anurajms/meta_analysis huggingface dataset:
primary outcome:
Psychological therapies for the treatment of mental disorders in low‐ and middle‐income countries affected by humanitarian crises
Efficacy outcome (symptom severity)PTSD: mean change from baseline to study endpoint on the Harvard Trauma Questionnaire (HTQ) (Mollica 1992), the Posttraumatic Stress Disorder Checklist ‐ Civilian version (PCL‐C) (Weathers 1993), the Clinician‐Administered PTSD Scale for adults (CAPS) (Blake 1995), the Clinician‐Administered PTSD Scale for Children and Adolescents (CAPS‐CA) (Nader 1996), or other rating scalesAnxiety disorders: mean change from baseline to study endpoint on the Hospital Anxiety and Depression Scale ‐ Anxiety Subscale (HAD‐A) for adults (Zigmond 1983), the Screen for Anxiety Related Emotional Disorders (SCARED‐5) for children and adolescents (Birmaher 1997), or any other commonly used rating scaleMajor depressive disorder: mean change scores from baseline to study endpoint on the Depression Self‐Rating Scale (Birleson 1987), the Beck Depression Inventory (Beck 1961), the Hamilton Depression Rating Scale (HDRS) (Hamilton 1960), the Montgomery‐Asberg Depression Rating Scale (MADRS) (Montgomery 1979), or any other commonly used rating scaleSomatic symptom and related disorders: mean change scores from baseline to study endpoint on Somatic Symptom Scale‐8 (Gierk 2014), Patient Health Questionnaire‐15 (Kroenke 2002), or any other commonly used rating scaleAcceptability outcomeNumber of participants who dropped out of psychological treatment for any reason
primary outcome:
Effects of total fat intake on bodyweight in children
Body fatness, including bodyweight (kg), BMI (kg/m2), waist circumference (cm), skinfold thickness (mm) and percentage body fat.
primary outcome:
Negative pressure wound therapy for open traumatic wounds
The primary outcomes for this review are wound healing, wound infection and adverse events.
primary outcome:
Antifibrinolytic therapy for preventing oral bleeding in people on anticoagulants undergoing minor oral surgery or dental extractions
Number of participants with major postoperative bleeding episodes (defined as postoperative bleeding episodes requiring intervention*)Side effects or other adverse events**
primary outcome:
Lamotrigine versus carbamazepine 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:
Pharmacological treatment for attention deficit hyperactivity disorder (ADHD) in children with comorbid tic disorders
ADHD and tic symptom severity measured by validated clinician, teacher, or parent report scales. Specifically, we evaluated:ADHD symptom‐related behavior in the home setting assessed with, for example, Conners Abbreviated Symptom Questionnaire (ASQ) for Parents (Conners 1990), or ADHD Rating Scale (DuPaul 2016);ADHD symptom‐related behavior in the school setting assessed with, for example, Conners ASQ for Teachers (Conners 1990); andtic severity assessed with, for example, Yale Global Tic Severity Scale (TGTSS) (Leckman 1989), Tic Symptom Self‐Report Scale (Leckman 1998), or the Tourette Syndrome Severity Scale (Shapiro 1988).
primary outcome:
Antibiotics for exacerbations of asthma
Intensive care unit/high dependence unit (ICU/HDU) admissionDuration of symptoms/exacerbation (as measured by trialists using, for example, diary cards, symptom scores, and assessments of the time taken to return to normal activities)All adverse events/side effects
primary outcome:
Early planned removal versus expectant management of peripherally inserted central catheters to prevent infection in newborn infants
Incidence of laboratory‐confirmed bloodstream infection confirmed by culture from blood sampled from peripheral sites (not from indwelling catheters) during hospital admission. 'False‐positive' results due to skin contaminants are possible, therefore (where data were available), we planned to exclude cases where infection was attributed to diphtheroids, micrococci, Propionibacteriaceae or mixed microbial flora. If sufficient data were available, we planned to examine specific infections with these organisms:coagulase‐negative staphylococci;other bacteria (Gram‐negative bacilli, S. aureus, enterococci);fungi.
primary outcome:
Nurse‐led versus doctor‐led care for bronchiectasis
Exacerbations requiring treatment with antibiotics* (self‐reported and physician/specialist nurse reported)Hospital admissionsEmergency department attendance
primary outcome:
Immunosuppressive drug therapy for preventing rejection following lung transplantation in cystic fibrosis
Episodes of rejectionhyperacute rejectionacute rejectionchronic rejection (bronchiolitis obliterans syndrome (BOS))MortalityQuality of life (QoL) ‐ all instruments, of any validity, that measure the ability of participants to perform activities of daily living (including but not limited to the Cystic Fibrosis Questionnaire‐Revised version (CFQ‐R) (Quittner 2009) and the Cystic Fibrosis Quality of Life Questionnaire (CFQoL) (Gee 2000))
primary outcome:
Dual antibiotics for bronchiectasis
Successful treatment of exacerbationLength of exacerbationLength of hospitalisationTime to next exacerbationFrequency of exacerbationsSerious adverse event ‐ We used the definitions from Hansen 2015 to describe serious adverse events, which were those that resulted in death or life‐threatening events; requirement for hospitalisation or prolongation of existing hospitalisation; persistent or significant disability; or congenital anomalies, or events that were considered medically important.
