anurajms/meta_analysis huggingface dataset:
primary outcome:
Treatment of enteric fever (typhoid and paratyphoid fever) with cephalosporins
Clinical failure: defined as the presence of symptoms or development of complications that necessitate a change in antimicrobial therapy or prolongation of existing therapy at the time period specified by trial authors; or, death related to the disease within the trial time period as opposed to an adverse event arising from any therapy administered.Microbiological failure: defined as a positive culture from blood, bone marrow or any sterile anatomical site during the period specified by the trial authors.Relapse: defined as the recurrence of symptoms with a positive culture from blood, bone marrow or any sterile anatomical site to the point of follow‐up defined by the trial author.
primary outcome:
Electromagnetic‐guided versus endoscopic‐guided postpyloric placement of nasoenteral feeding tubes
Technical success in insertion, defined as the proportion of postpyloric placements of nasoenteral feeding tubes that were successful at the first attempt. ‘Success’ meant the tip of the tube was located postpylorus on the electromagnetic monitor or abdominal radiograph. We calculated this as the number of participants with successful first placement divided by the total number of participants in the electromagnetic monitor or endoscopic group.Proportion of participants with aspiration pneumonitis, defined by radiographic evidence of an infiltrate in a characteristic bronchopulmonary segment (Kalil 2016; Marik 2001). We calculated this for each group as the number of participants with aspiration pneumonitis within six hours of the primary placement procedure divided by the total number of participants. We also accepted the authors' definitions of pneumonitis.
primary outcome:
Certolizumab pegol for maintenance of medically induced remission in Crohn’s disease
Failure to maintain clinical remission at week 26.Clinical remission was defined as a total CDAI score of 150 points or fewer, a total HBI score of 4 points or fewer, or a total PCDAI score of less than 10 points during CZP treatment.For outcomes analyzed outside the time point of week 26, we included outcome data collected at the longest follow‐up duration closest to week 26 (week 22 as the minimum).Failure to maintain clinical response at week 26.Clinical response was defined in accordance with the definition in Types of participants section.For outcome data that were not available at week 26, we included findings reported at the longest follow‐up time point closest to week 26 (week 22 as the minimum).Serious adverse events during remission maintenance treatment.We evaluated the occurrence of the following serious adverse events: infection, blood and lymphatic system disorder, immune system disorder, neoplasm, demyelinating disorders, drug‐induced systemic lupus erythematosus, or death.
primary outcome:
Physical activity for treatment of irritable bowel syndrome
Global improvement of symptoms (participant‐reported or clinician‐evaluated or both) as measured by a global IBS symptoms score (e.g. Irritable Bowel Syndrome Severity Scoring System (IBS‐SSS), Adequate Relief Measure, GI Symptom Rating Scale, Functional Bowel Disorder Severity Index or IBS Symptom Questionnaire) or as defined by the included studies.
primary outcome:
Antibiotics for uncomplicated diverticulitis
Primary outcomes were failure of antibiotics treatment with:
1. Progression from uncomplicated to complicated acute diverticulitis defined as: abscess, fistula, stricture, peritonitis or sepsis;
or
2. Emergency surgery related to acute diverticulitis.
Primary outcomes had to occur within 30 days of randomisation.When pooled in meta‐analysis, a total of 1329 participants were included: 665 under no‐antibiotic management and 664 who received antibiotic treatment. Risk of complications within 30 days was equal in the groups (1.4% vs. 1.4%) and there may be little or no difference between the no‐antibiotic and antibiotic groups and no important heterogeneity (RR 0.89; 95% CI [0.30 to 2.62]; I2 = 19%; 3 studies, 1329 participants; low‐certainty evidence, Analysis 1.1).Emergency surgery within 30 days occurred less frequently in the no‐antibiotic group (0.5% vs. 1.0%). Estimates may indicate that there is a possible effect of no‐antibiotic management, however, there is considerable imprecision due to wide confidence intervals. The evidence is uncertain which means that there may also be a benefit with antibiotics. The evidence is without important heterogeneity (RR 0.47; 95% CI [0.13 to 1.71]; I2 = 0%; 3 studies; 1329 participants, low‐certainty evidence; Analysis 1.2). The qualities of the evidence for primary outcomes were of low quality because of the lack of blinding, leading to possible risk of detection bias and the relatively wide confidence intervals indicating imprecision. Trial sequential analyses were performed for the primary outcome in order to assess total sample size needed or for identification of possible evidence of early futility. However, according to the parameters we had chosen (alpha 5%, beta 20%, relative risk reduction 20%), we knew too little (2%) based on the diversity‐adjusted required information size to perform analyses.
primary outcome:
Stem cell transplantation for induction of remission in medically refractory Crohn’s disease
Clinical remission, as defined by the original studies.Crohn's Disease Activity Index (CDAI) of < 150),or a Pediatric Crohn’s Disease Activity Index (PCDAI) of < 15 at weeks four to six (early), weeks 10 to 12 (middle), and weeks 15 or later (late) following initiation of therapy. But no paediatric population was present in all the included studies.Complete closure of the fistula as defined by original studies (e.g. complete closure of the fistula tract including internal and external openings without drainage or any sign of inflammation either detected; assessed clinically or by magnetic resonance imaging (MRI) or Perianal Disease Activity Index score (PDAI score)).
