anurajms/meta_analysis huggingface dataset:
primary outcome:
Probiotics for the prevention of pediatric antibiotic‐associated diarrhea
The primary outcomes included:1. Incidence of diarrhea using the primary investigators' definition (i.e. frequency, consistency of bowel movements); and
2. Number and type of adverse events (e.g. bacteremia, meningitis).
primary outcome:
MVA85A vaccine to enhance BCG for preventing tuberculosis
Active tuberculosis, defined by:clinical signs and symptoms plus confirmation by microscopy, culture, or Xpert® MTB/RIF (an automated nucleic‐acid amplification test);treatment commenced for tuberculosis.
primary outcome:
Haloperidol discontinuation for people with schizophrenia
We divided all outcomes into short term (up to three months), medium term (over three and up to six months) and long term (over six months).
primary outcome:
Eradication therapy for Burkholderia cepacia complex in people with cystic fibrosis
Eradication (i.e. no BCC positive cultures from bronchoalveolar lavage (BAL), sputum or oropharyngeal aspirate for a period of 12 months over a minimum of six samples)Length of time remaining infection free (post‐eradication therapy)
primary outcome:
Medical treatment for botulism
In‐hospital death from any cause occurring within four weeks from randomization or the beginning of treatment.
primary outcome:
First aid glucose administration routes for symptomatic hypoglycaemia
Resolution of symptomsTime to resolution of symptomsBlood or plasma glucose concentration at 20 minutes
primary outcome:
Home use of interdental cleaning devices, in addition to toothbrushing, for preventing and controlling periodontal diseases and dental caries
Gingivitis ‐ assessed by gingival indices and bleeding indices in separate analyses;Periodontitis ‐ assessed by clinical attachment loss and pocket probing depth;Interproximal caries ‐ assessed by (a) progression of caries into enamel or dentine, (b) change in decayed, missing and filled tooth surfaces (D(M)FS) index, (c) radiographic evidence. Studies had to contain explicit criteria for diagnosing dental caries. As caries increment could be reported differently in different trials, we planned to use a set of a priori rules to choose the primary outcome data for analysis from each study (Marinho 2013; see Table 1);Plaque – assessed by plaque scores or indices;Harms and adverse effects.
primary outcome:
Psychological therapies (remotely delivered) for the management of chronic and recurrent pain in children and adolescents
Pain symptomsDisabilityDepressionAnxietyAdverse events
primary outcome:
Long‐term antibiotics for preventing recurrent urinary tract infection in children
The primary outcome was the number of repeat symptomatic UTIs, confirmed by bacterial growth in the urine, in combination with signs or symptoms of a urine infection while on treatment/placebo.
primary outcome:
Constraint‐induced movement therapy in children with unilateral cerebral palsy
In the original review (Hoare 2007a; Hoare 2007b), we broadly grouped outcome measures according to the domains of the International Classification of Functioning, Disability and Health (ICF) (WHO 2001). For this review update, we categorised measures into primary or secondary outcomes, to better reflect the expected effect of CIMT (Eliasson 2014a). The goal of CIMT is to improve unilateral upper‐limb ability to transfer into improved bimanual functional performance (self‐care, manual ability, individual performance). The primary outcomes, therefore, focused on both bimanual and unimanual function. Secondary measures included those that CIMT may effect but are not the primary target of intervention.We considered outcome measures ineligible for inclusion if they: 1) did not possess adequate reported validity or reliability (or both) for children with CP; 2) were standardised assessments that were invalidated because the administration or scoring was adapted; or 3) both. Ineligible measures and the reasons for ineligibility are listed in Table 3.We deemed the following measures eligible for inclusion.
primary outcome:
Supplemental perioperative intravenous crystalloids for postoperative nausea and vomiting
Risk of PON, defined as the presence of subjective nausea, reported dichotomously or based on a study‐defined dichotomous threshold on a continuous scale such as a visual analogue scale (VAS).Risk of POV, reported dichotomously by any discrete episodes of vomiting.
primary outcome:
Family‐based prevention programmes for alcohol use in young people
Alcohol use (yes/no).Alcohol use (quantity, frequency).'Binge' drinking (e.g. defined as drinking five or more drinks on any one occasion) (yes/no).Incidence of drunkenness.
primary outcome:
Multiple‐micronutrient supplementation for women during pregnancy
Preterm births (births before 37 weeks of gestation)Small‐for‐gestational age (SGA) (as defined by the authors of the trials)Low birthweight (LBW) (birthweight less than 2500 g)Perinatal mortalityStillbirthsNeonatal mortality
primary outcome:
Probiotics to prevent infantile colic
Occurrence of new cases of colic at study end, as defined by the Wessel criteria.Adverse effects, including parental depression and mental illness, choking, bacterial infection or apparent life‐threatening/serious events (dichotomous outcome).
primary outcome:
Dental cavity liners for Class I and Class II resin‐based composite restorations
Postoperative hypersensitivity to hot, cold, biting, chewing, and/or sweets experienced by the patient within 1 month following the intervention. Postoperative hypersensitivity could be measured by a visual analog scale (VAS) or by hypersensitivity present or absent as tested by dentist or patient self‐report.Restoration failure. Survival time of the resin‐based composite restoration (in months) from the time of placement with a minimum follow‐up of 1 year.
