anurajms/meta_analysis huggingface dataset:
primary outcome:
Responsive versus scheduled feeding for preterm infants
Growth: (a) weight gain (g/day or g/kg/day); linear growth (mm/week); head circumference (mm/week); skinfold thickness (mm/week) during the trial period. (b) Proportion of infants who remain below the 10th percentile for the index population's distribution of weight, height, or head circumference when assessed at hospital discharge, 40 weeks' postmenstrual age, during infancy, and beyond.Duration of hospital admission: postmenstrual age or chronological age (days from birth or from trial enrolment), or both, to discharge to home from hospital.Measures of parental satisfaction using validated assessment tools.
primary outcome:
Cup feeding versus other forms of supplemental enteral feeding for newborn infants unable to fully breastfeed
Weight gain (g/kg/day)Time to full breastfeeding with acceptable weight gain (15 to 30 grams/day)Proportion not breastfeeding at hospital discharge and at three and six months of ageProportion not fully breastfeeding at hospital discharge and at three and six months of age
primary outcome:
Early additional food and fluids for healthy breastfed full‐term infants
Duration of breastfeedingIncidence of infant morbidity, for example, hypo‐ or hyperthermia, hypo‐ or hyperglycaemia, gastro‐intestinal infection, ear infection, asthma, eczema or other allergy (depending on how defined in individual trials)Infant mortality (at discharge, 28 days, or one year)Physiological jaundice, absence or presence, and if present, duration (days) (as defined in the Background)
primary outcome:
Instruments for assessing readiness to commence suck feeds in preterm infants: effects on time to establish full oral feeding and duration of hospitalisation
Time from randomisation to full oral feeding (days).Duration of hospitalisations (days from randomisation until the end of the trial).
primary outcome:
Sucrose for analgesia in newborn infants undergoing painful procedures
Composite pain score: A composite pain score includes indicators of pain from multiple dimensions (e.g. behavioural and physical ‐ e.g.PIPP‐R). Multidimensional behavioural pain score: A multidimensional behavioural pain score includes multiple indicators of pain but from one dimension (e.g. NFCS). Validated pain scores in this review included the Premature Infant Pain Profile (PIPP; Stevens 1996), Revised PIPP (PIPP‐R; Stevens 2014a), Douleur Aiguë du Nouveau‐né Scale (DAN; Carbajal 1997), Neonatal Infant Pain Scale (NIPS; Lawrence 1993), Neonatal Facial Coding System (NFCS; Grunau 1987), Neurobehavioural Assessment of Preterm Infants (NAPI; Snider 2005), Neonatal Pain Agitation and Sedation Scale (N‐PASS; Hummel 2010) and the Bernese Pain Scale for Neonates (BPSN; Cignacco 2004). We did not include the results for the COMFORTneo Scale in the 'Summary of findings' tables (van Dijk 2009), as it has not been fully validated. We do report on the results from studies that used that pain scale in the Results section.Long‐term neurodevelopmental outcomes (assessed by a standardized and validated assessment tool, a child developmental specialist, or both) at 18 to 24 months, or at any later age in childhood.
primary outcome:
Epinephrine for transient tachypnea of the newborn
Duration of supplemental oxygen therapy (hours).Need for continuous positive airway pressure (yes/no).Need for mechanical ventilation (yes/no).
primary outcome:
Heparin for the prevention of intraventricular haemorrhage in preterm infants
Any IVH (grade 1 to 4 according to Papile classification) (Papile 1978).Severe IVH (grade 3 and 4 according to Papile classification) (Papile 1978).
primary outcome:
Co‐bedding in neonatal nursery for promoting growth and neurodevelopment in stable preterm twins
Growth: average rate of weight gain between twin pairs for the whole period of the study, expressed in grams/kg/d. We used a standard formula to derive the rate of weight gain (Patel 2005).Apnea: average number of episodes between twin pairs. Apnea was defined as cessation of breathing for at least 20 seconds, or for a shorter period if accompanied by bradycardia or cyanosis (American Academy of Pediatrics 2003).Bradycardia: average number of episodes between twin pairs. Bradycardia was defined as a fall in heart rate of greater than 30% to below baseline (Henderson‐Smart 1986) or to less than 100 beats per minute for at least 10 seconds (Bredemeyer 2012).Neurobehavior in the nursery measured by validated scales such as the Brazelton Neonatal Behavior Assessment Scale (NBAS) and the Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) (Lester 2004), including infant co‐regulation, stress response, and sleep/wake state, as defined by the proportion of time in quiet sleep.
primary outcome:
Antimicrobial dressings for the prevention of catheter‐related infections in newborn infants with central venous catheters
Proven CRBSI: expressed by the authors of the individual studies as absolute rates or episodes per 1000 catheter‐days, or both. Episodes per 1000 catheter‐days were calculated as follows: absolute rate divided by the total catheter‐days (the sum of the in‐dwelling time for all catheters in the assigned group) multiplied by 1000. We used a broad definition of CRBSI based on CDC criteria (CDC 2011; CDC 2014). We have provided a detailed description of these criteria below. We planned to include studies that define CVC‐related and CVC‐associated infections using criteria that are not covered by the CDC definitions, provided the authors justified their definitions with valid sources;Clinically diagnosed sepsis (with or without concurrent microbiological evidence of a CRBSI), expressed as absolute rates or episodes per 1000 catheter‐days, or both, if data are available;All‐cause mortality, assessed throughout the hospital stay of the participants.
