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Locally advanced breast cancer (LABC) is a subset of breast cancer with locoregional progression without distant metastasis. The multimodality treatment (surgery, chemotherapy, radiotherapy, hormonal and targeted therapy if required) could significantly improve results in this specific group of patients. The complex and multiple options of treatment with similar mortality rates but different outcomes depending on the patient’s desires, preferences and social environment require aid to facilitate the individual patient’s decisions (e.g. Decision Aids (DAs) targeting patients considering primary or adjuvant treatment in LABC). In this context, DAs have been proven fundamental to help patients and clinicians share and agree on the best value option. The current systematic review aimed to evaluate the existing DAs related to these patients with LABC and identify current status and possible improvement areas (possible scarcity and heterogeneity of instruments, the status of their development, explanation of their purpose,…). No previous systematic reviews have been published on this topic. Following Prospero registration no: CRD42021286173, studies about LABC DAs were identified, without data or language restrictions, through a systematic search of bibliographic databases in December 2021. Quality was assessed using Qualsyst criteria (range 0.0–1.0). The quality of the 17 selected studies ranged from 0.46 to 0.95. Of them, 14/17 (82%) were DAs about treatment, only one (6%) about diagnosis, and 2/17 (12%) about the employment of DAs. No screening or follow-up DAs were retrieved. Twelve (70.6%) DAs were online tools. They varied broadly regarding their characteristics and purposes. Most of the studies focused on developing and testing different DAs (5/17; 29.4%) and their impact (7/17; 41.2%). Only 4/17 (23.5%) analysed their implementation and cost. These instruments have proven to improve patient’s knowledge and decision-making, decrease patient anxiety, and patients tend to undergo treatment. However, nowadays, there is still a need for further research and consensus on methodology to develop practical DAs.

High-quality clinical practice guidelines (CPGs) and consensus statements (CSs) are essential for evidence-based medicine. The purpose of this systematic review was to appraise the quality and reporting of colorectal cancer (CRC) screening CPGs and CSs. After prospective registration (Prospero no: CRD42021286156), a systematic review searched CRC guidances in duplicate without language restrictions in ten databases, 20 society websites, and grey literature from 2018 to 2021. We appraised quality with AGREE II (% of maximum score) and reporting with RIGHT (% of total 35 items) tools. Twenty-four CPGs and 5 CSs were analysed. The median overall quality and reporting were 54.0% (IQR 45.7-75.0) and 42.0% (IQR 31.4-68.6). The applicability had low quality (AGREE II score50%) in 83% of guidances (24/29). Recommendations and conflict of interest were low-reported (RIGHT score50%) in 62% guidances (18/29) and 69% (20/29). CPGs that deployed systematic reviews had better quality and reporting than CSs (AGREE: 68.5% vs. 35.5%; p = 0.001; RIGHT: 74.6% vs. 41.4%; p = 0.001). In summary, CRC screening CPGs and CSs achieved low quality and reporting. It is necessary a revision and an improvement of the current guidances. Their development should apply a robust methodology using proper guideline development tools to obtain high-quality evidence-based documents.

Evidence-based medicine is essential for clinical practice. Clinical practice guidelines (CPGs) and consensus statements (CSs) ought to follow a consistent methodology to underpin high-quality healthcare. We systematically analysed the quality and reporting of colorectal (CRC) and anal cancer CPGs and CSs.Embase, MEDLINE, Scopus, Web of Science, the Cochrane Database of Systematic Reviews and online sources (59 professional society websites and eight guideline databases) were systematically searched following prospective registration (PROSPERO no. CRD42021286146) by two reviewers independently, without language restrictions. CPGs and CSs about CRC and anal cancer treatment were included from January 2018 to November 2021 and were assessed using the AGREE II tool (per cent of maximum score) and the RIGHT tool (per cent of total 35 items) for quality and reporting respectively.The median overall quality and reporting of the 59 guidelines analysed were 55.0% (interquartile range 47.0-62.0) and 58% (interquartile range 50.0-67.9), respectively, with a proportion scoring less than half (50%) for quality (20/59, 33.9%) and reporting (15/59, 25.4%). Guidance reported that following AGREE II methodology scored better on average than that without (AGREE II 77.7% vs. 47.6%, P = 0.001; RIGHT 50.0% vs. 33.9%, P = 0.001). Guidelines based on systematic reviews had better quality and reporting on average than those based on consensus (AGREE II 56.5% vs. 46.6%, P = 0.001; RIGHT 36.9% vs. 35.4%, P = 0.019).The quality and reporting of colorectal and anal cancer treatment CPGs and CSs were poor. Despite AGREE II and RIGHT inherent methodological limitations, few high-quality guidelines were found. Despite wide variability in scoring different domains, they merit urgent improvement in all areas. It has also been demonstrated that CPGs and CSs should be underpinned by systematic reviews collecting the best available clinical research findings.

