To systematically evaluate the effectiveness of psychological interventions for women with breast cancer on sexual function, sexual satisfaction, sexual relationships, sexual distress and sexual quality of life.
Sexual dysfunction is common in women with breast cancer and seriously affects their quality of life and marital harmony. Several studies have explored the effects of psychological interventions related to sexual function of women with breast cancer, but results were inconclusive.
A systematic review and meta-analysis based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
A search of PubMed, EMBASE, PsycINFO, Web of Science, the Cochrane Library, Scopus, CINAHL, ProQuest Dissertations and Theses Global, ClinicalTrials.gov. and Open Grey was conducted from inception to 9 May 2021. Two reviewers independently screened studies, extracted data and conducted a quality appraisal of included studies using the Joanna Briggs Institute critical appraisal checklists.
Fifteen studies involving 1307 participants were included. The current study showed that psychological interventions made statistically significant improvements in sexual function (SMD = 0.82; 95% CI = [0.43, 1.20]; p < .001), sexual satisfaction (SMD = 0.95; 95% CI = [0.19, 1.72]; p = .01), sexual relationships (SMD = 0.37; 95% CI = [0.15, 0.60]; p = .001) and sexual distress (MD = −5.05; 95% CI = [−7.88, −2.22]; p = .0005) of women with breast cancer. A subgroup analysis regarding the types of psychological interventions indicated that cognitive behavioural therapy and psychoeducational therapy were beneficial to sexual function and satisfaction, and psychosexual counselling could also improve sexual function.
Psychological interventions, especially psychoeducational therapy and cognitive behavioural therapy, are effective for improving the sexual health of women with breast cancer.
This current study provides evidence for the application of psychosexual interventions in women with breast cancer.
The study has been registered on the PROSPERO on 6 June 2021, with the registration number CRD42021253493.
To describe the development of the Patient Centeredness Index (PCI), evaluate its psychometric characteristics and evaluate the relationships between scores on the PCI and an established measure of empathy.
Patient centeredness helps patients manage multiple chronic conditions with their providers, nurses and other team members. However, no instrument exists for evaluating patient centeredness within primary care practices treating this population.
Multi-site instrument development and validation. STROBE reporting guidelines were followed.
To identify themes, we consulted literature on patient centeredness and engaged stakeholders who had or were caring for people with multiple chronic conditions (n = 7). We composed and refined items to represent those themes with input from clinicians and researchers. To evaluate reliability and convergent validity, we administered surveys to participants (n = 3622) with chronic conditions recruited from 44 primary care practices for a large-scale cluster randomised clinical trial of the effects of a practice-level intervention on patient and practice-level outcomes. Participants chose to complete the 16-item survey online, on paper or by phone. Surveys assessed demographics, number of chronic conditions and ratings of provider empathy. We conducted exploratory factor analysis to model the interrelationships among items.
A single factor explained 93% of total variance. Factor loadings ranged from 0.55–0.85, and item-test correlations were ≥.67. Cronbach's alpha was .93. A moderate, linear correlation with ratings of provider's empathy (r = .65) supports convergent validity.
The PCI is a new tool for obtaining patient perceptions of the patient centeredness of their primary care practice. The PCI shows acceptable reliability and evidence of convergent validity among patients managing chronic conditions.
The PCI rapidly identifies patients' perspectives on patient centeredness of their practice, making it ideal for administration in busy primary care settings that aim to efficiently address patient-identified needs.
Clinicaltrials.org Protocol ID: WLPS-1409-24372. Title: Integrating Behavioural Health and Primary Care for Comorbid Behavioural and Medical Problems (IBHPC).
To describe beginning nursing student learning styles and to determine whether there are relationships between learning style and sociodemographic or educational background. We also aim to compare these data with the normative values of the 3.1 version of the Kolb learning style inventory and verify its reliability.
