Future Clinical Practice Guidelines Research Articles

Exploring the lived experience of renal cachexia for individuals with end-stage renal disease and the interrelated experience of their carers: Study protocol.

Renal cachexia is an important consideration in the person-centred care that is needed in end-stage renal disease (ESRD). However, given that clinical guidelines relating to renal cachexia are largely absent, this is an unmet care need. To inform guidelines and future renal service planning, there is an urgency to understand individuals' experiences of renal cachexia and the interrelated experiences of the carers in their lives. We report here the protocol for an interpretative phenomenological study which will explore this lived experience. A purposive sampling strategy will recruit individuals living with ESRD who have cachexia and their carers. A maximum of 30 participants (15 per group) dependent on saturation will be recruited across two nephrology directorates, within two healthcare trusts in the United Kingdom. Individuals with renal cachexia undergoing haemodialysis will be recruited via clinical gatekeepers and their carers will subsequently be invited to participate in the study. Participants will be offered the opportunity to have a face-to-face, virtual or telephone interview. Interviews will be audio-recorded, transcribed verbatim and analysed using interpretative phenomenological analysis. NVivo, will be used for data management. Ethical approval for this study was granted by the Office for Research Ethics Committees Northern Ireland (REC Reference: 22/NI/0107). Scientific evidence tends to focus on measurable psychological, social and quality of life outcomes but there is limited research providing in-depth meaning and understanding of the views of individuals with renal disease who are experiencing renal cachexia. This information is urgently needed to better prepare healthcare providers and in turn support individuals with ESRD and their carers. This study will help healthcare providers understand what challenges individuals with ESRD, and their carers face in relation to cachexia and aims to inform future clinical practice guidelines and develop supportive interventions which recognise and respond to the needs of this population.

Women’s Experiences of Symptoms of Suspected or Confirmed COVID-19 Illness During the Pandemic

ObjectiveTo explore experiences of symptoms of suspected or confirmed COVID-19 illness among women using the CovidWatcher mobile citizen science app. DesignConvergent parallel mixed-methods design. ParticipantsTwenty-eight self-identified women consented for follow-up after using CovidWatcher. Participants’ ages ranged from 18 to 83 years old. MethodsWe collected data via semistructured, virtual interviews and surveys: the COVID-19 Exposure and Family Impact Survey and Patient-Reported Outcomes Measurement Information System measures. We used directed content analysis to develop codes, categories, themes, and subthemes from the qualitative data and summarized survey data with descriptive statistics. ResultsWe derived five themes related to symptom experiences: (a) Physical Symptoms, (b) Mental Health Symptoms, (c) Symptom Intensity, (d) Symptom Burden, and (e) Symptom Trajectories. Subthemes reflected more nuanced experiences of suspected or confirmed COVID-19 disease. For those without COVID-19, anxiety and mental health symptoms were still present. Of those who attested to one of the PROMIS-measured symptoms, all but one had at least mild severity in one of their reported symptoms. ConclusionThis study demonstrates the cross-cutting impact of the COVID-19 pandemic on individuals who identify as women. Future research and clinical practice guidelines should focus on alleviating physical and mental health symptoms related to the ongoing pandemic, regardless of COVID-19 diagnosis. Furthermore, clinicians should consider how patients can use symptom reconciliation apps and tracking systems.

Clinical practice guidelines for the management of patients with complex regional pain syndrome: a systematic appraisal using the AGREE II instrument.

Aim: Complex regional pain syndrome (CRPS) is a debilitating, painful condition of limbs that often arises after an injury and is associated with significant morbidity. Materials & methods: The Appraisal of Guidelines for Research and Evaluation (AGREE II) instrument, used to assess the quality of clinical practice guidelines (CPGs), was used to evaluate sevenCRPS management guideline. Results: Out of the sevenCPGs evaluated using the AGREE II instrument, only one from Royal College of Physicians was found to have high-quality consensus guidelines for diagnosis and management of CRPS. Conclusion: Future CPGs should be backed by systematic literature searches, focus on guidelines clinical translation into clinical practice and applicability to the desired patient population.

Guidelines for Cancer Treatment during Pregnancy: Ethics-Related Content Evolution and Implications for Clinicians.

