Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis, may provide cross-protection against the closely related bacterium N. gonorrhoeae. This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+).
This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm3), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies.
Ethical approval was obtained from the St Vincent’s Hospital Human Research Ethics Committee, St Vincent’s Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences.
To determine and describe what interventions exist to improve nurse–family communication during the waiting period of an emergency department visit.
Communication between nurses and families is an area needing improvement. Good communication can improve patient outcomes, satisfaction with care and decrease patient and family anxiety.
Scoping Review.
A scoping review was conducted following the Joanna Briggs Institution methodology: (1) identify the research question, (2) define the inclusion criteria, (3) use a search strategy to identify relevant studies using a three-step approach, (4) select studies using a team approach, (5) data extraction, (6) data analysis, and (7) presentation of results.
Medline, CINAHL, EMBASE, PsychInfo and grey literature were searched on 3 August 2022.
The search yielded 1771 articles from the databases, of which 20 were included. An additional seven articles were included from the grey literature. Paediatric and adult interventions were found targeting staff and family of which the general recommendations were summarised into communication models.
Future research should focus on evaluating the effectiveness of interventions using a standardised scale, understanding the specific needs of families, and exploring the communication models developed in this review.
Communication models for triage nurses and all emergency department nurses were developed. These may guide nurses to improve their communication which will contribute to improving family satisfaction.
PRISMA-ScR.
Protocol has been registered with the Open Science Framework, registration number 10.17605/OSF.IO/ETSYB.
No patient or public contribution.
The purpose of this study was to investigate the communication challenges and successes that people with ostomies experienced during their healthcare encounters.
We conducted semistructured interviews of people with ostomies. Interviews focused on important social situations and health communication strategies for managing these situations. We transcribed interviews and coded them to create themes.
Participants were eligible to participate if they were above the age of 18 and have had an ostomy for at least a year. 27 people participated in the study.
The study was conducted in a university setting.
Interviews with ostomates surfaced several themes related to ostomate needs. Participants benefited from communication that was open, thorough and had a positive outlook on ostomies. Participants found patient–clinician communication to be challenging when there was a lack of knowledge surrounding ostomy care, communication was unclear or inadequate, and when clinicians had a negative outlook on ostomies.
Findings from this project are intended to amplify existing patient and clinician education materials and to inform the creation of a communication guide specifically for the ostomy context.
Long-term chikungunya disease is characterised by persistent rheumatic symptoms following chikungunya virus infection. As there is no specific treatment available, affected individuals need strategies to adapt. However, research on these is scarce. This study aimed to explore which adaptive coping strategies are employed to manage persistent rheumatic symptoms in daily life.
The study was conducted in Curacao.
An explorative qualitative study was conducted between September and October 2020, among a purposive sample of adults, 19 women and 4 men affected by long-term chikungunya disease. In-depth interviews were semi-structured and transcribed verbatim. The data were analysed using inductive thematic analysis.
The disease duration for all participants ranged between 68 and 74 months (6 years). In narrating their experiences of coping with long-term chikungunya disease, four themes were identified: (1) learning to live with the disease; (2) resilience for dealing with pain; (3) maintaining positive self-image and attitude; and (4) coping through spirituality.
To live with long-term chikungunya disease with dignity in spite of physical pain and discomfort, participants tried to retain a sense of control of oneself and one’s lives, to not let the disease take over, focusing on the positive in their lives, and finding strength and remain hopeful. Interventions such as cognitive–behavioural therapy and mindfulness exercises may be effective in strengthening or regain affected individual’s sense of competence and control by fostering adaptive coping skills and resilience. Subsequently, these interventions may improve health-related quality of life when rheumatic symptoms persist following chikungunya virus infection.
