anurajms/meta_analysis huggingface dataset:
primary outcome:
Treatment for recurrent vulvovaginal candidiasis (thrush)
Number of clinical recurrences per participant per year (recurrence defined as clinical features and positive culture or microscopy)Proportion of participants with at least one clinical recurrence during the treatment and follow‐up periodAdverse events
primary outcome:
Surgical interventions for the management of chronic pelvic pain in women
Effectiveness of treatment: pain: measured by validated pain scales, for example, visual analogue pain scale (VAS) scores, the McGill Pain Questionnaire (MPQ), a pain improvement rating scale, general pain experience and a gynaecological pain questionnaire. If studies used multiple pain measures, we preferred VAS, followed by the MPQ and then any other validated pain scale. Most studies were expected to have assessed these outcomes at three, six and beyond six months to exclude placebo effect. Outcomes that were reported out of this three, six, 12 months period were combined with the nearest quarter if appropriate. Where trials expressed their outcomes as recommended by Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT), which are benchmarked in terms of pain intensity, physical function, emotional functioning and global rating of improvement (Dworkin 2008), these were to be analysed accordingly.Adverse events (e.g. intraoperative and postoperative surgical complications).
primary outcome:
Levonorgestrel‐releasing intrauterine device (LNG‐IUD) for symptomatic endometriosis following surgery
1) Overall painEffectiveness of treatment: pain measured by validated pain scales, for example, visual analogue pain scale (VAS) scores, the McGill Pain Questionnaire (MPQ), a pain improvement rating scale, general pain experience, and a gynaecological pain questionnaire. All time‐points were measured, with a preference of outcomes reported at 12 months post‐randomisation.
primary outcome:
Ultrasound‐guided transvaginal ovarian needle drilling for clomiphene‐resistant polycystic ovarian syndrome in subfertile women
Live birth rate (per woman): the percentage of women who gave birth to a living baby.Incidence of surgical complications (per woman, bleeding or infection).
primary outcome:
Pentoxifylline for the treatment of endometriosis‐associated pain and infertility  
Live birth rate: delivery of a live foetus after 22 completed weeks of gestational age.Overall pain (as measured by a visual analogue scale (VAS) of pain, other validated scales, or dichotomous outcomes).
primary outcome:
Medical abortion offered in pharmacy versus clinic‐based settings
Complete abortion, defined as completion of abortion within 30 days of taking the first medication, and not requiring surgical intervention for completionBlood transfusion within 30 days of medical abortionUterine or systemic infection within 30 days of medical abortion
primary outcome:
Selective oestrogen receptor modulators (SERMs) for endometriosis
Relief of pelvic pain, assessed on a visual analogue scale (VAS) (0 (no pain) to 10 (worst pain imaginable)), or subjective improvement (cured, better, same, or worse)Pelvic pain as reported in studiesPainful symptoms defined as dysmenorrhoea, dyspareunia, or pelvic or lower abdominal painAdverse events resulting from treatment (hot flushes, endometrial cancer, vaginal bleeding, thrombosis, or other adverse events) during or after treatment
primary outcome:
Dopamine agonists for preventing ovarian hyperstimulation syndrome
Incidence of moderate or severe OHSS (as determined by study authors) per woman randomised.Live birth rate (as a result of an embryo transferred in a fresh cycle using fertilised oocytes from the same menstrual cycle) defined as a live infant born after 20 weeks' gestation per woman randomised.
primary outcome:
Metformin treatment before and during IVF or ICSI in women with polycystic ovary syndrome
Live birth rate (per woman), defined as a baby born after 20 weeks of gestation.Incidence of OHSS (per woman), defined according to the definition of reporting authors.
primary outcome:
Progestogens or progestogen‐releasing intrauterine systems for uterine fibroids (other than preoperative medical therapy)
1. Uterine fibroid‐related symptoms, abnormal uterine bleeding (blood loss), measured by objective disease measures, such as haemoglobin, haematocrit, or ferritin levels; pain assessed subjectively by the individual or with a visual analogue scale (VAS)2. Fibroid size1.1 Uterine fibroid‐related symptoms: no data were available.1.2 Fibroid size: we were unable to estimate the mean differences between groups, because the fibroids were removed in the women with a hysterectomy.
primary outcome:
Pessaries (mechanical devices) for managing pelvic organ prolapse in women
Women's perceived resolution of prolapse symptomsWomen's perceived improvement in prolapse symptoms (assessed using validated symptom questionnaires such as the Pelvic Floor Disability Index (PFDI) (Barber 2001; Barber 2005), or the Pelvic Organ Symptom Score (POP‐SS) (Hagen 2009))
primary outcome:
Pre‐ and postsurgical medical therapy for endometriosis surgery
Painful symptoms of endometriosis (including pelvic pain, dyspareunia, dysmenorrhea, pain recurrence) as measured by a visual analogue scale (VAS) of pain, other validated scales, or dichotomous outcomes.Recurrence of disease as evidenced by EEC (Endoscopic Endometriosis Classification), rAFS (revised American Fertility Society), or rASRM scores at second‐look laparoscopy.
primary outcome:
Laparoscopic surgery for endometriosis
Overall pain measured by a continuous measure, for example, visual analogue scale (VAS).Live birth defined as the complete expulsion or extraction from a woman of a product of fertilisation, after 20 completed weeks of gestational age; which, after such separation, breathed or showed any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord had been cut or the placenta was attached. A birth weight of 350 g or more was used if gestational age was unknown (accounting for singleton, twin and higher multiple pregnancies).