primary outcome:
Tacrolimus (FK506) for induction of remission in corticosteroid‐refractory ulcerative colitis
Number of participants achieving clinical remission at study end, as defined by the primary studies and expressed as a percentage of participants randomised (intention‐to‐treat (ITT) analysis).Number of participants achieving clinical improvement of symptoms of UC at study end, as defined by the primary studies and expressed as a percentage of participants randomised (ITT analysis).
primary outcome:
Guidewire‐assisted cannulation of the common bile duct for the prevention of post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis
The primary outcome measure was post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP), as defined by the primary studies. If different definitions of PEP were provided by the same study, the consensus definition (Cotton 1991) or the revised Atlanta Classification (Banks 2013) was used for the assessment of this outcome.The primary outcome was post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). We expected dichotomous data for PEP, and we expressed this as risk ratio (RR) with 95% confidence interval (CI). We defined RR as the risk of PEP in the guidewire‐assisted cannulation technique compared to the contrast‐assisted cannulation technique.
primary outcome:
Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding
The primary outcome measure in this review was all‐cause mortality, defined as any death occurring within 30 days or at the time point closest to 30 days after randomisation.The primary outcome was mortality rate, defined as death from any cause within 30 days of randomisation. We expected dichotomous mortality data, expressed as odds ratios (OR) with 95% confidence intervals (CI).
primary outcome:
Intraperitoneal local anaesthetic instillation versus no intraperitoneal local anaesthetic instillation for laparoscopic cholecystectomy
Proportion of participants dying (all‐cause mortality).Proportion of participants with one or more serious adverse events: any untoward medical occurrence that, at any dose, 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/birth defect, or any medical event that might have jeopardised the person, or required intervention to prevent it (ICH‐GCP 1997).Health‐related quality of life (however defined by the trial authors using a validated scale such as Euro‐QoL or 36‐item Short‐Form (SF‐36)).
primary outcome:
Mesh fixation techniques in primary ventral or incisional hernia repair
Recurrence, diagnosed by a physician or radiologically; we included trials irrespective of the method used for diagnosis or the length of follow‐up.Pain, classified as:Early postoperative (0 to 14 days postoperatively)Late follow‐up (15 days to 6 weeks postoperatively)Chronic (more than 6 to 8 weeks postoperatively) (LeBlanc 2004; Den Hartog 2008).Health‐related quality of life (HRQOL): measured with the Short Form Health Surveys (SF) (SF 2014) or the EuroQol (EQ‐5D) instruments (EQ‐5D 2014) in the early postoperative period (0 to 14 days) or long‐term  (at least 6 weeks).
primary outcome:
Primary prevention of variceal bleeding in people with oesophageal varices due to liver cirrhosis: a network meta‐analysis
All‐cause mortality at maximal follow‐up (time‐to‐death).Health‐related quality of life using a validated scale such as the EQ‐5D or 36‐Item Short Form Health Survey (SF‐36) (EuroQol 2018; Optum 2018), at maximal follow‐up.Serious adverse events (during or within six months after cessation of intervention). We defined a serious adverse event as any event that increased mortality; was life‐threatening; required hospitalisation; resulted in persistent or significant disability; was a congenital anomaly/birth defect; or any important medical event that might have jeopardised the person or require intervention to prevent it (ICH‐GCP 1997). However, none of the trial authors defined serious adverse events. Therefore, we used the list provided by trial authors for serious adverse events (as indicated in the protocol; Gurusamy 2018).Proportion of people with one or more serious adverse events.Number of serious adverse events per participant.
primary outcome:
Secondary prevention of variceal bleeding in adults with previous oesophageal variceal bleeding due to decompensated liver cirrhosis: a network meta‐analysis
All‐cause mortality at maximal follow‐up (time‐to‐death).Health‐related quality of life using a validated scale such as the EQ‐5D or 36‐Item Short Form Health Survey (SF‐36) (EuroQol 2018; Optum 2018), at maximal follow‐up.Serious adverse events (during or within six months after cessation of intervention). We defined a serious adverse event as any event that would increase mortality; is life‐threatening; requires hospitalisation; results in persistent or significant disability; is a congenital anomaly/birth defect; or any important medical event that might jeopardise the person or require intervention to prevent it (ICH‐GCP 1997). However, none of the trial authors defined serious adverse events. Therefore, we used the list provided by trial authors for serious adverse events (as indicated in the protocol).Proportion of people with one or more serious adverse events.Number of serious adverse events per participant.
primary outcome:
Risk of postoperative infectious complications from medical therapies in inflammatory bowel disease
The primary outcome was postoperative infection within 30 days of surgery.
