anurajms/meta_analysis huggingface dataset:
primary outcome:
Adhesives for fixed orthodontic bands
Dichotomous data on the success of each adhesive (whether the metal band stays cemented to the tooth or not) were recorded. Where these data were not available, annualised failure rates of adhesives, i.e. the rate at which the metal bands become detached during treatment, were noted.Dichotomous data on the presence or absence of decay (decalcification) associated with or around the bands were recorded. If data exist on size/area of decalcifications, these were also included.
primary outcome:
Endodontic procedures for retreatment of periapical lesions
One‐year healing of periapical pathosis evaluated by assessment of clinical signs and symptoms (absence of pain, suppuration, swelling) and through two‐dimensional or three‐dimensional radiological examinationAbsence or presence of adverse effects or unexpected sequelae after endodontic surgery (tooth loss, mobility, soft tissue recession, abscess, infection, neurological damage, loss of root sealing material evaluated through radiographs)Patient‐reported outcomes such as postoperative pain and discomfort or completion of an appropriate quality of life measurement during the first week after surgery
primary outcome:
Oral appliances and functional orthopaedic appliances for obstructive sleep apnoea in children
Reduction to less than one episode of apnoea per hour measured by standard polysomnography.
primary outcome:
Oral health education (advice and training) for people with serious mental illness
We planned to divide 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:
Preoperative analgesics for additional pain relief in children and adolescents having dental treatment
Postoperative pain measures (either expressed as intensity of pain or presence or absence of pain)
primary outcome:
Fluoride mouthrinses for preventing dental caries in children and adolescents
Caries increment in permanent tooth surfaces (D(M)FS), reported as change from baseline (and D(M)FT, whenever reported)Caries increment in primary tooth surfaces (d(e)fs), reported as change from baseline (and d(e)ft, whenever reported)
primary outcome:
Infraorbital nerve block for postoperative pain following cleft lip repair in children
Pain measured by valid instruments (e.g. Neonatal Infant Pain Scale (NIPS) (Hudson‐Barr 2002); the Face, Legs, Activity, Cry, Consolability (FLACC) Scale (Merkel 1997))Duration of postoperative analgesiaAdverse events
primary outcome:
Preformed crowns for decayed primary molar teeth
Major failure: this outcome is a composite measure of signs and symptoms leading to diagnosis of irreversible pulpitis or periradicular periodontitis, and so includes one or more of the following; pain, pulp infection, discharging sinus, dental abscess, or periradicular pathology on radiographs. Where that was not discernable from the data, authors were contacted for further details, to allow a sensitivity analysis to be undertaken to investigate the impact of including all restoration failure data as major failures.Pain.Satisfaction with treatment (including satisfaction with aesthetics).
primary outcome:
Interventions for preventing oral mucositis in patients with cancer receiving treatment: oral cryotherapy
Mucositis incidence of any severity. We used mucositis measured on a 0 to 4 point scale (none to severe) and dichotomised it as any mucositis (0 versus 1+), moderate to severe mucositis (0 to 1 versus 2+), and severe mucositis (0 to 2 versus 3+).Some studies measure mucositis using a composite scale. If it was possible to extract the 'mucositis only' data from the total score, we would have included the data in the analyses. If it was not possible, we would have recorded the composite data in an additional table.
primary outcome:
Interventions for treating traumatised ankylosed permanent front teeth
Tooth survival, expressed as the ratio between extracted and non‐extracted teeth at specific time intervals. Regarding implant‐supported crowns, failure can be defined as mobile implants, removal of stable implants dictated by progressive marginal bone loss or infection, implant fractures, or implants which were left 'sleeping' due to wrong alignment (Esposito 2005).Pain, discomfort or aesthetic complaints.Participant satisfaction.
primary outcome:
Magnification devices for endodontic therapy
one year after treatmentbetween one and four years after treatmentmore than four years after treatment.
primary outcome:
Interventions for the management of external root resorption
(1) Change in the amount of root resorption visible on radiological examination.
(2) The number of teeth extracted at any follow‐up period.These additional primary outcomes were considered if studies included patients with acute symptoms:
(1) Pain/discomfort: patient‐assessed using any recognised validated pain scale
(2) Tooth mobility
(3) Infection (abscess, inflammation, fistulae).
primary outcome:
Micro‐invasive interventions for managing proximal dental decay in primary and permanent teeth
Progression of existing carious lesion into enamel or dentine, as detected by radiographs, over a minimum period of six months.Change in decayed, missing and filled (DMF for permanent dentition/dmf for primary dentition) figures at surface, tooth and whole mouth level. Studies were to assess this over a minimum period of six months.
primary outcome:
Parasympathomimetic drugs for the treatment of salivary gland dysfunction due to radiotherapy
The primary outcome measure of the review was xerostomia, that is the subjective sensation of dryness of the mouth.
primary outcome:
Sedation versus general anaesthesia for provision of dental treatment to patients younger than 18 years
Mortality (if any).Completion of treatment: yes or no.Postoperative morbidity.