primary outcome:
Surgical treatment for tubal disease in women due to undergo in vitro fertilisation
LBR per woman randomised, defined as the delivery of a live fetus after 22 completed weeks of gestational age (Zegers‐Hochschild 2017)Surgical complication rate per woman randomised, e.g. intraoperative bleeding or vasomotor instability, infection, need for repeat surgery or overall complications as reported by trialists
primary outcome:
Tubal flushing for subfertility
Primary effectiveness outcome: live birth or ongoing pregnancy per woman. Ongoing pregnancy was only used when live birth was not reported.Primary safety outcome: intravasation.
primary outcome:
Levonorgestrel‐releasing intrauterine system for endometrial hyperplasia
Regression of EH on subsequent biopsy or final histology. Regression included 'complete regression' defined as a return of EH to normal, often with associated secretory glandular changes and atrophy; and 'partial regression' defined as a change from atypical hyperplasia to EH without atypia. If provided, we planned to present regression as an overall pooled hazard ratio (HR). In addition, we planned to present pooled HRs at different time points. The regression rate includes the complete and partial regression rates. We planned to consult a statistician to see if we could perform a time‐to‐event analysis using the data available. If these data were unavailable, then we presented regression as a dichotomous outcome based on length of follow‐up (short = less than six months; medium = six months up to one year; long = one year or more).Adverse effects associated with LNG‐IUS device (such as pelvic inflammatory disease, device expulsion, and uterine perforation).
primary outcome:
Oral versus intra‐vaginal imidazole and triazole anti‐fungal treatment of uncomplicated vulvovaginal candidiasis (thrush)
Clinical cure of the infection, both short (5 to 15 days) and long term (2 to 12 weeks), as measured by the disappearance of symptoms either on examination or by self‐report
primary outcome:
Interventions for non‐tubal ectopic pregnancy
Treatment success (success after initial treatment) ‐ defined as an uneventful decline of serum hCG to undetectable levels by the initial treatment. Also defined as 'a steady decline in serum β‐hCG to normal levels by the initial treatment, coupled with a lack of major complications (including massive acute bleeding, recurrence of active bleeding, incomplete abortion and hysterectomy)'.Complications (need for further treatment for reasons such as heavy bleeding, recurrence of active bleeding, pelvic infection, organ injury, hysterectomy, or death).
primary outcome:
Progestogen‐releasing intrauterine systems for heavy menstrual bleeding
Objective assessment of menstrual blood loss (mL; measured by the alkaline haematin method) (Hallberg 1966) or semi‐objective assessment by the pictorial bleeding assessment chart score (PBAC) (Higham 1990)measurement of menstrual blood loss at end of study compared between groupsmeasurement of change from baseline compared between groupprevalence of amenorrhoea, hypomenorrhoea or eumenorrhoea after treatmentSubjective assessment of menstrual blood losswomen's perception of improvement recorded in a reproducible format.
primary outcome:
In‐bag manual versus uncontained power morcellation for laparoscopic myomectomy
Composite intraoperative complications included at least one of the following:accidental morcellation of the liver;conversion to laparotomy;endoscopic bag disruption;bowel injury;bleeding;accidental injury to any viscus or vessel.
primary outcome:
Self‐administered versus provider‐administered medical abortion
The primary outcome was successful abortion (effectiveness), defined as complete uterine evacuation without the need for surgical intervention.
primary outcome:
Traditional suburethral sling operations for urinary incontinence in women
Urinary incontinenceNumber of continent (dry) women in the short term (less than 12 months), medium term (one to five years), and long term (longer than five years) as defined by women's report, quantified measures, clinician's observations, or combined measures (as defined by trialists; Table 1)Number of women who have had repeat continence surgery
primary outcome:
Metformin for ovulation induction (excluding gonadotrophins) in women with polycystic ovary syndrome
1. Live birth rate, as defined by included studies2. Gastrointestinal side effects
primary outcome:
Laparoscopic colposuspension for urinary incontinence in women
Subjective outcome (women's perception of incontinence cure)Subjective cure of urinary incontinence within 18 months (short‐term)Subjective cure of urinary incontinence after 18 months and within five years (medium‐term)Subjective cure of urinary incontinence after five years (long‐term)
primary outcome:
Long‐term GnRH agonist therapy before in vitro fertilisation (IVF) for improving fertility outcomes in women with endometriosis
Live birth rate: delivery of a live foetus after 22 completed weeks of gestational ageComplication rate: adverse effects per woman (e.g. infection, ovarian hyperstimulation syndrome (OHSS), serious vasomotor instability, overall adverse effects)
primary outcome:
Exercise for dysmenorrhoea
Menstrual pain intensity, as a continuous variable measured preferably by VAS, NRS or other validated scales, such as McGill Pain Questionnaire (MPQ), or pain relief, measured as a dichotomous outcome (i.e. sufficient pain relief: yes or no)Adverse events, measured as rate of side effects overall and any injuries, such as muscle sprains or strains
primary outcome:
Non‐steroidal anti‐inflammatory drugs for heavy menstrual bleeding
MBL:objective assessment of blood loss, by the alkaline haematin method (mL/cycle) (Newton 1977);subjective assessment of blood loss by the pictorial chart method (score on PBAC chart) (Higham 1990), or patient perception (on questionnaire or survey instrument).Quality of life: women's perceived change in quality of life where it was recorded in a reproducible and validated format. This included improvement in symptoms of dysmenorrhoea, headache, diarrhoea, depression and other menstrually related symptoms.