primary outcome:
Antithrombin for the prevention of intraventricular hemorrhage in very preterm infants
GM‐IVH: Any severity, grade 1 to 4 (Papile 1978)Severe IVH: grade 3 and 4 (Papile 1978)
primary outcome:
Frequency of endotracheal suctioning for the prevention of respiratory morbidity in ventilated newborns
Respiratory support or oxygen, or both, at 28 days of life (NIH 1979).Treatment with oxygen greater than 21% for at least 28 days, with grade of severity scored at 36 weeks of postmenstrual age (PMA) (Jobe 2001).Physiologic definition (measured at 36 weeks' PMA) (Walsh 2004).
primary outcome:
Transcutaneous carbon dioxide monitoring for the prevention of neonatal morbidity and mortality
Bronchopulmonary dysplasia/chronic lung disease, defined as: respiratory support or oxygen, or both, at 28 days of life (NIH 1979)/ respiratory support or oxygen, or both, at 36 weeks of postmenstrual age (PMA) (Jobe 2001); physiological definition (Walsh 2004).Death during initial hospitalization (all‐cause mortality).Major neurodevelopmental disability (cerebral palsy, developmental delay (Bayley or Griffith assessment more than two SD below the mean) or intellectual impairment (IQ more than two SD below mean), blindness (vision < 6/60 in both eyes), sensorineural deafness requiring amplification) (Jacobs 2013).
primary outcome:
Alternative lipid emulsions versus pure soy oil based lipid emulsions for parenterally fed preterm infants
Death before discharge or neonatal death (within the first 28 days of life).Physical growth: a) days to regain birth weight; b) growth rate (g/kg/day) during study period and hospital stay.BPD or CLD: a) oxygen requirement at 28 days; b) oxygen therapy or any form of respiratory support at 36 weeks postmenstrual age.Neurodevelopmental outcome (neurodevelopmental outcome assessed by a standardised and validated assessment tool or a child developmental specialist) at any age reported (outcome data grouped at 12, 18, and 24 months if available).
primary outcome:
Diuretics for transient tachypnoea of the newborn
Duration of oxygen therapy in hours.Number of infants receiving CPAP.Number of infants receiving positive pressure ventilation.
primary outcome:
Chest shielding for prevention of a haemodynamically significant patent ductus arteriosus in preterm infants receiving phototherapy
Unselected infants (not enrolled on the basis of a PDA detected clinically or echocardiographically): presence of a clinically1 and/or haemodynamically2 significant PDA.Infants with a PDA (enrolled with clinical or echocardiographic signs of a PDA): persistence (at least seven days after enrolment) of a clinically1 and/or haemodynamically2 significant PDA.
primary outcome:
Specialist teams for neonatal transport to neonatal intensive care units for prevention of morbidity and mortality
Deaths occurring:
a. During transport‐team stabilisation. (Stabilisation time is defined as the time interval between arrival at the referring hospital and departure of the transport team);
b. During transport (defined as between time of departure from the referring hospital and arrival at the NICU);
c. Within 24 hours of NICU admission;
d. Prior to NICU discharge.
primary outcome:
Rescue high‐frequency jet ventilation versus conventional ventilation for severe pulmonary dysfunction in preterm infants
Mortality at 28 to 30 days and at hospital discharge.Chronic lung disease at 28 days (defined as oxygen supplementation at 28 days).Chronic lung disease at 36 weeks' postmenstrual age (defined as supplemental oxygen at 36 weeks' gestation).Chronic lung disease or death at 36 weeks' postmenstrual age.*
primary outcome:
Percutaneous central venous catheters versus peripheral cannulae for delivery of parenteral nutrition in neonates
Average daily input of parenteral calories (kcal/kg/d) and protein (g/kg/d) during trial period.Average daily proportion of prescribed parenteral calories and protein actually delivered during trial period.Short‐term (before discharge from the hospital) growth: weight gain (g/kg/d), weight z‐score at discharge, linear growth (mm/wk), head growth (mm/wk) and skinfold thickness growth (mm/wk).Long‐term (after discharge from the hospital) growth: weight gain (g/kg/d), linear growth (mm/wk), head growth (mm/wk) and skinfold thickness growth (mm/wk).Neurodevelopmental outcomes during infancy and beyond, using validated assessment tools, such as Bayley Scales of Infant Development, and classifications of disability, including auditory and visual disability. Severe neurodevelopmental disability was defined as any one or combination of the following: non‐ambulant cerebral palsy, developmental delay (developmental quotient less than 70) or auditory and visual impairment.
primary outcome:
Antimicrobial‐impregnated central venous catheters for prevention of catheter‐related bloodstream infection in newborn infants
Incidence (and rates per 1000 catheter‐days) of laboratory‐confirmed bloodstream infection, where the CVC was in place on the day or the day before the blood sample for microbial culture was obtained. If the CVC was placed on the first postnatal day, then it must have been in place for more than two calendar days on the day that the blood sample for microbial culture was obtained.Catheter‐related bloodstream infection (Analysis 1.1):Bertini 2013 found that a statistically significant reduced incidence in infants allocated to the intervention (RR 0.11, 95% CI 0.01 to 0.87; RD ‐0.17, 95% CI ‐0.30 to ‐0.04; NNTB 6, 95% CI 3 to 25; Figure 1).