primary outcome:
Single crowns versus conventional fillings for the restoration of root‐filled teeth
Catastrophic failure of the restored tooth or restoration leading directly to extraction (to include the reasons for failure ‐ endodontic complications, restoration failure, tooth fracture).Non‐catastrophic failure of the restoration requiring further treatment* categorised as i) failure of the restoration; ii) failure of the post.
primary outcome:
Fluoridated milk for preventing dental caries
Changes in caries experience or caries increment, as measured by changes in decayed, missing and filled figures on permanent teeth or surfaces (DMFT or DMFS) or primary teeth or surfaces (dmft or dmfs). Caries was assessed clinically. However, if a combined clinical and radiographic assessment was used, then this was recorded and notedAdverse effects: dental fluorosis
primary outcome:
Fluoride gels for preventing dental caries in children and adolescents
Caries increment in permanent tooth surfaces (D(M)FS), reported as change from baseline (and D(M)FT, whenever reported)Caries increment in primary tooth surfaces (d(e/m)fs), reported as change from baseline (and d(e/m)ft, whenever reported)
primary outcome:
Chlorhexidine treatment for the prevention of dental caries in children and adolescents
Caries increment at the dentine level measured by change from baseline (or final measurement where caries increment was not reported) in the decayed, (missing) and filled surface/teeth (D(M)FS/T) index in all permanent teeth or molar teeth, and d(m)fs/t for primary teeth, erupted at the start and erupting over the course of the study (following Marinho 2004). Caries incidence could also be expressed as the number of children developing caries over the course of the study. The time point of interest was at final follow‐up examination.Mutans streptococci bacteria, measured as a dichotomous outcome: either its presence or absence, or high or low levels.
primary outcome:
Interventions for the cessation of non‐nutritive sucking habits in children
The primary outcome was cessation of the habit.
primary outcome:
Intraoperative local anaesthesia for reduction of postoperative pain following general anaesthesia for dental treatment in children and adolescents
Postoperative pain or distress measures, or both (either expressed as intensity of pain or presence or absence of pain).
primary outcome:
Powered versus manual toothbrushing for oral health
The primary outcome measures employed were quantified levels of plaque or gingivitis or both. Where possible, values recorded on arrival at the assessment were used. If necessary, measures of gingivitis taken after participants had been instructed or permitted to brush their teeth at the assessment visit were used as it was assumed that toothbrushing would not affect gingivitis within such a short period. However, measures of plaque taken after participants had been instructed or permitted to brush their teeth at the assessment visit were not used. It was assumed that plaque scores achieved during toothbrushing under these circumstances would not reflect scores achieved in normal home use.
primary outcome:
Triclosan/copolymer containing toothpastes for oral health
Plaque levels measured using any appropriate scale.Gingival health measured using any appropriate scale.
primary outcome:
Enamel etching for bonding fixed orthodontic braces
Bond failure rate of braces (the rate at which braces fall off the teeth during treatment).
primary outcome:
Interventions for replacing missing teeth: antibiotics at dental implant placement to prevent complications
Implant failure: implant mobility and removal of stable implants dictated by progressive marginal bone loss or infection.Prosthesis that could not be placed, or prosthesis failure if secondary to implant failures.
primary outcome:
Fluoride varnishes for preventing dental caries in children and adolescents
The primary outcome measure in this review was caries increment, as measured by change from baseline in the number of decayed, (missing) and filled permanent surfaces / number of decayed, (extracted/missing) and filled primary surfaces (D(M)FS / d(e/m)fs). Caries is defined here as being recorded at the dentine level of diagnosis. If caries data only reported caries at both dentine and enamel lesions combined then this was used in the analysis (seeData collection and analysis for the different ways of recording caries and reporting the D(M)FT/S / d(m)ft/s scores in permanent and primary teeth in clinical trials of caries preventive interventions).The following outcomes were considered relevant: coronal dental caries and dental fillings, in both the permanent and the primary dentitions, tooth loss, dental pain, specific adverse effects (oral allergic reactions, mucosal irritation, adverse symptoms such as nausea, gagging, vomiting), use of health service resources (such as visits to dental care units, length of dental treatment time).
Studies reporting no dental caries data, reporting only on plaque/gingivitis, calculus, dentine hypersensitivity or fluoride physiological outcome measures (fluoride uptake by enamel or dentine, salivary secretion levels, etc.) were excluded.
primary outcome:
Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood
Treatment efficacy, PTSD symptoms: response to treatment, determined by differences in scores for PTSD symptoms, assessed by independent observer or self‐report. Validated observer‐rated instruments include the Clinician‐Administered PTSD Symptom Scale (Kulka 1988), Clinician‐Administered PTSD Scale (CAPS; Blake 1990; Blake 1995), and the PTSD Symptom Scale ‐ Interview (PSS‐I; Foa 1993). Validated self‐report measures include the PTSD Symptom Scale ‐ Self‐Report (PSS‐SR; Foa 1993), Impact of Event Scale (IES; Horowitz 1979), Impact of Event Scale ‐ Revised (IES‐R; Weiss 1997), and PCL‐5 (Bovin 2016), which is the self‐reported PTSD Checklist for the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM–5; APA 2013).Treatment efficacy, depressive symptoms: response to treatment, determined by differences in scores for depressive symptoms, assessed by independent observer or self‐report measures, including the Hospital Anxiety and Depression Scale (HADS; Zigmond 1983), Beck Depression Inventory (BDI; Beck 1961), Center for Epidemiologic Studies Depression Scale (CES‐D; Radloff 1977), Patient Health Questionnaire (PHQ; Spitzer 1999), and Hamilton Depression Rating Scale (HAM‐D; Hamilton 1960).Treatment acceptability: the number of participants who dropped out of the intervention (as distinct from attrition), including in studies of two intervention types and other assessments of acceptability (e.g. measures of patient/client satisfaction).Adverse effects, such as counts of mortality, completed suicides and attempted suicides, or worsening of symptoms (specifically, group differences on PTSD, depression, self‐harm and suicidality ‐ see below for tools), including those summarised in narrative form, or using a tool such as the Negative Effects Questionnaire (Rozental 2018). We recorded whether or not studies made reference to this outcome.