primary outcome:
Interventions for treating recurrent stress urinary incontinence after failed minimally invasive synthetic midurethral tape surgery in women
Number of women whose incontinence was improved or cured (assessed by subjective report, urinary diary or validated incontinence questionnaires in the short‐term (less than 12 months) and longer‐term (more than 12 months))
primary outcome:
Cyclical progestogens for heavy menstrual bleeding
Menstrual blood lossObjective assessment of blood loss, either during the intervention or for up to one year of follow‐up after the intervention, measured by the alkaline haematin method (Hallberg 1964), or the pictorial blood assessment chart (Higham 1990)Subjective (woman's perception) assessment of blood loss, also measured either during the intervention or for up to one year of follow‐up after the intervention.Satisfaction: overall satisfaction with treatment.
primary outcome:
Antibiotic therapy for adults with neurosyphilis
Serological cure: defined as a decrease in the CSF Venereal Disease Research Laboratory test (VDRL) titre by two dilutions or reversion to non‐reactive within two years after completion of therapy for patients with definitive diagnosis of syphilis (Ali 2002; Nayak 2012). The CSF should be examined at the end of treatment to document a fall in cell count, and it should then be examined at six‐month intervals for two to three years. The leukocyte count should return to normal within one year of treatment (usually six months), and the protein level should return to normal within two years (Berger 2014).Clinical cure: defined as continued absence of signs or symptoms, or the serum RPR decreasing by four‐fold within two years of treatment (Bilgrami 2014)Adverse events: in general defined by the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice (ICH‐GCP 1997), as any untoward medical occurrence that at any dose 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. We considered all other adverse events as non‐serious (ICH‐GCP 1997). Within adverse events, we planned to describe reported outcomes, such as the Jarisch‐Herxheimer reaction, a common manifestation that is a transient immunological reaction characterised by constitutional symptoms such as fever, chills, headache, myalgias, and exacerbation of existing cutaneous lesions after the administration of β‐lactam antibiotics (Belum 2013). Also, we planned to describe other adverse events related to other antibiotic regimes administered, such as pill oesophagitis, photosensitivity, staining of teeth and bone in tetracycline administration, or fever, eosinophilia, and rashes in macrolides.
primary outcome:
Robot‐assisted surgery in gynaecology
Intraoperative complications including injury to the bladder, ureters, bowel, blood vessels, and nervesPostoperative complications including vascular (e.g. haemorrhage, deep vein thrombosis), wound (e.g. infection, dehiscence (wound breakdown)), gastrointestinal (e.g. bowel obstruction due to fibrous adhesions, paralytic ileus due to paralysis of intestinal muscles), incisional hernia (swelling caused by tissue poking through a surgical scar of a previous operation), neurological, respiratory (e.g. pneumonia, embolism (blood clot in a lung blood vessel)), and urinary complications (e.g. acute urinary retention)
primary outcome:
Lifestyle changes in women with polycystic ovary syndrome
To be measured at the end of intervention (endpoint or change).
primary outcome:
Combined hormonal contraceptives for heavy menstrual bleeding
Menstrual blood loss (MBL) was measured in different ways:treatment success (defined by authors of the included studies in terms of reduction in MBL);objectively assessed MBL (as measured by the alkaline haematin method in a laboratory);semi‐objectively assessed MBL (as measured by participants using the Pictorial Blood Assessment Chart (PBAC) or similar tool);subjectively assessed MBL (as measured by the participant's assessment of change in blood loss, if recorded on a valid scale).Participant satisfaction with treatment:Recent trials have focused more on women's experiences of the impact of treatments on their condition, rather than objective quantification of the amount of menstrual blood lost; this change of focus is supported by NICE (NICE 2018).
primary outcome:
Interventions to reduce shoulder pain following gynaecological laparoscopic procedures
Incidence (number of women experiencing STP within one week of surgery) or severity of shoulder pain (as measured by a visual analogue scale or dichotomous data within one week of surgery)Any adverse outcome that was likely to be directly attributable to the intervention utilised in the study
primary outcome:
Endometrial resection and ablation techniques for heavy menstrual bleeding
Assessment of most of the following outcomes was related to duration of follow‐up after the initial surgical procedure. Given that the aim of endometrial resection and ablation therapies is to induce permanent resolution of heavy menstrual bleeding, long‐term follow up of these treatments is needed to enable informed decision‐making between surgical options. Thus, for the following outcomes, evaluation at different time points is considered important for assessing effects over time: 6 months, 12 months, 2 years, 2 to 5 years, and longer than 5 years. When trials measured outcomes at two different follow‐up times within categories (e.g. at 3 years and at 5 years), they recorded longer follow‐up time only within the category of 2 to 5 years.