Simple SummaryClinical practice guidelines for cancer treatment during pregnancy have been available for the past 20 years; however, whether they contain bioethical guidance is currently unknown. A systematic medical literature review was performed to identify the presence of biomedical ethics principles present in guidelines published until 2021. Most of the included guidelines (25 out of 32) refer to biomedical ethics principles such as respect for patient’s autonomy, beneficence and justice. Earlier guidelines stress the importance of patient wishes and choices in light of limited evidence and vast unknowns while balancing maternal and fetal wellbeing. More recent guidelines tend to focus on evidence-based data to balance favorable outcomes for pregnant patients and their fetuses with counselling support to help the patients and their support network understand the rationale behind available treatment options. However, ethics-related content in such guidelines is not presented in a structured manner, indicating the need for methodological upgrades. Therefore, a more structured approach is needed when addressing existing and potential ethical issues in clinical practice guidelines for cancer treatment during pregnancy.(1) Background: Current scientific evidence suggests that most cancers, including breast cancer, can be treated during pregnancy without compromising maternal and fetal outcomes. This, however, raises questions regarding the ethical implications of clinical care. (2) Methods: Using a systematic literature search, 32 clinical practice guidelines for cancer treatment during pregnancy published between 2002 and 2021 were selected for analysis and 25 of them mentioned or made references to medical ethics when offering clinical management guidance for clinicians. (3) Results: Four bioethical themes were identified: respect for patient’s autonomy, balanced approach to maternal and fetal beneficence, protection of the vulnerable and justice in resource allocation. Most guidelines recommended informing the pregnant patient about available evidence-based treatment options, offering counselling and support in the process of decision making. The relational aspect of a pregnant patient’s autonomy was also recognized and endorsed in a significant number of available guidelines. (4) Conclusions: Recognition and support of a patient’s autonomy and its relational aspects should remain an integral part of future clinical practice guidelines. Nevertheless, a more structured approach is needed when addressing existing and potential ethical issues in clinical practice guidelines for cancer treatment during pregnancy.

A Case of Bipolar Disorder due to Multiple Sclerosis with Episodes of Mania

Bipolar and related disorders are common and disabling psychiatric conditions. Bipolar illness with manic manifestations is commonly found in patients suffering from multiple sclerosis (MS). This case report highlights the development of manic symptoms in a patient with MS and the association between them. We report a 16-year-old female patient with relapsing–remitting MS (aggressive disease) with 8 relapses in the first 2 years of illness who developed recurrent episodes of mania during each relapse of MS. Neuroimaging showed new left frontal plaques in addition to frontal lobe deficit found during neuropsychiatric assessment. She was stabilized with rituximab therapy 6 monthly and risperidone 2 mg daily. There is a high prevalence of mood disturbances in patients with MS, thus increases their morbidity. A comprehensive psychiatric assessment is important to ascertain the psychiatric diagnosis (primary, secondary, or idiopathic), and prompt treatment is needed. To date, there is no specific treatment guideline for mood disorder secondary to MS available. Future research and clinical practice guidelines are needed in this area.

Technical Capacity Mapping for Clinical Practice Guideline Development in the Philippines

Background. A 2017 situational analysis assessing Clinical Practice Guidelines (CPG) development in the Philippines revealed CPGs of inconsistent quality. In response, the Department of Health (DOH)-Philippine Health Insurance Corporation Manual for CPG Development was developed to outline the standardized steps of the CPG development process. To implement this, technically qualified institutions and individuals should be commissioned.
 Objective. To identify qualified institutions and individuals and map out their technical skills and potential for capacit building in CPG development
 Methods. Mixed methods were used in this cross-sectional study. A snowballing method identified specific institutions and individuals. Self-administered surveys and key informant interviews were conducted to determine competence, strengths, and gaps in the development of CPGs.
 Results. A total of 74 individuals from 45 institutions with competencies in CPG development were identified. Of the 45 institutions, 72% were non-clinical, with roughly half working on formal research. Of the 74 individuals, 96% possessed relevant knowledge and skills and 85% already provided training on CPG development topics. Around half of the respondents have been part of a CPG development task force. Only about half were able to incorporate social concepts of equity, and only one-third had experience in managing conflicts of interest.
 Conclusion. Qualified institutions and individuals identified in this capacity mapping can be tapped in future CPG development in the country. Incorporation of social concepts and management of conflicts of interest still need to be ensured.

Reevaluating the Use of Sound Therapy for Tinnitus Management: Perspectives on Relevant Systematic Reviews.