by Daniel W. Flowers, Brian T. Swanson, Stephen M. Shaffer, Derek J. Clewley, Sean P. Riley
The primary objective of this review was to create a ‘trustworthy,’ living systematic review and meta-analysis for the application of manual therapy interventions in treating patients with shoulder dysfunction. Included studies were English-language randomized controlled trials published between 1/1/2010 and 8/3/2023, with searches performed in: PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), CINHAL, ProQuest Nursing & Allied Health, EBSCO Medline, and PEDro. The population of focus included adults 18 years and older with musculoskeletal impairments related to shoulder dysfunction. Our primary outcomes included pain and region-specific outcome measures. We excluded trials, including participants having shoulder dysfunction resulting from surgery, radicular pain, instability/dislocation, fracture, lymphedema, and radiation. Our screening methodology was based upon a previously published ‘trustworthy’ systematic review protocol. This included the application of our PICOTS criteria in addition to screening for prospective clinical trial registration and following of prospective intent, as well as assessment of PEDro scores, risk-of-bias ratings, GRADE scoring, and examination of confidence in estimated effects. Twenty-six randomized controlled trials met our PICOTS criteria; however, only 15 of these were registered. Only three were registered prospectively. Two of these did not have discussions and conclusions that aligned with their primary outcome. The remaining single study was found to have a high risk-of-bias, meaning the remainder of the protocol could not be employed and that no randomized controlled trials could undergo further assessment or meta-analysis. The results of this systematic review indicate there are no ‘trustworthy’ randomized controlled trials examining the effectiveness of manual therapy interventions for the treatment of patients with shoulder dysfunction, as defined by the prospectively established methodology. Therefore, these findings signal that creating a ‘trustworthy,’ living systematic review on this clinically relevant topic is not yet possible due to a lack of ‘trustworthy’ randomized controlled trials.by Vijay M. Ravindra, Lorraina Robinson, Hailey Jensen, Elena Kurudza, Evan Joyce, Allison Ludwick, Russell Telford, Osama Youssef, Justin Ryan, Robert J. Bollo, Rajiv R. Iyer, John R. W. Kestle, Samuel H. Cheshier, Daniel S. Ikeda, Qinwen Mao, Douglas L. Brockmeyer
IntroductionThe fibrous posterior atlanto-occipital membrane (PAOM) at the craniocervical junction is typically removed during decompression surgery for Chiari malformation type I (CM-I); however, its importance and ultrastructural architecture have not been investigated in children. We hypothesized that there are structural differences in the PAOM of patients with CM-I and those without.
MethodsIn this prospective study, blinded pathological analysis was performed on PAOM specimens from children who had surgery for CM-I and children who had surgery for posterior fossa tumors (controls). Clinical and radiographic data were collected. Statistical analysis included comparisons between the CM-I and control cohorts and correlations with imaging measures.
ResultsA total of 35 children (mean age at surgery 10.7 years; 94.3% white) with viable specimens for evaluation were enrolled: 24 with CM-I and 11 controls. There were no statistical demographic differences between the two cohorts. Four children had a family history of CM-I and five had a syndromic condition. The cohorts had similar measurements of tonsillar descent, syringomyelia, basion to C2, and condylar-to-C2 vertical axis (all p>0.05). The clival-axial angle was lower in patients with CM-I (138.1 vs. 149.3 degrees, p = 0.016). Morphologically, the PAOM demonstrated statistically higher proportions of disorganized architecture in patients with CM-I (75.0% vs. 36.4%, p = 0.012). There were no differences in PAOM fat, elastin, or collagen percentages overall and no differences in imaging or ultrastructural findings between male and female patients. Posterior fossa volume was lower in children with CM-I (163,234 mm3 vs. 218,305 mm3, p Conclusions
In patients with CM-I, the PAOM demonstrates disorganized architecture compared with that of control patients. This likely represents an anatomic adaptation in the presence of CM-I rather than a pathologic contribution.
In this study, we aimed to characterize the impact of long COVID on quality of life and approaches to symptom management among Black American adults.
As a novel condition, qualitative evidence concerning long COVID symptoms and their impact on quality of life can inform the refinement of diagnostic criteria and care plans. However, the underrepresentation of Black Americans in long COVID research is a barrier to achieving equitable care for all long COVID patients.