Learning style is related to the way in which an individual interacts with learning conditions, involving cognitive, affective, physical and environmental aspects. In nursing education, few studies have focused on knowing the learning styles of beginning nursing students, despite the need for students to develop critical thinking skills required of nurses.
Descriptive, cross-sectional, correlational, multi-site study.
The study took place at five universities in Brazil and one university in the United States. Data were collected from a sample of beginning nursing students (n = 176) in 2019, using the Portuguese and English 3.1 versions of Kolb's learning style inventory.
Most students’ learning styles were classified as divergers (34.10%), while 28.41% were assimilators, 23.86% were accommodators and 13.63% were convergers. Kolb describes learning as a four-stage cyclical process grounded in experience. The mean score of one learning stage, the concrete experience, showed those who attended public high schools compared with private high schools was higher (mean = 26.22; p = .0019), and there were different results between Brazilian state universities, Brazilian federal universities and the American university (p = .0149).
The diverger style was the most common among beginning nursing students in Brazil and the United States. There was a significant relationship between learning style, the educational background of students, the type of institution they attend and their previous experience with some active learning methodologies.
Aligned with Kolb's experiential learning theory, nurse educators must be aware of student learning styles so they may use teaching strategies to meet their students’ needs.
El carácter de emergencia de una pandemia implica un crecimiento acelerado de la capacidad instalada para la atención de pacientes en los hospitales. El departamento de Antioquia en Colombia no cuenta con suficiente infraestructura hospitalaria para atender la excesiva demanda que se podría generar. El Hospital Manuel Uribe Ángel de Envigado (HMUA) hace una planeación estratégica para lograr la atención médica que será requerida durante la pandemia de Sars-CoV 2.
Sistematización de la experiencia del Hospital MUA en la preparación de la pandemia de Sars-cov2, esta es realizada en 4 fases entre los meses de febrero a noviembre de 2020.
Se logra para el momento de la llegada de la Pandemia a Colombia, tener un crecimiento de capacidad instalada en el área de urgencias del 40%, en el área de cuidados intensivos de 142% y adecuación de 68 unidades hospitalarias para atender este tipo de pacientes. Conservamos los estándares de calidad y se hizo gestión del riesgo de contagio. El personal de Enfermería fue vital durante todo el desarrollo de la pandemia. Los resultados de mortalidad en cuidados Intensivos en la institución fueron más bajos que los reportados a nivel regional y mundial.
Un plan estratégico de respuesta al Covid-19 y la adecuada gestión del riesgo de contagio, permitieron ampliar la capacidad instalada, para enfrentar con estándares de calidad la emergencia sanitaria. Este artículo pretende ser una guía para un futuro en donde se evidencien las medidas que se tomaron en la preparación de una institución de tercer nivel para la atención de la pandemia del año 2020.
Palabras clave: Salud Pública, Pandemia, COVID-19, SARS-CoV2, Preparación
Objetivo. Determinar la relación entre la satisfacción laboral, la calidad de vida profesional con percepción de salud en personal de enfermería de un hospital público en Guadalajara, México 2018. Método. Estudio de tipo observacional, transversal y de correlación. Se encuestó a 151 profesionales de enfermería mediante un censo. Los cuestionarios que se utilizaron fueron: MSL-35 de motivación y satisfacción laboral, el CVP-35 para la calidad de vida profesional y para la identificación de la autopercepción del estado de salud fue mediante un cuestionario ad hoc. Los datos se analizaron por el método de Wald de regresión logística. Resultados. El 35% de la población no percibe salud, de estos, los que se encontraron en respuesta de riesgo fueron para las dimensiones de la satisfacción laboral: motivación 23%, satisfacción laboral 26% y jerarquía 22%; las correspondientes a la calidad de vida profesional: apoyo de directivo 13%, carga de trabajo 32% y motivación intrínseca 15%. En cuanto al análisis de regresión logística, éste índico que solo las dimensiones de jerarquía, apoyo directivo, carga de trabajo y motivación intrínseca están asociadas con no percibir salud. Conclusión. Los profesionales de enfermería con sobrecarga de trabajo, sin oportunidades de ascenso laboral, bajos salarios, pocas prestaciones, que no se perciben apreciados respecto a su función, con baja motivación, sin apoyo por sus familiares y compañeros de trabajo, así como, no valorados por sus jefes, presentan mayor percepción inadecuada de salud.