primary outcome:
Ribavirin for treating Crimean Congo haemorrhagic fever
Death (in hospital or 28 days post‐admission)
primary outcome:
Continuous versus intermittent antibiotics for bronchiectasis
Exacerbations (frequency, proportion with one or more, duration, time to next exacerbation), defined using study authors' criteria.Antibiotic resistance, defined as either the presence of antibiotic resistance after the administration of antibiotics for at least three months, or the development of antibiotic resistance within at least three months of antibiotic administration. We planned to only evaluate resistance to the antibiotic(s) being investigated.Serious adverse events.
primary outcome:
Intramuscular versus oral corticosteroids to reduce relapses following discharge from the emergency department for acute asthma
The primary dichotomous outcome was relapse to additional care defined as an unscheduled visit to a health practitioner for worsening asthma symptoms, or requiring subsequent treatment with corticosteroids, which may have occurred at any time point after discharge from the ED. We also accepted the occurrence of relapse at any point as well as whether the occurrence of relapse was reported via self‐report or verification via health records.
primary outcome:
Interventions for childhood apraxia of speech
Accuracy of production on treated or non‐treated* items (may be associated with motor‐based, linguistic or multi‐modal communication approaches noted under How the intervention might work)
primary outcome:
Neuromuscular electrostimulation for adults with chronic obstructive pulmonary disease
Peripheral muscle force (using any method): defined as the peak force (or torque) elicited during a maximum voluntary contraction or a twitch force elicited in response to stimulation of a peripheral nerve.Peripheral muscle endurance/fatigability (using any method): defined as performance during any test that aimed to elicit a decline in muscle force over time using repeated muscle contractions.Thigh muscle size (using any method).Serious adverse events (e.g. mortality) recorded during the intervention period only.
primary outcome:
Mirtazapine adjunct for people with schizophrenia
We intended to categorise outcomes into either short term (less than six months), medium term (seven to 12 months), or long term (over one year).
primary outcome:
Educational interventions for improving primary caregiver complementary feeding practices for children aged 24 months and under
Improved complementary feeding practices (measured as a continuous outcome or dichotomous outcome), of the following:age at introduction of complementary foods;duration of exclusive breastfeeding;adequacy of complementary foods (measured by number of children fed with adequate amount and consistency of complementary foods, children fed with at least five different classes of food, consisting mainly of protein, carbohydrate, vegetable, fats and oils, fruits; vitamin supplementation (for infant and mother); energy density of complementary foods; and meal frequency (number of times children are fed in a day); or based on the WHO minimum acceptable diet, minimum dietary diversity, minimum meal frequency or as assessed by study authors); andhygiene practices: safe preparation and storage of complementary foods (measured by handwashing practices (washing of caregiver's and child's hands with soap before cooking, feeding, or eating); water sanitation practices; food preparation and storage practices; serving foods immediately after preparation; using clean utensils, plates, pots, etc. for preparing or serving food and for feeding the child; and avoiding the use of feeding bottles).Adverse events (as defined by study authors). For example, overburdening of personnel delivering the intervention who were also responsible for other tasks in the health facility, stress on caregivers.
primary outcome:
Trihexyphenidyl for dystonia in cerebral palsy
*Change in dystonia from baseline, as assessed using the Barry‐Albright Dystonia scale (Barry 1999), Dyskinesia Impairment Scale (Monbaliu 2012), or electrophysiological measures of dystonia*Adverse effects (mood disturbance, irritability, behavioural change, constipation)
primary outcome:
Cyclamen europaeum extract for acute sinusitis
Proportion of participants with resolution or improvement of symptoms up to 14 days.Proportion of participants with resolution or improvement of symptoms up to 30 days.
primary outcome:
Grommets (ventilation tubes) for recurrent acute otitis media in children
Treatment success, defined as the proportion of children who have no AOM recurrences at three to six months post‐randomisation (intermediate‐term follow‐up).Significant adverse event: tympanic membrane perforation persisting for three months or longer. This has been listed as an important adverse event outcome because a further surgical procedure may ultimately be required to close the perforation if this persists after extrusion of the grommet.
primary outcome:
Early intensive behavioral intervention (EIBI) for young children with autism spectrum disorders (ASD)
Adaptive behaviorAutism symptom severity, rated by parents on autism screening and diagnostic instruments such as the Autism Diagnostic Interview — Revised (ADI‐R) (Lord 1994)Adverse effects, defined as a deterioration or worsening in adaptive behaviour or autism symptom severity
primary outcome:
Lower versus higher oxygen concentrations titrated to target oxygen saturations during resuscitation of preterm infants at birth
Mortality, near term corrected or at discharge (latest reported).Neurodevelopmental disability (after at least 18 months postnatal age):neurological abnormality including cerebral palsy on clinical examination, developmental delay more than two standard deviations below population mean on any standard test of development;blindness (visual acuity < 6/60);deafness (any hearing impairment requiring amplification).
primary outcome:
Cyclodestructive procedures for non‐refractory glaucoma
The primary outcome of this review was control of IOP at one year, defined as a decrease in IOP by 15% from baseline value (or by another percentage of IOP reduction, as reported by included trials). We also assessed mean change in IOP measurements by any recording device; contact or non‐contact tonometry, collected prior to intervention and at one year.
primary outcome:
Smectite for acute infectious diarrhoea in children
Duration of diarrhoea, measured in hours.Clinical resolution at day 3 after starting treatment.
