Protocol for the development of consensus-based clinical case reporting guideline extension: CARE for acupuncture

BackgroundHealth research reporting guidelines for case reports (CARE - CAse REport) published in 2013 and 2017 have become a generally accepted standard for publishing case reports. The CARE guidelines represent an architectural framework for writing an evidence-based case report that can be customized as need for a specialty (or disease) if needed. We aim to develop a CARE guideline extension for acupuncture following the EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) and the 2010″Guidance for Developers of Health Research Reporting". We have established a group of international experts including; clinicians, researchers and methodologists. We performed a needs assessment based on a review of acupuncture case reports published in the indexed medical literature. The needs assessment will be followed by (1) a series of expert interviews to establish a draft, (2) a modified Delphi process, and (3) a consensus meeting. Following the consensus meeting we will pilot test the CARE draft before publishing the CARE extension for acupuncture.MethodsWe will develop the CARE extensions for acupuncture following recommendations of the EQUATOR Network and the 2010 "Guidance for Developers of Health Research Reporting". We will establish an international multidisciplinary group including clinical practitioners, acupuncturists, researchers of reporting guidelines on acupuncture, clinical epidemiologists and statisticians.We performed a needs assessment, reviewing published case reports using acupuncture as a therapeutic intervention from indexed medical journals (PubMed-PMC and Medline, Scopus, Embase, the Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Wan Fang database, Chinese BioMedicine database (CBM), China National Knowledge Infrastructure (CNKI), and VIP). In consultations with advisors we will develop a draft of potential items to be included in the CARE extension for acupuncture. Then we will conduct a modified Delphi process of at least three rounds, hold a face-to-face consensus meeting, pilot test and submit the CARE extension for acupuncture for publication.ConclusionThe development of a widely accepted CARE extension for acupuncture for case reports published in indexed medical journals. These guidelines will follow the EQUATOR Network recommendations and the 2010 "Guidance for Developers of Health Research Reporting".     

Improvement in the quality of abstracts in major clinical journals since CONSORT extension for abstracts: A systematic review

BackgroundWe sought to determine if the publication of the Consolidated Standards of Reporting Trials (CONSORT)¹ extension for abstracts in 2008 had led to an improvement in reporting abstracts of randomized controlled trials (RCTs).²MethodsWe searched PubMed for RCTs published in 2007 and 2012 in top-tier general medicine journals. A random selection of 100 trial abstracts was obtained for each year. Data were extracted in duplicate on the adherence to the CONSORT extension for abstracts. The primary outcome was the mean number of items reported and the secondary outcome was the odds of reporting each item. We also estimated incidence rate ratios (IRRs).³ResultsSignificantly more checklist items were reported in 2012 than in 2007: adjusted mean difference was 2.91 (95% confidence interval [CI]⁴ 2.35, 3.41; p < 0.001). In 2012 there were significant improvements in reporting the study as randomized in the title, describing the trial design, the participants, and objectives and blinding. In the Results section, trial status and numbers analyzed were also reported better. The IRRs were significantly higher for 2012 (IRR 1.32; 95% CI 1.25, 1.39; p < 0.001) and in multisite studies compared to single site studies (IRR 1.08; 95% CI 1.03, 1.15; p = 0.006).ConclusionsThere was a significant improvement in the reporting of abstracts of RCTs in 2012 compared to 2007. However, there is still room for improvement as some items remain under-reported.     

A randomized controlled trial of homeopathic treatment of weaned piglets in a commercial swine herd

AimTo evaluate the zootechnic performance and occurrence of diarrhea in piglets in the week post-weaning comparing supplementation with sucrose saline which contained or did not contain added homeopathic medicine.MethodAnimals were randomly divided into three groups of 24 piglets each. The control group did not receive any treatment. Another group received sucrose saline, and the third group received sucrose saline with homeopathic medicine added, in the period of zero to seven days post-weaning. The homeopathic treatment consisted of Echinacea angustifolia, Avena sativa, Ignatia amara, Calcarea carbonica, all 6cH. Piglets were weighed daily for weight gain or loss, and observed for diarrhea and feed intake.ResultsAnimals receiving sucrose saline alone and sucrose saline with homeopathy had less weight loss than control (p = 0.017, p = 0.0001 respectively). There was no statistical difference in relation to overall incidence of diarrhea or food consumption. These data suggest that the supplementation with sucrose saline with added homeopathic medicine in the first seven days post-weaning may be an useful option to reduce weight loss in weaned piglets.     