Tinnitus is a highly prevalent condition that can severely reduce health functioning. In spite of extant clinical practice guidelines (CPGs), implementation of these CPGs is relatively uncommon. As a result, patients seeking professional services for tinnitus often have no assurance of receiving evidence-based care. The purpose of this tutorial was to clarify the evidence for sound therapy so that it may be included in future CPGs for tinnitus. "Best clinical evidence" is obtained from high-quality systematic reviews, which are generally considered the highest level of evidence. Our review of recent, comprehensive, high-quality systematic reviews of interventions for tinnitus concludes that cognitive behavioral therapy is the only effective intervention, though the strength of evidence was generally rated as low in these reviews. Although trials of sound therapy for tinnitus have been included in these reviews, they have been rated as having high risk of bias (RoB) and not included in syntheses or rated as insufficient strength of evidence. Conclusions from these and other reviews have influenced recommendations made in CPGs for tinnitus. These conclusions, however, can make it appear that an intervention for tinnitus is not effective, even if the opposite is true. We contend that the strict inclusion criteria for these reviews are counterproductive and have the effect of obscuring decades of evidence demonstrating the clinical effectiveness of sound therapies for tinnitus. Ultimately, this process has resulted in many patients not receiving sound therapy, despite what should be sufficient evidence that this is an effective form of intervention. If we rely on systematic reviews using contemporary RoB assessment criteria for studies published prior to these reporting guidelines, then we risk excluding important conclusions regarding interventions that could help patients in need.

Risk factors, outcomes, and predictors of resolution of acute kidney injury in children with diabetic ketoacidosis.

Acute kidney injury (AKI) is a common complication in patients with diabetic ketoacidosis (DKA) (incidence 35-77%). AKI evolution during DKA treatment/recovery is poorly understood. Our aim was to assess children with DKA for prevalence, short-term kidney outcomes, severity, and predictors of AKI development and resolution. This retrospective cohort study included children aged 2-14years admitted with DKA between January 2016 and May 2020 in a Saudi tertiary care hospital. We defined AKI as an increase in serum creatinine of > 1.5 times baseline or > 3mg/dL (26mmol/L) within 48h. Of 213 patients admitted with DKA, 172 (80.75%) developed AKI: stage 1 in 83 (38.96%), stage 2 in 86 (40.37%), and stage 3 in 3 (1.4%). No patient required dialysis. Multivariate analysis showed an increased risk of developing AKI with male gender (OR = 2.85) and lower serum bicarbonate (OR = 0.83) when adjusted for initial heart rate, hematocrit, new onset diabetes, and recurrent AKI. The mean time to AKI resolution was 13.21 ± 6.78h. Factors leading to prolonged recovery from AKI in linear regression analysis were older age (B coefficient = 0.44, p = 0.01), recurrent DKA episodes (B coefficient = 3.70, p value 0.003), increased acidosis severity (B coefficient = - 0.44, p = 0.04), increased time to anion gap normalization (B coefficient = 0.44, p = 0.019), and increased initial glucose (B coefficient = 0.01, p = 0.011). In our cohort, AKI is a common, but mostly transient complication in children presenting with DKA, and its severity is associated with longer intensive care stays and time for acidosis resolution. AKI was associated with male gender, and lower serum bicarbonate. Proper consideration of such risk factors is needed for AKI assessment and management in future DKA clinical practice guidelines. A higher resolution version of the Graphical abstract is available as Supplementary information.

Cost-Effectiveness of Interventions for Musculoskeletal Foot and Ankle Conditions: A Systematic Review.

Musculoskeletal conditions of the foot and ankle are common, yet the cost-effectiveness of the variety of treatments available is not well defined. The aim of this systematic review was therefore to identify, appraise, and synthesize the literature pertaining to the cost-effectiveness of interventions for musculoskeletal foot and ankle conditions. Electronic databases were searched for studies presenting economic evaluations of nonsurgical and surgical treatments for acute or chronic musculoskeletal conditions of the foot and ankle. Data on cost, incremental cost-effectiveness, and quality-adjusted life years for each intervention and comparison were extracted. Risk of bias was assessed using the Drummond checklist for economic studies (range 0-35). Thirty-six studies were identified reporting nonsurgical interventions (n=10), nonsurgical versus surgical interventions (n=14), and surgical interventions (n=12). The most common conditions were osteoarthritis, ankle fracture, and Achilles tendon rupture. The strongest economic evaluations were for interventions managing end-stage ankle osteoarthritis, ankle sprain, ankle fracture, calcaneal fracture, and Achilles tendon rupture. Total ankle replacement and ankle arthrodesis for end-stage ankle osteoarthritis, in particular, have been demonstrated through high-quality studies to be cost-effective compared to the nonsurgical alternative. Selected interventions for musculoskeletal foot and ankle conditions dominate comparators, whereas others require thoughtful consideration as they provide better clinical improvements, but at an increased cost. Researchers should consider measuring and reporting costs alongside clinical outcome to provide context when determining the appropriateness of interventions for other foot and ankle symptoms to best inform future clinical practice guidelines.