primary outcome:
Standardised formal resuscitation training programmes for reducing mortality and morbidity in newborn infants
Neonatal mortality defined as death in the first 28 days after birth in neonates who were randomised including those requiring resuscitation. Subgroup categories for neonatal mortality were:early neonatal mortality: death in the first seven days after birth;late neonatal mortality: death between eight and 28 days after birth;neonatal mortality in the first 28 days after birth.*Neonatal morbidity defined as:hypoxic ischaemic encephalopathy ‐ moderate‐to‐severe encephalopathy defined using a combination of clinical and biochemical parameters. This was defined as: in infants greater than 36 weeks' gestational age, either cord or arterial pH less than 7 or base deficit greater than 16 within the first hour of life or if there is no blood gas or cord or arterial pH 7 to 7.15 and base deficit 10 to 16, then additional criteria of history of an acute perinatal event and Apgar less than 5 at 10 minutes or need for mechanical ventilation at 10 minutes of age (Shankaran 2005);low Apgar scores defined as a 10‐minute Apgar score less than 5;seizures: electroencephalographically confirmed seizure within 72 hours of birth;hypothermia (defined as a temperature less than 36 °C) on admission to the neonatal unit (de Almeida 2014); admission to the neonatal unit in randomised infants including those requiring resuscitation;meconium aspiration syndrome ‐ defined as respiratory distress in an infant born through meconium‐stained amniotic fluid whose symptoms cannot be otherwise explained (Cleary 1998);neurodevelopmental outcome at 18 to 24 months as assessed by a validated scoring tool.
primary outcome:
Intravenous in‐line filters for preventing morbidity and mortality in neonates
Mortality from any cause.Proven septicaemic infection; positive bacterial or fungal blood culture.
primary outcome:
Regional (spinal, epidural, caudal) versus general anaesthesia in preterm infants undergoing inguinal herniorrhaphy in early infancy
Apnoea ‐ any episodes of apnoea in the first 24 hours postoperatively or mean rate of apnoea per 24 hours. Apnoea is defined as a pause in breathing of greater than 20 seconds; or one less than 20 seconds and associated with cyanosis, marked pallor, hypotonia or bradycardia (NIH 1987).Desaturations ‐ any episodes of desaturation in the first 24 hours postoperatively or mean rate of desaturation per 24 hours. Desaturation is defined as a haemoglobin oxygen saturation (SpO2) of less than 90% for more than 10 seconds. Again this will be recorded in the 24 hour period immediately postoperatively and the frequency of episodes will be recorded over a 24 hour period.The use of postoperative respiratory support (continuous positive airways pressure or intermittent positive pressure ventilation) beyond the end of the surgical procedure. Once neuromuscular blockade has been antagonised we classify postoperative respiratory support as an adverse effect if it is required for more than 1 hour past reversal of anaesthesia.Neurodevelopmental state at two‐year follow‐up as reflected in the Bayley scales of infant development (MDI/PDI).
primary outcome:
Strategies for the discontinuation of humidified high flow nasal cannula (HHFNC) in preterm infants
Time (from treatment group allocation) to successfully remaining off HHFNC altogether (hours, days);Failure to wean off HHFNC (e.g. needing to restart HHFNC once it has stopped, or needing to restart HHFNC during time off HHFNC, or delaying any further weaning off HHFNC, or needing to commence/return to NCPAP or ventilation), however defined in individual studies.
primary outcome:
Elective high frequency oscillatory ventilation versus conventional ventilation for acute pulmonary dysfunction in preterm infants
Outcomes from trials were not eligible if there was a 20% or greater rate of missing or unreported data.
primary outcome:
Methods for securing endotracheal tubes in newborn infants
Accidental extubation (number of episodes per patient‐days of intubation)The need for re‐intubation (number of episodes per patient‐days of intubation)Rate of tube malposition on x‐ray (number of episodes per patient‐days of intubation)
primary outcome:
Home‐ versus hospital‐based phototherapy for the treatment of non‐haemolytic jaundice in infants at more than 37 weeks' gestation
Rate of change of serum bilirubin (micromoles/L/h) from initiation of phototherapy to cessation of phototherapy.Duration of phototherapy from initiation to end (hours).Duration of time exposed to phototherapy (hours). Some infants will have short periods off phototherapy for feeding, etc.Incidence of acute bilirubin encephalopathy, which ranges from the initial phase of lethargy, hypotonia, reduced movement and a poor suck to the advanced phase of deep stupor, hypertonia, inability to feed and a shrill cry or seizures.Incidence (percentage) of chronic bilirubin encephalopathy or kernicterus, defined by a tetrad of choreoathetoid cerebral palsy, high‐frequency sensorineural hearing loss, palsy of vertical gaze and dental enamel hypoplasia.Rate of treatment failure (percentage) (defined as the need for exchange transfusion).
primary outcome:
Physical activity programs for promoting bone mineralization and growth in preterm infants
Bone mineralization: bone mineral content, bone mineral density, and bone area as measured by absorptiometric x‐ray techniques:at completion of the physical activity program;at discharge;at term; andat 12 to 24 months corrected age.Fractures: proportion of infants with one or more fractures:at completion of the physical activity program;at discharge;at term; andat 12 to 24 months corrected age.Somatic growth: weight, length, head circumference:at completion of the physical activity program;at discharge;at term; andat 12 to 24 months corrected age.
