anurajms/meta_analysis huggingface dataset:
primary outcome:
Antipsychotic dose reduction compared to dose continuation for people with schizophrenia
We divided all outcomes into very short term (up to three months), short term (up to six months), medium term (up to one year, i.e. seven to 12 months), and long term (more than 12 months). The primary time point of interest was up to one year.We reported data for separate time points when available, and calculated subtotals without calculating totals in order to avoid double counting when one study contributed for multiple time points. When we combined the time points, if multiple time points were reported for the same study, we selected the one closest to 12 months for the primary analysis.
primary outcome:
Hypoxia‐inducible factor stabilisers for the anaemia of chronic kidney disease
CV deathLife participationFatigue
primary outcome:
Antipsychotics for schizophrenia spectrum disorders with catatonic symptoms
We aimed to divide all outcomes into short‐term (6 months or less), medium‐term (7 to 12 months), and long‐term (over 12 months) outcomes.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 included trials) before any others. Thereafter, we listed other binary outcomes, and then those that were continuous.For outcomes such as 'clinically important change', 'any change', and 'relapse', we employed the definition used in each of the included trials.We used data from valid scales (see Data extraction and management).
primary outcome:
Cognitive behavioural therapy (group) 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:
Negative pressure wound therapy for managing the open abdomen in non‐trauma patients
Primary fascial closure of the abdomenAdverse events
primary outcome:
Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia
Urologic symptom scores.Quality of life.Major adverse events.
primary outcome:
Self‐management interventions for people with chronic obstructive pulmonary disease
Health‐related quality of life (HRQoL)Respiratory‐related hospital admissionsRespiratory‐related mortalityAll‐cause mortality
primary outcome:
Integrated disease management interventions for patients with chronic obstructive pulmonary disease
Health‐related quality of life (HRQoL), as reported by a validated disease‐specific questionnaire (e.g. St. George's Respiratory Questionnaire (SGRQ) ‐ Jones 1991; Jones 2005; Clinical COPD Questionnaire (CCQ) ‐ Kocks 2006, van der Molen 2003; Chronic Respiratory Questionnaire (CRQ) ‐ Guyatt 1987; Guyatt 2011; COPD Assessment Test (CAT) ‐ Jones 2009) or a generic quality of life questionnaire (e.g. Short Form‐36 (SF‐36) ‐ Ware 1992 EuroQol‐5D (EQ‐5D) ‐ EuroQol Group 1990)Maximal or functional exercise capacity, as reported by peak capacity measured in the exercise laboratory by an incremental exercise test defined according to results of the 6‐minute walking distance test (6MWD) ‐ Redelmeier 1997 ‐ or the shuttle run test ‐ Singh 1992Exacerbation‐related outcomes, as reported by one of the following: all‐cause hospital admissions, respiratory‐related hospital admissions, all‐cause hospital days, emergency department (ED) visits, patients with at least one exacerbation and patients with at least one prescription for prednisone and at least one for antibiotics. These outcomes follow the latest definitions of moderate and severe COPD exacerbations in the GOLD guideline and are also used in the two latest Cochrane Reviews assessing exacerbations as a primary outcome (GOLD 2020; Threapleton 2019; Walsh 2019)
primary outcome:
Exercise training for adult lung transplant recipients
Maximal and functional exercise capacity: measured during either lab exercise tests (e.g. cardiopulmonary exercise test (CET), incremental shuttle walking test (ISWT)) or field exercise tests (e.g. six‐minute walk test (6MWT)).Health‐related quality of life (HRQoL): measured by validated generic or specific questionnaires (e.g. SF‐36).Adverse events: untoward haemodynamic or respiratory changes, musculoskeletal complications, postoperative complications such as wound dehiscence and thoracic instability, and any other adverse event.
primary outcome:
Telehealth interventions: remote monitoring and consultations for people with chronic obstructive pulmonary disease (COPD)
Exacerbations (as defined by trialists; depending on available data, we extracted numbers of participants experiencing one or more exacerbation, exacerbation rate, or both)Quality of life (validated scales, such as St George's Respiratory Questionnaire (SGRQ))Dyspnoea symptoms (validated scales)Hospital service utilisation (e.g. emergency department presentation, hospitalisation, re‐admission, length of stay, as defined by trialists; depending on available data; we extracted numbers of participants who require hospitalisation, hospitalisation utilisation rate, or both)Mortality (all‐cause)Three months or longer to less than six months.Six months or longer to less than 12 months.12 months or longer.
primary outcome:
Pharmacological interventions versus placebo, no treatment or usual care for osteoporosis in people with chronic kidney disease stages 3‐5D
Incidence of fracture at any sites (clinical or radiographic)Mean change in the BMD measured using dual‐energy radiographic absorptiometry (DXA) at the femoral neck, total hip, lumbar spine, or distal radius.Adverse events: osteonecrosis of the jaw that delays dental healing, atypical femoral fracture, any gastroesophageal disorder (oesophagitis, oesophageal ulcer, oesophageal stricture, oesophageal erosions, dysphagia, gastric bleeding, duodenitis, or ulceration), nausea, diarrhoea, any musculoskeletal disorders (bone pain, arthralgia, myalgia, and muscle cramps), fever, hypersensitivity reactions, cellulitis, venous thromboembolism, stroke, oedema, hot flushes, acute kidney injury (AKI), histological osteomalacia or low‐bone turnover renal osteodystrophy, urinary tract infections (UTI), sepsis, and any other complication that may occur.
