaDropouts for any reason in the short term (as a proxy for treatment acceptability)
primary outcome:
Chlorpromazine versus atypical antipsychotic drugs for schizophrenia
If possible, we divided outcomes into short term (up to six months), medium term (seven to 12 months) and long term (over one year).
primary outcome:
Psychological therapies for post‐traumatic stress disorder and comorbid substance use disorder
1. Severity of traumatic stress symptoms using a standardised measure such as the Clinician Administered PTSD Symptom Scale (CAPS) (Blake 1995), the Impact of Event Scale (Horowitz 1979), the Davidson Trauma Scale (Davidson 1997), or the Post‐Traumatic Diagnostic Scale (Foa 1997a). In circumstances where an individual study utilised both a clinician‐administered and a self report measure, primacy was given to outcomes using the clinician‐administered measure, as such measures are considered to provide the 'gold standard' in the traumatic stress field (for example Foa 1997b).2. Reduction in drug use, alcohol use, or both as measured by a standardised measure such as the Addiction Severity Index (ASI) (McLellan 1992), the Substance Use Inventory (Weiss 1995b), the Opiate Treatment Index (Darke 1992), the Severity of Drug Dependence Scale (Gossop 1995), or the Substance Abuse Module (Haro 2006), or biological markers of drug and alcohol use, such as urine, saliva, and hair analysis, or self reported days of substance use/abstinence within a specified period such as the Timeline Followback Interview (Sobell 1995). There is less consensus about gold‐standard outcomes in the addiction field. We prioritised outcomes in the order of standardised instruments, followed by biological markers, followed by self report measures.3. Treatment completion as measured by number of participants who were identified as treatment completers by study authors. We undertook to interpret drop‐out data with caution, as it is recognised that participants can withdraw from studies for various and complex reasons and reported drop‐out can be influenced by experimental factors related to practice of the research team (Loke 2011).
primary outcome:
Therapist‐supported Internet cognitive behavioural therapy for anxiety disorders in adults
Efficacy of therapist‐supported ICBT in leading to clinically important improvement in anxiety as determined by a diagnostic interview, for example, the SCID‐I (First 2002) or the Anxiety Disorders Interview Schedule (ADIS‐IV) (DiNardo 1994) or a defined cut‐off on a validated scale, for example, the Yale Brown Obsessive Compulsive Scale (YBOCS) (Goodman 1989). In case the Clinical Global Impression scale change or improvement items (CGI) (Guy 1976) were used, we employed a score of 1 = 'very much' or 2 = 'much improved' to indicate clinically important improvement.Efficacy of therapist‐supported ICBT in leading to reduction in anxiety symptom severity measured by scores on a validated, observer‐rated instrument, for example, the Hamilton Anxiety Rating Scale (Hamilton 1959), or a validated self‐report measure of: (a) disorder‐specific symptoms, for example, the Social Phobia Scale (SPS) (Mattick 1998), and (b) anxiety symptoms in general, for example, the Beck Anxiety Inventory (BAI) (Beck 1991).
primary outcome:
Interventions for preventing delirium in hospitalised non‐ICU patients
Incidence of delirium, using a validated diagnostic method
primary outcome:
Antiglucocorticoid and related treatments for psychosis
We grouped outcomes into immediate (under two weeks), short‐term (two to 12 weeks) and long‐term (over 12 weeks).
primary outcome:
Statins for the prevention of dementia
Objective diagnosis of dementia.Objective diagnosis of AD according to standard criteria.Objective diagnosis of VaD according to standard criteria.Change in Mini Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale ‐ Cognition (ADAS‐Cog) or other accepted objective and standardised tests of cognitive performance in people at risk of AD/VaD on treatment with statins.Incidence and severity of adverse effects.
primary outcome:
Interventions for self‐harm in children and adolescents
The primary outcome measure in this review was the occurrence of repeated SH (defined above) over a maximum follow‐up period of two years. Repetition was identified through self‐report, collateral report, clinical records, or research monitoring systems. As we wished to incorporate the maximal amount of data from each trial, we included both self‐reported and hospital records of SH where available. We report both proportions of participants repeating SH and frequency of repeat episodes.
primary outcome:
Zuclopenthixol versus placebo for schizophrenia
We defined the outcome periods depending on the type of formulation of zuclopenthixol. However, we only found trial data for Zuclopenthicxol dihydrochloride and only for short‐term use. For zuclopenthixol decanoate and dihydrochloride, we had predefined trial duration as short term for those between zero and 12 weeks, medium term as those between 13 to 26 weeks and long term as those longer than 26 weeks. For zuclopenthixol acetate, given that the indications for its use are different and it has a different half life, we considered trials as being short term if the duration was between zero to six hours, medium term from seven to 36 hours, and long term greater than 36 hours.
