Publications by authors named "Malgorzata M Bala"

89 Publications

What are the effects of teaching Evidence-Based Health Care (EBHC) at different levels of health professions education? An updated overview of systematic reviews.

PLoS One 2021 22;16(7):e0254191. Epub 2021 Jul 22.

Centre for Evidence-based Health Care, Division of Epidemiology and Biostatistics, Department of Global Health, Stellenbosch University, Cape Town, South Africa.

Background: Evidence-based healthcare (EBHC) knowledge and skills are recognised as core competencies of healthcare professionals worldwide, and teaching EBHC has been widely recommended as an integral part of their training. The objective of this overview of systematic reviews (SR) was to update evidence and assess the effects of various approaches for teaching evidence-based health care (EBHC) at undergraduate (UG) and postgraduate (PG) medical education (ME) level on changes in knowledge, skills, attitudes and behaviour.

Methods And Findings: This is an update of an overview that was published in 2014. The process followed standard procedures specified for the previous version of the overview, with a modified search. Searches were conducted in Epistemonikos for SRs published from 1 January 2013 to 27 October 2020 with no language restrictions. We checked additional sources for ongoing and unpublished SRs. Eligibility criteria included: SRs which evaluated educational interventions for teaching EBHC compared to no intervention or a different strategy were eligible. Two reviewers independently selected SRs, extracted data and evaluated quality using standardised instrument (AMSTAR2). The effects of strategies to teach EBHC were synthesized using a narrative approach. Previously published version of this overview included 16 SR, while the updated search identified six additional SRs. We therefore included a total of 22 SRs (with a total of 141 primary studies) in this updated overview. The SRs evaluated different educational interventions of varying duration, frequency, and format to teach various components of EBHC at different levels of ME (UG, PG, mixed). Most SRs assessed a range of EBHC related outcomes using a variety of assessment tools. Two SRs included randomised controlled trials (RCTs) only, while 20 reviews included RCTs and various types of non-RCTs. Diversity of study designs and teaching activities as well as aggregated findings at the SR level prevented comparisons of the effects of different techniques. In general, knowledge was improved across all ME levels for interventions compared to no intervention or pre-test scores. Skills improved in UGs, but less so in PGs and were less consistent in mixed populations. There were positive changes in behaviour among UGs and PGs, but not in mixed populations, with no consistent improvement in attitudes in any of the studied groups. One SR showed improved patient outcomes (based on non-randomised studies). Main limitations included: poor quality and reporting of SRs, heterogeneity of interventions and outcome measures, and short-term follow up.

Conclusions: Teaching EBHC consistently improved EBHC knowledge and skills at all levels of ME and behaviour in UGs and PGs, but with no consistent improvement in attitudes towards EBHC, and little evidence of the long term influence on processes of care and patient outcomes. EBHC teaching and learning should be interactive, multifaceted, integrated into clinical practice, and should include assessments.

Study Registration: The protocol for the original overview was developed and approved by Stellenbosch University Research Ethics Committee S12/10/262.

Update Of The Overview: Young T, Rohwer A, Volmink J, Clarke M. What are the effects of teaching evidence-based health care (EBHC)? Overview of systematic reviews. PLoS One. 2014;9(1):e86706. doi: 10.1371/journal.pone.0086706.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0254191PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8297776PMC
July 2021

Evaluating adults' health-related values and preferences about unprocessed red meat and processed meat consumption: protocol for a cross-sectional mixed-methods study.

F1000Res 2020 11;9:346. Epub 2020 May 11.

Iberoamerican Cochrane Centre, Biomedical Research Institute San Pau (IIB Sant Pau), Barcelona, Spain.

People need to choose from a wide range of foods, and in addition to availability and accessibility, people's values and preferences largely determine their daily food choices. Given the potential adverse health consequences of red and processed meat and the limited knowledge on individuals' health-related values and preferences on the topic, such data would be useful in the development of recommendations regarding meat consumption. We will perform a cross-sectional mixed methods study. The study population will consist of adult omnivores currently consuming a minimum of three weekly servings of either unprocessed red meat or processed meat. We will explore participants' willingness to stop or reduce their unprocessed red meat, or their processed meat consumption through a direct-choice exercise. This exercise will consist of presenting a scenario tailored to each individual's average weekly consumption. That is, based on a systematic review and meta-analysis of the best estimate of the risk reduction in overall cancer incidence and cancer mortality, we will ask participants if they would stop their consumption, and/or reduce their average consumption. We will also present the corresponding certainty of the evidence for the potential risk reductions. Finally, we will measure their meat consumption three months after the interview and determine if they have made any changes to their average consumption. The research protocol was approved by the ethics committees in Canada (Research Ethics Board, Dalhousie University), Spain (Comitè Ètic d'Investigació Clínica de l'IDIAP Jordi Gol), Poland (The Bioethics Committee of the Jagiellonian University), and Brazil (National Research Ethics Commission). The study is based on voluntary participation and informed written consent. Results from this project will be disseminated through publications and presentations.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.12688/f1000research.23593.2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8176263PMC
July 2021

Electrocoagulation for liver metastases.

Cochrane Database Syst Rev 2021 01 28;1:CD009497. Epub 2021 Jan 28.

Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Jagiellonian University Medical College, Krakow, Poland.

Background: Primary liver tumours and liver metastases from colorectal carcinoma are two of the most common malignant tumours to affect the liver. The liver is second only to the lymph nodes as the most common site for metastatic disease. More than half of the people with metastatic liver disease will die from metastatic complications. Electrocoagulation by diathermy is a method used to destroy tumour tissue, using a high-frequency electric current generating high temperatures, applied locally with an electrode (needle, blade, or ball). The objective of this method is to destroy the tumour completely, if possible, in a single session. With the time, electrocoagulation by diathermy has been replaced by other techniques, but the evidence is unclear.

Objectives: To assess the beneficial and harmful effects of electrocoagulation by diathermy, administered alone or with another intervention, versus no intervention, other ablation methods, or systemic treatments in people with liver metastases.

Search Methods: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE Ovid, Embase Ovid, LILACS, Science Citation Index Expanded, Conference Proceedings Citation Index - Science, CINAHL, ClinicalTrials.gov, ICTRP, and FDA to October 2020.

Selection Criteria: We considered all randomised trials that assessed beneficial and harmful effects of electrocoagulation by diathermy, administered alone or with another intervention, versus comparators, in people with liver metastases, regardless of the location of the primary tumour.

Data Collection And Analysis: We used standard methodological procedures expected by Cochrane. We assessed risk of bias of the included trial using predefined risk of bias domains, and presented the review results incorporating the certainty of the evidence using GRADE.

Main Results: We included one randomised clinical trial with 306 participants (175 males; 131 females) who had undergone resection of the sigmoid colon, and who had five or more visible and palpable hepatic metastases. The diagnosis was confirmed by histological assessment (biopsy) and by carcinoembryonic antigen (CEA) level. The trial was conducted in Iraq. The age of participants ranged between 38 and 79 years. The participants were randomised to four different study groups. The liver metastases were biopsied and treated (only once) in three of the groups: 75 received electrocoagulation by diathermy alone, 76 received electrocoagulation plus allopurinol, 78 received electrocoagulation plus dimethyl sulphoxide. In the fourth intervention group, 77 participants functioning as controls received a vehicle solution of allopurinol 5 mL 4 x a day by mouth; the metastases were left untouched. The status of the liver and lungs was followed by ultrasound investigations, without the use of a contrast agent. Participants were followed for five years. The analyses are based on per-protocol data only analysing 223 participants. We judged the trial to be at high risk of bias. After excluding 'nonevaluable patients', the groups seemed comparable for baseline characteristics. Mortality due to disease spread at five-year follow-up was 98% in the electrocoagulation group (57/58 evaluable people); 87% in the electrocoagulation plus allopurinol group (46/53 evaluable people); 86% in the electrocoagulation plus dimethyl sulphoxide group (49/57 evaluable people); and 100% in the control group (55/55 evaluable people). We observed no difference in mortality between the electrocoagulation alone group versus the control group (risk ratio (RR) 0.98, 95% confidence interval (CI) 0.94 to 1.03; 113 participants; very low-certainty evidence). We observed lower mortality in the electrocoagulation combined with allopurinol or dimethyl sulphoxide group versus the control group (RR 0.87, 95% CI 0.80 to 0.95; 165 participants; low-certainty evidence). We are very uncertain regarding post-operative deaths between the electrocoagulation alone group versus the control group (RR 1.03, 95% CI 0.07 to 16.12; 152 participants; very low-certainty evidence) and between the electrocoagulation combined with allopurinol or dimethyl sulphoxide groups versus the control group (RR 1.00, 95% CI 0.09 to 10.86; 231 participants; very low-certainty evidence). The trial authors did not report data on number of participants with other adverse events and complications, recurrence of liver metastases, time to progression of liver metastases, tumour response measures, and health-related quality of life. Data on failure to clear liver metastases were not provided for the control group. There was no information on funding or conflict of interest. We identified no ongoing trials.

