Recommendations in the design and conduction of randomised controlled trials in human and veterinary homeopathic medicine

BackgroundRandomised controlled trials (RCTs) are an established research method to investigate the effects of an intervention. Several recent systematic reviews and meta-analyses of RCTs with homeopathic interventions have identified shortcomings in design, conduct, analysis, and reporting of trials. Guidelines for RCTs in homeopathic medicine are lacking.ObjectivesThis paper aims to fill this gap in order to enhance the quality of RCTs in the field of homeopathy.MethodsIdentification of the homeopathy-specific requirements for RCTs by reviewing literature and experts’ communications. Systematization of the findings using a suitable checklist for planning, conducting, and reporting RCTs, namely the SPIRIT statement, and high-quality homeopathy RCTs as examples. Cross-checking of the created checklist with the RedHot-criteria, the PRECIS criteria, and a qualitative evaluation checklist. Consideration of the REFLECT statement and the ARRIVE Guidelines 2.0 for veterinary homeopathy.ResultsRecommendations for future implementation of RCTs in homeopathy are summarized in a checklist. Alongside, identified useful solutions to the issues encountered when designing and conducting homeopathy RCTs are presented.ConclusionsThe formulated recommendations present guidelines additional to those in the SPIRIT checklist, on how to better plan, design, conduct, and report RCTs in homeopathy.     

Completeness of Reporting Is Suboptimal in Randomized Controlled Trials Published in Rehabilitation Journals,With Trials With Low Risk of Bias Displaying Better Reporting: A Meta-research Study

ObjectivePrimary: To evaluate the completeness of reporting of randomized controlled trials (RCTs) published in rehabilitation journals through the evaluation of the adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist and investigate the relationship between reporting and risk of bias (ROB). Secondary: To study the association between completeness of reporting and the characteristics of studies and journals.Data SourcesA random sample of 200 RCTs published between 2011 and 2020 in 68 rehabilitation journals indexed under the “rehabilitation” category in the InCites Journal Citation Report.Study SelectionOne reviewer evaluated the completeness of reporting operationalized as the adherence to the CONSORT checklist. Two independent reviewers evaluated the ROB using the Cochrane risk-of-bias 2.0 tool.Data ExtractionOverall adherence and adherence to each CONSORT section were calculated. Regression analyses investigated the association between completeness of reporting, ROB, and other characteristics (quartile range, publication modalities, study protocol registration).Data SynthesisThe mean overall CONSORT adherence across studies was 65%. Studies with high ROB have less adherence than those with low ROB (?5.5%; CI, ?10.9 to 0.0). There was a 10.2% (% CI, 6.2-14.3) increase in adherence if the RCT protocol was registered. Studies published in first quartile journals displayed an overall adherence of 11.7% (% CI 17.1-6.4) higher than those published in the fourth quartile.ConclusionsReporting completeness is still suboptimal and is associated with ROB, journal impact ranking, and registration of the study protocol. Trial authors should improve adherence to the CONSORT guideline, and journal editors should adopt new strategies to improve the reporting.     

Assessing validity of observational intervention studies – the Benchmarking Controlled Trials

Background: Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations.

Aims: To create and pilot test a checklist for appraising methodological validity of a BCT.

Methods: The checklist was created by extracting the most essential elements from the comprehensive set of criteria in the previous paper on BCTs. Also checklists and scientific papers on observational studies and respective systematic reviews were utilized. Ten BCTs published in the Lancet and in the New England Journal of Medicine were used to assess feasibility of the created checklist.

Results: The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.

Conclusions: The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies. However, the piloted checklist should be validated in further studies.

• Key messages

• Benchmarking Controlled Trial (BCT) is a concept which covers all observational studies aiming to assess impact of interventions or health care system features to patients and populations.

• This paper presents a checklist for appraising methodological validity of BCTs and pilot-tests the checklist with ten BCTs published in leading medical journals. The appraised studies seem to have several methodological limitations, some of which could be avoided in planning, conducting and reporting phases of the studies.

• The checklist can be used for planning, conducting, reporting, reviewing, and critical reading of observational intervention studies.