primary outcome:
Fluoride toothpastes of different concentrations for preventing dental caries
change from baseline in the decayed, (missing), and filled surface or teeth index (D(M)FS/T), in all permanent teeth erupted at the start and erupting over the course of the study (dental caries is defined here as being clinically and radiologically recorded at the dentine level of diagnosis);change from baseline in the decayed, (missing/extraction indicated), and filled surface or teeth index (d(e/m)fs/t) in all primary teeth;change in the proportion of participants developing new caries.DFS/T data would be chosen over DMFS/T data, and these would be chosen over DS/T or FS/Tdata for 'all surface types combined' would be chosen over data for 'specific types' onlydata for 'all erupted and erupting teeth combined' (E + U) would be chosen over data for 'erupted' (E) only, and these over data for 'erupting' (U) onlydata for dentinal/cavitated caries lesions (D3 level) would be chosen over data for enamel/non‐cavitated lesions (D1 level)net caries increment data would be chosen over crude (observed) increment datadata from 'clinical and radiological examinations combined' would be chosen over data from 'clinical' (cl) only, and these over 'radiological' (xr) only. We defined clinical examinations as an examination using visual or tactile methods or both (VT) using a conventional lighting source. We excluded studies reporting caries using a non‐clinical examination alone (e.g. electronic caries monitor, quantitative light‐induced fluorescence)follow‐up nearest to 3 years (often the one at the end of the study period) would be chosen over all follow‐up.non‐cavitated incipient enamel lesions clinically visible as white spots or discoloured fissures (NCA);lesions showing loss of enamel continuity that can be recorded clinically (undermined enamel, softened floor, walls) or showing frank cavitation (CA).any radiolucency in enamel/enamel‐dentine junction (ER);radiolucency into dentine (DR).
primary outcome:
Physical exercise training for type 3 spinal muscular atrophy
Walking distance on the six‐minute walk test (6MWT; Dunaway 2016; Montes 2010).Functional performance, measured with the Hammersmith Functional Motor Scale ‐ Expanded (HFMSE; O'Hagen 2007), Motor Function Measure (MFM; Vuillerot 2013), and timed tests (10‐meter walk/run test (10MWT), Gower's time, or Timed Up and Go Test (TUG; Dunaway 2014)).
primary outcome:
The use of ultrasound guidance for perioperative neuraxial and peripheral nerve blocks in children
Success rate (study author's definition).Pain scores at one hour after surgery (any ascendent or descendent pain scale used by study authors).Block duration (study author's definition; 0 to 1 day).
primary outcome:
Positive end‐expiratory pressure for preterm infants requiring conventional mechanical ventilation for respiratory distress syndrome or bronchopulmonary dysplasia
Eligible outcomes varied slightly between the three objectives. Outcomes from cross‐over trials were limited to those measured at the end of the first cross‐over period.
primary outcome:
Iodine supplementation for the prevention of mortality and adverse neurodevelopmental outcomes in preterm infants
Neonatal mortality and mortality prior to hospital discharge.Neurodevelopmental outcomes assessed by a validated test after 12 months' post‐term: neurological evaluations, developmental scores, and classifications of disability, including auditory and visual disability.
primary outcome:
Parenteral versus oral iron therapy for adults and children with chronic kidney disease
Death (all causes)Cardiovascular deathQuality of life
primary outcome:
Education of family members to support weaning to solids and nutrition in infants born preterm
Growth rates (weight gain, linear growth, and head growth) in the first two years of life; change in weight, height/length or head circumference z‐scores;neurodevelopmental scores in children aged 12 months or older of CGA, measured using validated assessment tools, using neurological examination and Bayley Scale Index II (Black 2000). We considered these scores to be abnormal if Bayley II Mental Developmental Index was < 70, Psychomotor Developmental Index was < 70, or if there is visual or hearing impairment. We considered neurological examination abnormal if there were impaired motor or sensory functions, or both.
primary outcome:
Interventions for primary vesicoureteric reflux
Number of patients with symptomatic UTI: defined as symptoms consistent with a UTI which may include local symptoms only e.g. dysuria or systemic symptoms such as fever, together with a positive urine culture. This outcome includes febrile UTI
primary outcome:
Antibiotic treatment for newborns with congenital syphilis
Neonatal death rate due to congenital syphilis.Neonatal death rate due to any cause.Absence of clinical manifestations of congenital syphilis during follow‐up (defined as proportion of newborns without hepatosplenomegaly, lymphadenopathy, organ involvement or any other clinical manifestation after treatment).Serious adverse events (proportion of neonates who experience any adverse effect that was life‐threatening or required discontinuation of therapy or intervention to prevent permanent impairment or damage).
primary outcome:
Dietary interventions for induction and maintenance of remission in inflammatory bowel disease
Induction of remission involves the therapeutic reduction of intestinal symptoms below a clinical threshold as measured by CD and UC symptom scores, including the Pediatric Crohn’s Disease Activity Index (PCDAI), the Crohn’s Disease Activity Index (CDAI), the Harvey‐Bradshaw Index (HBI), the Mayo score, modified Mayo score or Colitis Activity Index (CAI).Maintenance of remission involves the continual abatement of symptoms over time attributable to a therapeutic modality (in this case, diet). Maintenance of remission will be assessed based on available fixed time intervals (e.g. six months, one year) and as variable time contributions (e.g. person‐years). A clinical relapse is defined as the transition from a state of clinical remission to active disease, based on symptom scores (i.e. PCDAI, CDAI, HBI, Mayo score, or CAI).
