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.
To identify the preferences of women regarding management of urinary tract infections (UTIs).
A discrete choice experiment of the preferences for certain treatment attributes was conducted by survey. Attributes included treatment duration, time to complaint resolution, complication risk, side effect risk and contribution to antimicrobial resistance.
General population in the Netherlands, recruited via social media.
Women aged 18 years or older.
The primary outcome was the relative importance of the attributes for treatment choice, using a conditional logit model. The secondary outcome was the heterogeneity in these preferences.
The discrete choice experiment was completed by 833 women. Most attributes were important to decisions for UTI treatment. Women were willing to accept management with, for example, a higher chance of complications or longer time to resolution, if it could help avoid antimicrobial resistance. However, there was heterogeneity in the preferences. Women who had one previous UTI had a stronger preference for faster symptom resolution compared with those who had no previous UTI. Younger women also preferred faster symptom resolution. Finally, women with a low or middle education level gave less importance to preventing antimicrobial resistance than women with a high education level.
The current study indicated that a considerable part of women valued alternatives to antimicrobial treatment and were prepared to tolerate management that was less optimal in certain respects to avoid antimicrobial treatment.
Paediatricians, general practitioners (GPs) and midwives in primary care are important sources of information for parents on early childhood allergy prevention (ECAP). Research has shown that preventive counselling by health professionals can be effective in improving patients’ health literacy (HL) and health behaviour. Providing effective advice relies on two factors. First, health professionals need be up-to-date with research evidence on ECAP, to consider popular misconceptions and fears and to translate this knowledge into clear recommendations for parents (knowledge translation). Second, they need to know and apply counselling techniques and create a practice setting which accommodates parental HL needs (health literacy-responsive care). The objective of this study is to explore and assess how German health professionals take up and translate ECAP evidence into appropriate recommendations for parents, how they consider HL in counselling and practice organisation and what barriers and enablers they find in their performance of HL-responsive ECAP.
The study has a sequential mixed-method design, in two phases. In the first phase, qualitative semi-structured expert interviews will be conducted with health professionals (paediatricians, GPs and midwives) at primary care level and professional policy level. Data collection is ongoing until January 2022. In the second phase, based on the qualitative results, a standardised questionnaire will be developed, and pilot-tested in a wider population of German health professionals. The findings of both phases will be integrated.
The study has received ethical approval from the Ethics Committee of the University of Regensburg (18-1205-101). The results will be published in international peer-reviewed open access journals and via presentations at scientific conferences. The results will also be shared with German health professionals, decision-makers and potential funders of interventions.
Apolipoprotein Cs (apoCs), especially apoC-II and apoC-III, as the components of triglyceride-rich lipoproteins, play a key role in the pathophysiology of diabetes. However, prospective studies examining direct associations between apoCs and diabetes are not reproducible. The aim of this study was to evaluate the impact of apoCs on the risk of developing diabetes in a middle-aged population, and to explore possible mediators responsible for the relationship between apoCs and diabetes.
Prospective cohort study.
Community-based study carried out in Beijing.
ApoCs were measured in 1085 participants aged 45–74 years and free of type 2 diabetes mellitus (T2DM) at baseline from the Chinese Multi-Provincial Cohort Study-Beijing Project. Multivariate logistic regression was performed to examine the association of apoCs with a 5-year risk of new-onset T2DM. The impacts of triglycerides, insulin and high-sensitivity C reactive protein (hs-CRP) on the association between apoC-III and the risk of T2DM were explored by a mediation test.
During the 5 years of follow-up, 97 (8.9%) participants developed T2DM. ApoC-III was significantly associated with the risk of developing T2DM after multivariable adjustment (OR=1.40; 95% CI 1.07 to 1.82). This association was mainly mediated by triglyceride levels with a significant indirect effect (OR 1.61; 95% CI 1.19 to 2.18), followed by hs-CRP and insulin.
Our findings demonstrated that higher serum apoC-III was independently associated with increased 5-year risk of new-onset T2DM in the Chinese population, and triglyceride plays a crucial role in mediating this relationship. More attention should be paid to preventive strategies of T2DM targeting apoC-III.