primary outcome:
Pharmacotherapy for chronic cognitive impairment in traumatic brain injury
• Global severity of cognitive impairment• Memory performance on psychometric tests• Performance on neuropsychological tests that evaluate other aspects of cognitive functioning• Scores on screening measures assessing cognitive function or general severity of cognitive impairment (e.g. mini–mental state examination (MMSE), Cambridge cognitive assessment (CAMCOG), Alzheimer disease assessment scale‐cognitive (ADAS‐Cog) or clinical dementia rating (CDR) scale• Clinical global impression of change
primary outcome:
Asenapine versus placebo for schizophrenia
Where possible, we divided outcomes into short‐term (up to 12 weeks), medium‐term (13 weeks to 26 weeks) and long‐term (over 26 weeks).
primary outcome:
Lithium for schizophrenia
We grouped all outcomes into short‐term (up to 12 weeks), medium‐term (13 to 26 weeks), and long‐term (over 26 weeks).
primary outcome:
Cognitive behavioural therapy (brief versus standard duration) for schizophrenia
All outcomes were to be divided into short‐term (within 6 months of the onset of therapy), medium‐term (within 6 to 12 months of the onset of therapy) and long‐term (over 12 months since the onset of therapy).
primary outcome:
Rivastigmine for Alzheimer's disease
In the original protocol and during the review, we looked for all the following outcomes:
primary outcome:
Endoscopic third ventriculostomy (ETV) for idiopathic normal pressure hydrocephalus (iNPH)
Postoperative change in clinical signs and symptoms of iNPH measured using validated assessment tools. These were divided into:short‐term outcomes (up to and including six months);long‐term outcomes (measured more than six months postoperatively);Postoperative complications, perioperative mortality and morbidity rates.
primary outcome:
Individual psychological therapy in the outpatient treatment of adults with anorexia nervosa
1. Weight: mean BMI (weight in kg/height² in metres) at end of treatment where groups were not significantly different in mean BMI at start of treatment.2. Recovery is a dichotomous outcome according to the Morgan 1975 narrow scale of a good outcome (normal body weight > 85% of average for age, gender and height, with normal menstruation) or intermediate outcome (normal body weight > 85% of average for age, gender and height with no menstruation) versus poor outcome or similar categorical outcome.3. Proportion of treatment dropouts or non‐completers for any reason.
primary outcome:
Pharmacological interventions for self‐harm in adults
The primary outcome measure in this review was the occurrence of repeated SH (defined above) over a maximum follow‐up period of two years. Repetition was identified through self‐report, collateral report, clinical records, or research monitoring systems. As we wished to incorporate the maximal amount of data from each trial, we included both self‐reported and hospital records of SH where available. We also assessed frequency of repetition of SH at final follow‐up.
primary outcome:
Treatments for delusional disorder
As delusional disorder is potentially a long‐term condition, we considered outcomes with respect to the long term as well as the short term. We divided all outcomes into short‐term (less than six months), medium‐term (seven to 12 months) and long‐term (over one year).
primary outcome:
Opioids for agitation in dementia
The primary outcome was reduction in agitation at the end of the scheduled follow‐up. We specified that the endpoint should be assessed by recognised measures of agitation, such as the Cohen‐Mansfield Agitation Inventory (Cohen‐Mansfield 1989) or the NPI (Cummings 1994), and defined by change from baseline or final value scores, or the patient no longer meeting the criteria for significant agitation (however defined).We considered measures of safety and acceptability of treatment including the incidence of adverse effects (to include mortality, nausea and vomiting, constipation, dry mouth, sedation, confusion, mood changes, hallucinations etc.) and dropout rates, and reasons for withdrawal.Primary outcomes are to be included in a 'summary of findings' table.
primary outcome:
Augmentation of cognitive and behavioural therapies (CBT) with d‐cycloserine for anxiety and related disorders
1. Treatment efficacy: treatment responders as defined by each study, for instance using the Clinical Global Impressions scale ‐ Improvement item (CGI‐I), a widely used global outcome measure (Guy 1976).2. Treatment acceptability: withdrawals from treatment, indicating the number of participants who dropped out of cognitive and behavioural therapies for any reason. This served as a surrogate measure of treatment acceptability in the absence of other more direct indicators of acceptability.All primary outcome measures were binary in nature.
primary outcome:
Psychoeducation for siblings of people with severe mental illness
Since psychoeducation usually aims to impact on outcomes ranging from immediate changes (such as changes in knowledge) to changes in more intricate behavioural and attitudinal outcomes that may take longer to change, we planned to treat all outcomes as either short term (less than one month), medium term (two to five months) or long term (more than six months) following completion of the psychoeducational intervention.
primary outcome:
Aerobic exercise to improve cognitive function in older people without known cognitive impairment
The primary outcome measurement was cognitive function, tested with a neuropsychological test (sensitive to changes in cognitive function in adults) or test battery (a combination of several neuropsychological tests).
