anurajms/meta_analysis huggingface dataset:
primary outcome:
Pit and fissure sealants versus fluoride varnishes for preventing dental decay in the permanent teeth of children and adolescents
Occurrence of new dentinal carious lesions on treated occlusal surfaces of molars or premolars observed within 12 months from the initial treatment: assessed by visual‐tactile clinical assessment as a dichotomous measure using the participant as the unit of analysis in parallel studies and the tooth pair within an individual to be the unit of measurement (yes or no) in split‐mouth studies.Changes from baseline in decayed, missing and filled (DMF) figures at surface, tooth and whole‐mouth levels.Progression of dentinal carious lesions into dentine on treated occlusal surfaces of molars or premolars, observed within 12 months from the initial treatment: assessed by visual‐tactile clinical assessment as a dichotomous measure using a tooth/individual/pair of teeth as the unit of measurement.
primary outcome:
Myofunctional therapy (oropharyngeal exercises) for obstructive sleep apnoea
Daytime sleepiness, measured by a validated scale or questionnaire (e.g. the Epworth Sleepiness Scale (ESS); Johns 1991)Morbidity (including accidents and cardiovascular diseases) and mortality
primary outcome:
Specialised early intervention teams for recent‐onset psychosis
Global stateRecovery, as defined by the studyService useDisengagement from services, as defined by the study
primary outcome:
Specialised early intervention teams (extended time) for recent‐onset psychosis
Global stateRecovery, as defined by the studyService useDisengagement from services, as defined by the study
primary outcome:
Physical activity interventions for people with congenital heart disease
Maximal cardiorespiratory fitness (CRF)Health‐related quality of life determined by a validated questionnaireDevice‐worn ‘objective’ measures of physical activity
primary outcome:
Strategies for improving adherence to antiepileptic drug treatment in people with epilepsy
Improved adherence to medication (including any definition of adherence and noting how this was defined and measured in each study)
primary outcome:
Virtual reality distraction for acute pain in children
1. during the procedure, measured using:self‐report;observer‐report;behavioural measurements (observer‐report).2. post‐procedure (up to one hour), measured using:self‐report;observer‐report;behavioural measurements (observer‐report).
primary outcome:
Drug treatments for managing cystic fibrosis‐related diabetes
Biochemical measures of glycemic control, i.e. HbA1c, fasting and two‐hour post‐meal serum blood sugar valuesPulmonary function (absolute values and change from baseline)forced expiratory volume (FEV1) ( % predicted and L)forced vital capacity (FVC) ( % predicted and L)Assessment of nutritional status (e.g. body mass index (BMI))
primary outcome:
Early versus delayed continuous positive airway pressure (CPAP) for respiratory distress in preterm infants
Use of intermittent positive‐pressure ventilation (IPPV) before dischargeMortality (first 28 days of life and before discharge)Failure of treatment ‐ death or IPPV before hospital discharge
primary outcome:
Continuous positive airway pressure (CPAP) for respiratory distress in preterm infants
Treatment failure (death or respiratory failure as measured by use of any additional assisted ventilation, blood gas criteria or transfer to a neonatal intensive care unit (NICU)).Use of assisted ventilation.Respiratory failure by blood gas criteria.Transfer to a NICU.Mortality at 28 days and at hospital discharge.
primary outcome:
Interventions to reduce contaminated aerosols produced during dental procedures for preventing infectious diseases
Incidence of infection of dental staff or patientsReduction in volume of contaminated aerosols in the operative environmentReduction in level of contamination in aerosols in the operative environment
primary outcome:
Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass
In‐hospital, postoperative mortalityDuration of postoperative mechanical ventilation (days)
primary outcome:
Household interventions for secondary prevention of domestic lead exposure in children
Cognitive and neurobehavioural outcomes in children, assessed with standardised measures of outcome such as assessment of a child's intelligence quotient (IQ), development or behaviour. Suitable IQ measures were the Stanford Binet Intelligence Scale (Smith 1989), the Wechsler Intelligence Scale for Children (Wechsler 1991), and the Wechsler Preschool and Primary Scale of Intelligence (Wechsler 1989). An example of a suitable development measure is the Griffiths Mental Development Scales (Griffiths 1954; Griffiths 1970), and for behaviour, the Child Behavior Checklist (Achenbach 1991).Adverse events of the intervention in children (e.g. injuries or poisoning through cleansing agents).
primary outcome:
Branched‐chain amino acid supplementation for improving growth and development in term and preterm neonates
Physical developmentWeight gain during the 28 days after birth (grams)Increase in height during the 28 days after birth (centimetres)Increase in head circumference during the 28 days after birth (centimetres)Neurological developmentMajor neurodevelopmental disability after 18 months' post‐term ageCerebral palsy (yes/no)Developmental delay (more than two standard deviations (SD) below the mean in a validated mental development test) or intellectual impairment (more than two SD below the mean in a validated intelligence test) (yes/no)Blindness (vision < 6/60 in both eyes) (yes/no)Sensorineural deafness (requiring amplification) (yes/no)
primary outcome:
Pine bark (Pinus spp.) extract for treating chronic disorders
Any clinical outcome directly related to the disorder, stratified asparticipant‐reported outcomes (e.g. joint pain in individuals with osteoarthritis)investigator‐reported outcomes (e.g. serum cholesterol levels in people with hyperlipidaemia, retinal blood flow with diabetic retinopathy)All‐cause mortality
primary outcome:
Protein supplementation of human milk for promoting growth in preterm infants
Growth: weight, length, head circumference, skinfold thickness (WHO 1995), body mass index and measures of body composition (lean, fat mass) and growth restriction (proportion of infants below the 10th percentile for the index population distribution of weight, length, or head circumference). Growth parameters were assessed from birth to hospital discharge, at or after two years’ corrected age, during adolescence, and as adults.Neurodevelopmental outcomes after 12 months’ post term: neurological evaluations, developmental scores, and classifications of disability, including auditory and visual disability. We defined neurodevelopmental impairment as the presence of one or more of the following: non‐ambulant cerebral palsy, developmental quotient more than two standard deviations below the population mean, blindness (visual acuity less than 6/60), or deafness (any hearing impairment requiring or unimproved by amplification).
