anurajms/meta_analysis huggingface dataset:
primary outcome:
Non‐pharmacological interventions for stuttering in children six years and younger
Stuttering frequency, measured by calculating percentage of syllables stuttered, percentage of words stuttered or SLDs, etc.Stuttering severity, measured using severity rating scales or stuttering severity instruments (e.g. SSI‐4; Riley 2009), etc.Speech efficiency, reported as speech rate, measured by calculating the number of words or syllables spoken per minute, or articulation rate, measured by calculating the number of words or syllables spoken per minute, excluding non‐speaking time (e.g. pauses and non‐speech sounds).
primary outcome:
Behavioural and cognitive behavioural therapy for obsessive compulsive disorder (OCD) in individuals with autism spectrum disorder (ASD)
Treatment efficacy: change in core OCD symptomatology compared to measures of symptomatology at baseline, measured on a validated OCD symptom rating scale, including the Yale‐Brown Obsessive Compulsive Scale (Y‐BOCS) which is considered the ‘gold standard’ measure of OCD symptoms (Rosenfeld 1992), the children’s version (CY‐BOCS) (Storch 2004), the National Institute of Mental Health Global Obsessive Compulsive Score, and the Obsessive Compulsive Inventory–Revised (Foa 2002). Total number of dropouts
primary outcome:
Vitamin D supplementation for chronic liver diseases in adults
All‐cause mortality.Liver‐related mortality.Serious adverse events. Depending on the availability of data, we attempted to classify adverse events as serious or non‐serious. Serious adverse events were defined as any outward medical occurrence that was life‐threatening; resulted in death, or persistent or significant disability; or any medical event that may have jeopardised the person; or required intervention to prevent it (ICH‐GCP 1997). We considered all other adverse events as non‐serious (see Secondary outcomes below).
primary outcome:
Recombinant growth hormone therapy for cystic fibrosis in children and young adults
Pulmonary function testsforced expiratory volume at one second (FEV1) (% predicted or litres)forced vital capacity (FVC) (% predicted or litres)maximal inspiratory pressure (PImax)maximal expiratory pressure (PEmax)Anthropometric parametersheight (cm) and height z score or standard deviation score (SDS)height velocityweight (kg) and weight z score or SDSweight velocitylean body mass (LBM) measured by DEXA scanQoL (measured by a validated tool such as the Cystic Fibrosis Questionnaire‐Revised version (CFQ‐R (Quittner 2009)) and the Cystic Fibrosis Quality of Life Questionnaire (CFQoL (Gee 2000))
primary outcome:
Heliox for croup in children
Change in croup score.Change in croup score between pre‐ and postintervention.Croup score postintervention.
primary outcome:
Chloral hydrate as a sedating agent for neurodiagnostic procedures in children
Proportion of children who successfully completed neurodiagnostic procedure without interruption by the child awakening.Proportion of children who required a further dose of either the same sedative agent or the addition of a different sedative agent.Time to adequate sedation (in minutes or as measured by specific validated scales such as the Ramsay Sedation Score).
primary outcome:
Direct composite resin fillings versus amalgam fillings for permanent posterior teeth
Restoration failure (or survival)Harms, including toxicity, sensitivity, allergic reaction, injury
primary outcome:
Continuous versus bolus intermittent intragastric tube feeding for preterm and low birth weight infants with gastro‐oesophageal reflux disease
Gastro‐oesophageal reflux disease, as diagnosed by pH metry, multiple intraluminal impedance, or endoscopy within two hours postprandial (after eating a meal)
primary outcome:
Push versus gravity for intermittent bolus gavage tube feeding of preterm and low birth weight infants
Time taken to establish full gavage feeding (days)Feeding intolerance (number of episodes per day): defined as significant abdominal distension or discolouration, signs of perforation, obvious blood in stool; gastric residuals ≥ 25% to 50% of interval volume for two to three feedings; bilious gastric residual or emesis; significant apnoea or bradycardia; significant cardiopulmonary instability (Kuzma‐O'Reilly 2003)
primary outcome:
Timing of pancreatic enzyme replacement therapy (PERT) in cystic fibrosis
Fat malabsorption (absolute CFA based on 72‐hour stool collection)Nutritional status (change from baseline)weight in kg, % of predicted weight or z scoreheight in cm, % of predicted height or z scoreBMI, % of predicted BMI or z scoreAdverse eventsrelating to gastrointestinal systemrelating to other systems
primary outcome:
Schedules for home visits in the early postpartum period
Maternal mortality at 42 days post‐birth.Neonatal mortality.
primary outcome:
Opioid treatment for opioid withdrawal in newborn infants
Treatment failure: including failure to achieve control, defined as a failure to reduce a standardised score of NAS from a clinically significant level to a clinically 'safe' level defined by author of trial, or the use of additional pharmacological treatments for control of NAS in the neonatal period.Seizures (paroxysmal alterations in neurological function. This can be behavioural, motor or autonomic (Volpe 2008). Neonatal seizures can be clinical (with no EEG correlate), electroclinical (clinical associated with EEG findings) or electrographic (no clinical correlate) (Mizrahi 1987).)Neonatal (latest time reported to discharge) and infant mortality.Neurodevelopmental disability at 18 months' postnatal age or greater, defined as a neurological abnormality including any one of the following.Cerebral palsy on clinical examination.Developmental delay more than two standard deviation (SDs) below population mean on a standardised test of development.Blindness (visual acuity less than 6/60).Deafness (any hearing impairment requiring amplification) at any time after term corrected.