     

CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM) : Recommendations,explanation and elaboration

BackgroundN-of-1 trial is a desired and appropriate approach to assessing the efficacy and safety of traditional Chinese medicine (TCM) interventions. There have been an increasing number of N-of-1 trials for TCM published. However, a lack of preferred reporting guidance led in the general poor reporting quality of these trials. Due to the unique characteristics of TCM, the working group developed this CONSORT Extension for reporting N-of-1 Trials for Traditional Chinese Medicine (CENT for TCM) to assist TCM researchers in reporting N-of-1 trials for TCM.MethodsWe registered CENT for TCM at the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network (available at equator-network.org). The development was a comprehensive process through collection of the initial reporting items, two-round scientific Delphi consensus survey with 17 panelists, revision and formation of the final reporting checklist.ResultsThe checklist includes 25 items within six domains, eight items in which were extended and elaborated on the items of the CENT 2015 checklist. Explanation of the items were listed adequately considering the nature of TCM, introducing the concept of TCM syndrome differentiation and TCM interventions.ConclusionsCENT for TCM can be used to assess the completeness of the reporting of N-of-1 trials for TCM. The working group expect that CENT for TCM could be a practical tool to enhance the comprehensiveness and transparency of the design, implementation and reporting of N-of-1 trials for TCM.     

Preventive strategies for the reduction of central line-associated bloodstream infections in adult intensive care units: A systematic review

BackgroundThe use of central lines (CLs) is essential for adult patients admitted in intensive care units (ICUs). However, CLs increase the risk of central line-associated bloodstream infections (CLABSIs).AimThis systematic review aimed to explore and identify all existing evidence-based interventions to prevent and/or reduce CLABSIs in adult ICUs.MethodsA systematic review of related studies published from January 2016 to June 2020 was carried out. The databases of Web of Science, CINAHL Plus with Full Text, MEDLINE Complete, Scopus, and Science Direct were systematically searched. All studies were evaluated in accordance with the established inclusion and exclusion criteria and appraised by the researchers independently.FindingsFifteen studies were included after the quality evaluation of full-text studies. The selected studies investigated several evidence-based interventions to prevent and/or reduce CLABSI rates that were consistent with and added to a previous systematic review. These interventions included compliance with and improvement of CL bundle implementation using checklists before and after CL insertion, chlorhexidine and silver-plated dressings, infection control and multidisciplinary intervention through real-time bedside monitoring, use of positive displacement needleless connectors, and mandatory reporting laws on CLABSIs.ConclusionEvidence-based findings showed that a zero CLABSI rate was achievable with the use of positive displacement needleless connectors. Other additional interventions that could reduce CLABSI rates include checklist placement and monitoring of the CL care bundle, use of silver-plated dressings, constant education of ICU personnel, regular real-time bedside monitoring, and mandatory reporting of CLABSIs.     

Refining a checklist for reporting patient populations and service characteristics in hospice and palliative care research

ContextIn specialist hospice and palliative care services, variations occur in diagnoses and prognoses of subpopulations referred, service configuration, and the health systems delivering care. These three levels of variation limit the ability to generalize study findings.ObjectivesThis article reports on coding one year of palliative care research using a previously developed checklist. The aims were to 1) quantify current reporting of factors related to generalizability in specialist palliative care research; 2) review and potentially refine the checklist in light of the first aim; 3) demonstrate the feasibility of collecting these data; and 4) set out simple processes to aid researchers in reporting, and clinicians in applying, new research evidence in hospice and palliative care.MethodsA previously published checklist (five domains, 14 core subdomains, and 24 noncore subdomains) was used to code all research articles (n = 189) published in 2007 in the three leading palliative care research journals.ResultsThe most frequently reported subdomains were patient age, gender, and diagnosis; model of service delivery; and patient performance status. Data in subdomains, including time from referral to death, socioeconomic indices, and ethnicity, were rarely reported; none reported whole-of-service or whole-of-population data. In total, 2646 (189 × 14) core subdomains could have been reported. Data were provided in 28% (746/2646).ConclusionChecklists such as the Consolidated Standards of Reporting Trials evaluate study design, focusing mainly on internal validity. The proposed checklist deals with specific content of hospice and palliative care, focusing on external validity.     