primary outcome:
Interventions from pregnancy to two years after birth for parents experiencing complex post‐traumatic stress disorder and/or with childhood experience of maltreatment
Parental psychological or socio‐emotional wellbeing:trauma‐related symptoms (including PTSD and CPTSD symptom clusters);psychological wellbeing symptoms (including anxiety symptoms, depression symptoms, other validated measures of psychological wellbeing, or a combination of these);substance use (commenced, recommended, increased, decreased);parents' relationship quality (with partner or significant others); andparental self‐harm (attempted or actual).Parenting capacity:parent–child relationship (e.g. interaction, warmth, attachment, mutual responsivity); andparenting skills (e.g. problem‐solving, coping, self‐efficacy, parent sensitivity and responsiveness).
primary outcome:
Crisis interventions for adults with borderline personality disorder
Death: sudden and unexpected death and death from natural causes in a seemingly healthy individual who is a participant in an RCT or has recently completed an RCTSelf‐harm and suicidality (including dying by suicide), for example, frequency of self‐harm, number of participants reporting self‐harm or mean score on a suicide risk scale such as the Beck Scale for Suicidal Ideation (BSSI; Beck 1979)Violence perpetration, for example, number of participants perpetrating violence or number of incidences of violenceHospital admissions (either mental health admission or general admission), for example, number of nights of inpatient care or number of admissions to hospitalQuality of life assessed on an instrument such as the World Health Organization Quality of Life questionnaire (WHOQOL; WHOQOL 1994), or the EuroQol five‐dimension questionnaire (EQ‐5D; Herdman 2011)
primary outcome:
Medications for daytime sleepiness in individuals with idiopathic hypersomnia
Subjective measure of daytime sleepiness using the Epworth Sleepiness Scale (ESS).
primary outcome:
Immediate‐release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults
Efficacy: changes in symptoms of ADHD (hyperactivity, impulsivity, and inattentiveness), based on clinical assessment by a physician or by self‐report, and measured by any validated clinical scale reported in the trials (e.g. Adult ADHD Self‐Report Screening Scale (Ustun 2017)).Harms: all adverse events, classified as serious or non‐serious, including but not restricted to: cardiovascular, neurological, gastrointestinal, metabolic events, and psychiatric disorders. Serious events were defined as any adverse effect that resulted in death or was life‐threatening, required hospital admission or prolonged hospitalization, caused persistent or significant disability or incapacity, or required intervention to prevent permanent damage to a body structure or impairment of a body function (ICH 2016). See Differences between protocol and review.
primary outcome:
Psychological interventions to foster resilience in healthcare students
Resilience*, measured by improvements in specific resilience scales (Bengel 2012; Earvolino‐Ramirez 2007; Pangallo 2015; Windle 2011b), such as the Resilience Scale for Adults (Friborg 2003).Mental health and well‐being, subsumed into the categories below, and measured by improvements in the respective assessment scales, such as the Depression Anxiety and Stress Scale (DASS‐21; Lovibond 1995). See Appendix 6 for further examples.Anxiety*Depression*Stress or stress perception*Well‐being or quality of life* (e.g. well‐being, life satisfaction, (health‐related) quality of life, vitality, vigour)Adverse events*
primary outcome:
Speech and language therapy for management of chronic cough
Health‐related quality of life (assessed via a validated measure)Serious adverse events
primary outcome:
Amphetamines for attention deficit hyperactivity disorder (ADHD) in adults
Severity of ADHD symptoms, assessed by clinicians and patients using a standardised instrument (e.g. the ADHD Rating Scale‐IV (ADHD‐RS‐IV; DuPaul 1998), Conners' Adult ADHD Rating Scale (CAARS; Conners 1999))
primary outcome:
De‐escalation techniques for managing non‐psychosis induced aggression in adults
Frequency of aggression‐related, serious untoward incidents (including mortality) leading to physical restraint or seclusion, or both, recorded in staff reports or routinely collected dataFrequency of aggression‐related injuries to staff, recorded in staff reports or routinely collected data such as untoward incident forms
primary outcome:
Antidepressants for insomnia in adults
Efficacy: any subjective improvement in sleep quality or satisfaction with sleep, total sleep duration (measured in hours or minutes), sleep onset latency (measured as time taken to fall asleep), number of nocturnal awakenings or total nocturnal awakening time (measured in hours or minutes) or sleep efficiency (measured as a ratio of time asleep to time in bed).Safety: number and type of spontaneously reported and measured adverse events, including reports of toxicity.