primary outcome:
Sunlight for the prevention and treatment of hyperbilirubinemia in term and late preterm neonates
Use of conventional phototherapy (CPT), if sunlight (with or without filters or amplification) was first used for prevention or early treatment.Treatment failure requiring exchange transfusion (as defined by receiving an exchange transfusion; or bilirubin level greater than 15 mg/dL in the first 24 hours of life, greater than 17 mg/dL in the first 48 hours of life, or greater than 20 mg/dL after 72 hours of life) (Bhutani 1999).Acute bilirubin encephalopathy, defined as retrocollis and opisthotonus in association with irritability, drowsiness, poor or no feeding, alternating tone, high‐pitched or shrill cry, lethargy, coma, fever, or seizures (AAP 2004; Johnson 2002).Chronic bilirubin encephalopathy or kernicterus, defined as athetoid cerebral palsy, auditory dysfunction, dental‐enamel dysplasia, paralysis of upward gaze, and, occasionally, intellectual and other disabilities (AAP 2004) assessed at 12 to 24 months of age.Death.
primary outcome:
Bisphosphonate use in children with cerebral palsy
Change in areal BMD z‐score of the lumbar spine, total body minus the head, or lateral distal femur, measured by dual X‐ray absorptiometry (DXA scan)Volumetric BMD of distal tibia or radius, using peripheral, quantitative computerised tomography (pQCT)Fracture frequency: number of incident fractures (clinical, radiographic, or both) noted per participant per year before and after bisphosphonate treatmentAdverse effects associated with bisphosphonate use, experienced by the participants (which could have included acute symptoms (fever, chills, malaise); gastrointestinal symptoms, including nausea, vomiting, and abdominal pain; or possible sequelae, including hypocalcaemia, hypophosphataemia, bone pain, transient uveitis, nephrocalcinosis, acute tubular necrosis, delayed fracture healing, and death)
primary outcome:
Ivermectin treatment in humans for reducing malaria transmission
Prevalence of malaria parasite infection measured by microscopy, rapid diagnostic tests (RDTs), or molecular methodsIncidence of clinical malaria, defined by symptoms with parasitaemia, detected by microscopy or RDTs
primary outcome:
Altered dietary salt intake for people with chronic kidney disease
Cardiovascular deathDeath (any cause)
primary outcome:
Continuous nasogastric milk feeding versus intermittent bolus milk feeding for preterm infants less than 1500 grams
Age at full enteral feedings (days)Feeding intolerance as measured by number of days of feeding interruptionsDays to regain birth weightRate of gain in weight (grams/week)Rate of gain in length (cm/week)Rate of gain in head circumference (cm/week)Necrotising enterocolitis (NEC), including suspected and confirmed (Bell's Stage II or greater)
primary outcome:
Eslicarbazepine acetate add‐on therapy for drug‐resistant focal epilepsy
A 50% or greater reduction in seizure frequency – the proportion of people with a 50% or greater reduction in seizure frequency within the treatment period compared to the prerandomization baseline period. This was chosen as a primary outcome because it is a commonly reported and can be calculated for studies that did not report this outcome provided that baseline seizure data were recorded.Freedom from seizures – the proportion of participants with complete cessation of seizures from the time of randomization to the trial conclusion.
primary outcome:
Prophylactic drug management for febrile seizures in children
Efficacy: the proportion of children with recurrence of febrile or non‐febrile seizures at certain time points after treatment onset (6 months, 12 months, 24 months, 36 months, and where data were available at age 5 to 6 years).
primary outcome:
Oral antibiotics for chronic blepharitis
Subjective improvement in symptoms, as judged by participant symptom report and measured by questionnaire, interview, or visual analogue scale (VAS), including but not limited to: irritation, burning, tearing, itching, eyelid sticking, photophobia, and increased frequency of blinking.Since there were no standardized diagnostic criteria for blepharitis and no standardized scales on which to judge symptom severity, clinical improvement in symptoms was expected to vary among studies. Although studies should ideally use validated scales, all reported scales were considered for inclusion since standardized information was unavailable.
primary outcome:
Topical azole treatments for otomycosis
Clinical resolution as measured by the proportion of participants with complete resolution at between two and four weeks after treatment (however defined by the authors of the studies).Significant adverse events (e.g. severe topical allergic reaction).
primary outcome:
New generation antidepressants for depression in children and adolescents: a network meta‐analysis
1. Depressive disorder according to DSM or ICD criteria and established by a clinician conducting a structured or semi‐structured diagnostic interview such as the Schedule for Affective Disorders and Schizophrenia for School Aged Children, Present Episode Version (K‐SADS‐P) (Chambers 1985). We chose this as the most robust approach to establishing the resolution of a depressive episode.2. Death by suicide established via recording of this adverse outcome within the trial period or by medical record or direct inquiry with appropriate contact person at follow‐up.
primary outcome:
Piperonyl butoxide (PBO) combined with pyrethroids in insecticide‐treated nets to prevent malaria in Africa
Trials had to include at least one of the following primary outcomes to be eligible for inclusion.