primary outcome:
Vitamin D supplementation for the treatment of COVID‐19: a living systematic review
We evaluated core outcomes in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) Initiative for COVID‐19 patients (COMET 2020; Marshall 2020), and additional outcomes that have been prioritised by consumer representatives and the German guideline panel for inpatient therapy of people with COVID‐19.We defined outcome sets for two populations. Those are: hospitalised individuals with a confirmed diagnosis of COVID‐19 and moderate to severe disease, and ambulatory‐managed individuals with a confirmed diagnosis of SARS‐CoV‐2 infection and asymptomatic or mild disease, according to WHO clinical progression scale (WHO 2020e, see Table 1).
primary outcome:
Digital interventions for the management of chronic obstructive pulmonary disease
Impact on health behaviours, such as physical activity (e.g. step count), smoking cessation (we chose continuous abstinence over point prevalence and validated abstinence over self‐report), weight loss.Self‐efficacy for managing chronic disease (as defined by trialists).Quality of life (e.g. St. George's Respiratory Questionnaire (SGQ)).Dyspnoea symptoms (as defined by trialists).Exacerbations (as defined by trialists; depending on the data available, we extracted the number of participants experiencing one or more exacerbation, or the exacerbation rate, or both).
primary outcome:
Exercise training for bronchiectasis
Exercise tolerance: measured via field walking tests (e.g. incremental shuttle walk test (ISWT), 6‐minute walk test (6MWT), endurance shuttle walk test (ESWT)) or cardiopulmonary exercise testing (e.g. maximal incremental treadmill or cycle ergometer cardiopulmonary exercise test (CPET), constant‐load exercise test (CLET)). The principal units of analysis for these tests were distance (metres) for ISWT and 6MWT; time (minutes) for endurance or CLET; and peak oxygen uptake (VO₂ peak) for maximal incremental CPET. We reported these outcomes separately. Assessment occurred upon completion of the exercise training intervention and at the longest time point available up to 12 months after intervention completionHealth‐related quality of life (HRQoL): measured via disease‐specific questionnaires for bronchiectasis (i.e. Quality of Life‐Bronchiectasis) or respiratory quality of life questionnaires (e.g. St George's Respiratory Questionnaire, Chronic Respiratory Disease Questionnaire (CRDQ), symptom‐specific questionnaires (e.g. Leicester Cough Questionnaire (LCQ)) or generic health questionnaires (e.g. Short Form‐36, EuroQol). Both total scores and symptom‐specific domain scores were used but were reported separately. Data from both disease‐specific and generic instruments were pooled for analysis; however, disease‐specific quality‐of‐life total scores were considered the principal analysis of interest. These were assessed upon completion of the exercise training intervention and at the longest time point available up to 12 months after intervention completion
primary outcome:
High versus low positive end‐expiratory pressure (PEEP) levels for mechanically ventilated adult patients with acute lung injury and acute respiratory distress syndrome
Mortality before hospital discharge (if information on mortality before hospital discharge was unavailable, we considered mortality within 28 days of randomisation or mortality in the intensive care unit)
primary outcome:
Prevention of depression in adults with long‐term physical conditions
Incidence of depression: depression was defined by meeting the criteria of major depression set out by DSM (DSM‐III (APA 1980), DSM‐III‐R (APA 1987), DSM‐IV (APA 1994), DSM‐IV‐TR (APA 2000); DSM‐V (APA 2013)), or the criteria of a depressive episode set out by ICD (ICD‐9 (WHO 1978), ICD‐10 (WHO 1992)). Depression had to be measured or assessed by standardised interviews (such as the Structured Clinical Interview for DSM‐IV Axis I Disorders (SCID‐I) (First 1996), Composite International Diagnostic Interview (CIDI) (WHO 1990), Mini‐International Neuropsychiatric Interview (MINI) (Sheehan 1998), or Schedules for Clinical Assessment in Neuropsychiatry (SCAN) (Wing 1990)), or treating physician.Tolerability and acceptability: adverse events (harms, side‐effects) and drop‐outs during preventive intervention were a proxy measure for preventive intervention tolerability and acceptability.total number of adverse events experienced;drop‐outs due to adverse events; anddrop‐outs due to any cause.
primary outcome:
Video games for people with schizophrenia
We divided all outcomes into short term (less than six months), medium term (six to 12 months), and long term (over 12 months).We sought 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 defined within the trials). Thereafter, we listed other binary outcomes and then those that were continuous.
primary outcome:
Urgent‐start peritoneal dialysis versus conventional‐start peritoneal dialysis for people with chronic kidney disease
Mechanical complications occurring within 30 days (early complication) and 90 days (late complication) of commencement of PD (proportion of patients for each relevant outcome listed below).Dialysate leakCatheter blockageCatheter malpositionPD dialysate flow problem.Exit‐site complications occurring within 30 days (early complication) and 90 days (late complication) of commencement of PD.Exit‐site infection (proportion of patients with exit‐site infection and episodes of exit‐site infections per patient‐year)Tunnel tract infection (proportion of patients with tunnel tract infection and episodes of tunnel tract infections per patient‐year)Exit‐site bleeding (proportion of patients developing exit‐site bleeding).Technique survival (number of patients remaining on PD at study completion).
