457 research outputs found
Predicting major complications in patients undergoing laparoscopic and open hysterectomy for benign indications
Background: Hysterectomy, the most
common gynecological operation,
requires surgeons to counsel women
about their operative risks. We aimed to
develop and validate multivariable logistic
regression models to predict major
complications of laparoscopic or abdominal
hysterectomy for benign conditions.
Methods: We obtained routinely collected
health administrative data from
the English National Health Service (NHS)
from 2011 to 2018. We defined major
complications based on core outcomes
for postoperative complications including
ureteric, gastrointestinal and vascular
injury, and wound complications. We
specified 11 predictors a priori. We used
internal–external cross-validation to
evaluate discrimination and calibration
across 7 NHS regions in the development
cohort. We validated the final
models using data from an additional
NHS region.
Results: We found that major complications
occurred in 4.4% (3037/68 599) of
laparoscopic and 4.9% (6201/125 971) of
abdominal hysterectomies. Our models
showed consistent discrimination in the
development cohort (laparoscopic,
C-statistic 0.61, 95% confidence interval
[CI] 0.60 to 0.62; abdominal, C-statistic
0.67, 95% CI 0.64 to 0.70) and similar or
better discrimination in the validation
cohort (laparoscopic, C-statistic 0.67, 95%
CI 0.65 to 0.69; abdominal, C-statistic
0.67, 95% CI 0.65 to 0.69). Adhesions
were most predictive of complications in
both models (laparoscopic, odds ratio
[OR] 1.92, 95% CI 1.73 to 2.13; abdominal,
OR 2.46, 95% CI 2.27 to 2.66). Other
factors predictive of complications
included adenomyosis in the laparoscopic
model, and Asian ethnicity and
diabetes in the abdominal model. Protective
factors included age and diagnoses
of menstrual disorders or benign
adnexal mass in both models and diagnosis
of fibroids in the abdominal model.
Interpretation: Personalized risk estimates
from these models, which
showed moderate discrimination, can
inform clinical decision-making for
people
with benign conditions who may
require hysterectomy.British Society
for Gynaecological Endoscop
Ferritin screening and Iron treatment for maternal anemia and fetal growth restriction prevention - A multicenter randomized controlled trial (FAIR Study)
Background: Non-anemic iron deficiency precedes iron deficiency anaemia and has an estimated prevalence of 1-2
billion worldwide. Few studies have comprehensively researched the idea of treating non-anemic iron deficiency
(NAID) with iron to improve the outcome of the mother and the offspring.
Methods and Analysis: FAIR will be a multicenter randomized controlled trial that will be conducted in multiple clinical
academic obstetrics units in Lahore (including Services Institute of Medical Sciences, Lahore, Allama Iqbal Medical
College, Lahore and Fatima Jinnah Medical University). Pregnant women at gestational age <20 weeks with hemoglobin
11-13 g/L and ferritin below the threshold (<30 ng/ml) will be invited to take part in the study. Randomization will
be done by computer based generated random numbers. One group (usual care or oral group) will be offered routine
care prophylactic dose of oral iron (30-45 mg/day) and the other group (intervention arm or IV group) will be offered
therapeutic dose of IV iron (dose calculated by Ganzoni formula) in addition to usual care. All patients will be followed
up till delivery. Primary maternal outcome will be hemoglobin at 36 weeks’ gestation. Secondary outcomes are fetal
birthweight or small for gestational age, preterm birth, preeclampsia, multidimensional fatigue inventory, breast
feeding initiation, blood transfusion, and fetal cord ferritin and hemoglobin.
Discussion: The study will generate evidence as to whether screening serum ferritin in non-anemic pregnant women
and replenishing their iron stores will likely reduce the rate of predelivery anemia in pregnant women, improve
birthweight and preventing perinatal complications.
Roles and responsibilities: Tayyiba Wasim is principal Investigator and other members of data management team
are Natasha Bushra, Shamsa Humayoun, Khalid Saeed Khan, Fatima Shehbaz, Saba Rasool, Anam Riaz and Sonia
Irshad. Principal investigator will assume the full responsibility of Fair trial including training of research assistants,
administration of informed consent and protecting participants confidentiality. Data management team will help in
the management, development and execution of trial. Khadija Irfan Khawaja is the operational lead for fair trial´s
technology team comprising of Aziz Fatima and Zubia Zafar, responsible for gathering requirements from study teams
and supporting the operational implementation of technology to drive the collection of high-quality study data.