primary outcome:
Internet‐based cognitive and behavioural therapies for post‐traumatic stress disorder (PTSD) in adults
Severity of PTSD symptoms (measured using a standardised scale, such as the Clinician‐Administered PTSD Symptom Scale (CAPS‐5; Blake 1995), or the PTSD Checklist (PCL‐5; Weathers 2013). When a study reported both a clinician‐administered scale and a self‐report measure, we used the clinician‐administered measure in the meta‐analysis).Dropouts (measured by the number of participants still receiving treatment at the end of the intervention).
primary outcome:
Sedatives for opioid withdrawal in newborn infants
Treatment failure: including failure to achieve control defined as a failure to reduce a standardised score of NAS from a clinically significant level to a clinically 'safe' level defined by author of trial, or the use of additional pharmacological treatments for control of NAS in the neonatal period.Seizures (paroxysmal alterations in neurological function. This could have been behavioural, motor or autonomic (Volpe 2008). Neonatal seizures could have been clinical (with no EEG correlate), electroclinical (clinical associated with EEG findings) or electrographic (no clinical correlate) (Mizrahi 1987).)Neonatal (latest time reported to discharge) and infant mortality.Neurodevelopmental disability at 18 months' postnatal age or greater defined as a neurological abnormality including any one of the following:cerebral palsy on clinical examination;developmental delay more than two standard deviations (SDs) below population mean on a standardised test of development;blindness (visual acuity less than 6/60) ordeafness (any hearing impairment requiring amplification) at any time after term corrected.
primary outcome:
Antibiotic regimens for early‐onset neonatal sepsis
All‐cause mortality.
primary outcome:
Pharmacological and surgical interventions for the treatment of gastro‐oesophageal reflux in adults and children with asthma
Acute asthma exacerbations (either number of participants with events or rate) as reported by trialistsHospital admissions (either number of participants with events or rate) and length of stayEmergency room or unscheduled doctor visits (either number of participants with events or rate)
primary outcome:
Rubber dam isolation for restorative treatment in dental patients
Survival rate of the restorations at 6 months, 1, 2, 5, and 10 years after restorative treatments. Survival means the restorations were still correctly present or having only a slight wear or defect at the margin less than 0.5 mm in depth when assessed. If the restorations were either completely lost, or were fractured with defects 0.5 mm in depth or greater, had secondary caries or inﬂammation of the pulp, any of these situations were labelled as treatment failures.Adverse events. Any reported adverse events related to any of the active interventions during the treatment phase. These included events affecting the operator or the patient (e.g. damage to skin or mucosa, allergic reactions to latex).
primary outcome:
Surfactant therapy via thin catheter in preterm infants with or at risk of respiratory distress syndrome
Death or bronchopulmonary dysplasia (BPD): the composite outcome of death or BPD, defined as the need for oxygen or respiratory support at 36 weeks' postmenstrual age (PMA) (Shennan 1988).Need for intubation within the first 72 hours of life.Air leak requiring drainage (during first hospitalisation).Severe intraventricular haemorrhage (IVH), including grades III and IV (Papile 1978).Death during first hospitalisation (all causes).BPD (clinical definition) among survivors to 36 weeks' PMA.Death or survival with neurosensory disability, with the latter measured beyond one year PMA and defined as any of (1) cerebral palsy by clinical examination or other means; (2) developmental delay more than two standard deviations below the population mean on standardised testing; (3) blindness (visual acuity < 6/60); or (4) deafness (hearing impairment requiring amplification).
primary outcome:
Topical emollient for preventing infection in preterm infants
Coagulase‐negative staphylococciOther bacteria (gram‐negative bacilli, S aureus, enterococci)Fungi
primary outcome:
Paying for performance to improve the delivery of health interventions in low‐ and middle‐income countries
patient health outcomes (e.g. mortality rates, treatment success);changes in targeted measures of provider performance, such as the utilization, delivery or quality of healthcare services;unintended effects, including motivating unintended behaviours, distortions (ignoring important tasks that were not rewarded with incentives), 'cherry‐picking'/'cream‐skimming' (prioritizing patients that were most profitable over those who released fewer financial rewards), gaming (improving or cheating on reporting rather than improving performance), increased inequities and dependency on financial incentives;changes in resource use, including for incentives, administration and services.
primary outcome:
Immediate antiepileptic drug treatment, versus placebo, deferred, or no treatment for first unprovoked seizure
1. Seizure recurrence five years after randomisation (in other words, the occurrence of one or more seizures in the five years following randomisation)
2. Five‐year immediate remission after randomisation (in other words, the immediate achievement of a seizure‐free period of five years following randomisation)
primary outcome:
Rapid versus standard antimicrobial susceptibility testing to guide treatment of bloodstream infection
Mortality (all‐cause 30‐day mortality, after date of positive blood culture)Time‐to‐discharge from hospital after positive blood culture, in days
primary outcome:
Drug therapies for reducing gastric acidity in people with cystic fibrosis
Measures of nutritional status as assessed by weight, height and other indices of growthSymptoms related to increased gastric acidity such as epigastric pain, heartburnComplications of increased gastric acidity such as gastric or duodenal ulcers
primary outcome:
Cough augmentation techniques for people with chronic neuromuscular disorders
Number of unscheduled hospital admissions for episodes of acute respiratory exacerbations over one year for 'maintenance' therapy.Duration of hospital stay (days) for 'rescue' therapy.
