anurajms/meta_analysis huggingface dataset:
primary outcome:
Souvenaid for Alzheimer's disease
Incidence of Alzheimer's disease dementia in individuals with MCI/prodromal AD at baselineChanges in global cognitive function and specific cognitive functions (e.g. memory) measured by validated tools such as:Alzheimer's Disease Assessment Scale‐Cognitive subscale (ADAS‐cog) (Rosen 1984);Mini‐Mental State Exam (MMSE) (Folstein 1975);Rey Auditory Verbal Learning Test (RAVLT) (Schmidt 1996);Wechsler Memory Scale (Wechsler 2010);Neuropsychological Test Battery (NTB) (Harrison 2007).Changes in functional outcomes (e.g. activities of daily living) measured by validated tools such as:Alzheimer’s Disease Activities of Daily Living International Scale (ADCS‐ADL) (Galasko 1997);Gottries‐Bråne‐Steen‐Skala, Activities of Daily Living (ADL) subscale (GBS‐ADL) (Bråne 2001).Changes in combined cognitive‐functional outcomes measured by validated tools such as:Clinical dementia rating scale ‐ Sum of Boxes (CDR‐SOB) (O'Bryant 2008);Alzheimer's Disease Co‐operative Study‐Clinical Global Impression of Change (CIBIC‐Plus) (Schneider 1997).Adverse events and adverse effects
primary outcome:
Effects of low sodium diet versus high sodium diet on blood pressure, renin, aldosterone, catecholamines, cholesterol, and triglyceride
Outcome measures were effects on SBP, DBP, renin, aldosterone, adrenaline, noradrenaline, triglyceride, cholesterol, LDL and HDL. In studies reporting BP only as mean arterial pressure (MAP), SBP was estimated from SBP = 1.3 MAP + 1.4, and DBP was estimated from DBP = 0.83 MAP – 0.7 (Tozawa 2002). Separate meta‐analyses were performed for each outcome measure. Concerning blood pressure, outcomes were stratified by race (white, black and Asian populations) and according to level of blood pressure (hypertension or normotension). All other outcome variables were stratified according to level of BP (normotension/hypertension) but not by race. A minimum duration of intervention before time of measurement was not defined, but additional analyses were performed on studies with a duration of at least 7 days.
primary outcome:
Acupuncture for chronic nonspecific low back pain
Pain intensity (measured with a visual analogue scale (VAS), numeric rating scale (NRS), Chronic Pain Grade Classification‐pain (CPGS‐pain), etc.)Back‐specific functional status (measured with the Roland Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), Hannover Functional Ability Questionnaire (HFAQ), etc.)Quality of life (measured with the 36‐ or 12‐item Short Form Health Survey (SF‐36, SF‐12), etc.)
primary outcome:
Melatonin for preoperative and postoperative anxiety in adults
Preoperative anxiety measured by a visual analogue scale (VAS), State‐Trait Anxiety Inventory (STAI), or any other validated assessment tool. We regarded the preoperative period as the two hours leading up to either surgery or induction of anaesthesia. There were no restrictions regarding how long after premedication preoperative anxiety had to be assessed.The STAI is a validated questionnaire used to assess anxiety. The scale is divided into two subscales: the Trait‐Anxiety subscale consists of 20 questions focusing on a person's general level of fearfulness, whereas the State‐Anxiety subscale measures immediate situational anxiety. The range of scores is 20 to 80 per subscale, with higher scores indicating greater anxiety. Trait‐anxiety is a constant, whereas State‐anxiety can differ according to the situation. The two subscales are not combined but are viewed separately.VAS is a 100‐mm scale, ranging from 0 to 100, whereby the extremes are marked "no anxiety" and "worst anxiety ever".Both the simple VAS and the STAI have proved to be useful and valid measures of preoperative anxiety, and they are equivalent in terms of the assessment of preoperative anxiety (Kindler 2000; Millar 1995).A minimal clinically important difference for preoperative and postoperative anxiety has not yet been fully established; however, for acute pain assessment, a difference of 9 to 14 on a VAS has previously been estimated to be the minimal clinically significant difference (Kelly 1998; Kelly 2001). Therefore, we regarded a difference in preoperative and postoperative anxiety of 9 to 14 mm on a 0 to 100 mm VAS as clinically important.To our knowledge, no minimal clinically important difference in STAI for preoperative and postoperative anxiety has been established. We viewed a difference of 10% (8 points on the STAI) as the minimal clinically important difference.
primary outcome:
Iron chelators for acute stroke
Death from all causes at end of scheduled follow‐upGood functional outcome: either no significant disability or slight disability with independence for assistance (dependency assessed at least one month after acute stroke)
primary outcome:
Pharmacotherapies for sleep disturbances in dementia
Any or all the following objective sleep outcomes measured with polysomnography or – more feasibly for people with dementia – actigraphy:total nocturnal sleep time (TNST);consolidated sleep time at night (i.e. longest period of uninterrupted sleep between nocturnal sleep onset and final awakening);sleep efficiency (%; i.e. TNST/time in bed × 100);nocturnal time awake (wakenings after sleep onset (WASO); after sleep onset and before final awakening);number of nocturnal awakenings;sleep latency;ratio of daytime sleep to night‐time sleep, or of night‐time sleep to total sleep over 24 hours.Adverse events.