We employed an interpretive description study design.
We recruited a convenience sample of 15 Black American adults with long COVID. We analysed the anonymized transcripts from race-concordant, semi-structured interviews using an inductive, thematic analysis approach. We followed the SRQR reporting guidelines.
We identified four themes: (1) The impact of long COVID symptoms on personal identity and pre-existing conditions; (2) Self-management strategies for long COVID symptoms; (3) Social determinants of health and symptom management; and (4) Effects on interpersonal relationships.
Findings demonstrate the comprehensive ramifications of long COVID on the lives of Black American adults. Results also articulate how pre-existing conditions, social risk factors, distrust due to systemic racism, and the nature of interpersonal relationships can complicate symptom management.
Care approaches that support access to and implementation of integrative therapies may be best suited to meet the needs of long COVID patients. Clinicians should also prioritize eliminating patient exposure to discrimination, implicit bias, and microaggressions. This is of particular concern for long COVID patients who have symptoms that are difficult to objectively quantify, such as pain and fatigue.
While patient perspectives and experiences were the focus of this study, patients were not involved with the design or conduct of the study, data analysis or interpretation, or writing the manuscript.
Daily calcium supplements are recommended for pregnant women from 20 weeks’ gestation to prevent pre-eclampsia in populations with low dietary calcium intake. We aimed to improve understanding of barriers and facilitators for calcium supplement intake during pregnancy to prevent pre-eclampsia.
Mixed-method systematic review, with confidence assessed using the Grading of Recommendations, Assessment, Development and Evaluations-Confidence in the Evidence from Reviews of Qualitative research approach.
MEDLINE and EMBASE (via Ovid), CINAHL and Global Health (via EBSCO) and grey literature databases were searched up to 17 September 2022.
We included primary qualitative, quantitative and mixed-methods studies reporting implementation or use of calcium supplements during pregnancy, excluding calcium fortification and non-primary studies. No restrictions were imposed on settings, language or publication date.
Two independent reviewers extracted data and assessed risk of bias. We analysed the qualitative data using thematic synthesis, and quantitative findings were thematically mapped to qualitative findings. We then mapped the results to behavioural change frameworks to identify barriers and facilitators.
Eighteen reports from nine studies were included in this review. Women reported barriers to consuming calcium supplements included limited knowledge about calcium supplements and pre-eclampsia, fears and experiences of side effects, varying preferences for tablets, dosing, working schedules, being away from home and taking other supplements. Receiving information regarding pre-eclampsia and safety of calcium supplement use from reliable sources, alternative dosing options, supplement reminders, early antenatal care, free supplements and support from families and communities were reported as facilitators. Healthcare providers felt that consistent messaging about benefits and risks of calcium, training, and ensuring adequate staffing and calcium supply is available would be able to help them in promoting calcium.
Relevant stakeholders should consider the identified barriers and facilitators when formulating interventions and policies on calcium supplement use. These review findings can inform implementation to ensure effective and equitable provision and scale-up of calcium interventions.
CRD42021239143.
The output of scholarly publications in scientific literature has increased exponentially in recent years. This increase in literature has been accompanied by an increase in retractions. Although some of these may be attributed to publishing errors, many are the result of unsavory research practices. The purposes of this study were to identify the number of retracted articles in nursing and reasons for the retractions, analyze the retraction notices, and determine the length of time for an article in nursing to be retracted.
This was an exploratory study.
A search of PubMed/MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, and Retraction Watch databases was conducted to identify retracted articles in nursing and their retraction notices.
Between 1997 and 2022, 123 articles published in the nursing literature were retracted. Ten different reasons for retraction were used to categorize these articles with one-third of the retractions (n = 37, 30.1%) not specifying a reason. Sixty-eight percent (n = 77) were retracted because of an actual or a potential ethical concern: duplicate publication, data issues, plagiarism, authorship issues, and copyright.