primary outcome:
Gonadotrophins for ovulation induction in women with polycystic ovary syndrome
1. Live birth rate per woman2. Multiple pregnancy per woman
primary outcome:
Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women
A subcommittee (Outcome Research in Women) of the Standardisation Committee of the International Continence Society suggested that research investigating the effect of therapeutic interventions for women with UI consider five outcome categories: the woman's observations (symptoms), quantification of symptoms (e.g. urine loss), the clinician's observations (anatomical and functional), quality of life (QoL) and socioeconomic measures (Lose 1998). One or more outcomes of interest from each domain were chosen for this review.The review authors also considered the International Classification of Function, Disability, and Health (ICF), a World Health Organization (WHO) initiative describing a conceptual framework for understanding health and the consequences of health conditions, when choosing the primary outcomes of interest for the review (WHO 2002). The framework describes the inter‐relationships between a woman's impairment of body functions and structures (e.g. pelvic floor muscle dysfunction), limitations in activity (e.g. avoiding running because of leakage), and restricted participation (e.g. avoiding social activities with friends and family because of leakage). Thus, the choice of condition‐specific QoL as one of the primary outcome measures reflects the importance the authors placed on the effects of incontinence on women's activities and participation, while a measure of impairment (e.g. of pelvic floor muscle function) was of secondary importance.
primary outcome:
Surgery for women with pelvic organ prolapse with or without stress urinary incontinence
Women's observations related to stress urinary incontinence (subjective outcome)Subjective postoperative stress urinary incontinence (de novo, persistent, cured, or improved SUI)
primary outcome:
Acupuncture and acupressure for premenstrual syndrome
Overall premenstrual symptoms, measured using a validated prospective screening tool (such as the Premenstrual Symptom Screening Tool (PSST) or Daily Record of Severity of Problems (DRST)), or by pre‐defined medical diagnostic criteria. These may be reported as an overall score or by separate sub scales such as mental and physical symptoms.Adverse events (all adverse events, specific adverse effects, withdrawals for adverse effects).
primary outcome:
Oral contraceptives for pain associated with endometriosis
Self‐reported pain (dysmenorrhoea) at the end of treatment (as defined by trialists).
primary outcome:
Surgery for women with posterior compartment prolapse
Ap is a point on the posterior vaginal wall 3 cm from the vaginal entrance, range ‐3 to +3 cmBp is approximately at the midpoint of the posterior vaginal wall, range ‐3 to +10 cmC describes the vaginal apex, ranging from ‐10 to non‐determined limitBa is approximately at the midpoint of the anterior vaginal wall, range ‐3 to +10 cm
primary outcome:
Insulin‐sensitising drugs (metformin, rosiglitazone, pioglitazone, D‐chiro‐inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility
1. Live birth rate, as defined by included studies2. Adverse events (gastrointestinal side effects)
primary outcome:
Preoperative medical therapy before surgery for uterine fibroids
Reduction in uterine volume or fibroid volume or both (as reported in the primary study).Preoperative haemoglobin.Preoperative bleeding (only if measured by a validated scale).Duration of surgery.Intraoperative blood loss.Frequency of blood transfusions.Postoperative morbidity (complications such as pyrexia, haematoma formation and incidence of postoperative adhesions).
primary outcome:
Anterior vaginal repair for urinary incontinence in women
We selected the outcome measures used in this review on the basis of their relevance to the clinical cure or improvement of incontinence. We regard the principal measures of effectiveness as the proportion of patients cured (continent or dry) following surgery, and the proportion of women whose condition is improved.We adopted the recommendations made by the Standardisation Committee of the International Continence Society for outcomes of research investigating the effect of therapeutic interventions for women with urinary incontinence. These outcome categories include: women's observation (symptoms), quantification of symptoms, the clinician's measures (anatomical and functional), and quality of life (Lose 1998).Trialists obtained data from history and questionnaire assessment, supplemented by the use of urinary diaries (including time and type of incontinence, frequency of micturition and voided volumes) and pad tests (quantitative estimate of weight of urine lost under standard conditions). This review also included other surgical measures and adverse events as outcome measures.
primary outcome:
Mid‐urethral sling operations for stress urinary incontinence in women
We selected the outcome measures used in this review on the basis of their relevance to the clinical cure or improvement of incontinence. We regarded the principal measures of effectiveness as being:
primary outcome:
Open retropubic colposuspension for urinary incontinence in women
This review adopted the recommendations by the Standardisation Committee of the International Continence Society on the outcome domains of research investigating the effect of therapeutic interventions for women with urinary incontinence. These outcome domains include: the woman's observation (symptoms), quantification of symptoms, the clinician's observations (anatomical and functional) and quality of life measures (Lose 1998).A crucial consideration in the choice of surgical intervention for benign disease is the attendant complications and consequences of the different procedures. Thus, this review included adverse events as outcome measures.
primary outcome:
Bladder neck needle suspension for urinary incontinence in women
We selected the outcome measures used in this review on the basis of their relevance to the subjective cure or improvement of incontinence. We regard the principal measures of effectiveness as the proportion of women cured (continent or dry) following surgery, and the proportion of women whose symptoms are improved.We adopted the recommendations made by the Standardisation Committee of the International Continence Society for outcomes of research investigating the effect of therapeutic interventions for women with urinary incontinence. These outcome categories include: women's observations (symptoms), quantification of symptoms, the clinician's observations (anatomical and functional) and quality of life.(Lose 1998).Relevant data could come from both history and questionnaire assessment, supplemented by the use of urinary diaries (including time and type of incontinence, frequency of micturition and voided volumes) and pad tests (quantitative estimate of weight of urine lost under standard conditions). This review also included other surgical information and adverse events as outcome measures.