primary outcome:
Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke
Frenchay Activities Index (FAI) (Schuling 1993)Barthel ADL Index (BI) (Mahoney 1965)Rivermead ADL Assessment (Whiting 1980)Modified Rankin Scale (mRS) (Bonita 1988)Functional Independence Measure (FIM) (Hamilton 1994)
primary outcome:
Phlebotonics for venous insufficiency
Oedema in the lower limb measured by the dichotomous variable 'oedema' and the continuous variables 'ankle perimeter circumference' and 'volume of the leg'Specific quality of life (QoL) scales (e.g. Chronic Venous Insufficiency International Questionnaire (CIVIQ))
primary outcome:
Low protein diets for non‐diabetic adults with chronic kidney disease
Death (all causes)ESKD as defined by the need to commence dialysis during follow up or to receive a kidney transplant during follow‐up.
primary outcome:
Magnesium for skeletal muscle cramps
Cramp frequency (percentage change from baseline at 4 weeks), measured as the per cent change from baseline in the number of muscle cramps per week at four weeksWe chose per cent change from baseline in the number of muscle cramps per week as the primary outcome because we believe it to be the most clinically relevant outcome measure and because the effect of cramp treatments in general is more likely to be proportional to baseline cramp rate than to be additive (i.e. a person with 20 cramps per week and a person with two cramps per week who receive benefit from a therapy are more likely to see a similar percentage reduction in cramps than to share a similar absolute reduction in the number of cramps per week).While all studies attempted to measure the cramp frequency, or change in cramp frequency, three trials in pregnant women used frequency measures that prevented data pooling and only one clearly used a cramp diary (Nygaard 2008). Cramp frequency measures that could not be pooled included cramp frequency on a five‐point ordinal scale (Dahle 1995), change in cramp frequency on a three‐point ordinal scale (Sohrabvand 2006), and number of days and nights in which cramps occurred (Nygaard 2008). In contrast, all five idiopathic rest cramp trials used cramp diaries and recorded the occurrence of each cramp, permitting analysis of cramp frequency as a continuous variable. The resulting pooled estimates of cramp frequency measures include data from two trials rated as having a high risk of bias, either due to a high dropout rate (Roffe 2002), which we mitigated by using only the first cross‐over period, or selective reporting (NCT00963638).
primary outcome:
Antioxidants for female subfertility
Live birth rate per woman randomly assigned: if live birth data were unavailable and the trial reported ongoing pregnancy, we reported ongoing pregnancy as live birth (footnoted in the forest plot). We defined live birth as delivery of a live fetus after 20 completed weeks of gestation, and ongoing pregnancy as evidence of a gestational sac with fetal heart motion at 12 weeks, confirmed with ultrasound.
primary outcome:
Reduction in saturated fat intake for cardiovascular disease
All‐cause mortality (deaths from any cause)Cardiovascular (CVD) mortality (deaths from myocardial infarction, stroke, and/or sudden death)Combined CVD events. These included data available on number of people experiencing any of the following: cardiovascular death, cardiovascular morbidity (non‐fatal myocardial infarction, angina, stroke, heart failure, peripheral vascular events, atrial fibrillation) and unplanned cardiovascular interventions (coronary artery bypass surgery or angioplasty).
primary outcome:
Aromatherapy for dementia
AgitationOverall behavioural and psychological symptoms (BPSD)Adverse effects
primary outcome:
Therapeutic ultrasound for chronic low back pain
symptoms (e.g. pain),back‐specific functional status (e.g. measured with the Roland Morris Questionnaire, Oswestry Disability Index),overall improvement or satisfaction with treatment,well‐being (e.g. quality of life measured with the 36‐item Short Form Health Survey (SF‐36), 12‐item Short Form Health Survey (SF‐12), EuroQol)disability (e.g. ability to perform activities of daily living, return‐to‐work status, work absenteeism) (Furlan 2015).
primary outcome:
Tea tree oil for Demodex blepharitis
Mean change in number of Demodex mites per eight eyelashes from baseline to four to six weeks, measured by any method.Mean change in participant‐reported symptoms, including, but not limited to, irritation, burning, tearing, itching, eyelid sticking, photophobia, and increased frequency of blinking, from baseline; measured using participant symptom reports, questionnaires, interviews, or visual analog scale (VAS) at four to six weeks. Although it is ideal for studies to use validated scales, we considered all scales used in included studies since standardized information was unavailable. We planned to conduct sensitivity analyses to examine the impact of any assumptions made in this regard.
primary outcome:
Dietary interventions for multiple sclerosis‐related outcomes
Relapse among individuals with MS, within the follow‐up period. Relapse is typically defined as a clinical episode with symptoms and signs typical of MS, with a duration of at least 24 hours, with or without recovery, in the absence of fever or infection (Thompson 2018).Change in any validated disability scale, among individuals with MS, over the study period including:Expanded Disability Status Scale (EDSS) (Kurtzke 1983); andMultiple Sclerosis Functional Composite (MSFC) (Cohen 2012).
primary outcome:
Chelation therapy for atherosclerotic cardiovascular disease
all‐cause mortality;coronary heart disease (CHD) deaths;vascular deaths
primary outcome:
Probiotics for induction of remission in ulcerative colitis
Remission (clinical, endoscopic, histologic or surgical remission, as defined by study authors)
primary outcome:
Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease
all‐cause mortality (deaths);cardiovascular mortality (cardiovascular deaths);cardiovascular events (cardiovascular events);coronary heart disease mortality (coronary heart disease deaths);coronary heart disease events;stroke; andarrhythmia (atrial fibrillation).