Objective. Determine the relationship of job satisfaction and professional quality of life with of the perception of health in nursing personnel of a public hospital in Guadalajara, Mexico 2018. Method. It is an observational, cross-sectional, and of correlation study. 151 nursing professionals were surveyed through a census. The questionnaires used were: MSL-35 for job motivation and satisfaction, CVP-35 for professional quality of life and for the identification of self-perception of health status through an ad hoc questionnaire. Data was analyzed using the Ward method of logistical regression. Results. 35% of the population does not perceive health, of these those who presented risk response they were for the dimensions of the job satisfaction: motivation 23%, job satisfaction 26% and hierarchy 22%; those corresponding to the quality of professional life: support from the manager 13%, workload 32% and intrinsic motivation 15%. Regarding the logistic regression analysis, it indicated that only the dimensions of hierarchy, managerial support, workload and intrinsic motivation are associated with not perceiving health. Conclusion. Nursing professionals with work overload, without job promotion opportunities, low salaries, few benefits, who are not perceived as being appreciated regarding their role, with low motivation, without support from their family members and coworkers, as well as, not valued by their bosses, they present a greater inadequate perception of health.
The WHO, the International Council of Nurses and Nursing Now, had planned to raise the global public profile of nursing in 2020 as a consequence of Florence Nightingales 200th anniversary. However, with the unexpected arrival of the coronavirus pandemic in late 2019, nurses and the nursing profession found themselves having unexpected media attention. The degree and type of media attention that nursing achieved during this time were never anticipated. This article considers the reality of nursing, both the role and profession in the UK in 2021 compared with the public perception and temporal media portrayal.
The media mediates public perception(s) through imagery and messaging. However, with reduced public understanding of healthcare services, inadequate understanding of healthcare professional roles and responsibilities, and reduced health literacy in the general population,
Commentary on: Hastie R, Tong S, Wikström AK, et al. Aspirin use during pregnancy and the risk of bleeding complications: a Swedish population-based cohort study. Am J Obstet Gynecol. 2020 Jul 17:S0002-9378(20)30737-7. doi:10.1016/j.ajog.2020.07.023.
Using aspirin for prevention of pre-eclampsia is associated with increased risk of postpartum haemorrhage, postpartum hematoma and possibly neonatal intracranial haemorrhage. More liberal or universal administration of aspirin may have more risk than benefits due to bleeding risk, but still strongly advised in high-risk pre-eclampsia pregnant women. Future prospective studies are needed to determine bleeding risks with widespread use of aspirin in pregnancy.
Using aspirin for prevention of pre-eclampsia is associated with increased risk of postpartum haemorrhage, postpartum hematoma and possibly neonatal intracranial haemorrhage.
More liberal or universal administration of aspirin may have more risk than benefits due to bleeding risk, but still strongly advised in high-risk pre-eclampsia pregnant women.
Future prospective studies are needed to determine bleeding risks with widespread use of aspirin in pregnancy.
Aspirin is widely offered to pregnant women at risk of developing pre-eclampsia, secondary to its anti-inflammatory and antiplatelet properties.
This study describes and explores the influences in registered nurses’ use of early warning scores to support clinical decisions in a hospital setting.
A focussed ethnography allowed for the investigation of registered nurses’ clinical practices in two wards in a Danish University Hospital. The study adhered to the ‘Standards for Reporting Qualitative Research’.
Participant observation and ethnographic interviews were conducted from March 2019 to August 2019. Ten registered nurses were observed and interviewed, and four physicians were interviewed. Data were analysed using LeCompte and Schensul's ethnographic analysis.
