anurajms/meta_analysis huggingface dataset:
primary outcome:
Synbiotics, prebiotics and probiotics for solid organ transplant recipients
GI function: change in any GI upset or intolerance; microbiota composition; faecal characteristics (such as the Bristol Stool Chart) (Lewis 1997); colonic transit timeGraft health: organ rejection, organ acceptance, graft infectionQoL issues: using any validated QoL scaleAdverse events and serious adverse eventsDeath and cause‐specific death
primary outcome:
Fluvoxamine for the treatment of COVID‐19
We evaluated core outcomes in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative for people with COVID‐19 (COMET 2021; Marshall 2020), and additional outcomes that have been prioritised by consumer representatives and the German guideline panel for inpatient therapy of people with COVID‐19, as well as the German Primary Care Association Guidelines (DEGAM) for the treatment of acute COVID‐19 in the outpatient setting (DEGAM 2022). The current outcome set is in alignment with the previous review in this series of Cochrane Reviews investigating the use of potential pharmacotherapies for COVID‐19 in both inpatients and outpatients (Popp 2021a).We defined outcome sets with primary and secondary outcomes for two populations.Primary outcomes were used to inform the summary of findings Table 1.
primary outcome:
Water for wound cleansing
The primary outcome of interest was wound infection, as measured using either clinical signs and symptoms or wound cultures (Lakshmi 2011). The clinical signs and symptoms included abscess, cellulitis, wound discharge, discolouration, delayed healing, friable granulation tissue, unexpected pain and tenderness, pocketing at the base of the wound, epithelial bridging, abnormal smell, wound breakdown (Cutting 2005) fever (Weiss 2013), surgical debridement or early removal of sutures (Moscati 2007)(Appendix 1).There were no trials that reported on wound infection.Pooled data (Olufemi 2017; Museru 1989) involving 152 participants indicated that the effect of using distilled water compared to normal saline on infection is uncertain (RR 0.70, 95% CI 0.45 to 1.09) Analysis 3.1. Using the GRADE approach, we judged the certainty of evidence for this result to be very low (downgraded twice for high risk of bias; and once for imprecision).Results of the one study (Museru 1989) involving 51 participants indicated that the effect of cleansing with cooled boiled water compared to normal saline on infection rate is uncertain (RR 0.83, 95% CI 0.37 to 1.87) Analysis 4.1. Using the GRADE approach, we judged the certainty of evidence for this result to be very low (downgraded twice for risk of bias and twice for imprecision).Six out of 35 participants (17.1%) in the distilled water group and nine out of 31 (29%) in the cooled boiled water group developed a wound infection (RR 0.59, 95% CI 0.24 to 1.47) Analysis 5.1. The small number of wounds cleansed using distilled water (n = 35) and cooled boiled water (n = 31) means that the study lacked power to detect clinically important differences (Museru 1989). Using the GRADE approach, we consider the certainty of the evidence to be very low (downgraded twice for risk of bias, and twice for imprecision) and the effect of distilled water compared with cooled boiled water on infection is uncertain.
primary outcome:
Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients
Initiation of immunosuppressant medication regimenImplementation of immunosuppressant medication regimen. This phase of adherence included:Taking adherence: the proportion of prescribed immunosuppressant medications takenDosing adherence: the proportion of days with the correct dosage taken, as per the prescribed immunosuppressant medication regimenTiming adherence: the proportion of doses taken on time, as per the prescribed immunosuppressant medication regimenDrug holidays: the proportion of drug holidays taken within the prescribed immunosuppressant medication regimenPersistence with immunosuppressant medication regimen. Non‐persistence was defined as discontinuation of the prescribed immunosuppressant medication regimen.
primary outcome:
Adding rapid diagnostic tests to community‐based programmes for treating malaria
All‐cause mortalityHospitalizationsNumber of people receiving an antimalarial within 24 hours
primary outcome:
Stiripentol add‐on therapy for drug‐resistant focal epilepsy
Reduction in seizure frequency: proportion of participants with a reduction of at least 50% in seizure frequency at the end of the study compared with baselineSeizure freedom: proportion of participants achieving total cessation of seizures. If the length of follow‐up was long enough, we used the most current ILAE‐proposed definition of seizure freedom: no seizures of any type for 12 months, or three times the longest (pre‐intervention) seizure‐free interval, whichever was longer (Kwan 2010).Reduction in seizure frequency: number of participants with a reduction of at least 50% in seizure frequency at the end of the study (numerator)/number of participants at prerandomisation baseline period (denominator)Seizure freedom: number of participants achieving total cessation of seizures (numerator)/number of participants at prerandomisation baseline period (denominator)
primary outcome:
D‐mannose for preventing and treating urinary tract infections