primary outcome:
Interventions for infantile haemangiomas of the skin
Clearance, as assessed by a clinician at any follow‐up: proportion of children with lesions completely cleared or with minimal residual signs (defined as faint macular erythema with no palpable component).A subjective measure of improvement, as assessed by the parent or child, at any follow‐up.Adverse events experienced at short (immediately after treatment until 48 hours after) or long term (more than 48 hours after treatment) related to each intervention. These included skin atrophy (scarring where the skin is thinned, with or without depression at the skin surface), skin hypopigmentation (loss of skin pigmentation), and complications (including bleeding, ulceration, infection, deformation, disfigurement, vision impairment, airway obstruction, pain associated with treatment or ulceration, and/or side effects of treatments). We also considered reports of number of adverse events in general, as well as serious/severe adverse events (as defined by trial authors).
primary outcome:
Honey for acute cough in children
Duration of cough.Symptomatic relief of cough (frequency of cough, reduction in severity, and less bothersome cough).
primary outcome:
Glucocorticosteroid‐free versus glucocorticosteroid‐containing immunosuppression for liver transplanted patients
All‐cause mortality.Graft loss including death.Acute rejection. This is diagnosed by the combination of abnormal liver biochemical variables (e.g. bilirubin, aspartate transaminase, alanine transaminase, alkaline phosphatases, gamma glutamyl transpeptidase), clinical signs such as fever, and liver histological changes including mononuclear portal inflammation, bile duct damage, and subendothelial inflammation of portal or terminal hepatic veins (IWP 1995; IP 2000).Infection.
primary outcome:
Ivermectin and permethrin for treating scabies
Complete clearance (outcome assessment at 7, 14, and 30 days' post‐initiation of treatment).
primary outcome:
Enteral nutritional therapy for induction of remission in Crohn's disease
The studies used one of various measures to assess remission: the Crohn's Disease Activity Index (CDAI), van Hees Index, the simple Crohn's Disease Index (or Harvey‐Bradshaw simple CDI), the International Organization of Inflammatory Bowel Disease Index (IOIBD) and the Pediatric Crohn's Disease Activity Index (PCDAI). The definition of remission can vary across studies using the same assessment scale. Thus, the primary outcome was the number of patients achieving remission, as defined by each individual study, and expressed as a percentage of the patients randomized (intention‐to‐treat analysis). Additional analysis was performed on a per‐protocol basis, excluding patients who withdrew due to lack of acceptability of a nasogastric tube for feeding or palatability of the enteral feed. Patients who withdrew for other reasons were still counted as treatment failures. Secondary outcomes included adverse events, withdrawals due to adverse events and serious adverse events.
primary outcome:
Early intervention (mobilization or active exercise) for critically ill adults in the intensive care unit
Physical function (the ability to perform everyday activities such as basic ADLs) as measured by a validated scale (e.g. Barthel Index, Functional Independence Measure (FIM)) or physical performance tasks (as measured by a scale such as the Physical Function ICU Test (PFIT), Acute Care Index of Functional Status (ACIF), Short Physical Performance Battery, walking tests)Adverse events (falls, accidental dislodgement of attachments, haemodynamic instability, oxygen desaturation or any other adverse events defined by study authors)
primary outcome:
Oral versus inhaled antibiotics for bronchiectasis
Duration of exacerbation (short‐term)Exacerbation (both), e.g. frequency during follow‐up or time to first exacerbationHospitalisations due to exacerbations (both)Serious adverse events (both)
primary outcome:
Nutritional supplements for patients being treated for active visceral leishmaniasis
Primary cure (clinical and parasitological improvement after treatment), defined as the absence of parasites at the end of treatment, resolution of clinical signs and symptoms of VL (defervescence, weight gain, and decrease in spleen size), and absence of clinical signs attributable to PKDL.
primary outcome:
Vascular access specialist teams for device insertion and prevention of failure
First‐time insertion success (generally insertion success is reported as a percentage): insertion of a PIVC where venous return occurs, a saline flush passes, and the PIVC is secured and ready for use (Riker 2011), or as defined by the study authors; in CVCs, the number of reported insertion attempts (generally insertion success is reported as a percentage) and where the tip of the CVC is confirmed in the lower third of the superior vena cava (Moureau 2013), or as defined by the study authors.Insertion‐related adverse events/complications:pneumothorax: inadvertent injury to the pleura of the lung during cannulation of a large vein (defined by each study) (Ayas 2007);arterial puncture: inadvertent puncture of an artery during cannulation of a large vein (defined by each study) (Guilbert 2008);nerve damage: inadvertent damage to the nerve that is adjacent to the vein/artery (defined by each study) (Guilbert 2008);other: as defined by the study author(s).Cost as defined by the study authors (in the currency of the country where the publication originated).
primary outcome:
Immunoglobulin for alloimmune hemolytic disease in neonates
use of ET (proportion of infants receiving one or more ETs);ETs performed per infant.
primary outcome:
Laryngeal mask airway versus bag‐mask ventilation or endotracheal intubation for neonatal resuscitation
Need for endotracheal intubation (LMA versus BMV studies only).Failure with primary modality of resuscitation (LMA versus BMV studies only)Ventilation time (time from birth, or from the beginning of intervention, until the discontinuation of positive pressure ventilation as part of resuscitation).Time to spontaneous breathing or described as time to definitive response following the onset of intervention. (LMA vs. BMV studies only)Admission to NICU.Failure to correctly insert the device (LMA versus endotracheal intubation studies only).Successful insertion of device at first attempt (LMA versus endotracheal intubation studies only).Time to complete procedure, defined as time required to correctly insert the device from the onset of intervention (LMA versus endotracheal intubation studies only).Death or hypoxic ischaemic encephalopathy (HIE) in the delivery room.