primary outcome:
Portosystemic shunts versus endoscopic intervention with or without medical treatment for prevention of rebleeding in people with cirrhosis
All‐cause mortality, defined as death due to any causeRebleeding, defined as a clinically significant episode of bleeding (i.e. requiring transfusion) from oesophagogastric varices or portal hypertensive gastropathy. The diagnosis should ideally have been confirmed by endoscopic examination to distinguish variceal bleeding or bleeding from portal hypertensive gastropathy from other causes of non‐portal hypertensive gastrointestinal haemorrhageHealth‐related quality of life, as measured by trial authors
primary outcome:
Interventions for preventing postpartum constipation
Pain or straining on defecationIncidence of postpartum constipation, as per self‐report and other diagnostic criteriaQuality of life, as measured in included studies (using e.g. maternal postpartum quality of life (MAPP‐QOL) questionnaire)Time to first bowel movement (days; outcome not prespecified at the protocol stage ‐ see Differences between protocol and review)
primary outcome:
Adalimumab for maintenance of remission in Crohn's disease
The proportion of participants with CD who failed to maintain clinical remission, as defined by the original trials. Clinical remission is often defined as a Crohn's Disease Activity Index (CDAI) score of < 150.
primary outcome:
Antibiotic prophylaxis for prevention of postoperative wound infection in adults undergoing open elective inguinal or femoral hernia repair
Wound infection after inguinal or femoral repair surgery. We classified wound infections as superficial surgical site infections (SSSI), deep surgical site infections (DSSI) or all wound infections (a sum total of SSSI and DSSI). SSSI can occur up to 30 days postoperatively and DSSI can occur up to one year postoperatively (Mangram 1999). We included studies reporting wound infections as defined by Centers for Disease Control and Prevention (CDC) (Horan 1992; Berrios‐Torres 2017); or as defined specifically by authors (definitions including parameters such as discharge of pus from the wound; a wound that was opened and not closed; spreading erythema indicative of cellulitis). We excluded other postoperative infections (i.e. pulmonary, urinary tract and other infections) from analysis.
primary outcome:
Nasogastric versus nasojejunal tube feeding for severe acute pancreatitis
Mortality
primary outcome:
Anti‐IL‐12/23p40 antibodies for maintenance of remission in Crohn's disease
Proportion of participants who failed to maintain clinical remission (as defined by the original study).
primary outcome:
Adalimumab for induction of remission in Crohn's disease
The primary outcome was the proportion of participants who failed to achieve clinical remission, as defined by the original studies.
primary outcome:
Band ligation versus beta‐blockers for primary prophylaxis of oesophageal variceal bleeding in children with chronic liver disease or portal vein thrombosis
All‐cause mortality.Upper gastrointestinal bleeding.Serious adverse events and liver‐related morbidity (i.e. proportion of participants who developed ascites, hepatorenal syndrome, hepatocellular carcinoma, or hepatic encephalopathy). A serious adverse event, defined according to the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (ICH‐GCP 1997), is any untoward medical occurrence that results in death, is life‐threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. All other adverse events were considered non‐serious adverse events.Health‐related quality of life, determined exclusively by validated scales, classification and measurement systems such as the Paediatric Quality of Life Inventory (PedsQL), Child Health Questionnaire (CHQ), and DISABKIDS.
primary outcome:
Certolizumab pegol for induction of remission in Crohn's disease
The primary outcome was the proportion of CD patients achieving remission at week eight after CZP administration. We selected week eight because this week is the recommended time for switching to maintenance dosing according to the approved dosing regimen (Schreiber 2011). If the outcome was not assessed at week 8, we selected the nearest week between weeks 4 and 12 as the outcome assessment point. If only dates from two time points equally distant from week 8, such as weeks 6 and 10, were available despite inquiring with the original investigators, the earlier point (week 6) was planned to be selected. Remission was defined as CDAI ≤ 150 or HBI ≤ 4. If both CDAI and HBI were reported in the primary studies, the CDAI was planned to be used for outcome assessment. The proportion of participants in remission was calculated in accordance with the intention‐to‐treat (ITT) principle; the denominator was the number of the randomized patients in each arm. Participants with missing data for the primary outcome were assumed to be treatment failures.
primary outcome:
Plasma expanders for people with cirrhosis and large ascites treated with abdominal paracentesis
All‐cause mortality at the end of the maximal follow‐up.Serious adverse events at the end of the maximal follow‐up, excluding those for which definition of other liver‐related complications could be applied (see below). We considered an event as a serious adverse event if it fulfilled the definition of serious adverse events of the International Conference on Harmonization (ICH) Guidelines (ICH 1997), that is, any event that leads to death, is life‐threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability, congenital birth or anomaly, and any important medical event which may have jeopardised the patient or requires intervention to prevent it. We considered all other adverse events as non‐serious.Health‐related quality of life as measured by the trials.
primary outcome:
Lateral pararectal versus transrectal stoma placement for prevention of parastomal herniation
Incidence of parastomal herniation.