primary outcome:
Cognitive‐behavioural interventions for attention deficit hyperactivity disorder (ADHD) in adults
We assessed the core symptoms of ADHD (inattention, hyperactivity and impulsivity) as a whole. If the authors of a study reported these symptoms separately, we included the data in the analysis. We assessed the core symptoms using validated measures such as those listed below.
primary outcome:
Point‐of‐use fortification of foods with micronutrient powders containing iron in children of preschool and school‐age
Anaemia (defined as Hb lower than 110 g/L for children aged 24 to 59 months and lower than 115 g/L for children aged five to 11.9 years, adjusted by altitude where appropriate).*Hb (in grams per litre).*Iron deficiency (defined by using ferritin concentrations less than 15 µg/L).*Ferritin (in micrograms per litre).*All‐cause mortality (number of deaths during the trial).*Diarrhoea (three liquid stools or more per day).*Adverse effects (any, as defined by trialists).
primary outcome:
Methylphenidate for children and adolescents with autism spectrum disorder
Clinical efficacyAn improvement in ADHD‐like symptoms (inattention, impulsivity and hyperactivity), as measured by psychometric instruments or observations of behaviour such as the fourth revision of the Swanson, Nolan and Pelham (SNAP‐IV) questionnaire, Conners' Global Index, and Conners' Parent Rating Scale ‐ Revised (CPRS‐R) (Kollins 2010)An improvement in the core symptoms of ASD (impaired social interaction, impaired communication, and stereotypical behaviours), and overall ASD, as measured by psychometric instruments or observations of behaviour such as the Aberrant Behaviour Checklist (ABC) and the Child Autism Rating Scale (CARS) (Lord 2014)
primary outcome:
Bupropion for attention deficit hyperactivity disorder (ADHD) in adults
Efficacy outcomes.Change in severity of ADHD symptoms from baseline, as assessed by a standardised instrument (participant‐ or investigator‐rated) such as the Wender‐Reimherr Adult Attention Deficit Disorder Scale (WRAADS; Marchant 2013), ADHD Rating Scale (ADHD‐RS; DuPaul 1990) or the Adult ADHD Rating Scale (AARS; Murphy 1996).Proportion of participants achieving a significant clinical improvement. Significant improvement is defined as a reduction of at least 30% in the severity of ADHD symptoms or a score of one or two on the Clinical Global Impression (CGI)‐Improvement scale (NIMH 1984).Any adverse effects.Proportion of participants withdrawn due to any adverse effect (somatic or psychiatric).
primary outcome:
Atypical antipsychotics for disruptive behaviour disorders in children and youths
Aggression: reduction in aggressive behaviour, measured through reduction in scores of validated rating scales.Conduct problems: reduction in conduct problems or disruptive behaviour problems, measured through reduction in scores on relevant validated rating scales or subscales.Adverse events: weight gain (absolute weight gain or changes in body mass index (BMI)) and metabolic parameters (specifically glucose and lipid profiles).
primary outcome:
Task‐oriented interventions for children with developmental co‐ordination disorder
Changes in fine and gross motor function following intervention as measured by standardised performance outcome tests such as the following.Bruininks Oseretsky Test of Motor Performance (BOTMP; Bruininks 1978; Bruininks 2005).McCarron Assessment of Neuromuscular Development (MAND; McCarron 1997).Movement Assessment Battery for Children Test (MABC; Henderson 1992).Test of Gross Motor Development (TGMD; Ulrich 1985; Ulrich 2000).Adverse effects or events: By the very nature of task‐oriented interventions, everyday tasks are performed under closer than usual scrutiny or supervision, or both, and therefore are assumed to be safer than those encountered in everyday life. However, we searched for any reports of adverse events that conceivably could include musculoskeletal injury, falls, or pain.
primary outcome:
Treadmill interventions in children under six years of age at risk of neuromotor delay
Body structure and functions (neuro‐musculoskeletal and movement‐related functions ‐ gait pattern functions):Step frequency (number of alternating treadmill steps per minute, cadence during independent walking); andStep quality (foot doing toe versus flat contact during treadmill stepping).Activity and participation functions:Age of onset of independent walking;Age of onset of walking with assistance;Gross motor function; andAdverse events (such as falls and injuries due to falls).