primary outcome:
Electrical stimulation for treating pressure ulcers
Proportion of pressure ulcers healed; the data expressed as the number of pressure ulcers healed in each group.Composite measures of pressure ulcers that captured different aspects of severity; this includes measures such as the Pressure Ulcer Scale for Healing (PUSH) (Gardner 2005), Sussman Wound Healing Tool (Sussman 1997) and Pressure Sore Status Tool (Bates‐Jensen 1992).Surface area of pressure ulcers; data expressed as cm2. If not provided in the study, areas were calculated by multiplying the length and width of the pressure ulcers.Time to complete healing; these data expressed as days to wound closure (time‐to‐event data).Complications/adverse events; these include death, skin irritation, spasm, or pain, or the number of pressure ulcer infections.
primary outcome:
Psychosocial interventions for preventing and treating depression in dialysis patients
Depression (any measure)HRQoL
primary outcome:
Treatment and prevention of pouchitis after ileal pouch‐anal anastomosis for chronic ulcerative colitis
The primary outcome was the proportion of participants with clinical improvement or remission of pouchitis in participants with acute or chronic pouchitis (treatment of pouchitis), or the proportion of participants with no episodes of pouchitis after IPAA (prevention of pouchitis). The exact definition of improvement and remission varied from study to study limiting the ability to make comparisons across studies. However, the definition of improvement or remission used in each study was used for extraction of data from the individual studies for the purposes of this systematic review.
primary outcome:
Animal‐assisted therapy for dementia
Affect and emotional well‐being, in particular, depression, as measured by suitable scales such as the Cornell Scale for Depression in Dementia (CSDD) (Alexopoulos 1988) or Geriatric Depression Scale (GDS) (Yesavage 1982).Social functioning, measured by suitable scales such as the Social Functioning in Dementia Scale (SF‐DEM); De Jong Gierveld Loneliness Scale (de Jong Gierveld 2006); Communication Observation Scale; and Multidimensional Observation Scale for Elderly Subjects (MOSES) Withdrawal subscale (Helmes 1987).Overall behavioural and psychological symptoms of dementia (BPSD), measured with any validated instrument, for example, the Neuropsychiatric Inventory (NPI) (Cummings 1994).Agitation and irritability, measured with any validated instrument, for example, Cohen‐Mansfield Agitation Inventory (CMAI) (Cohen‐Mansfield 1989), MOSES Irritability subscale (Helmes 1987).Health‐related quality of life (HRQOL), using validated condition‐specific quality‐of‐life scales.Adverse effects, including injuries or trauma.
primary outcome:
Biofeedback for treatment of irritable bowel syndrome
Global or clinical improvement, as defined by the included studies (e.g. IBS Severity Scoring System [IBS‐SSS], or the Gastrointestinal Symptom Rating Scale [GSRS])Quality of life (e.g. overall well‐being, Irritable Bowel Syndrome Quality of Life questionnaire [IBS‐QoL], Short Form Health Survey [SF‐36])
primary outcome:
Xiao Chai Hu Tang, a herbal medicine, for chronic hepatitis B
All‐cause mortality: death from any cause.Proportion of participants with one or more serious adverse events; that is, any untoward medical occurrence that resulted in death, was life threatening, required hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability or incapacity, or was a congenital anomaly or birth defect (ICH‐E2A 1994; ICH‐GCP E6(R2) 2016).Health‐related quality of life: any scale used by trialists to assess the participants' reporting of their quality of life.
primary outcome:
Interventions for pityriasis rosea
The proportion of participants with good or excellent rash improvement within two weeks, as rated by the participant.Serious adverse events, i.e. serious enough to require withdrawal of the treatment.
primary outcome:
Acupuncture for chronic hepatitis B
All‐cause mortalityProportion of participants with one or more serious adverse events, that is, any untoward medical occurrences that result in death, are life‐threatening, require hospitalisation or prolongation of existing hospitalisation, result in persistent or significant disability or incapacity, or present as a congenital anomaly or birth defect (ICH‐E2A 1994; ICH‐GCP E6(R2) 2016)Health‐related quality of life: any scale used by trialists to assess participants' reporting of their quality of life
primary outcome:
Acupuncture for polycystic ovarian syndrome
Live birth rate (defined as delivery of live foetus after 20 completed weeks of gestation) – for women seeking fertility.Multiple pregnancy rate (defined as more than one intrauterine pregnancy) – for women seeking fertility.Ovulation rate (as determined by ultrasound or increased progesterone) – for women seeking symptom control.
primary outcome:
Melatonin and agomelatine for preventing seasonal affective disorder
The primary outcome for benefit was the incidence of SAD. We defined incidence of SAD as the proportion of participants with a SIGH‐SAD (Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders) score of 20 or higher (Williams 2002), or as defined by authors.The primary outcome for harm was the overall rate of adverse events related to preventive interventions.