Adverse effects of homeopathy,what do we know? A systematic review and meta-analysis of randomized controlled trials

ObjectivesHomeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients’ symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed.Design and settingSixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis.ResultsA total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86–1.14, I² = 54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high.ConclusionAdverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine.     

Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment

BackgroundTo date, our programme of systematic reviews has assessed randomised controlled trials (RCTs) of individualised homeopathy separately for risk of bias (RoB) and for model validity of homeopathic treatment (MVHT).ObjectivesThe purpose of the present paper was to bring together our published RoB and MVHT findings and, using an approach based on GRADE methods, to merge the quality appraisals of these same RCTs, examining the impact on meta-analysis results.DesignSystematic review with meta-analysis.MethodsAs previously, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were the subject of study.Main outcome measuresFor each trial, the separate ratings for RoB and MVHT were merged to obtain a single overall quality designation (‘high’, ‘moderate, “low”, ‘very low’), based on the GRADE principle of ‘downgrading’.ResultsMerging the assessment of MVHT and RoB identified three trials of ‘high quality’, eight of ‘moderate quality’, 18 of ‘low quality’ and three of ‘very low quality’. There was no association between a trial’s MVHT and its RoB or its direction of treatment effect (P > 0.05). The three ‘high quality’ trials were those already labelled ‘reliable evidence’ based on RoB, and so no change was found in meta-analysis based on best-quality evidence: a small, statistically significant, effect favouring homeopathy.ConclusionAccommodating MVHT in overall quality designation of RCTs has not modified our pre-existing conclusion that the medicines prescribed in individualised homeopathy may have small, specific, treatment effects.     

Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT

When homeopathy is tested in clinical trials, understanding and appraisal is likely to be improved if published reports contain details of prescribing strategies and treatments. An international Delphi panel was convened to develop consensus guidelines for reporting homeopathic methods and treatments. The panel agreed 28 treatment- and provider-specific items that supplement the Consolidated Standards of Reporting Trials (CONSORT) Statement items 2, 3, 4 and 19. The authors recommend these for adoption by authors and journals when reporting trials of homeopathy.     

Research without results: inadequate public reporting of clinical trial results

ObjectiveIn order to increase transparency in the medical literature, the Food and Drug Administration (FDA) Modernization Act of 1997 and the FDA Amendment Act of 2007 required registration of all “applicable trials” with required “basic results” reporting.We evaluated the rate of compliance with the FDA mandatory results reporting in www.clinicaltrials.gov.MethodsAll completed registered interventional studies that may be subject to FDA regulation, one year prior to required results reporting (October 2006 to September 2007, n = 1097) and during the two years after required reporting (October 2007 to September 2008 (07–08), n = 2231 and October 2008 to September 2009 (08–09), n = 2923).ResultsDownloading all 99,315 records from clinicaltrials.gov, we excluded all non-applicable studies. Results reporting increased from 6.8% (n = 75) prior to mandatory reporting to 19.1% (n = 427, p < .01) in 07–08 and 10.8% (n = 316, p < .01) in 08–09. The odds ratio for results reporting using the 06–07 time period as the reference was 3.31 (95% CI 2.54–4.32) for 07–08 and 1.74 (1.33–2.28) for 08–09. Of the 818 trials with results in clinicaltrials.gov, the rate of published articles found decreased from 60% (n = 45) in the year prior to required reporting to 33% (n = 140, p < .001) for 07–08 and 20% (n = 63, p < .001) for 08–09 time period.ConclusionThe majority of studies registered in clinicaltrials.gov are not required to report data. Of studies that may be required to report data, compliance with data reporting has improved. The clinicaltrials.gov website is not yet a comprehensive resource for study results.     

Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT

When homeopathy is tested in clinical trials, understanding and appraisal is likely to be improved if published reports contain details of prescribing strategies and treatments. An international Delphi panel was convened to develop consensus guidelines for reporting homeopathic methods and treatments. The panel agreed on 28 treatment- and provider-specific items that supplement the CONSORT (Consolidated Standards of Reporting Trials) Statement items 2, 3, 4, and 19. The authors recommend these for adoption by authors and journals when reporting trials of homeopathy.     

A randomized controlled trial of a homeopathic syrup in the treatment of cold symptoms in young children

BackgroundThere is little evidence that the decongestant, antihistamine, or cough suppressant medications commonly used to treat cold symptoms in preschool children are effective. One option for treating cold symptoms in young children is with homeopathy. This study was conducted to determine if a homeopathic syrup was effective in treating cold symptoms in preschool children.MethodsChildren 2–5 years old diagnosed with an upper respiratory tract infection were randomized to receive a commercial homeopathic cold syrup or placebo. Parents administered the study medication as needed for 3 days. The primary outcome was change in symptoms one hour after each dose. Parents also assessed the severity of each of the symptoms of runny nose, cough, congestion and sneezing at baseline and twice daily for 3 days, using a 4-point rating scale. A composite cold score was calculated by combining the values for each of the four symptoms.ResultsAmong 261 eligible participants, data on 957 doses of study medication in 154 children were analyzed. There was no significant difference in improvement one hour after the dose for any symptom between the two groups. Analysis of twice daily data on the severity of cold symptoms compared to baseline values found that improvements in sneezing, cough and the composite cold score were significantly greater at both the first and second assessments among those receiving the cold syrup compared to placebo recipients.ConclusionThe homeopathic syrup appeared to be effective in reducing the severity of cold symptoms in the first day after beginning treatment.     

Interexaminer agreement of clinical examination of the neck in manual medicine

ObjectivesTo assess interexaminer agreement in a structured, manual, clinical examination of the neck. To correlate these data with the score in a functional questionnaire (a validated, French-language version of the neck pain and disability scale).PatientsFifty-nine ambulatory patients (26 males and 33 females, mean ± SD age: 46.3 ± 12 yrs) with common neck pain but no radiation below the elbow.MethodsTwo medical practitioners (a junior and a senior consultant) assessed neck rotation (in degrees) and the presence of pain during maximum neck flexion and extension, muscle palpation trapezius, levator scapulae, splenius cervicis, semispinalis) and cervical spine palpation. Cohen's kappa coefficient was calculated for qualitative variables. Angular rotational values (as a continuous variable) were compared using the p coefficient. Pearson coefficient was used to correlate the number of tender spots to the results of the questionnaire.ResultsThere was no significant interexaminer difference (±10°) in the neck rotation measurement. Kappa was (i) 0.71 and 0.76 for pain in flexion or extension, respectively, (ii) 0.44 on average for palpation of various muscles and (iii) 0.53 on average for cervical spine palpation. The number of tender spots correlated strongly with the questionnaire score (Pearson's coefficient: 0.35; p = 0.007).ConclusionThe interexaminer agreement for our clinical examination was moderate. The number of tender spots correlated strongly with the functional impairment. Pain at the lower attachment of the levator scapulae was associated with dysfunction of the median or upper cervical spine.     

Reliability of two functional clinical tests to evaluate trunk and lumbopelvic neuromuscular control and proprioception in a healthy population