primary outcome:
Exercise interventions for cerebral palsy
Activity, defined as a person's ability to execute a task (WHO 2001). Examples of outcome measures for activity include the Gross Motor Function Measure 66‐ or 88‐item (GMFM‐66 or GMFM‐88; Russell 1989), Assisted Hand Assessment (AHA) (Krumlinde‐Sundholm 2003), timed walk tests, Melbourne Assessment of Unilateral Upper Limb Function (MAUULF; Randall 1999), ABILHAND‐Kids questionnaire (Arnould 2004), Activities Scale for Kids (ASK; Young 2000), International Physical Activity Questionnaire (IPAQ; Craig 2003), accelerometers, and pedometers. Subdomains of activity are:activity capacity (i.e. a person's ability to execute a task in a standardised environment);activity capability (i.e. a person's ability to execute a task in his or her daily environment); andactivity performance (i.e. what a person actually does in his or her environment) (Holsbeeke 2009).Participation, defined as a person's involvement in a life situation. This may include participation in domestic life (e.g. acquiring a place to live or managing a household); employment or education; and community, social, and civic life (WHO 2001). Examples of outcome measures for participation include the Paediatric Evaluation of Disability Inventory (PEDI; Haley 1992), the Waisman Activities of Daily Living Scale (W‐ADL; Maenner 2013), and Assessment of Life Habits questionnaire (LIFE‐H; Fougeyrollas 1998).Quality of life, defined as the impact of disease and treatment on physical, psychological and social functioning (Schipper 1996; Solans 2008), as measured by, for example, the Short Form‐36 (SF‐36) health survey (Ware 1993) and the Child Health Questionnaire (CHQ; Landgraf 1998).Incidence and nature of adverse events such as injury, cardiac events, stiffness and delayed onset muscle soreness, where reported.
primary outcome:
Family therapy for autism spectrum disorders
Quality or quantity of social interaction and communication (e.g. Social Responsiveness Scale by Constantino 2003; Autism Diagnostic Observation Schedule by Lord 2000).Mental health morbidity, including stress, anxiety or depression (e.g. Hospital Anxiety and Depression Scale by Zigmond 1983).Quality of life (e.g. EQ‐5D by Szenda 2007), including quality of relationships with family members (e.g. Family Questionnaire by Wiedemann 2002).Adverse effects or events (e.g. increased mental health morbidities, as measured by the Hospital Anxiety and Depression Scale (Zigmond 1983); or an increase in challenging behaviour).
primary outcome:
Dietary interventions for recurrent abdominal pain in childhood
Pain intensity, duration, or frequency.
primary outcome:
Psychosocial interventions for recurrent abdominal pain in childhood
Treatment success (as a dichotomous variable; yes or no).Pain intensity (continuous or categorical variable).Pain duration or pain frequency (continuous or categorical variable).
primary outcome:
Group‐based parent training programmes for improving emotional and behavioural adjustment in young children
Total emotional and behavioural problems, as measured using a standardised instrument, such as the Behaviour Screening Questionnaire (BSQ, Richman 1971) or the Child Behaviour Questionnaire (CBQ, Rutter 1970).Externalising problems, as measured using subscales from standardised instruments, such as the intensity subscale of the Eyberg Child Behaviour Inventory (ECBI, Eyberg 1978), or the externalising subscale of the Child Behaviour Checklist (CBCL, Achenbach 2000). Specific externalising problems, such as hyperactivity and inattention, as measured using subscales from standardised instruments, such as the inattentive subscale of the ECBI (Eyberg 1978), or the hyperactivity subscale of the Strengths and Difficulties Questionnaire (SDQ, Goodman 1997).Internalising problems, as measured using a standardised instrument such as the Behavioural Inhibition Questionnaire (BIQ, Bishop 2003), or the internalising subscale of the CBCL (Achenbach 2000).
primary outcome:
Aripiprazole for autism spectrum disorders (ASD)
Emotional and behavioural symptoms, as measured by validated clinician‐ or parent‐reported scales.Irritability (e.g. Aberrant Behaviour Checklist (ABC) ‐ Irritability subscale (Aman 1986)).Hyperactivity (e.g. ABC ‐ Hyperactivity subscale (Aman 1986)).Stereotypy (e.g. ABC ‐ Stereotypy subscale (Aman 1986)).Inappropriate speech (e.g. ABC ‐ Inappropriate Speech subscale (Aman 1986)).Lethargy/withdrawal (e.g. ABC ‐ Lethargy/Withdrawal subscale (Aman 1986)).Aggression (e.g. Overt Aggression Scale (OAS) (Yudofsky 1986)).Clinical Improvement (e.g. Clinical Global Impression (CGI) ‐ Improvement scale (Guy 1976)).Extrapyramidal side effects*, as measured by scales such as the modified Webster Scale (mWS) (Webster 1968), the Abnormal Involuntary Movements Scale (AIMS) (Guy 1976) or the Barnes Akathisia Scale (BARS) (Barnes 1989).
primary outcome:
Amphetamines for attention deficit hyperactivity disorder (ADHD) in children and adolescents
Change in core ADHD symptoms* (inattention, hyperactivity, impulsivity), as measured by a validated scale rated by children, parents, teachers, clinicians, or investigators such as Conners’ Parent Rating Scale ‐ Revised (CPRS‐R) (Conners 1998a), Conners’ Teacher Rating Scale ‐ Revised (CTRS‐R) (Conners 1998b), or the ADHD Rating Scale, Fourth Version (ADHD‐RS‐IV) (DuPaul 1998).
primary outcome:
Advocacy interventions to reduce or eliminate violence and promote the physical and psychosocial well‐being of women who experience intimate partner abuse
We used the incidence of physical, sexual, emotional, and overall abuse as primary outcomes in summary of findings Table for the main comparison and summary of findings Table 2, presenting findings for intensive advocacy interventions and brief advocacy interventions, respectively.