primary outcome:
Early light reduction for preventing retinopathy of prematurity in very low birth weight infants
Acute ROP: any stage of ROP during the weeks after birth, observed by direct or indirect ophthalmoscope (ICROP 2005).Poor ROP outcome: in either the acute period, or in follow‐up, the ROP observed advanced to Stage 4b (partial retinal detachment involving the macula), extensive cicatrix obscuring the visual axis, or stage 5 ROP (total retinal detachment), or the ROP advanced to the point where cryotherapy or laser treatment was used for threshold ROP.
primary outcome:
Lung lavage for meconium aspiration syndrome in newborn infants
Death.Use of ECMO.Death or use of ECMO.Pneumothorax.All air leak (pneumothorax, pneumomediastinum, pneumopericardium, pneumoperitoneum, pulmonary interstitial emphysema).Days of mechanical ventilation via an endotracheal tube.Days of supplemental oxygen.Length of stay in hospital.Total cost of hospitalisation.
primary outcome:
Surgical versus medical treatment with cyclooxygenase inhibitors for symptomatic patent ductus arteriosus in preterm infants
All causes of mortality during the initial hospital stay.
primary outcome:
Early trophic feeding versus enteral fasting for very preterm or very low birth weight infants
Feed intolerance: days to establish full enteral feeding independently of parenteral nutrition.Necrotising enterocolitis confirmed by at least two of the following features:
primary outcome:
Vasopressin and its analogues for the treatment of refractory hypotension in neonates
Efficacy as measured by any of the following:mortality: 'all‐cause mortality' during hospital stay.survival at 18 or more months of age.neurodevelopmental outcome assessed by a validated test at 18 or more months of age.
primary outcome:
Nasal versus oral route for placing feeding tubes in preterm or low birth weight infants
Time to establish full enteral tube feeds independently of parenteral fluids or nutrition (days).
primary outcome:
Hydralazine in infants with persistent hypoxemic respiratory failure
Survival at 36 weeks' PMA, in‐hospital survival at hospital discharge, and at 18 and 36 months of age.
primary outcome:
Immunomodulators and immunosuppressants for relapsing‐remitting multiple sclerosis: a network meta‐analysis
We estimated the relative effects of the competing interventions according to the following primary outcomes:
primary outcome:
Local corticosteroid injection versus placebo for carpal tunnel syndrome
Improvement in symptoms at up to three months of follow‐up. Preferably this was demonstrated through a validated participant‐reported outcome measure for CTS (in order of preference: Boston Carpal Tunnel Questionnaire (BCTQ; Levine 1993)), Global Symptom Score (GSS; Herskovitz 1995), Disabilities of the Arm, Shoulder and Hand (DASH/QUICKDASH; Hudak 1996). If a study used more than one of the preferred measures, we used the measure that was highest in the hierarchy.
primary outcome:
Treatment for sialorrhea (excessive saliva) in people with motor neuron disease/amyotrophic lateral sclerosis
Participant‐reported improvement in sialorrhea reported in the short term (one to 12 weeks) and long term (more than 12 weeks). Participant‐reported improvement was the change from baseline measured using a validated scale, or by asking participants if they improved or not.
primary outcome:
Topical clonidine for neuropathic pain in adults
Participant‐reported pain relief of 50% or greater during longest follow‐up periodParticipant‐reported pain relief of 30% or greater during longest follow‐up periodMuch or very much improved on PGIC during longest follow‐up periodVery much improved on PGIC during longest follow‐up period
primary outcome:
Ocrelizumab for multiple sclerosis
Three trials reported adverse events and serious adverse events (Kappos 2011; OPERA I 2017; OPERA II 2017).
primary outcome:
Immunoglobulin for multifocal motor neuropathy
Proportion of participants with an improvement in disability between two and six weeks after the last treatment as determined and defined by the study authors and compared to baseline.
primary outcome:
Siponimod for multiple sclerosis
The number of participants who experienced new relapses during the treatment and follow‐up periods. A relapse is defined as the appearance of one or more new symptoms due to MS or the deterioration of pre‐existing symptoms, persisting more than 24 hours in the absence of fever and preceded by a period of stability of at least one month (McDonald 2001).The number of participants who experienced disability worsening measured by Expanded Disability Status Scale (EDSS; Kurtzke 1983). The EDSS is a common measure of MS disability (0 = normal, 3 = mild disability, 6 = care requirement, 7 = wheelchair use, 10 = death from MS) and is used to measure disability worsening in clinical studies. Disability worsening should be confirmed after at least six months of follow‐up, because worsening confirmed after only three months of follow‐up is considered a surrogate marker for unremitting disability. Disability worsening is defined as at least a 1‐point EDSS increase or a 0.5‐point increase if the baseline EDSS was 5.5 or higher, confirmed during two subsequent neurological examinations separated by at least a six‐month interval free of attacks (Kurtzke 1983).The number of participants who withdrew due to any adverse event out of the total number of participants randomly assigned to each treatment arm.
primary outcome:
Rituximab for people with multiple sclerosis
We included short‐term (12 to 24 months) and long‐term (> 24 months) outcomes reported in the included studies.