Cognitive impairment after anaesthesia and surgery is a recognised consequence. This often leads to poor health outcomes and increases healthcare resource utilisation and associated costs, especially in elderly people. However, thus far, there have not been any effective therapies for managing postoperative cognitive dysfunction (POCD). Furthermore, research on the association of multimodal warming with POCD and the clinical outcomes in older patients after gynaecological surgery has not been rigorous. For these reasons, our investigation aims to evaluate whether perioperative multimodal warming would reduce the incidence of POCD and improve prognosis in elderly patients with gynaecological cancer.
This is a single-centre, prospective, single-blinded randomised controlled trial. One hundred and fifty patients for gynaecological cancer surgery and 16 non-surgical controls aged 65 years or older will be studied in this trial. A series of neuropsychological tests will be completed to evaluate cognitive function in surgery patients before, at day 7 and 3 months after gynaecological cancer surgery. In addition, POCD and cognitive decline will be assessed using the reliable change index using the control group’s results. The primary outcome is the prevalence of POCD in elderly gynaecological cancer surgery patients and association between perioperative multimodal warming and POCD.
The protocol for this prospective observational study was approved by the ethics committee of the West China Second University Hospital, Sichuan University (NO. KX215). Recruitment will commence in April 2021 and continue to April 2022. The findings of this trial will be disseminated in peer-reviewed journals and scientific meetings.
To characterise low-tier female sex workers (FSWs) who engage in commercial sex with old male clients (OMCs).
Twenty-one counties in Zhejiang province, China.
A total of 2647 low-tier FSWs who participated in our survey from September to November 2013, and responded to the question regarding whether they engaged in commercial sex with OMCs during the previous month.
Data on sociodemographic characteristics, sexual behaviours, risk perception of HIV/sexually transmitted infection (STI), ever exposure to an HIV prevention service and degree of self-efficacy regarding condom use were collected via a face-to-face questionnaire administered by trained interviewers.
Of the 2647 participants, 1165 (44.0%) had engaged in commercial sex with OMCs in the previous month. Low-tier FSWs working out of roadside shops, those who had engaged in sex work for longer, those with a larger number of clients, those who had engaged in anal or oral sex during the previous month, those currently using contraception measures, those who had STI symptoms and those who had been exposed to HIV prevention services during the previous 6 months were more likely to engage in commercial sex with OMCs. FSWs with a high level of education; those working out of small venues other than streets, hair salons and roadside shops; those who charged more for commercial sex; those who had sex with young clients during the previous month and those who had seen a doctor during the previous 6 months were less likely to engage in commercial sex with OMCs.
Low-tier FSWs who engaged in commercial sex with OMCs reported more risky behaviours than those who did not engage in this behaviour. Attention should be paid to these behaviours in future interventions targeting low-tier FSWs.
The impacts of violence have a significant effect on health and well-being, particularly for women and children. Violence within families is widely recognised as a complex problem constituted by constantly interacting and evolving social, economic, health and cultural elements. Calls for integrated services have arisen from growing understanding about the implications of this complexity, which suggest family violence and solutions to it are generated endogenously from the reflexive nonlinear interactions of system agents. Despite these calls for integration, services designed to support families impacted by violence and the systems that design and fund them are often responsive only to one part of the problem and might not pay attention to agent interactions and their adaptive reflexivity. This paper outlines a scoping protocol to explore how integrated approaches to family violence are conceptualised in current literature, with innovative use of a complexity theory lens.
Our scoping review protocol follows the framework outlined by Arksey and O’Malley and refined by Levac. It searches 6 databases, 3 journals and 10 websites using keywords to capture the notion of integration and a complex adaptive system, namely the participant (system agents), concept (system agent interaction) and the context (family violence). Selection criteria require the articles to be written in English, have full-text article available, and were published after 2010. Items selected also need to be evidence based showing interaction between system agents. Applying complexity theory, sensitises us to the reflexive patterns of interaction between system elements and routine ways of interacting.