primary outcome:
Progesterone receptor modulators for endometriosis
Pain measures: relief of endometriosis‐related pain at completion of therapy (decrease in pain scores, dysmenorrhoea, and dyspareunia) or other pain‐related outcomes, as reported by included studiesSide effects that occur during therapy (Including fatigue, nausea, anorexia, vomiting, weight loss, skin rash, amenorrhoea, endometrial hyperplasia, or hypoadrenalism)
primary outcome:
Antibiotic prophylaxis for elective hysterectomy
Infection: measured as the proportion of women who within eight weeks of surgery developed one of the following as defined by the study.Total postoperative infection.Abdominal wound infection (e.g. wound cellulitis, abscess, dehiscence).Pelvic infection (including vaginal cuff (vault) infection, pelvic inflammatory disease, pelvic abscess, infected haematoma).Urinary tract infection.Other serious infection or infectious complication, such as septicaemia, septic shock, distant infection (e.g. pneumonia).Postoperative fever of > 38° on at least two occasions more than four hours apart, excluding the day of surgery.Total adverse effects: morbidity (e.g. allergic reaction, diarrhoea, bacterial resistance, or as defined by the study) and mortality (infection‐related and all‐cause).
primary outcome:
Selective progesterone receptor modulators (SPRMs) for uterine fibroids
Change in fibroid‐related symptomsQuality of life assessed through standardised and validated measures. Examples of scales that measured health‐related quality of life for women with uterine fibroids (Williams 2006) included but were not limited to Uterine Fibroid Symptom Quality of Life Scale (UFS‐QoL) (Spies 2002), EuroQoL (Brooks 1996) and Short Form‐36 (SF‐36) (Ware 1992)Abnormal uterine bleeding measured objectively (e.g. haemoglobin levels, haematocrit, ferritin levels, alkaline haematin technique) or subjectively (e.g. pictorIal blood loss assessment)Pain and pelvic pressure measured subjectively (e.g. visual analogue scales, Likert scales)
primary outcome:
Washout policies in long‐term indwelling urinary catheterisation in adults
symptomatic urinary tract infections (UTIs) (as defined by the trialists);number of catheters used;length of time each catheter was in situ;catheter removal rates due to blockage or infection (definitions of blockage or infection were those used in the trial reports); andrates of asymptomatic bacteriuria.
primary outcome:
Surgery for tubal infertility
Cumulative livebirth rate per couple, where cumulative refers to time‐specific or cycle‐specific rates over a given time or number of cycles, and livebirth is defined as the delivery of one or more living infants after 20 completed weeks of gestational age.
primary outcome:
Nonsteroidal anti‐inflammatory drugs for pain in women with endometriosis
Pain relief (measured by visual analogue scale (VAS) or another validated scale, or as a dichotomous outcome, e.g. improved, not improved)Unintended effects of treatment (incidence and duration of total side effects and types of side effects)
primary outcome:
Long‐term hormone therapy for perimenopausal and postmenopausal women
We considered only studies reporting at least one of the following outcomes for inclusion in this review.We planned to restrict our focus to long‐term clinical outcomes and to not include menopausal symptom control and early‐onset side effects of HT as outcomes. HT for control of hot flushes is the topic of another systematic review (MacLennan 2004).We restricted inclusion to studies reporting one of our outcomes of interest because HT may be studied in the same population for different purposes, and we wished to ensure that we included only relevant studies.
primary outcome:
Surgery for women with anterior compartment prolapse
1. Awareness of prolapse: any affirmative response to questions related to awareness of prolapse or vaginal bulge, or any affirmative response to question three of the Pelvic Floor Distress Inventory (PFDI‐20): “Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?”2. Repeat surgery2.1 Repeat surgery for prolapse
2.2 Repeat surgery for stress urinary incontinence2.3 Repeat surgery for prolapse, stress urinary incontinence or mesh exposure (composite outcome), if relevant3. Recurrent anterior prolapse ‐ defined as any stage 2 or greater anterior vaginal prolapse (Pelvic Organ Prolapse Quantification (POPQ): prolapse 1 cm above or below the hymen)
primary outcome:
Interventions for preventing and treating incontinence‐associated dermatitis in adults
Number of participants with incontinence‐associated dermatitis (IAD) (residual, i.e. not healed)Number of participants with IAD (new) (only suitable to evaluate interventions for preventing IAD)Number of participants not satisfied with treatment
primary outcome:
Short‐term and long‐term effects of tibolone in postmenopausal women
Vasomotor symptoms measured as occurrences or through scales, defined as any otherwise unexplained sensation of flushing/sweating experienced by the participant. We included studies that measured hot flushes (with or without night sweats), provided that they measured hot flushes as an outcome of efficacy in populations including symptomatic womenUnscheduled bleeding (vaginal bleeding and/or spotting)Long‐term adverse events: endometrial cancer, breast cancer, venous thromboembolic events, cardiovascular events, cerebrovascular events, mortality from any cause
primary outcome:
Antibiotic treatment for the sexual partners of women with bacterial vaginosis
Recurrence of BV in women treated for BV (proportion of participants who were previously healthy following treatment for BV that developed a new episode of BV, according to Amsel's criteria or any other clinical criteria).Clinical improvement (according to Amsel's criteria or any other clinical criteria) in women treated for BV.Symptomatic improvement defined as the (self‐reported) improvement or disappearance of symptoms in women treated for BV.Serious adverse events of the intervention (hypersensitivity, pseudomembranous colitis or Stevens‐Johnson syndrome) in sexual partners of women treated for BV.