primary outcome:
Latrepirdine for Alzheimer's disease
Clinical global impression of change (Clinician's Interview ‐ Based Impression of Change Plus Caregiver Input (CIBIC‐Plus), Alzheimer's Disease Cooperative Study‐Clinical Global Impression of Change (ADCS‐CGIC))Cognitive function (Alzheimer’s Disease Assessment Scale cognitive subscale (ADAS‐Cog), Mini‐Mental State Examination (MMSE), Severe Impairment Battery (SIB))
primary outcome:
Debriefing interventions for the prevention of psychological trauma in women following childbirth
1. Prevalence of psychological trauma. The Impact of Event Scale (IES) (Horowitz 1979; Sundin 2002) is the most widely used validated instrument to measure the presence of symptoms of psychological trauma. When IES data were unavailable, data on any comparable scales, such as the Clinician Administered PTSD Scale (Blake 1995), were used.
primary outcome:
Psychoeducation (brief) for people with serious mental illness
We divided all outcomes into short term (up to 12 weeks), medium term (13‐52 weeks) or long term (over 52 weeks), and were interpreted as defined by each of the studies.
primary outcome:
Perphenazine for schizophrenia
We divided all outcomes into short‐term (less than three months), medium‐term (three to six months) and long‐term follow‐up (longer than six months).
primary outcome:
Cholinesterase inhibitors for rarer dementias associated with neurological conditions
Cognition (measured by psychometric tests, including tests of single cognitive domains as well as multi‐domain scales and neuropsychological test batteries).Clinical global impression of change (measured by scales or by the physician's or participant's self‐reported impression of any change).Global severity of dementia.Activities of daily living (measured by scales such as Alzheimer's Disease Co‐operative Study ‐ Activities of Daily Living Scale).Adverse effects.
primary outcome:
Cognitive behavioural therapy for anxiety disorders in children and adolescents
Remission ‐ the absence of a diagnosis of an anxiety disorder, as diagnosed by reliable and valid structured interviews for DSM or ICD child and adolescent anxiety disorders, including:Anxiety Disorder Interview Schedule for Parents (ADIS‐P) (Silverman 1987).Anxiety Disorder Interview Schedule for Children (ADIS‐C) (Silverman 1987).Diagnostic Interview Schedule for Children, Adolescents and Parents (DISCAP) (Holland 1995).Acceptability, as determined by the numbers of participants who were lost to follow‐up.
primary outcome:
Fluphenazine decanoate (depot) and enanthate for schizophrenia
1. Death and all causes of mortality2. Clinical global state
2.1 Relapse
2.2 Clinically significant change in global state ‐ as defined by each of the studies3. Leaving the study early4. Service utilisation outcomes
4.1 Hospital admission
primary outcome:
Pharmacotherapy for anxiety and comorbid alcohol use disorders
Clinical treatment response. The number of responders versus non‐responders was determined from the Clinical Global Impressions scale ‐ Improvement item (CGI‐I) (or closely related measure), a widely used global outcome measure (Guy 1976). Responders are defined on the CGI‐I as those with a score of 1 = 'very much' or 2 = 'much' improved.Reduction of symptom severity determined from a variety of validated continuous outcome measures, such as the Liebowitz Social Anxiety Scale (LSAS) (Liebowitz 1987), the Clinician Administered PTSD Scale (CAPS) (Blake 1990), the Hamilton Anxiety scale (HAM‐A) (Hamilton 1959), and the Panic Disorder Severity Scale (PDSS) (Shear 1997).Acceptability of medication determined by the total proportion of participants who withdrew from RCTs due to treatment‐emergent adverse events, which is a surrogate measure used in the absence of other more direct indicators of acceptability. This quantitative measure of the acceptability of medication was supplemented with a narrative review of the most common drug‐related adverse events for both the included and excluded studies (defined as those occurring in at least 10% of the participants given medication), as well as significant differences in the rate of occurrence of drug‐related adverse events between medication and control groups.
primary outcome:
Haloperidol versus first‐generation antipsychotics for the treatment of schizophrenia and other psychotic disorders
Global state: Clinically important response to treatment.If presented, we used a cut‐off of at least 50% reduction of the baseline value of a rating scale such as the 'Positive and Negative Syndrome Scale' (PANSS; Kay 1987) or the 'Brief Psychiatric Rating Scale' (BPRS; Overall 1962), because studies showed that this definition is clinically meaningful (Leucht 2005a; Leucht 2005b; Leucht 2006). Otherwise we, used the definition of the original studies.
primary outcome:
Antidepressant treatment for postnatal depression
Response or remission of depression, using defined dichotomous response, remission or improvement as reported in the individual studies.Adverse events (or side effects) experienced by:mother (e.g. headaches, diarrhoea, nausea);nursing baby (e.g. respiratory depression, poor sleep, poor feeding).