primary outcome:
Adjuvant therapy with antidepressants for the management of inflammatory bowel disease
Anxiety and depression as measured by any well‐established anxiety or depression scale
primary outcome:
Glucocorticosteroids for people with alcoholic hepatitis
All‐cause mortality: up to three months' follow‐up after randomisation (the primary time point for drawing our main conclusion); at the end of treatment (post hoc analysis); and one year following randomisation (post hoc analysis).Health‐related quality of life as defined by the trial authors.Serious adverse events during treatment. We used the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice's definition of a serious adverse event (ICH‐GCP 1997), 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. We considered all other adverse events as non‐serious (see Secondary outcomes).
primary outcome:
N‐acetylcysteine as an adjuvant therapy for Helicobacter pylori eradication
successful H pylori eradication; andgastrointestinal adverse events (e.g. diarrhoea, nausea, vomiting, or any other reported adverse event).
primary outcome:
Antibiotics for induction and maintenance of remission in Crohn's disease
The primary outcome measure for induction of remission studies was the proportion of patients who failed to achieve remission, as defined by the original studies. The primary outcome for maintenance of remission studies was the proportion of patients who relapsed, as defined by the included studies.
primary outcome:
Acetyl‐L‐carnitine for patients with hepatic encephalopathy
All‐cause mortalityQuality of life (any validated scale used by trialists, such as Short Form (SF)‐36)Serious adverse events (A serious adverse event, defined according to the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (ICH‐GCP 1997), is any untoward medical occurrence that at any dose results in death, is life‐threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, leads to persistent or significant disability or incapacity, or comprises a congenital anomaly or birth defect.) All other adverse events were considered non‐serious (see below)
primary outcome:
Cannabis for the treatment of ulcerative colitis
The primary outcome for induction of remission studies was clinical remission at study endpoint (as defined by the primary studies). The primary outcome for maintenance of remission studies was relapse at study endpoint (as defined by the primary studies). We included any validated scoring system. We included all short‐term and long‐term outcome time points.
primary outcome:
Surgical portosystemic shunts versus transjugular intrahepatic portosystemic shunt for variceal haemorrhage in people with cirrhosis
All‐cause mortality at 30 days, and five yearsSerious adverse events. We defined serious adverse events as any untoward medical occurrence that was life‐threatening, resulted in death or persistent or significant disability, or any medical event that may have jeopardised the person or required intervention to prevent it (ICH‐GCP 1997). We considered all other adverse events (i.e. any medical occurrence not necessarily having a causal relationship with the treatment, yet causing a dose reduction or discontinuation of treatment) as non‐serious (see below).Health‐related quality of life. We defined health‐related quality of life as any deviation from a person's usual or expected physical, emotional, and social well‐being that is due to an intervention.
primary outcome:
Swallowing therapy for dysphagia in acute and subacute stroke
Functional outcome assessed as death or dependency (modified Rankin Scale: mRS > 2), or death or disability (Barthel Index: BI < 60), at the end of the trial
primary outcome:
Carvedilol versus traditional, non‐selective beta‐blockers for adults with cirrhosis and gastroesophageal varices
Mortality (all‐cause)Upper gastrointestinal bleedingSerious adverse events. We defined adverse events as any untoward medical occurrence (ICH GCP 1997), and considered adverse events as serious if they resulted in death, were life‐threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, or resulted in persistent or significant disability or incapacity. In this review serious adverse event included mortality and upper gastrointestinal bleeding and we analysed them as a composite outcome (hbg.cochrane.org/information‐authors)
primary outcome:
Prokinetics for functional dyspepsia
Global (overall) symptoms of dyspepsia, reported as binary outcome (yes or no) or symptom scores. We used the most stringent definition of not symptom‐free or no overall symptom improvement by the patient at the end of treatment. If that was not available, we used overall symptom assessment as assessed by the doctor/researcher. If global symptoms were not reported, we used epigastric pain/discomfort improvement as the outcome measure, but these studies were removed in the sensitivity analysis.