primary outcome:
Techniques for the interruption of tubal patency for female sterilisation
Failure rate (yearly incidence of unintended pregnancy) including extrauterine pregnancy.Operative mortality, major and minor morbidity (procedure‐related intestinal, vascular or bladder injuries, injury to other pelvic organ, blood transfusion, re‐admission).Failure of technical approach (e.g. clip converted to partial salpingectomy).operative time;changes in menstrual bleeding pattern;postoperative pain: pain scores or use of analgesics;postoperative complications: wound infection, reoperation, urinary tract infection, pelvic inflammatory disease;length of hospital stay;difficulty of procedure;persistent pain;women's satisfaction;surgeons' satisfaction.
primary outcome:
Bioidentical hormones for women with vasomotor symptoms
1. Frequency or intensity of vasomotor menopausal symptoms (hot flushes or night sweats) measured by any validated scale.
primary outcome:
Policies for replacing long‐term indwelling urinary catheters in adults
Participant satisfactionSymptomatic catheter‐associated urinary tract infection (CAUTI) as defined by trialists
primary outcome:
Antibiotics for treating septic abortion
Clinical improvement: defined as absence of fever, vaginal discharge, or pelvic pain, or improvement in ultrasound findings such as a reduction in the size of a tubo‐ovarian abscessMicrobiological cure: defined as disappearance of the micro‐organism from appropriate samples that were previously positiveDeath
primary outcome:
Chinese herbal medicine for menopausal symptoms
1. Improvement in frequency or severity of vasomotor symptoms (i.e. hot flushes, night sweats); evaluated either subjectively by participants, usually in daily diaries, or by any validated objective scoring system such as the Kupperman Index (Kupperman 1959).Methods used for evaluationA diary may be used to capture one or more of these three types of symptoms, hot flushes, night sweats or combination of hot flushes with night sweats. Either frequency or intensity of these symptoms may be measured. For frequency, the daily number of episodes is recorded as one point. As for severity, the total number of hot flush points is calculated by assigning a number to the severity of the hot flush (mild = I, moderate = 2, severe = 3, very severe = 4), and multiplied by the daily number of hot flushes experienced at that severity level. The resulting points may be summed to give a total daily score, and each daily score is averaged over 14 days, before consultation at baseline, after treatment, and at follow‐up (Sloan 2001).Kupperman Index (KI), also called Kupperman Index Score (KIS), is a questionnaire containing 11 menopausal‐related symptoms. Each symptom is rated from 0 ‐ 3 according to severity and symptoms (where 0 = no symptoms, and 3 = most severe), weighted, and the total sum is calculated with a possible maximum score of 51; higher scores indicate more severe symptoms.4.1 Vasomotor symptomsNo data were available for these primary outcomes: frequency of daily hot flushes; frequency of daily night sweats; severity of daily hot flushes; severity of daily night sweats; overall scores of daily hot flushes; overall scores of daily night sweats measured in a diary.
primary outcome:
Tricyclic and related drugs for nocturnal enuresis in children
mean number of wet nights per week (over the previous two weeks) at the end of treatment;number of participants failing to attain 14 consecutive dry nights by the end of treatment (which is equivalent to the number failing to achieve a complete response).
primary outcome:
Trocar types in laparoscopy
Major trocar‐related complications:mortality;conversion to laparotomy due to any trocar‐related adverse event;visceral injury (such as perforation of the intestines or stomach, or injury of the bladder or liver);vascular injury (such as perforation of the aorta, vena cava, iliac artery or iliac vein); andother injuries that required intensive care (IC) or intensive care unit (ICU) management or a subsequent surgical, endoscopic or radiological intervention.
primary outcome:
Urethral (indwelling or intermittent) or suprapubic routes for short‐term catheterisation in hospitalised adults
Number of participants with symptomatic urinary tract infection (UTI)
primary outcome:
Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women
The Standardisation Committee of the International Continence Society recommended that research looking into the effects of therapeutic interventions for women with urinary incontinence should take into consideration the following five outcome domains: patient's observations with respect to the symptoms of urinary incontinence, quantification of patient's symptoms, clinician's observations (functional and anatomical), patient's quality of life and socioeconomic implication of treatment (Lose 1998). For this review, one or more outcomes of interest were considered from each domain.
primary outcome:
Hormonal and intrauterine methods for contraception for women aged 25 years and younger
Contraceptive failure rate (pregnancy)
primary outcome:
Nonsteroidal anti‐inflammatory drugs for dysmenorrhoea
Pain relief ‐ measured with a visual analogue scale (VAS) (i.e. a measure of the amount of pain relief on a 1 to 10 scale) or as dichotomous data (i.e. at least moderate pain relief versus no pain relief).Adverse effects:Total number of adverse effects ('all')Gastrointestinal adverse effects (for example, nausea, vomiting)Neurological (nervous system) adverse effects (for example, headache, fatigue, dizziness).