Protocol contributors are Gynae unit I of Services Institute of Medical Sciences/ Services hospital, Lahore, Gynae Unit
II of Allama Iqbal Medical College/ Jinnah hospital, Lahore and Gynae unit 1 of Fatima Jinnah Medical College/ Sir
Ganga Ram hospital, Lahore. These coordinating centres will recruit patients (sample size=600) and will discuss their
progress in trial management meetings quarterly.
Steering committee has an independent chair Prof Samia Malik, one expert member Prof Faiza Bashir and Ms Neelam
to represent patients, public and consumers. Trial steering committee with independent chair and member with a
patient representative will oversee the study. Chair of steering committee has the authority to stop the trial whenever
needed in case of positive or negative results. Steering committee meetings will be held on annual basis.
Independent Data monitoring committee comprises of Dr. Shehnoor Azhar as chair and Prof Ejaz Hussain and Dr.
Shehla Javed Akram as members. Data monitoring committee will assess the progress, data safety and if needed critical
efficacy points of the clinical study and will show their results quarterly in data interim meetings. The committee
will focus on integrity of the whole process and compliance of all sites with all aspects of the protocol. It will
perform confidential interim analyses quarterly, which may be used to determine if an effect` is observed and if the
study should continue to its planned sample size. Data monitoring committee will report to the Chair of the steering
committee
Standardising outcome reporting for clinical trials of interventions for heavy menstrual bleeding: Development of a core outcome set
Objective: To develop a core outcome set for heavy menstrual bleeding (HMB).
Design: Core outcome set (COS) development methodology described by the
COMET initiative.
Setting: University hospital gynaecology department, online international survey
and web-based
international consensus meetings.
Population or sample: An international collaboration of stakeholders (clinicians,
patients, academics, guideline developers) from 20 countries and 6 continents.
Methods: Phase 1: Systematic review of previously reported outcomes to identify
potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes
most important to them. Phase 3: Online two-round
Delphi survey to achieve
consensus about which outcomes are most important. Phase 4: A consensus meeting
to finalise the COS.
Main outcome measures: Outcome importance was assessed in the Delphi survey
on a 9-point
scale.
Results: From the ‘long list’ of 114, 10 outcomes were included in the final COS:
subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea;
number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction;
number of patients going on to have further treatment for HMB and haemoglobin
level.
Conclusions: The final COS includes variables that are feasible for use in clinical trials
in all resource settings and apply to all known underlying causes of the symptom
of HMB. These outcomes should be reported in all future trials of interventions,
their systematic reviews, and clinical guidelines to underpin policy.Academy of Medical Sciences (AMS)National Institute for Health Research (NIHR)Beatriz Galindo (senior modality) Programme Gran
Protocol of Pakistan randomized and observational trial to evaluate coronavirus treatment among newly diagnosed patients with COVID-19: Azithromycin, Oseltamivir, and Hydroxychloquine
Background & Objective: This study aimed to assess the clinical effectiveness of Hydroxychloroquine
Sulfate (200 mg orally 8 hourlies thrice a day for 5 days), oseltamivir (75 mg orally twice a day for 5
days), and Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5)
alone and in combination (in seven groups).
Methods & Analysis: An adaptive design is deployed, set within a comprehensive cohort study, to permit
flexibility in fast-changing clinical and public health scenario. Primary outcomes include turning the test
negative for coronavirus nucliec acid and in bringing about clinical improvement on day 7 of follow-up
on a seven-point ordinal scale. The randomized study will recruit participants of either gender above
18 years of age who will test positive for SARS-CoV-2 on Quantitative Reverse Transcription Polymerase
Chain Reaction (PCR). Pregnant or lactating females, and those with severe respiratory distress, or
with serious comorbidities will be excluded. Randomization will be done maintaining concealment of
allocation sequence using a computer-generated random number list. The sample size will be subjected
to periodic reviews by National Data Safety and Monitoring Board.