primary outcome:
Flupenthixol versus low‐potency first‐generation antipsychotic drugs for schizophrenia
We analysed the outcomes for different lengths of follow‐up: up to three months, six months or more than six months.
primary outcome:
Fluphenazine versus low‐potency first‐generation antipsychotic drugs for schizophrenia
All outcomes were grouped into short term (up to 12 weeks), medium term (up to six months) and long term (longer than six months)
primary outcome:
Alternating current cranial electrotherapy stimulation (CES) for depression
Primary benefit outcome: differences in change scores between intervention and control groups on validated rating scales such as the following:Observer‐rated depression rating scale such as the Montgomery‐Asberg Depression Rating Scale (MADRS) (Montgomery 1979) and the Hamilton Rating Scale for Depression (HAM‐D) (Hamilton 1960).Self‐rated depression scale such as the Beck Depression Inventory (BDI) (Beck 1988; Beck 1993).Primary harm outcome: differences in rates of discontinuation due to adverse events between active treatment and control groups.
primary outcome:
Pharmacological interventions for preventing post‐traumatic stress disorder (PTSD)
1. Treatment efficacy: we determined treatment efficacy from the number of participants who developed PTSD after a minimum period of three months after the traumatic event (APA 1994). We determined diagnosis according to the relevant DSM‐IV criteria (APA 1994), as implemented in scales such as the Clinician‐Administered PTSD Scale (CAPS) (Blake 1995), and the Comprehensive International Diagnostic Interview (CIDI) (WHO 1997). We also accepted outcomes from studies assigning a probable diagnosis of PTSD using the Posttraumatic Stress Symptom 10 Questionnaire Inventory (PTSS‐10), given evidence that this measure has moderate to high (77%) sensitivity and excellent (97.5%) specificity in diagnosing clinically confirmed cases of PTSD (Weisaeth 1989).2. Treatment acceptability: we included the total proportion of participants who withdrew from the RCTs due to treatment‐emergent side effects in the analysis as a surrogate measure of treatment acceptability, in the absence of other more direct indicators of acceptability.3.1 Treatment efficacy: number of participants who developed PTSDThere was no evidence in the single trial of escitalopram that medication was more effective than placebo in preventing the onset of PTSD, with 13/21 (61.9%) of participants receiving medication and 10/18 (55.6%) in the placebo group meeting diagnostic criteria at the five‐month assessment (P value > 0.05) (Shalev 2012). Similar results were reported for the nine months post‐trauma assessment (8/19 (42.1%) versus 8/17 (47.1%), respectively).
primary outcome:
Flupenthixol decanoate (depot) for schizophrenia or other similar psychotic disorders
Outcomes were grouped into immediate (zero to five weeks), short term (six weeks to five months), medium term (six months to 12 months) and longer term (over 12 months).
primary outcome:
Pericyazine for schizophrenia
Where possible, outcomes were made dichotomous by dividing them into two categories ‐ 'clinically significant change' and 'no clinically significant change'. All outcomes were reported for the short term (up to six weeks), medium term (seven to 26 weeks) and long term (over 26 weeks).
primary outcome:
Carbamazepine for schizophrenia
No clinically important response to treatment (at least 50% reduction of overall symptoms or at least much improved)
primary outcome:
Different regimens of intravenous sedatives or hypnotics for electroconvulsive therapy (ECT) in adult patients with depression
Remission of depressive symptoms (risk and score reduction) (using validated international scales for measures of depressive symptoms) (see Table 1).ECT‐induced seizure electroencephalogram (EEG) duration (time in seconds).ECT‐induced seizure motor duration (time in seconds) (muscular contractions observed and measured by stopwatch–hand/limb‐cuff method).Anaesthesia‐related mortality and morbidity (lung aspiration, cardiac arrest, severe allergy).
primary outcome:
Sulpiride versus placebo for schizophrenia
As schizophrenia is often a lifelong illness, and sulpiride is used as an ongoing treatment, outcomes were grouped according to time periods: short‐term (less than three months), medium‐term (3 to 12 months) and long‐term (more than one year).
primary outcome:
General physical health advice for people with serious mental illness
For the purposes of this review we divided outcomes into four time periods, i. immediate (within one week) ii. short term (one week to six months) iii. medium term (six months to one year) and, iv. long term (over one year).
primary outcome:
Metal protein attenuating compounds for the treatment of Alzheimer's dementia
Cognitive function (as measured by psychometric tests)
primary outcome:
Physical health care monitoring for people with serious mental illness
For the purposes of this review we divided the outcomes into four time periods: i. immediate (within one week), ii. short term (one week to six months), iii. medium term (six months to one year), and iv. long term (over one year).
primary outcome:
Respite care for people with dementia and their carers
The primary outcome for this review was rate of institutionalisation.None of the three studies that compared respite care with no respite care reported on the rate of institutionalisation, which was the primary outcome of this review.The study that compared respite care with polarity therapy did not report on the rate of institutionalisation.