primary outcome:
Macrolide antibiotics for bronchiectasis
Exacerbations (defined by study authors' criteria)Hospitalisation (defined by study authors' criteria)Serious adverse events defined by Hansen 2015, as follows: adverse events that result in death or life‐threatening events, requirement for hospitalisation or prolongation of existing hospitalisation, persistent or significant disability, or congenital anomalies; or events that are considered medically important
primary outcome:
Systemic corticosteroids for acute otitis media in children
Proportion of children with pain at various time points (24 hours; 2 to 3 days; and 4 to 7 days (time points taken from Venekamp 2015)).Reduction of overall or specific symptoms (e.g. ear discomfort, hearing loss, irritability, sleep disturbance, diminished appetite). Reduction of overall or specific symptoms may have been measured using visual analogue scales or validated symptom scales specific to otitis media such as the Acute Otitis Media Severity of Symptoms Scale (AOM‐SOS), Otitis Media Outcome‐22 questionnaire (OMO‐22), Otitis Media‐6 quality of life survey (OM‐6), or others (Timmerman 2007).Reduction in overall or specific symptom duration.Adverse effects.
primary outcome:
The Neonatal Behavioral Assessment Scale (NBAS) and Newborn Behavioral Observations (NBO) system for supporting caregivers and improving outcomes in caregivers and their infants
Quality of caregiver‐infant interaction, including frequency and contingency (e.g. CARE index (Crittenden 2001), Nursing Child Assessment Teaching Scale (NCATS; Barnard 1978)), sensitivity and responsiveness (e.g. Nursing Child Assessment of Feeding Scale (NCAFS; Sumner 1994)), and responsiveness to infant distress (Britt 1994a).Caregiver mental health (e.g. Edinburgh Postnatal Depression Scale (EPDS; Cox 1987)).Adverse effects or unintended consequences (e.g. outcomes, such as caregiving quality, that worsen following the intervention).
primary outcome:
Interventions for preventing high altitude illness: Part 2. Less commonly‐used drugs
Risk of acute mountain sickness (AMS ‒ as defined by each study) at any time
primary outcome:
Standard (head‐down tilt) versus modified (without head‐down tilt) postural drainage in infants and young children with cystic fibrosis
Appearance or exacerbation of gastroesophageal reflux episodes (number and duration of episodes) identified by:clinical symptoms (e.g. vomiting, regurgitation, rumination)clinical tests (e.g. oesophageal pH monitoring, oesophageal impedance‐pH monitoring, ultrasonography, oesophagogastric scintigraphy)pulmonary events (e.g. pulmonary aspiration episodes)
primary outcome:
Provision of respiratory support compared to no respiratory support before cord clamping for preterm infants
Mortality up to two years after hospital discharge ‐ to be reported as death before 28 days, death before hospital discharge, or death after discharge.Neurodevelopmental disability (mild, moderate, or severe) at age 18 to 24 months (Doyle 2010).Death or neurodevelopmental disability at two to three years of age (Doyle 2010).
primary outcome:
Endovascular revascularisation versus conservative management for intermittent claudication
Functional performance outcomesMaximum walking distance (MWD), as assessed on a treadmillPain‐free walking distance (PFWD), as assessed on a treadmillSecondary invasive interventions during follow‐upEndovascular or surgical revascularisationAmputation
primary outcome:
Interventions for autumn exacerbations of asthma in children
The primary outcome was number of children (adjusted for the number of participants per group) experiencing one or more asthma exacerbations during the autumn period (the first three‐month period following the autumn school return) or during the intervention period if this included the autumn months. An exacerbation was defined as increased asthma symptoms requiring treatment with OCS or hospitalisation.
primary outcome:
Antibiotics at the time of removal of central venous catheter to reduce morbidity and mortality in newborn infants
Incidence of any late‐onset blood stream infection after catheter removal: defined as bacteraemia with at least one positive blood culture in an infant who has had a previous CVC removal plus clinical and/or laboratory manifestations of infectionNeonatal mortality
primary outcome:
Higher versus lower amino acid intake in parenteral nutrition for newborn infants
Mortality before hospital dischargeNeurodevelopmental disability at ≥ 18 months' postnatal age (defined as neurological abnormality including cerebral palsy on clinical examination, developmental delay more than two standard deviations below the population mean on a standardised test of development, blindness (visual acuity < 6/60), or deafness (any hearing impairment requiring amplification) at any time after term corrected)Postnatal growth failure (weight < 10th percentile near term corrected age or at discharge)
primary outcome:
Beta‐blockers for prevention and treatment of retinopathy of prematurity in preterm infants
Functional outcomes at six to 12 months' corrected age: severe visual impairment (acuity < 20/200) or blindness (acuity < 20/400) as defined by the World Health Organization (who.int/blindness/en/).Need for additional treatment.Anti‐VEGF agent.Laser photocoagulation.Cryotherapy.Vitrectomy.Structural outcomes (International Committee Retinopathy 2005).For prevention trials.Progression of ROP to stage 2 with plus disease.Progression of ROP to stage 3 with or without plus disease.Progression of ROP to stage 4 or 5 disease.For treatment trials.Progression of ROP to stage 4 or 5 disease.