primary outcome:
Interventions for pain with intrauterine device insertion
For this review, the primary outcomes were self‐reported pain scores related to IUC insertion: at tenaculum placement, during IUC insertion, and after IUC insertion (up to six hours). The trials may have had a different primary outcome, such as ease of insertion for the provider.
primary outcome:
Doctors or mid‐level providers for abortion
Failure/incomplete abortion, including continuing pregnancy at follow‐up and incomplete abortion.Complications of abortion, including haematometra, haemorrhage, endocervical injury, anaesthesia‐related reactions, uterine perforation, infection, injury to bowel, any complication requiring blood transfusion and any complication requiring hospitalisation.
primary outcome:
Immediate postpartum insertion of intrauterine device for contraception
Successful placement (insertion), subsequent expulsion, and method use at study assessment
primary outcome:
Invasive urodynamic studies for the management of lower urinary tract symptoms (LUTS) in men with voiding dysfunction
Number of men with continuing symptoms of voiding dysfunction after treatment following assessment with and without urodynamic studies at least one year after assessment.
primary outcome:
Preoperative ripening of the cervix before operative hysteroscopy
Effectiveness of cervical dilatation, defined as requirement for mechanical cervical dilatationIntraoperative complications of the procedure including:
primary outcome:
Add‐back therapy with GnRH analogues for uterine fibroids
Quality of life (QoL): defined by scores measured with any validated questionnaire. When multiple questionnaires were reported in studies, preference was given to the Short Form 36 (SF‐36), followed by any generic questionnaires and condition‐specific questionnaires.
primary outcome:
Transurethral radiofrequency collagen denaturation for the treatment of women with urinary incontinence
Measurement of outcomes assessed in this review was not a criterion for inclusion.
primary outcome:
Hormone therapy for preventing cardiovascular disease in post‐menopausal women
Death from any causeCardiovascular deathNon‐fatal myocardial infarctionStrokeAngina
primary outcome:
Nitric oxide donors for cervical ripening in first‐trimester surgical abortion
Complications (infection requiring antibiotic treatment, need for blood transfusion, any complication requiring an unintended operation, cervical injury, uterine perforation, maternal death, or serious maternal morbidity).Cervical changes: dilatation, length, and cervical resistance.
primary outcome:
Conservative management for postprostatectomy urinary incontinence
Number of men reporting urinary incontinence (UI) after 12 monthsQuality of life assessed using the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ‐UI‐SF) or (ICIQ‐SF)Number of men reporting adverse effects
primary outcome:
Imiquimod for anogenital warts in non‐immunocompromised adults
Complete regression after treatment (total clearance of the warts).                                 Partial regression after treatment (at least 50% clearance of the lesions).Dyspareunia after treatment.
primary outcome:
Minimally invasive surgical techniques versus open myomectomy for uterine fibroids
Postoperative pain, defined as the value on the subjectively assessed VAS pain scale at six, 24 and 48 hours postoperatively.In‐hospital adverse events: perioperative and postoperative morbidity (e.g. unscheduled return to theatre in perioperative period, laparoconversion, immediate hysterectomy, injury to pelvic organs, uterine rupture, postoperative fever (defined as body temperature of 38°C or higher at two consecutive measurements at least six hours apart postoperatively excluding the first 24 hours after surgery), thromboembolism, blood transfusion, haemoglobin or hematocrit drop and mortality).
primary outcome:
Types of indwelling urethral catheters for short‐term catheterisation in hospitalised adults
The primary outcome of interest was the number of people with symptomatic CAUTI.
primary outcome:
Non‐surgical interventions for the management of chronic pelvic pain
Effectiveness of treatment: pain measured by validated pain scales, for example, visual analogue pain scale (VAS) scores, the McGill Pain Questionnaire (MPQ), a pain improvement rating scale, general pain experience and a gynaecological pain questionnaire.
primary outcome:
Pre‐operative endometrial thinning agents before endometrial destruction for heavy menstrual bleeding
1. Number of complications during surgery.2. Proportion of women with amenorrhoea (no periods) postoperatively, at 12 months or less and at 24 months or longer.3. Proportion of women requiring or requesting further surgical therapy during follow‐up.
primary outcome:
Aromatase inhibitors for uterine fibroids
Relief of symptoms: menstrual loss, as measured by objective assessments (e.g. menstrual volume, duration of flow); presence or severity of dysmenorrhoea, as assessed subjectively by participant or with the use of a scale
primary outcome:
Paracervical local anaesthesia for cervical dilatation and uterine intervention
Pain during or after cervical dilatation and uterine intervention, measured as categorical or continuous data (for example on a visual analogue scale)Adverse effects (such as nausea, vomiting, hypotension)The requirement of additional analgesia
primary outcome:
Prophylactic antibiotics for transcervical intrauterine procedures
Postoperative complications.Postoperative febrile morbidity (defined as a postoperative body temperature greater than 38 degrees Celsius after the operation, within 10 days but not the first 24 hours).Postoperative infectious complications (defined as any documented sites of infection identified by cultivation or clinical symptoms and signs, or both) including:endometritis;pelvic inflammatory disease;pelvic abscess.Postoperative treatment needed for infection including:antibiotic treatment;hospitalisation needed for longer duration than usual;surgical treatment, for example exploratory laparotomy for abscess evacuation or drainage.