primary outcome:
Perazine for schizophrenia
As schizophrenia is often a lifelong illness and perazine is used as an ongoing treatment, we grouped outcomes according to time periods: short term (up to three months), medium term (three months to one year) and long term (more than one year).
primary outcome:
Chlorpromazine versus placebo for schizophrenia
We classified these outcomes as primary outcomes for the 2002 update to help minimise the potential for multiple statistical testing that could be undertaken within sensitivity analyses. We tried to choose these on the grounds of clinical importance and were helped in this by inclusion of a new co‐reviewer, JR, who was not as familiar with the data as the previous authors. We have used the same outcomes but rearranged into new sub‐headings for this 2012 update.
primary outcome:
Aripiprazole versus other atypical antipsychotics for schizophrenia
We grouped outcomes into the short term (up to 12 weeks), medium term (13‐26 weeks) and long term (over 26 weeks).
primary outcome:
Anticholinergic medication for non‐clozapine neuroleptic‐induced hypersalivation in people with schizophrenia
All outcomes were to be divided into short‐term (within three months), medium‐term (3 to 12 months) and long‐term (longer than one year).
primary outcome:
Agomelatine versus other antidepressive agents for major depression
the number of participants who responded to treatment, showing a reduction of at least 50% on the Hamilton Rating Scale for Depression (HAM‐D) (Hamilton 1960), the Montgomery Asberg Depression Rating Scale (MADRS) (Montgomery 1979), or any other depression scale (e.g. the Beck Depression Inventory (Beck 1987), or the CES‐D scale (Radloff 1977)); or were 'much or very much improved' (score 1 or 2) on the Clinical Global Impression‐Improvement (CGI‐I) (Guy 1976).
primary outcome:
Quetiapine versus other atypical antipsychotics 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:
Haloperidol versus placebo for schizophrenia
We also grouped outcomes into immediate (up to six weeks), short (six weeks to six months), medium (six months to one year), and long (over one year) term.
primary outcome:
Pimozide for schizophrenia or related psychoses
As schizophrenia is often a life‐long illness and pimozide is used as an ongoing treatment, we grouped outcomes according to time periods: short term (<3 months), medium term (3 to 12 months) and long term (>1 year).
primary outcome:
Dietary supplements for preventing postnatal depression
an estimate of depression as measured by investigators using any of the following: screening instruments such as the Edinburgh Postnatal Depression Scale (EPDS) (Cox 1987a), Hamilton or Beck Depression Inventory (Beck 1961; Hamilton 1960), the Montgomery‐Asberg scale (Montgomery 1979); oruse of standard observer‐rated depression symptom scales by a recognised diagnostic scheme, e.g. DSM IV‐TR (APA 2000), ICD10,(WHO/DIMDI 2006) or by other standardised criteria such as the Research Diagnostic Criteria (Spitzer 1978).
primary outcome:
Valproic acid, valproate and divalproex in the maintenance treatment of bipolar disorder
study withdrawal due to recurrence of any mood episode;admission to hospital: (i) time to next admission; (ii) number of admissions during trial period;institution of additional treatment for affective episode and time to institution; andnumber of episodes during the trial period.
primary outcome:
Atypical antipsychotics for psychosis in adolescents
We divided all outcomes into short term (less than six months), medium term (seven to 12 months) and long term (over one year).
primary outcome:
Exercise for depression
1. Our primary outcome was a measure of depression or mood at the outcome assessment, either as a continuous measure or as a dichotomous outcome.Continuous measures of depression were reported using a variety of depression scales, the most common of which were the Beck Depression Inventory (Beck 1961) and the Hamilton Rating Scale for Depression (Hamilton 1960).In previous versions of the review, where trials used a number of different tools to assess depression, we included the main outcome measure only in the meta‐analysis. The main outcome measure was defined using a hierarchy of criteria as follows: identified by the trial authors as the main outcome measure, outcome reported in the abstract, first outcome reported in the Results section.Where trials used dichotomous data as primary outcomes, and also provided data on continuous outcome measures, we used the data provided in the trial reports for the continuous outcome measure in our meta‐analysis. This was because we knew from previous updates that trials generally reported only continuous outcomes.
primary outcome:
Driving assessment for maintaining mobility and safety in drivers with dementia
Our primary outcome was the number of people who remain driving after assessment compared to the control or placebo group. A second primary outcome was the number of road traffic accidents (RTAs) after assessment.
primary outcome:
Cognitive training and cognitive rehabilitation for mild to moderate Alzheimer's disease and vascular dementia
For each of the outcomes described previously, we intended to conduct separate comparisons for those measured short term (immediately post‐intervention), medium term (3 to 12 months post‐intervention) and long term (> 12 months post‐intervention). However, no study reported relevant outcomes beyond the medium term.