primary outcome:
Maintenance treatment with antipsychotic drugs for schizophrenia
Relapse at one year (seven to 12 months) as defined by the original studies or by a deterioration in mental state requiring further treatment. Overall relapse and relapse at other time points were considered as secondary outcomes.
primary outcome:
Psychosocial interventions for conversion and dissociative disorders in adults
Reduction in physical signs.
primary outcome:
Repositioning for pressure injury prevention in adults
The cumulative incidence of PI (i.e. proportion of participants with a new PI) of any stage using previously defined criteria (EPUAP 1998; EPUAP/NPUAP 2009; NPUAP 2007; NPUAP/EPUAP/PPPIA 2014), or as defined by the trial authors, anywhere on the body following recruitment into the study. Studies in which the incidence of PI was not included as a primary or secondary outcome were excluded.
primary outcome:
Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women
Self‐reported urinary or faecal incontinence.Urinary incontinence‐specific quality of life (e.g. International Consultation on Incontinence Questionnaire (ICIQ; 4 items, higher score worse), Incontinence Impact Questionnaire (IIQ; 30 items, higher score worse), Urogenital Distress Inventory (UDI; 19 items, higher score worse) (Avery 2004; Avery 2007; Shumaker 1994).Faecal incontinence‐specific quality of life (e.g. Faecal Incontinence Quality of Life questionnaire (FIQOL; 29 items, 4 domain scores, each item scored 1‐5, higher score better) (Rockwood 2000).
primary outcome:
Non‐steroidal anti‐inflammatory drugs for acute low back pain
Primary outcome measures were:1) pain intensity (e.g. Visual Analogue Scale (VAS) or Numerical Rating Scale (NRS))2) back pain‐specific functional status (e.g. Roland Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI))3) global measure (e.g. overall improvement, proportion of participants recovered)4) adverse events (proportion of participants experiencing adverse events)5) return to work (e.g. return to work status, number of days off work)We evaluated pain intensity and disability as continuous outcomes. We considered a between‐group difference of more than 10% of the scale (e.g. 10 points on a 0 to 100 scale) to be clinically relevant. A mean difference smaller than this was considered not clinically relevant. For the global measure of improvement, we used dichotomous outcomes; if there were categories in range of improvement, we counted categories such as 'almost recovered' and 'completely recovered', 'good' and 'very good or excellent', and 'a lot' to 'complete recovery' responses as recovered. For adverse events and return to work, we used dichotomous outcomes, usually proportion of participants.
primary outcome:
Subcuticular sutures for skin closure in non‐obstetric surgery
Incidence of surgical site infection (SSI) within 30 days of the operation.
primary outcome:
Epidural corticosteroid injections for lumbosacral radicular pain
Leg pain intensity measured by a self‐reported scale (e.g. visual analogue scale or numerical rating scale); andDisability measured by a self‐reported questionnaire (e.g. Oswestry Disability Index or Roland‒Morris Disability Questionnaire).
primary outcome:
Benzodiazepines for treatment of patients with delirium excluding those who are cared for in an intensive care unit
The length of delirium episode (defined as the time from which it was first identified to when it was first resolved, measured in days).Severity of delirium (we anticipated that this may have been measured differently in different trials. Where possible, we used the highest severity recorded. If this was not available, other measures of severity were used. Symptom severity may have been measured using any validated scale, e.g. the DRS (Trzepacz 1988), the Memorial Delirium Assessment Scale (Breitbart 1997), or the Delirium Index (McCusker 1988)).Any adverse event (counted as the number of participants who experienced at least one adverse event).
primary outcome:
Percutaneous pinning for treating distal radial fractures in adults
FunctionPatient‐reported outcome measure (PROM) scores of hand/wrist/upper limb function (short‐, medium‐, long‐term), e.g. Patient Rated Wrist Evaluation (PRWE) Questionnaire (MacDermid 1998; MacDermid 2000), Disability of the Arm, Shoulder and Hand (DASH) (Hudak 1996) and QuickDASH Outcome Measures (Beaton 2005), Patient Evaluation Measure (PEM) (Macey 1995), Michigan Hand Questionnaire (MHQ) (Chung 1998) and Short MHQ (Waljee 2011).ComplicationsNumbers of participants who incurred any complication that would typically receive substantive treatment (e.g. secondary surgical intervention, antibiotics for pin‐track infection; physiotherapy for Complex Regional Pain Syndrome (CRPS)). Finger stiffness during cast use, for which specific additional treatment, such as an unscheduled cast change or physiotherapy, was not undertaken, would generally not fall into this category.Overall number of participants with complications.Numbers of participants with individual complications
primary outcome:
Pharmacological interventions for treatment‐resistant depression in adults
1. Change in depressive symptoms as measured on rating scales for depression, either clinician‐rated (e.g. Hamilton Rating Scale for Depression (HAM‐D; Hamilton 1960) or Montgomery‐Asberg Depression Rating Scale (MADRS; Montgomery 1979)), or self‐report (e.g. Beck Depression Inventory (BDI; Beck 1961; Beck 1996) (or other validated measures)). Data on observer‐rated and self‐report outcomes were analysed separately.2. Number of dropouts from study or treatment (all‐cause dropout) within the trials. Where available, we extracted data on reasons for dropout and summarised these in narrative form.
