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"Calvache, Jose A."
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Comment on: “Operator gender differences in major mechanical complications after central line insertions: a subgroup analysis of a prospective multicentre cohort study”
by
Klimek, Markus
,
Calvache, Jose A.
in
Anesthesiology
,
Catheterization, Central Venous - adverse effects
,
Cohort analysis
2024
We read with great interest the recent study by Naddi et al. in BMC Anesthesiology, which explores operator gender differences in major mechanical complications following central venous catheterization. The study identifies male operator gender as an independent risk factor for complications. However, our attempt to replicate these findings using Colombian data did not support this association. We caution against oversimplifying the influence of sex and gender on health outcomes, as numerous factors, including cultural norms, healthcare practices, and resource availability, significantly impact procedural outcomes. Differences in complication rates may reflect risk-taking behaviors and systemic healthcare disparities rather than inherent biological differences. We emphasize the need for a comprehensive approach to understand the multifaceted nature of central venous related complications. Replication studies across diverse populations are crucial for validating these findings and informing effective strategies for complication prevention and management.
Journal Article
Methodological transparency of preoperative clinical practice guidelines for elective surgery. Systematic review
by
Calvache, Jose A.
,
Trujillo, Cristian
,
Alonso-Coello, Pablo
in
Adult
,
Anesthesiology
,
Clinical medicine
2023
Clinical practice guidelines (CPG) are statements that provide recommendations regarding the approach to different diseases and aim to increase quality while decreasing the risk of complications in health care. Numerous guidelines in the field of perioperative care have been published in the previous decade but their methodological quality and transparency are relatively unknown.
To critically evaluate the transparency and methodological quality of published CPG in the preoperative assessment and management of adult patients undergoing elective surgery.
Systematic review and methodological appraisal study.
We searched for eligible CPG published in English or Spanish between January 1, 2010, and June 30, 2022, in Pubmed MEDLINE, TRIP Database, Embase, the Cochrane Library, as well as in representatives' medical societies of Anaesthesiology and developers of CPG.
CPG dedicated on preoperative fasting, cardiac assessment for non-cardiac surgery, and the use of routine preoperative tests were included. Methodological quality and transparency of CPG were assessed by 3 evaluators using the 6 domains of the AGREE-II tool.
We included 20 CPG of which 14 were classified as recommended guidelines. The domain of \"applicability\" scored the lowest (44%), while the domains \"scope and objective\" and \"editorial interdependence\" received the highest median scores of 93% and 97% respectively. The remaining domains received scores ranging from 44% to 84%. The top mean scored CPG in preoperative fasting was ASA 2017 (93%); among cardiac evaluation, CPG for non-cardiac surgery were CCS 2017 (91%), ESC-ESA 2014 (90%), and AHA-ACC 2014 (89%); in preoperative testing ICSI 2020 (97%).
In the last ten years, most published CPG in the preoperative assessment or management of adult patients undergoing elective surgery focused on preoperative fasting, cardiac assessment for non-cardiac surgery, and use of routine preoperative tests, present moderate to high methodological quality and can be recommended for their use or adaptation. Applicability and stakeholder involvement domains must be improved in the development of future guidelines.
Journal Article
Developing research priorities for palliative care in Colombia: a priority setting partnership approach
2024
Background
A recent Lancet commission called for more research on palliative care in low- and middle-income (LMIC) countries such as Colombia. A research priority setting approach has been recommended by The Global Forum for Health Research to address the huge gap in research output between LMIC and high-income countries, with influential health service bodies recommending the active involvement of non-research expert stakeholders in establishing research priorities to address service user needs.
Method
Priority setting partnership (PSP) following the four stages of the James Lind Alliance methodology; establishing the partnership, identifying evidence uncertainties, refining questions and uncertainties, and prioritization. Data from MS forms were analysed using descriptive statistics.