primary outcome:
Flow‐regulated versus differential pressure‐regulated shunt valves for adult patients with normal pressure hydrocephalus
Death from any cause.Participants with one or more serious adverse events (SAEs) including and excluding all‐cause mortality, defined according to International Conference of Harmonization of Good Clinical Practice (ICH‐GCP) for devices. Additionally, we will include complications and adverse events specific for hydrocephalus shunt systems, such as (1) clinical and radiological signs of shunt obstruction; (2) computed tomography (CT)‐ or x‐ray－confirmed shunt disconnection; and (3) clinical and radiological signs of overdrainage including subdural hematoma.Worsening of clinical symptoms of NPH (triad of gait disturbance, urinary incontinence, and subcortical cognitive problems (dementia)).Quality of life (QOL), measured with any score.
primary outcome:
Rivastigmine for vascular cognitive impairment
The review assessed the following outcomes:
primary outcome:
Quetiapine versus typical antipsychotic medications for schizophrenia
We grouped outcomes into the short term (up to 12 weeks), medium term (13‐26 weeks) and long term (over 26 weeks).
primary outcome:
Intermittent phototherapy versus continuous phototherapy for neonatal jaundice
Rate of decline of serum bilirubin (micromol/L/h)Bilirubin‐induced brain dysfunction (defined as either the pathological finding of deep‐yellow staining of neurons and neuronal necrosis of the basal ganglia and brainstem nuclei or acute or chronic neurological deficit including athetoid cerebral palsy, impaired upward gaze and deafness or isolated conditions, such as auditory neuropathy or dyssynchrony)
primary outcome:
Volume‐targeted versus pressure‐limited ventilation in neonates
Death, defined in two ways:death before discharge from the primary hospital;death before two years' corrected age.Death or BPD (BPD defined as need for supplemental oxygen requirement), assessed at two time points:BPD at 28 days or death prior to 28 days;BPD at 36 weeks' postmenstrual age or death prior to 36 weeks' postmenstrual age.
primary outcome:
Early planned removal of umbilical venous catheters to prevent infection in newborn infants
Incidence of bloodstream infection confirmed by culture of blood sampled from peripheral sites (not from indwelling catheters) during hospital admission. When data were available, we excluded cases in which infection was attributed to diphtheroids, micrococci, Propionibacteriaceae, or mixed microbial flora. When sufficient data were available, we examined the effect on infection with:coagulase‐negative staphylococci;other bacteria (Gram‐negative bacilli, Staphylococcus aureus, enterococci); orfungi.
primary outcome:
Cerebral near‐infrared spectroscopy monitoring for prevention of brain injury in very preterm infants
All‐cause mortality: neonatal mortality (death during the first 28 days of life) and during the first year of life.Major neurodevelopmental disability.Cerebral palsy.Severe neurodevelopmental impairment as evaluated by validated developmental assessment tool, e.g. more than 2 standard deviations (SD) below the mean in Bayley Scales of Infant Development.Blindness (vision < 6/60 in both eyes).
primary outcome:
Sildenafil for pulmonary hypertension in neonates
Haemodynamic parameters (absolute values and change from baseline measured after the first dose, after 24 hours, after 30 hours, after 36 hours, after 42 hours, and at the end of treatment)Pulmonary arterial pressure (PAP) in mmHgOxygenation (PaO2) or FiO2 requirementCardiac output in L/kg/minMean arterial blood pressure in mmHgAll‐cause mortality within the first 28 days of life (neonatal mortality)
primary outcome:
Fluid supplementation for neonatal unconjugated hyperbilirubinaemia
Incidence of acute bilirubin encephalopathy (defined as acute clinical manifestations of bilirubin toxicity seen in the first weeks after birth, which was characterised by signs of irritability and hypertonia, with early retrocollis and opisthotonus, together with anyone of the following: drowsiness, poor feeding, alternating tone, high‐pitched cry, or a failed auditory brainstem response hearing screen).Incidence of kernicterus (defined as the long‐term sequelae of bilirubin toxicity, which was characterised by extrapyramidal movement disorders, gaze abnormalities, auditory disturbances, intellectual deficits, and the posticteric sequelae of enamel dysplasia of the deciduous teeth) (Johnson 2002; AAP 2004).Proportion of infants with moderate or severe cerebral palsy, defined as a non‐progressive disorder with abnormal muscle tone in at least one arm or leg that was associated with abnormal control of movement or posture and a modified Gross Motor Function Classification System (GMFCS) score (Palisano 2008) of 2 or greater (Rosenbaum 2007), measured at predefined intervals (e.g. at 6, 12, 18, and 24 months). We included results from individual assessments that measured other specific aspects of neurodevelopmental outcome, if available, as secondary outcomes (see eighth to 11th Secondary outcomes).