Authors' Conclusions: The evidence on the beneficial and harmful effects of electrocoagulation alone or in combination with allopurinol or dimethyl sulphoxide in people with liver metastases is insufficient, as it is based on one randomised clinical trial at low to very low certainty. It is very uncertain if there is a difference in all-cause mortality and post-operative mortality between electrocoagulation alone versus control. It is also uncertain if electrocoagulation in combination with allopurinol or dimethyl sulphoxide may result in a slight reduction of all-cause mortality in comparison with a vehicle solution of allopurinol (control). It is very uncertain if there is a difference in post-operative mortality between the electrocoagulation combined with allopurinol or dimethyl sulphoxide group versus control. Data on other adverse events and complications, failure to clear liver metastases or recurrence of liver metastases, time to progression of liver metastases, tumour response measures, and health-related quality of life were most lacking or insufficiently reported for analysis. Electrocoagulation by diathermy is no longer used in the described way, and this may explain the lack of further trials.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD009497.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094173PMC
January 2021

Efficacité et innocuité des corticostéroïdes dans le traitement de la COVID-19 selon des données pour la COVID-19, d’autres infections aux coronavirus, l’influenza, la pneumonie extrahospitalière et le syndrome de détresse respiratoire aiguë : revue systématique et méta-analyse.

CMAJ 2020 Nov;192(47):E1571-E1584

Département de Health Research Methods, Evidence and Impact (Ye, Tangamornsuksan, Rochwerg, Guyatt, Colunga-Lozano, Yao, Motaghi, Fang, Xiao), Université McMaster, Hamilton, Ont.; département de pharmacie (Wang), hôpital de Chaoyang à Beijing, Capital Medical University, Beijing (Chine); département de médecine clinique (Colunga-Lozano), centre des sciences de la santé, université de Guadalajara, Guadalajara (Mexique); département de médecine Communautaire (Prasad), North DMC Medical College, New Delhi (Inde); Faculté de médecine et de santé publique (Tangamornsuksan), HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok (Thaïlande); département de médecine (Rochwerg); DeGroote Institute for Pain Research and Care (Couban), Université McMaster, Hamilton, Ont.; département de pharmacie clinique (Ghadimi), Faculté de pharmacie, Tehran University of Medical Sciences, Téhéran (Iran); chaire d'épidémiologie et de médecine préventive (Bala), École de médecine de l'Université Jagellonne, Cracovie (Pologne); département de biostatistique (Gomaa), High institute of Public Health, Alexandria University, Alexandrie (Égypte); Centre d'information sur les médicaments (Gomaa), Tanta Chest Hospital, ministère de la Santé et des Populations, Égypte; Clinical Medicine College of Acupuncture, Moxibustion and Rehabilitation (Fang), Guangzhou University of Chinese Medicine, Guangdong (Chine); West China School of Nursing (Xiao), West China Hospital, Sichuan University (Chine)

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1503/cmaj.200645-fDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7721260PMC
November 2020

Efficacy of probiotics in patients with morbid obesity undergoing bariatric surgery: a systematic review and meta-analysis.

Surg Obes Relat Dis 2020 Dec 4;16(12):2105-2116. Epub 2020 Sep 4.

Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland; Systematic Reviews Unit, Jagiellonian University Medical College, Krakow, Poland. Electronic address:

Bariatric surgery is considered effective for morbid obesity, and probiotic supplementation might provide some benefits. We aimed to revise the evidence regarding probiotic supplementation in patients with morbid obesity undergoing bariatric surgery. MEDLINE, Embase, Web of Science, CENTRAL, and trial registers were searched up to April 1, 2020. We included randomized controlled trials and controlled clinical trials, and outcomes of interest were weight change, quality of life, gastrointestinal symptoms, and adverse events. All stages of the review were done by 2 authors independently and we followed Cochrane Handbook guidance. We screened 2541 references and included 5 studies. Probiotics may have minor to no effect regarding percentage excess weight loss (%EWL) at 6 weeks (mean difference [MD], .28; 95% CI, -9.53 to 10.09; 44 participants, 2 studies), 3 months (MD, 5.47; 95% CI, -3.22 to 14.17; 165 participants, 3 studies), 6 months (MD, .46; 95% CI, -8.14 to 9.07; 115 participants, 2 studies), and 12 months post surgery (MD, .35; 95% CI, -8.66 to 9.37; 123 participants, 2 studies). We observed short-term improvement in gastrointestinal symptoms. There was no important effect on quality of life and no meaningful adverse events. Because probiotic supplementation might provide some benefit with respect to weight loss, might alleviate some gastrointestinal symptoms, and is associated with minor or no adverse events, continuous supplementation might be worth considering in certain individuals. Our findings are based on the body of evidence of very low certainty, and further well-designed randomized controlled trials are required to elucidate the effect and strengthen the certainty in the estimates.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.soard.2020.08.038DOI Listing
December 2020

Antiplatelet and anticoagulant agents for secondary prevention of stroke and other thromboembolic events in people with antiphospholipid syndrome.

Cochrane Database Syst Rev 2020 10 12;10:CD012169. Epub 2020 Oct 12.

Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.

Background: Antiphospholipid syndrome (APS) is a systemic autoimmune disease characterized by arterial or venous thrombosis (or both), and/or pregnancy morbidity in association with the presence of antiphospholipid antibodies. The prevalence of APS is estimated at 40 to 50 cases per 100,000 people. The most common sites of thrombosis are cerebral arteries and deep veins of the lower limbs. People with a definite APS diagnosis have an increased lifetime risk of recurrent thrombotic events.

Objectives: To assess the effects of antiplatelet (AP) or anticoagulant agents, or both, for the secondary prevention of recurrent thrombosis, particularly ischemic stroke, in people with APS.

Search Methods: We last searched the MEDLINE, Embase, CENTRAL, Cochrane Stroke Group Trials Register, and ongoing trials registers on 22 November 2019. We checked reference lists of included studies, systematic reviews, and practice guidelines. We also contacted experts in the field.

Selection Criteria: We included randomized controlled trials (RCTs) that evaluated any anticoagulant or AP agent, or both, in the secondary prevention of thrombosis in people with APS, according to the criteria valid when the study took place. We did not include studies specifically addressing women with obstetrical APS.

Data Collection And Analysis: Pairs of review authors independently worked on each step of the review, following Cochrane methods. We summarized the evidence using the GRADE approach.

Main Results: We identified eight studies including 811 participants that compared different AP or anticoagulant agents. NOAC (non-VKA oral anticoagulant: rivaroxaban 15 or 20 mg/d) versus standard-dose VKA (vitamin K antagonist: warfarin at moderate International Normalized Ratio [INR] - 2.5) or adjusted [INR 2.0-3.0] dose): In three studies there were no differences in any thromboembolic event (including death) and major bleeding (moderate-certainty evidence), but an increased risk of stroke (risk ratio [RR] 14.13, 95% confidence interval [CI] 1.87 to 106.8; moderate-certainty evidence). One of the studies reported a small benefit of rivaroxaban in terms of quality of life at 180 days measured as health state on Visual Analogue Scale (mean difference [MD] 7 mm, 95% CI 2.01 to 11.99; low-certainty evidence), but not measured as health utility on a scale from 0 to 1 (MD 0.04, 95% CI -0.02 to 0.10; low-certainty evidence). High-dose VKA (warfarin with a target INR of 3.1 to 4.0 [mean 3.3] or 3.5 [mean 3.2]) versus standard-dose VKA (warfarin with a target INR of 2.0 to 3.0 [mean 2.3] or 2.5 [mean 2.5]): In two studies there were no differences in the rates of thrombotic events and major bleeding (RR 2.22, 95% CI 0.79 to 6.23, low-certainty evidence), but an increased risk of minor bleeding in one study during a mean of 3.4 years (standard deviation [SD] 1.2) of follow-up (RR 2.55, 95% CI 1.07 to 6.07). In both trials there was evidence of a higher risk of any bleeding (hazard ratio [HR] 2.03 95% CI 1.12 to 3.68; low-certainty evidence) in the high-dose VKA group, and for this outcome (any bleeding) the incidence is not different, only the time to event is showing an effect. Standard-dose VKA plus a single AP agent (warfarin at a target INR of 2.0 to 3.0 plus aspirin 100 mg/d) versus standard-dose VKA (warfarin at a target INR of 2.0 to 3.0): One high-risk-of-bias study showed an increased risk of any thromboembolic event with combined treatment (RR 2.14, 95% CI 1.04 to 4.43; low-certainty evidence) and reported on major bleeding with five cases in the combined treatment group and one case in the standard-dose VKA treatment group, resulting in RR 7.42 (95% CI 0.91 to 60.7; low-certainty evidence) and no differences for secondary outcomes (very low- to low-certainty evidence). Single/dual AP agent and standard-dose VKA (pooled results): Two high-risk-of-bias studies compared a combination of AP and VKA (aspirin 100 mg/d plus warfarin or unspecified VKA at a target INR of 2.0 to 3.0 or 2.0 to 2.5) with a single AP agent (aspirin 100 mg/d), but did not provide any conclusive evidence regarding the effects of those drugs in people with APS (very low-certainty evidence). One of the above-mentioned studies was a three-armed study that compared a combination of AP and VKA (aspirin 100 mg/d plus warfarin at a target INR of 2.0 to 2.5) with dual AP therapy (aspirin 100 mg/d plus cilostazol 200 mg/d) and dual AP therapy (aspirin 100 mg/d plus cilostazol 200 mg/d) versus a single AP treatment (aspirin 100 mg/d). This study reported on stroke (very low-certainty evidence) but did not report on any thromboembolic events, major bleeding, or any secondary outcomes. We identified two ongoing studies and three studies are awaiting classification.