Ethics and Dissemination: The trial is approved by the National Bioethics Committee (No.4-87/NBC-
471-COVID-19-05/20/) and institutional Ethical Review Committee. This clinical trial conducted under
Good Clinical Practice is expected to inform patients clinical guidelines for the use of these drugs in
newly diagnosed with SARS-CoV-2.Spanish Governmen
Early cryoprecipitate transfusion versus standard care in severe postpartum haemorrhage: a pilot cluster-randomised trial
The trial was prospectively registered on ISRCTN (12146519). The trial was approved by the NHS LondonBrighton and Sussex Research Ethics Committee and the NHS Confidentiality Advisory Group. The study was funded by Barts Charity. We would like to acknowledge the support of the Joint Research Management Office, Queen Mary University of London as sponsor for the study; the contributions of members of Katie's Team, the East London women's health research patient and public advisory group; and the clinical, laboratory and maternity research teams at Barts Health NHS Trust hospitals and Homerton University Hospital. We are also grateful for all the support and advice provided by the project steering committee chaired by an independent consultant anaesthetist (M. Wilson, University of Sheffield), with four other independent members: A. Khalil, St George's University Hospital; B. Leurent, London School of Hygiene and Tropical Medicine; N. Moss, lay representative; and S. Robinson, Guy's and St Thomas' NHS Trust. No other external funding or competing interests declared.There is a lack of evidence evaluating cryoprecipitate transfusion in severe postpartum haemorrhage. We
performed a pilot cluster-randomised controlled trial to evaluate the feasibility of a trial on early cryoprecipitate
delivery in severe postpartum haemorrhage. Pregnant women (>24 weeks gestation), actively bleeding within
24 h of delivery and who required at least one unit of red blood cells were eligible. Women declining
transfusion in advance or with inherited clotting deficiencies were not eligible. Four UK hospitals were randomly
allocated to deliver either the intervention (administration of two pools of cryoprecipitate within 90 min of first
red blood cell unit requested plus standard care), or the control group treatment (standard care, where
cryoprecipitate is administered later or not at all). The primary outcome was the proportion of women who
received early cryoprecipitate (intervention) vs. standard care (control). Secondary outcomes included consent
rates, acceptability of the intervention, safety outcomes and preliminary clinical outcome data to inform a
definitive trial. Between March 2019 and January 2020, 199 participants were recruited; 19 refused consent,
leaving 180 for analysis (110 in the intervention and 70 in the control group). Adherence to assigned treatment
was 32% (95%CI 23–41%) in the intervention group vs. 81% (95%CI 70–90%) in the control group. The
proportion of women receiving cryoprecipitate at any time-point was higher in the intervention (60%) vs. control
(31%) groups; the former had fewer red blood cell transfusions at 24 h (mean difference 0.6 units, 95%CI 1.2
to 0); overall surgical procedures (odds ratio 0.6, 95%CI 0.3–1.1); and intensive care admissions (odds ratio 0.4,
95%CI 0.1–1.1). There was no increase in serious adverse or thrombotic events in the intervention group. Staff
interviews showed that lack of awareness and uncertainty about study responsibilities contributed to lower
adherence in the intervention group. We conclude that a full-scale trial may be feasible, provided that protocol
revisions are put in place to establish clear lines of communication for ordering early cryoprecipitate in order to
improve adherence. Preliminary clinical outcomes associated with cryoprecipitate administration are
encouraging and merit further investigation.Barts CharityJoint Research Management Office, Queen Mary University of Londo
MEMPHIS: a smartphone app using psychological approaches for women with chronic pelvic pain presenting to gynaecology clinics: a randomised feasibility trial
Objectives To evaluate the feasibility of a randomised
trial of a modified, pre-existing,
mindfulness meditation
smartphone app for women with chronic pelvic pain. Primary and secondary outcome measures Outcomes
included length of recruitment, follow-up
rates, adherence
to the app interventions, and clinical outcomes measured
at baseline, two, three and 6 months.
Results The target sample size was recruited in 145 days.
Adherence to the app interventions was extremely low
(mean app use 1.8 days mindfulness meditation group, 7.0
days active control). Fifty-seven
(63%) women completed
6-month
follow-up,
and 75 (83%) women completed at
least one postrandomisation follow-up.