The nature of this review means that ethics approval is not required. Findings will be disseminated via academic publications, conferences and discussions with policy decision-makers. The findings will be used to develop a plan for stakeholder consultation to share and validate learnings and inform future research.
Global prevalence rates of psoriasis differ significantly, with lowest rates in the equator region and increasing tendencies towards the north but also differences within-country. Information on regional variations in Germany is missing. This study aims to analyse the change of psoriasis prevalence in Germany over time and to detect regional variations.
Cross sectional, spatio-epidemiological study on regional psoriasis prevalence in Germany.
Claims data study based on nationwide outpatient billing data on county level.
Analyses based on outpatient billing data for 2010–2017 derived from all people insured in statutory health insurances (about 72.8 million). We performed descriptive spatio-temporal analyses of prevalence rates using probability mapping and statistical smoothing methods, identified spatial clusters and examined a north-south gradient using spatial statistics.
The prevalence increased from 147.4 per 10 000 in 2010 to 173.5 in 2017. In 2017, counties’ prevalence rates ranged between 93.8 and 340.9. Decreased rates occurred mainly in southern counties, increased rates in northern and eastern counties. Clusters of low rates occur in southern and south-western Germany, clusters of high rates in the north and north-east. The correlation between counties’ latitudes and their prevalence rates was high with Pearson’s r=0.65 (p
Increased prevalence of psoriasis over time and marked regional variations in Germany were observed which need further investigation.
The aim of the project was to examine the acceptability and feasibility of a mobile phone application-based intervention ‘TechCare’, for individuals with psychosis in the North West of England. The main objectives were to determine whether appropriate individuals could be identified and recruited to the study and whether the TechCare App would be an acceptable intervention for individuals with psychosis.
This was a mixed methods feasibility study, consisting of a test-run and feasibility evaluation of the TechCare App intervention.
Early Intervention Services (EIS) for psychosis, within an NHS Trust in the North West of England.
Sixteen participants (test-run n=4, feasibility study n=12) aged between 18 and 65 years recruited from the East, Central and North Lancashire EIS.
A 6-week intervention, with the TechCare App assessing participants’ symptoms and responses in real-time and providing a personalised-guided self-help-based psychological intervention based on the principles of Cognitive Behaviorual Therapy (CBT).
A total of 83.33% (n=10) of participants completed the 6-week feasibility study, with 70% of completers achieving the set compliance threshold of ≥33% engagement with the TechCare App system. Analysis of the qualitative data suggested that participants held the view that the TechCare was both an acceptable and feasible means of delivering interventions in real-time.
Innovative digital clinical technologies, such as the TechCare App, have the potential to increase access to psychological interventions, reduce health inequality and promote self-management with a real-time intervention, through enabling access to mental health resources in a stigma-free, evidence-based and time-independent manner.
ClinicalTrials.gov Identifier: NCT02439619.
The short-term economic benefit of embedding best practice tobacco dependence treatment (TDT) into healthcare services prior to surgery across different populations and jurisdictions is largely unknown. The aim of this systematic review is to summarise the cost-effectiveness of preoperative smoking cessation interventions for preventing surgical complications compared with usual care. The results will provide hospital managers, clinicians, healthcare professionals and policymakers with a critical summary of the economic evidence on providing TDT routinely before surgery, aiding the development and dissemination of unified, best practice guidelines, that is, implementation of article 14 of the WHO Framework Convention on Tobacco Control.
A comprehensive search of peer-reviewed literature will be conducted from database inception until 23 June 2021 (Cochrane, Econlit, Embase, Health Technology Assessment, Medline Complete, Scopus). Published, English-language articles describing economic evaluations of preoperative smoking cessation interventions for preventing surgical complications will be included. One researcher will complete the searches and two researchers will independently screen results for eligible studies. Any disagreement will be resolved by the third researcher. A narrative summary of included studies will be provided. Study characteristics, economic evaluation methods and cost-effectiveness results will be extracted by one reviewer and descriptive analyses will be undertaken. A second reviewer will review data extracted for accuracy from 10% of the included studies. Reporting and methodological quality of the included studies will be evaluated independently by two reviewers using the Consolidated Health Economic Evaluation Reporting Standards statement and the Quality of Health Economic Studies Instrument checklist, respectively.