Authors' Conclusions: The evidence identified indicates that NOACs compared with standard-dose VKAs may increase the risk of stroke and do not appear to alter the risk of other outcomes (moderate-certainty evidence). Using high-dose VKA versus standard-dose VKA did not alter the risk of any thromboembolic event or major bleeding but may increase the risk of any form of bleeding (low-certainty evidence). Standard-dose VKA combined with an AP agent compared with standard-dose VKA alone may increase the risk of any thromboembolic event and does not appear to alter the risk of major bleeding or other outcomes (low-certainty evidence). The evidence is very uncertain about the benefit or harm of using standard-dose VKA plus AP agents versus single or dual AP therapy, or dual versus single AP therapy, for the secondary prevention of recurrent thrombosis in people with APS (very low-certainty evidence).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD012169.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094585PMC
October 2020

Systematic review and meta-analysis of perioperative behavioral lifestyle and nutritional interventions in bariatric surgery: a call for better research and reporting.

Surg Obes Relat Dis 2020 Dec 26;16(12):2088-2104. Epub 2020 Aug 26.

Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Faculty of Medicine, Jagiellonian University Medical College, Krakow, Poland; Systematic Reviews Unit, Jagiellonian University Medical College, Krakow, Poland. Electronic address:

Bariatric surgery is considered the most effective treatment for people with morbid obesity, and certain interventions could enhance its long-term results. We searched MEDLINE, Embase, Web of Science, CENTRAL, and trial registers up to January 1, 2020. Randomized controlled trials, where behavioral lifestyle or nutritional interventions were provided perioperatively were included. Primary outcome was weight change. Two reviewers independently performed each stage of the review. Altogether 6652 references were screened. 31 studies were included for qualitative synthesis and 22 studies for quantitative synthesis. Interventions varied greatly, thus limiting possibility of synthesizing all results. Six groups of interventions were discerned, and we used standardized mean differences for synthesis. Low to very-low certainty evidence suggests that physical activity, nonvitamin nutritional interventions, vitamins, psychotherapy, and counseling but not combined interventions might bring some benefit regarding short-term postsurgery follow-ups (up to 12 mo), but the estimates varied and results were not statistically significant, except for 12 months follow-ups regarding counseling. Psychotherapy and counseling, but not vitamins and combined interventions, may provide some benefit at longer follow-ups (over 12 mo), but the certainty of evidence was low to very-low and statistically significant results were observed in comparisons including data from single studies with small sample sizes only. Included studies expressed an outcome "weight change" using 20 different measures. Misreporting of data and huge variety of outcomes do not benefit systematic analyses and may possibly lead to confusion of both researchers and readers. We suggest that authors follow a predefined set of outcomes when reporting the results of their studies. The initiative to produce "core outcome set" for clinical trials in bariatric surgery trials is currently underway.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.soard.2020.08.008DOI Listing
December 2020

Anti-cytokine targeted therapies for ANCA-associated vasculitis.

Cochrane Database Syst Rev 2020 09 29;9:CD008333. Epub 2020 Sep 29.

2nd Department of Internal Medicine, Jagiellonian University Medical College, Krakow, Poland.

Background: Anti-neutrophilic cytoplasmic antibodies (ANCA)-associated vasculitis (AAV) are a group of rare auto-inflammatory diseases that affects mainly small vessels. AAV includes: granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA). Anti-cytokine targeted therapy uses biological agents capable of specifically targeting and neutralising cytokine mediators of the inflammatory response.

Objectives: To assess the benefits and harms of anti-cytokine targeted therapy for adults with AAV.

Search Methods: We searched the Cochrane Central Register of Controlled Trials (2019, Issue 7), MEDLINE and Embase up to 16 August 2019. We also examined reference lists of articles, clinical trial registries, websites of regulatory agencies and contacted manufacturers.

Selection Criteria: Randomised controlled trials (RCTs) or controlled clinical trials of targeted anti-cytokine therapy in adults (18 years or older) with AAV compared with placebo, standard therapy or another modality and anti-cytokine therapy of different type or dose.

Data Collection And Analysis: We used standard methodological procedures expected by Cochrane.

Main Results: We included four RCTs with a total of 440 participants (mean age 48 to 56 years). We analysed the studies in three groups: 1) mepolizumab (300 mg; three separate injections every four weeks for 52 weeks) versus placebo in participants with relapsing or refractory EGPA; 2) belimumab (10 mg/kg on days 0, 14, 28 and every 28 days thereafter until 12 months after the last participant was randomised) or etanercept (25 mg twice a week) with standard therapy (median 25 months) versus placebo with standard therapy (median 19 months) in participants with GPA/MPA; and 3) infliximab (3 mg/kg on days 1 and 14, before the response assessment on day 42) versus rituximab (0.375g/m on days 1, 8, 15 and 22) in participants with refractory GPA for up to 12 months. None of the studies were assessed as low risk of bias in all domains: one study did not report randomisation or blinding methods clearly. Three studies were at high risk and one study was at unclear risk of bias for selective outcome reporting. One trial with 136 participants with relapsing or refractory EGPA compared mepolizumab with placebo during 52 weeks of follow-up and observed one death in the mepolizumab group (1/68, 1.5%) and none in the placebo group (0/68, 0%) (Peto odds ratio (OR) 7.39, 95% confidence interval (CI) 0.15 to 372.38; low-certainty evidence). Low-certainty evidence suggests that more participants in the mepolizumab group had ≥ 24 weeks of accrued remission over 52 weeks compared to placebo (27.9% versus 2.9%; risk ratio (RR) 9.5, 95% CI 2.30 to 39.21), and durable remission within the first 24 weeks sustained until week 52 (19.1% mepolizumab versus 1.5% placebo; RR 13.0, 95% CI 1.75 to 96.63; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% Cl 4 to 13). Mepolizumab probably decreases risk of relapse (55.8% versus 82.4%; RR 0.68, 95% CI 0.53 to 0.86; NNTB 4, 95% CI 3 to 9; moderate-certainty evidence). There was low-certainty evidence regarding similar frequency of adverse events (AEs): total AEs (96.9% versus 94.1%; RR 1.03, 95% CI 0.96 to 1.11), serious AEs (17.7% versus 26.5%; RR 0.67, 95% CI 0.35 to 1.28) and withdrawals due to AEs (2.9% versus 1.5%; RR 2.00, 95% CI 0.19 to 21.54). Disease flares were not measured. Based on two trials with different follow-up periods (mean of 27 months for etanercept study; up to four years for belimumab study) including people with GPA (n = 263) and a small group of participants with MPA (n = 22) analysed together, we found low-certainty evidence suggesting that adding an active drug (etanercept or belimumab) to standard therapy does not increase or reduce mortality (3.4% versus 1.4%; Peto OR 2.45, 95% CI 0.55 to 10.97). Etanercept may have little or no effect on remission (92.3% versus 89.5%; RR 0.97, 95% CI 0.89 to 1.07), durable remission (70% versus 75.3%; RR 0.93, 95% CI 0.77 to 1.11; low-certainty evidence) and disease flares (56% versus 57.1%; RR 0.98, 95% CI 0.76 to 1.27; moderate-certainty evidence). Low-certainty evidence suggests that belimumab does not increase or reduce major relapse (1.9% versus 0%; RR 2.94, 95% CI 0.12 to 70.67) or any AE (92.5% versus 82.7%; RR 1.12, 95% CI 0.97 to 1.29). Low-certainty evidence suggests a similar frequency of serious or severe AEs (47.6% versus 47.6%; RR 1.00, 95% CI 0.80 to 1.27), but more frequent withdrawals due to AEs in the active drug group (11.2%) compared to the placebo group (4.2%), RR 2.66, 95% CI 1.07 to 6.59). One trial involving 17 participants with refractory GPA compared infliximab versus rituximab added to steroids and cytotoxic agents for 12 months. One participant died in each group (Peto OR 0.88, 95% CI, 0.05 to 15.51; 11% versus 12.5%). We have very low-certainty evidence for remission (22% versus 50%, RR 0.44, 95% Cl 0.11 to 1.81) and durable remission (11% versus 50%, RR 0.22, 95% CI 0.03 to 1.60), any severe AE (22.3% versus 12.5%; RR 1.78, 95% CI 0.2 to 16.1) and withdrawals due to AEs (0% versus 0%; RR 2.70, 95% CI 0.13 to 58.24). Disease flare/relapse and the frequency of any AE were not reported.