primary outcome:
Needle aspiration versus intercostal tube drainage for pneumothorax in the newborn
Mortality: neonatal (first 28 days of life) or during hospitalisation.
primary outcome:
Intermittent iron supplementation for reducing anaemia and its associated impairments in adolescent and adult menstruating women
Anaemia (haemoglobin concentration below a cut‐off defined by the trialists, adjusted by altitude and smoking, as appropriate)*Haemoglobin (g/L)*Iron deficiency (as defined by the trialists using indicators of iron status such as ferritin or transferrin)*Ferritin (µg/L)*Iron deficiency anaemia (as defined by the presence of anaemia plus iron deficiency, diagnosed with an indicator of iron status selected by the trialists)*All‐cause morbidity (the most frequent event associated with the intervention, independent of the cause, as defined by the trialists)*
primary outcome:
Phosphodiesterase 5 inhibitors for pulmonary hypertension
Change in WHO functional classSix‐minute walk distance (6MWD)Mortality
primary outcome:
Pharmacotherapies for cannabis dependence
Number of participants abstinent from cannabis at the end of treatment as determined by self‐report or urine drug screens, or both.Intensity of withdrawal as determined by scores on withdrawal scales, the need for symptomatic medications in addition to the experimental intervention or overall assessments by clinicians and participants.Nature, incidence and frequency of adverse effects and whether the planned medication regimen was modified in response to adverse effects.Completion of scheduled treatment.
primary outcome:
School‐based self‐management interventions for asthma in children and adolescents: a mixed methods systematic review
Asthma symptoms or exacerbations leading to admission to hospital (children with one or more admissions or high admission rates)Asthma symptoms or exacerbations leading to emergency department visitsParent‐reported absence from schoolDays of restricted activity
primary outcome:
Antibiotics for treating urogenital Chlamydia trachomatis infection in men and non‐pregnant women
Microbiological failure: defined as a positive result for CT on any diagnostic tests after antibiotic treatment. The test was done within one to four weeks after the end of the antibiotic treatment. Diagnostic tests were cell culture for CT, antigen‐based detection methods, immunofluorescence tests, enzyme immunoassay or NAAT.Any adverse event (AE). AEs included gastrointestinal symptoms (pyrosis or abdominal pain) or any serious or non serious systemic reactions (serious: Steven Johnson syndrome, cutaneous lupus erythematosus or erythema multiforme; non‐serious: headache, fatigue, myalgia, nausea, decrease of haemoglobin or white blood cells or platelets) during treatment.
primary outcome:
Surgical versus conservative interventions for treating fractures of the middle third of the clavicle
Function or disability (mean or mean change), measured by upper limb functional outcome measures. Ideally, these should be participant‐reported measures of function, validated for people with clavicle fractures (however, we are not aware of any outcome measures in this category). Validated patient‐reported measures include the Disability of the Arm, Shoulder, and Hand questionnaire (DASH; Hudak 1996), and the Constant score (Constant 1987), which is a composite score for shoulder function that includes subjectively rated pain and activities of daily living, as well as objectively rated range of movement and strength.Pain: preference was given to reports of pain measured using validated pain scales (visual analogue scale (VAS) or numerical rating scale (NRS)), and reported as a dichotomous outcome, for example, number with a clinically important change in pain score in the short‐term phase (e.g. proportion with at least 30% improvement in pain), or participant‐reported long‐term pain (e.g. proportion above 30/100‐mm VAS scale, i.e. worse than mild pain). Examples are drawn from recommendations in Eccleston 2010 and Moore 2010. When data were not reported as a dichotomous measure, we used a continuous measure: mean pain or mean change in pain.Treatment failure measured by the number of participants who have undergone or are being considered for a non‐routine secondary surgical intervention for symptomatic non‐union, malunion or other complications (e.g. mechanical failure, defined as a condition in which an implant loses its capacity to carry a load). This does not include plate removal for hardware irritation.
primary outcome:
Oral H1 antihistamines as ‘add‐on’ therapy to topical treatment for eczema
Mean change in patient‐assessed symptoms of eczema, as measured by a standardised or validated eczema symptoms score (e.g. visual analogue scale for itching, patient‐oriented eczema measure (Charman 2004))Proportion of participants reporting adverse effects and serious adverse events throughout the study period
primary outcome:
Inpatient versus outpatient care, partial hospitalisation and waiting list for people with eating disorders
Note: Studies of anorexia nervosa reported main outcomes at one year after baseline.All included studies reported both primary outcomes of weight, BMI, or frequency of binge eating, and numbers completing treatment. One study did not provide outcomes at the end of treatment, but one year following the initial assessment, regardless of when treatment finished; treatment finished at different points in the 12 months following baseline (Crisp 1991).
primary outcome:
Adverse events in people taking macrolide antibiotics versus placebo for any indication
Any reported adverse event that occurred in 5% or more of any group (Zarin 2016).Death.Subsequent carriage of macrolide‐resistant bacteria.