Results
A total of 33 stakeholders attended an online PSP workshop and completed the Mentimeter exercise in Microsoft Teams. A total of 48 attended the subsequent in person prioritisation exercise in urban Bogota (
n
= 22) and rural Popayan (
n
= 25). The stakeholders were a diverse group of health professionals (physicians, medical students, nurses, dentists, physiotherapists, nutritionist, occupational and speech therapists), financial and administrative staff and patients with life-limiting illness and caregivers. Top research priorities included patient and caregiver needs, service provider education and training, and better integration of palliative care with cancer and non-cancer services. The key challenges included a lack of interest in palliative care research, along with funding, time and resource constraints. Key solutions included collaboration across disciplines and settings, highlighting benefits of palliative research to help secure adequate resources, and multicentre, mixed method research, with patient involvement from the research development stage.
Conclusion
The findings of this PSP should be disseminated among palliative care associations worldwide to inform international multicentre studies, and among governmental and nongovernmental organisations that promote research in Colombia. A focus on patient and family caregiver palliative care needs in Colombia should be prioritised.
Journal Article
Knowledge of end-of-life wishes by physicians and family caregivers in cancer patients
by
de Vries, Esther
,
Calvache, Jose A
,
Arroyo, Lucia I
in
Advance Directives
,
Beliefs, opinions and attitudes
,
Cancer
2021
Objectives
To describe communication regarding cancer patient’s end-of-life (EoL) wishes by physicians and family caregivers.
Methods
An online questionnaire and telephone-based surveys were performed with physicians and family caregivers respectively in three teaching hospitals in Colombia which had been involved in the EoL care of cancer patients.
Results
For 138 deceased patients we obtained responses from physicians and family caregivers. In 32 % physicians reported they spoke to the caregiver and in 17 % with the patient regarding EoL decisions. In most cases lacking a conversation, physicians indicated the treatment option was “clearly the best for the patient” or that it was “not necessary to discuss treatment with the patient”.
Twenty-six percent of the caregivers indicated that someone from the medical team spoke with the patient about treatment, and in 67% who had a conversation, caregivers felt that the provided information was unclear or incomplete. Physicians and family caregivers were aware if the patient had any advance care directive in 6% and 26% of cases, respectively, with low absolute agreement (34%).
Conclusions
There is a lack of open conversation regarding EoL in patients with advanced cancer with their physicians and family caregivers in Colombia. Communication strategies are urgently needed.
Journal Article
Influence of time of birth in early neonatal mortality and morbidity: retrospective cohort study
by
Ruiz, Gissel V
,
Aguirre-Acevedo, Daniel Camilo
,
Cabra-Bautista, Ginna
in
Adult
,
Apgar Score
,
Births
2025
BackgroundA key target of the 2030 Sustainable Development Goals is to eliminate preventable deaths in newborns and children under 5. This study aimed to estimate the effect of time of birth on early neonatal mortality (ENM) and low Apgar scores at 5 min (LA5) in newborns.MethodsA retrospective cohort study was conducted using vital statistics data on live births, maternal morbidity, congenital defects and perinatal mortality in Cauca-Colombia (2017–2021) excluding out-of-hospital, multiple and major defect cases. A directed acyclic graph was constructed to define the confounder adjustment set. Multivariable logistic, linear and propensity score models evaluated the effect of birth timing on neonatal outcomes, estimating crude and adjusted incidence rate ratios (IRRa).ResultsWe assessed 65 182 live births, finding similar baseline characteristics for daytime and night-time births. ENM was 0.2% (95% CI 0.19% to 0.26%) at 7 days of follow-up, absolute mortality difference 0.1% (95% CI –0.01% to 0.12%). Night-time births increased the incidence of ENM in the primary analysis IRRa 1.27 (95% CI 0.90 to 1.82), in the secondary IRRa 1.45 (95% CI 0.94 to 2.20), and in the primary and secondary sensitivity analysis, respectively, IRRa 1.48 (95% CI 1.06 to 2.07) and 1.70 (95% CI 1.16 to 2.59). LA5 was present in 0.7% (95% CI 0.60% to 0.72%) of birth, with absolute LA5 difference 0.1% (95% CI –0.02% to 0.22%). Night-time births increased the incidence of LA5 in the primary analysis IRRa 1.31 (95% CI 1.00 to 1.49), in the secondary IRRa 1.44 (95% CI 1.13 to 1.83), and in the primary and secondary sensitivity analysis, respectively, IRRa 1.31 (95% CI 1.08 to 1.59) and IRRa 1.54 (95% CI 1.23 to 1.92).ConclusionsBirth at night-time is associated with worse neonatal outcomes, ENM and low Apgar scores in Colombia’s diverse population, highlighting the need for optimised prenatal care, revised work schedules and improved referral systems in maternal health.