Authors' Conclusions: We found four studies but concerns about risk of bias and small sample sizes preclude firm conclusions. We found moderate-certainty evidence that in patients with relapsing or refractory EGPA, mepolizumab compared to placebo probably decreases disease relapse and low-certainty evidence that mepolizumab may increase the probability of accruing at least 24 weeks of disease remission. There were similar frequencies of total and serious AEs in both groups, but the study was too small to reliably assess these outcomes. Mepolizumab may result in little to no difference in mortality. However, there were very few events. In participants with GPA (and a small subgroup of participants with MPA), etanercept or belimumab may increase the probability of withdrawal due to AEs and may have little to no impact on serious AEs. Etanercept may have little or no impact on durable remission and probably does not reduce disease flare.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD008333.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8094990PMC
September 2020

Mortality in patients after acute myocardial infarction managed by cardiologists and primary care physicians: a systematic review.

Pol Arch Intern Med 2020 10 4;130(10):860-867. Epub 2020 Aug 4.

Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Jagiellonian University Medical College, Kraków, Poland

Introduction: Mortality following acute myocardial infarction (AMI) remains high despite of progress in invasive and noninvasive treatments.

Objectives: This study aimed to compare the outcomes of ambulatory treatment provided by cardiologists versus general practitioners (GPs) in post‑AMI patients.

Patients And Methods: We conducted a systematic search in 3 electronic databases for interventional and observational studies that reported all‑cause mortality, mortality from cardiovascular causes, stroke, and myocardial infarction at long‑term follow‑up following AMI. We assessed the risk of bias of the included studies using the Risk of Bias in Nonrandomized Studies of Interventions (ROBINS‑I) tool. For randomized trials, we used the revised Cochrane risk of bias tool (RoB 2.0).

Results: Two nonrandomized studies fulfilled the inclusion criteria. We assessed these studies as having a moderate risk of bias. We did not pool the results owing to significant heterogeneity between the studies. Patients consulted by both a cardiologist and a GP were at lower risk of all‑cause death as compared with patients consulted by a cardiologist only (risk ratio [RR], 0.92; 95% CI, 0.85-0.99). Patients consulted by a cardiologist with or without GP consultation were at lower risk of all‑cause death compared with those consulted by a GP only in both studies (RR, 0.8; 95% CI, 0.75-0.85 and RR, 0.44; 95% CI, 0.41-0.47).

Conclusions: Patients after AMI consulted by both a cardiologist and a GP may be at lower risk of death compared with patients consulted by a GP or a cardiologist only. However, these findings are based on moderate‑quality nonrandomized studies. We found no evidence on the relation between the specialization of the physician and the risk of cardiovascular death, stroke, or myocardial infarction in AMI survivors.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.20452/pamw.15542DOI Listing
October 2020

Correction: Offline Digital Education for Postregistration Health Professions: Systematic Review and Meta-Analysis by the Digital Health Education Collaboration.

J Med Internet Res 2020 Jun 23;22(6):e20316. Epub 2020 Jun 23.

Centre for Population Health Sciences, Lee Kong Chian School of Medicine, Nanyang Technological University Singapore, Singapore, Singapore.

[This corrects the article DOI: 10.2196/12968.].
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2196/20316DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7381050PMC
June 2020

Support for Metastatic Breast Cancer Patients-a Systematic Review.

J Cancer Educ 2020 12;35(6):1061-1067

Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland.

Our study objective was to evaluate existing evidence on different types of support received by metastatic breast cancer patients as well as the need for support expressed by such patients. We searched Medline and EMBASE up to January 2019 for survey studies that aimed to assess any type of support among women of any age, with metastatic breast cancer diagnosis. Two reviewers independently screened titles and abstracts, then full texts of retrieved records against inclusion/exclusion criteria, and extracted the data and assessed the quality of included studies with AXIS tool. From a total of 2876 abstracts, we selected 100 potentially eligible full-text articles, and finally, we included 12 records reporting on 11 studies. Due to the variability of methods used to measure and define support, it was not possible to quantitatively synthesize data; therefore, we synthesized them narratively. The quality of the included studies was moderate. We found that most patients are satisfied with the received psychosocial, emotional, informational, and medical support. In the analysis of any support received from a certain type of group of people, we found that the majority of patients reported receiving sufficient support from their family, friends, and healthcare providers. Ten studies showed a high need for informational support. If asked about the need for psychosocial, medical, and sexual support, women also declared the need for such support. Our review revealed that the patients generally receive support from their community but they express high need for information and treatment choice. PROSPERO CRD42019127496.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s13187-020-01783-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7679297PMC
December 2020

Development and Validation of the Polish Version of Questionnaire for the Assessment of Psychosocial and Functional Effects of Metastatic Breast Cancer.

J Cancer Educ 2020 Jun 3. Epub 2020 Jun 3.

Department of Hygiene and Dietetics, Faculty of Medicine, Jagiellonian University Medical College, Krakow Systematic Reviews Unit - Polish Cochrane Branc, Jagiellonian University Medical College, Krakow, Poland.

The aim of this study is to adapt culturally and validate a questionnaire assessing experiences of metastatic breast cancer (MBC) patients in Poland. The questionnaire development was divided into three phases: bidirectional translation of the survey, testing it for acceptability and relevance, and field testing. In the field study, 320 women with MBC completed the questionnaire, 50 of them twice for retest. Basic psychometric properties of the items used in questionnaire were analyzed. Test-retest reliability was assessed using kappa coefficient. In case of some items, known-group validity was verified. We made minor revisions to the construction and wording of the questionnaire. The analysis of the variables distributions used in the final version of the questionnaire showed that there were no redundant response categories across items. We checked for the floor and ceiling effect. It was found that there were a total of < 40% respondents selecting the lowest or the highest possible score. The observed values of the Kappa coefficients indicated high tool's stability. We compared predefined groups for known-group validity; few expected associations reached statistical significance, which supported the overall validity of the tool. The questionnaire has been successfully developed. The results confirm the validity, reliability, and applicability.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s13187-020-01780-8DOI Listing
June 2020

Efficacy and safety of corticosteroids in COVID-19 based on evidence for COVID-19, other coronavirus infections, influenza, community-acquired pneumonia and acute respiratory distress syndrome: a systematic review and meta-analysis.

CMAJ 2020 07 14;192(27):E756-E767. Epub 2020 May 14.

Department of Health Research Methods, Evidence and Impact (Ye, Tangamornsuksan, Rochwerg, Guyatt, Colunga-Lozano, Yao, Motaghi, Fang, Xiao), McMaster University, Hamilton, Ont.; Department of Pharmacy (Wang), Beijing Chaoyang Hospital, Capital Medical University, Beijing, China; Department of Clinical Medicine (Colunga-Lozano), Health Science Center, Universidad de Guadalajara, Guadalajara, Mexico; Department of Community Medicine (Prasad), North DMC Medical College, New Delhi, India; Faculty of Medicine and Public Health (Tangamornsuksan), HRH Princess Chulabhorn College of Medical Science, Chulabhorn Royal Academy, Bangkok, Thailand; Department of Medicine (Rochwerg); DeGroote Institute for Pain Research and Care (Couban), McMaster University, Hamilton, Ont.; Department of Clinical Pharmacy (Ghadimi), Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran; Chair of Epidemiology and Preventive Medicine Jagiellonian (Bala), University Medical College, Krakow, Poland; Biostatistics Department (Gomaa), High institute of Public Health, Alexandria University, Alexandria, Egypt; Drug Information Center (Gomaa), Tanta Chest Hospital, Ministry of Health and Population, Egypt; Clinical Medicine College of Acupuncture, Moxibustion and Rehabilitation (Fang), Guangzhou University of Chinese Medicine, Guangdong, China; West China School of Nursing (Xiao), West China Hospital, Sichuan University, China

Background: Very little direct evidence exists on use of corticosteroids in patients with coronavirus disease 2019 (COVID-19). Indirect evidence from related conditions must therefore inform inferences regarding benefits and harms. To support a guideline for managing COVID-19, we conducted systematic reviews examining the impact of corticosteroids in COVID-19 and related severe acute respiratory illnesses.

Methods: We searched standard international and Chinese biomedical literature databases and prepublication sources for randomized controlled trials (RCTs) and observational studies comparing corticosteroids versus no corticosteroids in patients with COVID-19, severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS). For acute respiratory distress syndrome (ARDS), influenza and community-acquired pneumonia (CAP), we updated the most recent rigorous systematic review. We conducted random-effects meta-analyses to pool relative risks and then used baseline risk in patients with COVID-19 to generate absolute effects.