primary outcome:
Memory rehabilitation for people with multiple sclerosis
For subjective reports of memory: we considered Everyday Memory Questionnaire (EMQ) (Sunderland 1983), over the Cognitive Failures Questionnaire (Broadbent 1982), over the Subjective Memory Questionnaire (Davis 1995), over the Memory Assessment Clinics Questionnaire (Crook 1992). If more than one questionnaire was used, we used the following hierarchy: memory problems in daily life, over general forgetting, over domain‐specific questions. If a questionnaire was used that was not in this hierarchy, we arrived at a consensus through discussion prior to data extraction to avoid bias.For objective verbal measure of memory: we considered California Verbal Learning Test (CVLT‐II) (Delis 2000) over Selective Reminding Test (SRT) (Buschke 1973), over Doors and People Test (Baddeley 1994). For neuropsychological test batteries, we used verbal domain‐specific scores over composite scores.For objective visual measures of memory: we considered Brief Visuospatial Memory Test – Revised (BVMT‐R) (Benedict 1996), 10/36 Spatial Recall Test (SPART) (Rao 1990), Contextual Memory Text (CMT) (Toglia 2004), Rey‐Osterrieth Complex Figure text (ROCF) (Rey 1941 and Osterrieth 1944). For neuropsychological test batteries, we used visual domain‐specific scores over composite battery scores.For objective working measures of memory: we considered Rivermead Behavioural Memory Test (RBMT) (Wilson 1985 or newer versions of this test), over Wechsler Memory Scale (WMS) (Wechsler 1997 or newer versions of this test), over Cambridge Test of Prospective Memory (Wilson 2005), over Doors and People Test (Baddeley 1994).For information processing measures: we considered the Symbol Digit Modalities Test (SDMT) (Smith 1973) over other measures, because we were aware that this is one of the most frequently used tests of information processing in MS research (Benedict 2017).
primary outcome:
Interventions for promoting physical activity in people with neuromuscular disease
Physical activity: measured by self‐report or objectively, using monitoring devices (e.g. accelerometer or pedometer).
primary outcome:
GLP‐1 receptor agonists for Parkinson's disease
PD motor impairment as measured by the Movement Disorder Society‐Unified Parkinson's Disease Rating Scale (MDS‐UPDRS) subscale Part III (Fahn 1987)Health‐related quality of life (HRQoL) as measured by a validated scale such as:Parkinson’s Disease Questionnaire (PDQ)‐39 (Peto 1995), or short form PDQ‐8 (Jenkinson 1997);Parkinson's Disease Quality of Life Questionnaire (PDQL) (de Boer 1996); or36‐Item Short Form Health Survey (SF‐36) (Ware 1992)Adverse events, including rapid weight loss (> 1.5 kg/week) (we have defined adverse events as serious based on information reported by individual trials)
primary outcome:
Anti‐epidermal growth factor receptor therapy for glioblastoma in adults
Overall survival (OS): defined as time from randomisation to death from any cause.Severe adverse events: classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI‐CTCAE) (NCI 2017), including percentage of treatment‐related deaths.
primary outcome:
Cell‐based therapies for amyotrophic lateral sclerosis/motor neuron disease
Functional impairment, assessed using a functional rating scale (change from baseline to six months): change in functional rating scale, such as the Amyotrophic Lateral Sclerosis Functional Rating Scale‐Revised (ALSFRS‐R) (Cedarbaum 1999) at 6 or 12 months.
primary outcome:
Interventions for preventing falls in people with multiple sclerosis
The rate of falls (the number of falls per person year), baseline measure using retrospective (e.g. retrospective falls diary) and prospective measures, recommended by the International MS Falls Prevention Research Network (IMSFPRN) was the primary outcome for falls prevention trials (Sosnoff 2014b).The risk of falling, i.e. the number of fallers: number of participants who fell at least once during the study.The number of adverse events resulting from the intervention.
primary outcome:
Indomethacin for intracranial hypertension secondary to severe traumatic brain injury in adults
ICP (mmHg) (measured by an epidural, subdural or intraparenchymatous brain catheter with continuous monitoring). We planned to group ICP values measured at similar time points across studies.
primary outcome:
Exercise therapy for chronic fatigue syndrome
Fatigue: measured using any validated scale (e.g. Fatigue Scale (Chalder 1993), Fatigue Severity Scale (Krupp 1989))Adverse effects: measured using any reporting system (e.g. serious adverse reactions (European Union Clinical Trials Directive 2001))
primary outcome:
Psychological therapies for the prevention of migraine in adults
Migraine frequency (we defined migraine frequency as either the number of days with migraine or the number of migraine attacks in the four‐week period after treatment, based on participant report using a headache diary).
primary outcome:
Mixed exercise training for adults with fibromyalgia
We designated seven outcomes as major outcomes: HRQL, pain intensity, fatigue, stiffness, physical function, number of participants who withdrew or dropped out, and adverse events; and three as minor outcomes: submaximal cardiorespiratory function, muscle strength, and number of participants with greater than 30% improvement in pain. In selecting these outcomes, we considered the consensus statement regarding the core set of outcome measures for clinical trials in fibromyalgia provided by Choy 2009, along with the anticipated effects of mixed exercise training on physical fitness. We extracted data for selected outcomes at any time points measured; however, we included baseline, post‐treatment, and follow‐up (or long‐term) time points in this review. Each included study was required to report measurement of one or more outcomes at these time periods. Five outcomes were assessed using self‐report measures: HRQL, pain intensity, fatigue, stiffness, and physical function. Two outcomes were assessed using assessor‐reported measures: cardiorespiratory submaximal and muscle strength. Two outcomes were measured using counts: number of participants who withdrew from the study, and number of participants with a reduction in pain intensity greater than 30%.