Journal Article
Medical decisions concerning the end of life for cancer patients in three Colombian hospitals – a survey study
by
de Vries, Esther
,
van der Heide, Agnes
,
Diaz-Amado, Eduardo
in
Cancer
,
Chronic illnesses
,
Colombia
2021
Background
Cancer patients’ end-of-life care may involve complex decision-making processes. Colombia has legislation regarding provision of and access to palliative care and is the only Latin American country with regulation regarding euthanasia. We describe medical end-of-life decision-making practices among cancer patients in three Colombian hospitals.
Methods
Cancer patients who were at the end-of-life and attended in participating hospitals were identified. When these patients deceased, their attending physician was invited to participate. Attending physicians of 261 cancer patients (out of 348 identified) accepted the invitation and answered a questionnaire regarding end-of-life decisions: a.) decisions regarding the withdrawal or withholding of potentially life-prolonging medical treatments, b.) intensifying measures to alleviate pain or other symptoms with hastening of death as a potential side effect, and c.) the administration, supply or prescription of drugs with an explicit intention to hasten death. For each question addressing the first two decision types, we asked if the decision was fully or partially made with the intention or consideration that it may hasten the patient’s death.
Results
Decisions to withdraw potentially life-prolonging treatment were made for 112 (43%) patients, 16 of them (14%) with an intention to hasten death. For 198 patients (76%) there had been some decision to not initiate potentially life-prolonging treatment. Twenty-three percent of patients received palliative sedation, 97% of all patients received opioids.
Six patients (2%) explicitly requested to actively hasten their death, for two of them their wish was fulfilled. In another six patients, medications were used with the explicit intention to hasten death without their explicit request. In 44% (
n
= 114) of all cases, physicians did not know if their patient had any advance care directives, 26% (
n
= 38) of physicians had spoken to the patient regarding the possibility of certain treatment decisions to hasten death where this applied.
Conclusions
Decisions concerning the end of life were common for patients with cancer in three Colombian hospitals, including euthanasia and palliative sedation. Physicians and patients often fail to communicate about advance care directives and potentially life-shortening effects of treatment decisions. Specific end-of-life procedures, patients’ wishes, and availability of palliative care should be further investigated.
Journal Article
Efficacy of different routes of acetaminophen administration for postoperative pain in children: a systematic review and network meta-analysis
by
van der Marel, Caroline
,
Calvache, Jose A.
,
Osorio, Danilo
in
Acetaminophen - administration & dosage
,
Administration, Oral
,
Analgesics
2024
Purpose
Acetaminophen is the most common drug used to treat acute pain in the pediatric population, given its wide safety margin, low cost, and multiple routes for administration. We sought to determine the most efficacious route of acetaminophen administration for postoperative acute pain relief in the pediatric surgical population.
Methods
We conducted a systematic review of randomized controlled trials (RCTs) that included children aged between 30 days and 17 yr who underwent any type of surgical procedure and that evaluated the analgesic efficacy of different routes of administration of acetaminophen for the treatment of postoperative pain. We searched MEDLINE, CENTRAL, Embase, CINAHL, LILACs, and Google Scholar databases for trials published from inception to 16 April 2023. We assessed the risk of bias in the included studies using the Cochrane Risk of Bias 1.0 tool. We performed a frequentist network meta-analysis using a random-effects model. Our primary outcome was postoperative pain using validated pain scales.