High-quality research underpins the best healthcare practice. This article focuses on analyzing the current literature to promote research integrity across clinical trials.Recent admissions of questionable practices by researchers have undermined practitioner and public confidence. There is limited evidence specifically for ethical and professional standards in clinical trials to guide researchers and institutions to embed integrity into research practice.Unintentional errors and spin in research are not uncommon as training in design and conduct of clinical trials is not part of health education for medical and allied health professions. There is unfamiliarity with procedures, such as prospective registration, a priori documentation of statistical analysis plans, openness in data sharing, and so forth. This, combined with the academic culture of secrecy, has led to an environment where scientific suspicion, instead of trust, is the norm. Existing science integrity documents are devoid of specific recommendations about how to translate any guidance into clinical trial practice. There is a need for constructive, supportive and multidisciplinary approaches based on open dialogue and continuous training, targeting the research environment. Research integrity now needs to take centre stage to re-instill confidence in randomized trial evidence to inform clinical practice.

The women’s sexual and reproductive healthcare sector, one of the largest employers delivering services globally, does not always commit to equality, diversity, and inclusion. There is objective, published evidence that not only care provision but also workforce treatment permits inequality and discrimination. The black and ethnic minority workforce in the women’s health specialty, compared to their white counterparts, is often treated unfavorably in appointments, is less often afforded academic development opportunities, is, at many sites, subjected to disproportionately greater disciplinary penalties, tends not have representation in positions of authority, and undertakes training in what is often perceived as a climate of fear due to racism. This problem deserves immediate action by professional bodies. They have the responsibility to remove feelings of exclusion and lack of belonging to all staff, the negative impact on wellbeing caused by unnecessary stress, and concerns over career progression among minority ethnic healthcare workforce and other workers who report discrimination. This duty is part of the societal responsibility to ensure fairness and eradicate discrimination under the equality, diversity and inclusion agenda.

Listeria monocytogenes is a commonly found organism in processed and prepared food and the disease of listeriosis is associated with a high morbidity and mortality. Compared with the general population, the risk of being diagnosed with listeriosis increases during pregnancy. Listeriosis can lead to miscarriage, spontaneous preterm labour and preterm birth, stillbirth and congenital neonatal infections. We conducted a universal review of listeriosis in pregnancy and in the newborn. The EMBASE, PubMed, Cinahl and Web of Science databases were searched for systematic reviews indexed before 1 December 2020. Any systematic reviews evaluating the prevalence, treatment, diagnosis and effects of listeriosis during pregnancy and up to 4 weeks postnatally were included. Eligibility assessment, data extraction and quality assessment by the Methodological Quality Assessment of Systematic Reviews (AMSTAR-2) were performed in duplicate. We identified 397 citations of which nine systematic reviews comprising 330 studies and 487 patients' reviews were included. Most systematic reviews (seven of nine) were of moderate to high quality. Prevention in pregnant women was based on adherence to strict dietary recommendations, such as reheating leftovers until steamed and avoiding unpasteurised dairy products. Listeriosis infections were likely to occur in the third trimester (66%) rather than in the first trimester (3%) of pregnancy. Symptoms are mostly fever and other flu-like symptoms, such as fatigue. Diagnosis was primarily made by culture of the pathogen. Intravenous amoxicillin or ampicillin were first-line treatment. Listeriosis, a rare but serious infectious disease in pregnancy, can cause devastating consequences for the fetus and newborn. Appropriate preventative treatment should be initiated during early pregnancy to avoid complications. Listeria is commonly found in processed and prepared food. Prevention is the best way to avoid listeriosis during pregnancy.