primary outcome:
Non‐pharmacological interventions for chronic pain in multiple sclerosis
at least 30% pain relief over baseline (moderate);at least 50% pain relief over baseline (substantial);much improved on Patient Global Impression of Change Scale (PGIC; moderate);very much improved on PGIC (substantial).
primary outcome:
Information provision for people with multiple sclerosis
disease‐related ('risk') knowledge measured by any type of instrument used in the included studies (e.g. questionnaire or interview);measures of (shared) decision making, e.g. the OPTION scale (Elwyn 2005), the Shared Decision Making Questionnaire (SDM‐Q) (Simon 2006), or the Decisional Conflict Scale (O'Connor 1995a).
primary outcome:
Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia
Self‐reported pain relief of 50% or greater. Number of participants who reported a pain relief of 50% or greater in parallel and cross‐over design studies. For EERW design, loss of therapeutic response of self‐reported pain relief was defined as less than 30% reduction in visual analog scale (VAS) pain from pre‐drug exposure or worsening of fibromyalgia requiring alternative treatment.Patient perceived global improvement (Patient Global Impression of Change (PGIC), or Clinical Global Impression (CGI) of severity): number of participants who reported to be much or very much improved for parallel and cross‐over design studies; number of participants who reported a loss of therapeutic response to be much or very much improved in studies with EERW design.Tolerability (withdrawals due to adverse events)Safety (serious adverse events)
primary outcome:
Combination pharmacotherapy for the treatment of fibromyalgia in adults
Patient‐reported pain relief of 30% or greaterPatient‐reported pain relief of 50% or greaterPatient‐reported global impression of clinical change (PGIC) much or very much improvedPatient‐reported global impression of clinical change (PGIC) very much improved
primary outcome:
Absorbable versus non‐absorbable sutures for skin closure after carpal tunnel decompression surgery
early pain: reported by participants at approximately 10 days postoperatively;late pain: reported by participants at approximately 6 weeks postoperatively.
primary outcome:
Drug management for acute tonic‐clonic convulsions including convulsive status epilepticus in children
1. Presenting convulsion/episode of convulsive status epilepticus stopped with the drug(s) used.2. Time taken from administration of any drug in the hospital to stopping of the convulsion.3. The incidence of specific adverse effects: respiratory depression/arrest; cardiac arrhythmia; hypotension and extravasation of any intravenously‐administered anticonvulsant
primary outcome:
Botulinum toxin for motor and phonic tics in Tourette's syndrome
Severity of motor and phonic tics as measured by one of the rating scales listed below.Tourette Syndrome Severity Scale.Yale Global Tic Severity Scale.Videotape review of tic count or rate.Tic Symptom Self Report.
primary outcome:
Treatment of fatigue in amyotrophic lateral sclerosis/motor neuron disease
The primary outcome was level of fatigue at the end of the follow‐up period.Fatigue could be evaluated using any validated patient‐ or clinician‐administered fatigue questionnaire that measures general fatigue, including the Modified Fatigue Impact Scale (MFIS) (Fisk 1994) and the Fatigue Severity Scale (FSS) (Krupp 1989). We also included questionnaires that measured general fatigue and reversible muscle weakness, such as the Neurological Fatigue Index–MND (NFI‐MND) (Gibbons 2011).
primary outcome:
Corticosteroids for chronic inflammatory demyelinating polyradiculoneuropathy
Change in disability, measured by a validated scale such as the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale (Hughes 2001), Overall Disability Status Scale (ODSS) (Merkies 2002), Overall Neuropathy Limitations Scale (ONLS) (Graham 2006) or Rasch‐built Overall Disability Scale (R‐ODS) (Van Nes 2011) after one year.
primary outcome:
alemtuzumab versus interferon beta 1a for relapsing‐remitting multiple sclerosis
number of participants experiencing at least one relapse at 24 and 36 months. Relapse was deﬁned as new or worsening pre‐existing neurological symptoms, without fever, that lasted for 48 hours or more and that were accompanied by a change in Functional Score on Kurtzke's EDSS scale assessed by the examining physician. One or more of the following changes compared with baseline was required for relapse confirmation: an increase in total EDSS by 0.5 points; an increase of at least 1 point in two functional‐systems scores, or of at least 2 points in one functional‐system score. Other less stringent criteria were accepted.number of participants whose disability worsened at 24 and 36 months, defined as an increase of at least 1.5 points on the EDSS scale for participants with a baseline score of 0, of at least 1.0 point for participants with a baseline score of 1.0 or more, and of at least 0.5 point for participants with a baseline score of 5.5 or more, sustained for six months (Kurtzke 1983).number of participants with at least one adverse event, including serious adverse events.
primary outcome:
Mechanical ventilation for amyotrophic lateral sclerosis/motor neuron disease
The primary outcome was overall survival after initiation of assisted ventilation, as assessed by a pooled hazard ratio using life table/Cox regression methods to combine disparate periods of observation from all studies. This would have been supplemented where possible by pooled estimates of the 75%, 50% (median) survival times and confidence intervals (CIs). This is to allow for the situation where the proportional hazards assumption, necessary for Cox regression, has not been met.