This research does not require ethics approval because the study is a planned systematic review of published literature. Findings will be presented at health economic, public health and tobacco control conferences, published in a peer-reviewed journal and disseminated via social media.
Intensive care audits point to family refusal as a major barrier to organ donation. In this study, we sought to understand refusal by accounting for the decision-maker’s mindset. This focused on: (1) how decisions compare when made on behalf of a relative (vs the self); and (2) confidence in decisions made for family members.
Cross-sectional survey in Singapore.
Participants were recruited from community settings via door-to-door sampling and community eateries.
973 adults who qualified as organ donors in Singapore.
Although 68.1% of participants were willing to donate their own organs, only 51.8% were willing to donate a relative’s organs. Using machine learning, we found that consistency was predicted by: (1) religion, and (2) fears about organ donation. Conversely, participants who were willing to donate their own organs but not their relative’s were less driven by these factors, and may instead have resorted to heuristics in decision-making. Finally, we observed how individuals were overconfident in their decision-making abilities: although 78% had never discussed organ donation with their relatives, the large majority expressed high confidence that they would respect their relatives’ wishes on death.
These findings underscore the distinct psychological processes involved when donation decisions are made for family members. Amidst a global shortage of organ donors, addressing the decision-maker’s mindset (eg, overconfidence, the use of heuristics) may be key to actualizing potential donors identified in intensive care units.
Sarcopenia is associated with reduced pulmonary function in healthy adults, as well as with increased risk of pneumonia following abdominal surgery. Consequentially, postoperative pneumonia prolongs hospital admission, and increases in-hospital mortality following a range of surgical interventions. Little is known about the function of the diaphragm in the context of sarcopenia and wasting disorders or how its function is influenced by abdominal surgery. Liver surgery induces reactive pleural effusion in most patients, compromising postoperative pulmonary function. We hypothesise that both major hepatic resection and sarcopenia have a measurable impact on diaphragm function. Furthermore, we hypothesise that sarcopenia is associated with reduced preoperative diaphragm function, and that patients with reduced preoperative diaphragm function show a greater decline and reduced recovery of diaphragm function following major hepatic resection. The primary goal of this study is to evaluate whether sarcopenic patients have a reduced diaphragm function prior to major liver resection compared with non-sarcopenic patients, and to evaluate whether sarcopenic patients show a greater reduction in respiratory muscle function following major liver resection when compared with non-sarcopenic patients.
Transcostal B-mode, M-mode ultrasound and speckle tracking imaging will be used to assess diaphragm function perioperatively in 33 sarcopenic and 33 non-sarcopenic patients undergoing right-sided hemihepatectomy starting 1 day prior to surgery and up to 30 days after surgery. In addition, rectus abdominis and quadriceps femoris muscles thickness will be measured using ultrasound to measure sarcopenia, and pulmonary function will be measured using a hand-held bedside spirometer. Muscle mass will be determined preoperatively using CT-muscle volumetry of abdominal muscle and adipose tissue at the third lumbar vertebra level (L3). Muscle function will be assessed using handgrip strength and physical condition will be measured with a short physical performance battery . A rectus abdominis muscle biopsy will be taken intraoperatively to measure proteolytic and mitochondrial activity as well as inflammation and redox status. Systemic inflammation and sarcopenia biomarkers will be assessed in serum acquired perioperatively.
This trial is open for recruitment. The protocol was approved by the official Independent Medical Ethical Committee at Uniklinik (Rheinish Westphälische Technische Hochschule (RWTH) Aachen (reference EK309-18) in July 2019. Results will be published via international peer-reviewed journals and the findings of the study will be communicated using a comprehensive dissemination strategy aimed at healthcare professionals and patients.
ClinicalTrials. gov (EK309-18); Pre-results.
To clarify high-risk factors for adverse pregnancy outcomes (APOs) in systemic lupus erythaematosus (SLE).