Symptomatic and bacteriuria‐confirmed UTI according to defined clinical symptomatic criteria (including dysuria, urinary frequency, urgency and suprapubic pain, voiding issues, worsening of symptoms), plus a positive quantitative urine culture (as confirmed by a catheter specimen of urine, midstream urine specimen if possible, or a clean catch specimen and defined as > 10⁵ CFU/mL, or as defined by authors), as any of the following measures.Total number of symptomatic bacteriuria (> 10⁵ CFU/mL) (cystitis or pyelonephritis) in each group following treatment (all time points included)Recurrent symptomatic bacteriuria (> 10⁵ CFU/mL) (cystitis or pyelonephritis) following treatment (all time points included)Persistent symptomatic bacteriuria (> 10⁵ CFU/mL) (cystitis or pyelonephritis) following treatment (all time points included)Re‐infection symptomatic bacteriuria (> 10⁵ CFU/mL) (cystitis or pyelonephritis) following treatment (all time points included)Relapse symptomatic bacteriuria (> 10⁵ CFU/mL) (cystitis or pyelonephritis) following treatment (all time points included)Short‐term reduction in symptomatic bacteriuria episodes and bacteriologically confirmed up to two weeks after the start of treatmentLong‐term reduction in symptomatic bacteriuria episodes and bacteriologically confirmed up to eight weeks after the start of treatment.Symptomatic‐only UTI (dysuria, urinary frequency, urgency and suprapubic pain, voiding issues, worsening of symptoms), with negative urine specimen, as any of the following measures.Total number of patients who develop urinary symptoms following treatment (all time points included)Recurrent urinary symptoms following treatment (all time points included)Persistence of urinary symptoms following treatment (all time points included)Re‐infection of urinary symptoms following treatment (all time points included)Relapse of urinary symptoms following treatment (all time points included)Short‐term symptomatic cure: the absence of urinary symptoms up to two weeks after the start of treatmentLong‐term symptomatic cure: the absence of urinary symptoms up to eight weeks after the start of treatment.Asymptomatic bacteriuria (irrespective of the presence of symptoms suggestive of UTI). "The number of UTI confirmed by appropriate microbiological criteria. Bacteriuria on quantitative urine analysis of more than 100,000 organisms of a single species per mL is the accepted standard ‐ however, the colony count may vary from 100 to 100,000 depending on the clinical setting (Stamm 1988). Therefore in some situations, (such as a clean suprapubic tap) a colony count of less than 100,000 is acceptable." (Nicolle 2005).Changes to previous treatment regimen prior to study including antibiotic regimen; reduction in analgesics; or the number of return visits to the GP; probiotics; alternative therapies; reduction in the use of acute and prophylactic antibiotics.Pain (any scale visual analogue scale (VAS)), including neuropathic pain; abdominal or pelvic pain (suprapubic pain, loin pain); other measures of pain.
primary outcome:
Strategies for enhancing the implementation of school‐based policies or practices targeting diet, physical activity, obesity, tobacco or alcohol use
Implementation of policies, practices or programmes that promote student health in schools
primary outcome:
Memantine for autism spectrum disorder
 Core symptoms of autism.Social communication problems, measured by diagnostic instruments such as the Childhood Autism Rating Scale (CARS; Schopler 1986), Autism Diagnostic Observation Schedule (ADOS; Lord 2012), Autism Diagnostic Interview‐Revised (ADI‐R; Lord 1994) or Diagnostic Instrument for Social Communication Disorders (DISCO; Wing 2002)Repetitive and rigid behaviour, including stereotypy, measured by diagnostic instruments such as the CARS (Schopler 1986), ADOS (Lord 2012), ADI‐R (Lord 1994) and DISCO (Wing 2002).Adverse effects, including the number of dropouts due to adverse side effects, and the risk or presence of side effects directly attributable to the use of memantine, such as:gastrointestinal adverse effects (e.g. constipation, nausea);neurological adverse effects (e.g. headache, irritability, somnolence); andcardiovascular adverse effects (e.g. hypertension).
primary outcome:
Probiotics for preventing acute upper respiratory tract infections
Number of participants who were diagnosed with acute URTIs.Incidence rate (number of cases/person year) of acute URTIs.Mean duration of an episode of acute URTIs.
primary outcome:
Psychological therapies for temporomandibular disorders (TMDs)
Pain intensity, e.g. Characteristic Pain Intensity (CPI) (Von Korff 1992), single visual analogue scale (VAS) or numerical rating scales of pain (NRS), or quantitative measures based on pain descriptors such as the McGill Pain Questionnaire (MPQ) (Melzack 1975)Disability caused by pain (pain impact), e.g. Graded Chronic Pain Scale (GCPS) (Von Korff 1992), Roland‐Morris Disability Questionnaire (RMDQ) (Roland 2000), Oral Health Impact Scale (Slade 1994) or Pain Self‐Efficacy Questionnaire (PSEQ) (Nicholas 2007)Adverse events
primary outcome:
Physical activity and exercise training in cystic fibrosis
Exercise capacity (VO2 peak reported either as L/min, mL/min and per kg bodyweight or kg fat‐free mass or as per cent (%) predicted)Lung function measured as FEV1 (reported either as L or % predicted and as absolute values or change from baseline)HRQoL (measured by generic or disease‐specific instruments, or both, using validated instruments or patient reports)physical functioningrespiratoryother
primary outcome:
Inhaled antibiotics for pulmonary exacerbations in cystic fibrosis
QoL (as measured by a validated tool such as Cystic Fibrosis Quality of Life (CFQoL) (Gee 2000) or Cystic Fibrosis Questionnaire ‐ Revised (CFQ‐R) (Quittner 2009))Time off work or schoolLung function (spirometry)FEV1 (litres or per cent (%) predicted) absolute values or change valuesforced vital capacity (FVC) (litres or % predicted) absolute values or change valuesAnnual change in FEV1
primary outcome:
Anti‐IL‐5 therapies for asthma
Clinically significant asthma exacerbation, defined by treatment with a course (three days or more) of systemic corticosteroids (with or without hospital admission)
primary outcome:
Child protection training for professionals to improve reporting of child abuse and neglect
Number of reported cases of child abuse and neglect:as measured subjectively by participant self‐reports of actual cases reported;as measured subjectively by participant responses to vignettes; andas measured objectively in official records of reports made to child protection authorities.Quality of reported cases of child abuse and neglect, as measured via coding of the actual contents of reports made to child protection authorities (i.e. in government records or archives).Adverse events, such as:increase in failure to report cases of child abuse and neglect that warrant a report as measured subjectively by participant self‐reports (i.e. in questionnaires); andincrease in reporting of cases that do not warrant a report as measured subjectively by participant self‐reports (i.e. in questionnaires).