The Efficacy of Electrotherapy for Bell's Palsy: A Systematic Review

Abstract

There are many unresolved views on the efficacy of a wide range of therapeutic approaches in the treatment of Bell's palsy. The purpose of this paper was to review systematically randomised controlled trials, controlled trials and case studies relating to the efficacy of electrotherapy modalities in the management of acute and chronic Bell's palsy. The electrotherapy modalities reviewed included electrical stimulation, electromyography biofeedback, ultrasound, laser and short-wave diathermy.All the included studies were reviewed according to a self-devised checklist. Methodological considerations including the paucity of literature, and overall poor quality of trials impact the conclusions of this review. A clinical reasoning model and reflective practice, which consider the physiological effects of electrotherapeutic modalities according to the stages of healing of nerve injury, is offered. Guidance for electrotherapy intervention is suggested as well as possible areas for future research.     

Model for defining and reporting reference-based validation protocols in medical image processing

Objectives Image processing tools are often embedded in larger systems. Validation of image processing methods is important because the performance of such methods can have an impact on the performance of the larger systems and consequently on decisions and actions based on the use of these systems. Most validation studies compare the direct or indirect results of a method with a reference that is assumed to be very close or equal to the correct solution. In this paper, we propose a model for defining and reporting reference-based validation protocols in medical image processing. Materials and methods The model was built using an ontological approach. Its components were identified from the analysis of initial publications (mainly reviews) on medical image processing, especially registration and segmentation, and from discussions with experts from the medical imaging community during international conferences and workshops. The model was validated by its instantiation for 38 selected papers that include a validation study, mainly for medical image registration and segmentation. Results The model includes the main components of a validation procedure and their inter-relationships. A checklist for reporting reference-based validation studies for medical image processing was also developed. Conclusion The proposed model and associated checklist may be used in formal reference-based validation studies of registration and segmentation and for the complete and accurate reporting of such studies. The model facilitates the standardization of validation terminology and methodology, improves the comparison of validation studies and results, provides insight into the validation process, and, finally, may lead to better quality image management and decision making.     

Adherence to the PRISMA statement and its association with risk of bias in systematic reviews published in rehabilitation journals: A meta-research study

BackgroundSystematic reviews (SRs) and meta-analyses are essential resources for the clinicians. They allow to evaluate the strengths and the weaknesses of the evidence to support clinical decision-making if they are adequately reported. Little is known in the rehabilitation field about the completeness of reporting of SRs and its relationship with the risk of bias (ROB).ObjectivesPrimary: 1) To evaluate the completeness of reporting of systematic reviews (SRs) published in rehabilitation journals by evaluating their adherence to the PRISMA 2009 checklist, 2) To investigate the relationship between ROB and completeness of reporting. Secondary: To study the association between completeness of reporting and journals and study characteristics.MethodsA random sample of 200 SRs published between 2011 and 2020 in 68 rehabilitation journals was indexed under the “rehabilitation” category in the InCites database. Two independent reviewers evaluated adherence to the PRISMA checklist and assessed ROB using the ROBIS tool. Overall adherence and adherence to each PRISMA item and section were calculated. Regression analyses investigated the association between completeness of reporting, ROB, and other characteristics (impact factor, publication options, publication year, and study protocol registration).ResultsThe mean overall PRISMA adherence across the 200 studies considered was 61.4%. Regression analyses show that having a high overall ROB is a significant predictor of lower adherence (B=-7.1%; 95%CI -12.1, -2.0). Studies published in fourth quartile journals displayed a lower overall adherence (B= -7.2%; 95%CI -13.2, -1.3) than those published in first quartile journals; the overall adherence increased (B= 11.9%; 95%CI 5.9, 18.0) if the SR protocol was registered. No association between adherence, publication options, and publication year was found.ConclusionReporting completeness in rehabilitation SRs is suboptimal and is associated with ROB, impact factor, and study registration. Authors of SRs should improve adherence to the PRISMA guideline, and journal editors should implement strategies to optimize the completeness of reporting.     