primary outcome:
Adrenaline and vasopressin for cardiac arrest
Survival to hospital discharge.Survival to hospital admission.Neurological outcome, assessed using either the Glasgow Outcome Scale (Jennett 1975; Teasdale 1998) or Cerebral Performance Category (Jennett 1975) or modified Rankin scale (Quinn 2009).
primary outcome:
Postoperative epidural analgesia versus systemic analgesia for thoraco‐lumbar spine surgery in children
Pain (at rest and on movement up to 72 hours after surgery). We included pain measured on any ascending or descending scale as provided by study authors.Vomiting up to 48 hours after surgery (number of participants with event). We extracted data on this outcome as the number of participants who experienced vomiting episodes.Return of gastrointestinal function measured as time to first:flatus (hours);bowel movement (hours);liquid ingestion (hours);solid food ingestion (hours).
primary outcome:
Antiamoebic drugs for treating amoebic colitis
Clinical failure, defined as absence of E histolytica in stools or scrapings but with little or no relief of signs or symptoms, or with persistent rectal ulcerations on sigmoidoscopyParasitological failure, defined as persistence of E histolytica cysts or trophozoites in stools or colonic ulcer scrapings, with or without the presence of symptoms or rectal ulcersRelapse, defined as reappearance of cysts or trophozoites of E histolytica after their initial disappearance, with or without recurrence of clinical signs or symptoms of amoebic colitis after completion of treatmentSerious adverse events (death, life‐threatening events, hospitalization required or duration of hospitalization prolonged, development of a persistent or significant disability or incapacity, having offspring with a congenital anomaly or birth defect, or development of cancer)
primary outcome:
Potentiators (specific therapies for class III and IV mutations) for cystic fibrosis
Survival (in a post hoc change mortality data were also considered)Quality of life (QoL) (measured using validated quantitative scales or scores (e.g. Cystic Fibrosis Questionnaire‐Revised (CFQ‐R) (Quittner 2009))total QoL scoredifferent sub‐domains which may be reportedForced expiratory flow rate at one second (FEV1) (relative change from baseline)
primary outcome:
Transfusion of red blood cells stored for shorter versus longer duration for all conditions
Mortality measured at two time points: in hospital (with time points as defined by the participant group) and short term (up to 30 days).
primary outcome:
Interventions for treating wrist fractures in children
Physical function using validated measures, such as the Activities Scale for Kids (performance version) (Young 2000), or Paediatric Outcome Data Collection Instrument (PODCI) (Daltroy 1998)Treatment failure (a composite outcome defined as either the need for a second procedure (further immobilisation, unscheduled change in device such as reapplication of a cast, reduction or surgical intervention) or the presence of a symptomatic malunion/unacceptable anatomy (deformity))Serious adverse effects (these are partly comparison‐dependent): major sustained loss of elbow or wrist (or both) range of movement, infection, nerve or tendon injury, complex regional pain syndrome type 1, compartment syndrome, refracture
primary outcome:
First aid interventions by laypeople for acute oral poisoning
Incidence of mortalityIncidence of adverse events due to the interventionIncidence and severity of symptoms of poisoning, reported for example with the Poisoning Severity Score (PSS) (Persson 1998)
primary outcome:
Sedation of children undergoing dental treatment
Behaviour.
primary outcome:
Short‐acting insulin analogues versus regular human insulin for adult, non‐pregnant persons with type 2 diabetes mellitus
All‐cause mortalityMacrovascular and microvascular complicationsSevere hypoglycaemic episodes
primary outcome:
Maternal probiotic supplementation for prevention of morbidity and mortality in preterm infants
Preterm birth (1. any preterm birth < 37 weeks' gestation and 2. preterm birth < 34 weeks' gestation) (limited to infants in Comparison 1).Any NEC (Bell stage I to III) (Bell 1978).*Severe NEC (Bell stage II or more) (Bell 1978).Death (before discharge).Death or severe NEC.Death or any NEC.*
primary outcome:
Liberal versus conservative fluid therapy in adults and children with sepsis or septic shock
All‐cause mortalityAll‐cause mortality in hospital/ICUAll‐cause mortality at follow‐up
primary outcome:
Dressings and topical agents for preventing pressure ulcers
Pressure ulcer incidence (the proportion of people developing any new pressure ulcer(s) of any stage). For the purpose of this review, we defined a pressure ulcer as a localised injury to the skin, underlying tissue or both, usually over a bony prominence, as a result of pressure, or pressure in combination with shear. This review included all stages of pressure ulcer damage, following the definition of the NPUAP/EPUAP/PPPIA 2014. We accepted the definition of the method of assessment of pressure ulcer damage as outlined by trial authors.In five trials the intervention was fatty acid, which they compared with olive oil (two trials including 1060 participants); another topical compound (one trial, 331 participants) or standard care (two trials, 187 participants). There is an interest in essential fatty acids because of their suggested role in wound healing (McCusker 2010). However, analysis of the trial data yielded mixed results, for example, where the comparison was olive oil, data from two trials showed no clear difference in the incidence of pressure ulcers. Similarly, when an application of fatty acid was compared with standard care, no clear difference could be demonstrated. Conversely, one trial found fewer pressure ulcers in a group using a compound including fatty acid when compared with those using a compound containing tristostearin and a perfume. We rated evidence for most of the outcomes in these comparisons as low or very low certainty due to serious risk of bias in trial design or imprecision, or both, due mostly to small sample sizes.Four trials investigated the use of an active topical agent versus placebo. Once again, data analysis yielded mixed results with only one trial (61 participants) finding that DMSO cream may increase the risk of pressure ulcer incidence compared with a placebo treatment; we graded evidence for the trial as low certainty. In the other three trials there were no clear differences in pressure ulcer development between the trial groups.We summarised results from the six trials that used a silicone dressing as the intervention. The main results suggest that use of silicone dressings over bony prominences may reduce the incidence of pressure ulcers. We rated the combined evidence as low certainty for all stages of pressure ulcers (due to serious risk of bias with trial designs) (see Quality of the evidence).We also reviewed evidence for a number of other dressings that were used to prevent pressure ulcers. In three trials of very low‐certainty evidence (334 participants), there was no clear difference in pressure ulcer incidence in polyurethane film versus hydrocolloid dressing, Kang’ huier versus routine care, or PPD dressing versus no dressing.A further trial (39 participants) compared an adhesive dressing with no dressing. We also assessed the evidence for this trial as low certainty, but found that there may be a difference in the incidence of pressure ulcers, favouring the no‐dressing group.