ObjectivesThe need to accurately assess trunk and lumbopelvic proprioception and neuromuscular control is widely accepted. However, based on current literature, there is a lack of reliable clinical tests to evaluate these aspects in clinical practice. The objective of this study is to investigate intra- and inter-tester reliability of the lateral step down test and the lumbopelvic position–reposition test in a healthy population.MethodsProtocol and scoring methods were developed for the lateral step down test and lumbopelvic position–reposition test, used to assess trunk and lumbopelvic neuromuscular control and proprioception respectively. Each test was performed once by thirty participants and video analysis for test scoring was performed. Three items on the lateral step down test were scored to evaluate neuromuscular control and, four items on the lumbopelvic position–reposition test were scored to evaluate proprioception. Aggregate scores for each test were calculated based on the separate item scores. Intraclass correlation coefficients and linear weighted kappa coefficients were determined for intra- and inter-tester reliability.ResultsBased on the aggregate score, excellent intra- and inter-tester reliability (ICC (2,1) = 0.73–0.88) was found for both tests. Moderate/almost perfect intra-and inter-tester agreement (K = 0.62–0.91) was found for the separate items of the lateral step down test and fair/substantial agreement (K = 0.25–0.76) for the items of the lumbopelvic position–reposition test.ConclusionCurrent testing protocol and scoring method for the lateral step down test is reliable. Adjustments for the scoring method of the lumbopelvic position–reposition test are warranted to improve reliability.     

Online Reporting of Adverse Drug Reactions: A Study from a French Regional Pharmacovigilance Center

BackgroundIn France, online reporting via a website is a new method for notifying adverse drug reactions (ADRs). The French Midi-Pyrénées Regional Pharmacovigilance Center (RPVC) set up in July, 2010 a Web-based ADR reporting tool in order to improve ADR reporting rate.ObjectivesTo assess feasibility, use and performances of this new ADR reporting system. To evaluate the main characteristics of these online reports.MethodsIn a retrospective study, we evaluated characteristics (numbers, ADR reporting and file processing times, type of reporters, suspected drugs, “seriousness” and nature of ADRs) of online notifications reported to the RPVC between July 7^th, 2010 (first online notification) and December 31^th, 2011. We performed comparisons to a random sample of “conventional” notifications, i.e. spontaneously reported to the RPVC via traditional tools (post, fax, e-mail or telephone) during the same period.ResultsThe total number of online reports was 312 over the 18-month period. There was a 45% increase in numbers of reports from ambulatory healthcare professionals after the implementation of the new reporting tool. Online reports were transmitted to the French Medicine Agency on average almost one month (26 days) earlier than “conventional” ones. This difference was mainly due to a faster ADR notification process via the online form (on average, the reporting period was decreased by 19 days with the new tool). In comparison to “conventional” notifications, online reports came more often from ambulatory healthcare professionals, and involved more frequently neuropsychiatric drugs and neuropsychiatric ADRs. None difference was observed for “seriousness” of ADRs.ConclusionsIt is feasible to deploy an online ADR reporting system used by health professionals in current practice. We underline the efficiency of this new online reporting tool for increasing ADRs reporting. Moreover, this is the first published study demonstrating that an online reporting tool can help to save time on the ADR reporting period and file processing, which is essential to generate early safety signals.     

Development and assessment of the validity and reliability of a scale for measuring the mentoring competencies of Japanese clinical midwives: An exploratory quantitative research study

BackgroundMidwives are always involved in educational activities whenever novice midwives are present. Although various scales for measuring the educational competencies of nurses have already been developed in previous studies, a scale for the educational competencies particular to midwives has yet to be developed, or even no previous studies have revealed their functions as clinical educators.ObjectivesThe purpose of this study was to develop a scale to measure the mentoring competencies of clinical midwives (MCCM Scale) and to confirm its validity and reliability.DesignAn exploratory quantitative research study.MethodsQuestionnaires were distributed to 1,645 midwives at 148 facilities who had previously instructed novice midwives. 1,004 midwives (61.0%) voluntarily returned valid responses and 296 (18.0%) voluntarily agreed to participate in the survey for test–retest reliability.ResultsExploratory factor analyses were performed over 41 items and the following seven factors were extracted with a reliability coefficient (Cronbach's α) of 0.953: (i) supporting experimental study, (ii) personal characteristics particularly in clinical educators, (iii) thoughtfulness and empathy for new midwives, (iv) self-awareness and self-reflection for finding confidence, (v) making effective use of the new midwives' own experience, (vi) commitment to educational activities, and (vii) sharing their midwifery practice. Test–retest reliability was measured based on a convenience sample of 246 (83.1%). Pearson's test–retest correlation coefficient for the entire scale was r = 0.863. The factor loadings of each item on its respective factor were 0.313–0.925. The total score of the MCCM Scale was positively correlated with that of the Quality of Nurses' Occupational Experience Scale (r = 0.641, p = 0.000) and was negatively correlated with the total score of the Japanese Burnout Scale (r = − 0.480, p = 0.000).ConclusionThe MCCM Scale is composed of 41 items and three subscales measured from a total of seven factors. The validity and reliability of the MCCM Scale was supported by the statistical analyses.     