primary outcome:
Transcutaneous electrical nerve stimulation (TENS) for chronic neck pain
Pain (e.g. Visual Analogue Scale (VAS), assessed as dichotomous or continuous data)Disability (e.g. Neck Disability Index (NDI), assessed as dichotomous or continuous data)Adverse events
primary outcome:
Modafinil for people with schizophrenia or related disorders
We grouped outcomes into single dose, short term (chronic dose for up to 12 weeks), medium term (chronic dose for up to 26 weeks), and long term (chronic dose for over 26 weeks).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 in the trials) before any other outcomes. We thereafter listed other binary outcomes, and then continuous outcomes.For outcomes such as 'clinically important change', 'any change', and 'relapse', we used the definition used in each of the trials.We used data from valid scales; see Data extraction and management.
primary outcome:
Perioperative restrictive versus goal‐directed fluid therapy for adults undergoing major non‐cardiac surgery
Major complications (as defined by the authors of included studies) during longest follow‐up period, analysed as dichotomous outcomes (number of participants with at least one major complication) (We accepted the study authors' definition provided that it referred to life‐threatening conditions including the need for reoperation or transfer to an intensive care unit, fitting into Grade III or IV of the Clavien‐Dindo Classification of Surgical Complications (Appendix 2; Dindo 2004))All‐cause mortality during longest follow‐up period
primary outcome:
Treatments for primary delusional infestation
We intended, where possible, to divide outcomes into short term (less than six months), medium term (six to 12 months) and long term (over one year).We intended 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 planned to list other binary outcomes and then those that are continuous.For outcomes such as 'clinically important change', 'any change', and 'relapse', we planned to employ the definition used by each of the trials.For valid scales please see (Data extraction and management).
primary outcome:
Interventions for prodromal stage of psychosis
We divided all outcomes into short‐term (less than six months), medium‐term (7 to 12 months) and long‐term (over one year) outcomes.
primary outcome:
Surgical versus conservative interventions for treating acromioclavicular dislocation of the shoulder in adults
Shoulder function (preferably patient reported): an example of a validated patient‐reported measure of upper limb function is the Disability of the Arm, Shoulder, and Hand questionnaire (DASH) (Hudak 1996). A commonly used instrument for assessing shoulder function is the Constant score (Constant 1987), which is a composite score for shoulder function that includes subjectively rated pain and activities of daily living, as well as objectively rated range of movement and strength.Pain: measured by validated pain scales (visual analogue scale (VAS) or numerical rating scale (NRS)) (Revill 1976).Treatment failure: measured by the number of symptomatic participants who have undergone or are being considered for a non‐routine secondary surgical intervention formechanical failure, defined as a condition in which an implant loses its capacity to carry a load (e.g. fixation failure, migration of wires, broken screw or surgical implant);loss of reduction;distal clavicle fractures.
primary outcome:
Acetylsalicylic acid (aspirin) for schizophrenia
We divided all outcomes into short‐term (up to eight weeks), medium term (eight weeks to six months) and long term (six months or longer).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 were continuous.For outcomes such as 'clinically important change', 'any change' and 'relapse', we used the definition used by each of the trials.For valid scales, see Data extraction and management.
primary outcome:
Rigid dressings versus soft dressings for transtibial amputations
Wound healing measured as time from amputation to wound healing and proportion of wounds healed.Complications/adverse events measured as proportion of skin‐related complications/adverse events (e.g. wound infections/breakdowns/stump revisions/further amputations/pressure areas), proportion of non skin‐related complications/adverse events (e.g. deaths, chest infections, falls, pain) and severity of pain on the visual analogue scale.
primary outcome:
Head‐to‐head oral prophylactic antibiotic therapy for chronic obstructive pulmonary disease
Exacerbations (as defined by trialists and grouped by exacerbation severity where possible, e.g. those requiring hospitalisation versus those requiring ambulatory management only). Depending on the available data, we planned to extract either the number of participants experiencing one or more exacerbations, or the exacerbation rate, or both.Quality of life (validated scales such as the St George's Respiratory Questionnaire preferred)Drug resistance/microbial sensitivity (as reported by trialists), including emergence of atypical bacteriaSerious adverse events
primary outcome:
Mucolytic agents versus placebo for chronic bronchitis or chronic obstructive pulmonary disease
Exacerbations, as measured by the number of participants with no exacerbations during the study period, as well as the total number of acute exacerbations per participant* and time to first exacerbation. Exacerbation was defined as an increase in cough and by volume and/or purulence of sputumNumber of days of disability variously defined as days in bed, days off work, or days on which the participant was unable to undertake normal activities. We also assessed days on antibiotics
primary outcome:
Conservative management following closed reduction of traumatic anterior dislocation of the shoulder
Re‐dislocation: separation of the joint requiring reduction and, ideally, verified.Validated patient‐reported outcome measures (PROMs) for shoulder instability (e.g. Oxford Shoulder Instability Score (Dawson 1999), Western Ontario Shoulder Instability Index (WOSI) (Kirkley 1998)).Resumption of pre‐injury activities (work, sport, recreational activities) (yes or no).