primary outcome:
Oral and intrauterine progestogens for atypical endometrial hyperplasia
Regression rate (complete or partial): a 'complete regression' is defined as a return of the atypical endometrium to normal, often with associated secretory glandular changes and atrophy; a 'partial regression' is defined as a change from atypical to non‐atypical hyperplasia. The regression rate includes the complete and partial regression rate.Adverse effects associated with hormonal problems: weight gain, acne, nausea, headache, dizziness, vomiting, depression, breast tenderness
primary outcome:
Inhaled steroids with and without regular salmeterol for asthma: serious adverse events
All‐cause mortalityAll‐cause non‐fatal serious adverse events
primary outcome:
Laparoscopic versus open surgery for suspected appendicitis
(1) Pain intensity on day one (any validated score such as visual analogue scale);
(2) Wound infections (defined by the study authors as a rate) up to 14 days after surgery;
(3) Intra‐abdominal abscesses (defined by the study authors as a rate) up to 14 days after surgery.
primary outcome:
Oral isotretinoin for acne
Improvement in acne severity assessed by a decrease in total inflammatory lesion count, measured in participants who were treated for a minimum period of 16 weeks.Frequency of serious adverse effects.
primary outcome:
Omega‐3 fatty acid addition during pregnancy
Preterm birth < 37 weeksEarly preterm birth < 34 weeksProlonged gestation (> 42 weeks)early preterm birth (< 34 weeks) (RR 0.91, 95% CI 0.13 to 6.38; Analysis 7.1); orprolonged gestation (> 42 weeks) (RR 0.91, 95% CI 0.06 to 14.44; Analysis 7.2) (Harris 2015).
primary outcome:
Phonics training for English‐speaking poor readers
Mixed/regular word reading accuracy (British Ability Scale – Word Reading).Non‐word reading accuracy (e.g. Castles and Coltheart 2 Test).Irregular word reading accuracy (e.g. Castles and Coltheart 2 Test).Mixed/regular word reading fluency (e.g. Test of Word Reading Efficiency – Sight Word Efficiency).Non‐word reading fluency (e.g. Test of Word Reading Efficiency – Phonemic Decoding Efficiency).Reading comprehension (e.g. Neale Analysis of Reading Ability).Spelling (e.g. Test of Written Spelling).
primary outcome:
Protocol‐directed sedation versus non‐protocol‐directed sedation in mechanically ventilated intensive care adults and children
Duration of mechanical ventilation, measured in hours for the entire duration of the first ICU stay for each patientICU and hospital mortality
primary outcome:
Communication interventions for autism spectrum disorder in minimally verbal children
Spoken communication (expressive language or speech, or both), measured using formal standardised assessments, standardised parent‐report checklists and tools, novel instruments (newly designed scales specific to a study), language samples and vocabulary counts. Spoken communication could have been in the form of sounds, words and phrases or sentences, and used in a variety of ways (e.g. to request, comment).Non‐verbal communication or AAC, measured by, for example, the phase of PECS (Bondy 1998), frequency of use of vocabulary on a speech generating device, number of initiations using PECS or the number of key word signs a child uses.Combined spoken and non‐verbal communication. This refers to measures that do not distinguish whether they are spoken or non‐verbal. For example, the outcome 'frequency of initiations' may include both spoken and unspoken initiations.Adverse events (e.g. increased stress in parents or increased anxiety in the child in response to completing a particular intervention), measured by tools such as the Parenting Stress Index (Abidin 1995) or the Spence Children's Anxiety Scale (Spence 1998).
primary outcome:
Caseworker‐assigned discharge plans to prevent hospital readmission for acute exacerbations in children with chronic respiratory illness
Proportion of children requiring emergency department (ED) visithospitalisation or rate/frequencysubsequent ED visits and readmissionsAdverse events (all causes)
primary outcome:
One‐to‐one oral hygiene advice provided in a dental setting for oral health
Outcome measures considered in this review included clinical status, patient‐centred and economic factors. The outcome measure must have been assessed at least 8 weeks following the intervention.