The findings show the registered nurses’ ambivalence towards the early warning score as a decision support system. Early warning score monitoring created a space for registered nurses to identify and initiate optimized care. However, when early warning scores contradicted registered nurses’ clinical judgments, the latter were given priority in decisions even though elevated scores were not always accounted for in the situation. Moreover, we found unspoken expectations in the collaboration between physicians and registered nurses, which influenced the registered nurses’ workloads and decisions regarding early warning scores.
Registered nurses’ clinical judgment is essential to clinical decisions on the care and safety of patients if used combined with the early warning score. Interprofessional collaboration between registered nurses and physicians about the early warning score is challenged. Future research may address this challenge to explore how it should be operated as a collaboration tool.
The study adds knowledge to the evidence base of registered nurses’ use of early warning score and the advantages and challenges associated with the use of these scoring systems. The study may provide valuable knowledge for the future development of policies or implementation strategies.
To evaluate the impact of a trauma and violence-informed cognitive behavioural therapy (TVICBT) intervention, compared with standard care on mental health, coping, bonding and maternal-infant attachment among pregnant women with a history of intimate partner violence and who displayed symptomatology consistent with anxiety, depression or post-traumatic stress disorder (PTSD).
A mixed-methods case study design was employed, where women either received standard perinatal care or were referred to a specialized TVICBT program.
Data were collected through a retrospective obstetric medical chart audit in 2017 at an Ontario hospital in a large urban centre. Multiple choice and ‘yes/no’ questions were analysed using measures of central tendency and dispersion, in addition to frequency counts. Qualitative data from clinical notes were subjected to an inductive content analysis approach to identify key concepts.
In total, 69 women participated (intervention group = 37, standard care group = 32). Prevalence of mental illness between groups was consistent, apart from the TVICBT group having a significant increase in PTSD. In the TVICBT group, 83.8% of women (n = 31) expressed perinatal concerns, compared with only 37.5% (n = 12) of the standard care group. More women in the intervention group (94.6%, n = 35) coped successfully in the intrapartum period than the standard care group (78.1%, n = 25). However, more women in the standard care group (97.0%, n = 31) exhibited appropriate bonding behaviours than the TVICBT group (88.6%, n = 31).
The TVICBT intervention was effective in assisting women to identify triggers during their pregnancy journey, develop appropriate coping strategies and advocate for their needs to best cope.
TVICBT offers an effective, individualized, trauma and violence-informed approach to optimize the health outcomes of perinatal women and their infants by promoting positive coping and maternal-infant bonding, thus filling an existing practice gap of a lack of individualized, trauma-informed care.
Thousands of anogenital and oropharyngeal cancers every year might be prevented through increased receipt of vaccination against the human papillomavirus (HPV). This project aimed to (1) increase the rate of HPV vaccination status assessment, and (2) improve HPV vaccine initiation and completion rates among 18 to 26-year-old patients in the family practice setting.
Quality improvement project, pre/post intervention design.
This project implemented the HIYA! (HPV Immunization among Young Adults) Intervention in a private sports and family practice in central New Jersey. HIYA! implemented 10 pre-, during, and post-visit outcome measures during every family medicine visit with an 18 to 26-year-old patient for HPV. Data collection involved retrospective chart review of every eligible patient during the 12-week implementation period from 17 August to 06 November 2020 and during the same 12-week control period in 2019.
One hundred sixteen charts from 2019 and 129 charts from 2020 were reviewed for assessment of HPV vaccination status and HPV vaccine initiation and/or completion. Multivariable logistic regression analysis demonstrated that participants in the control group were 84% less likely to be assessed for HPV vaccination status and were 91% less likely to initiate and complete HPV vaccination compared with the intervention group.
This QI project found HIYA! to be an effective and feasible strategy to improve HPV vaccination rates among 18 to 26-year-old patients in a family practice setting.