primary outcome:
Modifying the consistency of food and fluids for swallowing difficulties in dementia
Aspiration of food or fluids, or both, as rated on objective instrumental swallowing assessment (e.g. videofluoroscopy, fibreoptic endoscopic examination of swallowing (FEES) safety)Nutritional status, as measured by change in weight, change in grip strength, change in calorific intake, change in standardised and validated screening tool, such as the Mini Nutritional Screening Tool (Guigoz 1996), or the Malnutrition Universal Screening Tool (Stratton 2004); change in number of hospitalisations for rehydrationRespiratory status, defined by clinical assessment that may include a chest x‐ray, change in incidence of aspiration‐related pneumoniaAdverse events associated with diet modification, including hospitalisation, psychological effects, aspiration pneumonia, malnutrition, dehydration and death
primary outcome:
Mesh versus non‐mesh for inguinal and femoral hernia repair
Recurrence of the same hernia (this excludes formation of a hernia at a new site not previously repaired or reinforced)Surgical complicationsNeurovascular or visceral injuryWound infection at single or multiple sites, including deep and superficial wound infectionsHaematomaSeromaPostoperative wound swellingWound dehiscenceTesticular injury or complications, including testicular swelling and atrophyUrinary retention postoperativelyPostoperative pain, including acute and chronic painMortality (number of associated deaths within 30 days of the operation during the study trial period)
primary outcome:
Epidural analgesia versus patient‐controlled intravenous analgesia for pain following intra‐abdominal surgery in adults
Pain score at rest and on movement, by a visual analogue scale (VAS) on a 0‐to‐100 scale or similar, during the initial 6‐hour period (early phase), 6‐ to 24‐hour period (mid‐phase), and 24‐ to 72‐hour period (late phase). We considered analysis of the data as continuous (compare mean pain scores between groups).All‐cause mortality rate at 30 days
primary outcome:
Surgical portosystemic shunts versus devascularisation procedures for prevention of variceal rebleeding in people with hepatosplenic schistosomiasis
All‐cause mortalityimmediate (30 days)intermediate (one year)long term (five years)Serious adverse events (procedure‐related complications). We used the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice's definition of a serious adverse event (ICH‐GCP 1997), that is any untoward medical occurrence that resulted in death, is life‐threatening, requires hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. We considered all other adverse events as non‐serious.Quality of life. We defined quality of life as the extent to which a person's usual or expected physical, emotional, and social well‐being has been affected by the intervention (Cella 1995). Since trial authors are likely to use different instruments to measure quality of life, we planned to use the recommendation for choosing a statistical method to enhance interpretability to evaluate quality of life estimates in this meta‐analysis (Thorlund 2011b).
primary outcome:
Prosthetic mesh placement for the prevention of parastomal herniation
Overall incidence of Parastomal Hernias at a minimum of 6 months' postsurgery, with or without placement of a parastomal mesh support at the time of the index operation
primary outcome:
Glucocorticosteroids for infants with biliary atresia following Kasai portoenterostomy
All‐cause mortalitySerious adverse events, defined as any untoward medical occurrence that was life threatening, resulted in death, or was persistent or led to significant disability, or any medical event that had jeopardised the patient, or required intervention to prevent it (ICH‐GCP 1997). All other adverse events (that is, any medical occurrence not necessarily having a causal relationship with the treatment, but that did, however, cause a dose reduction or discontinuation of the treatment) were considered as non‐serious.Health‐related quality of life
primary outcome:
Withdrawal of immunosuppressant or biologic therapy for patients with quiescent Crohn's disease
The primary outcome was the proportion of patients who relapsed (as defined by the included studies) following discontinuation of immunosuppressant or biologic drugs, administered alone or in combination.
primary outcome:
Interventions for paracetamol (acetaminophen) overdose
Mortality: all‐cause and liver‐related.Liver transplantation.
primary outcome:
Feed thickener for infants up to six months of age with gastro‐oesophageal reflux
1. Symptoms or signs of GOR including:a) regurgitation, posseting, or vomiting,b) failure to thrive.We noted each symptom or sign as a dichotomous and separate outcome. We note that no sign or symptom is sensitive or specific to GOR.We noted number of episodes per day of regurgitation, posseting, or vomiting separately as continuous outcomes. We used change in measurement from baseline to the end of the intervention period in preference to final measurement value. In trials where multiple measurements were performed, we used only the measurement at the end of the intervention period.2. Measures of gastric and oesophageal acidity based on pH monitoring. We included pH probe study parameters of reflux index (i.e. percentage of time pH < 4) as quantitative discrete variables.
primary outcome:
Laparoscopic versus open resection for sigmoid diverticulitis
Mean length of hospital stay (days)
primary outcome:
Proton pump inhibitors for functional dyspepsia
Global symptoms of dyspepsia (using the most stringent definition of not symptom‐free) or epigastric pain/discomfort if global symptoms were not reported.
primary outcome:
Closure methods of the appendix stump for complications during laparoscopic appendectomy
Total complications (defined as all complications, i.e. sum of intraoperative and postoperative complications)Intraoperative complications:Intraoperative bleedingIntraoperative rupture of appendixIntraoperative organ injury/faecal soilingAccess‐related visceral injuryPostoperative complications:Surgical site infection (superficial)Deep infectionPostoperative bleedingParalytic ileusPurulent peritonitis
primary outcome:
Mesalamine (5‐ASA) for the prevention of recurrent diverticulitis
Rate of recurrence of diverticulitis
primary outcome:
Needle syringe programmes and opioid substitution therapy for preventing hepatitis C transmission in people who inject drugs
Our review focused on one primary outcome, HCV incidence, and no other secondary outcomes. We excluded studies that did not report on HCV incidence since they would have addressed questions outside the main review question. Incidence of HCV infection in PWID was measured via repeat testing such as detection of HCV RNA positive among HCV antibody negative results or antibody avidity. We also included studies if they reported a minimum of two HCV seroconversions (HCV antibody negative to HCV antibody positive) in participants from tests conducted at different time points.