primary outcome:
Acetyl‐L‐carnitine for the treatment of diabetic peripheral neuropathy
Pain: measured using a validated scoring system such as a visual analogue scale (VAS) or numerical rating scale reported as the proportion of participants with at least 30% (moderate) pain relief over baseline or 50% (substantial) pain relief over baseline or as a continuous outcome on a VAS or Likert scale (Cruccu 2004). The time scale was six months (at minimum) after treatment, and, when possible, at a year or even two or more years after treatment.We used pain as the primary outcome measure because a significant proportion of people with diabetes have painful DPN, it causes significant ill health and disability, and many trials use pain as a surrogate measure of disease severity.We had planned to evaluate this outcome as the proportion of participants with a moderate (30%) or substantial (50%) improvement in pain, but this was not possible with the available data.Three studies comparing ALC and placebo reported pain as an outcome and measured it using a visual analogue scale (0 to 100 mm, on which higher scores indicate worse pain) (De Grandis 2002; Sima 2005a; Sima 2005b). At 6‐ to 12‐months' follow‐up, the mean change in pain from baseline favoured ALC over placebo (MD ‐9.16, 95% CI ‐16.76 to ‐1.57; three studies; 540 participants; I² = 56%; random‐effects; Analysis 1.1; Figure 3).We judged the certainty of evidence to be very low, because of study limitations, indirectness (as ALC does not have a direct function on pain relief and pain was reported as a mean change), inconsistency of effect (possibly owing to differences in ALC dose), and imprecision.The included study did not measure this outcome.
primary outcome:
Transcranial direct current stimulation (tDCS) for improving aphasia in adults with aphasia after stroke
Amsterdam‐Nijmegen Everyday Language Test (ANELT) (Blomert 1994)Communicative Abilities of Daily Living (CADL) (Holland 1980)Boston Diagnostic Aphasia Examination (BDAE) (Goodglass 1972)Scenario Test (Van der Meulen 2010)Communicative Effectiveness Index (CETI) (Lomas 1989)Discourse Analysis (DA) (Ulatowska 1983)
primary outcome:
Yoga as part of a package of care versus non‐standard care for schizophrenia
We aimed to divide all outcomes into short term (less than six months), medium term (six to 12 months) and long term (over 12 months).We would have endeavoured 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. Thereafter, we would have listed other binary outcomes and then those that are continuous. Of note: to ensure uniformity with the portfolio of yoga reviews under construction, the following outcomes were consistent with reviews outlined in Table 1.
primary outcome:
Radix Sophorae flavescentis versus no intervention or placebo for chronic hepatitis B
All‐cause mortalityProportion of participants with one or more serious adverse events, that is, any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect (ICH‐E2A 1994; ICH‐GCP E6(R2) 2016)Health‐related quality of life: any scale used by trialists to assess participants' reporting of their quality of life
primary outcome:
Herbal medicinal products or preparations for neuropathic pain
Participant‐reported pain relief of 30% or greater, over baseline (moderate)Participant‐reported pain relief of 50% or greater, over baseline (substantial)Participant‐reported global impression of clinical change (PGIC) much or very much improved (moderate)Participant‐reported global impression of clinical change (PGIC) very much improved (substantial)
primary outcome:
Light therapy for preventing seasonal affective disorder
The primary outcome for benefit was the incidence of SAD, measured as the proportion of participants with a score of 20 or higher on the Structured Interview Guide for the Hamilton Depression Rating Scale, Seasonal Affective Disorders (SIGH‐SAD; Williams 2002).The primary outcome for harms was the overall rate of adverse events related to preventive interventions.
primary outcome:
Mediterranean‐style diet for the primary and secondary prevention of cardiovascular disease
Cardiovascular mortality.All‐cause mortality.Non‐fatal endpoints such as MI, CABG, PTCA, angina or angiographically defined CHD, stroke, carotid endarterectomy or peripheral arterial disease (PAD).
primary outcome:
Yoga for treating urinary incontinence in women
Number of women who report they are cured (they no longer experience urinary incontinence).Number of women who report cure or improvement of urinary incontinence.Urinary incontinence condition‐ or symptom‐specific quality of life, as measured by any relevant scale (e.g. the Urinary Incontinence Quality of Life scale (Patrick 1999), the Incontinence Impact Questionnaire (Uebersax 1995), the International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ‐LUTSqol) (Nystrom 2015), or the Pelvic Floor Distress Inventory (PFDI) and the Pelvic Floor Impact Questionnaire (PFIQ) (Barber 2001)).
primary outcome:
Exercise for preventing falls in older people living in the community
Rate of falls (falls per person‐year)
primary outcome:
Iron for the treatment of restless legs syndrome
The primary outcome considered in this review was restlessness or unpleasant sensations, as experienced subjectively by the participant. We did not prespecify a rating scale or other measure of restlessness, although the majority of studies employed the International Restless Legs Syndrome Study Group severity scale (IRLS; Walters 2003). This 10‐question, 40‐point scale addresses the severity and impact of RLS symptoms, with higher scores indicating more severe symptoms.
primary outcome:
Restriction of salt, caffeine and alcohol intake for the treatment of Ménière's disease or syndrome
Control of vertigo or decrease in the intensity, frequency and duration of vertigo attacks, as suggested by the AAO‐HNS* (Ménière's Guide 1995), using the results of the various questionnaire‐based assessment tools including the Vertigo Symptom Scale, the Vertigo Dizziness Imbalance Questionnaire and the Dizziness Handicap Inventory amongst others.Adverse effects; any reported adverse effects such as hyponatraemia, mood disturbance and headaches would be noted.
primary outcome:
Single herbal medicine for diabetic retinopathy
Progression of retinopathy, defined as any clinically meaningful progression from the baseline (based on the ETDRS severity scale, Airlie House classification, International Clinical Diabetic Retinopathy Disease Severity Scale, or similar) from stereoscopic colour fundus photographs.