The 95% CIs for
clinical outcomes were consistent with no benefit from
the mindfulness meditation app; for example, mean
differences in pain acceptance scores at 60 days (higher
scores are better) were −2.3 (mindfulness meditation vs
usual care, 95% CI: −6.6 to 2.0) and −4.0 (mindfulness
meditation vs active control, 95% CI: −8.1 to 0.1).
Conclusions Despite high recruitment and adequate
follow-up
rates, demonstrating feasibility, the extremely
low adherence suggests a definitive randomised trial of
the mindfulness meditation app used in this study is not
warranted. Future research should focus on improving
patient engagement.This research was supported by the UK National Institute of Health
Research, Research for Patient Benefit programme (RfPB PB-PG-
1013-32025)
Breast Cancer Risk and Breast-Cancer-Specific Mortality following Risk-Reducing Salpingo-Oophorectomy in BRCA Carriers: A Systematic Review and Meta-Analysis
The following supporting information can be downloaded at: https://www.mdpi.com/article/10.3390/cancers15051625/s1, Table S1: Search strategy for literature search.Background: Risk-reducing salpingo-oophorectomy (RRSO) is the gold standard method
of ovarian cancer risk reduction, but the data are conflicting regarding the impact on breast cancer
(BC) outcomes. This study aimed to quantify BC risk/mortality in BRCA1/BRCA2 carriers after
RRSO. Methods: We conducted a systematic review (CRD42018077613) of BRCA1/BRCA2 carriers
undergoing RRSO, with the outcomes including primary BC (PBC), contralateral BC (CBC) and
BC-specific mortality (BCSM) using a fixed-effects meta-analysis, with subgroup analyses stratified
by mutation and menopause status. Results: RRSO was not associated with a significant reduction
in the PBC risk (RR = 0.84, 95%CI: 0.59–1.21) or CBC risk (RR = 0.95, 95%CI: 0.65–1.39) in BRCA1
and BRCA2 carriers combined but was associated with reduced BC-specific mortality in BC-affected
BRCA1 and BRCA2 carriers combined (RR = 0.26, 95%CI: 0.18–0.39). Subgroup analyses showed that
RRSO was not associated with a reduction in the PBC risk (RR = 0.89, 95%CI: 0.68–1.17) or CBC risk
(RR = 0.85, 95%CI: 0.59–1.24) in BRCA1 carriers nor a reduction in the CBC risk in BRCA2 carriers
(RR = 0.35, 95%CI: 0.07–1.74) but was associated with a reduction in the PBC risk in BRCA2 carriers
(RR = 0.63, 95%CI: 0.41–0.97) and BCSM in BC-affected BRCA1 carriers (RR = 0.46, 95%CI: 0.30–0.70).
The mean NNT = 20.6 RRSOs to prevent one PBC death in BRCA2 carriers, while 5.6 and 14.2 RRSOs
may prevent one BC death in BC-affected BRCA1 and BRCA2 carriers combined and BRCA1 carriers,
respectively. Conclusions: RRSO was not associated with PBC or CBC risk reduction in BRCA1 and BRCA2 carriers combined but was associated with improved BC survival in BC-affected BRCA1 and
BRCA2 carriers combined and BRCA1 carriers and a reduced PBC risk in BRCA2 carriers.Rosetrees Trust CF1\100001Barts Charity ECMG1C3
Endogenous progesterone in unexplained infertility: a systematic review and meta‑analysis
Purpose To investigate the possibility that altered actions of endogenous progesterone affect receptivity and contribute to
unexplained infertility (UI).
Methods Two authors electronically searched MEDLINE, CINAHL and Embase databases from inception to 6 July 2022
and hand-searched according to Cochrane methodology. We included all published primary research reporting outcomes
related to endogenous progesterone in natural cycles in women with UI. Studies were assessed for risk of bias using a modified
Newcastle–Ottawa Score or NHLBI Score. We pooled results where appropriate using a random-effects model. Findings
were reported as odds ratios or mean differences.
Results We included 41 studies (n = 4023). No difference was found between the mid-luteal serum progesterone levels of
women with UI compared to fertile controls (MD 0.74, − 0.31–1.79, I2 36%). Women with UI had significantly higher rates
of ‘out-of-phase’ endometrium than controls. Nine out of 10 progesterone-mediated markers of endometrial receptivity were
significantly reduced in women with UI compared to fertile controls (the remaining 1 had conflicting results). Resistance
in pelvic vessels was increased and perfusion of the endometrium and sub-endometrium reduced in UI compared to fertile
controls in all included studies. Progesterone receptor expression and progesterone uptake were also reduced in women with
unexplained infertility.