Results: In ARDS, according to 1 small cohort study in patients with COVID-19 and 7 RCTs in non-COVID-19 populations (risk ratio [RR] 0.72, 95% confidence interval [CI] 0.55 to 0.93, mean difference 17.3% fewer; low-quality evidence), corticosteroids may reduce mortality. In patients with severe COVID-19 but without ARDS, direct evidence from 2 observational studies provided very low-quality evidence of an increase in mortality with corticosteroids (hazard ratio [HR] 2.30, 95% CI 1.00 to 5.29, mean difference 11.9% more), as did observational data from influenza studies. Observational data from SARS and MERS studies provided very low-quality evidence of a small or no reduction in mortality. Randomized controlled trials in CAP suggest that corticosteroids may reduce mortality (RR 0.70, 95% CI 0.50 to 0.98, 3.1% lower; very low-quality evidence), and may increase hyperglycemia.

Interpretation: Corticosteroids may reduce mortality for patients with COVID-19 and ARDS. For patients with severe COVID-19 but without ARDS, evidence regarding benefit from different bodies of evidence is inconsistent and of very low quality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1503/cmaj.200645DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7828900PMC
July 2020

Assessment of Psychosocial and Functional Effects of Metastatic Breast Cancer in Tarnow Region of Poland and Among the Social Media Polish Group-Results from the Survey from Patients.

J Cancer Educ 2020 May 13. Epub 2020 May 13.

Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics, Faculty of Medicine, Jagiellonian University Medical College, Kopernika 7A, 31-034, Krakow, Poland.

The aim of the study was a comprehensive assessment of metastatic breast cancer patients' needs in Poland. We conducted and culturally adapted and validated "Count Us, Know Us, Join Us" Metastatic Breast Cancer Survey between November 2018 and July 2019. Two hundred ten patients treated in Tarnów completed the paper questionnaires distributed conveniently by healthcare professionals, and 110 patients completed the online survey. Almost all patients believe that new therapies are necessary, and over a half find their options of treatment limited. Support from family, friends, and healthcare professionals seems sufficient. Most patients declare a negative impact of the disease on their emotional status and ability to maintain their lifestyle, finances, and job with one-third of respondents being employed. Three-quarters of patients actively seek data about cancer. The main source of information for Polish patients is the Internet, and they are primarily interested in the ways of managing side effects and available treatment options. We identified factors related to satisfaction with communication with the healthcare professionals. The results are generally consistent with similar studies across the universe. This may indicate that several issues have not been addressed over the years, and there is an urgent need to join international forces to raise awareness and support for metastatic breast cancer patients and lobby for better treatment outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s13187-020-01760-yDOI Listing
May 2020

In-hospital mortality in Poland: what can we learn from administrative data?

Pol Arch Intern Med 2020 04 30;130(4):264-265. Epub 2020 Apr 30.

Division of Infection Control and Environmental Health, Norwegian Institute of Public Health, Oslo, Norway

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.20452/pamw.15324DOI Listing
April 2020

Erratum to "A systematic survey identified 36 criteria for assessing effect modification claims in randomized trials or meta-analyses" [J Clin Epidemiol. 2019;113:159-67].

J Clin Epidemiol 2020 Jul 4;123:189. Epub 2020 May 4.

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Department of Medicine, McMaster University, 1200 Main Street West, Hamilton, Ontario L8S 4L8, Canada.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jclinepi.2020.04.003DOI Listing
July 2020

Transarterial (chemo)embolisation versus no intervention or placebo for liver metastases.

Cochrane Database Syst Rev 2020 03 12;3:CD009498. Epub 2020 Mar 12.

Jagiellonian University Medical College, Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics; Systematic Reviews Unit, Krakow, Poland.

Background: The liver is affected by two of the most common groups of malignant tumours: primary liver tumours and liver metastases from colorectal carcinoma or other extrahepatic primary cancers. Liver metastases are significantly more common than primary liver cancer, and long-term survival rate after radical surgical treatment is approximately 50%. However, R0 resection (resection for cure) is not feasible in the majority of people; therefore, other treatments have to be considered. One possible option is based on the concept that the blood supply to hepatic tumours originates predominantly from the hepatic artery. Transarterial chemoembolisation (TACE) of the hepatic artery can be achieved by administering a chemotherapeutic drug followed by vascular occlusive agents, and can lead to selective necrosis of the liver tumour while it may leave normal parenchyma virtually unaffected. This can also be performed without chemotherapy, which is called bland transarterial embolisation (TAE).

Objectives: To assess the beneficial and harmful effects of TAE or TACE compared with no intervention or placebo in people with liver metastases.

Search Methods: We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, and four more databases (December 2019). We also searched two trials registers and the US Food and Drug Administration database (September 2019).

Selection Criteria: Randomised clinical trials assessing beneficial and harmful effects of TAE or TACE compared with no intervention or placebo for liver metastases.

Data Collection And Analysis: We followed standard Cochrane methodological procedures. We extracted information on participant characteristics, interventions, study outcomes, study design, and trial methods. Two review authors independently extracted data and assessed risk of bias. We assessed the certainty of evidence with GRADE. We resolved disagreements by discussion.

Main Results: We included one randomised clinical trial with 61 participants (43 male and 18 female) with colorectal cancer with liver metastases: 22 received transarterial embolisation (TAE; hepatic artery embolisation), 19 received transarterial chemoembolisation (TACE; 5-fluorouracil hepatic artery infusion chemotherapy with degradable microspheres), and 20 received 'no active therapeutic intervention' as a control. Most tumours were synchronous, unresectable metastases involving up to 75% of the liver. Participants were followed for a minimum of seven months. The trial was at high risk of bias. Very-low-certainty evidence found inconclusive results for mortality at 44 months between the TAE and TACE versus no intervention groups (risk ratio (RR) 0.88, 95% confidence interval (CI) 0.74 to 1.06; 61 participants). Local recurrence was reported in 10 participants without any details about the group allocation. Very-low-certainty evidence found little or no difference in mortality between the TAE and no intervention groups (RR 0.91, 95% CI 0.75 to 1.10; 42 participants). Median survival was 7 months from trial entry (range 2 to 44 months) in the TAE group and 7.9 months (range 1 to 26 months) in the control group, and 8.7 months after diagnosis (range 2 to 49 months) in the TAE group and 9.6 months (range 1 to 27 months) in the control group. The trial authors reported the differences were not statistically significant. There were no reported side effects in the control group. In the TAE group, 18 participants experienced short-term symptoms of 'post-embolisation syndrome', which were relieved with symptomatic treatment; one participant also had a local puncture site haematoma. Very-low-certainty evidence found little or no difference in mortality between the TACE and no intervention groups (RR 0.83, 95% CI 0.65 to 1.07; 39 participants). Median survival in the TACE group was 10.7 months (range 3 to 38 months) from trial entry, and 13.0 months (range 3 to 38 months) after diagnosis. The trial authors reported that differences between groups were not statistically significant. All participants experienced short-term nausea, with or without vomiting, immediately after treatment; one participant developed a wound infection, and one developed deep vein thrombosis. The trial did not measure failure to clear liver metastases, time to progression of liver metastases, tumour response measures, or health-related quality of life. Cancer Research Campaign, a non-profit organisation, provided a grant for the trial; Pharmacia Ltd. delivered the Port-a-Cath arterial delivery systems and degradable starch microspheres. We identified one ongoing trial comparing TACE plus chemotherapy versus chemotherapy alone in people with unresectable colorectal liver metastases who failed with first-line chemotherapy (NCT03783559).

Authors' Conclusions: Based on one, small randomised trial at high risk of bias, the evidence is very uncertain about the effect of TAE or TACE versus no active therapeutic intervention on mortality for people with liver metastases as the true effect may be substantially different. The trial did not measure failure to clear liver metastases, time to progression of liver metastases, tumour response measures, or health-related quality of life. Short-term, minor adverse events were recorded in the intervention groups only. Large trials, following current standards of conduct and reporting, are required to explore the benefits and harms of TAE or TACE compared with no intervention or placebo in people with resectable and unresectable liver metastasis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD009498.pub4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7066934PMC
March 2020

Percutaneous ethanol injection for liver metastases.

Cochrane Database Syst Rev 2020 02 4;2:CD008717. Epub 2020 Feb 4.

Jagiellonian University Medical College, Chair of Epidemiology and Preventive Medicine, Department of Hygiene and Dietetics; Systematic Reviews Unit, Kopernika 7, Krakow, Poland, 31-034.

Background: The liver is affected by two of the most common groups of malignant tumours: primary liver tumours and liver metastases from colorectal carcinoma or other extrahepatic primary cancers. Liver metastases are significantly more common than primary liver cancer, and the reported long-term survival rate after radical surgical treatment is approximately 50%. However, R0 resection (resection for cure) is not feasible in the majority of patients; therefore, other treatments have to be considered. One of these is percutaneous ethanol injection (PEI), which causes dehydration and necrosis of tumour cells, accompanied by small-vessel thrombosis, leading to tumour ischaemia and destruction of the tumour.

Objectives: To assess the beneficial and harmful effects of percutaneous ethanol injection (PEI) compared with no intervention, other ablation methods, or systemic treatments in people with liver metastases.