primary outcome:
Interventions for preventing ophthalmia neonatorum
Proportion of infants developing blindness, defined as a visual acuity of 20/200 or worse measured, e.g., using a Teller visual acuity card at 12 months.Proportion of infants developing any adverse visual outcome measured, e.g., with a Teller visual acuity card at 12 months.Proportion of neonates developing gonococcal conjunctivitis (GC) within 28 days of birth, where diagnosis was made with a laboratory‐based method to identify the infecting organism. We anticipated that most studies would not have studied blindness as an outcome. Because severe GC is associated with a substantial risk for loss of vision, we considered this outcome as a substitute for the more important measure of blindness.
primary outcome:
Aural toilet (ear cleaning) 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 Outcome Test (COMOT)‐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:
Quarantine alone or in combination with other public health measures to control COVID‐19: a rapid review
We focused on time points that studies reported for primary outcomes but also included time points that facilitated comparisons of effects across studies.
primary outcome:
Systemic treatments for eczema: a network meta‐analysis
Proportions of participants who achieved EASI75 (achieved 75% improvement in EASI score) at short‐term (≤ 16 weeks) and long‐term (> 16 weeks) durations were the primary outcomes for assessing clinical severity of eczema. This outcome was selected because the HOME initiative had reached consensus that this should be a core instrument for clinician‐reported signs (Schmitt 2014), and dichotomous outcomes could reflect clinical differences in clinical severity better than continuous outcomesProportions of participants who achieved POEM50 (achieved 50% improvement in POEM score) at short‐term and long‐term durations were planned to be the primary outcome for participant‐reported symptoms because the HOME Initiative consensus indicates that this should be a core instrument for patient‐reported symptoms (Spuls 2017). However, only a few studies reported POEM50; therefore, POEM in continuous scores at short‐ and long‐term durations was used instead of POEM50Proportions of participants with serious adverse effects (SAEs) and proportions of participants with infection at short‐term and long‐term durations were used to evaluate the safety of each systemic treatment
primary outcome:
Carbohydrate supplementation of human milk to promote growth in preterm infants
Growth: weight, length, head circumference, skinfold thickness, body mass index, and measures of body composition (lean/fat mass) and growth restriction (proportion of infants who remain < 10th percentile for the index population distribution for weight, length, or head circumference)Researchers assessed growth parameters from birth to hospital discharge, at or after two years’ corrected age, during adolescence, and during adulthoodNeurodevelopmental outcomesNeurodevelopmental outcomes after 12 months post term included neurological evaluations, developmental scores, and classifications of disability, including auditory and visual disability. We defined neurodevelopmental impairment as the presence of one or more of the following: non‐ambulant cerebral palsy, developmental quotient greater than two standard deviations below the population mean, blindness (visual acuity < 6/60), or deafness (any hearing impairment requiring or unimproved by amplification)
primary outcome:
Psychological and social interventions for the prevention of mental disorders in people living in low‐ and middle‐income countries affected by humanitarian crises
We included studies that met the above inclusion criteria regardless of whether they reported on the following outcomes.
primary outcome:
Psychological treatments for people with epilepsy
Mean of change from baseline, or comparisons of postintervention scores from validated HRQOL measures
primary outcome:
Vitamin E supplementation in people with cystic fibrosis
Vitamin E total lipid ratioVitamin E levels in serumIncidence of vitamin E‐specific deficiency disordersperipheral neuropathyretinopathymyopathy and ataxiacognitive impairmenthaemolytic anemias
primary outcome:
Hydrosurgical debridement versus conventional surgical debridement for acute partial‐thickness burns
Time to complete healing after graft (defined by the original studies and based on clinical assessment).Postoperative infection (clinical diagnosis, as described by the original study and supported by microbiological evidence where possible).
primary outcome:
Pharmacotherapy for hyperuricaemia in hypertensive patients
Change in BP (24‐hour ambulatory systolic, 24‐hour ambulatory diastolic, or both; clinic‐measured systolic, clinic‐measured diastolic, or both)
primary outcome:
Oral 5‐aminosalicylic acid for maintenance of remission in ulcerative colitis
Endoscopic or clinical relapse as defined by the authors of each study.
primary outcome:
Surgical interventions for primary congenital glaucoma
change in IOP from before surgery (baseline) to one year after surgery;surgical success, defined as the proportion with postoperative IOP less than or equal to 21 mmHg with or without glaucoma medications at one year after surgery;qualified success, defined as the proportion with postoperative IOP less than or equal to 21 mmHg with or without glaucoma medications after additional surgeries.