primary outcome:
Interventions for preventing high altitude illness: Part 3. Miscellaneous and non‐pharmacological interventions
Risk of acute mountain sickness (AMS ‒ as defined by each study) at any time.
primary outcome:
Peer support for people with schizophrenia or other serious mental illness
We divided outcomes into short term (up to one month), medium term (one or more to six months) and long term (more than six months).
primary outcome:
Subfascial endoscopic perforator surgery (SEPS) for treating venous leg ulcers
Venous ulcer healing (i.e. proportion of ulcers healed within trial period, as defined by the trial authors).Time to complete healing (i.e. time from treatment commencement until ulcer resolution).Recurrence of venous ulcer (as reported in the trial).
primary outcome:
Aquablation of the prostate for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia
Urologic symptom scores (continuous outcome)Quality of life (continuous outcome)Major adverse events (dichotomous outcome)
primary outcome:
Immunonutrition for acute respiratory distress syndrome (ARDS) in adults
All‐cause mortality (longest period reported)
primary outcome:
Subacromial decompression surgery for rotator cuff disease
We ensured that the outcomes in our review were consistent with The Outcome Measures in Rheumatology (OMERACT) draft core domain set for clinical trials of shoulder disorders (Buchbinder 2017).
primary outcome:
Deep brain stimulation for dystonia
Any included study had to explicitly report at least one of the outcomes below.
primary outcome:
Effects of peri‐operative nonsteroidal anti‐inflammatory drugs on post‐operative kidney function for adults with normal kidney function
The primary outcome was AKI as defined by KDIGO which is based on SCr or urine output (KDIGO 2012). Change in SCr and urine output were also considered using the highest post‐operative creatinine or lowest post‐operative urine volume. These were analysed separately.
primary outcome:
Laryngeal mask airway versus endotracheal tube for percutaneous dilatational tracheostomy in critically ill adults
All‐cause mortality during hospital stayProcedure‐related mortality during procedure or follow‐up during hospital stayTally of participants with one or more serious adverse event(s), during procedure, or within 24 hours after procedure
primary outcome:
Perioperative alcohol cessation intervention for postoperative complications
Any type of postoperative complication (e.g. wound‐related complication, secondary surgery, cardiopulmonary complication, admission to intensive care) defined by the need for treatmentIn‐hospital and 30‐day postoperative mortality
primary outcome:
Chlorpromazine versus piperacetazine for schizophrenia
We divided all outcomes into short‐term (less than 6 months), medium‐term (7 to 12 months) and long‐term (over 12 months) outcomes.We reported 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.
primary outcome:
Prophylactic antibiotic therapy for chronic obstructive pulmonary disease (COPD)
Number of exacerbations, using an accepted definition. This included total numbers of participants with one or more exacerbation as well as the frequency of exacerbations in the study period and time to first exacerbation.Health‐related quality of life, using an accepted measure such as the St George's Respiratory Questionnaire (SGRQ) (Jones 2009) or Chronic Respiratory Diseases Questionnaire (CRQ) (Guyatt 1987).
primary outcome:
Antibiotics for exacerbations of chronic obstructive pulmonary disease
Treatment failure as observed between seven days and one month after treatment initiation (no resolution or deterioration of symptoms after trial medication of any duration, or death, when explicitly stated, due to exacerbation or additional course of antibiotics or another medication)
primary outcome:
Occupational therapy delivered by specialists versus non‐specialists for people with schizophrenia
We planned to divide outcomes into short‐term (less than six months), medium‐term (seven to 12 months), and long‐term (more than one year) outcomes.
primary outcome:
Phosphate binders for preventing and treating chronic kidney disease‐mineral and bone disorder (CKD‐MBD)
Death (all causes)
primary outcome:
Automated monitoring compared to standard care for the early detection of sepsis in critically ill patients
Time to initiation of antimicrobial therapy* (in minutes)Time to initiation of fluid resuscitation* (in minutes)30‐day mortality
primary outcome:
Fluphenazine (oral) versus placebo for schizophrenia
Where possible, outcomes were made binary by dividing them into two categories ‐ 'clinically significant change' and 'no clinically significant change'.
We categorised outcomes as short term (0‐8 weeks), medium term (9 to 26 weeks) and long term (27 weeks to 104 weeks).
primary outcome:
Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery in adults
Pain score at rest (0 to 10 cm, 0 to 100 mm visual analogue scale (VAS), numeric rating scale (NRS)), at 'early', 'intermediate', and 'late time points'Gastrointestinal recovery: postoperative ileus (dichotomous), time to first defaecation/bowel movement (hours), time to first flatus (hours), and time to first bowel sounds (hours)Adverse events (dichotomous; e.g. death, arrhythmias, other heart rate disorders or any sign of lidocaine toxicity)
primary outcome:
Psychological therapies for treatment‐resistant depression in adults
Clinician‐rated depressive symptoms (e.g. Hamilton Rating Scale for Depression (HAMD) ‐ Hamilton 1960; Montgomery‐Asberg Depression Rating Scale (MADRS) ‐ Montgomery 1979), orSelf‐reported depressive symptoms (e.g. Beck Depression Inventory (BDI) ‐ Beck 1961; Beck 1996; other validated measures). We analysed data on observer‐rated and self‐reported outcomes separately.