How does the introduction of a pain and sedation management guideline in the paediatric intensive care impact on clinical practice? A comparison of audits pre and post guideline introduction

Despite the use of guidelines to inform practice for pain and sedation management there are few evaluations of the effect of their introduction on clinical practice. Previous evaluations of the protocols and guidelines used to manage pain and sedation in the paediatric intensive care unit (PICU) report increases in pain and sedation medication administration post guideline introduction. In most reported cases the guideline was accompanied by a treatment algorithm. To our knowledge there is no published data on the effect of introducing a guideline without a treatment algorithm on pain and analgesia administration.PurposeTo evaluate the impact the introduction of a pain and sedation guideline will have on clinical practice.MethodsA 19 bed PICU was audited for one month prior to the introduction of a guideline and one month post.FindingsThe proportion of patients receiving oral Clonidine increased (p = 0.001) and the administration of Ketamine, particularly via bolus (p = 0.003), reduced after the introduction of the guideline. The use of a validated pain tool to assess pain increased by 25% and communication of management plans increased by 25%. The documentation of the use of boluses increased by 36%.ConclusionThe introduction of a clinical practice guideline for pain and sedation management in PICU contributes to changes in medication administration, use of validated pain assessments, improved documentation of boluses and communication of management plans.     

Assessment of bimanual performance in 3-D movement analysis: Validation of a new clinical protocol in children with unilateral cerebral palsy

BackgroundThe “Be an Airplane Pilot” (BE-API) protocol is a novel 3-D movement analysis (3DMA) protocol assessing the bimanual performance of children during a game.ObjectiveThis study aimed to investigate the reliability and validity of this protocol in children with unilateral cerebral palsy (uCP).MethodsAngular waveforms (WAVE), maximum angles (MAX) and range of motion (ROM) of the trunk, shoulder, elbow and wrist joints were collected in children with uCP and in typically developing children (TDC) during 4 tasks of the BE-API protocol designed to explore specific degrees of freedom (DoF). The inter-trial reliability for children with uCP was assessed with the coefficient of multiple correlation (CMC) for WAVE and the intraclass correlation coefficient (ICC) and standard error of measurement (SEM) for MAX and ROM. Clinical performance-based measures, including the Assisting Hand Assessment (AHA) and ABILHAND-Kids scores, were used to explore correlations between clinical measures and kinematic parameters in children with uCP.Results20 children with uCP (13 boys; mean age 12.0 [SD 3.2] years) and 20 TDC (11 boys; mean age 11.9 [SD 3.4] years) were included. In children with uCP, most kinematic parameters showed high reliability (WAVE: CMC ≥ 0.82; MAX and ROM: ICC ≥ 0.85, SEM ≤ 4.7°). Elbow extension, forearm supination, and wrist adduction were reduced and wrist flexion was increased for children with uCP versus TDC (P < 0.01). In children with uCP, MAX and ROM values were moderately correlated with clinical assessments (AHA score: r = 0.48–0.65; ABILHAND-Kids score: r = 0.48–0.49).ConclusionsThe BE-API protocol is a 3DMA-bimanual performance-based assessment that is highly reliable in children with uCP. Children with uCP and TDC significantly differed in some clinically relevant kinematic parameters. The BE-API is a promising playful tool, helpful for better understanding upper-limb motor movement abnormalities in bimanual conditions and for tailoring treatments to individual deficits.     

