Assessment of reporting completeness in acupuncture studies on patients with functional constipation using the STRICTA guidelines

ObjectiveTo evaluate the completeness of reporting of acupuncture interventions in trials for functional constipation (FC) following the STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines.MethodsWe searched eight databases for all published trials, including clinical trials, pilot/feasibility studies, observational studies, and case studies, for acupuncture in patients with FC up to June 31, 2021. The completeness of reporting was evaluated using the STRICTA guidelines.ResultsFinally, 99 studies were included and analysed based on the latest STRICTA guidelines. Out of the 17 analysed STRICTA sub-items, only five were found to be appropriately reported in more than 90% of the trials, while five were completely reported in less than 30%.ConclusionsThe reporting completeness of acupuncture trials for FC in accordance with STRICTA guidelines is moderate, with poor guideline adherence for several items. Clinical trial reports should be further improved in accordance with STRICTA guidelines to enhance the completeness of evidence. There is also a need to explore the underlying reasons as to why the authors did not report these items and to develop strategies for improving guideline compliance.     

Guidelines for research recruitment of underserved populations (EERC)

PurposeDespite concerted efforts to establish health equity, significant disparities persist. One roadblock to eliminating health disparities is the inadequate recruitment of underserved populations, which prevents researchers from creating culturally-tailored interventions. To further develop the science of recruitment, we argue that a systematic approach should be applied to research participant recruitment. Given the lack of practical and comprehensive recruitment conceptual frameworks or guidelines in the literature, the authors propose newly synthesized guidelines for research recruitment of underserved populations: EERC (evaluate, engage, reflect, and carefully match).MethodsThe EERC guidelines are delineated, and the application of these guidelines is illustrated through a study recently conducted by the authors.ResultsThe guidelines consist of the following four components: 1. Evaluate the composition of the research team; 2. Engage fully with the community by working with key informants and cultural insiders; 3. Reflect the unique cultural characteristics of the community in the research conduct; and 4. Carefully use a matching technique. The application component of the article demonstrates concrete examples of how the guidelines can enhance research recruitment for an underserved population.ConclusionThe authors intend these guidelines to be broadly applicable for research teams regardless of research design or characteristics of the underserved population.Application of these guidelines in nursing and health science will contribute to increasing research recruitment of underserved populations, with the goal of reducing health disparities and achieving health equity for all persons.     

The development of a register of randomized controlled trials in prehospital trauma care

Objectives. To establish a register of randomized controlled trials of interventions in the prehospital care of trauma patients. Methods. A systematic search was conducted for all randomized controlled trials of interventions in the prehospital care of trauma patients. The search included the Cochrane Controlled Trial Register, the Cochrane Injuries Group Specialised Register, Medline, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), Science Citation Index, National Research Register, Dissertation Abstracts, and PubMed for the time period 1966-2000. There were no language restrictions. In addition, full-text hand searching of a range of relevant journals was done, and the authors of included trials were contacted. Results. The combined search strategy identified 16,037 potentially eligible records, of which 28 were reports of randomized controlled trials evaluating prehospital trauma care interventions. After excluding duplicate reports, there were 24 separate randomized controlled trials including 6,806 patients. The largest and smallest trials involved 1,309 and 30 trauma patients, respectively. Conclusions. This register will facilitate the conduct of systematic reviews of the effectiveness of interventions in prehospital trauma care. However, despite the extensive searching, very few randomized trials in this area were found. In view of the absence of evidence for the effectiveness of many of the interventions that are used in the prehospital care of trauma patients, further randomized controlled trials are required. PREHOSPITAL EMERGENCY CARE 2002;6:27-30     

Proposed Performance Measures and Strategies for Implementation of the Fatigue Risk Management Guidelines for Emergency Medical Services