A retrospective chart review study.
Data were collected in a tertiary medical centre, Shanghai, China, from November 2010 to December 2018.
A total of 513 pregnancies with SLE were retrospectively analysed. Twenty-seven patients who underwent artificial abortions due to personal reasons were excluded.
APOs were primary outcomes, including foetal loss, premature birth, small for gestational age (SGA), asphyxia neonatorum, composite foetal APOs and hypertensive disorders of pregnancy (HDP). Multivariable logistic regression and Spearman correlation analysis were performed to determine the risk factors for APOs in SLE.
Risk factors for foetal loss included prepregnancy hypertension, hypocomplementaemia-C3, anticardiolipin antibodies-IgM positivity and disease flares during pregnancy. Risk factors for premature birth included disease flares, use of immunosuppressive agents and HDP. Moreover, twin pregnancy, disease flares and HDP were risk factors for SGA, and prepregnancy hypertension was an independent risk factor for asphyxia neonatorum. Independent risk factors for composite foetal APOs included twin pregnancy, prepregnancy hypertension, disease flares during pregnancy, HDP, hypocomplementaemia-C3 and the use of immunosuppressive agents. Risk factors for SLE complicated with HDP included prepregnancy hypertension, renal disorders and thrombocytopaenia. Conversely, the use of aspirin was a protective factor against foetal loss and premature birth. The ds-DNA value had a low diagnostic value for APOs, whereas the extent of complement reduction may predict the incidence of composite foetal APOs and foetal loss. Proteinuria occurring in the first 20 gestational weeks may lead to APOs.
Established risk factors for each APO were identified in this study. Indicators with more predictive significance have been screened out from conventional indicators, which may help clinicians predict the pregnancy outcome of patients with SLE more accurately and minimise the incidence of APOs.
The COVID-19 pandemic has resulted in widespread morbidity and mortality with the consequences expected to be felt for many years. Significant variation exists in the care even of similar patients with COVID-19, including treatment practices within and between institutions. Outcome measures vary among clinical trials on the same therapies. Understanding which therapies are of most value is not possible unless consensus can be reached on which outcomes are most important to measure. Furthermore, consensus on the most important outcomes may enable patients to monitor and track their care, and may help providers to improve the care they offer through quality improvement. To develop a standardised minimum set of outcomes for clinical care, the International Consortium for Health Outcomes Measurement (ICHOM) assembled a working group (WG) of 28 volunteers, including health professionals, patients and patient representatives.
A list of outcomes important to patients and professionals was generated from a systematic review of the published literature using the MEDLINE database, from review of outcomes being measured in ongoing clinical trials, from a survey distributed to patients and patient networks, and from previously published ICHOM standard sets in other disease areas. Using an online-modified Delphi process, the WG selected outcomes of greatest importance.
The outcomes considered by the WG to be most important were selected and categorised into five domains: (1) functional status and quality of life, (2) mental functioning, (3) social functioning, (4) clinical outcomes and (5) symptoms. The WG identified demographic and clinical variables for use as case-mix risk adjusters. These included baseline demographics, clinical factors and treatment-related factors.
Implementation of these consensus recommendations could help institutions to monitor, compare and improve the quality and delivery of care to patients with COVID-19. Their consistent definition and collection could also broaden the implementation of more patient-centric clinical outcomes research.
Follow-up care is important for gastric cancer survivors, but follow-up strategies for gastric cancer survivors remain inconsistent, and compliance of gastric cancer survivors with follow-up care is very low. Understanding the needs and preferences of gastric cancer survivors is conducive to developing appropriate and acceptable follow-up strategies, thereby improving patient compliance. Discrete choice experiments can quantify individual needs and preferences. However, to date, there is no discrete choice experiment on the preferences of gastric cancer survivors, and no studies have examined how gastric cancer survivors make choices based on different characteristics of follow-up. This paper outlines an ongoing discrete choice experiment that aims to (1) explore follow-up service-related characteristics that may affect gastric cancer survivors’ choices about their follow-up, (2) elicit how gastric cancer survivors consider the trade-offs among different follow-up service options using discrete choice experiment, (3) determine whether gastric cancer survivors’ needs and preferences for follow-up vary due to the economy, politics, technology and culture in different regions.