primary outcome:
Biocompatible dialysis fluids for peritoneal dialysis
Decline in RRF (changes in residual creatinine clearance (CrCl), urea clearance, Kt/V, glomerular filtration rate (GFR), and urine output)Peritoneal UF (during peritoneal equilibration test and daily UF)Peritonitis rate (episodes/y, episode/total patient‐months on PD) and incidence (number of events/follow‐up period)Technique survival (number of participants remaining on PD at study completion)Patient survival (number of participants alive at study completion)Toxicity/adverse events (e.g. rash, uncontrolled fluid overload)
primary outcome:
Carbamazepine versus phenobarbitone monotherapy for epilepsy: an individual participant data review
Time to treatment failure for any treatment‐related reason (continued seizures, side effects, non‐compliance or the initiation of additional add‐on treatment)Time to treatment failure due to adverse events (i.e. side effects)Time to treatment failure due to lack of efficacy (i.e. continued seizures)
primary outcome:
Oxcarbazepine versus phenytoin monotherapy for epilepsy: an individual participant data review
time to treatment failure for any treatment related reason (continued seizures, side effects, non‐compliance or the initiation of add‐on treatment);time to treatment failure due to adverse events (i.e. side effects);time to treatment failure due to lack of efficacy (i.e. continued seizures).
primary outcome:
Leukotriene receptor antagonists for eczema
Change in disease severity assessed by SCORAD (SCORing of Atopic Dermatitis) severity index, EASI (Eczema Area and Severity Index), SASSAD (Six Area, Six Sign Atopic Dermatitis) severity score, IGA (Investigator's Global Assessment), or any validated scoring system for eczema in the short and long term. A reduction in the score using these validated scoring systems equates to an improvement of the participant's eczema.Effect of long‐term control, such as time to relapse of 'flare' in the maintenance (flare‐free) phase.All adverse events, including allergic reactions and impact on quality of life and skin.
primary outcome:
Parent‐mediated interventions for promoting communication and language development in young children with Down syndrome
Expressive and receptive language skills measured through scores from standardised tests, criterion referenced tests, parent reports, experimental tasks, and language samples/conversations (for example, the Reynell Developmental Language Scales (RDLS; Edwards 1997). The scores from language samples included: m ean l ength of u tterance (MLU), measured in words or morphemes; n umber of d ifferent w ords (NDW) in a sample; or t otal n umber of w ords (TNW), which could be used to calculate t ype‐t oken ratios (TTRs).We also measured possible adverse effects of intervention such as an increase in parental stress as assessed by, for example, the Parenting Stress Index (PSI; Abidin 1995).
primary outcome:
Dietary modifications for infantile colic
Duration of crying* (postintervention versus baseline or postintevention). Data could have been continuous (for example, hours per day), or dichotomous (for example, reduction under a predefined threshold, as determined by the study authors). Data must have been collected prospectively, not through retrospective recollection at the end of the study period, using methods such as parent diaries, video or audio recordings, or actigraphy.
primary outcome:
Eszopiclone for insomnia
Outcomes of the review are a selection of outcomes considered in primary studies (see Characteristics of included studies). We selected the primary and secondary outcomes of the review with regard to the clinical relevance of outcome criteria and the avoidance of conceptual overlaps. All types of measurement including objective measures (e.g. polysomnography) and participant‐reported sleep measures, as well as different types of scores (change from baseline scores, double‐blind average scores), were considered. If both objective and subjective measures were provided in a study publication, subjective measures were included in the meta‐analysis and we examined the impact of measurement type with sensitivity analyses (see Sensitivity analysis). Change from baseline scores and double‐blind average scores were integrated in the same meta‐analyses, as outlined by Deeks 2011. For the assessment of adverse events (withdrawal symptoms and next‐day alertness), any types of outcome measures were included.
primary outcome:
Psychological interventions for needle‐related procedural pain and distress in children and adolescents
Primary outcomes of interest were pain intensity and distress. These are two core outcome domains recommended for clinical trials in pediatric acute pain (PedIMMPACT; McGrath 2008). Distress is broadly defined as any type of negative affect associated with the needle procedure (e.g. anxiety, fear, stress). We extracted pain and distress outcomes separately, as assessed by child self‐report, observer global report (e.g. parents, nurses, researchers, etc. report using single‐item scales), and/or behavioral measurement (e.g. validated rating scales assessing observed pain or distress behaviors or both, displayed by the child).
primary outcome:
Calcium supplementation during pregnancy for preventing hypertensive disorders and related problems
In the original protocol we prespecified 15 clinical measures of maternal and fetal or neonatal morbidity and mortality. In October 2004 we added seven additional outcomes (marked * below). For the 2013 update we added two outcome measures, marked ** below, in order to include newly published data. As such, these should be regarded as post‐hoc analyses, and interpreted with caution.
primary outcome:
Psychological therapies for the management of chronic and recurrent pain in children and adolescents
Pain intensityPain‐related disability
primary outcome:
Antibiotics for treating scrub typhus
Treatment failure, defined as persistence of symptoms at the end of the treatment course.Resolution of fever within 48 hours.