Abstract

Background: Performance measures are a key component of implementation, dissemination, and evaluation of evidence-based guidelines (EBGs). We developed performance measures for Emergency Medical Services (EMS) stakeholders to enable the implementation of guidelines for fatigue risk management in the EMS setting. Methods: Panelists associated with the Fatigue in EMS Project, which was supported by the National Highway Traffic Safety Administration (NHTSA), used an iterative process to develop a draft set of performance measures linked to 5 recommendations for fatigue risk management in EMS. We used a cross-sectional survey design and the Content Validity Index (CVI) to quantify agreement among panelists on the wording and content of draft measures. An anonymous web-based tool was used to solicit the panelists' perceptions of clarity and relevance of draft measures. Panelists rated the clarity and relevance separately for each draft measure on a 4-point scale. CVI scores ≥0.78 for clarity and relevance were specified a priori to signify agreement and completion of measurement development. Results: Panelists judged 5 performance measures for fatigue risk management as clear and relevant. These measures address use of fatigue and/or sleepiness survey instruments, optimal duration of shifts, access to caffeine as a fatigue countermeasure, use of napping during shift work, and the delivery of education and training on fatigue risk management for EMS personnel. Panelists complemented performance measures with suggestions for implementation by EMS agencies. Conclusions: Performance measures for fatigue risk management in the EMS setting will facilitate the implementation and evaluation of the EBG for Fatigue in EMS.     

COVID-19 and New Onset IgA Vasculitis: A Systematic Review of Case Reports

IntroductionImmunoglobulin A vasculitis is historically more commonly found in children after certain viral infections such as Epstein-Barr, varicella virus, and parvovirus B19. COVID-19 has not been formally established in literature as a trigger for immunoglobulin A vasculitis. However, a main pathogenetic mechanism of COVID-19 is vascular damage, which makes it likely that vasculitis associated with COVID-19 (ie, COVID-19–mediated immunoglobulin A vasculitis) could be biologically plausible, with serious implications, especially for adults. The purpose of this review is to assist emergency nurses in gaining knowledge on the pathophysiology, symptoms, and treatment of COVID-19–mediated immunoglobulin A vasculitis.MethodsA systematic search for case reports of COVID-19–associated immunoglobulin A vasculitis was conducted in the PubMed and Scopus electronic databases. The search terms used were COVID-19, coronavirus 2019, SARS COVID-19, and IgA vasculitis, case reports. The following were the inclusion criteria: publication dates between December 1, 2019, and December 1, 2021; full-text article, clinical case studies, and letters to the editor available electronically in English. The following were exclusion criteria: a summary of reports and newspaper publications.ResultsOnly 13 clinical cases met the inclusion criteria. The median age of patients described in the case reports were 38.1 years. Of them, 3 children were less than 5 years old. Twelve patients were male. In 7 of 13 cases of immunoglobulin A vasculitis, renal involvement was found.DiscussionThe analysis of published clinical cases showed that COVID-19–associated immunoglobulin A vasculitis affected mostly adults and was characterized by a more severe course because of renal involvement. COVID-19 may be a possible trigger for immunoglobulin A–related disorders. More research is needed to better understand the relationship between immunoglobulin A vasculitis and COVID-19.     

Acupuncture for major depressive disorder: A review of the recommendations stated at clinical practice guidelines

BackgroundThe use of acupuncture to treat depression is not uncommon. However, recommendations regarding acupuncture issued by clinical practice guidelines (CPG) vary widely.ObjectiveTo describe the recommendations regarding acupuncture in CPGs for depression in adults, and to assess the methodology used to reach them.MethodsWe conducted a scoping review of CPGs for depression management in adults, which performed systematic reviews (SRs) to answer their review questions, were published between January 2014 and May 2018, and assessed the use of acupuncture as a review question. We limited out search to articles published in English/Spanish. We assessed the SRs quality using the “A MeaSurement Tool to Assess Systematic Reviews-2” (AMSTAR-2), and described how the recommendation regarding acupuncture was reached.FindingsWe found five CPGs that fulfilled our inclusion criteria: three from the US, one from Canada, and one from China. Four CPGs fulfilled between two and three items of AMSTAR-2, and one CPG fulfilled seven items. The methodology used to formulate the recommendations varied between CPGs. Regarding acupuncture use recommendations: three CPGs did not issue any recommendation (although one mentions that it should not be used), whilst two were in favor.DiscussionsThe lack of a clearly stated review question presented in the majority of CPGs prevents the reader from understanding what the CPG developing group was trying to answer. Moreover, the arguments presented to support a decision are usually not detailed enough. Therefore, the assessment of the recommendations was extremely difficult.Clinical implicationsGiven that the formulation of recommendations is not always reliable, clinicians should carefully read and assess the recommendations presented in CPGs before implementing them.     