primary outcome:
Interventions for American cutaneous and mucocutaneous leishmaniasis
Percentage of participants 'cured' at least three months after the end of treatment.Adverse effects
primary outcome:
Fat supplementation of human milk for promoting growth in preterm infants
Growth: weight, length, head circumference, skinfold thickness (WHO 1995), body mass index, and measures of body composition (lean/fat mass) and growth restriction (proportion of infants who remained < 10th percentile for the index population distribution of weight, length, or head circumference). Growth parameters were assessed from birth to hospital discharge, at or after two years’ corrected age, during adolescence, and as adults.Neurodevelopmental outcomes: neurodevelopmental outcomes after 12 months post term included neurological evaluations, developmental scores, and classifications of disability, including auditory and visual disability. We defined neurodevelopmental impairment as the presence of one or more of the following: non‐ambulant cerebral palsy, developmental quotient more than two standard deviations below the population mean, blindness (visual acuity < 6/60) or deafness (any hearing impairment requiring or unimproved by amplification).
primary outcome:
Antibiotic therapy for pelvic inflammatory disease
Effectiveness: clinical cure according to the criteria defined by the treating physician (e.g. resolution or improvement of signs and symptoms related to PID).Adverse events: any antibiotic‐related adverse event leading to discontinuation of therapy.
primary outcome:
Stem cell‐based interventions for the prevention of morbidity and mortality following hypoxic‐ischaemic encephalopathy in newborn infants
All‐cause neonatal mortality (mortality less than 28 days of age).Major neurodevelopmental disability: cerebral palsy, developmental delay (Bayley Mental Developmental Index or Griffiths Mental Development Scale assessment greater than two standard deviations (SD) below the mean) (Bayley 1993; Bayley 2006; Griffiths 1954); intellectual impairment (intelligence quotient (IQ) greater than two SDs below the mean); blindness (vision less than 6/60 in both eyes); or sensorineural deafness requiring amplification (Jacobs 2013). We planned to separately assess data on children aged 18 to 24 months and aged three to five years.Death or major neurodevelopmental disability assessed at 18 to 24 months of age (defined as cerebral palsy, developmental delay (Bayley or Griffith assessment more than two SD below the mean) or intellectual impairment (IQ more than two SD below mean); blindness (vision less than 6/60 in both eyes); or sensorineural deafness requiring amplification) (Bayley 1993; Bayley 2006; Griffiths 1954; Jacobs 2013).
primary outcome:
Intravenous immunoglobulin for presumed viral myocarditis in children and adults
Event‐free survival, measured as risk of death or the requirement for cardiac transplant or placement of a left ventricular assist device.Overall survival, measured as risk of death.
primary outcome:
Primaquine alternative dosing schedules for preventing malaria relapse in people with Plasmodium vivax
P vivax parasitaemia (detected by light microscopy or PCR, or both) at 3, 6, and 12 months' follow‐up. We planned to describe this as recurrences of P vivax malaria due to the previously mentioned difficulties in distinguishing between relapse and re‐infection.
primary outcome:
Digital contact tracing technologies in epidemics: a rapid review
The number of secondary cases identified from contact tracing procedures. This can be measured with counts of secondary cases, or with the average number of secondary cases per index case (i.e. effective reproductive number, Reff).The number of close contacts identified from contact tracing proceduresThe average length of time to complete contact tracing for a case (end point would be the last day of follow‐up in the study and, if available, at seven days after case notification). Complete contact tracing is contextually dependent and could mean different things in different settings. For example, the time to complete contact tracing for a case in a study using an app designed to aid data management for contact tracers may mean the time to complete contact tracing with the end point of interest being how long it took to collect all the close contact details. However, a study evaluating an app maintained by the user may evaluate the time to complete contact tracing from the time of notification of the index case to the time of notification of the close contacts. Lastly, a study evaluating an app maintained by the user may evaluate the time to complete contact tracing from the time of notification of the index case to the time of isolation of the close contacts.Acceptability and accessibilityPrivacy issues (whether theoretical or realised)Safety concernsOther ethical issues
primary outcome:
Mobility management to prevent, reduce, or delay driving a car in teenagers
Driving frequency in a prespecified geographical area, measured as the number of journeys made by driving in a car at the end of study follow‐up.
primary outcome:
Metformin versus the combined oral contraceptive pill for hirsutism, acne, and menstrual pattern in polycystic ovary syndrome
(a) Clinical parameters1. Hirsutism as assessed clinically by a trained observer (using a scoring system such as the Ferriman and Gallwey (F‐G) score or a Visual Analogue Scale (VAS)), or participant self‐scoring of subjective improvement or not.