Development of an Evidence-Based Practical Diagnostic Checklist and Corresponding Clinical Exam for Low Back Pain

ObjectiveThe purpose of this study was to use scientific evidence to develop a practical diagnostic checklist and corresponding clinical exam for patients presenting with low back pain (LBP).MethodsAn iterative process was conducted to develop a diagnostic checklist and clinical exam for LBP using evidence-based diagnostic criteria. The checklist and exam were informed by a systematic review focused on summarizing current research evidence for office-based clinical evaluation of common conditions causing LBP.ResultsDiagnostic categories contained within the checklist and exam include nociceptive pain, neuropathic pain, and sensitization. Nociceptive pain subcategories include discogenic, myofascial, sacroiliac, and zygapophyseal (facet) joint pain. Neuropathic pain categories include neurogenic claudication, radicular pain, radiculopathy, and peripheral entrapment (piriformis and thoracolumbar syndrome). Sensitization contains 2 subtypes, central and peripheral sensitization. The diagnostic checklist contains individual diagnostic categories containing evidence-based criteria, applicable examination procedures, and checkboxes to record clinical findings. The checklist organizes and displays evidence for or against a working diagnosis. The checklist may help to ensure needed information is obtained from a patient interview and exam in a variety of primary spine care settings (eg, medical, chiropractic).ConclusionThe available evidence informs reasonable working diagnoses for many conditions causing or contributing to LBP. A practical diagnostic process including an exam and checklist is offered to guide clinical evaluation and demonstrate evidence for working diagnoses in clinical settings.     

The development and implementation of a clinical skills matrix to plan and monitor palliative care nurses' skills

AimTo develop and implement a region wide skills matrix for palliative care and district nurses in rural Victoria in order to identify and address individual learning needs and appropriate professional development strategies based on the Australian National Palliative Care Standards. This study is the first in a series of papers discussing and evaluating the development and implementation of a skills matrix. Future papers will report on participants’ data reporting.MethodsThe development and implementation of a skills matrix for palliative care nurses was based on using several evidence-based strategies involving four main stages. There were: stakeholder consultation, collaboration, consolidation and implementation. The initial stage of development of the matrix involved consultation with regional stakeholders to establish and refine the project objectives. The second stage involved collection of information from regional stakeholders; brainstorming and discussion of the technical skills required for palliative care and the cross over with district nursing. The third stage involved a facilitated process whereby action plans were devised and the final stage involved a plan for the survey dissemination and evaluation of the training needs.Other evidence-based strategies used were Benner’s theoretical model of clinical competence, the Australian National Palliative Care Standards and the triple C model of project implementation.ResultsThis study reported on the development and implementation of a self-assessment of competencies skills matrix for nurses working in palliative care based on the Australian National Standards of palliative care used by services.The matrix included all the aspects covered by the Australian National Palliative Care Standards and mapped them to various competencies using Benner’s model ranging from novice to expert. The availability of a skills matrix tool to self-assess is important to keep track of the clinical competencies gained by palliative care nurses. Targeted educational interventions identified by the skills matrix have the potential to improve quality of care provided in the palliative care setting.ConclusionThe successful development and implementation of the palliative skills matrix across the Gippsland region relied on using several evidence-based strategies to standardise the competencies across the palliative care setting in rural Victoria, Australia. Examples of these strategies included using Benner’s theoretical competency model, the Australian National Palliative Standards and the triple C model, which included stakeholders’ consultation, collaboration and consolidation.     

