Standard Items Research Articles

Effects of community family doctors-led intervention for self-management and medication adherence in type 2 diabetes mellitus patients: study protocol of a cluster randomised controlled trial

IntroductionThe management of diabetes has become a critical public health issue in China. The development of community-based type 2 diabetes management in China has not yet reached an ideal state,...

Effects of a hybrid digital cognitive–behavioural therapy for insomnia and emotion regulation in the workplace (SLEEP): study protocol for a randomised waitlist control trial

IntroductionThis trial tests the efficacy of implementing a hybrid digital cognitive–behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol...

A quality improvement initiative using peer audit and feedback to improve compliance

BackgroundThe Surgical Safety Checklist (SSC) published by the WHO in 2009 is used as standard in surgery worldwide to reduce perioperative patient mortality. However, compliance with the SSC and quality of its application are often not satisfactory. Internal audits and feedbacks seem promising for improving SSC application.ObjectiveThe purpose of this study is to investigate whether an intervention consisting of peer observation and immediate peer feedback can be implemented with high fidelity and acceptance.MethodData were obtained from a national pilot programme that was initiated in Switzerland in 2018 to measure and improve compliance with the SSC using peer audit and feedback. A total of 11 hospitals with 14 sites implemented the full intervention. Each hospital formed an interprofessional project team that should perform at least 30 observations with feedback on SSC application documented in an observation tool developed specifically for this programme. Since the SSCs of the study hospitals differ greatly regarding checklist items, for each of the three SSC sections standard items were defined: four at Sign In, five at Team Time Out and two at Sign Out. Frequency analyses were performed for initiation characteristics, SSC application at item level, feedback characteristics and programme evaluation.ResultsThe 11 hospitals documented 715 valid observations, and feedback on SSC application was provided for 79% of the observations. In 61%, all team members stopped their work for the SSC application, and in 71%, the items were read off from the checklist (instead of recalled from memory). On average, 86% of the standard items were read out by the checklist coordinator, whilst the two items at Sign Out were read out only in 60% and 74%. Additional visual checks with another source (e.g. patient wristband) took place in only 41%, and verbal confirmation of the items (by someone else other than the checklist coordinator) was obtained on an average of 76% across all three checklist sections. The surgical teams reacted positively in 64% to the peer feedback.ConclusionBoth implementation fidelity and acceptability of the intervention were high—the present intervention seems suitable for regular monitoring of the quality of SSC application with internal resources. Peer observation facilitated identifying weaknesses regarding the SSC process and application at item level. Across all hospitals, the Sign Out section in general, visual control for item checks and lack of work interruption of all team members during SSC application showed up as the main areas of improvement.

Az általánosított bizalom kérdőíves mérésének egyes megbízhatósági és érvényességi kérdései a magyarországi adatfelvételek tükrében

Trust is a field of research in social sciences that has complex, well-developed theoreticalapproaches, but its empirical tools are less precisely grounded. The most common survey toolfor measuring generalized trust is a formula often referred to in the literature as “standard”trust question, which reads as follows: “Generally speaking, would you say that most people canbe trusted or that you need to be very careful in dealing with people?” The aim of the paper is toexamine this standard survey item along the dimensions of reliability and validity. In our analysis,we use Hungarian data obtained from various international surveys. Our results indicate seriousvalidity problems, as the standard question shows only weak linkage with additional variables,which, based on the conceptual background, should be in a close relationship with trust.KEYWORDS: trust, generalized trust, survey methods, reliability, validity

Taḥlīl al Bunūd al Ikhtibar fi Mādah al Muḥādaṡah bi Ma`had Jāmi`ah ar Rānirīy Dār al Salām