primary outcome:
Physical activity, diet and other behavioural interventions for improving cognition and school achievement in children and adolescents with obesity or overweight
School achievement (Morris 2011), recorded by appropriately‐trained investigators (e.g. teachers, researchers). We excluded participant‐ and parent‐reported data.  Average achievement of subjects taught at school.Average across subjects taught at school over one academic year, for example, grade point average (GPA).Achievement in a single subject taught at school.Scores of subjects taught at school or standard achievement test scores for (a) mathematics, (b) reading or (c) language.Validated tests for school achievement in mathematics, reading or language, for example, Woodcock‐Johnson Tests of Achievement III (McGrew 2011).Special education classes.Need for special education class.Reduction of time allocated for special education class.Cognitive function (Carroll 1993): measures of general cognitive ability or different cognitive domains (e.g. composite executive function, inhibition control, attention, memory) assessed using validated cognitive tests administered by appropriately‐trained investigators, such as qualified psychologists. We excluded participant‐reported and parent‐reported data.Adverse outcomes: include, but are not limited to, reduced school attendance, musculoskeletal issues (e.g. activity‐related injury), and psychological issues (e.g. bullying, stigmatisation, depression, eating disorders) obtained from school records, medical records and self‐reports (for bullying and stigmatising events only). We included studies reporting adverse events only when measures of school achievement, cognitive function and/or future success were also reported.
primary outcome:
Slow‐release fluoride devices for the control of dental decay
Changes in decayed, missing, and filled teeth, or surfaces, or both (DMFT/DMFS in permanent teeth ‐ dmft/dmfs in primary teeth). We defined caries as being recorded at the dentine level of diagnosis. If caries data only reported caries at both dentine and enamel lesions combined then we used this in the analysis (see below for more information).Progression of caries lesion through enamel or into dentine.
primary outcome:
Prostaglandin E1 for maintaining ductal patency in neonates with ductal‐dependent cardiac lesions
All‐cause mortality at 28 days of life.Mortality prior to cardiac surgery.Improvement in the following cardiovascular and metabolic parameters expected due to ductal patency within four hours of therapy.Increase in oxygen saturations (%) or partial pressure of oxygen dissolved in arterial blood (PaO₂; mmHg) (or both) by 10% (indicative of increased pulmonary blood flow in pulmonary obstructive lesions or increased mixing of blood from pulmonary and systemic circulations; e.g. TGA with intact ventricular septum).Decrease in the upper limb systolic blood pressure and increase in lower limb systolic blood pressure by 5 mmHg (improvement in systemic blood flow in systemic obstructive lesions).Improvement in metabolic acidosis defined arbitrarily by decrease in base deficit by 5 mEq/L or decrease in lactate by 2 mmol/L.Echocardiographic visualization of the patency of the ductus.
primary outcome:
Welfare‐to‐work interventions and their effects on the mental and physical health of lone parents and their children
We extracted both reported, validated health scales and self‐reported health measures.Table 1 summarises the primary outcomes. We obtained data on parental health assessed by validated measures of parental physical and mental health, such as the Physical Health Scale, the Centre for Epidemiological Studies Depression Scale (CES‐D), and the WHO Composite International Diagnostic Interview (CIDI), as well as self‐reported physical or mental health. We also extracted data on child health such as parent‐ or child‐reported physical or mental health measures (e.g. the Health Status Scale and the Behavior Problems Index (BPI)). We also included studies reporting only child health outcomes. All included health outcomes are listed below.Studies used a range of measures and formats to report primary and secondary outcomes within and between studies and across different time points. The following provides a summary of which outcomes were reported by each intervention. Appendix 5 includes further details including the time points at which each outcome was reported. Although we searched for parental health outcomes, the vast majority of the sample in all included studies was female. Therefore, we describe adult health outcomes as 'maternal' for the remainder of the review.
primary outcome:
BIS monitoring versus clinical assessment for sedation in mechanically ventilated adults in the intensive care unit and its impact on clinical outcomes and resource utilization
Intensive care unit (ICU) length of stay (LOS), measured in days.
primary outcome:
Interventions to prevent hypothermia at birth in preterm and/or low birth weight infants
Temperature of the infant taken on admission to the neonatal intensive care unit (NICU) or up to two hours after birth. We assessed temperature as both continuous and dichotomous variables.We accepted rectal, axillary, oral, or tympanic temperature measurements as equivalent core body temperature, and we accepted abdominal skin temperature for skin temperature. When both core temperature and skin temperature were recorded, core temperature took priority. When multiple temperatures were recorded (i.e. within different time frames up to two hours after birth), the lowest temperature recorded took priority.A core body temperature < 36.5°C or a skin temperature < 36°C indicated the presence of hypothermia within control and intervention groups.For hypothermia, we used core body temperature and skin temperature subgroupings as defined by WHO 1997 to determine three levels of severity.Mild hypothermia or cold stress: core body temperature 36°C to 36.4°C, or skin temperature 35.5°C to 35.9°C.Moderate hypothermia: core body temperature 32°C to 35.9°C, or skin temperature 31.5°C to 35.4°C.Severe hypothermia: core body temperature < 32°C, or skin temperature < 31.5°C.