primary outcome:
Increasing antipsychotic dose versus switching antipsychotic for non response in schizophrenia
We planned to divide, if possible, all outcomes into short term (up to 3 months), medium term (more than 3 months and up to 6 months) and long term (more than 6 months).We reported 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 outcomes that are continuous.
primary outcome:
Laparoscopic‐endoscopic rendezvous versus preoperative endoscopic sphincterotomy in people undergoing laparoscopic cholecystectomy for stones in the gallbladder and bile duct
Overall mortality rate (procedure‐related and non‐procedure‐related), assessed at the latest follow‐up;Overall morbidity rate. We assessed surgical morbidity (i.e. pancreatitis, bleeding, intestinal perforations) and general morbidity (i.e. pneumonia, wound infection, cardiac complications, deep venous thrombosis, etc.), assessed at the latest follow‐up;.Failure of primary clearance (duct clearance as determined by cholangiogram, number of successful common bile duct cannulations).
primary outcome:
Risperidone for psychosis‐induced aggression or agitation (rapid tranquillisation)
Where possible, we grouped outcomes by time: by 30 minutes, up to two hours, up to four hours, up to 24 hours, and over 24 hours.
primary outcome:
Different durations of corticosteroid therapy for exacerbations of chronic obstructive pulmonary disease
Treatment failure (e.g. the need for additional treatment, hospital admission/re‐admission for index episode, return to emergency department, unscheduled physician visit for the index episode).Relapse after treatment (e.g. treatment for new acute exacerbation, re‐admission or hospitalisation for COPD).Adverse drug effects.
primary outcome:
Antipsychotic reduction and/or cessation and antipsychotics as specific treatments for 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:
Fitness training for cardiorespiratory conditioning after traumatic brain injury
laboratory‐based measures for maximal tests such as peak oxygen uptake (direct) and peak power output (indirect). Other measures such as peak heart rate, stroke volume and peak respiratory exchange ratio during exercise were used to evaluate whether performances were of a maximal nature (ACSM 2014);laboratory‐based measures for submaximal tests such as oxygen uptake, carbon dioxide production, minute ventilation, respiratory exchange ratio (direct) and peak power output, test duration, and heart rate and stroke volume (indirect) at set submaximal work rates (ACSM 2014); andfield‐based measures (indirect) such as Rating of Perceived Exertion (RPE) (Borg 1982), and distance or level achieved in walk/run tests such as the modified version of the 20‐metre shuttle test (Vitale 1997), or 12‐minute walk/run test (Cooper 1968).
primary outcome:
Peritoneal dialysis for acute kidney injury
All‐cause mortality (death from any cause at the end of follow‐up).
primary outcome:
Personalised asthma action plans for adults with asthma
Number of participants reporting at least one exacerbation requiring emergency department visit or hospitalisationAsthma symptom scores* (measured on a validated scale, e.g. Asthma Control Questionnaire)Adverse events (all‐cause)
primary outcome:
Bronchoscopic lung volume reduction procedures for chronic obstructive pulmonary disease
Percent change in forced expiratory volume in one second (FEV₁) (lung capacity).Perioperative and postoperative mortality (survival).Health‐related quality of life (e.g. St Georges Respiratory Questionnaire (SGRQ)).
primary outcome:
Fibrin glue for pilonidal sinus disease
Healing (time to wound healing in days)Adverse events (seroma and allergic reaction).
primary outcome:
Intensive case management for severe mental illness
We grouped outcomes by time into short term (up to and including 6 months), medium term (7 months to up to and including 12 months), and long term (over 12 months). Where available, 24 months was the preferred follow‐up point for calculating mean days per months in hospital. If more than one follow‐up point within the same period was available, we reported the latest one. During this period, participants remained allocated in their trial arm.We grouped outcomes assessed after active intervention was stopped or after participants could choose to which arm they were transferred, by time into short‐term follow‐up (up to and including one year), medium‐term follow‐up (from one to five years), and long‐term follow‐up (over five years). We calculated follow‐up length as time since intervention stopped.To simplify distinguishing between outcomes assessed during and after the active intervention, we entered ones explicitly reporting follow‐up (FUP) length.
primary outcome:
Protease‐modulating matrix treatments for healing venous leg ulcers
We list primary and secondary outcomes below. If a study was otherwise eligible (i.e. correct study design, population and intervention/comparator) but did not report a listed outcome then we contacted the study authors where possible to establish whether an outcome of interest here was measured but not reported.It is important to take time into account in the reporting of outcome measures. Where possible, we used or calculated time‐to‐event data. Otherwise, we categorised outcomes data as follows:If results were given at more than one time point in a study, we reported outcome measures at the latest time point available (assumed to be length of follow‐up if not specified) or the time point specified in the study report's Methods section as being of primary interest (if this was different from latest time point available). This avoided statistical issues inherent in the use of multiple time points. 'Follow‐up' is defined as the time from randomisation to outcome measurement. The review authors' judgement was used as to whether statistical pooling within the above time categories was appropriate.We analysed the data separately for the three durations for the complete healing outcome, but combined durations for adverse events (reasoning that local adverse events would probably occur fairly quickly).