primary outcome:
Antidepressants for people with epilepsy and depression
Depression scoresThe proportion of participants with a greater than 50% improvement in depressive symptoms (defined as a 'response') compared to baselineMean difference in depression scores following treatment (compared to baseline or between‐group comparison)The proportion of participants achieving complete remission of depressive symptomsChange in seizure frequencyThe mean difference in seizure frequencyThe proportion of participants with a seizure recurrenceThe proportion of participants with an episode of status epilepticus
primary outcome:
Regular treatment with formoterol and an inhaled corticosteroid versus regular treatment with salmeterol and an inhaled corticosteroid for chronic asthma: serious adverse events
All‐cause mortalityAll‐cause non‐fatal serious adverse events (see definition below)
primary outcome:
Anti‐seizure medications for Lennox‐Gastaut syndrome
Cessation of all seizures (defined as total cessation of all seizure types within the trial period)Quantitative reduction of all seizure types (measured as the number of all seizures occurring before treatment was commenced compared with the total number of seizures occurring at the end of the trial period)Adverse events leading to study discontinuation
primary outcome:
Circumcision devices versus standard surgical techniques in adolescent and adult male circumcisions
Serious adverse events defined as events requiring a blood transfusion, hospitalization or resulting in permanent damage (e.g. penile injury occurring within the intraoperative and early postoperative period [30 days]).Moderate adverse events defined as events requiring active treatment such as suturing, antibiotics, and surgical hemostasis within the intraoperative and early postoperative period (30 days).
primary outcome:
Lung recruitment manoeuvres for reducing mortality and respiratory morbidity in mechanically ventilated neonates
Mortality (death within 28 days of birth or mortality by hospital discharge)Incidence of BPD:supplemental oxygen at 36 weeks' postmenstrual agesupplemental oxygen at 28 days of liferequirement for home oxygen therapyDuration of supplemental oxygen (days)Duration of ventilatory support (CMV) (hours or days)Duration of continuous positive airway pressure (CPAP) therapy (hours or days)Duration of neonatal intensive care unit (NICU) stay (hours or days)Duration of hospital stay (days)
primary outcome:
Dornase alfa for cystic fibrosis
Changes in lung function from baselineforced expiratory volume at one second (FEV1)forced vital capacity (FVC)lung clearance index (LCI)forced expiratory volume at 0.5 seconds (FEV0.5 )Change from baseline in quality of life (QoL)Mean number of exacerbations
primary outcome:
Opioids for newborn infants receiving mechanical ventilation
Pain assessed by validated methods during administration of selected drugs. The following scales, developed to assess pain, fulfil validity and reliability criteria for newborn infants (term and preterm on mechanical ventilation for any respiratory disease) when critically reviewed (Giordano 2019; Olsson 2021): Neonatal Facial Coding System (NFCS) (Grunau 1990); Neonatal Infant Pain Scale (NIPS) (Lawrence 1993); Premature Infant Pain Profile (PIPP) (Stevens 1996); COMFORTneo (van Dijk 2009); Astrid Lindgren and Lund Children's Hospital's Pain and Stress Assessment Scale for Preterm and Sick Newborn Infants (ALPS‐Neo) (Lundqvist 2014); CRIES (acronym of Crying, Requires oxygen, Increased vital signs, Expression, Sleeplessness) Scale (Krechel 1995); Échelle Douleur Inconfort Nouveau‐né (EDIN) Scale (Debillon 2001); and Neonatal Pain, Agitation and Sedation Scale (N‐PASS) (Hummel 2008)Duration of mechanical ventilation (days)Neonatal mortality (death within 28 days of birth) and mortality to dischargeModerate to severe neurodevelopmental disability: cerebral palsy, developmental delay (Bayley Scales of Infant Development – Mental Development Index Edition II (BSID‐MDI‐II (Bayley 1993); Bayley Scales of Infant and Toddler Development – Edition III Cognitive Scale (BSITD‐III) (Bayley 2006); or Griffiths Mental Development Scale – General Cognitive Index (GCI) (Griffiths 1954; Griffiths 1970); assessment > 2 standard deviations (SDs) below the mean); intellectual impairment (intelligence quotient (IQ) > 2 SDs below the mean), blindness (vision < 6/60 in both eyes), or sensorineural deafness requiring amplification (Jacobs 2013). We separately assessed data on children aged 18 to 24 months and aged 3 to 5 years
primary outcome:
Zinc supplementation for improving pregnancy and infant outcome
We have included outcomes related to clinical complications of pregnancy for maternal, fetal, neonatal and infant outcomes. We have not included data related to biochemical outcomes or studies reporting only biochemical outcomes.
primary outcome:
Enteral zinc supplementation for prevention of morbidity and mortality in preterm neonates
All‐cause mortalityBefore hospital discharge (latest time reported at or after 36 weeks' postmenstrual age)Between hospital discharge and neurodevelopmental follow‐up at 18 to 24 months of age (post‐term)Neurodevelopmental disability at 18 to 24 months of age (post‐term), defined as a neurological abnormality including any of the following:Cerebral palsy on clinical examination;Developmental delay > 2 standard deviations (SD) below the population mean on a standardised test of development (Vohr 2004);Blindness (visual acuity < 6/60);Deafness (any hearing impairment requiring amplification).