Nurses rely on nursing-specific scholarly literature as evidence for clinical decisions. The findings demonstrated that retractions are increasing within published nursing literature. In addition, it was evident that retraction notices do not prevent previously published work from being cited. This study addressed a gap in knowledge about article retractions specific to nursing.
by Kenneth S. Noguchi, Kevin Moncion, Elise Wiley, Ashley Morgan, Eric Huynh, Marla K. Beauchamp, Stuart M. Phillips, Lehana Thabane, Ada Tang
BackgroundStroke impacts nearly 14 million people annually. Muscle strength and physical function are often affected by stroke and important determinants of stroke recovery. Resistance exercise training (RT) has been shown to improve muscle strength, but RT prescriptions may be suboptimal for other aspects of stroke recovery. Parameters such as frequency, intensity, type, and duration may influence the effectiveness of RT interventions but have not been systematically evaluated.
Objectives1) To determine the effects of RT on stroke recovery, and 2) to examine the influence of RT parameters on intervention effects.
Eligibility criteriaRandomized controlled trials examining the effects of RT will be eligible for this systematic review if they: 1) included only adults with stroke or transient ischemic attack, 2) compared RT to no exercise or usual care, and 3) did not apply a co-intervention.
Study selectionEight databases (MEDLINE, EMBASE, EMCARE, AMED, PsychINFO, CINAHL, SPORTDiscus, and Web of Science) and 2 clinical trials registries (ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform) will be searched from inception. Two independent pairs of authors will compare titles, abstracts, and full-text reports against the eligibility criteria. Conflicts will be resolved by consensus or third author.
Main outcome measuresThe construct of interest is stroke recovery. An advisory group of clinicians, researchers, and partners with lived experience of stroke will be consulted to determine specific outcome measures of interest, and to rank their relative importance. We expect to include measures of physical function, strength, cognition, and quality of life. Random-effects meta-analyses will be used to pool results for each outcome across studies, and RT parameters (frequency, intensity, type, and duration) will be used as covariates in meta-regression analyses.
ConclusionThe results of this review will inform the optimal RT prescription parameters for promoting stroke recovery.
This study aimed to evaluate primary care networks (PCNs) in the English National Health Service. We ask: How are PCNs constituted to meet their defined goals? What factors can be discerned as affecting their ability to deliver benefits to the community, the network as a whole and individual members? What outcomes or outputs are associated with PCNs so far? We draw policy lessons for PCN design and oversight, and consider the utility of the chosen evaluative framework.
Qualitative case studies in seven PCN in England, chosen for maximum variety around geography, rurality and population deprivation. Study took place between May 2019 and December 2022.
PCN members, staff employed in additional roles and local managers. Ninety-one semistructured interviews and approximately 87 hours of observations were undertaken remotely. Interview transcripts and observational field notes were analysed together using a framework approach. Initial codes were derived from our evaluation framework, with inductive coding of new concepts during the analysis.
PCNs have been successfully established across England, with considerable variation in structure and operation. Progress is variable, with a number of factors affecting this. Good managerial support was helpful for PCN development. The requirement to work together to meet the specific threat of the global pandemic did, in many cases, generate a virtuous cycle by which the experience of working together built trust and legitimacy. The internal dynamics of networks require attention. Pre-existing strong relationships provided a significant advantage. While policy cannot legislate to create such relationships, awareness of their presence/absence is important.
Networked approaches to service delivery are popular in many health systems. Our use of an explicit evaluation framework supports the extrapolation of our findings to networks elsewhere. We found the framework to be useful in structuring our study but suggest some modifications for future use.
Hospital-acquired pressure injuries (HAPIs) are a global high-stakes patient safety issue. Key stakeholder perspectives regarding their role and experiences with pressure injuries is critical as part of the solution to minimizing HAPI occurrence and attain sustainability.
A qualitative, descriptive approach provided multiple perspectives of key stakeholders to support the complexity of HAPI care. The qualitative data are a part of a mixed method convergent research study examining pressure injury prevention and management practices.