Quality of clinical practice guidelines on interventional management of low back pain: A systematic review.

To appraise the quality of low back pain (LBP) clinical practice guidelines (CPG) that include interventional management recommendations and to associate their quality with characteristics including publication year and creating organization. TYPE: Systematic Review. LBP (subacute or chronic) CPGs in English (symptom based, governmental or professional society created, January 1990-May 2020) were found using MEDLINE, EMBASE, CINAHL, Ortho Guidelines, CPG Infobase, ECRI, Guidelines International Network, NICE, and SIGN. In this third order systematic review, search results were deduplicated, title and abstract screened by two independent reviewers, and full texts reviewed by four reviewers. Discrepancies were resolved by a third reviewer. Resulted CPGs were appraised using the Appraisal of Guidelines for Research and Evaluation (AGREE II) Tool by four appraisers each. Association of their quality with creating organization, geographical region, and year of creation was calculated. Seven hundred fourteen screened documents resulted in 21 final CPGs. On appraisal, average overall CPG quality was 5.2 (range 2.5-6.75). Domain 5 (applicability) had the lowest average (44%) and domain 4 (clarity of presentation) had the highest average score (82%). For overall recommendation, 16 received "yes" or "yes with modifications," six received unanimous "yes" and two unanimous "no" votes. The interrater agreement of domain scoring was excellent (0.8-1.0; p < .001). There was no association found between quality of CPG and (1) year of publication (R2 =0.0006), (2) whether the CPG was updated or new (p=.17), and (3) region of publication (p=.37). The majority of the 21 CPGs identified in this systematic review were of high quality, but overall quality and recommendation ratings were variable. The quality of appraised CPGs showed no association with their characteristics. Some domains such as "applicability" scored uniformly lower, revealing opportunity for improvement in future CPG development. LBP CPGs should be scrutinized before adopting their recommendations.

Comparative effectiveness of glycyrrhizic acid preparations aimed at preventing and treating anti-tuberculosis drug-induced liver injury: A network meta-analysis of 97 randomized controlled trials

Background and objectivesClinical guidelines and expert consensus do not yet recommend glycyrrhizic acid (GA) preparations, such as compound glycyrrhizin, diammonium glycyrrhizin, magnesium isoglycyrrhizinate (MGIG), et al., for the prevention of anti-tuberculosis(anti-TB) drug-induced liver injury (DILI) due to insufficient evidence. Although these GA preparations are recommended for the treatment of anti-TB DILI, which one performs best is unclear. Previous conventional meta-analyses did not summarize the results of simultaneous comparisons of different glycyrrhizinate preparations. Therefore, we aimed to compare and rank different GA preparations on preventing and treating the anti-TB DILI by network meta-analysis (NMA). MethodsA systematic search on PubMed, Web of Science, Embase, the Cochrane Library, China National Knowledge Infrastructure, SinoMed, Chongqing VIP and, the Wanfang Database was performed up to December 19, 2020. The literature was screened according to predefined inclusion and exclusion criteria to extract important information. The outcomes were the incidence of liver injury (prevention section) and treatment response rate (treatment section). The NMA was conducted with a random-effects model under the Bayesian framework to calculate risk ratios (RRs) with 95% credible intervals (95% CrIs) using R software (version 3.6.1). ResultsFrom 1,411 publications, we included 97 relevant randomized clinical trials (RCTs) (10,923 participants). In terms of preventing anti-TB DILI (33 RCTs, comprising 5,762 patients), CGC, DGC, DGEC, and DGI, but not CGI, significantly reduced the incidence of liver injury than control group (RRs ranged from 0.26 to 0.58); CGC and DGEC were superior to DGC (RRs = 0.50 and 0.58, respectively). In terms of treating anti-TB DILI (64 RCTs, comprising 5,161 patients), MGIG was most effective among all regimens (RRs ranged from 1.15 to 1.72) while DGC ranked last (RRs ranged from 0.58 to 0.83). ConclusionsAll GA preparations except for CGI were effective in preventing the incidence of anti-TB DILI and CGC was superior to DGC. MGIG seems to be the best choice among all GA preparations for the treatment of anti-TB DILI. Future clinical practice guidelines should factor in these novel findings to improve patient outcomes; however, further high-quality trials are needed to validate these results.