The human papillomavirus (HPV) is the most common sexually transmitted disease in the United States, and causes thousands of cancers annually. Although vaccination against HPV can prevent these cancers, vaccination rates remain low, particularly among young adults ages 18 to 26 years. The positive impact of HIYA! was evident based on its success despite the unique challenges presented during the implementation period due to the COVID-19 pandemic.
The objective of this scoping review of reviews will be to synthesize the existing literature to identify key elements, conceptualizations and interventions of cultural safety to improve healthcare for Indigenous Peoples.
Eligible studies will include reviews (e.g. scoping reviews, systematic reviews and narrative reviews) focused on Indigenous cultural safety in healthcare.
Guided by Weber-Pillwax's Indigenous principles of relationality and Arksey and O’Malley's scoping review framework, a review of reviews will be conducted by searching peer-reviewed literature published between January 2010 and December 2020. The database search will include CINAHL, PubMed, Scopus, Web of Science, and Google Scholar. This scoping review protocol was registered with the Joanna Briggs Institute on January 28, 2021.
There is a paucity of knowledge on existing interventions and implementation strategies to support Indigenous cultural safety within the healthcare system. Improving Indigenous cultural safety in healthcare requires a comprehensive understanding of its core components and the specific interventions.
This review will help guide future research and enhance cultural safety interventions for Indigenous Peoples, including Indigenous Peoples with diverse genders and sexualities. The findings from this review will provide critical insight and knowledge to inform cultural safety policies, programs and practices to support healthcare for Indigenous populations.
Cause-of-death discrepancies are common in respiratory illness-related mortality. A standard epidemiological metric, excess all-cause death, is unaffected by these discrepancies but provides no actionable policy information when increased all-cause mortality is unexplained by reported specific causes. To assess the contribution of unexplained mortality to the excess death metric, we parsed excess deaths in the COVID-19 pandemic into changes in explained versus unexplained (unreported or unspecified) causes.
Retrospective repeated cross-sectional analysis, US death certificate data for six influenza seasons beginning October 2014, comparing population-adjusted historical benchmarks from the previous two, three and five seasons with 2019–2020.
48 of 50 states with complete data.
16.3 million deaths in 312 weeks, reported in categories—all causes, top eight natural causes and respiratory causes including COVID-19.
Change in population-adjusted counts of deaths from seasonal benchmarks to 2019–2020, from all causes (ie, total excess deaths) and from explained versus unexplained causes, reported for the season overall and for time periods defined a priori: pandemic awareness (19 January through 28 March); initial pandemic peak (29 March through 30 May) and pandemic post-peak (31 May through 26 September).
Depending on seasonal benchmark, 287 957–306 267 excess deaths occurred through September 2020: 179 903 (58.7%–62.5%) attributed to COVID-19; 44 022–49 311 (15.2%–16.1%) to other reported causes; 64 032–77 054 (22.2%–25.2%) unexplained (unspecified or unreported cause). Unexplained deaths constituted 65.2%–72.5% of excess deaths from 19 January to 28 March and 14.1%–16.1% from 29 March through 30 May.
Unexplained mortality contributed substantially to US pandemic period excess deaths. Onset of unexplained mortality in February 2020 coincided with previously reported increases in psychotropic use, suggesting possible psychiatric or injurious causes. Because underlying causes of unexplained deaths may vary by group or region, results suggest excess death calculations provide limited actionable information, supporting previous calls for improved cause-of-death data to support evidence-based policy.
Alopecia areata (AA) is a common cause of immune-mediated non-scarring hair loss. Links between AA and common mental health, autoimmune and atopic conditions, and common infections have previously been described but remain incompletely elucidated and contemporary descriptions of the epidemiology of AA in the UK are lacking.
Retrospective study series using a large population-based cohort (5.2 million) from the Oxford Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) database, exploring four themes: AA epidemiology, mental health comorbidities, autoimmune/atopic associations and common infections.