primary outcome:
Direct‐acting antivirals for chronic hepatitis C
Hepatitis C‐related morbidity (diagnosed after randomisation) or all‐cause mortality. Hepatitis C‐related morbidity was defined as the proportion of participants with either: cirrhosis, ascites, variceal bleeding, hepato‐renal syndrome, hepatic encephalopathy, or hepatocellular carcinoma.Proportion of participants with one or more serious adverse events. We defined a serious adverse event as any untoward medical occurrence that resulted in death, was life‐threatening, required hospitalisation or prolongation of existing hospitalisation, or resulted in persistent or significant disability or incapacity (ICH‐GCP 1997).Health‐related quality of life (any valid continuous outcome scale used by the trialists).
primary outcome:
Ursodeoxycholic acid for cystic fibrosis‐related liver disease
Change of hepatocellular enzymes from outside the normal range on at least one occasion to within the normal range of the method statedAbnormally large livers reduced to within normal limits, as measured by ultrasoundNeed for liver transplantation
primary outcome:
Flumazenil versus placebo or no intervention for people with cirrhosis and hepatic encephalopathy
All cause‐mortality.Hepatic encephalopathy (number of participants without improved manifestations).Serious adverse events defined as any untoward medical occurrence that resulted in death, was life‐threatening, required hospitalisation, led to prolongation of the existing hospitalisation, or resulted in persistent or significant disability (ICH‐GCP 1997). We analysed serious adverse events as a composite outcome (Gluud 2017).
primary outcome:
Terlipressin versus placebo or no intervention for people with cirrhosis and hepatorenal syndrome
Mortality.Hepatorenal syndrome (number of participants who did not achieve reversal of hepatorenal syndrome).Serious adverse events: any untoward medical occurrence that led to death, was life‐threatening, or required hospitalisation or prolongation of hospitalisation (ICH‐GCP 1997). We analysed serious adverse events as a composite outcome (Gluud 2017).
primary outcome:
Management for intussusception in children
Number of children with successfully reduced intussusception, characterised by radiologically confirmed passage of contrast media into the ileumNumber of children with radiologically confirmed or clinically suspected (intraoperative or endoscopic) bowel perforation(s)Number of children with recurrent intussusception (recurrence is defined as occurring after a minimum of 12 hours following a successful reduction)
primary outcome:
Oral calorie supplements for cystic fibrosis
Change in weight or height or body mass index (BMI) or z score or other indices of nutrition or growth
primary outcome:
Antimicrobial agents for preventing peritonitis in peritoneal dialysis patients
PeritonitisExit‐site infection/tunnel infectionCatheter removal/catheter replacement
primary outcome:
Maintenance immunosuppression for adults undergoing liver transplantation: a network meta‐analysis
Mortality at maximal follow‐up (time to death; maximal follow‐up).Graft loss at maximal follow‐up (time to graft loss or death).Adverse events (within three months after cessation of intervention). Depending on the availability of data, we attempted to classify adverse events as serious or non‐serious. We defined a non‐serious adverse event as any untoward medical occurrence not necessarily having a causal relationship with the intervention but resulting in a dose reduction or discontinuation of intervention (any time after commencement of intervention) (ICH‐GCP 1997). We defined a serious adverse event as any event that would increase mortality; is life‐threatening; requires hospitalisation; results in persistent or significant disability; is a congenital anomaly/birth defect; or any important medical event that might jeopardise the person or require intervention to prevent it. We used the definition used by study authors for non‐serious and serious adverse events:serious adverse events;any adverse events;renal impairment (requiring renal support or renal transplantation);chronic kidney disease (as defined by authors).Health‐related quality of life as defined in the included trials using a validated scale such as the EQ‐5D or 36‐Item Short Form Health Survey (SF‐36) (EuroQol 2014; Ware 2014):short term (up to one year);medium term (one to five years);long term (beyond five years).
primary outcome:
Deprescribing versus continuation of chronic proton pump inhibitor use in adults
Lack of symptom control: reported as harms due to no change, recurring, worsening, new onset of at least one upper GI symptom (heartburn, regurgitation, dyspepsia, epigastric pain, nausea, bloating, belching).Drug burden/PPI use.Cost/resource use.
primary outcome:
Antibiotic treatment for Clostridium difficile‐associated diarrhoea in adults
The following outcomes were sought:Sustained symptomatic cure: An initial resolution of the diarrhoea and no evidence of recurrence of diarrhoea due to CDI.Bacteriologic cure: Conversion from a stool positive for any CDI assay to negative and no recurrence of CDI.No specific minimum time limit was set for either of these determinations of recurrence.Death.Drug‐related adverse events (DRAE) of the antibiotic treatments.Cost of each of the major antibiotics.