primary outcome:
Saline irrigation for the management of skin extravasation injury in neonates
Complete tissue healing (defined as no residual breach of skin or inflammatory signs) without scar formation at discharge or latest assessment, preferably at least three months from the time of injury, as complete wound healing is expected by this time.
primary outcome:
Antibiotics for neonates born through meconium‐stained amniotic fluid
The primary outcome was incidence of sepsis in the first 28 days (symptomatic neonate was considered to have sepsis if blood or cerebrospinal fluid (CSF) culture was positive for bacterial organisms). We planned to classify this outcome into two groups.
primary outcome:
Orotracheal intubation in infants performed with a stylet versus without a stylet
Rate of successful first attempt at orotracheal intubationAn attempt was defined as introduction of the ETT into the infant's mouth after laryngoscopy. Successful placement within the tracheobronchial tree was confirmed immediately post intubation attempt, objectively, through a predetermined method, for example, by observation of colour change on an exhaled colorimetric carbon dioxide detector, misting within the ETT, or auscultation of the chest.
primary outcome:
Clonidine for sedation and analgesia for neonates receiving mechanical ventilation
All‐cause neonatal death (death within 28 days of birth)All‐cause death during initial hospitalizationDuration of mechanical ventilation (days)
primary outcome:
Effects of targeting lower versus higher arterial oxygen saturations on death or disability in preterm infants
Composite outcome of death or major disability by 18 to 24 months corrected for gestational age (aligned definition, trialist defined)
primary outcome:
Repeated lumbar or ventricular punctures in newborns with intraventricular haemorrhage
Placement of a hydrocephalus shunt.Death prior to 12‐month follow‐up.Major disability in survivors.Multiple disability in survivors.Death or disability.Death or shunt.
primary outcome:
Frenotomy for tongue‐tie in newborn infants
Infant feeding assessed within 48 hours, within two to seven days and after seven days following the procedure with the use of a validated scale such as the LATCH score (Jensen 1994) or the Infant Breastfeeding Assessment Tool (IBFAT) (Mathews 1988). The LATCH is a scoring system that assesses latch, swallowing, maternal nipple, maternal comfort and assistance the mother needs to position the infant. Each area gets a score between 0 and 2 with a total possible score of 10. The IBFAT assesses readiness to feed, rooting, fixing (latching on) and sucking. Each item is scored between 0 and 3, and a score of 10 to 12 represents successful breastfeeding. Bottle‐feeding will be assessed within 48 hours, within two to seven days and after seven days following the procedure, subjectively, by reports of more efficient sucking and less drooling
primary outcome:
Neonatal vitamin A supplementation for the prevention of mortality and morbidity in term neonates in low and middle income countries
All‐cause infant mortality at six months and 12 months
primary outcome:
Skin‐to‐skin care for procedural pain in neonates
Behavioural indicators (audible cry duration in seconds or milliseconds; audible crying time as a proportion of total procedure time; proportion of time of total procedure that had predefined facial actions reflecting grimace e.g. brow bulge, eye squeeze, nasolabial furrow; proportion of time that had predefined body movements e.g. limb thrashing, fisting, finger splaying, limb and torso flexion).Physiological indicator changes from baseline or between groups in heart rate (HR), respiratory rate, oxygen (O₂) saturation/transcutaneous oxygen tension (tcpO₂), and near‐infrared spectroscopy (NIRS). These measures should be reported before the tissue‐damaging part of the procedure, during the procedure, and in the time to recovery following the procedure.Hormonal indicators (salivary cortisol, serum beta‐endorphins) obtained from body fluids (saliva, serum) with description of analyses e.g. radio‐immune assay techniques.Validated composite pain scores (including a combination of behavioural, physiological, and contextual indicators). There are over 50 measures of pain in neonates in the literature. The ones that we assessed as being valid for neonates undergoing procedural pain include:Premature Infant Pain Profile (PIPP) (Stevens 1996; Stevens 2010). The PIPP includes gestational age, behavioural state, heart rate, oxygen saturation, and three facial reactions (brow bulge, eye squeeze, and nasolabial furrow). The range is 0 to 21 with a score of 6 indicating pain.COMFORT scale (van Dijk 2000). This scale measures alertness, calmness, respiratory response or crying, physical movement, muscle tone and facial tension, and separate latent variables for heart rate (HR) baseline and mean arterial blood pressure baseline (MAP).Behavioral Indicators of Infant Pain (BIIP) (Holsti 2007). The BIIP combines sleep and wake states, five facial actions and two hand actions.Neonatal Infant Pain Scale (NIPS) (Lawrence 1993). The NIPS includes facial expression, cry, breathing pattern, arms, legs, state of arousal.Neonatal Pain, Agitation, and Sedation Scale (N‐PASS) (Hummel 2008; Hummel 2010). N‐PASS was originally developed to measure ongoing pain but has recently been validated as a measure of acute pain. It includes crying and irritability, behaviour and state, facial expression, extremities and tone, and vital signs (heart rate, respiratory rate, blood pressure, oxygen saturation). It also has scores that rate sedation as well as pain and agitation.Douleur Aiguë du Nouveau‐né (DAN) (Carbajal 1997). The scale scores pain with a range from 0 to 10 with three items: facial expression, limb movements, and vocal expression with ratings per item ranging from 0 to 4, 0 to 3 and 0 to 3, respectively.