In the epidemiology theme, we will describe the incidence and point prevalence of AA overall and by age, sex and sociodemographic factors. Healthcare utilisation (primary care visits and secondary care referrals) and treatments for AA will also be assessed. In the mental health theme, we will explore the prevalence and incidence of mental health conditions (anxiety, depressive episodes, recurrent depressive disorder, adjustment disorder, agoraphobia, self-harm and parasuicide) in people with AA compared with matched controls. We will also explore the mental health treatment patterns (medication and psychological interventions), time off work and unemployment rates. Within the autoimmune/atopic associations theme, we will examine the prevalence of atopic (atopic dermatitis, allergic rhinitis, asthma) and autoimmune conditions (Crohn’s disease, ulcerative colitis, coeliac disease, type 1 diabetes, Hashimoto’s thyroiditis, Graves’ disease, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus (SLE), polymyalgia rheumatica, Sjögren’s syndrome, psoriasis, vitiligo, multiple sclerosis, pernicious anaemia) in people with AA compared with matched controls. We will also estimate the incidence of new-onset atopic and autoimmune conditions after AA diagnosis. Within the common infections theme, we will examine the incidence of common infections (respiratory tract infection, pneumonia, acute bronchitis, influenza, skin infection, urinary tract infection, genital infections, gastrointestinal infection, herpes simplex, herpes zoster, meningitis, COVID-19) in people with AA compared with matched controls.
The Health Research Authority decision tool classed this a study of usual practice, ethics approval was not required. Study approval was granted by the RCGP RSC Study Approval Committee. Results will be disseminated through peer-reviewed publications.
To compare hospital treatments for major stroke types in Chinese adults by stroke pathological types, sex, age, calendar year, hospital tier, region and other factors.
Cross-sectional analysis of medical records retrieved from 20 229 stroke cases in the China Kadoorie Biobank.
Ten diverse areas (five urban, five rural) in China.
First-incident stroke cases who were recruited during an 11-year follow-up of 0.5M participants in the China Kadoorie Biobank.
Electronic copies of medical records of stroke cases were retrieved for clinical adjudication by local neurologists. Stroke cases were classified as ischaemic stroke (IS) (including lacunar infarction (LACI) and non-LACI (non-LACI)), intracerebral haemorrhage (ICH), subarachnoid haemorrhage (SAH) and unspecified stroke types.
Among 20 299 first-ever stroke cases, 17 306 (85%) had IS, 7123 had non-LACI, 6690 had LACI, 3493 had silent LACI, 2623 (13%) had ICH and 370 (2%) had SAH. Among IS cases, antiplatelet treatment was used by 64% (65% non-LACI, 66% LACI, 56% silent LACI), lipid-lowering by 50% (52% non-LACI, 53% LACI, 43% silent LACI) and blood pressure-lowering by ~42% of all IS types, with positive trends in the use of these treatments by calendar year and hospital tier. Among ICH cases, 53% used blood pressure-lowering and 10% used lipid-lowering treatments, respectively. In contrast, traditional Chinese medicines (TCMs) were used by 59% of IS (50% non-LACI, 62% LACI, 74% silent LACI), 38% of ICH and 30% of SAH cases, with positive trends by calendar year and by hospital tier.
Among IS cases, use of antiplatelet and lipid-lowering medications increased in recent years, but use of TCM still exceeded use of blood pressure-lowering treatment. In contrast, blood pressure-lowering treatment was widely used for ICH, but only half of all ICH cases used blood pressure-lowering treatment.
To estimate the frequency of chronic conditions and geriatric syndromes in older patients admitted to hospital because of an exacerbation of their chronic conditions, and to identify multimorbidity clusters in these patients.
Multicentre, prospective cohort study.
Internal medicine or geriatric services of five general teaching hospitals in Spain.
740 patients aged 65 and older, hospitalised because of an exacerbation of their chronic conditions between September 2016 and December 2018.