Adherence to guideline creation recommendations for suicide prevention in the emergency department: A systematic review.

Suicide rates in the United States rose 35.2% from 1999-2018. As emergency department (ED) providers often have limited training in management of suicidal patients and minimal access to mental health experts, clinical practice guidelines (CPGs) may improve care for these patients. However, clinical practice guidelines that do not adhere to quality standards for development may be harmful both to patients, if they promote practices based on flawed evidence, and to ED providers, if used in malpractice claims. In 2011, the Institute of Medicine created standards to determine the trustworthiness of CPGs. This review assessed the adherence of suicide prevention CPGs, intended for the ED, to these standards. Secondary objectives were to assess the association of adherence both with first author/organization specialty (ED vs non-ED) and with inclusion of recommendations on substance use, a potent risk factor for suicide. This is a systematic review of available suicide-prevention CPGs for the ED in both peer-reviewed and gray literature. This review followed the PRISMA standards for reporting systematic reviews. Of 22 included CPGs, the 7 ED-sponsored CPGs had higher adherence to quality standards (3.1 vs 2.4) and included the highest-rated CPG (ICAR2E) identified by this review. Regardless of specialty, nearly all CPGs included some mention of identifying or managing substance use. Most suicide prevention CPGs intended for the ED are written by non-ED first authors or organizations and have low adherence to quality standards. Future CPGs should be developed with more scientific rigor, include a multidisciplinary writing group, and be created by authors working in the practice environment to which the CPG applies.

Developing Core Outcome Sets (COS) and Core Outcome Measures Sets (COMS) in Cosmetic Gynecological Interventions: Protocol for a Development and Usability Study.

BackgroundStudies evaluating cosmetic gynecological interventions have followed variable methodology and reported a diversity of outcomes. Such variations limit the comparability of studies and the value of research-based evidence. The development of core outcome sets (COS) and core outcome measures sets (COMS) would help address these issues, ensuring a minimum of outcomes important to all stakeholders, primarily women requesting or having experienced cosmetic gynecological interventions.ObjectiveThis protocol describes the methods used in developing a COS and COMS for cosmetic gynecological interventions.MethodsAn international steering group within CHORUS, including health care professionals, researchers, and women with experience in cosmetic gynecological interventions from 4 continents, will guide the development of COS and COMS. Potential outcome measures and outcomes will be identified through comprehensive literature reviews. These potential COS and COMS will be entered into an international, multi-perspective web-based Delphi survey where Delphi participants judge which domains will be core. A priori thresholds for consensus will get established before each Delphi round. The Delphi survey results will be evaluated quantitatively and qualitatively in subsequent stakeholder group consensus meetings in the process of establishing “core” outcomes.ResultsDissemination and implementation of the resulting COS and COMS within an international context will be promoted and reviewed.ConclusionsThis protocol presents the steps in developing a COS and COMS for cosmetic gynecological interventions. Embedding the COS and COMS for cosmetic gynecological interventions within future clinical trials, systematic reviews, and practice guidelines could contribute to enhancing the value of research and improving overall patient care.Trial RegistrationCore Outcome Measures in Effectiveness Trials (COMET) 1592; https://tinyurl.com/n8faysuhInternational Registered Report Identifier (IRRID)PRR1-10.2196/28032

Do neurosurgeons follow the guidelines? A world-based survey on severe traumatic brain injury.