primary outcome:
High versus standard volume enteral feeds to promote growth in preterm or low birth weight infants
Rates of weight gain (g/kg/d), linear growth (cm/week), or head growth (cm/week) during hospital stayProportion of infants with extrauterine growth restriction at discharge (weight less than 10th percentile for the index population)
primary outcome:
Timing of dornase alfa inhalation for cystic fibrosis
Lung function (absolute change and change in per cent (%) predicted)forced expiratory volume at one second (FEV1)forced vital capacity (FVC)Measures of quality of life and symptom scores (including cough or subjective ease of clearance)
primary outcome:
Interventions for self‐harm in children and adolescents
The primary outcome measure in this review was the occurrence of repeated SH over a maximum follow‐up period of two years. Repetition of SH was identified through self‐report, collateral report, clinical records, or research monitoring systems. As we wished to incorporate the maximum data from each trial, we included both self‐reported and hospital records of SH, where available. Preference was given to clinical records over self‐report where a study reported both measures. We also reported proportions of participants repeating SH, frequency of repeat episodes, and time to SH repetition (where available).
primary outcome:
High‐flow nasal cannulae for respiratory support in adult intensive care patients
The outcome measures in this review are a mix of surrogate, clinical and participant‐reported outcomes. We recognize that, while there may be a correlation between the surrogate and clinical outcomes, it is the clinical outcomes which will provide the strongest evidence regarding the safety and efficacy of HFNC. Similarly, participant‐reported outcomes may help patients to make informed decisions about their care. We considered the short‐term effects and the long‐term effects of treatment, and therefore we collected outcome data up to 24 hours from the initiation of treatment (short‐term) as well as at more than 24 hours (long‐term).We assessed all outcomes at the time points reported in the included studies. For participant‐reported outcomes, we accepted the study authors’ definitions.
primary outcome:
(Ultra‐)long‐acting insulin analogues for people with type 1 diabetes mellitus
All‐cause mortality.Health‐related quality of life.Severe hypoglycaemia.
primary outcome:
Interventions for bacterial folliculitis and boils (furuncles and carbuncles)
Clinical cure: clearance of all visible lesions of folliculitis or boils (i.e. disappearance of all papular or pustular lesions of folliculitis or boils at the end of treatment).Severe adverse events leading to withdrawal of treatment.
primary outcome:
Antibiotics to prevent complications following tooth extractions
Postsurgical infectious complications, which may occur with one or more of the following: pain, fever, swelling, trismus.
primary outcome:
Patient and lay carer education for preventing pressure ulceration in at‐risk populations
Risk of pressure ulceration, defined as a new ulcer of any grade developing during the study period. We regarded the following as adequate measures of this outcome:time to occurrence of a new ulcer;proportion of people developing a new ulcer.
primary outcome:
Fluid restriction in the management of transient tachypnea of the newborn
Duration of supplemental oxygen therapy in hours or days
primary outcome:
The effectiveness and adverse effects of D‐cycloserine compared with placebo on social and communication skills in individuals with autism spectrum disorder
Social communication and social interaction impairment, measured by validated instruments, such as the Social Responsiveness Scale (SRS) (Constantino 2005), Vineland Adaptive Behaviour Scales 2nd Edition (VABS‐II) (Sparrow 2005), and other valid scalesRestricted, repetitive, stereotyped patterns of behaviour and interests, assessed by valid scales, such as the Aberrant Behaviour Checklist (ABC) for stereotypies (Aman 1985), and other validated instrumentsAdverse events associated with D‐cycloserine, assessed by the number of non‐serious adverse events (headache, vomiting, cold, cough, restlessness, sadness, sedation, etc.) and serious adverse events (suicidal ideation etc.)
primary outcome:
Topical versus systemic antibiotics for chronic suppurative otitis media
Resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at:between one week and up to two weeks;two weeks to up to four weeks; andafter four weeks.Health‐related quality of life using a validated instrument for CSOM (e.g. Chronic Otitis Media Questionnaire (COMQ)‐12 (Phillips 2014a; Phillips 2014b; van Dinther 2015), Chronic Otitis Media Outcome Test (COMOT)‐15 (Baumann 2011), Chronic Ear Survey (CES) (Nadol 2000)).Ear pain (otalgia) or discomfort or local irritation.
primary outcome:
Salbutamol for transient tachypnea of the newborn
Duration of oxygen therapy (hours).Need for continuous positive airway pressure (yes/no).Need for mechanical ventilation (yes/no).
primary outcome:
Systemic antibiotics for chronic suppurative otitis media
Resolution of ear discharge or 'dry ear' (whether otoscopically confirmed or not), measured at:between one week and up to two weeks;two weeks to up to four weeks; andafter four weeks.Health‐related quality of life using a validated instrument for CSOM (e.g. Chronic Otitis Media Questionnaire (COMQ)‐12 (Phillips 2014a; Phillips 2014b; van Dinther 2015), Chronic Otitis Media Outcome Test (COMOT)‐15 (Baumann 2011), Chronic Ear Survey (CES) (Nadol 2000)).Ear pain (otalgia) or discomfort or local irritation.