Are plain-language summaries included in published reports of evidence about physiotherapy interventions? Analysis of 4421 randomised trials,systematic reviews and guidelines on the Physiotherapy Evidence Database (PEDro)

BackgroundA plain-language summary is a short and clearly stated version of a study’s results using non-scientific vocabulary that provide many advantages for patients and clinicians in the process of shared decision-making.ObjectivesThe primary objective was to investigate the extent to which published reports of physiotherapy interventions provide plain-language summaries. We investigate as the secondary objectives if the available plain-language summaries are at a suitable reading level for a lay person and if inclusion of plain-language summaries in these reports is increasing over time and is associated with trial quality (i.e. PEDro score).Data sourcesAll 4421 randomised controlled trials (RCT), systematic reviews and clinical practice guidelines that included plain-language summaries indexed on Physiotherapy Evidence Database (PEDro) were included.Main outcome measuresProportion of published reports with plain-language summaries, Flesch Reading Ease Score (FRES) and the Flesch–Kincaid Grade Level (FKGL).ResultsThe number of published reports with a plain-language summary doubled in the last 6 years. From a total of 34,444 reports indexed on PEDro, only 4421 reports had English plain-language summaries. RCTs with plain-language summaries had higher PEDro scores than RCTs without plain-language summaries (mean difference = 0.8 points, 95%CI 0.7 to 0.8). Only 2% of reports were considered at a suitable reading level by the FKGL formula and 0.1% by the FRES formula.ConclusionsAlthough the publication of plain-language summaries is increasing over time, the current number corresponds to only 13% of all published reports. In addition the majority of plain-language summaries are written at an advanced reading level.     

Preliminary efficacy and feasibility of referral to exercise specialists,psychologists and provision of a technology-based behavior change support package to promote physical activity in school teachers ‘at risk' of,or diagnosed with,type 2 diabetes: The ‘SMART Health’ Pilot Study Protocol

IntroductionType 2 diabetes mellitus (T2DM) is a global public health concern. Aerobic physical activity (PA) and resistance training (RT) play significant roles in the prevention and management of T2DM. The aim of this pilot trial is to determine the preliminary efficacy and confirm feasibility of referral to exercise physiologists, psychologists, and provision of a technology-based behavior change support package to promote aerobic PA and RT in school teachers ‘at risk' of or diagnosed with T2DM.Research design and methodsThe SMART (Support, Motivation and Physical Activity Research for Teachers’) Health pilot study will be evaluated using a three-arm randomized controlled trial. The intervention will be guided by Social Cognitive Theory, Health Action Process Approach Model and Cognitive Behavioral Therapy strategies. The participants will be randomly allocated to one of three study groups: Group 1: wait-list control group; Group 2: 5 face-to-face visits with a psychologist and exercise specialist over 3 months; and Group 3: same as Group 2 plus technology-based behavior change support package for an additional 6 months. Assessments will be conducted at baseline, 3-, 9- (primary time-point) and 18-months post-baseline. The primary outcome will be PA measured with pedometers.DiscussionSMART Health is an innovative, multi-component intervention, that integrates referral to exercise specialists, psychologists and provision of a technology-based behavior support package to promote PA and RT in adults diagnosed with T2DM or ‘at risk' of T2DM. The findings will be used to guide future PA interventions and to develop effective community-based diabetes prevention and treatment programs.Trial RegistrationAustralian New Zealand Clinical Trials Registry No: ACTRN12616001309471     

Continuous Sedation (CS) Until Death: Mapping the Literature by Bibliometric Analysis

ContextSedation at the end of life, regardless of the nomenclature, is an increasingly debated practice at both clinical and bioethical levels. However, little is known about the characteristics and trends in scientific publications in this field of study.ObjectivesThis article presents a bibliometric analysis of the scientific publications on continuous sedation until death.MethodsFour electronic databases (MEDLINE, PubMed, Embase, and PsycINFO^®) were searched for the indexed material published between 1945 and 2011. This search resulted in bibliographic data of 273 published outputs that were analyzed using bibliometric techniques.ResultsData revealed a trend of increased scientific publication from the early 1990s. Published outputs, diverse in type (comments/letters, articles, reviews, case reports, editorials), were widely distributed across 94 journals of varying scientific disciplines (medicine, nursing, palliative care, law, ethics). Most journals (72.3%) were classified under Medical and Health Sciences, with the Journal of Pain and Symptom Management identified as the major journal in the field covering 12.1% of the total publications. Empirical research articles, mostly of a quantitative design, originated from 17 countries. Although Japan and The Netherlands were found to be the leaders in research article productivity, it was the U.K. and the U.S. that ranked top in terms of the quantity of published outputs.ConclusionThis is the first bibliometric analysis on continuous sedation until death that can be used to inform future studies. Further research is needed to refine controversies on terminology and ethical acceptability of the practice, as well as conditions and modalities of its use.     

