anurajms/meta_analysis huggingface dataset:
primary outcome:
Anti‐adhesion therapy following operative hysteroscopy for treatment of female subfertility
Live birth.Live birth was defined as the delivery of at least one live foetus after 20 weeks of gestation that resulted in at least one live baby; we counted the delivery of singleton, twin or multiple pregnancies as one live birth.Ongoing pregnancy, defined as pregnancy surpassing the first trimester or 12 weeks of pregnancy and was used as a surrogate outcome for live birth.Term delivery, defined as birth at any time between three weeks before and two weeks after the expected date of delivery (37 to 42 weeks of gestation) was also used as a surrogate outcome for live birth.
primary outcome:
Oral medications including clomiphene citrate or aromatase inhibitors with gonadotropins for controlled ovarian stimulation in women undergoing in vitro fertilisation
Live‐birth rate per woman randomized, defined as delivery of a live foetus after 20 completed weeks of gestationOvarian hyperstimulation syndrome (OHSS) for the general IVF population only
primary outcome:
Pain relief for outpatient hysteroscopy
Pain scorePain score during the procedure (validated pain scale)Pain score after the procedure (validated pain scale): a) within the first 30 minutes of the procedure b) more than 30 minutes after the procedure
primary outcome:
Cycle regimens for frozen‐thawed embryo transfer
1. Live birth rate per woman, defined as delivery of a live fetus after 24 completed weeks of gestational age.2. Miscarriage rate per woman.
primary outcome:
Recombinant luteinizing hormone (rLH) and recombinant follicle stimulating hormone (rFSH) for ovarian stimulation in IVF/ICSI cycles
1. Live birth rate; defined as delivery of a live foetus after 20 completed weeks of gestation.2. Primary safety outcome: incidence of ovarian hyperstimulation syndrome (mild, moderate, or severe).
primary outcome:
Coasting (withholding gonadotrophins) for preventing ovarian hyperstimulation syndrome
incidence of moderate or severe OHSS, as defined in the included studies;live birth rate.
primary outcome:
Septum resection for women of reproductive age with a septate uterus
Effectiveness: live birth rate, defined as the birth of a live baby after 24 completed weeks of gestationSafety: surgical complications following septum resection: uterine perforation, fluid overload, endometritis, and repeat surgery
primary outcome:
Clomiphene and other antioestrogens for ovulation induction in polycystic ovarian syndrome
Live birth/ongoing pregnancy rate (per woman).Miscarriage rate (per woman), where miscarriage was defined as the involuntary loss of a pregnancy before 20 weeks gestation.
primary outcome:
Day three versus day two embryo transfer following in vitro fertilization or intracytoplasmic sperm injection
• Live birth rate ‐ live birth per woman
• Ongoing pregnancy rate ‐ pregnancy continuing beyond 12 weeks' gestation per woman
primary outcome:
Human chorionic gonadotrophin priming for fertility treatment with in vitro maturation
Live birth rate per woman randomised (live birth was defined as a live birth after 24 completed weeks gestation)Miscarriage rate per woman randomised
primary outcome:
Aspirin for in vitro fertilisation
Live birth rate (defined as delivery of a live foetus after 20 completed weeks of gestational age) per woman or couple randomised.
primary outcome:
Volume expanders for the prevention of ovarian hyperstimulation syndrome
1. Moderate or severe OHSS (as determined by established clinical criteria, such as Humaidan 2010; Rizk 1999; Navot 1992; Golan 1989; Schenker 1978; WHO 1973)
primary outcome:
Progestin‐only contraceptives: effects on weight
The primary outcome was the continuous outcome of mean change in body weight, BMI, or body composition (e.g. percent body fat) over time with the use of progestin‐only contraceptives. If mean change in body weight or BMI was not available per study arm, we examined the dichotomous outcome of loss or gain of a specified amount of weight in each study arm.For high quality evidence, the study had to include mean change in body weight, BMI, or body composition. The time frame had to be 12 months.We used measured weight and not self‐reported weight. We excluded studies that did not report change data but only reported mean weight or BMI at pre‐ and post‐treatment.
primary outcome:
Hormonal contraceptives for contraception in overweight or obese women
The main outcome was pregnancy. We examined BMI or weight as a potential predictor of contraceptive effectiveness. For consideration, studies must have assessed pregnancies.We did not include ovulation, since it is not a useful surrogate endpoint for pregnancy. A valid surrogate marker captures the effect of the treatment on the true outcome (Grimes 2010).
primary outcome:
Gonadotrophin‐releasing hormone antagonists for assisted reproductive technology
Live birth rate (LBR) per woman randomised, defined as delivery of a live fetus after 20 completed weeks of gestation.Ovarian hyperstimulation syndrome (OHSS) rate per woman randomised, with grading as detected by clinical grading of OHSS, laboratory investigations (e.g. haematocrit, haemoglobin, renal function) or imaging techniques (ovarian and abdominal ultrasound, chest X‐ray), or both: all women, moderate or severe OHSS.