primary outcome:
Short‐acting inhaled bronchodilators for cystic fibrosis
Change from baseline in forced expiratory volume in 1 second (FEV1) (L and per cent (%) predicted)*Quality of life (as measured by a validated tool such as Cystic Fibrosis Quality of Life (CFQoL) (Gee 2000) or Cystic Fibrosis Questionnaire‐Revised (CFQ‐R) (Quittner 2009))Number of exacerbations of respiratory symptoms, as defined by:individual clinicians or the use of a scoring system, such as the Respiratory and Systemic Symptoms Questionnaire (RSSQ) (Lymp 2009) (or both)need for hospitalisation or antibiotics (or both)
primary outcome:
Exercise versus airway clearance techniques for people with cystic fibrosis
Lung functionFEV1 (per cent (%) predicted) absolute change from baseline values and final valueFEV1 (L) absolute change from baseline values and final valueExercise capacitypeak oxygen uptake (VO2 peak) in L, mL/kg body weight or fat‐free mass or as % predicted (Hebestreit 2015)maximal work rate (Wpeak) (Hebestreit 2015)any validated field test (e.g. six‐minute walk test (metre), modified 10 metre shuttle test (level attained and distance covered)QoL (self‐reported)Cystic Fibrosis Questionnaire‐Revised (CFQ‐R) (Quittner 2009)Cystic Fibrosis Quality of Life Questionnaire (CF‐QoL) (Gee 2000)Chronic Respiratory Disease Questionnaire (CRQ) (Guyatt 1987)any other validated QoL scale (e.g. Nottingham Health Profile (NHP) (Wiklund 1990), Short Form‐36 (SF‐36) (Ware 1992))
primary outcome:
Interventions to improve water, sanitation, and hygiene for preventing soil‐transmitted helminth infection
Prevalence of infection with any STH species, defined by at least one ovum of A lumbricoides , T trichiura , hookworm, or Strongyloides stercoralis found in the participant’s faeces.
primary outcome:
Non‐pharmacological interventions for sleep promotion in hospitalized children
Changes in objective and validated measures of sleep, assessed using a polysomnography or actigraphy (or both); specifically, total sleep time (TST, based on age‐based normative data), percentage rapid eye movement (REM) sleep, minutes of wake, percentage of slow‐wave sleep, sleep efficiency (Laffan 2010), and Sleep Fragmentation Index (SFI), during the period of the intervention (Haba‐Rubio 2004)Subjective measures of sleep, as measured by:parent and nurse surveys; andsubjective, validated sleep assessment tools, such as the Patient Sleep Behavior Observation Tool (Corser 1996; Cureton‐Lane 1997a), or the Children's Sleep Habits Questionnaire (Owens 2000).
primary outcome:
Digital interventions to improve adherence to maintenance medication in asthma
Adherence to maintenance medication as assessed by any objective or validated subjective measure of adherence.Asthma control as determined by any validated self‐report instrument.Exacerbations requiring at least oral corticosteroid treatment (prescribed or taken — as measured by self‐report or via objective measurement, e.g. from pharmacy dispensing or prescription records), and/or emergency department visit and/or hospitalisation.
primary outcome:
Antibiotics for the induction and maintenance of remission in ulcerative colitis
Both dichotomous and continuous outcomes were considered for inclusion.
primary outcome:
Community‐based interventions for improving mental health in refugee children and adolescents in high‐income countries
Efficacy of the intervention; continuous measures of symptom severity using validated scales for each of the following conditions:PTSD (e.g. the clinician‐administered Children's PTSD Inventory (CPTSD‐I) (Saigh 2000));anxiety disorders (e.g. the self‐reported State Trait Anxiety Inventory for Children (STAIC) (Spielberger 1973));depression (e.g. the self‐reported Children's Depression Inventory (CDI) (Kovacks 1989));psychological distress (e.g. the clinician‐administered Child Psychosocial Distress Screener (CPDS) (Jordans 2008)).Adverse events (intervention acceptability); counts of suicide, self‐harm, or other adverse events.
primary outcome:
Music therapy for autistic people
Global improvement: binary (improved versus not improved or unknown, on a scale measuring clinical global impressions or on a global measure used as primary outcome in a study);Social interaction: continuous;Non‐verbal communication: continuous;Verbal communication: continuous;Quality of life: continuous; could be measured in various contexts (school, home, other) and with varying scope (individual, family);Total autism symptom severity: continuous;Adverse events: binary (any adverse event/no adverse event), as defined by study authors.
primary outcome:
Care delivery and self‐management strategies for children with epilepsy
No outcomes were specified as primary outcomes in the review protocol (Lindsay 2006).
primary outcome:
Probiotics for the prevention of Hirschsprung‐associated enterocolitis
Occurrence of Hirschsprung‐associated enterocolitis (HAEC)Serious adverse eventsSeverity of HAEC: the guidelines for the diagnosis of HAEC classifies severity as grade I (possible HAEC), grade II (mild or moderate HAEC), and grade III (severe HAEC), based on clinical history, physical examination, and radiographic findings (Gosain 2017; Appendix 1).