primary outcome:
Vitamin and mineral supplementation for maintaining cognitive function in cognitively healthy people in mid and late life
Mean overall cognitive functioning measured with any internationally accepted and validated measure: for example, Alzheimer's Disease Assessment Scale ‐ cognitive subscale (ADAS‐cog); Mini Mental State Examination (MMSE); Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); Cambridge Cognition Examination (CAMCOG).
primary outcome:
Traditional Chinese herbal medicine for vascular dementia
All 47 studies (3581 participants) assessed cognition using one or a combination of the following scales: MMSE (41 studies; 3227 participants), HDS (21 studies; 1544 participants), ADAS‐Cog (5 studies; 481 participants), CCSE (1 study; 26 participants) and CDT (1 study; 60 participants).32 studies (2267 participants) assessed global performance which was also called 'efficacy rate'. One study (26 participants) used the Sandoz Clinical Assessment‐Geriatric scale and one study (60 participants) used the Global Deterioration Scale. All other studies measured global performance on an ordinal scale based on different criteria: two studies (160 participants) used TCM criteria to define three response levels, 20 studies (1455 participants) used one or a combination of the MMSE‐, HDS‐ and ADL‐derived scores to define three or four response levels, and eight studies (566 participants) did not specify the criteria used to define the response levels. The three‐level ordinal responses were labelled 'very effective', 'effective' and 'no effect'; where a fourth level was recognised it was labelled either 'worsening', 'almost controlled' or 'almost normal'.Thirty‐two studies (2445 participants) explicitly reported collecting safety data but none reported the exact number of AE episodes. Twenty‐nine studies (2296 participants) reported the number of participants experiencing one or more AEs as well as the type of AEs. Two studies (123 participants) reported only the number experiencing one or more AEs without describing the AEs, and one study (26 participants) assessed safety based on electroencephalogram and regional cerebral blood flow measurements (Liuyujin 1997). Fifteen studies (1208 participants) did not report AEs, neither the number of participants experiencing AEs nor the type and number of AEs. Two of these studies (167 participants) reported the presence of dropouts without specifying reasons (Dengguiying 2011; Huangchaoyun 2004), and three studies (204 participants) drew a conclusion about the safety of the TCHM (Wuhongbin 2007; Yaoxinsheng 2011; Zhangtao 2000).
primary outcome:
Acupuncture and related interventions for the treatment of symptoms associated with carpal tunnel syndrome
Overall clinical improvement at short‐term follow‐up (less than or equal to 3 months), preferably measured by questionnaires, such as Patient Global Impression of Change (PGIC) or by any validated semi‐quantitative method (e.g. the 7‐point Likert scale or similar)
primary outcome:
Omega‐6 fats for the primary and secondary prevention of cardiovascular disease
All‐cause mortalityCVD mortalityCVD events (all available data on fatal and non‐fatal myocardial infarction, angina and/or stroke)Coronary heart disease events: myocardial infarction (fatal or non‐fatal) or anginaMajor adverse cardiac and cerebrovascular events (MACCEs), used where we could assess the numbers of participants experiencing fatal and non‐fatal myocardial infarction, unstable angina and strokeStroke (total, fatal and non‐fatal, ischaemic and haemorrhagic)
primary outcome:
Polyunsaturated fatty acids for the primary and secondary prevention of cardiovascular disease
all‐cause mortality;coronary heart disease events: number of participants experiencing at least one myocardial infarction (fatal or non‐fatal) or angina;stroke (number of participants experiencing an ischaemic and/or haemorrhagic stroke); andmajor adverse cardiac and cerebrovascular events (MACCEs, used where we could assess the numbers of participants experiencing fatal or non‐fatal myocardial infarction, unstable angina or stroke).
primary outcome:
Acupuncture for hypertension
Change in SBP from baseline.Change in DBP from baseline.
primary outcome:
Cannabis for the treatment of Crohn's disease
The primary outcome was remission at study endpoint for induction of remission studies (as defined by a CDAI < 150) and relapse (e.g. CDAI > 150) at study endpoint for maintenance studies. Any validated scoring system such as the CDAI or Disease Activity Score (DAS) was included.
primary outcome:
Rutosides for prevention of post‐thrombotic syndrome
Development of post‐thrombotic syndrome (PTS) (yes or no)
primary outcome:
Rutosides for treatment of post‐thrombotic syndrome
Occurrence of leg ulceration over time (yes or no)Any improvement of PTS (yes or no)Any deterioration of PTS (yes or no)
primary outcome:
Vitamin and mineral supplementation for preventing dementia or delaying cognitive decline in people with mild cognitive impairment
1. The incidence of all‐cause dementia (assessed using internationally accepted and validated criteria).The main time point of interest was end of trial, defined as the time point with the longest follow‐up duration as measured from randomisation (see also section, Data extraction and management). Outcome data reported at other time points after randomisation were extracted and presented. For this outcome, the minimum follow‐up period was 12 months.2. Overall cognitive functioning, measured with, for example, Alzheimer's Disease Assessment Scale‐cognitive subscale (ADAS‐cog); the Mini Mental State Examination (MMSE); Repeatable Battery for the Assessment of Neuropsychological Status (RBANS); Cambridge Cognition Examination (CAMCOG).