Results
We screened 2,344 studies and included 14 trials with 829 participants in the analysis. We conducted a network meta-analysis for the period from zero to two hours, including six trials with 496 participants. There was no evidence of differences between intravenous
vs
rectal routes of administration of acetaminophen (difference in means, −0.28; 95% confidence interval [CI], −0.62 to 0.06; very low certainty of the evidence) and intravenous
vs
oral acetaminophen (difference in means, −0.60; 95% CI, −1.20 to 0.01; low certainty of the evidence). For the comparison of oral
vs
rectal routes, we found evidence favouring the oral route (difference in means, −0.88; 95% CI, −1.44 to −0.31; low certainty of the evidence). Few trials reported secondary outcomes of interest; when comparing the oral and rectal routes in the incidence of nausea and vomiting, there was no evidence of differences (relative risk, 1.20; 95% CI, 0.81 to 1.78).
Conclusion
The available evidence on the effect of the administration route of acetaminophen on postoperative pain in children is very uncertain. The outcomes of postoperative pain control and postoperative vomiting may differ very little between the oral and rectal route. Better designed and executed RCTs are required to address this important clinical question.
Study registration
PROSPERO (CRD42021286495); first submitted 19 November 2021.
Journal Article
Assessing the feasibility and impact of clinical trial trustworthiness checks via an application to Cochrane Reviews: Stage 2 of the INSPECT-SR project
by
Thomas, Hugh
,
Weibel, Stephanie
,
Ahnström, Love
in
Annan klinisk medicin
,
Assessments
,
Authenticity
2025
The aim of the INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project is to develop a tool to identify problematic RCTs in systematic reviews. In stage 1 of the project, a list of potential trustworthiness checks was created. The checks on this list must be evaluated to determine which should be included in the INSPECT-SR tool.
We attempted to apply 72 trustworthiness checks to randomized controlled trials (RCTs) in 50 Cochrane reviews. For each, we recorded whether the check was passed, failed, or possibly failed or whether it was not feasible to complete the check. Following application of the checks, we recorded whether we had concerns about the authenticity of each RCT. We repeated each meta-analysis after removing RCTs flagged by each check and again after removing RCTs where we had concerns about authenticity to estimate the impact of trustworthiness assessment. Trustworthiness assessments were compared to Risk of Bias and Grading of Recommendations Assessment, Development and Evaluation (GRADE) assessments in the reviews.
Ninety-five RCTs were assessed. Following application of the checks, assessors had some or serious concerns about the authenticity of 25% and 6% of the RCTs, respectively. Removing RCTs with either some or serious concerns resulted in 22% of meta-analyses having no remaining RCTs. However, many checks proved difficult to understand or implement, which may have led to unwarranted skepticism in some instances. Furthermore, we restricted assessment to meta-analyses with no more than five RCTs (54% contained only 1 RCT), which will distort the impact on results. No relationship was identified between trustworthiness assessment and Risk of Bias or GRADE.
This study supports the case for routine trustworthiness assessment in systematic reviews, as problematic studies do not appear to be flagged by Risk of Bias assessment. The study produced evidence on the feasibility and impact of trustworthiness checks. These results will be used, in conjunction with those from a subsequent Delphi process, to determine which checks should be included in the INSPECT-SR tool.
Systematic reviews collate evidence from randomized controlled trials (RCTs) to find out whether health interventions are safe and effective. However, it is now recognized that the findings of some RCTs are not genuine, and some of these studies appear to have been fabricated. Various checks for these “problematic” RCTs have been proposed, but it is necessary to evaluate these checks to find out which are useful and which are feasible. We applied a comprehensive list of “trustworthiness checks” to 95 RCTs in 50 systematic reviews to learn more about them and to see how often performing the checks would lead us to classify RCTs as being potentially inauthentic. We found that applying the checks led to concerns about the authenticity of around 1 in three RCTs. However, we found that many of the checks were difficult to perform and could have been misinterpreted. This might have led us to be overly skeptical in some cases. The findings from this study will be used, alongside other evidence, to decide which of these checks should be performed routinely to try to identify problematic RCTs, to stop them from being mistaken for genuine studies and potentially being used to inform health care decisions.