primary outcome:
Anti‐TNF‐α treatment for pelvic pain associated with endometriosis
Relief of pelvic pain (pain scores, days off work, use of pain killers)Adverse events resulting from anti‐TNF‐α intervention
primary outcome:
Adapting shift work schedules for sleep quality, sleep duration, and sleepiness in shift workers
Sleep quality off‐shift: measured with a validated questionnaire such as the Bergen Insomnia scale (Pallesen 2008), Pittsburgh Sleep Quality Index (Buysse 1989), Basic Nordic Sleep Questionnaire (Partinen 1995), Jenkins Sleep Questionnaire (Lallukka 2011), or relevant questions in the Standard Shift Work Index. We also accepted sleep quality as reported in sleep diaries. If available, we used sleep quality after night shifts. Otherwise, we used the average sleep quality across shifts or across the week. We also included wrist‐worn actigraphy‐based measures as objective measures of sleep quality.Sleep duration off‐shift: average duration of sleep was based on the relevant questions from validated questionnaires (see examples in previous bullet point), sleep diaries, or wrist‐worn actigraphy. If available, we used sleep duration off‐shift, a measure that excludes naps and sleep during shifts but includes sleep after a shift and during days off. If sleep duration off‐shift was unavailable, we used the 24‐hour sleep duration.Sleepiness during shifts: we considered sleepiness during night shifts. If studies did not provide this information, we used the average sleepiness across shifts or across the week. We considered the following measures of sleepiness.Self‐rated (subjective) sleepiness measured with a validated questionnaire such as the Karolinska Sleepiness Scale (Kaida 2006), Stanford Sleepiness Scale (Herscovitch 1981; Hoddes 1972), relevant questions in the Standard Shift Work Index (Barton 1995), or other visual analogue scalesPhysiological sleepiness measured with electrophysiological methods during work (e.g. electroencephalogram or electro‐oculogram measurement such as PERCLOS (percentage of eyelid closure; Dinges 1998; Sommer 2010) or by standardised physiological tests of sleepiness such as the Multiple Sleep Latency Test (Carskadon 1986), the Maintenance of Wakefulness Test (Mitler 1982) or pupillometric assessmentBehavioural sleepiness measured as performance in a validated vigilance test such as a psychomotor vigilance test (e.g. Basner 2011; Thorne 2005), the Mackworth Clock Test (Mackworth 1950), or single or multiple choice reaction time testsBehavioural sleepiness measured as characteristics of overt behaviour subjectively rated by a researcher through video recording methods such as Observer Rating of Drowsiness (e.g. Wierwille 1994)Fatigue usually refers to exhaustion or tiredness due to long‐lasting exertion. However, fatigue can be considered a symptom or outcome related to sleepiness at work. Therefore, we included studies that measured fatigue at any moment during the shift, as a self‐reported outcome measured with a validated questionnaire or interview if sleepiness was not measured with one of the above‐mentioned validated measures of sleepiness.
primary outcome:
Splinting for carpal tunnel syndrome
CTS symptoms (prioritising BCTQ Symptom Severity Scale) at:Short term (up to 3 months prioritising the time closest to 3 months); andLong term (over 3 months).
primary outcome:
Collective leadership to improve professional practice, healthcare outcomes and staff well‐being
Professional practiceLeadership, e.g. Distributed Leadership Agency (DLA) (Jønsson 2016)Team performance, e.g. Non‐Technical Skills (NOTECHS) (Sevdalis 2008), Team Climate Inventory (TCI) (Anderson 1996)Clinical performance, e.g. time to critical intervention (Janssens 2021)Healthcare outcomesHealth status (inpatient mortality, mortality within 30 days of discharge)Staff well‐beingBurnout, psychological symptoms (anxiety, depression) and work‐related stress, e.g. Professional Quality of Life (ProQOL) (Stamm 2010)Unintended consequencesAny unintended safety of care events (including errors, healthcare‐associated complications), e.g. Patient Measure of Safety (PMOS) (McEachan 2014), or professional, organisational and staff consequences
primary outcome:
Pre‐deployment programmes for building resilience in military and frontline emergency service personnel
Resilience: defined by resilience levels from pre‐intervention to post‐intervention, measured on standardised psychological scales including: Connor‐Davidson Resilience Scale (CD‐RISC) (Connor 2003), the Resilience Scale (RS) (Wagnild 1993), the Resilience Scale for Adults (RSA) (Hjemdal 2011), Dispositional Resilience Scale‐15 (DRS‐15) (Bartone 2007), and the Brief Resilience Scale (BRS) (Smith 2008), among others.Symptoms of post traumatic stress e.g. PTSD‐8 (Hansen 2010), Clinically Administered PTSD Scale (CAPS‐1) (Weathers 2001).PTSD caseness (defined in this review as a participant reaching the clinical threshold on the following scales, or other, to be eligible for a diagnosis of post traumatic stress disorder) e.g. PTSD‐8 (Hansen 2010), Clinically Administered PTSD Scale (CAPS‐1) (Weathers 2001).
primary outcome:
Exercise therapy for chronic low back pain
Pain intensity, measured by a pain scale (for example, visual analogue scale (VAS), numerical rating scale (NRS), or McGill pain score (Melzack 1975))Functional limitations, measured by a back pain‐specific scale (for example, the Roland‐Morris Disability Questionnaire (RMDQ) (Roland 2000), or the Oswestry Disability Index (ODI) (Fairbank 1980))