primary outcome:
Non‐clinical interventions for reducing unnecessary caesarean section
Caesarean sectionSpontaneous vaginal birthInstrumental vaginal birth
primary outcome:
Vitamin D for the management of multiple sclerosis
Mean number of relapses per patient per year or annualised relapse rate (ARR)Change in Expanded Disability Status Scale (EDSS) score (Kurtzke 1983)Number of participants experiencing change in EDSS score (i.e. at least one point for EDSS < 6.0 or 0.5 point for EDSS > 5.5 over a period of six months)Mean change in magnetic resonance imaging (MRI) parameters of disease activity, including new lesions on T2‐weighted images, preexisting lesions enlarged on T2‐weighted images, or gadolinium‐enhancing lesions in T1‐weighted imagesTime to the first treated relapseQuality of life measured by validated generic or MS‐specific scales (e.g. MS Quality of Life (MSQOL‐54) (Vickrey 1995); Functional Assessment of MS (FAMS) (Cella 1996); RAYS Scale (Rotstein 2000))Adverse events (AEs) as defined by study authors in the following groups:Proportion of participants with at least one serious adverse event (SAE)Proportion of participants with minor AEs (or rate of AEs, i.e. number of AEs per person‐years)
primary outcome:
Art therapy for people with dementia
Cognition: includes the following cognitive domains: attention/orientation, memory, fluency, language skills (speech content and fluency) and visuospatial perceptionAffect and emotional well‐being (where 'affect' is considered the fluctuating changes in emotion or feelings)Social functioningBehaviourAdverse effects
primary outcome:
Interventions for preventing falls in older people in care facilities and hospitals
Rate of falls (falls per unit of person time that falls were monitored)Number of fallers (risk of falling)
primary outcome:
Mindfulness‐based stress reduction for family carers of people with dementia
Depressive symptoms. If the study specified a cut‐off score to identify clinically significant depressive symptoms,we also reported the presence of clinically significant depressive symptoms as an outcome.
primary outcome:
Music‐based therapeutic interventions for people with dementia
Emotional well‐being including quality of life.Mood disturbance or negative affect:depression;anxiety.Behavioural problems:agitation or aggression;overall.
primary outcome:
Prescribed hypocaloric nutrition support for critically‐ill adults
Mortality. Death occurring during the ICU and hospital stay, or 28‐ to 30‐day all‐cause mortality.Length of stay. Days stayed in the ICU and in the hospital.Infectious complications. Events of any type of infectious complications occurring during the hospital stay, registered by the study authors according to their diagnostic criteria of infections.
primary outcome:
Immersion in water during labour and birth
We chose primary outcomes that we thought would be the most clinically valuable in assessing safety and effectiveness for the woman, fetus/neonate and caregivers. In addition, we identified outcomes that were considered to be of interest from the perspective of the woman and her baby, primary caregivers and related service providers. We also included outcomes to be consistent with the overview of systematic reviews of interventions for pain management in labour (Jones 2012).We then selected the most pertinent maternal and fetal/neonatal outcomes for water immersion as primary outcomes. These (list below) are analysed within the comparison groups:
primary outcome:
Non‐invasive brain stimulation techniques for chronic pain
The primary outcome measure was change in pain intensity using validated measures of pain intensity such as visual analogue scales (VAS), verbal rating scales (VRS) or numerical rating scales (NRS).
primary outcome:
Acupuncture for acute stroke
The primary outcome was death or dependency at the end of follow‐up. Dependency is defined as a state of being dependent on others for activities of daily living (ADL), for example, a Barthel Index (BI) score ≤ 60, a modified Rankin Scale (MRS) grade of 3 to 6, or the trialists' own definition. We included in a secondary analysis death or dependency reported in trials that followed participants for at least three months.
primary outcome:
Relaxation techniques for pain management in labour
There were no data available on the outcomes; sense of control in labour, effect on mother/baby interaction, breastfeeding, and other poor outcomes for infants.There were no data available on sense of control in labour, effect on mother/baby interaction, breastfeeding, assisted vaginal birth, caesarean section, admission to special care nursery and other poor infant outcomes.There were no data available on satisfaction with maternal perception of pain, satisfaction with childbirth, sense of control in labour, Apgar score less than 7 at five minutes, effect on mother/baby interaction, breastfeeding, and other poor outcomes for infants.Only one outcome on maternal satisfaction was reported for this trial.
primary outcome:
Massage, reflexology and other manual methods for pain management in labour
This review is one in a series of Cochrane reviews examining pain management in labour. The following list of primary outcomes are the ones which are common to all the reviews, as specified in the generic protocol (Jones 2011).
primary outcome:
Oral vitamin B12 versus intramuscular vitamin B12 for vitamin B12 deficiency
Serum vitamin B12 levels.Clinical signs and symptoms of vitamin B12 deficiency.Adverse events.
primary outcome:
Aromatherapy for treatment of postoperative nausea and vomiting
Severity of nausea or vomiting, or both, post‐initiation of treatment as measured by a validated scale or medical or nursing observationDuration of nausea or vomiting, or both, post‐initiation of treatment as measured by patient report or medical or nursing observation
primary outcome:
Acupuncture for depression
Reduction in the severity of depression, measured at the end of the intervention primarily as a continuous variable on self‐rating scales such as the Beck Depression Inventory (BDI) (Beck 1961), or on clinician‐rated scales, such as the Hamilton Depression Rating Scale (HAMD) ‐ as discussed in Hamilton 1960Total numbers of adverse events
primary outcome:
Prophylactic vitamin K for the prevention of vitamin K deficiency bleeding in preterm neonates
Any bleeding (as reported by investigators):during the first week of life;after the first week of life;any severe bleeding requiring immediate transfusion:during the first week of life;after the first week of life;gastrointestinal bleeding (as reported by investigators):during the first week of life;after the first week of life;intracranial bleeding (as reported by investigators):during the first week of life;after the first week of life.