primary outcome:
Hepatitis B immunoglobulin during pregnancy for prevention of mother‐to‐child transmission of hepatitis B virus
All‐cause mortality or other serious adverse events of the newborn. A serious adverse event, defined according to the International Conference on Harmonisation (ICH) Guidelines (ICH‐GCP 1997), was any untoward medical occurrence that resulted in death, was life threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability or incapacity, or was a congenital anomaly/birth defect.All‐cause mortality or other serious adverse events of the mothers.Serological signs of hepatitis B infection of the newborn. These were reported as newborns with HBsAg‐positive laboratory result; newborns with HBeAg‐positive laboratory result; newborns with HBV‐DNA‐positive laboratory result; and newborns with antibodies to hepatitis B core antigen.
primary outcome:
Mesh fixation with glue versus suture for chronic pain and recurrence in Lichtenstein inguinal hernioplasty
Chronic pain: pain persisting beyond three months postoperatively.Hernia recurrence: clinically or radiologically diagnosed. We will use any time point reported by the authors, as there is no standard and widely accepted method to differentiate between recurrence and a new hernia that can be prespecified.
primary outcome:
Polymer‐based oral rehydration solution for treating acute watery diarrhoea
Total stool output (g/kg) during the first 24 hours after randomization.Total stool output (g/kg) from randomization to cessation of diarrhoea.Duration of diarrhoea (hours) from randomization until cessation of diarrhoea.
primary outcome:
Anti‐IL‐12/23p40 antibodies for induction of remission in Crohn's disease
The primary outcome measure was the proportion of patients who failed to enter clinical remission, as defined by the original studies (e.g. a Crohn's Disease Activity Index (CDAI) score of < 150)). An intention‐to‐treat analysis was used.
primary outcome:
Methods to decrease blood loss during liver resection: a network meta‐analysis
Mortality.Peri‐operative (30‐day mortality or postoperative mortality). We used in‐hospital mortality as defined in the included trials.Long‐term (at longest follow‐up).Adverse events. We defined an adverse event as any untoward medical occurrence not necessarily having a causal relationship with the treatment but resulting in a dose reduction or discontinuation of treatment (ICH‐GCP 1997). We considered a serious adverse event to be any event that would increase mortality; was life‐threatening; required inpatient hospitalisation; resulted in persistent or significant disability; might have jeopardised the person; or required intervention to prevent it. Serious adverse events correspond approximately to grade III or above of the Clavien‐Dindo classification ‐ the only validated system for classifying postoperative complications (Dindo 2004; Clavien 2009;Table 5). In cases where the authors did not classify the severity of adverse events, we followed the criteria provided in Table 5 to classify the severity. We analysed the following information.Proportion of participants experiencing serious adverse events.Number of serious adverse events.Proportion of participants experiencing adverse events.Number of adverse events.Quality of life as defined in the included trials.Short‐term (30 days, three months).Long‐term (longest follow‐up).
primary outcome:
Heated insufflation with or without humidification for laparoscopic abdominal surgery
Change in intra‐operative core temperature preferably measured via the tympanic membrane, nasopharynx, oesophagus, bladder or rectum (Cork 1983).
primary outcome:
Oral 5‐aminosalicylic acid for maintenance of medically‐induced remission in Crohn's disease
The primary outcome measure was the occurrence of clinical or endoscopic relapse as defined by the primary studies. Secondary endpoints included time to relapse, adverse events, withdrawals due to adverse events and serious adverse events.
primary outcome:
Internal dressings for healing perianal abscess cavities
We have included studies that report one or more of the outcomes below.
primary outcome:
Osmotic and stimulant laxatives for the management of childhood constipation
The primary outcome measure was the frequency of defecation (number of stools per week).
primary outcome:
Anti‐tuberculous therapy for maintenance of remission in Crohn's disease
The primary outcome was the proportion of patients who relapsed as defined by the included studies (e.g. Crohn's disease activity index (CDAI) > 150)).
primary outcome:
Epidural local anaesthetics versus opioid‐based analgesic regimens for postoperative gastrointestinal paralysis, vomiting and pain after abdominal surgery
Postoperative paralytic ileus as measured by first passage of flatus.
primary outcome:
Aminosalicylates for induction of remission or response in Crohn's disease
The primary outcome measure was a well defined clinical endpoint of induction of remission or response to treatment. Secondary outcomes included mean Crohn's disease activity index (CDAI) scores, adverse events, serious adverse events and withdrawal due to adverse events.
primary outcome:
Sequential versus standard triple first‐line therapy for Helicobacter pylori eradication
We considered reported efficacy, defined as the eradication/cure proportion/rate, to be the primary outcome.Trials were included if they reported the number of participants with H. pylori eradication. If percentages were reported rather than numbers, then we derived the proportion of participants cured from the intention‐to‐treat (ITT) randomised sample size for each treatment arm.Trials were eligible if H. pylori eradication was confirmed using RUT or histology of an endoscopic biopsy sample, or by a UBT or a monoclonal stool antigen test, at least four weeks after completion of treatment.We excluded trials in which assessments were by serology test alone or by culture alone.