primary outcome:
Oral vitamin D supplementation for adults with obesity undergoing bariatric surgery
Fractures: defined as the proportion of participants who experience any low trauma fracture, with or without adjudication, depending on the trials.Adverse events: defined as the total incidence of adverse events (hypercalcaemia, hypercalciuria, kidney stones, gastrointestinal symptoms, or any other adverse event reported in trials).Specific adverse events specified as:hypercalcaemia incidence defined as the proportion of participants who had a serum calcium level above the upper limit of normal;hypercalciuria incidence defined as the proportion of participants who had a 24‐hour urine collection of calcium greater than 250 mg in women and greater than 300 mg in men (Hodgkinson 1958) or greater than 4 mg/kg in both sexes (Coe 1977);nephrolithiasis incidence defined as the proportion of participants who experience a kidney stone clinically or radiologically;gastrointestinal symptoms incidence defined as the proportion of participants who experience constipation, anorexia, nausea, vomiting, or epigastric pain.
primary outcome:
Midwife continuity of care models versus other models of care for childbearing women
Spontaneous vaginal birth (defined by trial authors)Caesarean birthRegional analgesia (epidural/spinal)Intact perineumFetal loss at or after 24 weeks gestationPreterm birth (< 37 weeks)Neonatal death (baby born alive at any gestation and dies within 28 days)
primary outcome:
Antioxidants for adults with chronic kidney disease
Cardiovascular deathDeath (any cause)
primary outcome:
Synbiotics, prebiotics and probiotics for people with chronic kidney disease
Kidney function: eGFR; serum creatinine (SCr); albuminuria; proteinuria; infection (including pyelonephritis or urosepsis)Uraemic toxins: urea; indoxyl sulfate; p‐cresyl sulfate; trimethylamine N‐oxide; phenylacetylglutamine; kynurenineGI function: change in any GI upset or intolerance; microbiota composition; faecal characteristics (such as the Bristol Stool Chart) (Lewis 1997); colonic transit time.
primary outcome:
Antioxidant vitamin and mineral supplements for slowing the progression of age‐related macular degeneration
We modified our protocol for the update in 2017 to include outcomes specified by the UK National Institute for Health and Care Excellence (NICE) macular degeneration guideline panel (NICE 2018); see Differences between protocol and review.We considered the following outcomes:*As visual acuity is also commonly reported as a 'mean score', we also include mean visual acuity as a continuous outcome.We considered the maximum follow‐up identified in the studies at any point in time.
primary outcome:
Dance movement therapy for dementia
Challenging behaviours, which could be assessed with standardised instruments (e.g. Cohen Mansfield Agitation Inventory, CMAI (Cohen‐Mansfield 1989)) or with quantitative observational tools specifically designed for an individual study to measure frequency of occurrence of wandering, agitation, general restlessness, etc.Cognitive functioning, assessed with standardised instruments, e.g. the Mini‐Mental State Exam (MMSE) (Folstein 1975) or the Alzheimer's Disease Assessment Scale (ADAS‐cog; Rosen 1984).Depression, assessed with standardised instruments, e.g. the Cornell Scale for Depression in Dementia (Alexopoulos 1988).Quality of life, assessed with standardised instruments, e.g. Quality of Life‐Alzheimer's Disease (QOL‐AD, Logsdon 1999).
primary outcome:
Low glycaemic index or low glycaemic load diets for people with overweight or obesity
Anthropometric measures: body weight (kg); body mass index (BMI); BMI adjusted for ageAdverse events
primary outcome:
Serenoa repens for the treatment of lower urinary tract symptoms due to benign prostatic enlargement
Urologic symptom scores (continuous outcome)Quality of life (continuous outcome)Adverse events
primary outcome:
Non‐Chinese herbal medicines for functional dyspepsia
Global symptoms of dyspepsia, measured by a validated score or scale, such as the gastrointestinal symptom score (GIS), the severity of dyspepsia assessment scale (SODA), the dyspepsia symptom severity index (DSSI), or other validated instruments. This outcome could be measured both as a continuous outcome and the number of individuals with improved symptoms scores.Adverse events: number of participants with at least one adverse event.
primary outcome:
Antidepressants for smoking cessation
Efficacy, measured as smoking cessation
primary outcome:
Cephalic version by moxibustion for breech presentation
Baby's presentation at birth (non‐cephalic presentation).Need for ECV.
primary outcome:
Caffeine dosing regimens in preterm infants with or at risk for apnea of prematurity
All‐cause mortality prior to hospital discharge.Major neurodevelopmental disability: cerebral palsy, developmental delay (Bayley Mental Developmental Index (Bayley 1993; Bayley 2006), or Griffiths Mental Development Scale (Griffiths 1954), assessment greater than two standard deviations (SDs) below the mean), intellectual impairment (intelligence quotient (IQ) greater than two SDs below the mean), blindness (vision less than 6 out of 60 in both eyes), or sensorineural deafness requiring amplification (Jacobs 2013). We separately assessed outcomes at age 18 months to 24 months corrected age (CA) and at 3 to 5 years CA.Mortality or major neurodevelopmental disability. We separately assessed outcomes at age 18 to 24 months CA and at 3 to 5 years CA.
primary outcome:
The McKenzie method for (sub)acute non‐specific low back pain
We chose all major and minor outcomes according to the published protocol (Machado 2012).