primary outcome:
Vitamin E for antipsychotic‐induced tardive dyskinesia
We have defined clinical efficacy as an improvement in the symptoms of TD of more than 50%, on any scale. We grouped outcomes into short term (less than six weeks), medium term (between six weeks and six months) and long term (more than six months).
primary outcome:
Respiratory muscle training for multiple sclerosis
Respiratory muscle function parameters measured on the body function level of the International Classification of Functioning, Disability and Health (ICF) (WHO 2001), such as maximal expiratory pressure and maximal inspiratory pressure.Quality of life, measured with a validated instrument such as the EuroQoL EQ‐5D‐VAS (EuroQol 1990).
primary outcome:
Probiotics for the prevention of Clostridium difficile‐associated diarrhea in adults and children
The primary outcome was the incidence of C. difficile‐associated diarrhea.
primary outcome:
Antioxidants for preventing and reducing muscle soreness after exercise
Muscle soreness (pain) ‐ typically measured by a visual analogue scale (i.e. subjective)Subjective recovery (return to previous activities without signs or symptoms)Adverse effects (e.g. intestinal discomfort, diarrhoea)
primary outcome:
Acupuncture for neuropathic pain in adults
Participant‐reported pain intensity at the end of treatment measured using a validated visual analogue scale (VAS) or categorical pain scale. We are particularly interested in the number of people who achieve 'no worse than mild pain' (Moore 2013a). We consider 3 out of 10 on a numerical rating scale, or 30/100 mm on a VAS, as 'no worse than mild pain' (Wiffen 2013).Participant‐reported pain relief at the end of treatment measured using a validated VAS or categorical pain scale. Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) defines at least 30% pain relief over baseline as moderate pain relief, and at least 50% pain relief over baseline as substantial pain relief in chronic pain (Dworkin 2008).
primary outcome:
Probiotics for vulvovaginal candidiasis in non‐pregnant women
Clinical cure rate (disappearance of symptoms and signs, and no evidence of fungal infection proved by microscopic examination or vaginal culture), split into 'short‐term clinical cure rate' (zero to 14 days after treatment) and 'long‐term clinical cure rate' (one, three and six months after treatment).Mycological cure rate (no evidence of fungal infection proved by microscopic examination or vaginal culture), split into 'short‐term mycological cure rate' (zero to 14 days after treatment)' and 'long‐term mycological cure rate' (one, three and six months after treatment).Relapse rate (symptom recurrence confirmed by microscopic examination or vaginal culture at one, three and six after mycological cure).Rate of serious adverse events (death, internal organ injury, severe skin and mucosal injury).
primary outcome:
Music therapy for depression
Depressive symptoms: We assessed depressive symptoms according to continuous validated depression measures. We analysed clinician‐rated scales, such as the Hamilton Rating Scale for Depression (HAM‐D; Hamilton 1960), separately from patient‐reported scales, such as the Beck Depression Inventory (BDI; Beck 1961).Adverse effects: We assessed the number of adverse events.
primary outcome:
Combined diet and exercise interventions for preventing gestational diabetes mellitus
For this update, we used the standard outcomes agreed by consensus between review authors of Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of GDM and pre‐existing diabetes.
primary outcome:
Transcutaneous electrical nerve stimulation (TENS) for fibromyalgia in adults
Participant‐reported pain relief of 30% or greater, compared with baseline.Participant‐reported pain relief of 50% or greater, compared with baseline.PGIC much or very much improved.PGIC very much improved.
primary outcome:
Yoga for epilepsy
The following outcome measures from the time of randomisation to the completion of the study were analysed.
primary outcome:
Yoga as part of a package of care versus standard care for schizophrenia
We aimed to divide all outcomes into short term (less than six months), medium term (seven to 12 months) and long term (over one year).
primary outcome:
Yoga versus non‐standard care for schizophrenia
We aimed to divide all outcomes into short term (less than six months), medium term (seven to 12 months), and long term (over one year).We endeavoured 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. Thereafter, we listed other binary outcomes and then those that are continuous. Of note, to ensure uniformity with the portfolio of yoga reviews under construction, the following outcomes are consistent with reviews outlined in Table 1
primary outcome:
Transcutaneous electrical nerve stimulation (TENS) for neuropathic pain in adults
Pain intensity as measured using a visual analogue scale (VAS), numerical rating scale (NRS), verbal rating scale or Likert scale.Health related quality of life (HRQoL) using any validated tool (e.g. 36‐item Short Form (SF‐36), six‐item Short Form (SF‐6), EuroQol).
primary outcome:
Pharmacological and mechanical interventions for labour induction in outpatient settings
Clinically relevant outcomes for trials of methods of cervical ripening and labour induction have been pre‐specified by two authors of labour induction reviews (Justus Hofmeyr and Zarko Alfirevic) (Hofmeyr 2009). We have used most of these outcomes (relevant to both inpatient and outpatient settings) in this review.In addition, we attempted to use relevant outcome measures to quantify any cost effectiveness benefits of outpatient ripening.