Traumatic brain injury (TBI) is going to be the third-leading cause of death worldwide, according to the WHO. Two European surveys suggested that adherence to brain trauma guidelines is poor. No study has compared compliance between low- (LMICs) and high-income (UHICs) countries. Hence, this study aimed to investigate differences in the management of severe TBI patients, comparing low- and high-income, and adherence to the BTF guidelines. A web-based survey was spread through the Global Neuro Foundation, different neurosurgical societies, and social media. A total of 803 neurosurgeons participated: 70.4 from UHICs and 29.6% from LMICs. Hypertonic was administered as an early measure by the 73% and 65% of the responders in LMICs and UHICs, respectively (P=0.016). An invasive intracranial pressure monitoring was recommended by the 66% and 58% of the neurosurgeons in LMICs and UHICs, respectively (P<0.001). Antiseizure drugs (P<0.001) were given most frequently in LMICs as, against recommendations, steroids (87% vs. 61% and 86% vs. 81%, respectively). In the LMICs both the evacuation of the contusion and decompressive craniectomy were performed earlier than in UHICs (30% vs. 17% with P<0.001 and 44% vs. 28% with P=0.006, respectively). In the LMICs, the head CT control was performed mostly between 12 and 24 hours from the first imaging (38% vs. 23%, P<0.001). The current Guidelines on TBI do not always fit to both the resources and circumstances in different countries. Future research and clinical practice guidelines should reflect the greater relevance of TBI in low resource settings.

Frequency of repositioning for preventing pressure ulcers in patients hospitalized in ICU: protocol of a cluster randomized controlled trial

BackgroundDespite being considered preventable, ulcers due to pressure affect between 30 and 50% of patients at high and very high risk and susceptibility, especially those hospitalized under critical care. Despite a lack of evidence over the efficacy in prevention against ulcers due to pressure, hourly repositioning in critical care as an intervention is used with more or less frequency to alleviate pressure on patients’ tissues. This brings up the objective of our study, which is to evaluate the efficacy in prevention of ulcers due to pressure acquired during hospitalization, specifically regarding two frequency levels of repositioning or manual posture switching in adults hospitalized in different intensive care units in different Colombian hospitals.MethodsA nurse-applied cluster randomized controlled trial of parallel groups (two branches), in which 22 eligible ICUs (each consisting of 150 patients), will be randomized to a high-frequency level repositioning intervention or to a conventional care (control group). Patients will be followed until their exit from each cluster. The primary result of this study is originated by regarding pressure ulcers using clusters (number of first ulcers per patient, at the early stage of progression, first one acquired after admission for 1000 days). The secondary results include evaluating the risk index on the patients’ level (Hazard ratio, 95% IC) and a description of repositioning complications. Two interim analyses will be performed through the course of this study. A statistical difference between the groups < 0.05 in the main outcome, the progression of ulcers due to pressure (best or worst outcome in the experimental group), will determine whether the study should be put to a halt/determine the termination of the study.ConclusionThis study is innovative in its use of clusters to advance knowledge of the impact of repositioning as a prevention strategy against the appearance of ulcers caused by pressure in critical care patients. The resulting recommendations of this study can be used for future clinical practice guidelines in prevention and safety for patients at risk.Trial registrationPENFUP phase-2 was Registered in Clinicaltrials.gov (NCT04604665) in October 2020.

Efficacy and safety of preoperative preparation with Lugol's iodine solution in euthyroid patients with Graves’ disease (LIGRADIS Trial): Study protocol for a multicenter randomized trial

BackgroundCurrently, both the American Thyroid Association and the European Thyroid Association recommend preoperative preparation with Lugol's Solution (LS) for patients undergoing thyroidectomy for Graves’ Disease (GD), but their recommendations are based on low-quality evidence. The LIGRADIS trial aims to provide evidence either to support or refute the systematic use of LS in euthyroid patients undergoing thyroidectomy for GD. MethodsA multicenter randomized controlled trial will be performed. Patients ≥18 years of age, diagnosed with GD, treated with antithyroid drugs, euthyroid and proposed for total thyroidectomy will be eligible for inclusion. Exclusion criteria will be prior thyroid or parathyroid surgery, hyperparathyroidism that requires associated parathyroidectomy, thyroid cancer that requires adding a lymph node dissection, iodine allergy, consumption of lithium or amiodarone, medically unfit patients (ASA-IV), breastfeeding women, preoperative vocal cord palsy and planned endoscopic, video-assisted or remote access surgery.Between January 2020 and January 2022, 270 patients will be randomized for either receiving or not preoperative preparation with LS. Researchers will be blinded to treatment assignment. The primary outcome will be the rate of postoperative complications: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death. Secondary outcomes will be intraoperative events (Thyroidectomy Difficulty Scale score, blood loss, recurrent laryngeal nerve neuromonitoring signal loss), operative time, postoperative length of stay, hospital readmissions, permanent complications and adverse events associated to LS. ConclusionsThere is no conclusive evidence supporting the benefits of preoperative treatment with LS in this setting. This trial aims to provide new insights into future Clinical Practice Guidelines recommendations. Trial registrationClinicalTrials.gov identifier: NCT03980132.