primary outcome:
Negative pressure wound therapy for surgical wounds healing by primary closure
Mortality (all‐cause)Surgical site infection (superficial, deep or organ space)Dehiscence
primary outcome:
Fortification of salt with iron and iodine versus fortification of salt with iodine alone for improving iron and iodine status
Haemoglobin concentration (g/dL)Urinary iodine concentration (μg/L)Blood pressure (systolic and diastolic) (mmHg)
primary outcome:
Continuous positive airway pressure (CPAP) for acute bronchiolitis in children
Proportion of children requiring mechanical ventilation.Time to recovery (as defined by the study).
primary outcome:
Prophylactic cyclo‐oxygenase inhibitor drugs for the prevention of morbidity and mortality in preterm infants: a network meta‐analysis
Severe intraventricular haemorrhage (IVH) (grade 3 or 4) (Papile 1978)Mortality (at discharge or at last reported follow‐up, whichever is later)
primary outcome:
Probiotics for treatment of chronic constipation in children
The frequency of defecation (number of stools per week), measured at end of studyGlobal improvement or treatment success, as defined by primary studies, measured at end of studyWithdrawal due to adverse events
primary outcome:
Unconditional cash transfers for reducing poverty and vulnerabilities: effect on use of health services and health outcomes in low‐ and middle‐income countries
Use of health services, including but not limited to:registered birth;growth checks;up to date on vaccination calendar;treatment for parasites; anduse of any health service (prioritised outcome).Health outcomes, including but not limited to:stunting (prioritised outcome);underweight;death (prioritised outcome);disease or illness (prioritised outcome);food security (prioritised outcome);dietary diversity (prioritised outcome); anddepression (prioritised outcome).
primary outcome:
Oral dextrose gel for the treatment of hypoglycaemia in newborn infants
Correction of hypoglycaemia for each event of hypoglycaemia before discharge home (investigator defined) (event outcome).Major neurological disability at age two years or older (defined as any of the following: legal blindness, sensorineural deafness requiring hearing aids, moderate or severe cerebral palsy, developmental delay/intellectual impairment (defined as developmental quotient less than two standard deviations (SDs) below the mean) (child outcome)).
primary outcome:
Vitamin A supplementation for preventing morbidity and mortality in children from six months to five years of age
All‐cause mortality.
primary outcome:
Systemic interventions for treatment of Stevens‐Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and SJS/TEN overlap syndrome
SJS/TEN‐specific mortality: mortality within one month of onset of SJS/TEN that is not clearly attributed to another causeAdverse effects leading to discontinuation of SJS/TEN therapy: events that occur within one month following administration of therapy that are listed as potential adverse effects in the product monograph and lead to discontinuation of therapyDisease‐specific mortalityAdverse events leading to discontinuation of therapy
primary outcome:
Synbiotics to prevent necrotising enterocolitis in very preterm or very low birth weight infants
NEC before discharge from hospital, confirmed at surgery or autopsy or using standardized clinical and radiological criteria (VON 2020):at least one of: bilious gastric aspirate or emesis; or abdominal distention; or blood in stool; andat least one of: abdominal radiograph showing pneumatosis intestinalis; or gas in the portal venous system; or free air in the abdomenAll‐cause mortality before discharge from hospital
primary outcome:
Extended‐release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults
Functional outcomes (functional capacity), such as academic and job adherence, measured as days of lost work or study activities (Philipsen 2008).Self‐rated ADHD symptoms, measured on validated rating scales such as the Connors' Adult ADHD Rating Scale (Conners 1999).Serious adverse events, defined according to the International Council for Harmonisation (ICH) guideline (ICH 2003).
primary outcome:
Clonazepam monotherapy for treating people with newly diagnosed epilepsy
Proportion of participants seizure‐free at one, three, six, 12, and 24 months after randomizationProportion of responders (defined as those who experienced at least a 50% reduction in seizure frequency from baseline to end of treatment)Proportion of participants with treatment‐emergent adverse events (TEAEs)During the treatment periodLeading to discontinuation during the treatment period
primary outcome:
Sealants for preventing dental caries in primary teeth
Incidence of new dental caries on the treated occlusal surface(s) of sound surfaces of primary molar(s) (dichotomous outcome, presence or absence of a new carious lesion).Progression of non‐cavitated enamel caries (dichotomous outcome, cavitation into enamel/dentine or no progression).Mean caries increment, measured as change in decayed, missing and filled primary teeth/surfaces (dmft/s).
primary outcome:
Binocular versus standard occlusion or blurring treatment for unilateral amblyopia in children aged three to eight years
Change in distance best‐corrected visual acuity (BCVA) in the amblyopic eye from baseline to 16 (± 2) weeks of treatment, measured in logMAR units on an age‐appropriate acuity test. Lower logMAR values indicate better visual acuity, but as we examined change in BCVA, a higher logMAR difference indicates higher levels of improvement in BCVA following treatment (either conventional or binocular).
primary outcome:
Antiepileptic drugs for the primary and secondary prevention of seizures after stroke
Proportion of participants who experienced seizures in the scheduled follow‐up period. In cases where seizures had occurred, we noted their nature (generalised or focal) and timing, if reported.
primary outcome:
Low‐carbohydrate versus balanced‐carbohydrate diets for reducing weight and cardiovascular risk
Change in body weight (kg) from baselineNumber of participants per group with weight loss of at least 5% from baseline
primary outcome:
Cuffed versus uncuffed endotracheal tubes for neonates
stridor;subglottic stenosis.