primary outcome:
Vitamin A supplements for reducing mother‐to‐child HIV transmission
HIV infection status of the child.
primary outcome:
Whole grain cereals for the primary or secondary prevention of cardiovascular disease
Total cardiovascular mortality.Cardiovascular events (e.g. fatal and non‐fatal myocardial infarction, unstable angina, coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, stroke).
primary outcome:
Homocysteine‐lowering interventions for preventing cardiovascular events
Non‐fatal or fatal myocardial infarction.Non‐fatal or fatal stroke (ischaemic or haemorrhagic stroke).
primary outcome:
Low glycaemic index diets for the prevention of cardiovascular disease
Total and cardiovascular mortalityCardiovascular events (e.g. fatal and nonfatal myocardial infarction, unstable angina, coronary artery bypass graft surgery, percutaneous transluminal coronary angioplasty, stroke)Adverse events (e.g. bloating, nausea, weight gain, difficulty in eating out)
primary outcome:
Antioxidant vitamin and mineral supplements for preventing age‐related macular degeneration
We modified our protocol for the current update (2017) to include outcomes specified by the UK NICE macular degeneration guideline panel (NICE 2016) ‐ see Differences between protocol and review.We considered the following outcomes:Follow‐up:We considered the maximum follow‐up identified in the studies.
primary outcome:
Deep brain and cortical stimulation for epilepsy
(1) Seizure freedom: the proportion of participants that was free of seizures (complete absence of seizures, comparable with Engel classification class I (Jehi 2008)) during the randomized period, i.e. the phase of the trial during which, according to treatment allocation, one group of patients received the intracranial neurostimulation treatment and the other group the control treatment (in contrast to open‐label follow‐up periods of the same trials during which (nearly) all patients received the neurostimulation treatment under investigation in an unblinded manner, without any control group).(2) Responder rate: proportion of patients with at least a 50% seizure frequency reduction, compared to the baseline period, throughout the randomized period.
primary outcome:
Continuous support for women during childbirth
a spontaneous vaginal birth (21 trials, 14,369 women, average risk ratio (RR) 1.08, 95% confidence interval (CI) 1.04 to 1.12, I² = 61%, Tau² = 0.00, low‐quality evidence), Analysis 1.1;We included 21 studies that reported spontaneous vaginal birth that we assessed for small‐study effect (publication bias). For spontaneous vaginal birth, we observed that most studies clustered around the effect estimate without any obvious asymmetry, indicating a low risk of publication bias (Figure 4).reported negative rating of or negative feelings about childbirth experience (11 trials, 11,133 women, average RR 0.69, 95% CI 0.59 to 0.79, I² = 63%, Tau² = 0.03, low‐quality evidence), Analysis 1.2;we included 11 studies that reported negative rating of or negative feelings about birth experience that we assessed for small‐study effect (publication bias). For negative rating of or negative feelings about birth experience, we observed that most studies clustered around the effect estimate without any obvious asymmetry, indicating a low risk of publication bias (Figure 5). Two trials reported negative ratings or negative feelings about childbirth experience as satisfaction with care received (Bruggemann 2007) and overall rating of birth experience (Campbell 2006). We acknowledge that this is not ideal, and so carried out a sensitivity analysis to account for this. We removed Bruggemann 2007 and Campbell 2006 from the overall analysis to see if this made any difference to the result. The overall result was unchanged (9 trials, 10,427 women, average RR 0.72, 95% CI 0.61 to 0.84, I² = 62%,Tau² = 0.03).admission to the special care nursery (7 trials; 8897 infants, average RR 0.97, 95% CI 0.76 to 1.25, I² 37%, Tau² = 0.03, low‐quality evidence), Analysis 1.4; andexclusive or any breastfeeding at any time point, as defined by trial authors (4 trials, 5584 women, average RR 1.05, 95% CI 0.96 to 1.16, I² = 66%, Tau² = 0.01, low‐quality evidence), Analysis 1.5;trials reported exclusive or any breastfeeding at any time point as: self‐reported breastfeeding duration at one month postpartum (Langer 1998), at six weeks postpartum (Hofmeyr 1991), and at four months postpartum (Hans 2013). Hodnett 2002 reported "not breastfeeding at all" at six weeks postpartum and we calculated the reciprocal for this outcome for this analysis (Analysis 1.5). We acknowledge that this is not ideal, and so carried out a sensitivity analysis to account for this. We removed Hodnett 2002 from the overall analysis to see if this made any difference to the result. The overall result was unchanged (3 trials, 1025 women, average RR 1.11, 95% CI 0.98 to 1.27, I² = 48%,Tau² = 0.01).
primary outcome:
Wendan decoction (Traditional Chinese medicine) for schizophrenia
We aimed to divide all outcomes into short term (less than three months), medium term (three to 12 months) and long term (over one year).
primary outcome:
Music therapy for people with schizophrenia and schizophrenia‐like disorders
There is currently no consensus as to what should be the primary outcomes of music therapy for people with schizophrenia. Goals described by music therapists tend to describe 'soft' outcomes such as well‐being, self‐esteem, the ability to express oneself and to relate to others, or a sense of identity; outcomes such as overall symptom reduction or improved general functioning seem to be only indirectly related to those goals. However, symptom‐related outcomes are most commonly measured in research studies. Notably, measures of negative symptoms include impairments in the ability to express oneself and to relate to others, but also include other domains. Because of the importance to people with schizophrenia we regard the following as primary outcomes.