2. Adverse events (gastro‐intestinal and other): severe (requiring stopping of medication), and minor.
primary outcome:
Oral non‐steroidal anti‐inflammatory drugs versus other oral analgesic agents for acute soft tissue injury
When treating acute soft tissue injuries, pain, swelling, functional improvement, and adverse effects are of particular interest (Kellett 1986; Paoloni 2005; Weiler 1992). See Measures of treatment effect for further consideration on outcomes, including timing. More details of the measures listed below are provided in Measures of treatment effect.We did not seek economic data for this review.
primary outcome:
Oral 5‐aminosalicylic acid for induction of remission in ulcerative colitis
The primary outcome was the proportion of participants who failed to enter complete global or clinical remission, as defined by the authors of each study and expressed as a percentage of total participants randomized (intention‐to‐treat (ITT) analysis).
primary outcome:
Pancreatic enzyme replacement therapy for people with cystic fibrosis
Changes in nutritional status (absolute or relative change)weightheightBMI
primary outcome:
Perioperative antibiotics for preventing post‐surgical site infections in solid organ transplant recipients
Surgical site infectionsStratification by era of study (multi‐drug resistance organisms and technical issues)Microbiological data regarding resistance for surgical site infections.
primary outcome:
Glucose‐lowering agents for treating pre‐existing and new‐onset diabetes in kidney transplant recipients
Transplant or graft survivalDelayed graft function/dialysis within 7 daysGlycated haemoglobin A1c (HbA1c)FBGKidney function markers including creatinine, estimated glomerular filtration rate (eGFR), albuminuria
primary outcome:
Early fortification of human milk versus late fortification to promote growth in preterm infants
Time to regain birth weight (days) and subsequent rate of weight gain (g/kg/d), linear growth (cm/week), and increase in head circumference (cm/week) during the initial hospitalisation periodIncidence of necrotising enterocolitis (NEC) stage 2 or 3 (modified Bell’s staging; Walsh 1986)
primary outcome:
Topical treatment for facial burns
Time to complete wound healing, or the proportion of the burn wounds completely healed in a specified time period (as defined by trial authors). Both time to wound healing reported as a time to event outcome and mean time to wound healing outcome were included.Change in wound surface area over time, or the proportion of the burn wound completely healed (epithelialised) in a specific time period (as defined by the trial authors). In case of unclear definition of healing, data were included but this was mentioned.Wound infection (as defined by the trial authors). We did not include data on wound colonisation unrelated to infection.
primary outcome:
Education of family members to support weaning to solids and nutrition in later infancy in term‐born infants
Growth rates (weight gain, linear growth, and head growth) in the first two years of life; change in weight, height, or head circumference z scoresNeurodevelopmental scores in children aged 12 months or older based on validated assessment tools, using neurological examination and the Bayley Scale Index II (Black 2000). These scores were considered abnormal if the Bayley II Mental Developmental Index was less than 70, if the Psychomotor Developmental Index was less than 70, or if there was visual impairment and/or hearing impairment. Neurological examination was considered abnormal if motor and/or sensory functions were impaired
primary outcome:
Beta‐blockers for congestive heart failure in children
Mortality or referral for heart transplantationImprovement of congestive heart failure, expressed by rating systems such as the New York Heart Association (NYHA) classification (NYHA 1994), the Ross Score (Ross 1992), or standardised assessment by participants, parents, or doctorsAdverse events reported by study investigators and by participants
primary outcome:
Workplace pedometer interventions for increasing physical activity
If multiple physical activity measurements were reported, preference was first given to activity assessed over the whole day. For example (in order of preference), metabolic equivalents (METs), step count, METs for moderate and vigorous activity combined, incidental activity (incorporated into work or leisure time (Prodaniuk 2004)), duration of physical activity.Second, if one of these was not available, preference was given to one specific type of activity assessed over the whole day. For example (in order of preference), moderate and vigorous activity, moderate activity, vigorous activity, light activity.Third, preference was given to activity assessed within work time rather than within leisure time (Godin 1985).When more than one measure (e.g. objective, self‐report) was available within one of these three categories, preference was given to measures with less risk of bias. For example (in order of preference), physical activity that is objectively measured, followed by observed and then self‐reported activity (e.g. the Stanford Usual Activity Questionnaire (Sallis 1985), the Dutch short questionnaire to assess health‐enhancing physical activity (Wendel‐Vos 2003), the International Physical Activity Questionnaire (IPAQ 2011)).
primary outcome:
Interventions for the management of obesity in people with bipolar disorder
Changes in body mass, measured as change in BMI.Patient‐reported adverse events (e.g. pain, distress).Quality of life measured by the following validated quality of life measurement scales: the Quality of Life in Bipolar Disorder Scale (QOL‐BD) (Michalak 2010), as well as the suite of Short Form (SF) Health Surveys originating from the SF‐36 tool (Ware 1993).
primary outcome:
Antibiotic adjuvant therapy for pulmonary infection in cystic fibrosis
Pulmonary exacerbations (protocol defined)Respiratory functionper cent (%) predicted forced expiratory volume in one second (FEV1) values for age, sex and height% predicted forced vital capacity (FVC) values for age, sex and heightother validated measures of respiratory functionAdverse events (AEs)mild (not requiring treatment)moderate (requiring treatment or admission)severe (life‐threatening)
primary outcome:
Statins for asthma
Participants with exacerbations requiring hospitalisationParticipants with exacerbations needing a course of steroidsHealth‐related quality of life (change from baseline, assessed with validated questionnaire)Serious adverse events (all‐cause mortality, any life threatening events)
primary outcome:
Head midline position for preventing the occurrence or extension of germinal matrix‐intraventricular haemorrhage in preterm infants
Any germinal matrix‐intraventricular haemorrhage: any IVH, grades 1 to 4 (according to Papile classification (Papile 1978))Severe IVH: ultrasound diagnosis grades 3 and 4 (according to Papile classification (Papile 1978))Neonatal death (first 28 days) or during initial hospitalisation
primary outcome:
Psychological interventions for psychosis in adolescents
We divided outcomes into short‐term (less than six months), medium‐term (seven to 12 months) and long‐term (more than one year).