primary outcome:
Intrathecal baclofen for treating spasticity in children with cerebral palsy
The primary outcome measures sought were measures of spasticity and gross motor function. The Ashworth scale and the modified Ashworth scale categorise the degree of increase in muscle tone during examination of the affected limb on a five‐point scale. They are commonly‐used measures of spasticity (Ashworth 1964; Bohannon 1987). Measures of gross motor function include, for example, the Gross Motor Function Measure (GMFM) (Russell 1989), a validated assessment tool administered by a physiotherapist.We considered other measures of function, including the Pediatric Evaluation of Disability Inventory (PEDI), which measures functional capability and level of independence in the areas of self‐care, mobility and social function (Haley 1992).We also sought studies where other outcome measures were used, including measures of ease of care, comfort and quality of life.We also collected data regarding the subsequent need for orthopaedic surgery, safety and the economic implications of this therapy where these outcomes were reported.
primary outcome:
Sleep positioning systems for children with cerebral palsy
Hip migration percentage as determined by frontal anteroposterior, plain film radiograph, which measures the percentage of the femoral head that lies outside the acetabulum (Thomason 2014). Standardised measurement over time enables improvement, deterioration or no change to be determined.
primary outcome:
Pharmacological interventions for cognitive decline in people with Down syndrome
Improvement in:cognitive abilities, as measured by standardised scales, for example, the Dementia Scale for Down Syndrome (DSDS; Jozsvai 2009), the Cambridge Cognitive Examination (CAMCOG; Schmand 2000), or the Severe Impairment Battery (SIB; Panisset 1994; Saxon 1993);*global functioning, as measured by standardised scales, for example, the DSDS (Jozsvai 2009), or the International Classification of Functioning, Disability and Health (ICF) Scales (WHO 2001);behavioural problems, as measured by standardised scales, for example, the American Association on Mental Deficiency: Adaptive Behaviour Scale (AAMD: ABS; Nihira 1974), or the Neuropsychiatric Inventory (NPI; Cummings 1994);*daily living skills, including kitchen skills, laundry skills, self‐care skills, etc. (as measured by carer report).Adverse events, including headache, nausea, and dizziness.*
primary outcome:
Clozapine for psychotic disorders in adults with intellectual disabilities
Global outcomes* ‐ measures such as the Global Assessment of Functioning (GAF) scale (Jones 1995), or others, as defined by individual studies.Mental state* ‐ clinically important response as defined by individual studies, for example, changes in score on the Positive and Negative Syndrome Scale (PANSS) (Kay 1987).Behaviour ‐ clinical improvement as defined by individual studies.Seizures*.
primary outcome:
Screening women for intimate partner violence in healthcare settings
A. Identification of IPV by health professionals (data based on clinical encounter).Identification was defined as any form of acknowledgement by a healthcare professional during a consultation that the woman had experienced exposure to IPV. Identification therefore assumes communication between healthcare professional and participant that acknowledges the abuse. Studies use different terms such as identification, discussion, and patient disclosure of IPV. We carefully assessed how stated outcomes were operationalised across trials in order to determine if they met our definition of identification. Studies could collect identification data using a variety of methods (e.g. audio‐recordings of encounters, surveying women and healthcare professionals about what was discussed during the encounter, and medical record review). Identification of IPV through face‐to‐face interviews with researchers was dealt with separately on the basis that it did not properly represent the clinical context and may threaten the validity of the primary identification data.B. Information‐giving and referrals to support agencies by healthcare professionals (including take‐up rates when available).We included in this category any recording, documentation or organisational validation that women had been given information about, or referral to, support agencies.
primary outcome:
Non‐speech oral motor treatment for children with developmental speech sound disorders
Correct articulation of speech sounds targeted by the treatment as measured by standardised tests (e.g. Goldman‐Fristoe Test of Articulation Second Edition (GFTA‐2) (Goldman 2000)) or non‐standardised articulation tests (e.g. percentage of correct speech sounds produced as determined by perceptual evaluation of articulation).Speech intelligibility measured using a perceptual rating scale or percentage of words transcribed correctly by the investigator.Speech physiology as measured by instrumental techniques such as acoustic analysis (e.g. measure of format frequencies for assessing vowel production), kinematic analysis and articulatory placement.Adverse effect of an increase in articulation errors after treatment, which could be measured by the standardised and non‐standardised tests listed above. These articulation tests should be conducted by a speech‐language therapist (SLT).
primary outcome:
Food supplementation for improving the physical and psychosocial health of socio‐economically disadvantaged children aged three months to five years
The outcomes in this review cover both physical health and psychosocial health (including behaviour).
primary outcome:
Pharmacological interventions for those who have sexually offended or are at risk of offending
Sexual recidivism as measured by reconviction, self report, or caution (a legal construct valid in the UK and Hong Kong in which an official warning is given by police to someone who has committed a minor offence but has not been charged, to the effect that further action will be taken if they commit another such offence) or by self report.
primary outcome:
Parent‐infant psychotherapy for improving parental and infant mental health
We extracted data for the following outcomes at both post‐intervention and follow‐up, provided they had been measured using a standardised parent‐report or independent observation of the type listed as examples for each outcome below.