Nursing system theory, mixed method convergent design, and participatory action research methodologies were chosen to address both the gap analysis development and results, achieve collaborative comprehensiveness, and enable key stakeholder involvement throughout this HAPI prevention and management initiative. Participants were recruited and enrolled from a large Level I trauma hospital and the key stakeholders. Demographic information were collected prior to the individual interview. Focused interviews were conducted virtually using zoom technology. Qualitative data were analyzed using NVivo software and thematic analysis was confirmed across the co-investigators for congruence and applicability to the research questions.
Qualitative interviews with 26 key stakeholders provided data to support and integrate a link with gap analysis results on the complex health issue of HAPIs. Specific barrier and recommendation themes identified interventions that could be prioritized. The 52 barrier and 52 recommendation themes/sub-theme(s) respectively were organized by Donabedian (structure, process, and outcome) with structure elements the majority. The top three structure barrier themes involved equipment and standards for use, staff prevention education, and specialized health professionals. The top three structure recommendation themes involved specialized health professionals, equipment and standards for use, and an educational plan for those at risk or with HAPIs.
The article provides findings from the qualitative portion of a mixed method study related to HAPIs. The qualitative findings associated with the gap analysis quantitative results, achieved the goal of the participatory action research key stakeholders' input into HAPI care and can be replicated internationally.
The benefit of key stakeholder's involvement in solving a clinical problem is sustainability. A quantitative approach and integrating qualitative stakeholders' perspectives provide an in-depth solution that will advance nursing capacity toward health care delivery and HAPI nursing science and policy development on a global level.
Sciatica can be very painful and, in most cases, is due to pressure on a spinal nerve root from a disc herniation with associated inflammation. For some patients, the pain persists, and one management option is a spinal epidural steroid injection (ESI). The aim of an ESI is to relieve leg pain, improve function and reduce the need for surgery. ESIs work well in some patients but not in others, but we cannot identify these patient subgroups currently. This study aims to identify factors, including patient characteristics, clinical examination and imaging findings, that help in predicting who does well and who does not after an ESI. The overall objective is to develop a prognostic model to support individualised patient and clinical decision-making regarding ESI.
POiSE is a prospective cohort study of 439 patients with sciatica referred by their clinician for an ESI. Participants will receive weekly text messages until 12 weeks following their ESIand then again at 24 weeks following their ESI to collect data on leg pain severity. Questionnaires will be sent to participants at baseline, 6, 12 and 24 weeks after their ESI to collect data on pain, disability, recovery and additional interventions. The prognosis for the cohort will be described. The primary outcome measure for the prognostic model is leg pain at 6 weeks. Prognostic models will also be developed for secondary outcomes of disability and recovery at 6 weeks and additional interventions at 24 weeks following ESI. Statistical analyses will include multivariable linear and logistic regression with mixed effects model.
The POiSE study has received ethical approval (South Central Berkshire B Research Ethics Committee 21/SC/0257). Dissemination will be guided by our patient and public engagement group and will include scientific publications, conference presentations and social media.
Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care.
We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to ‘hardwire’ preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18–44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic’s assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects.
This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request.
ClinicalTrials.gov Registry (NCT04976881).
The inaugural expert consensus and guidance for Nutrition Interventions in Adults with Diabetic Foot Ulcers (DFU) have been welcomed by clinicians internationally. This short report aimed to determine how the macronutrient and micronutrient status of individuals living with DFU compared to the American Limb Preservation Society Nutrition Interventions in Adults with DFU expert consensus and guidance. Descriptive analysis was conducted as a secondary analysis of an existing dataset. Mean (SD) dietary intake, the proportion meeting the nutrition recommendations and the proportion exceeding the upper limit (UL) for specific vitamins and minerals were reported. Most individuals with DFU do not meet current consensus guidelines for optimal dietary intake for wound healing, with inadequacies evident for fibre, zinc, protein, vitamin E and vitamin A. Future iterations of the consensus guideline should consider using evidence-informed recommendations for clinical practice, with the inclusion of all nutrients that are essential for wound healing in DFU.