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Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.
The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.
The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.
To explore the feasibility of development and implementation of an educational intervention addressing sexual and gender minority healthcare issues; examine recruitment processes and instrument appropriateness.
Non-randomized feasibility study.
The educational intervention was developed and implemented in family nurse practitioner courses with data collection from August through December 2022. Clinical preparedness, attitudinal awareness and basic knowledge were measured using the lesbian, gay, bisexual and transgender Development of Clinical Skills Scale.
Development and implementation of the intervention was feasible but will require amendment before progressing to the pilot study. Clinical preparedness and basic knowledge increased post-intervention, but attitudinal awareness did not improve. Recruitment did not achieve the desired sample size. Instrument internal consistency reliability was confirmed.
Feasibility was established but will require amendment prior to the pilot study.
To prepare nurses and nurse practitioners to care for sexual and gender minority patients.
This study addressed the feasibility of developing and implementing a sexual and gender minority healthcare education using an e-Learning platform. Findings confirm that the intervention was feasible but will require amendment. The intervention increased knowledge and clinical preparedness in caring for this population, but recruitment was challenging. This research will impact nurses, nurse practitioners and nurse educators.
The authors adhered to the relevant EQUATOR guidelines. The Consolidated Standards of Reporting Trials guideline extension for reporting randomized and feasibility guidelines were used.
Sexual and gender minority community members contributed to the intervention development.
The feasibility of using interactive e-learning educational resources to provide sexual and gender minority healthcare curriculum. Evidence to support the use of the Lesbian, Gay, Bisexual, and Transgender Development of Clinical Skills Scale to measure learning outcomes.
This study was not prospectively registered because it was an educational intervention involving graduate student nurses and did not assess clinical outcomes of patients.
To psychometrically assess the Spanish version of the Self-Care of Chronic Illness Inventory (SC-CII-Sp) in community-dwelling older adults with chronic multimorbidity.
A methodological study.
A total of 1260 older adults participated in the study between May 2020 and February 2022. The data were analysed using SPSS Statistics® 26 and AMOS® 24. The items' content validity index and the Fleiss' kappa were calculated to assess the SC-CII-Sp's content validity. Convergent validity was assessed by calculating the Pearson correlation coefficient between the participants' scores on the SC-CII-Sp and their scores on the Spanish Chronic Disease Self-Efficacy scale (SCD-SE). Construct validity was tested by performing a confirmatory factor analysis (CFA). The SC-CII-Sp's reliability was tested by computing the Cronbach's alpha.
The SC-CII-Sp showed good content and convergent validity. The CFA showed that the SC-CII-Sp has three sub-scales. The 8-item Self-Care Maintenance sub-scale has good internal consistency and is comprised of two dimensions: illness-related and health-promoting behaviour. The Self-Care Monitoring sub-scale had excellent internal consistency and its five loaded items belonged to a single dimension. The 6-item Self-Care Management sub-scale has adequate internal consistency and two dimensions: autonomous and consulting behaviour.
The Spanish version of SC-CII is a valid and reliable instrument to be used in the assessment of self-care behaviours amongst Spanish-speaking, community-dwelling older adults with chronic multimorbidity.
Nurses need valid and reliable tools to assess self-care behaviours in Spanish-speaking community-dwelling older adults with chronic multimorbidity. This study provides a 19-item tool that allows for the comprehensive evaluation of self-care behaviours in healthy and ill states.
Using the SC-CII-Sp in clinical or research settings could help nurses to examine the effects of different interventions on self-care behaviours amongst Spanish-speaking, community-dwelling older adults with chronic multimorbidity.
None to be reported.
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