primary outcome:
Lamotrigine add‐on therapy for drug‐resistant generalised tonic‐clonic seizures
50% or greater reduction in primary generalised tonic‐clonic seizure frequency: the proportion of individuals with a 50% or greater reduction in seizure frequency during the treatment period compared to the pre‐randomizations baseline period. We chose this because it is commonly reported in this type of study, and can be calculated for studies that do not report this outcome, provided that baseline seizure data were recorded.
primary outcome:
Use of reflective materials during phototherapy for newborn infants with unconjugated hyperbilirubinaemia
Decline in serum bilirubin levels per unit of time over the first four to eight hours, at 24 hours, or until the first measurement of bilirubin (μmol/L per unit of time)
primary outcome:
Potassium binders for chronic hyperkalaemia in people with chronic kidney disease
Death (any cause and cardiovascular death)Health‐related quality of life (HRQoL) (using any validated HRQoL measure)GI symptoms (major or minor) (see Table 1 for definitions)
primary outcome:
Ketogenic diets for drug‐resistant epilepsy
Seizure freedom (100% reduction in seizure frequency);50% or greater reduction in seizure frequency (seizure reduction);Adverse effects.
primary outcome:
Cognitive‐behavioural therapy (CBT) interventions for young people aged 10 to 18 with harmful sexual behaviour
RecidivismAny sexual offenceBehavioural reports of sexual aggressionAny nonsexual offenceTime before re‐offenceAdverse events (e.g. Juvenile Risk Assessment Scale (Hiscox 2007))Increase in sexual offendingIncreased seriousness of sexual offendingSelf‐harmSuicide attemptSuicide
primary outcome:
Pitavastatin for lowering lipids
LDL cholesterol
primary outcome:
Low molecular weight heparin for prevention of central venous catheter‐related thrombosis in children
CVC‐related thrombosis (along the length of, or at the tip of, the catheter) as determined by either colour duplex Doppler ultrasonography or contrast venography, with or without clinical suspicion (symptomatic or asymptomatic). This was determined as dichotomous data (yes or no). We intended to obtain the incidence of CVC‐related thrombosis (number of thrombosis by 1000 catheter‐days), if data were available. A CVC‐related thrombosis was considered symptomatic if clinical signs or symptoms of thrombosis were present, including but not restricted to oedema, pain or erythema (Lee 2006).Major and minor bleeding complications, defined as follows (Mitchell 2011):Major bleeding: fatal bleeding, clinically overt bleeding associated with a decrease in haemoglobin of at least 20 g/L in a 24 hours period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the central nervous system; and bleeding that requires surgical intervention in an operating suiteMinor bleeding: any overt or macroscopic evidence of bleeding that does not fulfil the above criteria for major bleeding
primary outcome:
Ventriculo‐peritoneal shunting devices for hydrocephalus
Treatment failure: defined as morbidity associated with shunt placement (slit ventricles (i.e. over‐drainage), obstruction or infections)) or progression of hydrocephalus detected by signs or symptoms of intracranial hypertension or imaging studies that led to shunt revision in the early postoperative period (≤ 30 days) or beyond the early postoperative period (> 30 days).Adverse events: morbidity related to the shunt placement that has not led to shunt revision (e.g. subdural haematomas, secondary craniosynostosis and microcephaly) in the early postoperative period (≤ 30 days) or beyond the early postoperative period (> 30 days).Mortality: defined as death for all causes in the early postoperative period (≤ 30 days) or beyond the early postoperative period (> 30 days).
primary outcome:
Standard versus biofilm antimicrobial susceptibility testing to guide antibiotic therapy in cystic fibrosis
Lung functionforced expiratory volume at one second (FEV1) (absolute values or change from start of treatment (post hoc change) (L or per cent (%) predicted or both))forced vital capacity (FVC) (absolute values or change from start of treatment (post hoc change) (L or % predicted or both))mid‐expiratory flow (FEF25-75%) (absolute values or change from start of treatment (post hoc change) (L or % predicted or both))Pulmonary exacerbations, defined as an increase in respiratory symptoms requiring antibiotic therapy (Fuchs 1994)number of pulmonary exacerbationstime between pulmonary exacerbationstime to subsequent exacerbationAdverse events (including numbers of events, proportion of participants withdrawing and proportion of participants changing therapy)mild (transient event, no treatment change, e.g. rash)moderate (treatment discontinued, e.g. nephrotoxicity)severe (causing hospitalization or death)
primary outcome:
Antibiotic treatment for nontuberculous mycobacteria lung infection in people with cystic fibrosis
Lung functionforced expiratory volume in one second (FEV1) (absolute values L or per cent (%) predicted or both)forced vital capacity (FVC) (absolute values L or % predicted or both)mid‐expiratory flow (FEF25-75) (absolute values L or % predicted or both)Pulmonary exacerbations, defined as an increase in respiratory symptoms requiring intravenous antibiotic therapy (Fuchs 1994) (if pulmonary exacerbations are not defined in the trial, data from that trial relating to pulmonary exacerbations will not be reported in this review)number of pulmonary exacerbationstime between pulmonary exacerbationstime to subsequent exacerbationAdverse events (proportion of participants who had to withdraw or changed therapy)mild: transient event, no treatment change, e.g. rash, nausea, diarrhoeamoderate: treatment discontinued, e.g. nephrotoxicity, ototoxicity, hepatitis, visual impairmentsevere: causing hospitalization or death
primary outcome:
Vitamin K supplementation for cystic fibrosis
Clinical outcomes related to coagulopathy (Sutor 1995)time to cessation of bleeding manifestations (symptomatic coagulopathy)  time to normalisation of sub‐therapeutic international normalized ratio (INR) (asymptomatic or sub‐clinical coagulopathy)Bone formation outcome measures   BMD at the spine (L1‐L4) and the total hip (measured by dual energy X‐ray absorptiometry (DEXA) scans with z score compared to reference population) (Borowitz 2002)    reduction in risk of bone fractures QoL (e.g. the CFQ‐R (Quittner 2000) and the CFQoL (Gee 2000))