Ma’had Al-Jami’ah Ar-Raniry Darussalam has many students from different departments, including the Department of Biology, Department of Physics, and the some others, the researcher noticed that most of them are able to answer questions correctly in the exercises. In fact, that book shows the short material and many tests, and each test has a variety of items. Therefore, the researcher wanted to analyze the form of the test items. In this paper, the researcher determines whether the test items in the Conversation Subject at the Ma’had Al-Jami’ah Ar-Raniry Darussalam are appropriate in terms of level of validity, reability, difficulty and in terms of level of discrimination. As for the purposes of scientific writing are to find out the suitability of the test items in the Conversation Subject At The Ma’had Al - Jami’ah Ar-Raniry Darussalam in terms of the level of validity, reability, difficulty and in terms of level of discrimination. As for the research method that the researcher used, it is the content analysis method. The population in this research is all students in SCTV’s dormitory which 183 students and the research took 22 students for sampling. In data collection researcher used documentation, that is, the test items in the Arabic Language Lessons Book for Non-Native Speakers Part One and the author is Dr. F. Abdurrahim in the Conversation Subject At The Ma’had Al-Jami’ah Ar-Raniry Darussalam. Based on the research can be obtained that the questions test which presented by the teacher are not in accordance with the standard item test in terms of validity, reliability, level of difficulty and discrimination.

Workplace psychosocial resources and risk of cardiovascular disease among employees: a multi-cohort study of 135 669 participants.

In terms of prevention, it is important to determine effects on cardiovascular disease (CVD) when some workplace psychosocial resources are high while others are low. The aim of the study was to assess the prospective relationship between clustering of workplace psychosocial resources and risk of CVD among employees. We pooled data from three cohort studies of 135 669 employees (65% women, age 18-65 years and free of CVD) from Denmark, Finland and Sweden. Baseline horizontal resources (culture of collaboration and support from colleagues) and vertical resources (leadership quality and procedural justice) were measured using standard questionnaire items. Incident CVD, including coronary heart and cerebrovascular disease, was ascertained using linked electronic health records. We used latent class analysis to assess clustering (latent classes) of workplace psychosocial resources. Cox proportional hazard models were used to examine the association between these clusters and risk of CVD, adjusting for demographic and employment-related factors and pre-existing physical and mental disorders. We identified five clusters of workplace psychosocial resources from low on both vertical and horizontal resources (13%) to generally high resources (28%). High horizontal resources were combined with either intermediate [hazard ratio (HR) 0.84, 95% confidence interval (CI) 0.74-0.95] or high (HR 0.88, 95% CI 0.78-1.00) vertical resources were associated with lower risks of CVD compared to those with generally low resources. The association was most prominent for cerebrovascular disease (eg, general high resources: HR 0.80, 95% CI 0.67-0.96). Individuals with high levels of workplace psychosocial resources across horizontal and vertical dimensions have a lower risk of CVD, particularly cerebrovascular disease.

Culturally Safe eHealth Interventions With Aboriginal and Torres Strait Islander People: Protocol for a Best Practice Framework.

BackgroundThere is growing global evidence on the adoption and effectiveness of eHealth (including mobile health and telehealth) by First Nation peoples including Aboriginal and Torres Strait Islander people. Although there are frameworks to guide eHealth development, implementation, and evaluation, it is unknown whether they adequately encapsulate the health, cultural, and community-related priorities of Aboriginal and Torres Strait Islander people.ObjectiveThe aim of this research program is to prepare a best practice framework that will guide the co-design, implementation, and evaluation of culturally safe eHealth interventions within existing models of health care for Aboriginal and Torres Strait Islander people. The framework will be a synthesis of evidence that represents best practices in eHealth, as determined by Aboriginal and Torres Strait Islander people.MethodsResearch activities to develop the best practice framework will occur in stepped but overlapping qualitative research phases with governance from an existing multiagency research collaboration (the Collaboration). The research protocol has been informed by key research frameworks such as the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and Developers of Health Research Reporting Guidelines. The seven phases of research will include the following: systematic literature review, scoping review, theme development, theme consultation, Delphi processes for expert reviews, and dissemination.ResultsMembers of the Collaboration conceived this research program in August 2020, and a draft was produced in June 2021 with subsequent funding obtained in July 2021. The Collaboration approved the protocol in December 2021. Results for several research phases of the best practice framework development are expected by January 2023, commencing with the systematic literature review and the scoping review.ConclusionsThe research program outlined in this protocol is a timely response to the growing number of eHealth interventions with Aboriginal and Torres Strait Islander people. A best practice framework is needed to guide the rigorous development and evaluation of eHealth innovations to promote genuine co-design and ensure cultural safety and clinical effectiveness for Aboriginal and Torres Strait Islander people.International Registered Report Identifier (IRRID)DERR1-10.2196/34904