primary outcome:
Oral antihistamine‐decongestant‐analgesic combinations for the common cold
Global evaluation of effectiveness (expressed as complete relief, marked, moderate, slight/no relief at all; or the proportion of participants with treatment failure).Adverse effects of treatment.
primary outcome:
Delayed introduction of progressive enteral feeds to prevent necrotising enterocolitis in very low birth weight infants
NEC confirmed at surgery or autopsy or using standardised clinical and radiological criteria (VON 2020):at least one of: bilious gastric aspirate or emesis; or abdominal distention; or blood in stool; andat least one of: abdominal radiograph showing pneumatosis intestinalis; or gas in the portal venous system; or free air in the abdomen.All‐cause mortality before discharge from hospital
primary outcome:
Rapid versus slow withdrawal of antiepileptic drugs
Seizure freedom after one year of AED withdrawal.Seizure freedom after two years of AED withdrawal.Seizure freedom after five years of AED withdrawal.
primary outcome:
Intermittent prophylactic antibiotics for bronchiectasis
Frequency of exacerbations (defined using study authors' criteria).Serious adverse events defined as follows: adverse events resulting in death or life‐threatening events, hospitalisation or prolongation of existing hospitalisation, persistent or significant disability or congenital anomalies, or events considered medically important (Hansen 2015).
primary outcome:
Orthodontic treatment for crowded teeth in children
Amount of crowding (measured in mm or by any index of malocclusion)
primary outcome:
Orthodontic treatment for posterior crossbites
Correction of the posterior crossbite, measured as a dichotomous outcome.
primary outcome:
Interventions for treating distal intestinal obstruction syndrome (DIOS) in cystic fibrosis
Time taken from start of treatment until the resolution of DIOS (diagnosed clinically or radiologically)Treatment failure rate (e.g. clinician‐determined need to change treatment regimen or need for surgical intervention)
primary outcome:
Interventions for preventing distal intestinal obstruction syndrome (DIOS) in cystic fibrosis
Complete or incomplete DIOS diagnosed with a clinical (e.g. right iliac fossa or distension or pain) and radiological (e.g. small intestinal dilated bowel or faecal mass) combinationAdverse effects from treatmentserious adverse effects of treatment regimens (including, but not limited to, rectal bleeding, intestinal perforation, mucosal erosions, anaphylactic reaction, vomiting with electrolyte disturbance)other adverse effects of treatment (e.g. diarrhoea or soiling, abdominal distension, loss of continence or pain)
primary outcome:
Transfusion thresholds for guiding red blood cell transfusion
The primary outcome for the analysis was 30‐day mortality. Mortality is a clinically relevant outcome that is widely cited in studies including patients with acute illness, critical illness, and perioperative care.
primary outcome:
Continuous glucose monitoring for the prevention of morbidity and mortality in preterm infants
Neurodevelopmental outcome including: cerebral palsy, significant mental developmental delay (Bayley Scales of Infant Development Mental Developmental Index greater than two standard deviations (SDs) below the mean) (Bayley 1993; Bayley 2006), legal blindness (less than 20/200 visual acuity), and hearing deficit (aided or less than 60 decibel (dB) on audiometric testing). The composite outcome 'neurodevelopmental impairment' was defined as having any one of the aforementioned deficits (modified from definitions of moderate‐to‐severe developmental delay) (Schmidt 2007). We planned to assess the outcome assessed at 18 to 36 months and three to five years of age.
primary outcome:
Peer support interventions for parents and carers of children with complex needs
Psychological health outcomes.Psychological distress.Confidence and self‐efficacy.Perception of coping.Psychosocial outcomes.Quality of life and life satisfaction.Family functioning.Perceived social support.Skills acquisition outcomes.Confidence and skill in navigating medical services.Adverse outcomes.Mood contagion.Increased feelings of stigma from identifying with the group.Negative group interactions.Any decrease in psychological health on the measures listed above.As the measures for adverse outcomes fit the same broad categories as those for beneficial outcomes, we adopted the strategy outlined in the Cochrane Handbook for Systematic Reviews of Interventions of assessing beneficial and adverse effects together by the same method, with common eligibility criteria for included studies (Higgins 2011a).
primary outcome:
Nifedipine for primary dysmenorrhoea
Pain. Eligible measures of pain included:0 to 10 numeric pain rating scale (preferred);visual analogue scale;binary pain measures (i.e. yes/no); andother measures of pain as reported in the included studies.Health‐related quality of life, using a validated tool such as SF‐36 (preferred measure).