primary outcome:
Multi‐nutrient fortification of human milk for preterm infants
Growth: weight, length, head growth, skinfold thickness, body mass index, and measures of body composition (lean/fat mass) and growth restriction (proportion of infants who remain < 10th percentile for the index population distribution of weight, length, or head circumference)Neurodevelopmental outcomes assessed after 12 months post term: neurological evaluations, developmental scores, and classifications of disability, including auditory and visual disability. We defined neurodevelopmental impairment as the presence of one or more of the following: non‐ambulant cerebral palsy, developmental quotient more than two standard deviations below the population mean, and blindness (visual acuity < 6/60) or deafness (any hearing impairment requiring or unimproved by amplification)
primary outcome:
Effects of total fat intake on body fatness in adults
The main outcome was body fatness assessed using a variety of measures. These included body weight, body mass index, waist circumference, skinfold thickness and percentage fat. Studies had to assess or report at least one of these measures, or a change in these measures, to be included in the review. Measures of body fatness needed to be assessed at least six months after the intervention was initiated, and data at trial end, or from the latest available time during the trial, were used.
primary outcome:
Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non‐hospitalised term infants
Proportion of mothers who continued breastfeeding (exclusive or any) for at least 3, 4 and 6 months.Infant weight in trials where the infants received only own mother's milk (g) at latest time measured. We will not include this outcome if infants in the study were given supplemental milk, as the additional milk will invalidate the outcome.Volume of breast milk at the latest time measured (mL).
primary outcome:
Interventions for congenital talipes equinovarus (clubfoot)
Function: self‐reported or parent‐ or proxy‐reported day‐to‐day function at a minimum of one year post‐treatment, as measured by any validated assessment tool, for example, Clubfoot Disease Specific Index (DSI) (Dietz 2009); physical component of the Child Health Questionnaire (CHQ) (Landgraf 1999); and physical subscale of the Short Form 36 Health Survey (SF‐36) (Ware 1992).
primary outcome:
Combination antimicrobial susceptibility testing for acute exacerbations in chronic infection of Pseudomonas aeruginosa in cystic fibrosis
Lung functionforced expiratory volume in one second (FEV1) (L/min or % predicted)forced vital capacity (FVC) (L/min or % predicted)Time to next pulmonary exacerbation
primary outcome:
Artificial corneas versus donor corneas for repeat corneal transplants
Proportion of participants with best‐corrected visual acuity (BCVA) of 20/100 or better, measured as Snellen equivalent, at two years after corneal replacement
primary outcome:
Alarm interventions for nocturnal enuresis in children
Mean number of wet nights a week at the end of treatmentProportion of children achieving 14 consecutive dry nights by the end of treatment
primary outcome:
Topical azelaic acid, salicylic acid, nicotinamide, sulphur, zinc and fruit acid (alpha‐hydroxy acid) for acne
Participants' global self‐assessment of acne improvement (e.g. measured by a 4‐point scale: excellent, good, fair, and poor)Withdrawal for any reason
primary outcome:
Corticosteroids as standalone or add‐on treatment for sore throat
Complete resolution of pain at 24 and 48 hours.Mean time to onset of pain relief.Mean time to complete resolution of pain.
primary outcome:
Inhaled mannitol for cystic fibrosis
Health‐related quality of life (HRQoL) as measured by a validated tool such as the Cystic Fibrosis Questionnaire‐Revised version (CFQ‐R (Quittner 2009)) or Cystic Fibrosis Quality of Life Questionnaire (CFQoL (Gee 2000))Lung functionforced expiratory volume in one second (FEV1) (mL or % predicted)forced vital capacity (FVC) (mL or % predicted)forced expiratory flow between 25% and 75% expired volume (FEF25-75) (mL/s or % predicted)Adverse events relating to treatmenttype and number of adverse events defined as follows according to perceived effect on the participantmild (not requiring extra treatment, noted but tolerable)moderate (requiring extra treatment and cessation of the intervention)severe (life‐threatening or results in death, requiring hospitalisation, results in persistent or significant disability)number of participants who ceased inhalations because of poor tolerability e.g. cough or bronchoconstriction
primary outcome:
Normal saline (0.9% sodium chloride) versus heparin intermittent flushing for the prevention of occlusion in long‐term central venous catheters in infants and children
Occlusion of the CVC, determined by the inability to infuse fluids through the catheterCVC‐associated blood stream infection or colonisation of the catheter (as defined by studies)Duration in days of catheter placement
primary outcome:
Oscillating devices for airway clearance in people with cystic fibrosis
Respiratory functionforced expiratory volume at one second (FEV1)mid‐expiratory flow (FEF25-75 )forced vital capacity (FVC)expiratory reserve volume (ERV) or reserve volume (RV)
primary outcome:
Tonsillectomy versus tonsillotomy for obstructive sleep‐disordered breathing in children
Clinical effectiveness expressed as disease‐specific quality of life using any validated instrument, such as Obstructive Sleep Apnoea 18 (OSA‐18) or Obstructive Sleep Disorders 6‐survey (OSD‐6; see the Spruyt 2011 review for a comprehensive list) and/or disease‐specific symptom scores using any validated instrument, such as the Paediatric Sleep Questionnaire (PSQ; see the Spruyt 2011 review for a comprehensive list) at 0 to 6 months (short term), 7 to 12 months (medium term) and 13 to 24 months (long term).Peri‐ and postoperative morbidity and complications expressed as:peri‐operative blood loss (volume measured);proportion of children requiring medical intervention (with or without hospitalisation), within the first seven days after surgery, due to haemorrhage from the tonsillar bed, infection or dehydration.