Towards remote monitoring of dynamic arm supports for individuals with Duchenne muscular dystrophy using 3D accelerometry

ObjectiveActively actuated dynamic arm supports, such as the KINOVA O540, provide support for increased independence for individuals with upper limb weaknesses like young men with Duchenne muscular dystrophy. However, there is a significant need for a standardized method to evaluate the impact that dynamic arm supports have on functional activity within the community setting. ApproachThis study uses accelerometry and motor performance data collected during a dynamic arm support device trial with young men with Duchenne muscular dystrophy. Using the accelerometry data during each task of the Performance of Upper Limb test, we used the Support Vector Machine (SVM) learning method to test device sensitivity (identification of use of the device) and success sensitivity (identification of success with each task). Main ResultsThrough this method, we demonstrate high levels of accuracy, sensitivity and specificity when identifying the use or non-use of the device within the data. Further, in the times of device use, this method categorizes the data into “success” and “failure” groups with high accuracy. SignificanceThis study provides a novel application of accelerometry in tandem with the use of a dynamic arm support device. Utilizing standardized movement items, we present an important first step towards remote monitoring of a dynamic arm support device in the natural setting. Through these results, we push the state of the science forward and aim in future work to use remote monitoring to capture change in goal areas and daily tasks during device trials.

A hearing bolt-on item increased the measurement properties of the EQ-5D-5L in a community-based hearing loss screening program.

To investigate the measurement properties of a hearing item ('bolt-on') added to the EQ-5D-5L descriptive system. Cross-sectional data on the EQ-5D-5L descriptive system with the addition of a hearing bolt-on item, namely, 'I have no/slight/moderate/severe/extreme problems hearing', was collected through face-to-face interviews with 418 participants of a community-based hearing loss screening program in Singapore. The distribution of responses to the EQ-5D and the hearing items were compared in terms of the proportion of 'no problems' and the Shannon index (H'). The measurement properties of the hearing item were assessed by testing its correlation with the hearing thresholds in dBHL; and with the standard EQ-5D items. The properties were also evaluated by comparing the proportion of 'full health' in participants with different hearing severities between standard and hearing bolt-on EQ-5D-5L; and the ability in identifying the participants between the standard EQ-5D-5L index score and the level sum score (LSS) of the hearing bolt-on system. Compared to the standard EQ-5D items, the hearing item has a lower proportion of 'no problems' (80.1% vs. 80.9-97.9%); more evenly-distributed responses (H' value: 0.92 vs. 0.18-0.87); and much stronger correlation with the hearing thresholds (|r|: 0.322 and 0.325 vs. 0.008-0.139). It generally has a weak correlation with EQ-5D items (|r|: 0.055-0.160); and reduces the proportion of 'full health' for the participants with different hearing functions with the percentage reduction varying from 6.6 to 22.7%. The LSS is more discriminative than the standard EQ-5D-5L index score as well (F-statistic: 12.71 and 13.93 vs.4.06 and 4.70). A hearing bolt-on to EQ-5D-5L can validly measure hearing severities and is likely to increase the sensitivity of the resultant preference-based EQ-5D index to hearing loss.

Comparative effectiveness of aerobic exercise versus Yi Jin Jing on ovarian function in young overweight/obese women with polycystic ovary syndrome: study protocol for a randomized controlled trial