Conclusions End-organ measures of endogenous progesterone activity are reduced in women with UI compared to fertile
controls. This apparently receptor-mediated reduction in response affects endometrial receptivity and is implicated as the
cause of the infertility. Further research is required to confirm whether intervention could overcome this issue, offering a
new option for treating unexplained infertility
Variation in outcome reporting in studies of fertility-sparing surgery for cervical cancer: A systematic review
Background: Cervical cancer affects 3197 women in the UK, and 604 000 women
worldwide annually, with peak incidence seen in women between 30 and 34 years
of age. For many, fertility-sparing
surgery is an appealing option where possible.
However, absence of large-scale
data, along with a notable variation in reported
outcomes in relevant studies, may undermine future efforts for consistent evidence
synthesis.
Objectives: To systematically review the reported outcomes measured in studies
that include women who underwent fertility-sparing
surgery for cervical cancer and
identify whether variation exists.
Search strategy: We searched MEDLINE, EMBASE and CENTRAL from inception
to February 2019.
Selection criteria: Randomised controlled trials, cohort and observational studies,
and case studies of more than ten participants from January 1990 to date.
Data collection and analysis: Study characteristics and all reported treatment
outcomes.
Main results: A total of 104 studies with a sum of 9535 participants were identified.
Most studies reported on oncological outcomes (97/104), followed by fertility and
pregnancy (86/104), postoperative complications (74/104), intra-operative
complications
(72/104) and quality of life (5/104). There was huge variation and heterogeneity
in reported outcomes, with only 12% being good quality and 87% being of poor
quality.
Conclusions: There is significant heterogeneity in the reported outcomes. An agreed
Core Outcome Set is necessary for future studies to effectively harmonise reported
outcomes that are measurable and relevant to patients, clinicians and researchers.
This systematic review sets the groundwork for the development of a Core Outcome
Set for fertility-sparing
surgery in cervical cancer.British Medical Association's Strutt and Harper Gran
The effectiveness of kangaroo mother care in lowering postpartum depression in mothers of preterm and low birth weight babies: a systematic review and meta-analysis
Background: Kangaroo mother care (KMC) intervention involves skin-to-skin contact between mother and infant. Some studies
have shown a decrease in postpartum depression (PPD) in mothers of preterm and low birth weight (LBW) infants. However, the
literature is scattered and of variable quality.
Aims: To conduct a systematic review of available literature and provide a comprehensive picture of the effect of KMC on PPD
among mothers of preterm and LBW infants.
Methods: The study was reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA)
Guidelines. After PROSPERO registration, a systematic search was conducted using PubMed, Cochrane Central Library, and
Google Scholar from the inception of the databases till 14 June 2021. Of the 2944 studies assessed for titles and abstracts, nine
studies with 2042 participants were included in the review. Included articles targeted mothers with LBW (<2500 g) or preterm infants
(< 37 weeks), used an authentic PPD tool, and had standard care or an incubator as the control group. Studies not published in
English and in which mothers had a previous psychiatric illness were excluded. The risk of bias was assessed using the Cochrane
Risk of Bias Tool for randomized control trials and the Newcastle–Ottawa Scale for observational studies. All the results were
converted to standard mean deviation and pooled together using a random-effects model with a 95% CI. A P-value of less than 0.05
is considered significant.
Results: KMC Intervention was significantly associated with a lower depression score than control groups. The reduction in
depression in the intervention (KMC) group was moderate: SMD= − 0.38 (− 0.68 to − 0.08; 95% CI; I2 = 86%; P = 0.013). No
significant difference was found between the PPD scores of both groups using the Edinburgh Postpartum Depression
Scale score.
Conclusions: The authors conclude that the negative effects of LBW and preterm birth experience on maternal mental health
can be avoided to a moderate degree by KMC. Due to a lack of methodological uniformity, different scales for outcome
measurement, and discrepancies in intervention features, significantly high heterogeneity was detected. The authors need
further larger-scale studies with a uniform study design to better predict the efficacy of KMC bette
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