primary outcome:
Centre‐based day care for children younger than five years of age in low‐ and middle‐income countries
Child intellectual development.Cognitive ability (e.g. IQ, development quotient).*Attainment of educational goals (e.g. measures of reading, writing, or mathematics; retention in grade).*Child psychosocial developmentAny behavioural measure (i.e. self, parent or teacher reports of externalising behaviour or aggression, prosocial or antisocial behavior).*Disrupted child attachment to mother (e.g. using the Strange Situation (Ainsworth 1978) measurement or the Disturbances of Attachment Interview (Smyke 1999)).*
primary outcome:
Tricyclic antidepressants for attention deficit hyperactivity disorder (ADHD) in children and adolescents
Severity of core ADHD symptoms as measured by validated clinician, teacher or parent report scales such as the Conners' Rating Scale (Conners 1994)*, Child Behaviour Checklist (CBCL; Achenbach 1991)*, or Clinical Global Impression (CGI; NIMH 1985)*.The proportion of patients achieving a predefined improvement of core ADHD symptom severity as measured by validated clinician, teacher, or parent report scales such as the Conners' Rating Scale (Conners 1994)*, CBCL (Achenbach 1991)*, or CGI (NIMH 1985)*.Treatment adverse effects such as cardiovascular symptoms (e.g. changes in heart rate or blood pressure), gastrointestinal symptoms, and changes in weight, appetite, or sleep pattern.
primary outcome:
The WHO Health Promoting School framework for improving the health and well‐being of students and their academic achievement
The HPS framework is a highly complex, multi‐dimensional intervention, which presented particular methodological challenges for this systematic review. The intervention seeks to improve ‘health’ in general, and does not restrict itself to specific health issues; the focus of each intervention is determined by the schools and researchers according to need. Thus, while individual studies may focus on a specific health topic (for example, obesity or substance misuse), the range of topics included in the review is very broad. Consequently this review defined its primary outcome ‐ health ‐ to reflect the broad focus of the HPS framework (improving health in its widest sense) as well as educational outcomes.
primary outcome:
Interventions based on the Theory of Mind cognitive model for autism spectrum disorder (ASD)
Communication: overall level of non‐echoed language; stereotyped or idiosyncratic use of words or phrases; pointing; gestures; conversation.Social function: unusual eye‐contact; facial expressions directed to others; spontaneous initiation of joint attention; shared enjoyment in interaction; quality of rapport.
primary outcome:
Auditory‐verbal therapy for promoting spoken language development in children with permanent hearing impairments
Level of receptive and expressive language development (e.g. Preschool Language Age Scale, fourth edition (PLS‐4) (Zimmerman 2002); Clinical Evaluation of Language, fourth edition (CELF‐4) (Semel 2003); Reynell Developmental Language Scales (Edwards 2011))*.Rate of receptive and expressive language development (e.g. PLS‐4 (Zimmerman 2002); CELF‐4 (Semel 2003); Reynell Developmental Language Scales (Edwards 2011))*.
primary outcome:
Kinship care for the safety, permanency, and well‐being of children removed from the home for maltreatment
Eligible studies must analyse child welfare outcomes in the well‐being, permanency, or safety domains. Although caregiver and birth parent outcomes are very relevant, they were not considered in this review because child outcomes are what drive the policy and practice of kinship care. However, these outcomes may mediate or moderate the effect of kinship care on child welfare outcomes and should be explored in future research on the topic.Primary outcomes for the review are behavioural development, mental health, placement stability, and permanency. Secondary outcomes include educational attainment, family relations, service utilisation, and re‐abuse. The following list of outcome domains is meant to be exhaustive, although the examples in each domain are illustrative of the outcomes to be considered in this review.
primary outcome:
Fundoplication versus postoperative medication for gastro‐oesophageal reflux in children with neurological impairment undergoing gastrostomy
Resolution of clinically measured, identifiable symptoms of GOR following gastrostomy surgery.
primary outcome:
Gastrostomy feeding versus oral feeding alone for children with cerebral palsy
We planned to measure outcomes for both study participants (infant/child/teenager) and carers/family members.
primary outcome:
Psychoanalytic/psychodynamic psychotherapy for children and adolescents who have been sexually abused
Post traumatic stress disorder (PTSD)DepressionSexualised behaviourAggression/conduct problemsSelf harmSuicide
primary outcome:
Specially formulated foods for treating children with moderate acute malnutrition in low‐ and middle‐income countries
RecoveredNot recoveredProgression to severe acute malnutritionDiedDefaulted (i.e. dropped out of the programme)Weight gainWeight‐for‐heightMid‐upper arm circumferenceAny adverse effect, including predisposition to obesity (assessed by measuring rapid weight gain and increase in fat mass compared to lean body mass) and diarrhoea
primary outcome:
Specialist home‐based nursing services for children with acute and chronic illnesses
The study outcomes were measured using the following.
primary outcome:
Parent‐mediated early intervention for young children with autism spectrum disorders (ASD)
A range of measures is currently in use to confirm the diagnosis of ASD and characterise children with ASD. No particular measure or reporting of an outcome was used as an inclusion criterion for this review.