Systematic reviews rank at the top of the evidence hierarchy. Concise writing implies drafting the systematic review article succinctly, i.e. using as few words to express as full an extent of the research effort as possible. Precise writing means drafting the text with accuracy especially with respect to the methodological and statistical aspects. The Abstract ought to be succinct and structured to allow for editors, peer reviewers and readers to get the gist of the key aspects of the systematic review with a quick read. The readership needs to be able to critically appraisal systematic reviews for their internal and external validity rapidly. The Abstract also needs to be standalone, representing an independent summary that can be fully understood without the need for reading the full paper. The standard structure of the main text of a scientific article called IMRaD (Introduction, Methods, Results and Discussion) applies equally to systematic reviews in the same way as it does to any other kinds of research manuscripts whether related to laboratory experiments or clinical trials. Restricting the word count limits to those imposed by journals may at first seem difficult, even unfair, to systematic reviewers. However, with the availability of online appendices to transparently and fully report the details of the methods, results and other aspects of the work undertaken allows for a succinct print or PDF article. Writing a shorter manuscript is more effortful than writing a longer report. This commentary is aimed at novice systematic reviewers to help them learn the written and unwritten writing rules in order to assist them in producing impactful publications to support evidence-based medicine., Spanish Government

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

Background: Physiologic processes such as childbirth and menopause can alter vulvovaginal aesthetic appearance, reduce sexual satisfaction, and cause symptoms of vulvovaginal atrophy which affects a woman’s quality of life. There is debate about whether dynamic quadripolar radiofrequency (DQRF) can be used to improve such conditions. We conducted a meta-analysis of studies among patients undergoing treatment with DQRF. Methods: We conducted a literature search without language or article type restriction in PubMed, Cochrane library and Web of Science from inception to June 1, 2022. We included studies that reported outcomes of DQRF treatment. Article selection and data extraction in a predesigned data extraction form were conducted in duplicate. Individual studies reported outcomes in terms of the pre- and post-intervention repeated measures. Meta-analysis combined results across studies to produce effect sizes using random effects model with 95% confidence intervals (CI) taking into account sampling variance to adjust the estimated precision. PROSPERO: CRD42021227752. Results: The search yielded 781 articles, from which 4 case series (127 participants) were included. Two studies reported a significant improvement in patient and medical evaluation assessments of vulvovaginal aesthetic appearance. Significant improvements were reported by three studies for patient assessed sexual satisfaction/discomfort, vaginal laxity and symptoms of genitourinary syndrome of menopause. Meta-analysis showed a trend towards improvement in aesthetic appearance (4 studies; 0.89; 95% CI –0.15 to 1.93; I2 75.0%) and sexual satisfaction (2 studies; 0.62; 95% CI –0.03 to 1.27; I2 0.0%). Conclusion: Dynamic quaripolar radiofrequency is a potentially promising intervention to improve vaginal laxity, appearance and sexual satisfaction, as observed in four monocentric case series. Further studies with a control group, well-defined methods of patient selection and longer follow-up periods are necessary to reach a definitive conclusion. Abbreviations: CI = confidence intervals, DQRF = dynamic quadripolar radiofrequency, GSM = genitourinary syndrome of menopause.

We aimed to systematically evaluate quality of shared decision-making (SDM) in colorectal cancer (CRC) screening clinical practice guidelines (CPGs) and consensus statements (CSs).Search for CRC screening guidances was from 2010 to November 2021 in EMBASE, Web of Science, MEDLINE, Scopus and CDSR, and the World Wide Web. Three independent reviewers and an arbitrator rated the quality of each guidance using a SDM quality assessment tool (maximum score: 31). Reviewer agreement was 0.88.SDM appeared in 41/83 (49.4%) CPGs and 9/19 (47.4%) CSs. None met all the quality criteria, and 51.0% (52/102) failed to meet any quality items. Overall compliance was low (mean 1.63, IQR 0-2). Quality was better in guidances published after 2015 (mean 1, IQR 0-3 vs. mean 0.5, IQR 0-1.5; p = 0.048) and when the term SDM was specifically reported (mean 4.5, IQR 2.5-4.5 vs. mean 0.5, IQR 0-1.5; p 0.001). CPGs underpinned by systematic reviews showed better SDM quality than consensus (mean 1, IQR 0-3 vs. mean 0, IQR 0-2, p = 0.040).SDM quality was suboptimal and mentioned in less than half of the guidances, and recommendations were scarce. Guideline developers should incorporate evidence-based SDM recommendations in guidances to underpin the translation of evidence into practice.