primary outcome:
Urgent‐start peritoneal dialysis versus haemodialysis for people with chronic kidney disease
Catheter‐related infectious complications occurring within 30 days (early complication) and 90 days (late complication)Bacteraemia (defined as blood culture positive for bacteria) after commencement of dialysis (proportion of patients developing bacteraemia)Peritonitis as defined by the ISPD guidelines (Li 2010) after commencement of dialysis (proportion of patients developing peritonitis)Exit site or tunnel tract infection in PD patients was defined by the ISPD guidelines (Li 2010) after commencement of dialysis and CVC exit‐site infection was defined as presence of erythema, induration, and/or tenderness within 2 cm of the catheter exit site; may be associated with fever or purulent drainage from the exit site, with or without concomitant bloodstream infection (Mermel 2009) and tunnel infection, defined as tenderness, erythema, and/or induration > 2 cm from the catheter exit site, along the subcutaneous tract of a tunnelled catheter, with or without concomitant bloodstream infection (Mermel 2009). (proportion of patients developing exit site or tunnel tract infections)Catheter‐related non‐infectious complications occurring within 30 days (early complication) and 90 days (late complication)Exit site bleeding requiring intervention (e.g. additional application of suture) after commencement of dialysis (proportion of patients developing exit site bleeding)Catheter malfunction, defined as catheter flow problems requiring intervention (medical (e.g. urokinase) or surgical (e.g. catheter replacement)) or malposition after commencement of dialysis (proportion of patients developing catheter malfunction)Catheter re‐adjustment, defined as catheter malfunction requiring intervention to re‐adjust or replace the catheter (proportion of patients requiring catheter re‐adjustment procedure)Home dialysis (proportion of patients on home dialysis (e.g. PD or home HD)).
primary outcome:
Beta‐blockers versus placebo or no intervention for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis
All‐cause mortalitySerious adverse events and liver‐related morbidity (i.e. proportion of participants who developed ascites, hepatorenal syndrome, hepatocellular carcinoma, or hepatic encephalopathy). A serious adverse event, defined according to the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (ICH‐GCP 1997), was any untoward medical occurrence that results in death, is life‐threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. All other adverse events were considered non‐serious adverse events.Health‐related quality of life, determined exclusively by means of validated scales, classifications, and measurement systems, like the Paediatric Quality of Life Inventory (PedsQL), Child Health Questionnaire (CHQ), and DISABKIDS questionnaires.
primary outcome:
Surgical interventions for the early management of Bell's palsy
Degree of recovery of facial nerve function and resolution of symptoms at 12 months as measured using the House‐Brackmann scale, the Sunnybrook scale, the Yanagihara scale or other similar scale. Only complete recovery at 12 months was included, as surgical decompression is not typically first‐line treatment in Bell's palsy, and the risks involved with surgical decompression outweigh the benefits if recovery is not complete. Resolution of symptoms can be defined as 'complete' recovery. At present, the review includes only dichotomous data, but should any continuous data be reported in future studies, it will be appropriate to include it under this outcome as well, as a part of 'degree of recovery of facial nerve function'.
primary outcome:
Band ligation versus sham or no intervention for primary prophylaxis of oesophageal variceal bleeding in children and adolescents with chronic liver disease or portal vein thrombosis
All‐cause mortalitySerious adverse events and liver‐related morbidity (i.e. proportion of participants who developed ascites, hepatorenal syndrome, hepatocellular carcinoma or hepatic encephalopathy). According to the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (ICH‐GCP 1997), a serious adverse event is any untoward medical occurrence that: results in death; is life‐threatening; requires inpatient hospitalisation or prolongation of existing hospitalisation; results in persistent or significant disability or incapacity; or is a congenital anomaly or birth defect. All other adverse events were considered non‐serious adverse events.Quality of life, determined exclusively by means of validated scales, classifications and measurement systems like the Paediatric Quality of Life Inventory (PedsQL), Child Health Questionnaire (CHQ), and DISABKIDS Questionnaire.
primary outcome:
Effect of atorvastatin on testosterone levels
The primary outcome of this study was the absolute change in total testosterone concentrations. When the absolute change was reported at different time periods, we chose the absolute change reported at the longest time period.
primary outcome:
Ethosuximide, sodium valproate or lamotrigine for absence seizures in children and adolescents
Proportion of participants seizure free at one, three, six, 12 and 18 months after randomisation.Fifty per cent or greater reduction in the frequency of seizures.Incidence of adverse effects.
primary outcome:
Antibiotic therapy versus no antibiotic therapy for children aged 2 to 59 months with WHO‐defined non‐severe pneumonia and wheeze
Clinical cure: symptomatic and clinical recovery by the end of treatment (if the child had a fever, their temperature returned to normal, and the respiratory rate dropped to normal)Treatment failure: presence of any of the following: development of chest in‐drawing, convulsions, drowsiness, or inability to drink at any time, respiratory rate above the age‐specific cut‐off point on completion of treatment
primary outcome:
Indomethacin for symptomatic patent ductus arteriosus in preterm infants
Failure of PDA closure within one week of administration of the first dose of indomethacinBronchopulmonary dysplasia (defined as supplemental oxygen need at 28 days' postnatal age (Bancalari 1979) or supplemental oxygen at 36 weeks' postmenstrual age with or without compatible clinical and radiographic findings (Shennan 1988))All‐cause neonatal mortality at 28 days and before hospital discharge
primary outcome:
Early full enteral feeding for preterm or low birth weight infants
In hospital rate of weight gain (g/kg/day) until term equivalent.In hospital rate of head circumference growth (cm/week) until term equivalent.Growth restriction: z‐score and proportion of infants who remain below the 10th percentile for the index population distribution of weight at term equivalent.Necrotising enterocolitis, confirmed at surgery or autopsy or diagnosed by at least two of the following clinical features (Kliegman 1987):abdominal radiograph showing pneumatosis intestinalis or gas in the portal venous system or free air in the abdomen;abdominal distension with abdominal radiograph with gaseous distension or frothy appearance (or both) of bowel lumen;blood in stool;lethargy, hypotonia, or apnoea (or combination of these).