Ensuring Patient Access to Essential Medicines While Minimizing Harmful Use: A Revised World Health Organization Tool to Improve National Drug Control Policy

ABSTRACT

In 2011, the World Health Organization (WHO) published a series of 21 guidelines to assist governments in improving their national drug control laws, regulations, and administrative procedures to promote the availability of controlled medicines for pain relief and for a variety of acute and chronic diseases and conditions. These guidelines ultimately are designed to encourage the development of policies designed to fulfill a country's dual obligation concerning these medicines: to prevent their abuse, diversion and trafficking while ensuring access for medical and scientific purposes. This article summarizes each guideline and outlines the constituents who can actively participate in making controlled medicines available to the patients who need them. It is hoped that representatives of governments and medical institutions, as well as health care professionals, will commonly and effectively use the revised WHO guidelines as a policy change tool.     

Non-pharmaceutical Chinese medical therapies for degenerative lumbar spinal stenosis: A systematic review and meta-analysis of randomized controlled trials

ObjectiveThe objective of the study was to assess the effectiveness of utilizing Non-Pharmaceutical Chinese Medical (NPCM) therapy singularly or in combination for the treatment of Degenerative Lumbar Spinal Stenosis (DLSS).MethodsThe comprehensive search for all randomized controlled trials regarding NPCM therapies for the treatment of DLSS was performed through online databases searches, commencing from their inception to January 1st, 2023. The relevant literature underwent a thorough screening process, and the data was meticulously extracted and subjected to analysis through the implementation of RevMan 5.3 software. The Cochrane Risk of Bias tool was employed to assess the potential risk of bias. The synthesis of evidence was performed Grading of Recommendations Assessment, Development, and Evaluation.ResultsThe extensive search procedure produced 5674 records, including data from 37 studies of 38 comparisons (2965 participants). Moderate evidence was obtained demonstrating that the application of acupuncture for a duration of 6–8 weeks was significantly superior to sham acupuncture in terms of intermediate-term (6 months) alleviation of back pain (2 trials, n = 128; MD, −1.08; 95% CI, −1.81∼−0.34) and improvement in lumbar function (2 trials, n = 128; MD, −1.40; 95% CI, −2.93∼−0.13). The available low evidence suggested that, as compared to sham acupuncture, acupuncture was effective in reducing short-term (3 months) back pain and enhancing lumbar function but had no impact on leg pain. A trial with low risk of bias found that acupuncture was more effective than sham acupuncture in enhancing disability and walking capabilities. The other studies presented inconsistent evidence with regards to the efficacy of the various interventions employed.ConclusionsEvidence of low-to-moderate quality suggests that for DLSS patients, the implementation of acupuncture in comparison to sham acupuncture presents favorable outcomes in terms of short- and intermediate-term alleviation of back pain, improvement in lumbar function, enhancement of disability and walking capacity. The conclusion regarding the efficacy of other NPCM therapies was not obtained due to the insufficient quality of the available evidence.Registration: PROSPEROCRD42022307631.     