primary outcome:
Non‐steroidal anti‐inflammatory drugs for sciatica
Change in pain intensity (e.g. visual analogue scale (VAS) or numerical rating scale (NRS))Change in disability or functional status (reported on e.g. Oswestry Disability Questionnaire or Roland Morris Disability Questionnaire (RMDQ))Global measures (e.g. overall improvement)Adverse effects (proportions of participants experiencing adverse effects of NSAIDs) graded according to the standardised definitions published by the National Cancer Institute of the National Institutes of Health into mild (grade 1), moderate (grade 2), severe (grade 3), or life‐threatening (grade 4).
primary outcome:
Lung volume reduction surgery for diffuse emphysema
Short‐term (90 days) and long‐term (> 36 months) mortalityQuality of life (e.g. St George Respiratory Questionnaire (SGRQ))
primary outcome:
Fast‐track cardiac care for adult cardiac surgical patients
If a study did not report any of the following prespecified outcome data, we excluded that study from the systematic review.
primary outcome:
Inhaled nitric oxide for acute respiratory distress syndrome (ARDS) in children and adults
Overall mortality (longest follow‐up, regardless of the duration of follow‐up).Overall 28‐day mortality (studies reporting mortality at 25 to 30 days were included in the same analysis).
primary outcome:
Manual therapy and exercise for rotator cuff disease
We did not consider outcomes as part of the eligibility criteria.
primary outcome:
Back schools for acute and subacute non‐specific low‐back pain
The primary outcomes were pain and disability.
primary outcome:
Risperidone (depot) for schizophrenia
All outcomes were reported for the short term (up to 12 weeks), medium term (13‐26 weeks), and long term (more than 26 weeks).
primary outcome:
Surgical versus conservative interventions for treating anterior cruciate ligament injuries
Subjective knee scores, e.g. Knee Injury and Osteoarthritis Outcome Score (KOOS; Roos 1998), anterior cruciate ligament quality of life score (Mohtadi 1998) and International Knee Documentation Committee (IKDC), subjective part (Irrgang 2001).Adverse events (such as donor site morbidity, failure of graft including re‐rupture, infection, deep vein thrombosis and pulmonary embolism).Treatment failure including re‐operation (for surgery) or subsequent operation (for conservative treatment).
primary outcome:
Care delivery and self management strategies for adults with epilepsy
The outcomes we considered are:We assessed all outcome measures for reliability and validity (i.e. for clinical relevance and whether validated tools were used for outcome measurement). If trials misused measures (e.g. children's scales used on adults), we planned to investigate their effect on study results by a sensitivity analysis.
primary outcome:
Multi‐disciplinary rehabilitation for acquired brain injury in adults of working age
We were interested in outcomes that reflect the burden of disabling illness on individuals and families, and in the services provided for them. We excluded studies that reported only outcomes at the level of impairment.Measurement of outcomes after rehabilitation can be described on two principal axes.Many of these studies were undertaken when the previous WHO classification of Impairment, Disability and Handicap was current; therefore, we have included these terms in brackets alongside the current terms.
primary outcome:
Crisis intervention for people with severe mental illnesses
We divided outcomes into very short term (less than three months), short term (less than six months), medium term (seven to 12 months) and long term (over one year).
primary outcome:
Rehabilitation for distal radial fractures in adults
Functional outcomes: patient‐reported measures of wrist and hand function (e.g. PRWE) and upper limb function (e.g. DASH).Activities of daily living and health‐related quality of life scores (e.g. EuroQol (EQ‐5D); Short‐Form 36 (SF‐36) and Short‐Form 12 (SF‐12; Ware 1996).Serious adverse events (e.g. CRPS‐1), and need for substantive treatment, such as extensive physiotherapy.
primary outcome:
Early versus delayed dressing removal after primary closure of clean and clean‐contaminated surgical wounds
Surgical site infection (SSI) within 30 days of operation. We attempted to use the definition of SSI that matches the standard definition of SSI described by Horan 1992. Otherwise, we accepted the definitions used by the trial authors.Superficial SSI.Deep SSI.Wound dehiscence within 30 days of operation. Postoperative wound dehiscence is the term given to wound disruptions that result from poor wound healing; it is caused by a variety of factors, such as type of incision, infection, anaemia, diabetes, ascorbic acid deficiency, etc. (Keill 1973). Wound dehiscence is classified as:superficial (dehiscence involving skin and subcutaneous tissue); ordeep (burst abdomen).Other serious adverse events within 30 days of operation, defined as any event that would increase mortality; is life‐threatening; requires inpatient hospitalisation or prolongation of existing hospitalisation; results in a persistent or significant disability or incapacity; or any important medical event that might have jeopardised the person, or requires intervention to prevent it (ICH‐GCP 1996). We recognised that the main role of dressings is to prevent wound‐related complications, but we wanted to assess the impact of dressings in the overall context of the operation.
primary outcome:
Social skills programmes for schizophrenia
If possible we divided outcomes into short term (less than six months), medium term (seven to 12 months) and long term (over one year).