Assessing the necessity of including a crossover period with dual reporting when changing total prostate-specific antigen methods

ObjectivesOptions are limited for the laboratory when changing analytical methods for tumor markers. Standardization between methods should alleviate this burden. Our objective was to assess the necessity of dual reporting for total prostate-specific antigen (tPSA) when changing methods that have been calibrated against the World Health Organization PSA reference material.Design and methodsFollowing an initial validation where 40 patient samples were divided and analyzed on the Roche E-modular (current method) and Abbott ARCHITECT (new method) for tPSA, a crossover period ensued with dual reporting of tPSA over 54 days (n = 1110 samples with both tPSA results reported). Passing & Bablok regression was performed, with agreement during the crossover period also determined by two methods. Method#1: if the percent difference between the result pair was ≤ 0.33 × the intraindividual biological variation (0.33 × CVi = 6.0%) for tPSA; and Method#2: if the Roche tPSA result was within an acceptable analytical range based on Abbott's maximum allowable imprecision for the tPSA assay (CV ≤ 8%) to determine if there was a range of optimal agreement that might not require dual reporting.ResultsDuring the crossover period, Passing & Bablok regression yielded the following relationship: Abbott tPSA = 1.04(95% CI: 1.03 to 1.04) × (Roche tPSA) − 0.02(95% CI: − 0.03 to − 0.02). Only 52% (95%CI: 49 to55) of the results were in agreement by Method#1 whereas 95% (95% CI: 92 to 97) of the results between 3.3 and 19 μg/L were found to have acceptable agreement based on Method#2.ConclusionsThese findings suggest that dual reporting of tPSA is required when changing methods. However, the extent of dual reporting may be limited to specific concentration ranges with future studies required to validate selective dual reporting when changing tPSA assays.     

Effect of oil pulling in promoting oro dental hygiene: A systematic review of randomized clinical trials

AimTo critically appraise and evaluate the evidence from randomized clinical trials (RCTs) examining the effectiveness of oil pulling on oro dental hygiene.MethodsWe conducted electronic searches in Medline, Embase, Amed, The Cochrane Library and Cinahl databases from inception to February 2015, and assessed reporting quality using the Cochrane risk of bias criteria. We included RCTs that compared oil pulling using conventional cooking oils with a control intervention. Our primary outcomes were measures of oro dental hygiene using validated scales.ResultsElectronic searches yielded 26 eligible studies, of which five RCTs comprising a total of 160 participants were included. The studies varied in reporting quality, lasted between 10 and 45 days, and compared oil pulling with chlorhexidine, placebo or routine dental hygiene practice. Three studies reported no significant differences in post intervention plaque index scores between oil pulling and control groups (Chlorhexidine mouthwash +/− Placebo): p = 0.28, 0.94, and 0.38, respectively. Two studies reported no significant difference in post-intervention modified gingival index score between oil pulling and Chlorhexidine mouthwash groups (p = 0.32 and 0.64).ConclusionThe limited evidence to date from clinical trials suggests that oil pulling may have beneficial effects on oro dental hygiene as seen for the short period of time investigated. Given that this is a potentially cost-effective intervention, this practice might be of particular benefit. Future clinical trials should be more rigorous and better reported.     

An integrated model for the effects of self-reflection and clinical experiential learning on clinical nursing performance in nursing students: A longitudinal study