primary outcome:
Whole body vibration exercise training for fibromyalgia
We designated seven outcomes as major outcomes: HRQL, physical function, pain intensity, fatigue, stiffness, number of participants who withdrew or dropped out, and number of adverse events; and three as minor outcomes: muscle strength, balance, and number of participants with greater than 30% improvement in pain. In selecting these outcome measures, we considered the consensus statement of Choy and associates (Choy 2009) regarding a core set of outcome measures for clinical trials in fibromyalgia and anticipated effects of WBV exercise on physical fitness.We extracted data for selected outcomes (HRQL, physical function, pain intensity, fatigue, stiffness, muscle strength, and balance) at baseline (pretest), immediately at cessation of treatment (post‐treatment), and at any follow‐up assessment. We required that each included study report measurements for one or more outcomes in such a way that we could evaluate post‐test differences between groups (post‐test or pretest scores with change scores at post‐test). We extracted the number of participants who experienced adverse events, the number with greater than 30% improvement in pain, and the number who withdrew from the study during the intervention phase.
primary outcome:
Zonisamide for essential tremor
Functional abilities component related to tremor, measured by the Fahn‐Tolosa‐Marin Tremor Rating Scale (TRS) subscales B and C at the end of follow‐up (Fahn 1993).Study withdrawal, defined in a standard manner, and number of adverse events (AEs) associated with treatment.AEs: number and type
primary outcome:
Immunotherapy for diabetic amyotrophy
Time from randomisation to improvement in Neuropathy Impairment Scale (NIS) (Dyck 1980) by four points (time‐to‐event). We selected this outcome measure because the natural history of the condition without treatment is slow recovery and also because this is the outcome measure used in the only known completed RCT of immunotherapy in this condition (Dyck 1980).time from randomisation to a clinically significant improvement with whatever scale was used by the authors (time‐to‐event).
primary outcome:
Aerobic exercise training for adults with fibromyalgia
We designated seven outcomes as major outcomes ‐ heath‐related quality of life, pain intensity, fatigue, stiffness, physical function, number of participants who withdrew or dropped out, and adverse events ‐ and three as minor outcomes ‐ maximum cardiorespiratory function, submaximal cardiorespiratory function, and greater than 30% improvement in pain. In selecting these outcomes, we considered the consensus statement of Choy and associates (Choy 2009) regarding a core set of outcome measures for clinical trials in fibromyalgia, as well as anticipated effects of aerobic exercise training on physical fitness. We extracted data for the selected outcomes for any time points measured but included baseline, post‐treatment, and follow‐up data in this review. Review criteria required each included study to report measurement of one or more outcomes for at least one of these time periods.
primary outcome:
Drug therapy for chronic idiopathic axonal polyneuropathy
0 = healthy; no signs or symptoms.1 = no significant disability despite signs and/or symptoms; able to carry out all usual duties.2 = slight disability: unable to carry out usual duties but able to look after own affairs without assistance.3 = moderate disability: requires some help but able to walk without assistance, remains self‐supporting.4 = moderately severe disability: unable to walk without assistance and unable to attend to own bodily needs without assistance; is only partly self‐supporting.5 = severe disability: bedridden and requiring constant care‐taking and attention.
primary outcome:
Tramadol for neuropathic pain in adults
Participant‐reported pain relief of 30% or greaterParticipant‐reported pain relief of 50% or greaterPGIC much or very much improvedPGIC very much improved
primary outcome:
Gabapentin for chronic neuropathic pain in adults
Participant‐reported pain intensity reduction of 30% or greaterParticipant‐reported pain intensity reduction of 50% or greaterPatient‐reported global impression of clinical change (PGIC) much or very much improvedPatient‐reported global impression of clinical change (PGIC) very much improved
primary outcome:
Antiepileptic drugs for the treatment of infants with severe myoclonic epilepsy
Fifty per cent or greater reduction in seizure frequency: proportion of participants with 50% or greater reduction in seizure frequency at the end of the study compared with the pre‐randomisation baseline period.Seizure freedom: proportion of participants achieving total cessation of seizures by the end of the trial. We will use 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 is longest (Kwan 2010).
primary outcome:
Immunomodulatory treatment other than corticosteroids, immunoglobulin and plasma exchange for chronic inflammatory demyelinating polyradiculoneuropathy
Change in disability at 26 or more weeks after randomisation measured by a disability scale designed and validated for CIDP treatment trials such as the Inflammatory Neuropathy Cause and Treatment (INCAT) scale (Hughes 2001), the Overall Disability Status Score (ODSS) (Merkies 2002), Overall Neuropathy Limitations Scale (ONLS) (Graham 2006) (Appendix 1), or Rasch‐built Overall Disability Scale (R‐ODS) scale (van Nes 2011). Failing that, we would have accepted a validated generic disability scale such as the Modified Rankin Scale (van Swieten 1988) (Appendix 2).We selected a disability outcome as the primary outcome on the grounds that a patient‐centred outcome is more relevant to the needs of people with CIDP and healthcare purchasers than a measure of impairment or neurophysiology. We originally chose one year as the period for measurement of outcome on the grounds that the risk, expense and inconvenience of cytotoxic agents and interferons would not be worthwhile unless improvements lasted for at least 12 months. However, none of the trials of immunomodulatory drugs in CIDP have lasted as long as one year so we have reported change in disability at 26 or more weeks as the primary outcome since the 2010 update of the review.