primary outcome:
Treating progressive disseminated histoplasmosis in people living with HIV
We collected data on key outcomes, as summarized in the table below.Where possible, we collected dichotomous and time‐to‐event data for relevant outcomes. We also collected data on mortality, and severe adverse events, including type and frequency.
primary outcome:
Clonazepam add‐on therapy for drug‐resistant epilepsy
The proportion of participants with a 50% or greater reduction in seizure frequency in comparison to the pre‐randomisation baseline period (intention‐to‐treat analysis).The proportion of participants achieving total cessation of seizures.The proportion of participants having their treatment withdrawn during the course of the treatment period. The treatment might be withdrawn due to adverse effects, lack of efficacy, or a combination of both.
primary outcome:
Vitamin D, calcium or a combination of vitamin D and calcium for the treatment of nutritional rickets in children
Healing of rickets.Morbidity.Adverse events.
primary outcome:
Non‐invasive respiratory support for the management of transient tachypnea of the newborn
Need for mechanical ventilation (yes/no)Pneumothorax (diagnosis on chest X‐ray, any time after intervention)
primary outcome:
Interventions for fatigue in inflammatory bowel disease
The primary outcome for this review was fatigue. Therefore, eligible studies for inclusion must have fatigue or loss of energy measured as a primary or secondary outcome. Measures of fatigue are self‐reported as it is a subjective phenomenon and these instruments may be generic or disease‐specific. Examples of generic self‐reported measures include but are not limited to: the Fatigue Severity Scale (FSS) (Krupp 1989), Chalder Fatigue Scale (CFQ) (Chalder 1993), Fatigue Impact Scale (FIS) (Fisk 1994; Fisk 2002), Visual Analogue Scale of Fatigue (VAS‐F) (Lee 1991), Piper Fatigue Scale (PFS) (Piper 1998), Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT‐F) (Yellen 1997), Multidimensional Fatigue Inventory (MFI) (Smets 1996), and the Multidimensional Assessment of Fatigue (MAF) (Tack 1991). An example of a disease‐specific measure includes the Inflammatory Bowel Disease‐Fatigue scale (IBD‐F) (Czuber‐Dochan 2014c).In addition, studies that reported data on fatigue, loss of energy, vigour and vitality which was assessed as a single question or as a subscale of a questionnaire (e.g. the vitality subscale of the Short Form‐36 (SF‐36) or Inflammatory Bowel Disease Questionnaire (IBDQ) ( Irvine 1999; Ware 1992) were included. Multidimensional characteristics of fatigue symptoms may be measured. For example, these characteristics may include intensity, severity, frequency, duration, distress or dimensions including physical fatigue, mental fatigue or general fatigue.
primary outcome:
Anthelmintic drugs for treating ascariasis
Parasitological cure.
primary outcome:
Omega‐3 fatty acid supplementation for cystic fibrosis
Number of respiratory exacerbations including:hospitalisationsnumber of courses of antibiotics given (oral and intravenous) (moved from secondary outcomes in a post hoc change)Adverse events and dropoutsLung function includingper cent predicted forced expiratory volume in one second (FEV1)forced vital capacity (FVC)
primary outcome:
Rinse‐free hand wash for reducing absenteeism among preschool and school children
Student absenteeism for any reason. Absenteeism is defined as time absent from preschool or school when the student is scheduled to be attending, and does not include planned holidays or leave, or student‐free days.Student absenteeism due to any illness.Adverse skin reactions (such as a rash or irritation) within the trial period.
primary outcome:
Agricultural and nutritional education interventions for reducing aflatoxin exposure to improve infant and child growth in low‐ and middle‐income countries
We analysed the following outcomes from our included studies, where available. However, the outcomes reported by individual studies did not form part of the eligibility criteria for this review.
primary outcome:
EEG for children with complex febrile seizures
Proportions of children developing seizures of any type after follow‐up periods of one month, six months, 12 months, and two years in two comparison groups of EEG versus no EEG and early EEG versus late EEG. We decided to include any type of seizure in this outcome. We recorded the available outcome measures with respect to a particular time period. In addition, we planned to contact the original trial authors to enquire whether outcome measurements had been recorded for other time periods of interest. We believe that the most important clinically relevant time period was two years.Risk of recurrence between no EEG and EEG (early EEG, late EEG, or any other time), which will act as a surrogate outcome.Total number of seizure episodes in each group during two‐year follow‐up.Time to development of seizures as time‐to‐event outcome.Adverse events (although the EEG may not cause any adverse event per se, adverse events may be related to sedation given to children and may be transient).