Participation in randomised clinical trials (RCTs) entails taking part in the discovery of effects of health care interventions. The question of whether participants’ outcomes are different to those of non-participants remains controversial. This umbrella review was aimed at assessing whether there are health benefits of participation in RCTs, compared to non-participation. After prospective registration (PROSPERO CRD42021287812), we searched the Medline, Scopus,Web of Science and Cochrane Library databases from inception to June 2022 to identify relevant systematic reviews with or without meta-analyses. Data extraction and study quality assessment (AMSTAR-2) were performed by two independent reviewers. Of 914 records, six systematic reviews summarising 380 comparisons of RCT participants with non-participants met the inclusion criteria. In two reviews, the majority of comparisons were in favour of participation in RCTs. Of the total of comparisons, 69 (18.7%) were in favour of participation, reporting statistically significant better outcomes for patients treated within RCTs, 264 (71.7%) comparisons were not statistically significant, and 35 (9.5%) comparisons were in favour of non-participation. None of the reviews found a harmful effect of participation in RCTs. Our findings suggest that taking part in RCTs may be beneficial compared to non-participation., Ministry of Science and Innovation, Instituto de Salud Carlos III, FEDER co-funding from European Union PI20/01532, Centro de Investigacion Biomedica en Red-Epidemiologia y Salud Publica CIBERESP/CB06/02/1014

Background Shared decision making (SDM) is a key component of evidence-based and patient-centred care. The aim of this study is to systematically review the quality of SDM proposals in clinical practice guidelines (CPGs) and consensus statements (CSs) concerning breast cancer (BC) screening. Methods Guidances were identified, without language restrictions, using a prospectively planned systematic search (MEDLINE, EMBASE, Web of Science, Scopus and guideline websites) from January 2010 to August 2020. Duplicate data extraction used a 31-item SDM quality assessment tool; reviewer agreement was 98%. Results SDM appeared only in 38 (49.4%) (33/68 CPGs, 4/9 CSs) documents (overall compliance with the quality tool: mean 5.74, IQR 3–8). CPGs and CSs specifically mentioning the term SDM (n = 12) had higher quality (mean 6.8, IQR 4–9 vs. mean 2.1, IQR 0–3; P = 0.001). No differences were found in mean quality comparing CPGs with CSs (3 vs. 1.6; P = 0.634), use of systematic review (4.2 vs. 2.9; P = 0.929) and publication in a journal (4 vs. 1.9; P = 0.094). Guidances with SDM were more recently reported than those without it (mean 41 vs. 57 months; P = 0.042). Conclusion More than half of all the guidelines did not meet SDM quality criteria. Those that explored it were more recently reported. There is an urgent need for promoting SDM in guidances concerning BC screening issued by institutions, professional associations and medical journals.

BACKGROUND Intimate partner violence (IPV) during pregnancy is a public health issue with wide-ranging consequences for both the mother and fetus, and interventions are needed. Therefore, the Stop Intimate Partner Violence in Pregnancy (STOP) cohort was established with the overall aim to identify pregnant women exposed to IPV through digital screening and offer women screening positive for IPV a digital supportive intervention. OBJECTIVE The aim of this study was to (1) introduce the design and profile of the STOP cohort study, (2) assess the feasibility of implementing digital IPV screening among pregnant women, and (3) assess the feasibility of implementing a digital supportive intervention targeting pregnant women exposed to IPV. METHODS Pregnant women attending antenatal care in the Region of Southern Denmark and in Andalucía, Spain were offered digital screening for IPV using validated scales (Abuse Assessment Screen and Women Abuse Screening Tool). Women who screened positive were eligible to receive a digital supportive intervention. The intervention consisted of 3-6 video consultations with an IPV counselor and a safety planning app. In Denmark, IPV counselors were antenatal care midwives trained by a psychologist specialized in IPV, whereas in Spain, the counselor was a psychologist. RESULTS Data collection started in February 2021 and was completed in October 2022. Across Denmark and Spain, a total of 19,442 pregnant women were invited for IPV screening and 16,068 women (82.65%) completed the screening. More women in Spain screened positive for exposure to IPV (350/2055, 17.03%) than in Denmark (1195/14,013, 8.53%). Among the women who screened positive, only 31.39% (485/1545) were eligible to receive the intervention with only 104 (21.4%) of these women ultimately receiving it. CONCLUSIONS Digital screening for IPV among pregnant women is feasible in an antenatal care context in Denmark and Spain; however, a digital supportive intervention during pregnancy appears to have limited feasibility as only a minor subgroup of women who screened positive for eligibility received the intervention. More research is needed on how to best support pregnant women exposed to IPV if universal IPV screening is to be implemented in antenatal care.