Active chronic conditions and geriatric syndromes (including risk factors) of the patient, a score about clinical management of chronic conditions during admission, and destination at discharge were collected, among other variables. Multimorbidity patterns were identified using fuzzy c-means cluster analysis, taking into account the clinical management score. Prevalence, observed/expected ratio and exclusivity of each chronic condition and geriatric syndrome were calculated for each cluster, and the final solution was approved after clinical revision and discussion among the research team.
740 patients were included (mean age 84.12 years, SD 7.01; 53.24% female). Almost all patients had two or more chronic conditions (98.65%; 95% CI 98.23% to 99.07%), the most frequent were hypertension (81.49%, 95% CI 78.53% to 84.12%) and heart failure (59.86%, 95% CI 56.29% to 63.34%). The most prevalent geriatric syndrome was polypharmacy (79.86%, 95% CI 76.82% to 82.60%). Four statistically and clinically significant multimorbidity clusters were identified: osteoarticular, psychogeriatric, cardiorespiratory and minor chronic disease. Patient-level variables such as sex, Barthel Index, number of chronic conditions or geriatric syndromes, chronic disease exacerbation 3 months prior to admission or destination at discharge differed between clusters.
In older patients admitted to hospital because of the exacerbation of chronic health problems, it is possible to define multimorbidity clusters using soft clustering techniques. These clusters are clinically relevant and could be the basis to reorganise healthcare circuits or processes to tackle the increasing number of older, multimorbid patients.
Nipple-sparing mastectomy (NSM) can be performed for the treatment of breast cancer and risk reduction, but total mammary glandular excision in NSM can be technically challenging. Minimally invasive robot-assisted NSM (RNSM) has the potential to improve the ergonomic challenges of open NSM. Recent studies in RNSM demonstrate the feasibility and safety of the procedure, but this technique is still novel in the USA.
This is a single-arm prospective pilot study to determine the safety, efficacy and potential risks of RNSM. Up to 12 RNSM will be performed to assess the safety and feasibility of the procedure. Routine follow-up visits and study assessments will occur at 14 days, 30 days, 6 weeks, 6 months and 12 months. The primary outcome is to assess the feasibility of removing the breast gland en bloc using the RNSM technique. To assess safety, postoperative complication information will be collected. Secondary outcomes include defining benefits and challenges of RNSM for both surgeons and patients using surveys, as well as defining the breast and nipple-areolar complex sensation recovery following RNSM. Mainly, descriptive analysis will be used to report the findings.
The RNSM protocol was reviewed and approved by the US Food and Drug Administration using the Investigational Device Exemption mechanism (reference number G200096). In addition, the protocol was registered with ClinicalTrials.gov (NCT04537312) and approved by The Ohio State University Institutional Review Board, reference number 2020C0094 (18 August 2020). The results of this study will be distributed through peer-reviewed journals and presented at surgical conferences.
Primary retinitis pigmentosa (RP) is a common hereditary retinal disease in ophthalmology that has a considerable impact on quality of life, but there are few effective therapeutic strategies. This trial aims to determine the efficacy and safety of acupuncture versus sham acupuncture (SA) for RP.
This is a study protocol for a randomised, participant-blind, sham-controlled trial. 64 eligible patients with RP will randomly be divided into acupuncture group and SA group. All groups will receive 48 sessions over 3 months. Participants will complete the trial by visiting the research centre in month 6/9 for a follow-up assessment. The primary outcome is visual field mean sensitivity and visual field mean deviation at month 3/6/9 compared with baseline. Secondary outcomes include the best-corrected visual acuity, central macular thickness, subfoveal choroidal thicknes, traditional Chinese medicine syndrome score and the scale of life quality for diseases with visual impairment at month 3/6/9 compared with baseline. Adverse events and safety indexes will be recorded throughout the study. SPSS V.25.0 statistical software was used for analysis, and measurement data were expressed as mean±SD.
Ethics approval was obtained from the Ethics Committee of the Chinese Clinical Trial Registry (approval no: ChiECRCT20200460). The results of this study will be published in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.