Search Methods: We searched the following databases up to 10 September 2019: the Cochrane Hepato-Biliary Group Controlled Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL), in the Cochrane Library; MEDLINE Ovid; Embase Ovid; Science Citation Index Expanded; Conference Proceedings Citation Index - Science; Latin American Caribbean Health Sciences Literature (LILACS); and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). We also searched clinical trials registers such as ClinicalTrials.gov, the International Clinical Trials Registry Platform (ICTRP), and the US Food and Drug Administration (FDA) (17 September 2019).

Selection Criteria: Randomised clinical trials assessing beneficial and harmful effects of percutaneous ethanol injection and its comparators (no intervention, other ablation methods, systemic treatments) for liver metastases.

Data Collection And Analysis: We followed standard methodological procedures as outlined by Cochrane. We extracted information on participant characteristics, interventions, study outcomes, study design, and trial methods. Two review authors performed data extraction and assessed risk of bias independently. We assessed the certainty of evidence by using GRADE. We resolved disagreements by discussion.

Main Results: We identified only one randomised clinical trial comparing percutaneous intratumour ethanol injection (PEI) in addition to transcatheter arterial chemoembolisation (TACE) versus TACE alone. The trial was conducted in China and included 48 trial participants with liver metastases: 25 received PEI plus TACE, and 23 received TACE alone. The trial included 37 male and 11 female participants. Mean participant age was 49.3 years. Sites of primary tumours included colon (27 cases), stomach (12 cases), pancreas (3 cases), lung (3 cases), breast (2 cases), and ovary (1 case). Seven participants had a single tumour, 15 had two tumours, and 26 had three or more tumours in the liver. The bulk diameter of the tumour on average was 3.9 cm, ranging from 1.2 cm to 7.6 cm. Participants were followed for 10 months to 43 months. The trial reported survival data after one, two, and three years. In the PEI + TACE group, 92%, 80%, and 64% of participants survived after one year, two years, and three years; in the TACE alone group, these percentages were 78.3%, 65.2%, and 47.8%, respectively. Upon conversion of these data to mortality rates, the calculated risk ratio (RR) for mortality at last follow-up when PEI plus TACE was compared with TACE alone was 0.69 (95% confidence interval (CI) 0.36 to 1.33; very low-certainty evidence) after three years of follow-up. Local recurrence was 16% in the PEI plus TACE group and 39.1% in the TACE group, resulting in an RR of 0.41 (95% CI 0.15 to 1.15; very low-certainty evidence). Forty-five out of a total of 68 tumours (66.2%) shrunk by at least 25% in the PEI plus TACE group versus 31 out of a total of 64 tumours (48.4%) in the TACE group. Trial authors reported some adverse events but provided very few details. We did not find data on time to mortality, failure to clear liver metastases, recurrence of liver metastases, health-related quality of life, or time to progression of liver metastases. The single included trial did not provide information on funding nor on conflict of interest.

Authors' Conclusions: Evidence for the effectiveness of PEI plus TACE versus TACE in people with liver metastases is of very low certainty and is based on one small randomised clinical trial at high risk of bias. Currently, it cannot be determined whether adding PEI to TACE makes a difference in comparison to using TACE alone. Evidence for benefits or harms of PEI compared with no intervention, other ablation methods, or systemic treatments is lacking.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD008717.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7000212PMC
February 2020

The quality of systematic reviews/meta-analyses published in the field of bariatrics: A cross-sectional systematic survey using AMSTAR 2 and ROBIS.

Obes Rev 2020 05 29;21(5):e12994. Epub 2020 Jan 29.

Systematic Reviews Unit, Jagiellonian University Medical College, Krakow, Poland.

High-quality systematic reviews (SR) and meta-analyses (MA) are considered to be reliable sources of information. This study aims to assess the quality of studies published as SR or MA in the field of bariatrics in 2016 and 2017. We identified SR and MA in the field of bariatrics by searching electronic databases (MEDLINE, Embase, and Cochrane Database of Systematic Reviews). Eligible studies were those identified as SR/MA in the title/abstract, which aimed to assess any outcome in patients with morbid obesity undergoing or scheduled to undergo bariatric surgery. Two authors independently reviewed all titles and abstracts, assessed full texts of potentially eligible studies, and assessed the quality of included studies. Any discrepancies were resolved by the third reviewer. We evaluated the quality and risk of bias of each SR/MA using AMSTAR 2 checklist and ROBIS tool, respectively. Seventy-eight of 4236 references met inclusion criteria and were assessed for their quality/risk of bias. The methodological quality of 99% of all papers was classified as "critically low." A total of 6% of the studies were at low risk of bias, and 78% were assessed as being at high risk of bias. The methodological quality of studies published in 2016 and 2017 as SR/MA is highly unsatisfactory.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/obr.12994DOI Listing
May 2020

Correction to: Methods for trustworthy nutritional recommendations NutriRECS (Nutritional Recommendations and accessible Evidence summaries Composed of Systematic reviews): a protocol.

BMC Med Res Methodol 2019 Dec 17;19(1):240. Epub 2019 Dec 17.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada.

Following publication of the original article [1], the authors reported a change in the 'Competing interests' section as described below.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12874-019-0888-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6918667PMC
December 2019

Perioperative restrictive versus goal-directed fluid therapy for adults undergoing major non-cardiac surgery.

Cochrane Database Syst Rev 2019 12 12;12:CD012767. Epub 2019 Dec 12.

Jagiellonian University Medical College, Department of Interdisciplinary Intensive Care, Krakow, Poland.

Background: Perioperative fluid management is a crucial element of perioperative care and has been studied extensively recently; however, 'the right amount' remains uncertain. One concept in perioperative fluid handling is goal-directed fluid therapy (GDFT), wherein fluid administration targets various continuously measured haemodynamic variables with the aim of optimizing oxygen delivery. Another recently raised concept is that perioperative restrictive fluid therapy (RFT) may be beneficial and at least as effective as GDFT, with lower cost and less resource utilization.

Objectives: To investigate whether RFT may be more beneficial than GDFT for adults undergoing major non-cardiac surgery.

Search Methods: We searched the following electronic databases on 11 October 2019: Cochrane Central Register of Controlled Trials, in the Cochrane Libary; MEDLINE; and Embase. Additionally, we performed a targeted search in Google Scholar and searched trial registries (World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov) for ongoing and unpublished trials. We scanned the reference lists and citations of included trials and any relevant systematic reviews identified.

Selection Criteria: We included randomized controlled trials (RCTs) comparing perioperative RFT versus GDFT for adults (aged ≥ 18 years) undergoing major non-cardiac surgery.

Data Collection And Analysis: Two review authors independently screened references for eligibility, extracted data, and assessed risk of bias. We resolved discrepancies by discussion and consulted a third review author if necessary. When necessary, we contacted trial authors to request additional information. We presented pooled estimates for dichotomous outcomes as risk ratios (RRs) with 95% confidence intervals (CIs), and for continuous outcomes as mean differences (MDs) with standard deviations (SDs). We used Review Manager 5 software to perform the meta-analyses. We used a fixed-effect model if we considered heterogeneity as not important; otherwise, we used a random-effects model. We used Poisson regression models to compare the average number of complications per person.

Main Results: From 6396 citations, we included six studies with a total of 562 participants. Five studies were performed in participants undergoing abdominal surgery (including one study in participants undergoing cytoreductive abdominal surgery with hyperthermic intraperitoneal chemotherapy (HIPEC)), and one study was performed in participants undergoing orthopaedic surgery. In all studies, surgeries were elective. In five studies, crystalloids were used for basal infusion and colloids for boluses, and in one study, colloid was used for both basal infusion and boluses. Five studies reported the ASA (American Society of Anesthesiologists) status of participants. Most participants were ASA II (60.4%), 22.7% were ASA I, and only 16.9% were ASA III. No study participants were ASA IV. For the GDFT group, oesophageal doppler monitoring was used in three studies, uncalibrated invasive arterial pressure analysis systems in two studies, and a non-invasive arterial pressure monitoring system in one study. In all studies, GDFT optimization was conducted only intraoperatively. Only one study was at low risk of bias in all domains. The other five studies were at unclear or high risk of bias in one to three domains. RFT may have no effect on the rate of major complications compared to GDFT, but the evidence is very uncertain (RR 1.61, 95% CI 0.78 to 3.34; 484 participants; 5 studies; very low-certainty evidence). RFT may increase the risk of all-cause mortality compared to GDFT, but the evidence on this is also very uncertain (RD 0.03, 95% CI 0.00 to 0.06; 544 participants; 6 studies; very low-certainty evidence). In a post-hoc analysis using a Peto odds ratio (OR) or a Poisson regression model, the odds of all-cause mortality were 4.81 times greater with the use of RFT compared to GDFT, but the evidence again is very uncertain (Peto OR 4.81, 95% CI 1.38 to 16.84; 544 participants; 6 studies; very low-certainty evidence). Nevertheless, sensitivity analysis shows that exclusion of a study in which the final volume of fluid received intraoperatively was higher in the RFT group than in the GDFT group revealed no differences in mortality. Based on analysis of secondary outcomes, such as length of hospital stay (464 participants; 5 studies; very low-certainty evidence), surgery-related complications (364 participants; 4 studies; very low-certainty evidence), non-surgery-related complications (74 participants; 1 study; very low-certainty evidence), renal failure (410 participants; 4 studies; very low-certainty evidence), and quality of surgical recovery (74 participants; 1 study; very low-certainty evidence), GDFT may have no effect on the risk of these outcomes compared to RFT, but the evidence is very uncertain. Included studies provided no data on administration of vasopressors or inotropes to correct haemodynamic instability nor on cost of treatment.