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 Government

Ministry of Science, Innovation, and University of Granada/Consorcio de Bibliotecas Universitarias de Andalucia (CBUA), Introduction: Clinical practice guidelines (CPGs) and consensus statements (CSs) are being promoted to provide high-quality healthcare guidance. This systematic review has assessed the breast cancer (BC) screening CPGs and CSs quality and reporting. Methods: A search of bibliographic databases (MEDLINE, Embase, Web of Science, Scopus and CDSR), 12 guideline databases and 51 professional society websites was performed without language restrictions from January 2017 to June 2020, following prospective registration (Prospero no.: CRD42020203807). AGREE II (% of maximum score) and RIGHT (% of total 35 items) appraised quality and reporting individually, extracting data in duplicate; reviewer agreement was 98% and 93%, respectively. Results: Forty guidances with median overall quality and reporting 51% (interquartile range [IQR] 39–63) and 48% (IQR 35–65), respectively. Twenty-two (55%) and 20 (50%) did not reach the minimum standards (scores

All funding has been arranged by University of Health Sciences (UHS) Lahore, Punjab, Pakistan., Objectives: To evaluate patient safety attitudes of the frontline health workers in hospitals of Lahore, Pakistan. Methods: A self-administered Safety Attitudes Questionnaire (SAQ) survey was deployed in five hospitals across Lahore, Pakistan (July 2019 to June 2020). A total of 1250 consecutive consenting nurses and postgraduate trainee physicians of under five years working experience were recruited. Assessment for each of the six subdomains (teamwork climate, safety climate, job satisfaction, stress recognition, perception of management, working conditions) was done on a 0-100 scale. Multivariate analyses examined their relationship with job cadre (nurses and physicians), duration of respondents’ work experience (< 2 years, 3 - 4 years, > 4 years), and hospital sector (private and public). Results: The response rate was 97% (1212 individuals; 765 nurses, 447 physicians). Nurses scored less than physicians in teamwork climate (-2.4, 95% CI -4.5 – -0.2, p=0.02) and stress recognition (-10.6, 95% CI -13.5 – -7.7, p, University of Health Sciences (UHS) Lahore, Punjab, Pakistan

Summary Objective Women with pre‐eclampsia have elevated circulating levels of soluble fms‐like tyrosine kinase‐1 (sFlt‐1). Statins can reduce sFlt‐1 from cultured cells and improve pregnancy outcome in animals with a pre‐eclampsia‐like syndrome. We investigated the effect of pravastatin on plasma sFlt‐1 levels during pre‐eclampsia. Design Blinded (clinician and participant), proof of principle, placebo‐controlled trial. Setting Fifteen UK maternity units. Population We used a minimisation algorithm to assign 62 women with early‐onset pre‐eclampsia (24+0–31+6 weeks of gestation) to receive pravastatin 40 mg daily (n = 30) or matched placebo (n = 32), from randomisation to childbirth. Primary outcome Difference in mean plasma sFlt‐1 levels over the first 3 days following randomisation. Results The difference in the mean maternal plasma sFlt‐1 levels over the first 3 days after randomisation between the pravastatin (n = 27) and placebo (n = 29) groups was 292 pg/ml (95% CI −1175 to 592; P = 0.5), and over days 1–14 was 48 pg/ml (95% CI −1009 to 913; P = 0.9). Women who received pravastatin had a similar length of pregnancy following randomisation compared with those who received placebo (hazard ratio 0.84; 95% CI 0.50–1.40; P = 0.6). The median time from randomisation to childbirth was 9 days (interquartile range [IQR] 5–14 days) for the pravastatin group and 7 days (IQR 4–11 days) for the placebo group. There were three perinatal deaths in the placebo‐treated group and no deaths or serious adverse events attributable to pravastatin. Conclusions We found no evidence that pravastatin lowered maternal plasma sFlt‐1 levels once early‐onset pre‐eclampsia had developed. Pravastatin appears to have no adverse perinatal effects. Tweetable abstract Pravastatin does not improve maternal plasma sFlt‐1 or placental growth factor levels following a diagnosis of early preterm pre‐eclampsia #clinicaltrial finds.