BackgroundPolycystic ovary syndrome (PCOS) is the most common heterogeneous endocrine disease among women of childbearing age, characterized by androgen excess and ovarian dysfunction. Aerobic exercise is an important solution used to manage PCOS, due to its multiple benefits. Yi Jin Jing is an important component of traditional Chinese exercise (TCE), based on the root of traditional Chinese medicine theory (TCM), which focuses on keeping the body as a whole in a harmonious state. However, to date there is no literature on the benign effects of Yi Jin Jing on PCOS. The primary purpose of this protocol is to assess the effectiveness of aerobic exercise versus Yi Jin Jing, on the management of ovarian function in young overweight/obese women with PCOS.MethodsThe study will conduct a controlled randomized, superiority trial with three-arm parallel groups, recruiting 90 women diagnosed with PCOS, ages between 18 and 35 years, with a body mass index (BMI) ≥ 23 kg/m2. Women will be randomly assigned to either control group (combined oral contraceptives) or one of the intervention groups (Yi Jin Jing group or aerobic exercise group) with an allocation rate of 1:1:1. After randomization, the intervention will be conducted within a 12-week period. The primary outcome would be anti-Mullerian hormone (AMH) level; the secondary outcomes would be biochemical profiles, ovarian volume, antral follicle count, BMI, menstrual frequency, and homeostasis model assessment of insulin resistance (HOMA-IR). Outcome measures would be collected during baseline and end of treatment. Reporting of the study will follow the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement.DiscussionThis proposed study will be the first randomized clinical trial to evaluate the comparative effectiveness of aerobic exercise versus Yi Jin Jing on the management of ovarian function in young overweight/obese women with PCOS. The results may provide a new evidence-based management strategy for young women with PCOS.Trial registrationChinese Clinical Trial Registry ChiCTR1900022385. Registered on 9 April 2019

Puncture performance tests reveal distinct feeding modes in pinniped teeth

Marine mammals have undergone a dramatic series of morphological transformations throughout their evolutionary history that facilitated their ecological transition to life in the water. Pinnipeds are a diverse clade of marine mammals that evolved from terrestrial carnivorans in the Oligocene (∼27million years ago). However, pinnipeds have secondarily lost the dental innovations emblematic of mammalian and carnivoran feeding, such as a talonid basin or shearing carnassials. Modern pinnipeds do not masticate their prey, but can reduce prey size through chopping behavior. Typically, small prey are swallowed whole. Nevertheless, pinnipeds display a wide breadth of morphology of the post-canine teeth. We investigated the relationship between dental morphology and pinniped feeding by measuring the puncture performance of the cheek-teeth of seven extant pinniped genera. Puncture performance was measured as the maximum force and the maximum energy required to puncture a standardized prey item (Loligo sp.). We report significant differences in the puncture performance values across the seven genera, and identify three distinct categories based on cheek-teeth morphology and puncture performance: effective, ineffective and moderate puncturers. In addition, we measured the overall complexity of the tooth row using two different metrics, orientation patch count rotated (OPCR) and relief index (RFI). Neither metric of complexity predicted puncture performance. Finally, we discuss these results in the broader context of known pinniped feeding strategies and lay the groundwork for subsequent efforts to explore the ecological variation of specific dental morphologies.

Reconfigurable Intelligent Surface (RIS)-Aided Vehicular Networks: Their Protocols, Resource Allocation, and Performance

Reconfigurable intelligent surfaces (RISs) assist in paving the way for the evolution of conventional vehicular networks to autonomous driving. Having said that, the 3rd Generation Partnership Project (3GPP) faces numerous open challenges concerning the RIS-aided vehicle-to-everything (V2X) solutions of the near future. To tackle these challenges and to stimulate future research, this article focuses on the prospective transmission design of RIS-aided V2X communications. In particular, two V2X sidelink modes are enhanced by exploiting RISs and their variants, followed by a customized transmission frame structure that partitions the transmission efforts into different phases. Next, effective channel-tracking and resource allocation techniques are developed for attaining a high beamforming gain at low overhead and complexity. Finally, promising research topics are highlighted, and future 3GPP standardization items are proposed for RIS-aided V2X systems.

Assessment of clinical trial protocols for pathology content using the SPIRIT-Path guidelines highlights areas for improvement.