BackgroundThe use of clinical simulation in undergraduate nursing programs in Taiwan has gradually increased over the past 5 years. Previous research has shown that students' experience of anxiety during simulated laboratory sessions influences their self-reflection and learning effectiveness. Thus, further study that tracks what influences students' clinical performance in actual clinical sites is vital.ObjectiveThe aim of the study is to develop an integrated model that considers the associations among anxiety, self-reflection, and learning effectiveness and to understand how this model applies to student nurses' clinical performance while on clinical placement.DesignThis study used a correlational and longitudinal study design.MethodsThe 80 nursing students, who ranged in age from 19 to 21 (mean = 20.38, SD = 0.56), were recruited from a nursing school in southern Taiwan. Data were collected during three phases of implementation using four questionnaires. During the first phase, the State-Trait Anxiety Inventory (STAI), Simulation Learning Effectiveness Scale (SLES), and Self-Reflection and Insight Scale (SRIS) were used after students completed the simulation course in the school simulation laboratory. Nursing students also completed the Holistic Nursing Competence Scale at 2 months (Phase 2) and 4 months (Phase 3) after clinical practice experience. In Phase 3, students again completed the STAI and SRIS. Partial least squares (PLS), a structural equation modeling (SEM) procedure, was used to test the research model.ResultsThe findings showed that: (1) at the start of the simulation laboratory, anxiety had a significant negative effect on students' simulation learning effectiveness (SLE; β = − 0.14, p < 0.05) and on self-reflection with insight (SRI; β = − 0.52, p < 0.01). Self-reflection also had a significant positive effect on simulation learning effectiveness (β = 0.37, p < 0.01). Anxiety had a significant negative effect on students' nursing competence during the first 2 months of practice in a clinical nursing site (β = − 0.20, p < 0.01). Simulation learning effectiveness and self-reflection and insight also had a significant positive effect on nursing competence during the first 2 months of practice in a clinical site (β = 0.13; β = 0.16, p < 0.05), respectively; and (2) when students practice in a clinical setting, their previous experience of nursing competence during the first 2 months of clinical care and their self-reflection and insight have a significant positive effect on their 4-month nursing competence (β = 0.58; β = 0.27, p < 0.01). Anxiety, however, had a negative effect on 4-month nursing competence but not significantly. Overall, 41% of the variance in clinical nursing performance was accounted for by the variables in the integrated model.ConclusionThis study highlights that self-reflection with insight and clinical experience may help students to deflect anxiety that may influence the development of clinical competence. Of note is that real-life clinical experience has a stronger effect on enhancing clinical performance than does a simulation experience.     

A pre-test post-test study of a brief educational intervention demonstrates improved knowledge of potential acute myocardial infarction symptoms and appropriate responses in cardiac rehabilitation patients

BackgroundPatient delay in recognizing and responding to potential acute myocardial infarction (AMI) symptoms is an international issue. Cardiac rehabilitation provides an ideal opportunity to deliver an intervention.AimsThis study examines an individual educational intervention on knowledge of heart attack warning signs and specific chest pain action plans for people with coronary heart disease.MethodsCardiac rehabilitation participants at five hospitals were assessed at program entry and tailored education was provided using the Heart Foundation of Australia's Heart Attack Warning Signs campaign educational tool. Participants (n = 137) were reassessed at program conclusion (six to eight weeks).ResultsStudy participants had a mean age of 64.48 years (SD 12.22), were predominantly male (78%) and most commonly presented with a current referral diagnosis of a percutaneous coronary intervention (PCI) (80%) and/or AMI (60%). There were statistically significant improvements in the reporting of 11 of the 14 warning signs of heart attack, with patients reporting 2.56 more warning signs on average at outcome (p < .0001). Patients reported more heart attack warning signs if they had completed high school education (β = 1.14) or had better knowledge before the intervention (β = .57). There were statistically significant improvements in reporting of all appropriate actions in response to potential AMI symptoms, with patients reporting an average of 1.3 more actions at outcome (p < .001), with no change in the median time they would tolerate symptoms (p = .16).ConclusionsA brief education session using a single standardised tool and adapted to a patient assessment is effective in improving knowledge of potential AMI symptoms and appropriate responses in cardiac rehabilitation up to two months following.     

Diabetes nurse case management: Improving glucose control: 10 years of quality improvement follow-up data

The purpose of this retrospective case-control review is to determine the effectiveness of a registered nurse case managers (RNCMs) certified diabetes educator (CDE) quality improvement case management program. RNCMs have a long tradition of providing chronic care intervention, particularly for the high-risk diabetes population with glycosylated hemoglobin (A1C) of 9% or more. However, limited data are available with regard to evaluation of such programs in a Veterans Health Administration population.ResultsA large population (N = 3956) of high-risk veterans with a baseline A1C of 9% or more (mean = 10.6%) was seen by the RNCM's. Paired T-tests of A1C after the last RNCM visit showed a statistically significant A1C reduction (p < 0.001) (mean = 8.5%), after 14–26 months of intervention.ConclusionsRNCMs clinical intervention demonstrated significant A1C reduction (~ 2%). This is an important finding for health care policy makers for planning interventions with respect to long-term management of diabetes mellitus.