Khalid Saeed Khan is a Distinguished Investigator funded by the Beatriz Galindo (senior modality) Program grant given to the University of Granada by the Ministry of Science, Innovation, and Universities of the Spanish Government., Simple Summary Results from individual studies on the association between obesity and prostate cancer mortality remain inconclusive; additionally, several large cohort studies have recently been conducted. We aimed to systematically review all available evidence and synthetize it using meta-analytic techniques. The results of our study showed that obesity was associated with prostate cancer specific mortality and all-cause mortality. The temporal association was consistent with a dose-response relationship. Our results demonstrated that obesity, a potentially modifiable prognostic factor, was associated with higher prostate cancer mortality. This study improved the evidence regarding the potential impact of lifestyle on improving prostate cancer prognosis. Strategies aimed at maintaining normal, or reducing abnormal, body mass index in diagnosed prostate cancer patients might improve survival. These results should guide urologists, oncologists, patients, policy-makers and primary care providers with respect to evidence-based practice and counselling concerning lifestyle changes after prostate cancer diagnosis., The aim of this study was to systematically review all evidence evaluating obesity as a prognostic factor for PC mortality. Cohort and case-control studies reporting mortality among PC patients stratified by body mass index (BMI) were included. The risk of mortality among obese patients (BMI >= 30) was compared with the risk for normal weight (BMI < 25) patients, pooling individual hazard ratios (HR) in random-effects meta-analyses. Reasons for heterogeneity were assessed in subgroup analyses. Dose-response associations for BMI per 5 kg/m(2) change were assessed. Among 7278 citations, 59 studies (280,199 patients) met inclusion criteria. Obesity was associated with increased PC-specific mortality (HR: 1.19, 95% CI: 1.10-1.28, I-2: 44.4%) and all-cause mortality (HR: 1.09, 95% CI: 1.00-1.18, I-2: 43.9%). There was a 9% increase (95% CI: 5-12%, I-2: 39.4%) in PC-specific mortality and 3% increase (95% CI: 1-5%, I-2: 24.3%) in all-cause mortality per 5 kg/m(2) increase in BMI. In analyses restricted to the higher quality subgroup (NOS >= 8), obesity was associated with increased PC-specific mortality (HR: 1.24, 95% CI: 1.14-1.35, I-2: 0.0%) and maintained the dose-response relationship (HR: 1.11 per 5 kg/m(2) increase in BMI, 95% CI: 1.07-1.15, I-2: 26.6%). Obesity had a moderate, consistent, temporal, and dose-response association with PC mortality. Weight control programs may have a role in improving PC survival., Ministry of Science, Innovation, and Universities of the Spanish Government

BACKGROUND: Testing used in screening, diagnosis and follow-uof COVID-19 has been a subject of debate Given the limitation of resources compared to the enorm

We present an unusual case of a 9-year-old boy, who attended our emergency department with acute left knee swelling, abdominal pain and fever for the past two days. He was well known to our department with a history of constipation. After Orthopaedic, Surgical and Paediatric review a provisional diagnosis of septic arthritis was made. Later, a diagnosis of Crohn’s disease was confirmed and treated accordingly, with the improvement of his symptoms. This case highlights the importance of exploring vague symptoms of inflammatory bowel disease (IBD) at presentation. Knowledge of extra intestinal manifestations (EIM) is essential. Providers should be able to recognize the unusual manifestations of IBD and initiate an appropriate and timely evaluation.