primary outcome:
Clonidine for pain in non‐ventilated infants
Pain assessed using the pain scales listed in Table 1.
primary outcome:
Early versus late parenteral nutrition for critically ill term and late preterm infants
In‐hospital all‐cause mortality: defined as death from any cause during the initial hospital stayNeonatal mortality: defined as death in the first 28 days since birth from any cause
primary outcome:
Exercise versus no exercise for the occurrence, severity, and duration of acute respiratory infections
Number of ARI episodes per person per year.Proportion of participants who experienced at least one ARI over the study period.Severity of ARI symptoms.Number of symptom days in the follow‐up period (12 weeks).Number of symptom days per episode of illness.
primary outcome:
Antibiotic treatment for Burkholderia cepacia complex in people with cystic fibrosis experiencing a pulmonary exacerbation
Lung functionchange in absolute values for forced expiratory volume in one second (FEV1)change in per cent (%) predicted values for FEV1Survival (measured as hazard ratios)Adverse events    mild (transient and treatment continued, e.g. rash, nausea)moderate (necessitating discontinuation of treatment, e.g. reversible renal or hepatic impairment)severe (life threatening or seriously debilitating, e.g. aplastic anaemia, permanent hearing loss or renal impairment)
primary outcome:
Treatments for the prevention of Sudden Unexpected Death in Epilepsy (SUDEP)
Number of deaths from SUDEP
primary outcome:
Enteral lactoferrin supplementation for prevention of sepsis and necrotizing enterocolitis in preterm infants
Confirmed or suspected sepsis during hospital stay:Confirmed sepsis is defined as clinical signs and symptoms consistent with infection and microbiologically proven with a positive blood culture, cerebrospinal fluid (CSF) culture, urine culture (obtained by a suprapubic tap), or culture from a normally sterile site (e.g., pleural fluid, peritoneal fluid, autopsy specimens) for bacteria or fungi;Suspected sepsis is defined as clinical signs and symptoms consistent with sepsis without isolation of a causative organism.NEC Bell's stage II or III during hospital stay:necrotizing enterocolitis (NEC) (definitive NEC and perforated NEC, Bell's stage II or III) (Bell 1978) during hospital stay.'All‐cause mortality' during hospital stay.
primary outcome:
Interventions for preventing and managing advanced liver disease in cystic fibrosis
Change in variceal bleeding and portal pressuredevelopment of first bleeding episode (primary prevention)re‐bleeding following endoscopic treatment (secondary prevention)Adverse effectsof non‐surgical interventions (e.g. aggravated congestive cardiac failure, respiratory distress, hypotension from non‐selective beta‐blockers, stenosis, occlusion, thrombosis, worsened encephalopathy after TIPSS, perforation of oesophagus, oesophageal ulceration, oesophageal stricture after sclerotherapy)of surgical interventions (e.g. thrombosis, occlusion, onset or worsening of encephalopathy, infection, rejection)
primary outcome:
Physical therapies for postural abnormalities in people with cystic fibrosis
Change in QoL in carrying out activities of daily living over the short, medium and long term*, measured by a validated instrumentoverall (e.g. Medical Outcomes Study 36 – Item Short – Form Health Survey (SF‐36))health‐related QoL (HRQoL) (e.g. Cystic Fibrosis Questionnaire Revised (CFQ‐R) (Quittner 2009))Change in pain in carrying out activities of daily living over the short, medium and long term*, measured by a validated instrument (e.g. visual analogue scale (VAS)), or other available pain scales (Numerical Rating Scale for Pain, Chronic Pain Grade Scale)Change in trunk deformity in carrying out activities of daily living over the short, medium and long term*, measured by a validated instrument (e.g. Cobb method, biophotogrammetry)
primary outcome:
Glucocorticoid replacement regimens for treating congenital adrenal hyperplasia
QoL score (as assessed by Short Form Health Survey (SF‐36))Androgen normalisation (defined by 17 OHP monitoring)Prevention of adrenal crisis
primary outcome:
Sustained versus standard inflations during neonatal resuscitation to prevent mortality and improve respiratory outcomes
Death in the delivery roomDeath during hospitalisationDeath to latest follow‐up
primary outcome:
Diaphragm‐triggered non‐invasive respiratory support in preterm infants
Failure of modality requiring change or escalation to an alternative mode of respiratory support.Respiratory failure defined by one or more of the following: respiratory acidosis (e.g. pH < 7.25 with a normal base excess; PaCO₂ > 60 mmHg); increased oxygen requirement (e.g. oxygen requirement > 50% to maintain SpO₂ 91% to 95%; rapid rise in oxygen requirement of 10% in < 2 hours); frequent or severe apnoea leading to additional ventilatory support during the week post extubation; increased work of breathing (e.g. sternal and intercostal recession, grunting, tachypnoea).
primary outcome:
Postnatal corticosteroids for transient tachypnoea of the newborn
Need for nasal continuous positive airway pressure (yes/no)Need for mechanical ventilation (yes/no)