primary outcome:
Topiramate for essential tremor
Functional disability component related to tremor, measured by the Fahn‐Tolosa‐Marin Tremor Rating Scale (TRS) subscales B and C (Fahn 1993) at the end of follow‐up.examiner‐reported upper limb postural and action tremor severity (amplitude), four elements;examiner‐reported ability to perform specific motor tasks (writing, drawing and pouring with dominant and non‐dominant hands), nine elements;participant‐reported functional disabilities due to tremor (eating, speaking, drinking, hygiene, dressing, writing, working and social activities), eight elements.Withdrawal, defined in a standard manner, and number of AEs associated with treatment.
primary outcome:
Benzodiazepines for restless legs syndrome
Improvement of RLS symptoms, as assessed by a validated scale (Allen 2001; IRLSSG 2003).
primary outcome:
Plasma exchange for Guillain‐Barré syndrome
The main criterion was time after randomisation to recover walking with aid. In participants who did not lose the ability to walk, we used the time to onset of motor recovery as a main end point, and defined it as the time required to recover at least two functional items or one item with an improvement in cranial nerve function or trunk or respiratory muscle involvement (Raphaël 1992).
primary outcome:
Propofol versus thiopental sodium for the treatment of refractory status epilepticus
Total control of seizures (after the first course of study drug).In‐hospital mortality.Length of intensive care unit (ICU) stay.
primary outcome:
Interventions to prevent and treat corticosteroid‐induced osteoporosis and prevent osteoporotic fractures in Duchenne muscular dystrophy
Change in vertebral bone mineral density measured by dual‐energy X‐ray absorptiometry (DXA) and expressed as a Z‐score (which is based on age‐matched results with a correction for body height) between baseline and 24 months of intervention.
primary outcome:
Aspirin for acute treatment of episodic tension‐type headache in adults
Pain‐free rate at the end of two hours using any standard method of pain assessment and without the use of rescue medication.
primary outcome:
Gamma aminobutyric acid (GABA) modulators for amyotrophic lateral sclerosis/motor neuron disease
Survival at one year from study enrollment.
primary outcome:
Progesterone for acute traumatic brain injury
Mortality at end of scheduled follow‐upDisability at end of scheduled follow‐up: assessed via the Glasgow Outcome Scale (GOS) and any other validated measures of neurological functioning and disabilityIntracranial pressure within the treatment period
primary outcome:
Immediate‐release versus controlled‐release carbamazepine in the treatment of epilepsy
The outcome measures of interest to this review are listed below for studies addressing each objective.
primary outcome:
Antibiotics for the neurological complications of Lyme disease
Improvement in a measure of overall disability in the long term (three or more months) following treatment.Improvement or resolution of the person's presenting neurological deficits in the long term (three or more months) following treatment. In general, we considered improvement as determined and defined by the original authors, provided that they included objective findings as criteria for the outcome.
primary outcome:
Pregabalin for essential tremor
Subscale A: examiner‐reported upper limb postural and action tremor severity (amplitude), four elements.Subscale B: examiner reported ability to perform specific motor tasks (writing, drawing and pouring with dominant and non‐dominant hands), nine elements.Subscale C: patient‐reported functional disabilities due to tremor (eating, speaking, drinking, hygiene, dressing, writing, working and social activities), eight elements.
primary outcome:
External drains versus no drains after burr‐hole evacuation for the treatment of chronic subdural haematoma in adults
The primary outcome is risk of symptomatic recurrence, defined as reappearance of symptoms and signs attributable to an ipsilateral haematoma identified on a computed tomography (CT) scan within six months of the original drainage procedure.
primary outcome:
Pharmacological treatments for Friedreich ataxia
Scale for the Assessment and Rating of Ataxia (SARA);Friedreich Ataxia Rating Scale (FARS);International Cooperative Ataxia Rating Scale (ICARS).
primary outcome:
Corticosteroids for Bell's palsy (idiopathic facial paralysis)
Incomplete recovery of facial motor function six months or more after randomisation.
primary outcome:
Cannabinoids for fibromyalgia
Participant‐reported pain relief of 50% or greater.PGIC much or very much improved.Withdrawal due to adverse events (tolerability).Serious adverse events (safety). Serious adverse events typically include any untoward medical occurrence or effect that at any dose results in death, is life‐threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an 'important medical event' that may jeopardise the person, or may require an intervention to prevent one of the above characteristics/consequences.
primary outcome:
Opioids for restless legs syndrome
Improvement of restless legs symptoms, as assessed by a validated scale (Allen 2001; IRLSSG 2003).
primary outcome:
Paracetamol (acetaminophen) for acute treatment of episodic tension‐type headache in adults
Pain‐free rate at two hours using any standard method of pain assessment and without the use of rescue medication.
primary outcome:
Antipsychotics for fibromyalgia in adults
Participant‐reported pain relief of 50% or greaterPGIC much or very much improvedWithdrawal due to adverse events (tolerability)Serious adverse events (safety)
primary outcome:
Pharmacological treatment for Kleine‐Levin syndrome
Relief of KLS symptoms (hypersomnia, hyperphagia, abnormal behaviour) as measured by any objective or subjective validated scale.