Authors' Conclusions: Based on very low-certainty evidence, we are uncertain whether RFT is inferior to GDFT in selected populations of adults undergoing major non-cardiac surgery. The evidence is based mainly on data from studies on abdominal surgery in a low-risk population. The evidence does not address higher-risk populations or other surgery types. Larger, higher-quality RCTs including a wider spectrum of surgery types and a wider spectrum of patient groups, including high-risk populations, are needed to determine effects of the intervention.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD012767.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6953415PMC
December 2019

Effect of Lower Versus Higher Red Meat Intake on Cardiometabolic and Cancer Outcomes: A Systematic Review of Randomized Trials.

Ann Intern Med 2019 11 1;171(10):721-731. Epub 2019 Oct 1.

Institute of Science and Technology, Universidade Estadual Paulista, São José dos Campos, São Paulo, Brazil (R.E.).

This article has been corrected. The original version (PDF) is appended to this article as a Supplement.

Background: Few randomized trials have evaluated the effect of reducing red meat intake on clinically important outcomes.

Purpose: To summarize the effect of lower versus higher red meat intake on the incidence of cardiometabolic and cancer outcomes in adults.

Data Sources: EMBASE, CENTRAL, CINAHL, Web of Science, and ProQuest from inception to July 2018 and MEDLINE from inception to April 2019, without language restrictions.

Study Selection: Randomized trials (published in any language) comparing diets lower in red meat with diets higher in red meat that differed by a gradient of at least 1 serving per week for 6 months or more.

Data Extraction: Teams of 2 reviewers independently extracted data and assessed the risk of bias and the certainty of the evidence.

Data Synthesis: Of 12 eligible trials, a single trial enrolling 48 835 women provided the most credible, though still low-certainty, evidence that diets lower in red meat may have little or no effect on all-cause mortality (hazard ratio [HR], 0.99 [95% CI, 0.95 to 1.03]), cardiovascular mortality (HR, 0.98 [CI, 0.91 to 1.06]), and cardiovascular disease (HR, 0.99 [CI, 0.94 to 1.05]). That trial also provided low- to very-low-certainty evidence that diets lower in red meat may have little or no effect on total cancer mortality (HR, 0.95 [CI, 0.89 to 1.01]) and the incidence of cancer, including colorectal cancer (HR, 1.04 [CI, 0.90 to 1.20]) and breast cancer (HR, 0.97 [0.90 to 1.04]).

Limitations: There were few trials, most addressing only surrogate outcomes, with heterogeneous comparators and small gradients in red meat consumption between lower versus higher intake groups.

Conclusion: Low- to very-low-certainty evidence suggests that diets restricted in red meat may have little or no effect on major cardiometabolic outcomes and cancer mortality and incidence.

Primary Funding Source: None (PROSPERO: CRD42017074074).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/M19-0622DOI Listing
November 2019

Unprocessed Red Meat and Processed Meat Consumption: Dietary Guideline Recommendations From the Nutritional Recommendations (NutriRECS) Consortium.

Ann Intern Med 2019 11 1;171(10):756-764. Epub 2019 Oct 1.

McMaster University, Hamilton, Ontario, Canada (D.Z., G.H.G.).

This article has been corrected. The original version (PDF) is appended to this article as a Supplement.

Description: Dietary guideline recommendations require consideration of the certainty in the evidence, the magnitude of potential benefits and harms, and explicit consideration of people's values and preferences. A set of recommendations on red meat and processed meat consumption was developed on the basis of 5 de novo systematic reviews that considered all of these issues.

Methods: The recommendations were developed by using the Nutritional Recommendations (NutriRECS) guideline development process, which includes rigorous systematic review methodology, and GRADE methods to rate the certainty of evidence for each outcome and to move from evidence to recommendations. A panel of 14 members, including 3 community members, from 7 countries voted on the final recommendations. Strict criteria limited the conflicts of interest among panel members. Considerations of environmental impact or animal welfare did not bear on the recommendations. Four systematic reviews addressed the health effects associated with red meat and processed meat consumption, and 1 systematic review addressed people's health-related values and preferences regarding meat consumption.

Recommendations: The panel suggests that adults continue current unprocessed red meat consumption (weak recommendation, low-certainty evidence). Similarly, the panel suggests adults continue current processed meat consumption (weak recommendation, low-certainty evidence).

Primary Funding Source: None. (PROSPERO 2017: CRD42017074074; PROSPERO 2018: CRD42018088854).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/M19-1621DOI Listing
November 2019

Health-Related Values and Preferences Regarding Meat Consumption: A Mixed-Methods Systematic Review.

Ann Intern Med 2019 11 1;171(10):742-755. Epub 2019 Oct 1.

Iberoamerican Cochrane Centre Barcelona, Biomedical Research Institute San Pau (IIB Sant Pau), and CIBER de Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain, and McMaster University, Hamilton, Ontario, Canada (P.A.).

This article has been corrected. The original version (PDF) is appended to this article as a Supplement.

Background: A person's meat consumption is often determined by their values and preferences.

Purpose: To identify and evaluate evidence addressing health-related values and preferences regarding meat consumption.

Data Sources: MEDLINE, EMBASE, Web of Science, Centre for Agriculture and Biosciences Abstracts, International System for Agricultural Science and Technology, and Food Science and Technology Abstracts were searched from inception to July 2018 without language restrictions.

Study Selection: Pairs of reviewers independently screened search results and included quantitative and qualitative studies reporting adults' health-related values and preferences regarding meat consumption.

Data Extraction: Pairs of reviewers independently extracted data and assessed risk of bias.

Data Synthesis: Data were synthesized into narrative form, and summaries were tabulated and certainty of evidence was assessed using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Of 19 172 initial citations, 41 quantitative studies (38 addressed reasons for meat consumption and 5 addressed willingness to reduce meat consumption) and 13 qualitative studies (10 addressed reasons for meat consumption and 4 addressed willingness to reduce meat consumption) were eligible for inclusion. Thirteen studies reported that omnivores enjoy eating meat, 18 reported that these persons consider meat an essential component of a healthy diet, and 7 reported that they believe they lack the skills needed to prepare satisfactory meals without meat. Omnivores are generally unwilling to change their meat consumption. The certainty of evidence was low for both "reasons for meat consumption" and "willingness to reduce meat consumption in the face of undesirable health effects."

Limitation: Limited generalizability of findings to lower-income countries, low-certainty evidence for willingness to reduce meat consumption, and limited applicability to specific types of meat (red and processed meat).

Conclusion: Low-certainty evidence suggests that omnivores are attached to meat and are unwilling to change this behavior when faced with potentially undesirable health effects.

Primary Funding Source: None. (PROSPERO: CRD42018088854).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/M19-1326DOI Listing
November 2019

Patterns of Red and Processed Meat Consumption and Risk for Cardiometabolic and Cancer Outcomes: A Systematic Review and Meta-analysis of Cohort Studies.

Ann Intern Med 2019 11 1;171(10):732-741. Epub 2019 Oct 1.

Dalhousie University, Halifax, Nova Scotia, and McMaster University, Hamilton, Ontario, Canada (B.C.J.).

This article has been corrected. The original version (PDF) is appended to this article as a Supplement.

Background: Studying dietary patterns may provide insights into the potential effects of red and processed meat on health outcomes.

Purpose: To evaluate the effect of dietary patterns, including different amounts of red or processed meat, on all-cause mortality, cardiometabolic outcomes, and cancer incidence and mortality.

Data Sources: Systematic search of MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, CINAHL, Web of Science, and ProQuest Dissertations & Theses Global from inception to April 2019 with no restrictions on year or language.

Study Selection: Teams of 2 reviewers independently screened search results and included prospective cohort studies with 1000 or more participants that reported on the association between dietary patterns and health outcomes.

Data Extraction: Two reviewers independently extracted data, assessed risk of bias, and evaluated the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation) criteria.

Data Synthesis: Eligible studies that followed patients for 2 to 34 years revealed low- to very-low-certainty evidence that dietary patterns lower in red and processed meat intake result in very small or possibly small decreases in all-cause mortality, cancer mortality and incidence, cardiovascular mortality, nonfatal coronary heart disease, fatal and nonfatal myocardial infarction, and type 2 diabetes. For all-cause, cancer, and cardiovascular mortality and incidence of some types of cancer, the total sample included more than 400 000 patients; for other outcomes, total samples included 4000 to more than 300 000 patients.

Limitation: Observational studies are prone to residual confounding, and these studies provide low- or very-low-certainty evidence according to the GRADE criteria.