primary outcome:
Ultrasound and shockwave therapy for acute fractures in adults
Functional recovery, including return to former activities, was the prime focus of the review. However, we anticipated that most trials would not report patient‐reported outcome measures (PROMs), but would focus instead on fracture healing outcomes.The definition of a healed fracture is contentious. For the purpose of this review we adopted the widely accepted definitions in the literature. A fracture is healed when callus is present bridging three of four cortices on orthogonal radiographs, or there is an absence of pain and movement at the fracture site, or both. It was expected that most studies would report the time to union for each participant. These are the most frequently reported statistics when studies are published in this field. However, it was possible that some studies might have presented a proportional analysis of healed fractures at a number of fixed time points after treatment.
primary outcome:
Altered dietary salt intake for preventing diabetic kidney disease and its progression
Net change in 24‐hour UNaNet change in 24‐hour BP (SBP, DBP, mean arterial pressure (MAP))Death (any cause)
primary outcome:
Yoga for chronic non‐specific low back pain
We chose outcome measures that were important in assessment of low back pain, so that this review may produce results that are easily compared to or combined with those of other systematic reviews of treatment for low back pain. All outcomes were assessed at short‐term (closest to four weeks), short–intermediate term (closest to three months), intermediate‐term (closest to six months), and long‐term (closest to 12 months) time points.
primary outcome:
Ginkgo biloba for tinnitus
Tinnitus symptom severity (such as the impact of tinnitus on quality of life, activities of daily living and sleep), as measured by the global score on a multi‐item tinnitus questionnaire (Table 1). These include:Tinnitus Questionnaire (Hallam 1996; Hiller 1992);Tinnitus Functional Index (Meikle 2012);Tinnitus Handicap Inventory (Newman 1996);Tinnitus Handicap Questionnaire (Kuk 1990);Tinnitus Reaction Questionnaire (Wilson 1991);Tinnitus Severity Scale (Sweetow 1990).Serious adverse effects: bleeding, seizures.
primary outcome:
Upper limb exercise for arteriovenous fistula maturation in people requiring permanent haemodialysis access
Time to AVF maturation (months): defined as a duration spent waiting for a mature AVFUltrasound maturation: defined as a number of participants who have a mature AVF assessed using an ultrasound deviceClinical maturation: defined as a number of participants who have a mature AVF measured using a palpation method by a clinician.
primary outcome:
Repetitive peripheral magnetic stimulation for impairment and disability in people after stroke
Katz Index of Independence in Activities of Daily Living; andFrenchay Activities Index (FAI).
primary outcome:
Acupuncture for treating overactive bladder in adults
Number of participants whose overactive bladder symptoms were cured or improved, assessed using validated urinary symptom and incontinence‐specific patient‐reported outcome measures (e.g. the Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS) (Hiller 2002), International Consultation on Incontinence Questionnaire‐Urinary Incontinence (ICIQ‐UI) (Avery 2004), three‐day bladder diaries (Jimenez‐Cidre 2015)). Numbers of participants defined as cured in studies were reported. Where cure rates were not used, we used symptom improvement rates.Number of major adverse events (i.e. death, serious infection from needle insertion, pneumothorax from needle insertion, any complication resulting in hospitalisation as an inpatient or an outpatient).Number of minor adverse events (i.e. fainting, vomiting, pain on needle insertion, bleeding on needle removal, bruising and fatigue).
primary outcome:
Listening to music for insomnia in adults
sleep quality;insomnia severity;sleep‐onset latency;total sleep time;sleep interruption (number of awakenings and waking after sleep onset);sleep efficiency (percent of time in bed spent asleep);adverse events (as reported by trialists; e.g. discomfort or hearing loss).
primary outcome:
Marine‐derived n‐3 fatty acids therapy for stroke
The primary outcome was efficacy (functional outcome or disability/dependency) for the latest time point of assessment, using a validated scale (e.g. modified Rankin Scale (mRS); Barthel index (BI); or change in National Institutes of Health Stroke Scale (NIHSS)). For studies using multiple scales, we included all functional outcome and disability/dependency measures reported. However, for a meta‐analysis we would have selected the one with the largest amount of data available or, in the case of equal amounts of data, the one reported first in the study.
primary outcome:
Antioxidants for male subfertility
Live birth rate per couple randomised, defined as delivery of a live fetus after 20 completed weeks of gestation. Live births are counted as birth events, i.e. twin live birth is counted as one live birth event.
primary outcome:
Psychological treatments for depression and anxiety in dementia and mild cognitive impairment
Scale‐based measures of depressive symptoms (e.g. Cornell Scale for Depression in Dementia, Hamilton Depression Rating Scale (HDRS), Beck Depression Inventory, Geriatric Depression Scale (GDS)) and anxiety symptoms (e.g. Rating Anxiety in Dementia)Depression remission (defined by a pre‐specified threshold on a depression scale or no longer meeting clinical criteria for depression). We accepted the authors' definition provided that the remission scores were based on changes in depression measures that were either clinician‐rated or other validated measures, and that these were similar to definitions used in the literature.