•An extensive list of potential checks for assessing study trustworthiness was assessed via an application to 95 randomized controlled trials (RCTs) in 50 Cochrane Reviews.•Following application of the checks, assessors had concerns about the authenticity of 32% of the RCTs.•If these RCTs were excluded, 22% of meta-analyses would have no remaining RCTs.•However, the study showed that some checks were frequently infeasible, and others could be easily misunderstood or misinterpreted.•The study restricted assessment to meta-analyses, including five or fewer RCTs, which might distort the impact of applying the checks.
Journal Article
Translation and linguistic validation of the Sheffield Profile for Assessment and Referral for Care (SPARC) to Colombian Spanish
2024
We aimed to translate and linguistically and cross-culturally validate Sheffield Profile for Assessment and Referral for Care (SPARC) in Spanish for Colombia (SPARC-Sp).
The linguistic validation of SPARC followed a standard methodology. We conducted focus groups to assess the comprehensibility and feasibility. The acceptability was assessed using a survey study with potential users.
The comprehensibility assessment showed that additional adjustments to those made during the translation-back-translation process were required to apply SPARC-Sp in rural and low-schooled populations. It also identified the need for alternative administration mechanisms for illiterate people. The acceptability survey showed that potential users found SPARC-Sp as not only acceptable but also highly desirable. However, they desired to expand the number of items in all domains.
Beyond the semantic and conceptual validity attained through the back-translation process, actual cultural validity could be acquired thanks to the comprehensibility tests. Although extending the instrument is something potential users would like to do, it would make it less feasible to utilize the SPARC-Sp in clinical settings. Nonetheless, the instrument might benefit from the inclusion of a domain that evaluates challenges encountered when accessing the health-care system. For communities lacking literacy, alternate administration methods must also be considered.
Journal Article
Acute renal failure in children. Multicenter prospective cohort study in medium-complexity intensive care units from the Colombian southeast
by
Restrepo, Jaime M.
,
Lasso, Rubén E.
,
Zemanate, Eliana
in
Acute kidney failure
,
Acute Kidney Injury - diagnosis
,
Acute Kidney Injury - mortality
2020
Acute kidney injury is frequent in critically ill children; however, it varies in causality and epidemiology according to the level of patient care complexity. A multicenter prospective cohort study was conducted in four medium-complexity pediatric intensive care units from the Colombian southeast aimed to estimate the clinical prognosis of patients with diagnosis of acute kidney injury.
We included children >28 days and <18 years of age, who were admitted with diagnosis of acute kidney injury classified by Kidney Disease Improving Global Outcomes (KDIGO), during the period from January to December 2017. Severe acute kidney injury was defined as stage 2 and stage 3 classifications. Maximum KDIGO was evaluated during the hospital stay and follow up. Length of hospital stay, use of mechanical ventilation and vasoactive drugs, use of renal replacement therapy, and mortality were assessed until discharge.
Prevalence at admission of acute kidney injury was 5.2% (95%CI 4.3% to 6.2%). It was found that 71% of the patients had their maximum KDIGO on day one; an increment in the maximum stage of acute kidney injury increased the pediatric intensive care unit stay. Patients with maximum KDIGO 3 were associated with greater use of mechanical ventilation (47%), compared with maximum KDIGO 2 (37%) and maximum KDIGO 1 (16%). Eight patients with maximum KDIGO 2 and 14 with maximum KDIGO 3 required renal replacement therapy. Mortality was at 11.8% (95%CI 6.4% to 19.4%).
Acute kidney injury, established and classified according to KDIGO as severe and its maximum stage, was associated with worse clinical outcomes; early therapeutic efforts should focus on preventing the progression to severe stages.
Journal Article