primary outcome:
Recombinant versus urinary human chorionic gonadotrophin for final oocyte maturation triggering in IVF and ICSI cycles
Live birth rate per woman randomised (defined as the number of deliveries that resulted in a live birth). If studies did not report live birth rates, then we used the ongoing pregnancy rate per woman or per couple (defined as pregnancy beyond 12 weeks gestation)Incidence of ovarian hyperstimulation syndrome (OHSS) per woman randomised, or cancelled cycles as a result of high perceived risk of OHSS (as detected by clinical grading of OHSS, laboratory investigations such as haematocrit, haemoglobin, renal function, and imaging techniques such as ovarian and abdominal ultrasound or chest X‐ray)
primary outcome:
Psychological and educational interventions for subfertile men and women
We have presented an overview of the primary outcomes anxiety and depression in forest plots in Analysis 1.1 to Analysis 1.6 for summary purposes. To be consistent with the protocol, studies are stratified according to length of treatment (short duration, long duration, unknown duration) and therapy setting (individual, couple, group therapy). For reasons described in the methods, we have also presented results stratified by type of control (usual care, attentional control). We did not perform stratification by personnel because type of personnel appeared to coincide with the type of intervention (psychological personnel provided a psychological intervention and medical personnel provided an educational intervention).We have presented an overview of the primary outcomes anxiety and depression in forest plots in Analysis 2.1 to Analysis 2.6 for summary purposes. To be consistent with the protocol, studies are stratified by each of length of treatment (short duration, long duration, unknown duration) and therapy setting (individual, couple, group therapy). For reasons described in the methods, we have also presented results stratified by type of control (usual care, attentional control). We did not perform stratification by personnel because type of personnel appeared to coincide with the type of intervention (psychological personnel provided a psychological intervention and medical personnel provided an educational intervention).
primary outcome:
Brief educational strategies for improving contraception use in young people
Contraception use (at least three months after the intervention began)use of a new methodimproved use or continuation of a methodPregnancy (at least six months after the intervention began)
primary outcome:
Ultrasound versus 'clinical touch' for catheter guidance during embryo transfer in women
The primary outcome measure for this systematic review was live births/ongoing pregnancies per woman randomised. We defined live birth as a live fetus born after 20 completed weeks. We defined ongoing pregnancies as those continuing for at least 12 weeks after embryo transfer.
primary outcome:
Assisted reproductive technologies for male subfertility
Live birth rate, defined as delivery of a live foetus after 20 completed weeks of gestational age, per couple.Incidence of OHSS per couple.
primary outcome:
Culture media for human pre‐implantation embryos in assisted reproductive technology cycles
Live birth or ongoing pregnancy.
primary outcome:
Gonadotrophin‐releasing hormone agonist protocols for pituitary suppression in assisted reproduction
Number of live births or ongoing pregnancies per woman/couple randomised.
primary outcome:
Lactational amenorrhoea method for family planning
Primary outcome measuresPregnancy and 'menstruation' (after being amenorrheic) were primary outcome measures. The studies had to present the number of women per specific month who experienced 'menstruation' or who became pregnant. Pregnancy had to be confirmed by physical examination or by a pregnancy test.We considered several definitions of being amenorrheic. The original definition used in the Bellagio Consensus Statement ignores any bleeding before the 56th day postpartum (Family Health 1988). However, in 1995 in Bellagio menstruation was defined as the occurrence, after the 56th day postpartum, of "2 consecutive days of bleeding/spotting, or the women's perception that her menses have returned, whichever of the two comes first" (Kennedy 1996). Labbok used definitions of two continuous days of vaginal bleeding that the woman considered similar to a menstrual period or heavier, or two continuous days of spotting and one day of bleeding, or three continuous days of spotting (Labbok 1997). The World Health Organization used four different definitions to mark the end of amenorrhoea (WHO 1999a).In this systematic review we used three different definitions:
primary outcome:
Pain relief in hysterosalpingography
Pain score during the procedure (validated pain scale)Pain score after the procedure (validated pain scale)Within the first 30 minutes after the procedureMore than 30 minutes after the procedure
primary outcome:
Luteal phase support for assisted reproduction cycles
1. Live birth rate (LBR) or ongoing pregnancy per woman ('live birth' defined as the delivery of one or more living infants; 'ongoing pregnancy' defined as a pregnancy beyond 12 weeks' gestation).
primary outcome:
Ovarian cyst aspiration prior to in vitro fertilization treatment for subfertility
Live birth rate per woman, defined as the delivery of one or more living fetuses after 20 completed weeks of gestationAdverse events, such as infection, bleeding, injury to surrounding structures, need for further surgery including oophorectomy, anaesthetic complications and costs of both the procedure itself and any subsequent complications
primary outcome:
Gonadotropin‐releasing hormone agonist versus HCG for oocyte triggering in antagonist‐assisted reproductive technology
Live birth rate (LBR) per woman randomised: live birth defined as delivery of a live fetus after 20 completed weeks of gestation.Incidence of OHSS per woman randomised (mild, moderate or severe): detected by clinical, laboratory or imaging grading of OHSS.