Objective Evaluating effectiveness and cost-effectiveness of ‘Families for Health V2′ (FFH) compared with usual care (UC).\ud \ud Design Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families.\ud \ud Setting Three National Health Service Primary Care Trusts in West Midlands, England.\ud \ud Participants Overweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6–11 years and their parents/carers, recruited March 2012–February 2014.\ud \ud Interventions FFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site.\ud \ud Main outcome measures Primary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style.\ud \ud Results 115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI −0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p

© 2017 Royal College of Obstetricians and Gynaecologists Background: Randomised trials and their syntheses in meta-analyses offer a unique opportunity to assess the frequency and severity of adverse reactions. Objective: To assess safety reporting in pre-eclampsia trials. Search strategy: Systematic search using bibliographic databases, including Cochrane Central Register of Controlled Trials, Embase, and MEDLINE, from inception to August 2017. Selection criteria: Randomised trials evaluating anticonvulsant or antihypertensive medication for pre-eclampsia. Data collection and analysis: Descriptive statistics appraising the adequacy of adverse reaction and toxicity reporting. Main results: We included 60 randomised trials. Six trials (10%) were registered with the International Clinical Trials Registry Platform, two registry records referred to adverse reactions, stating ‘safety and toleration’ and ‘possible side effects’ would be collected. Twenty-six trials (43%) stated the frequency of withdrawals within each study arm, and five trials (8%) adequately reported these withdrawals. Adverse reactions were inconsistently reported across eligible trials: 24 (40%) reported no serious adverse reactions and 36 (60%) reported no mild adverse reactions. The methods of definition or measurement of adverse reactions were infrequently reported within published trial reports. Conclusions: Pre-eclampsia trials regularly omit critical information related to safety. Despite the paucity of reporting, randomised trials collect an enormous amount of safety data. Developing and implementing a minimum data set could help to improve safety reporting, permitting a more balanced assessment of interventions by considering the trade-off between the benefits and harms. Tweetable abstract: Developing @coreoutcomes could help to improve safety reporting in #preeclampsia trials. @NIHR_DC.

Background Variation in outcome collection and reporting is a serious hindrance to progress in our specialty; therefore, over 80 journals have come together to support the development, dissemination, and implementation of core outcome sets. Objective This study systematically reviewed and characterised registered, progressing, or completed core outcome sets relevant to women's and newborn health. Search strategy Systematic search using the Core Outcome Measures in Effectiveness Trial initiative and the Core Outcomes in Women's and Newborn Health initiative databases. Selection criteria Registry entries, protocols, systematic reviews, and core outcome sets. Data collection and analysis Descriptive statistics to describe characteristics and results. Results There were 49 core outcome sets registered in maternal and newborn health, with the majority registered in 2015 (n = 22; 48%) or 2016 (n = 16; 32%). Benign gynaecology (n = 8; 16%) and newborn health (n = 3; 6%) are currently under-represented. Twenty-four (52%) core outcome sets were funded by international (n = 1

OBJECTIVE: To develop consensus on a set of key clinical outcomes for the evaluation of preventive interventions for preterm birth in asymptomatic pregnant women. METHODS: A two-stage web-based Delphi survey and a face-to-face meeting of key stakeholders were employed to develop consensus on a set of critical and important outcomes. We approached five stakeholder groups (parents, midwives, obstetricians, neonatologists and researchers) from middle and high-income countries. Outcomes subjected to the Delphi survey were identified by systematic literature review and stakeholder input. Survey participants scored each outcome on a 9-point Likert scale anchored between 1 (limited importance) and 9 (critical importance). They had the opportunity to reflect upon total and stakeholder sub-group feedback between survey stages. For consensus, defined a priori, outcomes required at least 70% of participants of each stakeholder group scoring them as ‘critical’ and less than 15% as ‘limited’. RESULTS: A total of 228 participants from five stakeholder groups from three lower-middle-income countries, seven upper-middle-income countries and 17 high-income countries were asked to score 31 outcomes. Of these participants, 195 completed the first survey and 174 the second. Consensus was reached on 13 core outcome: four related to pregnant women: maternal mortality, maternal infection or inflammation, prelabor rupture of membranes, and harm to mother from intervention. Nine related to offspring: gestation age at birth, offspring mortality, birth weight, early neurodevelopmental morbidity, late neurodevelopmental morbidity, gastrointestinal morbidity, infection, respiratory morbidity, and harm to offspring from intervention. CONCLUSIONS: This core outcome set for studies that evaluate prevention of preterm birth developed with an international multidisciplinary perspective will ensure that data from trials that assess prevention of preterm birth can be compared and combined.