Psychosocial factors,musculoskeletal disorders and work-related fatigue amongst nurses in Brunei: structural equation model approach

IntroductionPsychosocial factors, musculoskeletal disorders and work-related fatigue have adverse effects on individual nurses and place a substantial financial burden on health care. Evidence of an association has been reported in the literature, but no theoretical explanation has been published to date.AimTo explore and develop a structural model to provide a theoretical explanation for this relationship.MethodsA cross-sectional study using data from 201 valid samples of emergency and critical care nurses across public hospitals in Brunei was performed via self-administered questionnaire. The structural equation model was assessed using partial least squares analysis.ResultsA valid and robust structural model was constructed. This revealed that 61.5% of the variance in chronic fatigue could be explained by psychosocial factors and musculoskeletal disorders pathways. Among the psychosocial factors, work–family conflict was identified as a key mediator for progression of musculoskeletal problems and subsequent fatigue through stress and burnout.ConclusionThis report provides a novel theoretical contribution to understanding the relationship between psychosocial factors, musculoskeletal disorders and work-related fatigue. These preliminary results may be useful for future studies on the development of work-related fatigue and musculoskeletal disorders, particularly the central role of work–family conflict.     

Laboratory critical values: Automated notification supports effective clinical decision making

ObjectiveFailure to adequately communicate a laboratory critical value (CV) is a potential cause of adverse events. The harmonization of CV reporting is increasingly recognized as a key issue in ensuring patient care and minimizing harm. With ongoing improvements in CV reporting, the patient's outcome should be audited to assess the effectiveness of CV notification.Design and methodsWe report the data audited throughout a six month-period during which an analysis was made of CVs, and we describe the approach of clinicians and general practitioners (GPs), and their decision making following CV reporting.ResultsCV notification led to a change of treatment in 98.0% of patients admitted to surgical and in 90.6% of those admitted to medical wards. Clinicians made a further evaluation of new complications in patients in 70.0% and 60.4% of cases, in surgical and medical wards respectively. In more than 40.0% of cases, CVs were unexpected findings. In the primary care setting, critical hyperkalemia was managed by GPs in 55% of patients, thus sparing patient's hospitalization. For all outpatients with critical INR (international normalized ratio), the GPs changed or stopped warfarin dosage. Twenty-four percent of patients were checked for an additional INR, whereas a further medical examination by a consultant in the hospital setting was requested for 5% of patients.ConclusionsThe laboratory plays a key role in ensuring patient safety, especially in CV reporting. An evaluation should be made of the patient's outcome and clinical decision making in order to assess the effectiveness of the CV process.     

Development of a Child Abuse Checklist to Evaluate Prehospital Provider Performance

Objectives: To develop and provide validity evidence for a performance checklist to evaluate the child abuse screening behaviors of prehospital providers. Methods: Checklist Development: We developed the first iteration of the checklist after review of the relevant literature and on the basis of the authors' clinical experience. Next, a panel of six content experts participated in three rounds of Delphi review to reach consensus on the final checklist items. Checklist Validation: Twenty-eight emergency medical services (EMS) providers (16 EMT-Basics, 12 EMT-Paramedics) participated in a standardized simulated case of physical child abuse to an infant followed by one-on-one semi-structured qualitative interviews. Three reviewers scored the videotaped performance using the final checklist. Light's kappa and Cronbach's alpha were calculated to assess inter-rater reliability (IRR) and internal consistency, respectively. The correlation of successful child abuse screening with checklist task completion and with participant characteristics were compared using Pearson's chi squared test to gather evidence for construct validity. Results: The Delphi review process resulted in a final checklist that included 24 items classified with trichotomous scoring (done, not done, or not applicable). The overall IRR of the three raters was 0.70 using Light's kappa, indicating substantial agreement. Internal consistency of the checklist was low, with an overall Cronbach's alpha of 0.61. Of 28 participants, only 14 (50%) successfully screened for child abuse in simulation. Participants who successfully screened for child abuse did not differ significantly from those who failed to screen in terms of training level, past experience with child abuse reporting, or self-reported confidence in detecting child abuse (all p > 0.30). Of all 24 tasks, only the task of exposing the infant significantly correlated with successful detection of child abuse (p < 0.05). Conclusions: We developed a child abuse checklist that demonstrated strong content validity and substantial inter-rater reliability, but successful item completion did not correlate with other markers of provider experience. The validated instrument has important potential for training, continuing education, and research for prehospital providers at all levels of training.