primary outcome:
Vitrification versus slow freezing for women undergoing oocyte cryopreservation
1. Live birth per woman undergoing an embryo transfer derived from thawed oocytes, defined as delivery of a live fetus after at least 24 completed weeks of gestation
primary outcome:
Surgical intervention versus expectant management for endometrial polyps in subfertile women
1. Live birth rates2. Reported surgical complications (e.g. infection; bleeding; injury to uterus, bowel, bladder, blood vessels)
primary outcome:
Steroidal contraceptives: effect on carbohydrate metabolism in women without diabetes mellitus
Outcomes included glucose and insulin levels, which were reported as fasting value or response to a glucose or insulin tolerance test. In the case of a tolerance test, the measure was usually the area under the curve (AUC) during the three‐hour test. If available, data were included on the number of women with glucose outside the normal range. Other outcome measures included glycosylated hemoglobin (HbA1c), which reflects longer‐term glucose control. In addition, C‐peptide levels reflect the amount of insulin produced by the body.
primary outcome:
Oral contraceptives for functional ovarian cysts
Resolution of cysts at follow up, as judged by ultrasound or physical examination, was the principal outcome. Time to resolution was reported in some trials.
primary outcome:
Combination contraceptives: effects on weight
Trials must have collected data on change in body weight to be eligible for inclusion. Weight change could have been measured as either the change in the study group's mean weight or as the proportion of the study group who lost or gained more than a specified amount.
primary outcome:
Heparin for assisted reproduction
Live birth rate per woman. Number of live births divided by the number of randomised women (live birth is defined as delivery of one or more live infants).Adverse effects of heparin e.g. any bleeding, bruising, heparin‐induced thrombocytopenia (HIT), anaphylaxis and any other unexpected side effects.
primary outcome:
Exercise as adjunctive therapy for systemic lupus erythematosus
Studies were not excluded on the basis of outcome reporting.
primary outcome:
Adjunctive therapies in addition to land‐based exercise therapy for osteoarthritis of the hip or knee
Participant‐reported pain.Participant physical function.
primary outcome:
Stem cell transplantation for systemic sclerosis
We based outcome measures on the suggested outcome measures from the Outcome Measures in Rheumatology (OMERACT) initiative (Distler 2008; Khanna 2009; Merkel 2003); and from discussion with experts.
primary outcome:
Dietary supplements for chronic gout
OMERACT (Outcome Measures in Rheumatology) is an international network, interested in outcome measurement across the spectrum of rheumatology intervention studies (Tugwell 1993). At the OMERACT‐9 conference, the core and discretionary domains for outcome measurement in clinical studies of acute and chronic gout were defined (Schumacher 2009). For acute gout, core domains included pain, joint swelling, joint tenderness, participant global assessment, and activity limitations. For chronic gout, core domains included sUA, acute gout attacks, tophus burden, health‐related quality of life, activity limitation, pain, and participant global assessment.We included only outcome core domains for chronic gout, plus safety in this review. For the purpose of this review, if feasible, we grouped trials into those of short‐term (less than three months), medium‐term (three to 12 months) and long‐term (greater than 12 months) duration.
primary outcome:
Autologous blood and platelet‐rich plasma injection therapy for lateral elbow pain
There is considerable variation in the outcome measures reported in clinical trials of interventions for pain. However, there is general agreement that outcome measures of greatest importance to patients should be considered, and people with lateral elbow pain typically suffer from pain as suggested by the name of the condition.The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has published consensus recommendations for determining clinically important changes in outcome measures in clinical trials of interventions for chronic pain (Dworkin 2008). Reductions in pain intensity ≥ 30% and ≥ 50% reflect moderate and substantial clinically important differences, respectively, and it is recommended that the proportion of patients that respond with these degrees of pain relief should be reported.NICE has recommended that trials of tendinopathy include functional and quality of life outcomes with minimum follow‐up of one year (NICE 2013).
primary outcome:
Colchicine for acute gout
There is considerable variation in the outcome measures reported in trials of interventions for acute gout (Araújo 2015). For the purpose of this review, we aimed to include outcome measures that are considered to be of greatest importance to patients with acute gout and the clinicians who care for them.OMERACT (Outcome Measures in Rheumatology Clinical Trials) has endorsed outcome measures to be used in evaluation of resolution of acute flares (Dalbeth 2014; Singh 2014). Intense pain is the hallmark of an acute gout flare and hence pain has been endorsed by OMERACT as an outcome measure; it has also been a consistent outcome measure in trials involving acute gout flares, although the instruments and time intervals used to measure pain vary (Araújo 2015). The additional outcome measures endorsed by OMERACT include joint swelling, joint tenderness and patient global assessment (Singh 2014).
primary outcome:
Tramadol for osteoarthritis
We included studies that reported the effect of tramadol on pain intensity, physical function and adverse events of tramadol. If a trial reported many time points, we recorded the last time point.