The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement provides evidence‐based recommendations for the minimum content of clinical trial protocols. The Cellular Molecular Pathology Initiative, hosted by the UK National Cancer Research Institute, developed an extension, SPIRIT‐Path, describing how to effectively incorporate pathology support into clinical trial protocols. The current study assessed the inclusion of SPIRIT‐Path items in protocols of active clinical trials. Publicly available clinical trial protocols were identified for assessment against the new guidelines using a single UK hospital as the ‘test site’. One hundred and ninety interventional clinical trials were identified as receiving support from the pathology department. However, only 38 had publicly available full trial protocols (20%) and following application of the inclusion/exclusion criteria, 19 were assessed against the SPIRIT‐Path guidelines. The reviewed clinical trial protocols showed some areas of compliance and highlighted other items that were inadequately described. The latter lacked information about the individuals responsible for the pathology content of the trial protocol, how pathology activities and roles were organised in the trial, where the laboratory work would be carried out, and the accreditation status of the laboratory. Only one trial had information specific to digital pathology, a technology certain to become more prevalent in the future. Adoption of the SPIRIT‐Path checklist will facilitate comprehensive trial protocols that address all the key cellular and molecular pathology aspects of interventional clinical trials. This study highlights once again the lack of public availability of trial protocols. Full trial protocols should be available for scrutiny by the scientific community and the public who participate in the studies, increasing the transparency of clinical trial activity and improving quality.

Not enough SPIRIT shown in the registration and reporting of orthodontic trial protocols.

To reduce bias associated with selective reporting, the registration and publication of clinical trial protocols before or at the time of patient enrolment has been advocated. The aim of this investigation was to assess the frequency of registration and reporting adherence of orthodontic trial protocols pre- and post-introduction of the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) Statement. Trial protocols registered in four online registries were sourced at two time periods: (1 January 2010-1 January 2013) and (1 January 2017-1 January 2021). Protocols were screened and data extracted, in duplicate and independently. The reporting adherence of each protocol was assessed in relation to the thirty-three item SPIRIT statement. Fisher's exact test was used to determine associations between time periods and trial protocol characteristics. Median regression was implemented to assess potential associations between the percent score per protocol and protocol characteristics. A total of 100 protocols were analysed. Thirty-three and sixty-seven protocols were registered in the first and second time periods, respectively. An association between period and the timing of registration (prospectively or retrospectively) (P < 0.001) and funding source (University or Company) (P < 0.001) was evident. Overall, 25 of the 33 (75.5%) SPIRIT statement items were not reported in either timeframe. The median percent reporting quality score was 26.9 (IQR 6.9). The type of registry was associated with percent scores and published studies received better percent scores compared to unpublished studies and academic or private protocol submissions. There is a general lack of awareness of the importance and relevance of the SPIRIT statement. Registration of orthodontic trial protocols has apparently improved; however, 75.5% SPIRIT statement items were not reported in either study time period. The registration and reporting of orthodontic trial protocols should be advocated to circumvent issues relating to selective reporting and outcome reporting bias.

An OECD TG 428 study ring trial with 14C-Caffeine demonstrating repeatability and robustness of the dermal absorption in vitro method

The dermal absorption potential of 14C-Caffeine applied as a 4 mg/mL concentration (10 μL/cm2 finite dose) was investigated in six laboratories under Good Laboratory Practice conditions using an OECD TG 428-compliant in vitro assay with flow-through cells and split-thickness human skin. Potential sources of variation were reduced by a standardized protocol, test item and skin source. Particularly, skin samples from same donors were distributed over two repeats and between labs in a non-random, stratified design. Very similar recovery was achieved in the various assay compartments between laboratories, repeats and donors, demonstrating that the assay can be robustly and reliably performed. The absorption in one laboratory was 5-fold higher than in the others. This did not clearly correlate with skin integrity parameters but might be associated with an accidental COVID-19 pandemic-related interruption in sample shipment. It is possible that other factors may affect dermal absorption variation not routinely assessed or considered in the current method. The mean receptor fluid recovery, potential absorption (recovery in receptor fluid and skin except tape strips 1 and 2) and mass balance of caffeine was 6.99%, 7.14% and 99.13%, respectively, across all and 3.87%, 3.96% and 99.00% in the subset of five laboratories.