primary outcome:
Oral hygiene care for critically ill patients to prevent ventilator‐associated pneumonia
Incidence of VAP (defined as pneumonia developing in a patient who has received mechanical ventilation for at least 48 hours)Mortality (either all‐cause ICU mortality if these data were available, or all‐cause 30‐day mortality)
primary outcome:
Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy
Symptomatic VTE: objectively verified by means of Doppler (compression) ultrasonography or venography for DVT, and spiral computed tomography, ventilation/perfusion lung scan, or pulmonary angiography for PE.Major bleeding; typically defined as overt bleeding associated with a decrease in haemoglobin of 2 g/dL or more, or leading to a transfusion of two or more units of packed red blood cells or whole blood; bleeding that occurred at a critical site (intracranial, intraspinal, intraocular, pericardial, intra‐articular, intramuscular with compartment syndrome, retroperitoneal); or bleeding contributing to death (Schulman 2005).
primary outcome:
Respiratory muscle training for cystic fibrosis
Pulmonary functionforced expiratory volume at one second (FEV1)forced vital capacity (FVC)peak expiratory flow (PEF)Exercise capacity (measured by e.g. maximal oxygen uptake (VO2max), exercise duration, etc.)Health‐related quality of life (measured by e.g. Chronic Respiratory Disease Questionnaire (CRDQ) (Chauvin 2008), Cystic Fibrosis Questionnaire (CFQ) (Wenninger 2003), etc.)
primary outcome:
Magnesium sulphate for treating acute bronchiolitis in children up to two years of age
Time to recoveryMortalityAdverse effects of magnesium sulphate treatment
primary outcome:
Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age
Linear growth (reported continuously in centimetres)Length/height‐for‐age (L/HAZ; reported continuously as WHO z‐score; WHO 2006)Stunting (reported as a categorical outcome; defined as L/HAZ more than 2 SDs below the reference WHO standard; WHO 2006)Adverse effects relevant to excessive vitamin D (reported as categorical outcomes)Hypercalciuria (high urinary calcium levels, defined by trialists)Hypercalcaemia (high serum calcium levels, defined by trialists)Hyperphosphataemia (high plasma phosphate levels, defined by trialists)Kidney stones (nephrolithiasis, defined by trialists)
primary outcome:
Vitamin D supplementation for term breastfed infants to prevent vitamin D deficiency and improve bone health
Bone mineral density measured by dual x‐ray absorptiometry (DXA) or other validated technique (Pezzuti 2017). Where bone mineral density was not reported, we included bone mineral content as an alternative measure of bone mineralisation. Both bone mineral density and bone mineral content are accepted as measures of paediatric bone health (Crabtree 2014).Vitamin D deficiency based on serum 25‐OH vitamin D levels (sufficiency > 50 nmol/L; insufficiency 30 to 50 nmol/L; deficiency < 30 nmol/L) (Munns 2016); (1 nmol/L = 0.4 ng/mL = 40 ng/dL = 400 ng/L = 0.4 μg/L)Nutritional rickets defined as clinical symptoms or signs; and/or radiological signs (including reduced mineralisation and ossification of the physes and metaphyseal splaying); and/or biochemical changes (raised PTH and alkaline phosphatase, hypophosphataemia and hyperphosphaturia with or without hypocalcaemia) (Munns 2016)Adverse effects including vitamin D toxicity (defined as hypercalcaemia and serum 25‐OH vitamin D > 250 nmol/L, with hypercalciuria and suppressed PTH) (Munns 2016)
primary outcome:
Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants
All‐cause mortality during hospital stay.
primary outcome:
N‐acetylcysteine for non‐paracetamol (acetaminophen)‐related acute liver failure
All‐cause mortalitySerious adverse events. We evaluated this outcome as the proportion in each group experiencing one or more serious adverse events. This included acute liver failure‐related complications, such as cerebral oedema, gastrointestinal bleeding, multi‐organ failure, sepsis, cardiac arrest, or respiratory failure, as well as other serious adverse events as defined by the International Conference on Harmonisation Guidelines (ICH‐GCP 1997).Proportion of people requiring liver transplantation.
primary outcome:
Interventions to increase patient and family involvement in escalation of care for acute life‐threatening illness in community health and hospital settings
Outcomes related to patients and family members, healthcare professionals, and health service use. The listed outcomes were not used as criteria for including studies. From those outcomes originally listed in the protocol, we added 'attitudes and beliefs' as an extra patient and family outcome, and broadened 'behavioural intent' to 'behaviours' to include care‐seeking behaviours and behavioural intent (motivation to take on an active role in escalation of care) as our team recognised their significance for escalation of care. See Figure 1 for the conceptual model underpinning the review (showing only primary outcomes). In the case of studies that reported more than one outcome within each of the groupings (e.g. patient and family outcomes; treatment outcomes; clinical outcomes), we had originally intended for two authors to independently list the outcomes for the trial (without considering either the size of the effect or its statistical significance) and make a decision about which one was most ‘clinically’ important. We found this to be restrictive given the paucity of reported outcomes within the groupings in our included papers, so expanded this to include those outcomes deemed 'clinically important' within each grouping rather than limit ourselves to one outcome. Where we made a selection, we described the selection process clearly, including the need for involvement of a third author for further discussion and decision.