primary outcome:
Down‐titration and discontinuation strategies of tumour necrosis factor–blocking agents for rheumatoid arthritis in patients with low disease activity
Mean disease activity: All three studies included in this comparison reported on this outcome, with 357 participants (Bejerano 2016 (OPTIBIO) (abstract only); Fautrel 2016 (STRASS); van Herwaarden 2015 (DRESS)). Anti‐TNF disease activity–guided dose tapering may result in little or no difference in mean disease activity score (MD 0.25, 95% CI −0.17 to 0.67). Analysis 3.1Proportion persistent remission: Of the three studies included in this comparison (365 participants), one study with 180 participants reported on this outcome (van Herwaarden 2015 (DRESS)). Anti‐TNF disease activity–guided dose tapering resulted in little or no difference in the proportion of participants with persistent remission (DAS28 < 2.6) after 18 months (RR 0.89, 95% CI 0.75 to 1.06). Analysis 3.2Proportion of participants that switched to another biologic due to persistent loss of response (refractory to re‐instalment of the tapered anti‐TNF in the intervention group): Of the three studies included in this comparison (365 participants), two studies, Fautrel 2016 (STRASS) and van Herwaarden 2015 (DRESS), with 317 participants reported on this outcome. Anti‐TNF disease activity–guided dose tapering may result in little or no difference in the proportion of participants that switch to another biologic after 18 months (RR 0.62, 95% CI 0.25 to 1.54). Analysis 3.3Proportion of participants with minimal radiographic progression: Of the three studies included in this comparison (365 participants), two studies, Fautrel 2016 (STRASS) and van Herwaarden 2015 (DRESS), with 312 participants reported on this outcome. Although Fautrel 2016 (STRASS) used a cut‐off value of 1 point and van Herwaarden 2015 (DRESS) a cut‐off value of 0.5 point mSvdH score, data could be pooled. Anti‐TNF disease activity–guided dose tapering may slightly increase the proportion of participants with minimal radiographic progression (mSvdH > 0.5 or > 1.0) after 18 months (RR 1.45, 95% CI 0.77 to 2.73). Analysis 3.4Function: Of the three studies included in this comparison (365 participants), one study with 123 participants reported on this outcome (Fautrel 2016 (STRASS)). IAnti‐TNF disease activity–guided dose tapering probably leads to a slight deterioration in function after 18 months (MD 0.20, 95% CI −0.02 to 0.42). Analysis 3.5Number of serious adverse events: Of the three studies included in this comparison (365 participants), two studies, Fautrel 2016 (STRASS) and van Herwaarden 2015 (DRESS), reported on this outcome, with 137 and 180 participants, respectively. Due to the very low certainty of the evidence and imprecision, it is uncertain whether anti‐TNF disease activity‐guided dose tapering influences the number of serious adverse events after 18 months. Analysis 3.6Withdrawals due to adverse events: None of the three included studies provided data on this outcome.
primary outcome:
Methotrexate for psoriatic arthritis
Major and minor outcomes were informed by the Outcome Measures in Rheumatology 8th Conference core domains for PsA (Gladman 2007). The final two minor outcomes were added 'post hoc' to allow meaningful inclusion of studies that preceded the inception of other outcomes.
primary outcome:
Exercise for rheumatoid arthritis of the hand
We included trials where the assessment had at least one measure covering the following constructs. For outcomes assessing benefits and harms, we extracted and defined outcomes at three time point categories: short term (less than 3 months), medium term (3 to 11 months), and long term (12 months or beyond), and at the end of the trial for adverse events. For trials that reported outcomes at multiple time points, we selected the longest follow‐up (Deeks 2011).
primary outcome:
Exercise interventions and patient beliefs for people with hip, knee or hip and knee osteoarthritis: a mixed methods review
The major outcomes of interest were pain, physical function, self‐efficacy, depression, anxiety, quality of life and adverse effects of exercise.For quantitative synthesis, randomised controlled trials (RCT) had to have measured either pain or function and at least one psychosocial outcome (self‐efficacy, depression, anxiety, quality of life). Quality of life related to a range of factors, which the World Health Organization (WHO) identifies as "physical health, psychological state, level of independence, social relationships, personal belief and their relationship to salient features of their environment" (WHO 1997).The qualitative synthesis studies had to have reported people's opinions and experiences of exercise (e.g. their views and beliefs about the utility of exercise in the management of chronic pain, or barriers to adherence to exercise advice).
primary outcome:
Surgery for trigger finger
We considered for inclusion studies that included at least one of the following outcome measures.
primary outcome:
Back Schools for chronic non‐specific low back pain
Pain (e.g. measured by visual analogue scale or numerical rating scale)Disability (e.g. measured by Oswestry Disability Index (ODI) or Roland‐Morris Disability Questionnaire (RMDQ))
primary outcome:
Celecoxib for rheumatoid arthritis
ACR20/30 (Felson 1995). ACR20/30 was defined as a 20% and 30% improvement, respectively, in the number of tender and swollen joints and a corresponding improvement in at least three of the following items: observer evaluation of overall disease activity, the individual's evaluation of overall disease activity, the individual's evaluation of pain, a score of physical disability, or improvements in blood acute‐phase responses (Felson 1998).Pain.Self‐reported function as measured on the Health Assessment Questionnaire (HAQ) Disability Index (Gardiner 1993) or modified HAQ. HAQ scores range from 0 to 3, with 3 indicating a worse health state; therefore negative change indicates health improvement.Cardiovascular events (myocardial infarction, stroke).Incidence of gastroduodenal ulcer ≥ 3 mm.Short‐term serious adverse events from trials.Long‐term adverse events or toxicity from observational studies.