Reporting quality of clinical trial protocols: a repeated cross-sectional study about the Adherence to SPIrit Recommendations in Switzerland, CAnada and GErmany (ASPIRE-SCAGE)

ObjectivesComprehensive protocols are key for the planning and conduct of randomised clinical trials (RCTs). Evidence of low reporting quality of RCT protocols led to the publication of the Standard Protocol...

Impact of pilates and plank exercise on leg strength of adolescent school boys in Prakasam District-Andhra Pradesh

In order to evaluate the real facts the detective made a challenge to examine the impact of Pilates and Plank Exercise on Leg Strength of adolescent school boys. Their aged of the subject ranged from 14 to 16 years. Selected subjects was randomly assigned to Three equal groups (n=15), group I underwent Pilates Exercise (PE) and group II underwent plank exercise, group III acted as control group (CG). The Pilates and Plank Exercise was given to the experimental group for 6 days per week for the period of 12 weeks. The control group did not practice in any training except their routine work. The following variables were measured with standard test items: Leg strength . Pre and post test was conducted on separate days with warm up. The leg strength measured by Standing Broad jump in meters. The obtained ‘F’ ratio was tested for significance at 0.05 level of confidence. Scheffe’s post-hoc test of significance was employed in order to test the significant difference between paired adjusted means.

Pharmacological Treatment of Pain and Agitation in Severe Dementia and Responsiveness to Change of the Italian Mobilization-Observation-Behavior-Intensity-Dementia (I-MOBID2) Pain Scale: Study Protocol.

Up to 80% of Alzheimer’s disease (AD) patients in nursing homes experiences chronic pain and 97% develops fluctuant neuropsychiatric symptoms (NPS). Agitation, associated with unrelieved pain, is managed through antipsychotics and may increase the risk of death. Evidence is accumulating in favor of analgesia for a safer, effective therapy of agitation. The Italian version of Mobilization–Observation–Behavior–Intensity–Dementia, I-MOBID2, recently validated in the Italian setting, shows: good scale content validity index (0.89), high construct validity (Spearman rank-order correlation Rho = 0.748), reliable internal consistency (Cronbach’s α coefficient = 0.751), good-excellent inter-rater (intraclass correlation coefficient, ICC = 0.778) and test-retest (ICC = 0.902) reliability, and good inter-rater and test-retest agreement (Cohen’s K = 0.744) with 5.8 min completion time. This study intends to identify the responsiveness of the I-MOBID2 based on COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) recommendations, assessing the a priori hypotheses of (1) the efficacy of painkillers administered to severe AD patients after proper pain assessment and (2) the effect of reduction of the Cohen-Mansfield Agitation Inventory (CMAI) score and of agitation rescue medications. This protocol is approved by Calabria Region Ethics Committee protocol No. 31/2017 and follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines.

Service Quality Measurement in Indian Hotels:Factor Structure &amp; Scale Validation

With the rapid growth of hospitality industry, many hoteliers have developed their online capabilities and evolved into competitive dual-channel service providers. In such a case, strategic consumers have more options to book a hotel enabling them to choose the best time and the best channel. This study aims at measuring service quality being offered by traditional hotels in Allahabad with the help of SERVPERF model. Besides, it also attempts to investigate the dimensionality, item structure and psychometric properties of the SERVPERF scale in Indian hotel industry. Findings reveal that SERVPERF scale fails to hold all the original items and hence, fails to confirm the standard item assemblage within the backdrop of hotel industry. In all, seven dimensions have emerged contrary to the original five-dimensions namely-tangibles, assurance, reliability, responsiveness and empathy. Besides this, there were also a number of considerable issues which form the basis for the current research. The outcome of the current study will be of help to managers of Indian hotel industry to analyze their service offerings with reference to the suggested seven key factors and accordingly develop strategies to highlight and prioritize them.

Single use versus reusable catheters in intermittent catheterisation for treatment of urinary retention: a protocol for a multicentre, prospective, randomised controlled, non-inferiority trial (COMPaRE)

IntroductionChronic urinary retention is a common lower urinary tract disorder, mostly neurogenic or idiopathic in origin. The preferred treatment is clean intermittent urinary self-catheterisation (CISC) four to six times a...