Appropriateness of intravenous cannulation by paramedics: A london study

Introduction. The number of patients undergoing intravenous (IV) cannulation by paramedics has increased dramatically over recent years in the UK. Treatment protocols for cannulation in the field are loosely defined. Variation in practice may lead to patients' receiving differential treatment according to customary practice, rather than according to their clinical conditions. Objectives. To explore variations in practice and assess level of appropriatenesss of IV cannulation by London Ambulance Service (LAS) paramedics; to revise treatment protocols and work toward clinical guidelines, if indicated by study findings. Methods. Skill usage data were analyzed for all LAS paramedics for 1995-96. All patients who were IV-cannulated and transported to three hospitals by LAS during March 1996 were identified. A panel of accident and emergency (A&E) and prehospital specialists judged each case for appropriateness. Results. Variation during the year was wide, with a range of 1 to 221 (mean 47) patients cannulated per paramedic, although the majority showed some consistency in frequency of skill usage. A sample of 183 cases was reviewed. The majority judged 149 (81.4%) to be appropriate, although there was considerable disagreement between reviewers (κ = 0.43, p < 0.001). Data suggested that those paramedics who cannulate more frequently cannulated less appropriately during the study period (lowest 30%: 73.9% appropriate; highest 30%: 45.8% appropriate, p = 0.05). Conclusion. Despite wide variation between paramedics, the panel judged overall appropriateness of cannulation to be high. The audit advisory group judged that new clinical guidelines might not achieve an improvement in practice and were not supported by study findings. It was recommended that variations be addressed through individual practice review. PREHOSPITAL EMERGENCY CARE 2000;4:156-163     

Amiodarone and rural emergency medical services cardiac arrest patients: A cost analysis

Objective: Recent American Heart Association guidelines suggest amiodarone as an antiarrhythmic in refractory ventricular fibrillation (VF) and pulseless ventricular tachycardia (VT). The authors sought to assess the impact of amiodarone use on outcomes and cost associated with this practice in a rural emergency medical services (EMS) state. Methods: Statewide EMS records were reviewed for the calendar year 1999. Data reviewed included prehospital diagnosis, medications given by prehospital providers to patients with cardiac arrest, and procedures performed, including cardiopulmonary resuscitation (CPR) and defibrillation. Cost-benefit analysis assumed the cost of amiodarone treatment to be $137.65 per patient encounter. Absolute risk reduction (ARR) and number needed to treat (NNT) analysis utilized resuscitation rates published in the ARREST and ALIVE trials. Results: During the study period, EMS providers diagnosed 2,189 patients as having cardiac arrest. Five hundred thirty-five (24.4%) cardiac arrest patients were defibrillated. One hundred sixty patients (7.3%), including 15 who did not receive defibrillation, were given lidocaine during resuscitation efforts. The annual cost increase from current practice for a statewide amiodarone VF/VT protocol was $21,822.40 (10,572.87%). The initial cost to stock EMS vehicles for this protocol would be $50,115.52. The cost-benefit analysis yielded a potential for one additional patient survival to hospital discharge in Maine per 3.125 years of system-wide practice at a cost of $68,840.00. Conclusion: Based on current data, instituting amiodarone treatment for refractory VF and pulseless VT in a rural EMS setting requires the investment of substantial resources, relative to current treatment strategies, for any potential survival benefit. PREHOSPITAL EMERGENCY CARE 2002;6:291-294     

Farnesoid X Receptor Targeting for Hepatitis C: Study Protocol for a Proof-of-concept Trial

ObjectiveTo test the modulation of farnesoid X receptor activity on the replication of hepatitis C virus in chronically infected patients.MethodsThis is a proof-of-concept trial that was approved by the ex-French Agency for the Safety of Health Products (ex-Afssaps [currently ANSM]) and an ethics committee. It has started in January 2010. This one-arm, open-label study examines the safety and efficacy of the oral administration of guggulsterone. The main outcome measure will be the assessment of blood viral loads.ResultsWe planned to enrol 15 genotype 1-infected patients that failed a firstline therapy.ConclusionWe think guggulsterone might be an effective therapeutic option for HCV genotype 1 patients who do not respond well to first-line therapy.Trial registration. ClinicalTrials NCT01492998     

Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture

Acupuncture treatment and control group interventions in parallel-group randomised trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journal editors are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.     

针刺临床对照试验中干预措施报告的标准:STRICTA(建议)

针刺平行随机对照试验通常没有准确报告试验组和对照组的干预方法。为促进标准化，国际上有经验的针刺医师和研究组成的小组制定了一些原则，即针刺临床对照试验中干预措施报告的标准(缩写为STRICTA)。在征求意见过程中，一些期刊编辑协助对此标准进行了修改，使之与随机对照试验报告的标准（CON-SORT)格式一致，作为该指南对针刺研究报告的延伸。参与此事的杂志编辑已确定要发表该标准，建议其作群按照此标准准备论，并将邀请更多杂志采用该标准。目的是使针刺对照试验的干预措施充分报告，从而有利于对这些研究的严格评价、分析及这些措施的推广。