primary outcome:
Topical anaesthesia for needle‐related pain in newborn infants
Pain using validated pain score (measured during the procedure, up to one hour following painful procedure or both) such as:NIPS (Lawrence 1993);PIPP (Stevens 1996);Neonatal Facial Action Coding System (Grunau 1987);other validated pain measures.
primary outcome:
Intravenous midazolam infusion for sedation of infants in the neonatal intensive care unit
behavioural measures: facial actions, excitability, muscle tone, physical movements and respiratory behaviour, which may be evaluated by age‐appropriate scoring systems; andphysiological parameters: changes in heart rate, respiratory rate, blood pressure, oxygen saturation and plasma cortisol or catecholamine levels, measured at baseline and at regular intervals during midazolam administration.behavioural measures: facial actions, excitability, muscle tone, physical movements and respiratory behaviour, which may be evaluated by age‐appropriate scoring systems; andphysiological parameters: changes in heart rate, respiratory rate, blood pressure, oxygen saturation and plasma cortisol or catecholamine levels, measured at baseline and at regular intervals during midazolam administration.
primary outcome:
Cromolyn sodium for the prevention of chronic lung disease in preterm infants
Mortality within the study period.Combined outcome of CLD or mortality at 28 days.CLD at 28 days and 36 weeks' PMA.
primary outcome:
Body positioning for spontaneously breathing preterm infants with apnoea
Episodes of apnoea ‐ defined as cessation of breathing for longer than 20 seconds, or a shorter pause but associated with bradycardia or cyanosis (AAP 2003)Episodes of bradycardia ‐ defined as a fall in heart rate to greater than 30% below baseline, or to less than 100 beats per minute, for 10 seconds or longerEpisodes of oxygen desaturation ‐ defined as a spontaneous fall in SpO2 to ≤ 85% for 10 seconds or longer
primary outcome:
Nitric oxide for respiratory failure in infants born at or near term
Death or use of ECMODeath before hospital dischargeUse of ECMO before hospital discharge
primary outcome:
Early administration of inhaled corticosteroids for preventing chronic lung disease in very low birth weight preterm neonates
among all randomised;among survivors.
primary outcome:
Inhaled nitric oxide for respiratory failure in preterm infants
Death before hospital dischargeBronchopulmonary dysplasia (oxygen dependence at 36 weeks' postmenstrual age)Death or bronchopulmonary dysplasia (at 36 weeks' postmenstrual age)Intraventricular haemorrhage (any grade and more severe, grades 3 and 4)
primary outcome:
Heparin for the treatment of thrombosis in neonates
Neonatal death (during first 28 days of life)Failure of resolution of the thrombus on imaging within 30 days after treatment initiationFailure of reperfusion of an affected limb clinically (ie, failure of capillary refill time to return within two seconds, determined by Doppler ultrasonography)
primary outcome:
Infant position in neonates receiving mechanical ventilation
Oxygenation during MV, measured by arterial oxygen tension (PO2), transcutaneous oxygen method (tcPO2), oxy‐haemoglobin saturation measured by a pulse oximeter (SpO2), oxy‐haemoglobin saturation measured by a pulse oximeter/fraction of inspired oxygen ratio (SpO2/FiO2) or arterial oxygen tension/fraction of inspired oxygen ratio (PO2/FiO2)Decrease in characteristics of ventilator: peak inspiratory pressure or mean airway pressure (cm H2O) and fraction of inspiratory oxygen (FiO2)Short‐term pulmonary complications: pneumothorax, pulmonary interstitial emphysema (PIE) or ventilator‐associated pneumonia (VAP)Duration of ventilator supportBronchopulmonary dysplasia (BPD) or chronic lung disease (CLD) at 28 days after birth or at 36 weeks' postmenstrual age, respectivelyChanges in carbon dioxide tension (PCO2)Changes on pulmonary mechanics: tidal volume (TV) or minute ventilationShort‐term complications (accidental extubation; dislodgement of central catheter, urinary or drainage tube)
primary outcome:
Synchronized mechanical ventilation for respiratory support in newborn infants
mortality;air leaks (pneumothorax or pulmonary interstitial emphysema (PIE));severe intraventricular haemorrhage (grades 3 and 4);bronchopulmonary dysplasia (BPD) (oxygen dependency beyond 28 days);moderate/severe BPD (oxygen dependency or respiratory support dependency (or both) at 36 weeks' postmenstrual age);duration of weaning/ventilation.