646 Appraisal of International Guidelines for Malignant Melanoma Management Using the AGREE II Assessment Tool

Abstract Background Recently, the widely accepted NICE guidelines for melanoma management have been challenged by a UK-based expert consensus statement. A review of alternative clinical practice guidelines (CPGs) could guide future CPG updates and developments. The AGREE II tool assesses CPGs across six domains: ‘Scope and purpose’, ‘Stakeholder involvement’, ‘Rigour of development’, ‘Clarity of presentation’, ‘Applicability’, and ‘Editorial independence’. Method We conducted a systematic search of Pubmed, Medline and online CPG databases to identify melanoma CPGs published between January 2014 and March 2020 providing recommendations for: adjuvant treatment, radiotherapy, surgical management, or follow-up care. Three authors independently assessed the quality of identified CPGs using the AGREE II assessment tool. Inter-rater reliability was assessed by Kendall’s coefficient of concordance (W). Results Twenty-nine CPGs were included and appraised with excellent reliability (Kendall’s W for overall GPC score 0.85, p &amp;lt; 0.001). Overall, melanoma CPGs scored highly in the scope and purpose and clarity of presentation domains, and poorly in the applicability domain. The NICE guideline achieved the best overall scores. Conclusions The NICE melanoma CPGs are higher quality than alternatives but should be updated to reflect recent landmark trials. The AGREE II tool is currently limited by its incapacity to compare guidelines to latest evidence.

Arteriovenous fistula cannulation in hemodialysis: A vascular access clinical practice guidelines narrative review.

The cannulation of an arteriovenous fistula (AVF) by the hemodialysis (HD) nurse is challenging. Despite it being the focus of extensive research, it is still one of the majors causes of damage making it prone to failure. A considerable number of Clinical Practice Guidelines (CPGs) for the management of vascular access (VA) have been published worldwide over the past two decades. This review aimed to assess all information available in the selected CPG regarding AVF cannulation for HD providing a comprehensive analysis in order to interpret possible future cannulation approaches. A total of seven CPGs were described in a coding table separated in seven subthemes: Initiation of cannulation, preparation, technique, needle selection, surveillance, pain, and education. Our analysis outlines current CPGs for HD VA cannulation with lack of good evidence support for the majority of the recommendations, showing that, there is an urgent need for international collaboration and coordination to ensure relevant and high-quality evidence. Future CPGs must consider recommendations with better grading of evidence aiming patient-centered care and nurse decision models that can potentially represent better AVF cannulation outcomes.

International clinical practice guidelines for gender minority/trans people: systematic review and quality assessment

ObjectivesTo identify and critically appraise published clinical practice guidelines (CPGs) regarding healthcare of gender minority/trans people.DesignSystematic review and quality appraisal using AGREE II (Appraisal of Guidelines for Research and Evaluation...

Perceptions and Misperceptions of Early Palliative Care Interventions for Patients With Hematologic Malignancies Undergoing Bone Marrow Transplantation

Hematopoietic stem cell or bone marrow transplantation (BMT) is one of the most promising and potentially curative therapeutic options available for eligible patients with hematologic malignancies (HMs) or leukemias. However, the nature and clinical course of HMs, specifically for patients undergoing BMT, are associated with significant morbidity, symptomatology, healthcare service utilization, psychosocial and end of life issues, and overall decreased quality of life. Early palliative care (PC) consultations and utilization for patients with HMs have been shown to improve patient outcomes, satisfaction, and autonomy as well as caregiver burden, shared-decision making, and holistic care management. Despite the complexity of care and complications for patients with HM undergoing BMT, early PC interventions are systematically underutilized and understudied in this population compared to patients with solid tumors or non-HMs. Herein, the authors reviewed the current literature and knowledge to assess and report the perceptions and barriers to early PC utilization in the care of patients with HMs undergoing BMT. Clinical and cultural aspects of PC perceptions as well as current PC care models and potential directions for PC implementation were reviewed to inform future research studies and clinical practice guidelines necessary for the improvement of care and quality of life for HM patients undergoing BMT.