primary outcome:
Autogenic drainage for airway clearance in cystic fibrosis
FEV1Quality of life (QoL) as measured by any of the scales including:Cystic Fibrosis Questionnaire‐Revised version (CFQ‐R) (Quittner 2009)Cystic Fibrosis Quality of Life Questionnaire (CFQoL) (Gee 2000)Quality of Well‐being (QWB) Scale (Kaplan 1989)Nottingham Health Profile (NHP) (Hunt 1985)any other validated QoL scale
primary outcome:
Antibiotic therapy for chronic infection with Burkholderia cepacia complex in people with cystic fibrosis
Lung functionforced expiratory volume in one second (FEV1)absolute change in volumes, % predicted or bothrelative change in volumes, % predicted or bothPulmonary exacerbationstime to next exacerbationhospitalisationsexacerbation rateIV antibiotic useAdverse eventsmild: transient event, no treatment change, e.g. rash, nausea, diarrhoeamoderate: treatment discontinued, e.g. nephrotoxicity, ototoxicity, hepatitis, visual impairmentsevere: causing hospitalisation or death
primary outcome:
Chemotherapy for second‐stage human African trypanosomiasis: drugs in use
Overall mortality (for any reason, including HAT and treatment toxicity) up to 24 months after the last drug administrationRelapse during follow‐up: trypanosomes detected in any body compartment (blood, lymph, or CSF) at any follow‐up examination (between one and 24 months after the last drug administration); or CSF leukocyte count > 50 WBC/μL CSF, or doubled from previous count, at any follow‐up examination; or CSF leukocyte count between 20 WBC/μL and 49 WBC/μL CSF, together with symptoms strongly suggestive of relapse (worsened clinical condition since previous examination, with long lasting headache, mental or neurological disturbances, increased somnolence, recurrent fever, etc.)
primary outcome:
Antibiotics for treatment of sore throat in children and adults
Symptoms of sore throat on day three.Symptoms of sore throat at one week (days six to eight).
primary outcome:
Pharmacological treatment for psychotic depression
Efficacy: clinical response of depression based on observer‐rated symptom reduction: reduction of at least 50% on the Hamilton Rating Scale for Depression (HRSD; Hamilton 1960), the Montgomery Åsberg Depression Rating Scale (MADRS; Montgomery 1979), or any other observer depression severity rating scale, or a change score on the Clinical Global Impression‐Change (CGI‐C) of 'much improved' or 'very much improved' (Guy 1976) Harm: overall dropout rate during acute treatment as a proxy measure of overall acceptability of treatment
primary outcome:
Carisbamate add‐on therapy for drug‐resistant focal epilepsy
50% or greater reduction in seizure frequency (responder rate)The proportion of participants with ≥ 50% reduction in focal seizure frequency during the treatment period versus the baseline phase.We used this as the primary outcome because it is commonly measured in this type of study. For studies not reporting responder rate, this information could be calculated provided that baseline seizure data were recorded and reported.
primary outcome:
Parenteral versus enteral fluid therapy for children hospitalised with bronchiolitis
Length of hospital stay (defined in hours or days). We defined a difference in length of stay of 12 hours to be clinically meaningful. As length of hospital stay is affected by factors unrelated to hospitalisation (e.g. transportation home), we also described the time children were medically stable for discharge (as defined in each individual study).
primary outcome:
Antioxidants to prevent respiratory decline in people with Duchenne muscular dystrophy and progressive respiratory decline
Change in respiratory function from baseline to 12 months or beyond, assessed as forced vital capacity (FVC): measured with standard spirometry at hospital visits with the aid of a qualified, trained, and certified operator and in accordance with the American Thoracic Society/European Respiratory Society guidelines (Miller 2005), converted to per cent of predicted values according to age, sex, race, and height. We considered an absolute change of 2% for improvement and 6% for worsening of the FVC predicted value as MCID (du Bois 2011).Hospitalisation due to respiratory infections, measured in the number of admissions per year since the beginning of treatment.
primary outcome:
Nasal continuous positive airway pressure levels for the prevention of morbidity and mortality in preterm infants
Death or BPD at 36 weeks' postmenstrual age (PMA); we defined BPD as supplemental oxygen or positive pressure support use at 36 weeks' PMA (for infants less than 32 weeks' gestational age) (Jobe 2001; Shennan 1988).Mortality at 28 days, hospital discharge, and one year.Moderate‐severe neurodevelopmental impairment at 18 to 26 months and at 3 to 5 years. We defined moderate‐severe neurodevelopmental impairment as: cerebral palsy or gross motor disability (defined as ≥ level 2 according to the Gross Motor Function Classification System (GMFCS)) (Palisano 1997); developmental delay (Bayley or Griffith assessment > 2 standard deviations (SD) below the mean) (Bayley 1993; Bayley 2006; Griffiths 1954) or intellectual impairment (intelligent quotient (IQ) > 2 SD below the mean); blindness (vision < 6/60 in both eyes); or sensorineural deafness requiring amplification. We planned to perform separate analyses for children aged 18 to 26 months and 3 to 5 years (Jacobs 2013).Bronchopulmonary dysplasia, defined as supplemental oxygen use at 28 days of age (NIH 1979).Bronchopulmonary dysplasia, defined as supplemental oxygen or positive pressure support use at 36 weeks' PMA (for infants less than 32 weeks' gestational age) (Jobe 2001; Shennan 1988).Treatment failure as indicated by study author prespecified values of recurrent apnea, hypoxia, hypercarbia, increasing oxygen requirement; or the need for mechanical ventilation. If this outcome was reported for more than one time point (e.g. failure by three days, failure by five days, etc.), we used the latest time point up to seven days from randomization.Need for mechanical ventilation.
primary outcome:
Topiramate for juvenile myoclonic epilepsy
We collected and analyzed the outcomes of all the participants initially randomized by intention‐to‐treat (ITT).
primary outcome:
Non‐corticosteroid adjuvant therapies for acute bacterial meningitis
All‐cause mortality during the follow‐up period.Any hearing loss (defined as 40 decibels (dB) or more not detected by the better ear). At this threshold, understanding of speech is partially lost, and difficulty in understanding conversation is noticeable (Dix 1947).Any neurological sequelae other than hearing loss. Neurological sequelae are defined as health consequences of the infection that involve the central nervous system. These can include seizure disorder, focal neurological deficit (loss of normal function of brain, spinal cord, or nerves that is localised to a specific area of the body), ataxia (loss of voluntary co‐ordination of muscle movement), paresis (partial paralysis or muscle weakness), or psychomotor retardation (slowing of thought and reduction of physical movements).Adverse effects attributed to the intervention.