primary outcome:
Day 5 versus day 3 embryo biopsy for preimplantation genetic testing for monogenic/single gene defects
Live birth, defined as the delivery of a foetus after 20 completed weeks of gestational age; which, after separation, shows signs of life such as a heart beat, umbilical cord pulsation, or definite movement of voluntary muscles.Miscarriage, defined as the spontaneous loss of a clinical intra‐uterine pregnancy prior to 20 completed weeks of gestational age.
primary outcome:
Impact of the diagnostic test Xpert MTB/RIF on patient outcomes for tuberculosis
All‐cause mortality from the time of the first diagnostic test to the end of trial follow‐upProportion of participants starting treatment for tuberculosis who had a successful treatment outcome (an unfavourable outcome was defined as death from any cause, default, failure, being transferred out, or lost to follow‐up). This outcome was added subsequently, at the request of the WHO guideline development group.
primary outcome:
Adenoidectomy for otitis media with effusion (OME) in children
Hearing:proportion of children whose hearing has returned to normal, with normal hearing defined as 20 dB HL or less (assessed using age‐appropriate tests);hearing threshold.Disease‐specific quality of life measured using a validated instrument, for example:OM8‐30 (Haggard 2003);Otitis Media‐6 (Rosenfeld 1997).Adverse events ‐ serious haemorrhage and its consequences.
primary outcome:
Pharmacological interventions for prophylaxis of vestibular migraine
Improvement in vertigoMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a vertigo rating scale.Change in vertigoMeasured as a continuous outcome, to identify the extent of change in vertigo symptoms.Serious adverse eventsIncluding any event that caused death, was life‐threatening, required hospitalisation, resulted in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experienced at least one serious adverse event during the follow‐up period.
primary outcome:
Pharmacological interventions for acute attacks of vestibular migraine
Improvement in vertigoMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a vertigo rating scale.Change in vertigoMeasured as a continuous outcome, to identify the extent of change in vertigo symptoms.Serious adverse eventsIncluding any event that caused death, was life‐threatening, required hospitalisation, resulted in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experienced at least one serious adverse event during the follow‐up period.
primary outcome:
Non‐pharmacological interventions for prophylaxis of vestibular migraine
Improvement in vertigoMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a vertigo rating scale.Change in vertigoMeasured as a continuous outcome, to identify the extent of change in vertigo symptoms.Serious adverse eventsIncluding any event that caused death, was life‐threatening, required hospitalisation, resulted in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experienced at least one serious adverse event during the follow‐up period.
primary outcome:
Pharmacological interventions for persistent postural‐perceptual dizziness (PPPD)
Improvement in vestibular symptomsMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a rating scale.Change in vestibular symptomsMeasured as a continuous outcome, to identify the extent of change in vestibular symptoms.Serious adverse eventsIncluding any event that caused death, was life‐threatening, required hospitalisation, resulted in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experienced at least one serious adverse event during the follow‐up period.
primary outcome:
Intratympanic corticosteroids for Ménière’s disease
Improvement in vertigoMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a vertigo rating scale.Change in vertigoMeasured as a continuous outcome, to identify the extent of change in vertigo symptoms.Serious adverse eventsIncluding any event that causes death, is life‐threatening, requires hospitalisation, results in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experience at least one serious adverse event during the follow‐up period.
primary outcome:
Intratympanic gentamicin for Ménière’s disease
Improvement in vertigoMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a vertigo rating scale.Change in vertigoMeasured as a continuous outcome, to identify the extent of change in vertigo symptoms.Serious adverse eventsIncluding any event that causes death, is life‐threatening, requires hospitalisation, results in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experience at least one serious adverse event during the follow‐up period. We also looked for data on the occurrence of the following specified, serious adverse event:complete loss of hearing in the affected ear.
primary outcome:
Lifestyle and dietary interventions for Ménière’s disease
Improvement in vertigoMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a vertigo rating scale.Change in vertigoMeasured as a continuous outcome, to identify the extent of change in vertigo symptoms.Serious adverse eventsIncluding any event that causes death, is life‐threatening, requires hospitalisation, results in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experience at least one serious adverse event during the follow‐up period.
primary outcome:
Surgical interventions for Ménière’s disease
Improvement in vertigoMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a vertigo rating scale.Change in vertigoMeasured as a continuous outcome, to identify the extent of change in vertigo symptoms.Serious adverse eventsIncluding any event that causes death, is life‐threatening, requires hospitalisation, results in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experience at least one serious adverse event during the follow‐up period. Where possible, we planned to identify data on the occurrence of the following specified, serious adverse events:cranial neuropathies, including facial paralysis;meningitis.
primary outcome:
Systemic pharmacological interventions for Ménière’s disease
Improvement in vertigoMeasured as a dichotomous outcome (improved/not improved), according to self‐report, or according to a change of a specified score (as described by the study authors) on a vertigo rating scale.Change in vertigoMeasured as a continuous outcome, to identify the extent of change in vertigo symptoms.Serious adverse eventsIncluding any event that causes death, is life‐threatening, requires hospitalisation, results in disability or permanent damage, or in congenital abnormality. Measured as the number of participants who experienced at least one serious adverse event during the follow‐up period.