primary outcome:
Celecoxib for osteoarthritis
Studies were included if any accepted method to assess outcomes of benefit was used because there is already an extensive body of literature available on adverse events and celecoxib.For benefit, the major outcomes were: (1) pain, (2) function and (3) quality of life, as currently recommended for OA trials (Altman 1996; Pham 2004). For harms, the major outcomes were the number of participants: (4) who withdrew because of adverse events; (5) experiencing any serious adverse events; (6) presenting clinically with perforations, ulcer or bleed; and (7) experiencing cardiovascular outcomes. The timing was the end of the RCT unless specified otherwise.
primary outcome:
Exercise for hand osteoarthritis
Published recommendations for a core set of outcome measures for phase 3 clinical trials in knee, hip and hand OA include physical function and pain and patient global assessment of disease impact, and for studies of one year or longer, joint imaging (Bellamy 1997; Maheu 2006). Recently, the Outcome Measures in Rheumatology (OMERACT) Hand OA Working Group published preliminary core sets for clinical trials of symptom and structure modification and for observational studies in hand OA (Kloppenburg 2015).Major outcomesThe main outcomes for benefit were hand pain and hand function, in addition to radiographic joint structure changes, quality of life and finger joint stiffness, according to proposed outcomes for OA intervention reviews recommended by the Cochrane Musculoskeletal Group (CMSG). When available, we included information on the numbers of intervention‐related adverse events (i.e. sustained joint inflammation or increased pain) and the numbers of participants withdrawn from studies because of adverse events.Listed are the seven main outcomes included in the 'Summary of findings' tables.Minor outcomesMinor outcomes included the following.Timing of outcome assessmentThe main time point of interest was the first assessment after completion of the exercise programme. When data for longer‐term follow‐up were available, we extracted such data and categorised them by short‐term (< 6 months), medium‐term (six to 12 months) and long‐term (> 12 months) follow‐up.
primary outcome:
Stretch for the treatment and prevention of contractures
Outcomes included measures of impairment, activity limitations and participation restrictions. To be included in this review studies needed to have measured joint mobility, the primary focus of this review. This focus is justified because joint mobility is the key outcome used to deem the success of stretch interventions. Without a change in joint mobility there is no known mechanism for changes in activity limitations or participation restrictions.
primary outcome:
Surgical options for lumbar spinal stenosis
pain intensity;physical function or disability status;quality of life; andrecovery.
primary outcome:
Bioabsorbable versus metallic interference screws for graft fixation in anterior cruciate ligament reconstruction
Subjectively‐rated knee function: wherever possible, we used validated, patient‐reported function measures for the knee including those designed specifically for knee ligament injuries (the International Knee Documentation Committee ‐ IKDC) (Irrgang 2001), the ACL Quality of Life outcome measure (Mohtadi 1998), and the Lysholm score (Lysholm 1982)); and those designed for the knee in general (Knee Injury and Osteoarthritis Outcome Score ‐ KOOS)Failure of treatment and adverse events: implant breakage, screw migration, graft loss or failure, need for revision surgery, superficial and deep infections, and symptomatic foreign body reactions. We also included arthrofibrosis, cyclops lesion and adhesions that required further surgeryActivity level: measured by Tegner activity level and return to sports, including time taken to resume sports
primary outcome:
Electrotherapy modalities for rotator cuff disease
We did not consider outcomes as part of the eligibility criteria.
primary outcome:
Biologic interventions for fatigue in rheumatoid arthritis
The primary outcomes for this systematic review were change in self reported fatigue scores using validated measures and adverse events. We defined validated measures as instruments used to assess fatigue in clinical trials or observational studies as detailed in a recent review (Hewlett 2007). We included adverse events in the initial protocol; however, since then a separate Cochrane review has assessed adverse events associated with anti‐TNF and non‐anti‐TNF biologic treatments, so we have referred to this publication rather than conducting a separate analysis (Singh 2011).
primary outcome:
Non‐steroidal anti‐inflammatory drugs for chronic low back pain
pain intensity (e.g. visual analogue scale (VAS) or Numerical Rating Scale (NRS))global measure (e.g. overall improvement, proportion of participants that recover)back pain‐specific functional status (e.g. Roland Disability Questionnaire, Oswestry Scale)return to work (e.g. return to work status, number of days off work)adverse events (proportion of participants experiencing adverse events)
primary outcome:
Surgery for Dupuytren's contracture of the fingers
The validity and reliability of any outcome measures commonly used in Dupuytren's disease have not been well studied. We have listed below outcomes expected to be reported by study investigators. We selected hand function as the top primary outcome, as this represents an important patient‐centred measure. In contrast, angular measurements are objective, surgeon‐centred measurements.
primary outcome:
High‐intensity versus low‐intensity physical activity or exercise in people with hip or knee osteoarthritis
We used data from the outcomes assessment conducted immediately on completion of the intervention program. When data were available, we analyzed the effects at mid‐term (6 to 12 months) and long‐term (after 12 months) follow‐up.