primary outcome:
Cognitive‐behavioural treatment for subacute and chronic neck pain
The primary outcome chosen for this review was pain, expressed by means of a visual analogue scale (VAS) or a numerical rating scale (NRS; Huskinson 1974).We reasoned that pain was a participant‐centred outcome that had better responsiveness, particularly in subacute participants, compared with disability. Furthermore, we expected trials in this field to have limited length of follow‐up, prohibiting assessment of disability improvement.
primary outcome:
Use of plastic adhesive drapes during surgery for preventing surgical site infection
Rates of surgical site infection (SSI). For the purposes of this review we accepted the definition of SSI used in the trial.
primary outcome:
Supportive therapy for schizophrenia
We reported outcomes for the short term (up to 12 weeks), medium term (13 to 26 weeks), and long term (more than 26 weeks)
primary outcome:
Hydrogel dressings for treating pressure ulcers
Time to complete wound healing (correctly analysed using censored data and preferably adjusted for prognostic covariates such as baseline size). We only considered mean or median time to healing without survival analysis as a valid outcome if reports specified that all wounds healed (i.e. if the trial authors regarded time to healing as a continuous measure as there is no censoring).Proportion of ulcers healed during follow‐up (frequency of complete healing).
primary outcome:
Protocolized versus non‐protocolized weaning for reducing the duration of mechanical ventilation in critically ill adult patients
Total duration of mechanical ventilation (time in hours, from mechanical ventilation initiation to discontinuation).
primary outcome:
Minimally invasive discectomy versus microdiscectomy/open discectomy for symptomatic lumbar disc herniation
pain measure by visual analogue scale (VAS) for each of sciatica and LBP;sciatica‐specific outcomes: the Sciatica Bothersomeness Index (SBI) and the Sciatica Frequency Index (SFI) (Grøvle 2008);neurological deficit of lower extremity or bowel/urinary incontinence;functional outcome including daily activity and return to work, measured by scales such as the Oswestry Disability Index (ODI) or the Roland‐Morris Disability score.
primary outcome:
Platelet‐rich therapies for musculoskeletal soft tissue injuries
Functional evaluation (assessed by subjective assessment questionnaires such as Disabilities of the Arm, Shoulder and Hand questionnaire (Hudak 1996), Victorian Institute of Sports Assessment ‐ Achilles questionnaire (VISA‐A) (Robinson 2001), and American Orthopaedic Foot and Ankle Society (AOFAS) foot questionnaire (Kitaoka 1994)).Pain (assessed by subjective scales such as visual analogue scales (VAS) (Revill 1976)).Local and systemic adverse effects of platelet‐rich therapy (or placebo) administration (including infection and anaphylactic reaction).
primary outcome:
Bronchial thermoplasty for moderate or severe persistent asthma in adults
Health‐related quality of life (HRQOL) evaluated through asthma‐specific or generic questionnaires.Asthma‐specific (e.g. Asthma Quality of Life Questionnaire (AQLQ; Juniper 1994)); considering a change in the score of 0.5 points the threshold of clinical relevance).Respiratory‐specific (e.g. St. George's Respiratory Questionnaire; considering a change in the score of four points the threshold of clinical relevance (Jones 2002)).Generic (e.g. Short Form (SF)‐36 Questionnaire on health status; Nottingham Health Profile (NHP); World Health Organization (WHO) instrument on health‐related quality of life (WHOQOL‐100)).Asthma control evaluated through validated questionnaires (e.g. Asthma Control Questionnaire (ACQ; Juniper 1999)); considering a change in the score of 0.5 points the threshold of clinical relevance.Number of exacerbations, defined as any of the following.Exacerbations requiring hospital or intensive care unit admissions.Exacerbations requiring emergency department visits or unscheduled healthcare visits.Exacerbations resulting in a course of oral or systemic corticosteroids, or an increase in the regular required doses.Serious adverse events, defined as any of the following.Fatal events.Hospital admission.Risk of death at the time of event.A permanent or significant disability.
primary outcome:
Trifluoperazine versus placebo for schizophrenia
1. Global state
1.1 Any clinically significant response in medium term global state (as defined by each study).2. Behaviour
2.1 Any clinically significant agitation or distress (as defined by each study).3. Relapse +/‐ hospitalisation
3.1 Relapse including any hospitalisation of a participant within a study.4. Severe adverse effects
4.1 Any clinically significant severe short term adverse effects based on relevant rating scales.
primary outcome:
Enhanced care by generalists for functional somatic symptoms and disorders in primary care
1. Patient health status as measured by a validated quality of life tool.We chose quality of life as this includes both symptoms and function. For the Short Form‐36 (SF‐36) (Ware 1992) and related tools (SF‐12 (Gandek 1998), SF‐8 (Turner‐Bowker 2003)), the primary outcome was specified as the physical and mental component summary scores or, if not available, the items physical functioning and mental health.
primary outcome:
User‐held personalised information for routine care of people with severe mental illness
Outcomes were not part of the criteria for including studies in the review. Outcomes of interest are listed below. We divided outcomes into very short term (less than three months), short term (less than six months), medium term (seven to 12 months) and long term (over one year).