Six attributes were developed through a literature review, semistructured interviews and experts and focus group discussions. A fractional factorial design was used to evaluate the interaction between attributes. A multiple logit model will be used to understand the trade-off between the follow-up characteristics of gastric cancer survivors. A mixed logit model will be used to explore the willingness to pay and uptake rate of gastric cancer survivors for follow-up attributes and further explore the preferences of different groups.
This study was approved by the ethics committee of the School of Nursing, Jilin University. The results of this study will be shared through online blogs, policy briefs, seminars and peer-reviewed journal articles and will be used to modify the current strategy of gastric cancer survivors’ follow-up services according to economic development and regional culture.
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.
Develop an individualised prognostic risk prediction tool for predicting the probability of adverse COVID-19 outcomes in patients with inflammatory bowel disease (IBD).
This study developed and validated prognostic penalised logistic regression models using reports to the international Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease voluntary registry from March to October 2020. Model development was done using a training data set (85% of cases reported 13 March–15 September 2020), and model validation was conducted using a test data set (the remaining 15% of cases plus all cases reported 16 September–20 October 2020).
We included 2709 cases from 59 countries (mean age 41.2 years (SD 18), 50.2% male). All submitted cases after removing duplicates were included.
COVID-19 related: (1) Hospitalisation+: composite outcome of hospitalisation, ICU admission, mechanical ventilation or death; (2) Intensive Care Unit+ (ICU+): composite outcome of ICU admission, mechanical ventilation or death; (3) Death. We assessed the resulting models’ discrimination using the area under the curve of the receiver operator characteristic curves and reported the corresponding 95% CIs.
Of the submitted cases, a total of 633 (24%) were hospitalised, 137 (5%) were admitted to the ICU or intubated and 69 (3%) died. 2009 patients comprised the training set and 700 the test set. The models demonstrated excellent discrimination, with a test set area under the curve (95% CI) of 0.79 (0.75 to 0.83) for Hospitalisation+, 0.88 (0.82 to 0.95) for ICU+ and 0.94 (0.89 to 0.99) for Death. Age, comorbidities, corticosteroid use and male gender were associated with a higher risk of death, while the use of biological therapies was associated with a lower risk.
Prognostic models can effectively predict who is at higher risk for COVID-19-related adverse outcomes in a population of patients with IBD. A free online risk calculator (https://covidibd.org/covid-19-risk-calculator/) is available for healthcare providers to facilitate discussion of risks due to COVID-19 with patients with IBD.
To develop a nomogram for incident chronic kidney disease (CKD) risk evaluation among community residents with high cardiovascular disease (CVD) risk.
In this retrospective cohort study, 5730 non-CKD residents with high CVD risk participating the National Basic Public Health Service between January 2015 and December 2020 in Guangzhou were included. Endpoint was incident CKD defined as an estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2 during the follow-up period. The entire cohorts were randomly (2:1) assigned to a development cohort and a validation cohort. Predictors of incident CKD were selected by multivariable Cox regression and stepwise approach. A nomogram based on these predictors was developed and evaluated with concordance index (C-index) and area under curve (AUC).
During the median follow-up period of 4.22 years, the incidence of CKD was 19.09% (n=1094) in the entire cohort, 19.03% (727 patients) in the development cohort and 19.21% (367 patients) in the validation cohort. Age, body mass index, eGFR 60–89 mL/min/1.73 m2, diabetes and hypertension were selected as predictors. The nomogram demonstrated a good discriminative power with C-index of 0.778 and 0.785 in the development and validation cohort. The 3-year, 4-year and 5-year AUCs were 0.817, 0.814 and 0.834 in the development cohort, and 0.830, 0.847 and 0.839 in the validation cohort.
Our nomogram based on five readily available predictors is a reliable tool to identify high-CVD risk patients at risk of incident CKD. This prediction model may help improving the healthcare strategies in primary care.