primary outcome:
Radiofrequency denervation for chronic low back pain
Primary outcomes considered were pain, functional status (disorder‐specific and generic), global improvement, health‐related quality of life and complications.
primary outcome:
Intra‐articular corticosteroid for knee osteoarthritis
global pain;pain on walking;Western Ontario and McMaster Universities Arthritis Index (WOMAC) osteoarthritis index pain subscore;composite pain scores other than WOMAC;pain on activities other than walking;rest pain or pain during the night;WOMAC global algofunctional score;Lequesne osteoarthritis index global score;other algofunctional scale;participant's global assessment;physician's global assessment.global disability score;walking disability;WOMAC disability subscore;composite disability scores other than WOMAC;disability other than walking;WOMAC global scale;Lequesne osteoarthritis index global score;other algofunctional scale;participant's global assessment;physician's global assessment
primary outcome:
Non‐steroidal anti‐inflammatory drugs (NSAIDs) for axial spondyloarthritis (ankylosing spondylitis and non‐radiographic axial spondyloarthritis)
BenefitsPain (as assessed by the mean change in pain score on a visual analogue scale (VAS) or numerical rating scale (NRS)); back pain was used but if not present in a study, overall pain was used;HarmsTotal number of withdrawals due to adverse events;Disease activity as assessed by the mean improvement in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (Garrett 1994);Physical function as assessed by the mean improvement in Bath Ankylosing Spondylitis Functional Index (BASFI) (Calin 1994);Spinal mobility as assessed by the mean improvement in the Bath Ankylosing Spondylitis Metrology Index (BASMI) (Jenkinson 1994);Radiographic progression as assessed by the mean change in the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) (Wanders 2004);Number of serious adverse events.
primary outcome:
TNF‐alpha inhibitors for ankylosing spondylitis
The primary and secondary outcomes defined in the protocol and listed in the Differences between protocol and review section were chosen in 2005 when the protocol for this review was published (Zochling 2005). Since then, the Cochrane Collaboration has developed Summary of Findings tables which require choosing a maximum of seven major outcomes for presentation in the table. The Assessment of SpondyloArthritis international Society (formerly ASsessment in Ankylosing Spondylitis) (ASAS) Working Group) (http://www.asas‐group.org) has developed core sets of standardized outcome measures for use in clinical practice and trial settings. This work has been undertaken in conjunction with the OMERACT (Outcome Measures in Rheumatology, www.omeract.org) initiative which aims to establish standardized, validated outcome measures for use in clinical trials in the field of rheumatology. Following discussion with experts from ASAS, the following outcomes were chosen to be the major outcomes for this review:The criteria for an ASAS40 response is: at least a 40% improvement with a minimum of 20 units (0 to 100 scale) improvement compared with baseline in at least three of four domains (spinal pain, function (BASFI), inflammation as measured by the mean of intensity and duration of morning stiffness in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), and patient global assessment), and with no worsening in the fourth domain. Partial remission is defined as a value of less than 2 on a 0 to 10 scale in each of the four domains as described above for the ASAS40.
primary outcome:
Mobile bearing vs fixed bearing prostheses for posterior cruciate retaining total knee arthroplasty for postoperative functional status in patients with osteoarthritis and rheumatoid arthritis
The outcome measurement in the studies had to be a functional or a clinical measure with a minimal follow‐up of six months.
primary outcome:
Rituximab for rheumatoid arthritis
The primary efficacy outcomes included in this review were the response of RA to treatment with rituximab as defined by the ACR (Felson 1995), the World Health Organization (WHO), and the International League of Associations for Rheumatology (ILAR) core set of disease activity measures (Furst 1994).
primary outcome:
Exercise for osteoarthritis of the knee
In accordance with international consensus regarding the core set of outcome measures for phase III clinical trials in OA (Bellamy 1997), each randomised clinical trial had to include assessment of at least one of the following.These outcomes were assessed at three time points: immediately at the end of treatment (post‐treatment), two to six months after cessation of monitored study treatment and longer than six months after cessation of monitored study treatment. Each included study was required to report measurement of outcomes in at least one of these time periods.We also noted the number of participants withdrawing from the study before post‐treatment assessment and the number of participants experiencing adverse events, if provided.
primary outcome:
Sulfasalazine for ankylosing spondylitis
Pain (visual analogue scale or numerical rating scale).Bath ankylosing spondylitis disease activity index (BASDAI).Bath ankylosing spondylitis function index (BASFI).Bath ankylosing spondylitis metrology index (BASMI).Radiographic progression.Total number of withdrawals due to adverse events.Serious adverse events.
primary outcome:
Uricosuric medications for chronic gout
We based the outcome measures on the 2010 Outcome Measures in Rheumatology Meeting (OMERACT 10) gout report recommended outcome domains for chronic gout (Schumacher 2009; Singh 2011).