primary outcome:
Vaccines for measles, mumps, rubella, and varicella in children
Effectiveness: clinical and/or laboratory‐confirmed cases of measles, mumps, rubella, or varicella.Safety: encephalitis or encephalopathy, aseptic meningitis, seizure (febrile/afebrile), autism spectrum disorders, inflammatory bowel disease, cognitive delay, developmental delay, idiopathic thrombocytopenic purpura, Henoch‐Schönlein purpura, type 1 diabetes, asthma, dermatitis or eczema, hay fever, rhinoconjunctivitis, hypersensitivity/allergy, acute leukaemia, demyelinating diseases, multiple sclerosis, encephalomyelitis, acute disseminated encephalomyelitis (ADEM), gait disturbances, bacterial or viral infections.
primary outcome:
Macrolides versus placebo for chronic asthma
Exacerbations requiring hospitalisation.Severe exacerbations (defined as requiring an emergency department (ED) visits or short‐course of systemic steroids, or both).Asthma symptoms, control and quality of life scores.Asthma medication requirements (need for rescue medications).Lung function, including morning and evening peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1).Non‐specific bronchial hyperresponsiveness (to histamine or methacholine).Lowest tolerated oral corticosteroid dose (in people requiring oral corticosteroids at baseline).
primary outcome:
Vitamin C supplementation for prevention and treatment of pneumonia
We did not consider evaluation of the outcomes listed below as criteria for inclusion in the review.We included both incidence and prevalence as outcomes in pneumonia prevention because we anticipated that there might be potentially eligible studies that presented prevalence data at individual or population level rather than incidence, due to the unavailability of surveillance system.
primary outcome:
Vaccines for preventing rotavirus diarrhoea: vaccines in use
Rotavirus diarrhoea: severe (as defined in trial report)All‐cause diarrhoea: severeAll‐cause deathSerious adverse events (that are fatal, life‐threatening, or result in hospitalization)Intussusception
primary outcome:
Palivizumab for preventing severe respiratory syncytial virus (RSV) infection in children
Hospitalisation due to RSV infection: defined as the number of children hospitalised with laboratory‐confirmed infection.Mortality: death due to all causes. We also reported the cause of deaths for each group (including deaths related to RSV infection).Adverse events: defined as any unexpected or harmful occurrence in the participant, such as rash, pain in the injection site, fever, nausea, vomiting, diarrhoea, etc., reported in absolute numbers or proportions. We intended to report non‐serious and serious adverse events (including death, disability, life‐threatening events or those requiring hospitalisations) separately. Had there been multiple events reported within one participant, we would have reported this separately.
primary outcome:
Late (≥ 7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants
Mortality at various ages (including at 28 days after birth, at 36 weeks' postmenstrual age, at discharge home after primary hospitalisation, and at latest age reported)BPD (including at 28 days after birth, at 36 weeks' postmenstrual age, and at 36 weeks' postmenstrual age among survivors)Mortality or BPD (at 28 days after birth and at 36 weeks' postmenstrual age)Longer‐term outcomes into childhood (including blindness, deafness, cerebral palsy, and major neurosensory disability)
primary outcome:
Decision coaching for people making healthcare decisions
Preparation for active participation in making a health decision (patient‐reported). Outcomes were reported as per the Preparation for Health Decision Making scale (Bennett 2010). Preparation for active decision making includes: recognise that a decision needs to be made, feels prepared to make a decision, is helped to consider advantages and disadvantages of the decision, considers which advantages and disadvantages matter the most to the patient, organise thoughts about the decision, think about how involved they want to be in the decision, prepare to talk with a healthcare provider about the decision, and identify questions to ask. Other indicators of preparation for active participation in making a health decision include decisional self‐confidence and patient involvement in decision making (patient, observer‐reported) including perceived involvement, preferred level of involvement, participated at preferred level of involvement.Resolution of modifiable decisional needs relevant to decision coaching (patient‐reported). Example outcomes, according to the Ottawa Decision Support Framework (Hoefel 2020; Stacey 2020), include: uninformed, unrealistic expectations; unclear values; and inadequate support.Any reports of adverse effects on patient or decision coach (patient, observer‐reported), that includes worsening effects such as increased decision regret and anxiety (meaning lower remorse or distress over a decision (Brehaut 2003)).