primary outcome:
Booster dose vaccination for preventing hepatitis B
Any sign or symptom of hepatitis B virus (HBV) infection, either acute or chronic hepatitis B infection, or the development of hepatitis B core antibody (anti‐HBc) in serum or plasma.Cirrhosis or hepatocellular carcinoma caused or associated with chronic hepatitis B infection, and mortality due to hepatitis B infection.Proportion of participants that developed serious adverse events after the booster dose injection, including fever, headache, malaise, irritability, rash, nausea, myalgia, arthralgia, or any other systemic adverse events (WHO 2001). Serious adverse events were defined as any outward medical occurrence that was life‐threatening, resulted in death, or persistent or significant disability, or any medical event, which may have jeopardised the patient, or required intervention to prevent it (ICH‐GCP 1997).
primary outcome:
Fasting for haemostasis in children with gastrointestinal bleeding
all‐cause case fatality rateincidence of re‐bleedingincidence of continued bleeding
primary outcome:
Pancreatic duct guidewire placement for biliary cannulation for the prevention of post‐endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis
The primary outcome measure was post‐ERCP pancreatitis (PEP), as defined by the primary studies. If the same study provided different definitions of PEP, we used the consensus definition for assessment of this outcome (Cotton 1991).The primary outcome was PEP. We expected dichotomous data for PEP, which we expressed as risk ratio (RR) with 95% confidence interval (CI). We defined RR as the risk of PEP with the PGW technique compared to persistent attempts with conventional cannulation techniques (contrast‐ or guidewire‐assisted cannulation) or other advanced techniques (for example precut sphincterotomy, pancreatic duct stent placement, endoscopic ultrasound rendezvous).
primary outcome:
Non‐absorbable disaccharides versus placebo/no intervention and lactulose versus lactitol for the prevention and treatment of hepatic encephalopathy in people with cirrhosis
Mortality.Hepatic encephalopathy. We based our assessment of hepatic encephalopathy on the definitions in included RCTs.Serious adverse events defined as any untoward medical occurrence that led to death, was life threatening, or required hospitalisation or prolongation of hospitalisation (ICH‐GCP 2007). We analysed serious adverse events as a composite outcome (Gluud 2015).
primary outcome:
Eradication therapy for peptic ulcer disease in Helicobacter pylori‐positive people
Proportion of peptic ulcers healed after initial therapy.Proportion of participants with peptic ulcer that remained free from relapse following successful ulcer healing.Proportion of participants that achieved complete relief from symptoms of peptic ulcer.
primary outcome:
Interventions for necrotising pancreatitis
Mortality.Short‐term mortality (in‐hospital mortality or mortality within six months).Long‐term mortality (at maximal follow‐up).Serious adverse events (within six months). We accepted the following definitions of serious adverse events.International Conference on Harmonisation ‐ Good Clinical Practice (ICH‐GCP) guideline (ICH‐GCP 1996): serious adverse events defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity.Other variations of ICH‐GCP classifications such as Food and Drug Administration (FDA) classification (FDA 2006), Medicines and Healthcare products Regulatory Agency (MHRA) classification (MHRA 2013).Infected pancreatic necrosis (cytology or culture confirmed).Organ failure (however defined by authors).Health‐related quality of life (using any validated scale).Short‐term (four weeks to three months).Medium‐term (greater than three months to one year).Long‐term (greater than one year).
primary outcome:
Perioperative dexmedetomidine for acute pain after abdominal surgery in adults
The opioid‐sparing effect of dexmedetomidine ‐ measured by amount of 'rescue' opioid, administered via any route, at three, six, 12 and 24 hours after end of surgery.The analgesic efficacy of dexmedetomidine ‐ measured at rest and on movement, as defined by study authors, by visual analogue scale (VAS) 0 to 100 mm, where 0 mm corresponds to no pain and 100 mm corresponds to worst imaginable pain. Use of a VAS scale 0 to 10 cm was converted to VAS 0 to 100 mm. We regarded any use of verbal or numerical rating scales (NRSs) from 0 to 10 as convertible with VAS. We selected the measuring time points of three, six, 12 and 24 hours after end of surgery.
primary outcome:
Interventions for dysphagia in long‐term, progressive muscle disease
The stabilisation of previously documented progressive weight loss not attributable to any other cause, weight gain of at least 5 kg in adults or increase in weight to at least the 10th centile in children, maintained for at least six months following the intervention.
primary outcome:
Glutamine for induction of remission in Crohn's disease
The primary outcome was clinical or endoscopic remission as defined by the primary studies. Secondary outcomes included clinical response as defined by the primary studies, improvement in intestinal permeability, quality of life, growth in children, and adverse events.
primary outcome:
Periodontal therapy as adjunctive treatment for gastric Helicobacter pylori infection
Eradication rate of gastric H. pylori.We assessed eradication at four weeks after therapy. We considered eradication successful in case of a negative result for that UBT, serology, RUT, or histology or culture of an endoscopic antral/body biopsy specimen.