primary outcome:
Insulin and glucose‐lowering agents for treating people with diabetes and chronic kidney disease
Glycated haemoglobin A1c (HbA1c)Fasting blood glucose (FBG)
primary outcome:
Topical and systemic antifungal therapy for chronic rhinosinusitis
Health‐related quality of life, using disease‐specific health‐related quality of life scores, such as the Sino‐Nasal Outcome Test‐22 (SNOT‐22), Rhinosinusitis Outcome Measures‐31 (RSOM‐31) and SNOT‐20.Disease severity, as measured by patient‐reported symptom score (such as the Chronic Sinusitis Survey (CSS) questionnaire and visual analogue scales). In the absence of validated symptom score data, patient‐reported individual symptom scores were reported for the following symptoms: nasal obstruction/blockage/congestion, nasal discharge (rhinorrhoea), facial pressure/pain, loss of sense of smell (adults) and cough (children).Significant adverse effects: hepatic toxicity (systemic antifungals).
primary outcome:
Oropharyngeal colostrum in preventing mortality and morbidity in preterm infants
Incidence of NEC (Bell's stage 2 or 3) until discharge to home (Walsh 1986)Incidence of microbiologically confirmed late‐onset invasive infection until discharge to home, defined as a blood or cerebrospinal fluid culture positive for microbial infection after 72 hours of life (Stoll 2002)Death before discharge to home
primary outcome:
Head‐to‐head trials of antibiotics for bronchiectasis
Exacerbation (e.g. frequency during follow‐up, time to first exacerbation).Serious adverse events, defined according to Hansen 2015.
primary outcome:
Autologous cells derived from different sources and administered using different regimens for 'no‐option' critical lower limb ischaemia patients
All‐cause mortalityAmputation rateWound/ulcer healing as determined by the number of ulcers healed and the change in ulcer size
primary outcome:
Impact of medication reconciliation for improving transitions of care
Medication discrepancies; this has previously been defined as unexplained differences in documented medication regimens across different sites of care (Mueller 2012). Discrepancies, dependent on available study data, were presented as:at least one medication discrepancy per participant (dichotomous);number of medication discrepancies per participant (continuous);discrepancies per participant medication (e.g. drug/dose/name/mode of administration/frequency – both continuous and dichotomous).
primary outcome:
Drugs for treating Buruli ulcer (Mycobacterium ulcerans disease)
Cure: healing of skin lesions without recurrence at 12 months or longer.Probable cure: healing of skin lesions with follow‐up to 12 months.Possible cure: healing of skin lesions at follow‐up.
primary outcome:
Client feedback in psychological therapy for children and adolescents with mental health problems
Improvement rates or numbers (e.g. percentage of clients who are clinically recovered), or level or change of continuous scores on relevant validated scales (e.g. Youth Self‐Report (YSR) (Achenbach 2001), Child Behavior Checklist (CBCL) (Achenbach 2001), Strengths and Difficulties Questionnaire (SDQ) (Goodman 1997)).Treatment acceptability, as measured by number of dropouts from therapy. Planned, early termination was not included in this outcome. We attempted to collect information from authors if it was unclear whether dropouts might have included planned, early terminations.
primary outcome:
Xenon as an adjuvant to therapeutic hypothermia in near‐term and term newborns with hypoxic‐ischaemic encephalopathy
Cerebral palsy (CP), graded according to the Gross Motor Function Classification System of Palisano 1997 for children two years of age and younger.Developmental delay (Bayley or Griffith assessment more than two standard deviations (SD) below the mean).Intellectual impairment (intelligence quotient (IQ) more than two SD below the mean).Blindness (vision < 6/60 in both eyes).Sensorineural deafness requiring amplification.
primary outcome:
E‐Health interventions for anxiety and depression in children and adolescents with long‐term physical conditions
Treatment efficacy: we measured changes in severity of anxiety and depression symptoms separately, using validated scales for each of these conditions (e.g. Children's Depression Inventory (CDI) for childhood depression (Kovacs 1989); State‐Trait Anxiety Inventory (STAI) for anxiety (Spielberger 1983)). We analysed clinician‐rated scales separately from those rated by the children, young people, parents, and others (e.g. teachers). We interpreted statistically‐significant results by taking into account the clinical significance of each scale (using T‐scores if these were available for all scales).Treatment acceptability: as reported by quantitative measures of treatment acceptability (e.g. the Treatment Evaluation Inventory‐Short Form (Newton 2004)), the number of participants who dropped out for any reason, and because of adverse events.
primary outcome:
Enteral nutrition for maintenance of remission in Crohn's disease
The primary outcome measure was the occurrence of clinical or endoscopic relapse as defined by the primary studies and expressed as a percentage of the number of patients randomised.
primary outcome:
Sodium valproate versus phenytoin monotherapy for epilepsy: an individual participant data review
Time to treatment failure (retention time).Time to treatment failure, for any treatment‐related reason (continued seizures, side effects, noncompliance or the initiation of additional add‐on treatment).Time to treatment failure, due to adverse events (i.e. side effects).Time to treatment failure, due to lack of efficacy (i.e. continued seizures).