primary outcome:
Antiepileptic drugs for seizure control in people with neurocysticercosis
Proportion of individuals experiencing seizuresTime to first seizure post randomisation
primary outcome:
Phototherapy for atopic eczema
Physician‐assessed changes in clinical signs of atopic eczemaUsing the following measurement instruments (in hierarchy, starting with the most preferred instrument): EASI (Ricci 2009), Objective SCORAD (or compound SCORAD if objective SCORAD was not reported (Kunz 1997), Costa (Costa 1989), SASSAD (Charman 2002)Patient‐reported changes in symptoms of atopic eczema, including itchUsing the following multi‐item measurement instruments for atopic eczema symptoms (in hierarchy, starting with the most preferred instrument): POEM (Charman 2004), subjective SCORAD; and the following single‐item measurement instruments for itch (in hierarchy, starting with the most preferred instrument): peak numerical rating scale (NRS (Yosipovitch 2019)), average NRS, visual analogue scale (VAS (Reich 2012)), verbal rating scale (VRS (Phan 2012))
primary outcome:
Intermittent catheter techniques, strategies and designs for managing long‐term bladder conditions
Number of people with symptomatic UTI (within 12 months)
primary outcome:
Avoidance of bottles during the establishment of breastfeeds in preterm infants
Full breastfeeding compared with not breastfeeding or partial breastfeeding on discharge home and at three months and six months postdischargeAny breastfeeding (full and partial combined) compared with not breastfeeding on discharge home and at three months and six months postdischarge
primary outcome:
Early (< 7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants
Mortality (at 28 days after birth, at 36 weeks' postmenstrual age, at discharge home, and at the latest reported age)Bronchopulmonary dysplasia (at 28 days after birth, at 36 weeks' postmenstrual age, and at 36 weeks' postmenstrual age in survivors)Mortality or bronchopulmonary dysplasia (at 28 days after birth and at 36 weeks' postmenstrual age)Long‐term outcomes (including blindness, deafness, cerebral palsy, and major neurodevelopmental disability)
primary outcome:
Anti‐interleukin‐13 and anti‐interleukin‐4 agents versus placebo, anti‐interleukin‐5 or anti‐immunoglobulin‐E agents, for people with asthma
Exacerbations requiring hospitalisation or emergency department visit (see section Unit of analysis issues for more details)Quality of life (measured on a validated asthma scale, e.g. Asthma Quality of Life Questionnaire)Serious adverse events (all causes; i.e. any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalisation, results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect)
primary outcome:
Prophylactic or very early initiation of continuous positive airway pressure (CPAP) for preterm infants
 We have underlined below the critical outcomes that we have graded and presented in the summary of findings tables.
primary outcome:
Provision of folic acid for reducing arsenic toxicity in arsenic‐exposed children and adults
Any type of cancer (as defined by trial authors)All‐cause mortality (as defined by trial authors)Neurocognitive function, measured only in children (as defined by trial authors; including, but not limited to, the assessments of memory, attention, intelligence, and other cognitive domains)Any congenital anomalies, measured only in pregnant women (as defined by trial authors; including, but not limited to, neural tube defects, cleft lip and cleft palate; and detected, for example, during periconceptional and neonatal screenings)
primary outcome:
Materials for retrograde filling in root canal therapy
Clinical methods included the assessment of clinical symptoms including pain, pain only on percussion or palpation, tenderness, increased tooth mobility, sinus tract formation or any other subjective discomfort. Any one of these was counted as treatment failure.Radiological methods were used to detect periapical bone regeneration on medical images. Lack of apical bone regeneration compared to the baseline was counted as treatment failure.The combination of clinical and radiological methods was used to assess the success of retrograde fillings in this review, unless specifically stated otherwise.All cases not assessed as treatment failure were considered as successes.
primary outcome:
Pharmacotherapy for trichotillomania
Treatment response: response to treatment determined using the Clinical Global Impressions‐Improvement item (CGI‐I, a widely‐used scale ranging from 1 = ‘very much improved’ to 7 = ‘very much worse’), used as a dichotomous measure of treatment response in which responders are defined as having a change item score of 1 = ‘very much improved’ or 2 = ‘much improved’ (Guy 1976). Where both dichotomous and continuous data for the CGI‐I were presented, we included only the categorical measure of ‘responders’ versus ‘non‐responders’. Where CGI‐I was not employed, we used other dichotomous measures of treatment response as reported in the original publication. Where no dichotomous measure was available, we report a continuous measure.Reduction of TTM symptom severity: reduction in TTM symptom severity based on outcome measures such as the Massachusetts General Hospital Hair‐Pulling Scale (MGH‐HPS) (Keuthen 1995), or similar, where available. The MGH‐HPS is a seven‐item, self‐report scale that rates urges to pull hair, actual amount of pulling, perceived control over behaviour and distress associated with hair‐pulling over the past seven days on a severity scale from 0 to 4 for each item (total scores range from 0 to 28, with higher scores reflecting greater illness severity). Clinician‐rated scales such as the National Institute for Mental Health ‐ Trichotillomania Severity and Impact Scales (NIMH‐TSS and NIMH‐TIS) are also reported where available. The NIMH‐TSS is a six‐item assessment, with total scores ranging from 0 to 20. Higher scores indicate greater severity or impairment. Where multiple scales were used within a study, we report on all for which data are available in the main text and data analysis. For the summary of findings tables, we prioritise reporting MGH‐HPS as a well‐validated scale for use in TTM, although it is a self‐report scale.
primary outcome:
Sulthiame monotherapy for epilepsy
Treatment withdrawal. We chose the proportion of participants who had treatment withdrawn during the course of the treatment period as a measure of global effectiveness. This outcome reflects both efficacy and tolerability, as treatment may be withdrawn because of continued seizures, adverse effects, or a combination of both. This outcome is recommended by the Commission on Antiepileptic Drugs of the International League Against Epilepsy as the primary outcome measure in monotherapy trials (Commission on Antiepileptic Drugs 1998).
primary outcome:
Treatments for seizures in catamenial (menstrual‐related) epilepsy
Seizure freedom, defined as the proportion of women who became seizure‐free over the treatment period.Responder rate, defined as the proportion of women with a 50% reduction in seizure frequency compared to baseline.Change in seizure frequency, defined as the absolute and percentage change in seizure frequency compared to baseline.