primary outcome:
Exercise training for adults undergoing maintenance dialysis
Death (any cause)Cardiovascular eventsFatigue
primary outcome:
Calcium supplementation for prevention of primary hypertension
Hypertension, defined as blood pressure ≥ 140/90 mmHgSystolic and diastolic blood pressure
primary outcome:
High versus low‐added sugar consumption for the primary prevention of cardiovascular disease
Incident cardiovascular event (coronary, carotid, cerebral and peripheral arterial disease)All‐cause mortality
primary outcome:
Dietary advice with or without oral nutritional supplements for disease‐related malnutrition in adults
MortalityMorbidity (assessed by risk of hospital admission or readmission and length of hospital stay and complications)Measures of nutritional status and body compositionchange in weightBMIfat‐free mass (FFM)mid‐arm circumference (MAC)mid‐arm muscle circumference (MAMC)triceps skinfold thickness (TSF)
primary outcome:
Effect of periodontal treatments on blood pressure
Change in SBP and DBP (mmHg).
primary outcome:
Mindfulness‐based psychological interventions for improving mental well‐being in medical students and junior doctors
Anxiety, measured using validated scales such as the Anxiety Inventory (Beck 1988)Depression, measured using validated scales such as the Depression, Anxiety and Stress Scale (DASS) (Antony 1998)
primary outcome:
Roselle for hypertension in adults
Change in trough (13 to 26 hours after the dose) and/or peak (1 to 12 hours after the dose) SBP and DBP. If blood pressure measurements were available at more than one time point within the acceptable window, we used the means of blood pressures taken in the 3‐ to 12‐week range.
primary outcome:
Omega‐3 fatty acids for depression in adults
1. Depressive symptomology (continuous data): We assessed depressive symptomology using any continuous validated measure. The most commonly‐used validated rating scales are the Beck Depression Inventory (BDI) (Beck 1987), the Montgomery‐Asberg Depression Rating Scale (MADRS) (Montgomery 1979), and the Hamilton Depression Rating Scale (HDRS) (Hamilton 1960), but we also included trials using other scales.2. Adverse events: We recorded measures of adverse events where possible. We recorded the number and type (e.g. gastrointestinal, psychiatric) of adverse events experienced, as reported in trials. We used the number of individuals experiencing adverse events, rather than the number of events, in analyses where possible. Where adverse events were not reported, we recorded this.
primary outcome:
Humour‐based interventions for people with schizophrenia
We aimed to divide all outcome measures into short‐term (less than six weeks), medium‐term (six to 12 weeks) and long‐term (over 12 weeks). For the better interpretation of the effect size of patient‐reported outcome measures, we would have attempted to report binary outcomes recording clear and clinically‐meaningful degrees of change (e.g. global impression of much improved, or more than 50% improvement on a rating scale (as defined within the trials) before any others (Collister 2021). Thereafter, we listed other binary outcomes and then those that are continuous. Our approach in identifying types of valid rating scales is further elaborated in the section 'Data extraction and management'.
primary outcome:
Palliative care interventions in advanced dementia
We developed the outcomes for this review by drawing on the EAPC definition of palliative care (Van der Steen 2014), along with the “domains and dimensions of outcome measures in palliative care” (Bausewein 2011). We chose to measure patient comfort and symptom management as our primary outcomes. The selection of these outcomes was informed by the fact that a central aim of palliative care is to ensure the best possible quality of life, while also managing symptoms (Dixon 2015).
primary outcome:
Cannabinoids for the treatment of dementia
Changes in global and specific cognitive functions, measured by any validated cognitive scale covering multiple cognitive domains or single cognitive domains (e.g. memory, executive function), such as the Standardised Mini‐Mental State Examination (sMMSE) (Folstein 1975)Overall behavioural and psychological symptoms of dementia (BPSD), measured with any validated instrument (e.g. the Neuropsychiatric Inventory (NPI) (Cummings 1994), the Alzheimer's Disease Assessment Scale (ADAS)) (Rosen 1984)Adverse events
primary outcome:
Chinese herbal medicine for subfertile women with polycystic ovarian syndrome
Live birth rate (per woman). Live birth is defined as the delivery of a live foetus more than 20 completed weeks of gestational age. Ongoing pregnancy is defined as the presence of a foetal heart beat on ultrasound scan over 12 weeks of gestation per woman or couple randomised. Cumulative live birth was also to be reported, if data were available.
primary outcome:
Ginseng for erectile dysfunction
Erectile functionAdverse events
primary outcome:
Probiotics for preventing gestational diabetes
The outcomes for this review are from the Cochrane Core Outcome Set for GDM prevention.
primary outcome:
Vegan dietary pattern for the primary and secondary prevention of cardiovascular diseases
CVD clinical eventsCVD mortality;MI;CABG;percutaneous transluminal coronary angioplasty (PTCA);angiographically‐defined CHD;stroke;carotid endarterectomy;peripheral artery disease (PAD).Changes in blood lipidstotal cholesterol;HDL cholesterol;LDL cholesterol;triglycerides.Changes in blood pressuresystolic blood pressure;diastolic blood pressure.Adverse events (number of participants with at least one event)
primary outcome:
Coenzyme Q10 for heart failure
All‐cause mortalityCardiovascular (CV) mortalityFatal and non‐fatal myocardial infarctionFatal and non‐fatal strokeRevascularisation procedures (percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG))Hospitalisation due to heart failure (number of people with at least one hospitalisation due to heart failure)All‐cause hospitalisation (number of people with at least one hospitalisation for any cause)New York Heart Association (NYHA) classification of clinical status (four classes, lower = better)
primary outcome:
Intermittent fasting for the prevention of cardiovascular disease
All‐cause mortalityCardiovascular (CV) mortalityStrokeMyocardial infarction (MI)Heart failure