primary outcome:
Needle size for vaccination procedures in children and adolescents
Postvaccination incidence of vaccine‐preventable diseases: in the protocol, we stated that the diagnosis of these diseases should be made using one or a combination of standard clinical or bacteriological or serological criteria (e.g. a diagnosis of pertussis (whooping cough) should be based on a characteristic clinical history as well as isolation of Bordetella pertussis from a clinical specimen or positive polymerase chain reaction (PCR) assay for B pertussis. A diagnosis of hepatitis B infection should be based on detection of the surface antigen of the hepatitis B virus (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B virus (HBV) DNA, or antibody to hepatitis B core (HBc) antigen in serum (anti‐HBc) with or without clinical or laboratory features of hepatitis or its complications).Pain, experienced during the vaccination procedure or at any time point postvaccination measured via self report, observer global reports, or behavioural measures using any age‐appropriate pain assessment tool with established validity and reliability (see Appendix 2):self report measures of pain:visual analogue scales (VAS);numerical rating scales (NRS);verbal rating scales (VRS);other scales with established validity and reliability (see Appendix 2).observer global reports: observer versions of the self report measures listed above, completed by parents, researchers, healthcare professionals, or other observers (see Appendix 2).behavioural measures:Face Legs Activity Crying Consolability scale (FLACC) (Merkel 1997);Children’s Hospital of Eastern Ontario Pain Scale (CHEOPS) (McGrath 1985);COMFORT scale (Ambuel 1992);Neonatal Infant Pain Scale (NIPS) (Lawrence 1993);Modified Behavioural Pain Scale (MBPS) (Taddio 1995);other scales with established validity and reliability (see Appendix 2).Crying measures:crying incidence following vaccination;persistent crying incidence following vaccination (defined as the presence of crying that is continuous (not episodic) and unaltered for three hours or more) (Bonhoeffer 2004);total cry duration (onset of first cry to cessation of all crying (seconds));duration of crying (in seconds) during a specified time period (e.g. three minutes) following vaccination;percentage of time spent crying during a specified time period (e.g. three minutes) following vaccination.
primary outcome:
Vitamin A and beta (β)‐carotene supplementation for cystic fibrosis
Vitamin A deficiency disordersvisual impairmentany other ocular dysfunctionskin manifestationsGrowth and nutritional statusweight (kg and z score)height (cm and z score)body mass index (BMI)Mortality
primary outcome:
Colloids versus crystalloids for fluid resuscitation in critically ill people
All‐cause mortality (at end of follow‐up)All‐cause mortality (within 90 days)All‐cause mortality (within 30 days)
primary outcome:
Antibiotics for prolonged wet cough in children
Children not cured or not substantially improved at follow‐up (measured as proportion of participants). We determined the children who failed to improve on treatment and the mean clinical improvement using the following hierarchy of assessment measures (i.e. where two or more assessment measures were reported in the same study, we used the outcome measure listed first).Objective measurements of cough indices (cough frequency, cough receptor sensitivity, cough amplitude).Symptomatic (Likert scale, visual analogue scale, level of interference of cough, cough diary, sputum production – quantity and colour, general well‐being) – assessed by the child.Symptomatic (Likert scale, visual analogue scale, level of interference of cough, cough diary, sputum production – quantity and colour, general well‐being) – assessed by the parents/carers.Symptomatic (Likert scale, visual analogue scale, level of interference of cough, cough diary, sputum production – quantity and colour, general well‐being) – assessed by clinicians.Airway markers (sputum or BAL) consistent with infection or inflammation.Sputum volume alone.Lung function tests alone.
primary outcome:
Treatment for chronic methicillin‐sensitive Staphylococcus aureus pulmonary infection in people with cystic fibrosis
Sputum clearance of S aureus (as determined by negative culture at the end of treatment)Pulmonary function testsforced expiratory volume at one second (FEV1) per cent (%) predicted or litresforced vital capacity (FVC) % predicted or litresany other validated measures of pulmonary functionAdverse eventsemergence of resistant organismsother adverse events such as rashes, Stevens‐Johnson type reactions, photosensitivity, tooth discolouration etc
primary outcome:
Ear drops for the removal of ear wax
Proportion of patients (or ears) with complete clearance of ear wax, as determined by follow‐up otoscopy (clearance being complete without the need for additional treatment as determined by each study's clinical aims).Adverse effects: discomfort, irritation or pain.
primary outcome:
Parent‐mediated communication interventions for improving the communication skills of preschool children with non‐progressive motor disorders
Children's ability to communicate effectively in everyday life. Outcomes included children's ability to:take turns in conversation, initiating conversation and responding to others' conversational gambits;use communication for a wide range of purposes such as requesting attention, asking questions, answering questions, making comments and repairing conversation when they have not been understood; anduse a range of modes of expression by vocalising, speaking, using gesture or using the AAC system.Adverse events, including reductions in the frequency with which children communicate, or increases in negative behaviour.
primary outcome:
Parent training interventions for parents with intellectual disability
Attainment of specific parenting skills targets, which were the focus of the intervention. Given the nature of interventions for intellectually disabled parents, some outcome measures were based explicitly on the skills taught in a particular intervention rather than a standardised scale. For example, if the aim is to teach parents to bathe children safely then the outcome is likely to be attainment (or otherwise) of the specific skill taught in relation to this childcare activity. Such tasks may be broken down into very specific actions for the purpose of assessment.Safe home practices, that is awareness of safety and danger in the home, as measured by, for example, the Home Inventory of Dangers and Safety Precautions 2 (Tymchuck 1999).*Understanding of child health, that is, understanding of issues related to child health, development and illness; for example, symptoms, emergencies, use of medication and health care. Scales were based on a validated scale such as those derived from the University of California, Los Angeles (UCLA) Parent‐Child Health and Wellness Project (Tymchuk 2003).*