primary outcome:
Electrotherapy modalities for adhesive capsulitis (frozen shoulder)
We did not consider outcomes as part of the eligibility criteria.Adhesive capsulitis is characterised by pain and global loss of range of movement. Given the mechanism by which electrotherapy modalities work, we determined reduction of pain to be the main aim of treatment. Considerable variation has been noted in the outcome measures reported in clinical trials of interventions for pain. However, there is general agreement that the outcome measures of greatest importance to patients should be considered. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has published consensus recommendations for determining clinically important changes in outcome measures in clinical trials of interventions for chronic pain (Dworkin 2008). Reductions in pain intensity of ≥ 30% and ≥ 50% reflect moderate and substantial clinically important differences, respectively, and it is recommended that the proportion of patients who respond with these degrees of pain relief should be reported.Continuous outcome measures used in pain trials, such as mean change on a 100 mm visual analogue scale (VAS), may not follow a Gaussian distribution. Often a bimodal distribution is seen instead, where patients tend to report either very good or very poor pain relief (Moore 2010). This creates difficulty in interpreting the meaning of average changes in continuous pain measures. For this reason, a dichotomous outcome measure (the proportion of participants reporting ≥ 30% pain relief) may or may not also be clinically relevant for trials of adhesive capsulitis.The original review determined that no trials had included a dichotomous outcome for pain, in keeping with the recognition that it has been the practice in most trials of interventions for chronic pain to report continuous measures only. We therefore also included a continuous measure of overall pain.A global rating of treatment success such as the Patient Global Impression of Change scale (PGIC), which provides an outcome measure that integrates pain relief, changes in function and adverse events into a single, interpretable measure, is also recommended by IMMPACT and was included as a main outcome measure (Dworkin 2008).
primary outcome:
Interleukin‐1 inhibitors for acute gout
OMERACT (Outcome Measures in Rheumatology) is an international network interested in outcome measures across the spectrum of rheumatology intervention studies. The OMERACT 9 conference defined a recommended core and discretionary set of domains for outcome measures in clinical studies of acute and chronic gout (Schumacher 2009). For acute gout, core domains included pain, joint swelling, joint tenderness, participant global assessment and activity limitations. Safety outcomes were not included in the final core domains, even though they were proposed in the preliminary set (Schumacher 2005).Intense pain is the hallmark of an acute gout attack; it has also been a consistent outcome measure in clinical trials involving acute gouty arthritis, although the instruments and time intervals used to measure pain are varied (Grainger 2009). It is recognised that interpreting the meaning of average changes in continuous measures of pain (e.g. mean change on a 100‐mm visual analogue scale (VAS)), is hampered where participants report either very good or very poor pain relief (Moore 2010). For trials of interventions for chronic pain, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has recommended that dichotomous pain outcomes (the proportion of participants improved by 30% or greater and 50% or greater) be reported (Dworkin 2008), although no recommendations have yet been published for acute pain. Therefore, we elected to include a dichotomous pain outcome measure (the proportion of participants reporting 30% or greater pain relief) as the primary benefit measure in this review. However, as most trials of interventions for acute gout report continuous measures, we also included mean change in pain score as a secondary benefit measure.
primary outcome:
Manual therapy and exercise for adhesive capsulitis (frozen shoulder)
We did not consider outcomes as part of the eligibility criteria.Considerable variation has been noted in the outcome measures reported in clinical trials of interventions for pain. However, it is generally agreed that outcome measures of greatest importance to patients should be considered.The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has published consensus recommendations for determining clinically important changes in outcome measures in clinical trials of interventions for chronic pain (Dworkin 2008). Reductions in pain intensity of ≥ 30% and ≥ 50% reflect moderate and substantial clinically important differences, respectively, and it is recommended that the proportion of participants who respond with these degrees of pain relief should be reported.Continuous outcome measures in pain trials (such as mean change on a 100‐mm visual analogue scale (VAS)) may not follow a Gaussian distribution. Often, a bimodal distribution is seen instead, in which participants tend to report very good or very poor pain relief (Moore 2010). This creates difficulty in interpreting the meaning of average changes in continuous pain measures. For this reason, a dichotomous outcome measure (the proportion of participants reporting ≥ 30% pain relief) may be clinically relevant for trials of adhesive capsulitis.The original review determined that no trials had included a dichotomous outcome for pain, in keeping with the recognition that it has been the practice in most trials of interventions for chronic pain to report continuous measures only. We therefore also included a continuous measure of overall pain.A global rating of treatment success, such as the Patient Global Impression of Change scale (PGIC), which provides an outcome measure that integrates pain relief, changes in function and adverse events into a single, interpretable measure, is also recommended by IMMPACT and was included as a main outcome measure (Dworkin 2008).
primary outcome:
Diacerein for osteoarthritis
Seven important outcomes were selected for reporting.
primary outcome:
Self‐management education programmes for osteoarthritis
No studies were excluded on the basis of outcomes reported. All immediate (up to six weeks from the start of the intervention), intermediate (up to and including one year after the intervention) and longer‐term outcomes (longer than one year after the intervention) are reported.
primary outcome:
Rehabilitation following surgery for lumbar spinal stenosis
The primary outcome measure considered by this review was functional status as measured by a back‐specific scale (Roland Morris Disability Questionnaire (RMDQ) or Oswestry Disability Index (ODI)).
primary outcome:
Lifestyle interventions for acute gout
We included the outcome measures for use in clinical trials of acute gout that have been proposed by the Outcome Measures in Rheumatology Clinical Trials (OMERACT) network (Grainger 2009).