Conclusion: Low- or very-low-certainty evidence suggests that dietary patterns with less red and processed meat intake may result in very small reductions in adverse cardiometabolic and cancer outcomes.

Primary Funding Source: None. (PROSPERO: CRD42017074074).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/M19-1583DOI Listing
November 2019

Reduction of Red and Processed Meat Intake and Cancer Mortality and Incidence: A Systematic Review and Meta-analysis of Cohort Studies.

Ann Intern Med 2019 11 1;171(10):711-720. Epub 2019 Oct 1.

Dalhousie University, Halifax, Nova Scotia, and McMaster University, Hamilton, Ontario, Canada (B.C.J.).

This article has been corrected. The original version (PDF) is appended to this article as a Supplement.

Background: Cancer incidence has continuously increased over the past few centuries and represents a major health burden worldwide.

Purpose: To evaluate the possible causal relationship between intake of red and processed meat and cancer mortality and incidence.

Data Sources: Embase, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL, and ProQuest from inception until July 2018 and MEDLINE from inception until April 2019 without language restrictions.

Study Selection: Cohort studies that included more than 1000 adults and reported the association between consumption of unprocessed red and processed meat and cancer mortality and incidence.

Data Extraction: Teams of 2 reviewers independently extracted data and assessed risk of bias; 1 reviewer evaluated the certainty of evidence, which was confirmed or revised by the senior reviewer.

Data Synthesis: Of 118 articles (56 cohorts) with more than 6 million participants, 73 articles were eligible for the dose-response meta-analyses, 30 addressed cancer mortality, and 80 reported cancer incidence. Low-certainty evidence suggested that an intake reduction of 3 servings of unprocessed meat per week was associated with a very small reduction in overall cancer mortality over a lifetime. Evidence of low to very low certainty suggested that each intake reduction of 3 servings of processed meat per week was associated with very small decreases in overall cancer mortality over a lifetime; prostate cancer mortality; and incidence of esophageal, colorectal, and breast cancer.

Limitation: Limited causal inferences due to residual confounding in observational studies, risk of bias due to limitations in diet assessment and adjustment for confounders, recall bias in dietary assessment, and insufficient data for planned subgroup analyses.

Conclusion: The possible absolute effects of red and processed meat consumption on cancer mortality and incidence are very small, and the certainty of evidence is low to very low.

Primary Funding Source: None. (PROSPERO: CRD42017074074).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/M19-0699DOI Listing
November 2019

Red and Processed Meat Consumption and Risk for All-Cause Mortality and Cardiometabolic Outcomes: A Systematic Review and Meta-analysis of Cohort Studies.

Ann Intern Med 2019 11 1;171(10):703-710. Epub 2019 Oct 1.

Dalhousie University, Halifax, Nova Scotia, Canada, and McMaster University, Hamilton, Ontario, Canada (B.C.J.).

This article has been corrected. The original version (PDF) is appended to this article as a Supplement.

Background: Dietary guidelines generally recommend limiting intake of red and processed meat. However, the quality of evidence implicating red and processed meat in adverse health outcomes remains unclear.

Purpose: To evaluate the association between red and processed meat consumption and all-cause mortality, cardiometabolic outcomes, quality of life, and satisfaction with diet among adults.

Data Sources: EMBASE (Elsevier), Cochrane Central Register of Controlled Trials (Wiley), Web of Science (Clarivate Analytics), CINAHL (EBSCO), and ProQuest from inception until July 2018 and MEDLINE from inception until April 2019, without language restrictions, as well as bibliographies of relevant articles.

Study Selection: Cohort studies with at least 1000 participants that reported an association between unprocessed red or processed meat intake and outcomes of interest.

Data Extraction: Teams of 2 reviewers independently extracted data and assessed risk of bias. One investigator assessed certainty of evidence, and the senior investigator confirmed the assessments.

Data Synthesis: Of 61 articles reporting on 55 cohorts with more than 4 million participants, none addressed quality of life or satisfaction with diet. Low-certainty evidence was found that a reduction in unprocessed red meat intake of 3 servings per week is associated with a very small reduction in risk for cardiovascular mortality, stroke, myocardial infarction (MI), and type 2 diabetes. Likewise, low-certainty evidence was found that a reduction in processed meat intake of 3 servings per week is associated with a very small decrease in risk for all-cause mortality, cardiovascular mortality, stroke, MI, and type 2 diabetes.

Limitation: Inadequate adjustment for known confounders, residual confounding due to observational design, and recall bias associated with dietary measurement.

Conclusion: The magnitude of association between red and processed meat consumption and all-cause mortality and adverse cardiometabolic outcomes is very small, and the evidence is of low certainty.

Primary Funding Source: None. (PROSPERO: CRD42017074074).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.7326/M19-0655DOI Listing
November 2019

Cryotherapy for liver metastases.

Cochrane Database Syst Rev 2019 07 10;7:CD009058. Epub 2019 Jul 10.

Chair of Epidemiology and Preventive Medicine; Department of Hygiene and Dietetics; Systematic Reviews Unit, Jagiellonian University Medical College, Kopernika 7, Krakow, Poland, 31-034.

Background: The liver is affected by two of the most common groups of malignant tumours: primary liver tumours and liver metastases from colorectal carcinoma. Liver metastases are significantly more common than primary liver cancer and long-term survival rates reported for patients after radical surgical treatment is approximately 50%. However, R0 resection (resection for cure) is not feasible in the majority of patients. Cryotherapy is performed with the use of an image-guided cryoprobe which delivers liquid nitrogen or argon gas to the tumour tissue. The subsequent process of freezing is associated with formation of ice crystals, which directly damage exposed tissue, including cancer cells.

Objectives: To assess the beneficial and harmful effects of cryotherapy compared with no intervention, other ablation methods, or systemic treatments in people with liver metastases.

Search Methods: We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE Ovid, Embase Ovid, and six other databases up to June 2018.

Selection Criteria: Randomised clinical trials assessing beneficial and harmful effects of cryotherapy and its comparators for liver metastases, irrespective of the location of the primary tumour.

Data Collection And Analysis: We used standard methodological procedures expected by Cochrane. We extracted information on participant characteristics, interventions, study outcomes, and data on the outcomes important for our review, as well as information on the design and methodology of the trials. Two review authors independently assessed risk of bias in each study. One review author performed data extraction and a second review author checked entries.

Main Results: We found no randomised clinical trials comparing cryotherapy versus no intervention or versus systemic treatments; however, we identified one randomised clinical trial comparing cryotherapy with conventional surgery. The trial was conducted in Ukraine. The trial included 123 participants with solitary, or multiple unilobar or bilobar liver metastases; 63 participants received cryotherapy and 60 received conventional surgery. There were 36 women and 87 men. The primary sites for the metastases were colon and rectum (66.6%), stomach (7.3%), breast (6.5%), skin (4.9%), ovaries (4.1%), uterus (3.3%), kidney (3.3%), intestines (1.6%), pancreas (1.6%), and unknown (0.8%). The trial was not reported sufficiently enough to assess the risk of bias of the randomisation process, allocation concealment, or presence of blinding. It was also not possible to assess incomplete outcome data and selective outcome reporting bias. The certainty of evidence was low because of risk of bias and imprecision.The participants were followed for up to 10 years (minimum five months). The trial reported that the mortality at 10 years was 81% (51/63) in the cryotherapy group and 92% (55/60) in the conventional surgery group. The calculated by us relative risk (RR) with 95% Confidence Interval (CI) was: RR 0.88, 95% CI 0.77 to 1.02. We judged the evidence as low-certainty evidence. Regarding adverse events and complications, separately and in total, our calculation showed no evidence of a difference in recurrence of the malignancy in the liver: 86% (54/63) of the participants in the cryotherapy group and 95% (57/60) of the participants in the conventional surgery group developed a new malignancy (RR 0.90, 95% CI 0.80 to 1.01; low-certainty evidence). The frequency of reported complications was similar between the cryotherapy group and the conventional surgery group, except for postoperative pain. Both insignificant and pronounced pain were reported to be more common in the cryotherapy group while intense pain was reported to be more common in the conventional surgery group. However, the authors did not report whether there was any evidence of a difference. There were no intervention-related mortality or bile leakages.We identified no evidence for health-related quality of life, cancer mortality, or time to progression of liver metastases. The study reported tumour response in terms of the carcinoembryonic antigen level in 69% of participants, and reported results in the form of a graph for 30% of participants. The carcinoembryonic antigen level was lower in the cryotherapy group, and decreased to normal values faster in comparison with the control group (P < 0.05).

Funding: the trial did not provide information on funding.

Authors' Conclusions: The evidence for the effectiveness of cryotherapy versus conventional surgery in people with liver metastases is of low certainty. We are uncertain about our estimate and cannot determine whether cryotherapy compared with conventional surgery is beneficial or harmful. We found no evidence for the benefits or harms of cryotherapy compared with no intervention, or versus systemic treatments.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/14651858.CD009058.pub3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6620095PMC
July 2019
-->