primary outcome:
Probiotics for treating acute infectious diarrhoea
Diarrhoea lasting ≥ 48 hoursDuration of diarrhoea
primary outcome:
Pneumococcal conjugate vaccines for preventing acute otitis media in children
Frequency of all‐cause AOM episodes, defined as AOM irrespective of causative pathogen. We considered this to be the most relevant outcome for children, parents, and clinicians.Adverse effects including local (redness, swelling) and systemic reactions (fever), pain/tenderness, and serious adverse events (SAEs) judged to be causally related to vaccination.
primary outcome:
Individualized versus standard diet fortification for growth and development in preterm infants receiving human milk
End of intervention growth velocityWeight (g/kg/d)Length (mm/d)Head circumference (mm/d)
primary outcome:
Comparison of different protein concentrations of human milk fortifier for promoting growth and neurological development in preterm infants
Growth as assessed at birth (or as defined by study author) to discharge from hospital, at 12 months or 18 months (or both) or beyond corrected age expressed in absolute terms or relative to intrauterine or postnatal growth standard for the following:weight gain (g/kg/day or g/day);length gain (cm/week);head circumference gain (cm/week);measures of body composition (lean/fat mass);proportion of infants who were small for gestational age (SGA) (less than 10th percentile of intrauterine growth standards or post‐term growth charts as defined by study author).Neurodevelopmental outcomesNeurodevelopmental disability at 18 months' corrected age or greater defined as a neurological abnormality including any one of the following:cerebral palsy on clinical examination;developmental delay more than two standard deviations (SD) below population mean on a standardised test of development;blindness (visual acuity less than 6/60);deafness (any hearing impairment requiring amplification) at any time after term corrected.Mortality.
primary outcome:
Mechanically assisted walking training for walking, participation, and quality of life in children with cerebral palsy
Mobility, measured directly by tests that produce continuous outcome data, such as the 10‐meter walk test (Watson 2002), or the six‐minute walk test (Maher 2008).Gross motor function, measured through gross motor assessment measures that include walking item(s) and scored on categorical scales (e.g. Gross Motor Function Measure [GMFM] dimensions D and E; Russell 2010).Adverse events, measured using the incidence of adverse outcomes, such as injury and pain, or any other reported adverse events. Pain may have been measured on a binary scale (e.g. pain, no pain), a categorical scale (e.g. the Faces Pain Scale; Bieri 1990), or a continuous scale (e.g. a visual analogue scale). We anticipated that two conditions might have occurred—one was that pain from the intervention did not interfere with training and so training could continue; the other was that pain from the intervention resulted in a need to discontinue training.
primary outcome:
Cognitive behavioural therapy for anxiety disorders in children and adolescents
Remission: the absence of the primary diagnosis of an anxiety disorder post‐treatment, made by reliable and valid structured interviews for DSM or ICD child and adolescent anxiety disorders, such as:Anxiety Disorder Interview Schedule for Children – Child and Parent (ADIS‐C/P) (Silverman 1987);Anxiety Disorder Interview Schedule for Children – Child (ADIS‐C) (Silverman 1987);Anxiety Disorder Interview Schedule for Children – Parent (ADIS‐P) (Silverman 1987);Diagnostic Interview Schedule for Children, Adolescents and Parents (DISCAP) (Holland 1995).Acceptability: loss of participants to post‐treatment assessment
primary outcome:
Band ligation versus sclerotherapy for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis
All‐cause mortality.Serious adverse events and liver‐related morbidity (i.e. proportion of participants who developed ascites, hepatorenal syndrome, hepatocellular carcinoma, or hepatic encephalopathy). A serious adverse event, defined according to the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (ICH‐GCP 1997), was any untoward medical occurrence that resulted in death, was life‐threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability or incapacity, or was a congenital anomaly or birth defect. All other adverse events were considered non‐serious adverse events.Quality of life determined exclusively by means of validated scales, classifications and measurement systems such as the Paediatric Quality of Life Inventory (PedsQL), Child Health Questionnaire (CHQ), and DISABKIDS questionnaires.
primary outcome:
Rufinamide add‐on therapy for drug‐resistant epilepsy
Fifty per cent or greater reduction in seizure frequency: proportion of people with 50% or greater reduction in seizure frequency during the treatment period compared with the pre‐randomisation baseline period
primary outcome:
Pharmacological treatment for continuous spike‐wave during slow wave sleep syndrome and Landau‐Kleffner Syndrome
Neuropsycological‐neurolinguistic function (evaluated by standardised and validated test batteries)intelligence quotient (IQ); Wechsler scales (WPPSI III for children between four and six years (Wechsler 2002), WISC IV for children older than 6 years (Wechsler 2005)); Leiter R scale for non‐verbal children (Roid 1997)attention and memory functionsexecutive and visuo‐spatial functions (Wisconsin card, Sorting test, Nepsy battery, Tower London test, Rey complex picture test; (Berg 1948)language (Peabody picture vocabulary test); (Dunn 2007)