primary outcome:
Non‐pharmacological interventions for fatigue in rheumatoid arthritis
The primary outcomes for this systematic review were self‐reported fatigue scores using validated measures, and adverse events. Adverse events were recorded as reported in the studies on the basis of the Cochrane definition of "harms associated with healthcare interventions". Distinctions were made between an adverse event (unfavourable outcome occurring during, but not necessarily caused by, the intervention), an adverse effect (reasonable possibility of causal relation) and a side effect (any unintended effect) (Cochrane Handbook for Systematic Reviews of Interventions sections 14.1.2 and 14.3.1) (Higgins 2011).
primary outcome:
Erythropoiesis‐stimulating agents for anemia in rheumatoid arthritis
Health‐related quality of life: “the degree to which persons perceive themselves able to function physically, emotionally, mentally, and socially” (Porta 2008). To be included in the review, trials had to use standardized scales (e.g. European League Against Rheumatism (EULAR), Disease Activity Score (DAS28), Health Assessment Questionnaire Disability Index (HAQ‐DI), Routine Assessment of Patient Index Data 3 (RAPID3), Clinical Disease Activity Index (CDAI)).Fatigue (Kirwan 2007).Safety:
primary outcome:
Treatments for alopecia areata: a network meta‐analysis
1. Short‐term hair regrowth ≥ 75%: the proportion of participants with clinically significant hair regrowth between 12 and 26 weeks of follow‐up, as rated by the participant or medical practitioner (where both types of rating were available, we used medical assessment). We deemed ≥ 75% regrowth of the affected area to constitute significant hair regrowth.2. Incidence of serious adverse events (SAE): mortality, hospitalisation, surgical intervention, temporary or permanent sequelae, and serious infections. We considered the number of participants with at least one serious adverse event.
primary outcome:
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta‐analysis
The proportion of participants who achieved clear or almost clear skin, that is, at least PASI 90 at induction phase.The proportion of participants with serious adverse events (SAEs) at induction phase. We used the definition of severe adverse events from the International Conference of Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, which includes death, life‐threatening events, initial or prolonged hospitalisation, and adverse events requiring intervention to prevent permanent impairment or damage.
primary outcome:
Negative pressure wound therapy for treating pressure ulcers
The proportion of ulcers healed (frequency of complete healing)Time to complete wound healing: we recorded whether this had been correctly analysed using censored data and with adjustment for prognostic covariates such as baseline size.Adverse events (generic): reported data were extracted on adverse events classed as 'serious adverse events' and 'non‐serious adverse events' where a clear methodology for the collection of adverse event data was provided. This methodology needed to make it clear whether events were reported at the participant level or, where multiple events/persons were reported, that an appropriate adjustment had been made for data clustering. Individual types of adverse events such as pain or infection that require specific assessment were not extracted under this outcome ‐ rather this is the assessment of any event classed as adverse by the patient and or health professional during the trial.
primary outcome:
Silicone gel sheeting for treating keloid scars
Severity of keloid scars, assessed by health professionals or other staff, measured using a validated scale. These included the Vancouver Scar Scale (VSS), the Manchester Scar Scale or the Patient and Observer Scar Assessment Scale (POSAS) (Draaijers 2004; Idriss 2009). Two versions of the VSS have been widely adopted for the assessment of scars: original VSS and modified VSS (Fearmonti 2010). The latter incorporated subjective parameters including pain (evaluated by Visual Analog Scale (VAS)) and pruritus into the original VSS.Severity of keloid scars, assessed by participant using a validated scale; for example, POSAS (Draaijers 2004; Idriss 2009).Adverse events (measured using a survey, questionnaire or data capture process), where a clear methodology for the collection of adverse event data was provided. This included making it clear whether (i) events were reported at the participant level or if multiple events per person were reported; and (ii) that an appropriate adjustment was made for data clustering. Where available, we extracted data on all serious and all non‐serious adverse events. We did not extract individual types of adverse events, such as pain or infection, which require specific assessment under this outcome; rather, we used the assessment of any event classed as adverse by the participant or health professional, or both, during the trial.
primary outcome:
Dressings and topical agents for the management of open wounds after surgical treatment for sacrococcygeal pilonidal sinus
Time to wound healing (time in days until wound has healed), assessed clinically by researchers or a clinical team, using a validated wound healing score. Where possible, we aimed to present time‐to‐event data as hazard ratios (HRs) with 95% confidence intervals (CIs). Mean time‐to‐healing data were only included where we were certain that all wounds had healed.Proportion of wounds healed (number of wounds healed/not healed) during short (30‐day), medium (6‐month) and long‐term (1‐year) follow‐up, assessed clinically by researchers or a clinical team
primary outcome:
Pressure redistributing static chairs for preventing pressure 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 would have contacted the study authors where possible to establish whether an outcome of interest here was measured but not reported.We intended to report outcome measures at the latest time point available (assumed to be length of follow‐up if not specified) and the time point specified in the methods as being of primary interest (if this was different from the latest time point available). For all outcomes we would have classed assessment of outcome measures as: