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Study protocol for a longitudinal observational study of disparities in sleep and cognition in older adults: the DISCO study

Por: Knutson · K. L. · Pershing · M. L. · Abbott · S. · Alexandria · S. J. · Chiluka · S. · Chirinos · D. · Giachello · A. · Gupta · N. · Harrington · K. · Rittner · S. S. · Sorond · F. · Wong · M. · Vu · T.-H. T. · Zee · P. C. · Carnethon · M. R.
Introduction

Cognitive dysfunction, a leading cause of mortality and morbidity in the USA and globally, has been shown to disproportionately affect the socioeconomically disadvantaged and those who identify as black or Hispanic/Latinx. Poor sleep is strongly associated with the development of vascular and metabolic diseases, which correlate with cognitive dysfunction. Therefore, sleep may contribute to observed disparities in cognitive disorders. The Epidemiologic Study of Disparities in Sleep and Cognition in Older Adults (DISCO) is a longitudinal, observational cohort study that focuses on gathering data to better understand racial/ethnic sleep disparities and illuminate the relationship among sleep, race and ethnicity and changes in cognitive function. This investigation may help inform targeted interventions to minimise disparities in cognitive health among ageing adults.

Methods and analysis

The DISCO study will examine up to 495 individuals aged 55 and older at two time points over 24 months. An equal number of black, white and Hispanic/Latinx individuals will be recruited using methods aimed for adults traditionally under-represented in research. Study procedures at each time point will include cognitive tests, gait speed measurement, wrist actigraphy, a type 2 home polysomnography and a clinical examination. Participants will also complete self-identified assessments and questionnaires on cognitive ability, sleep, medication use, quality of life, sociodemographic characteristics, diet, substance use, and psychological and social health.

Ethics and dissemination

This study was approved by the Northwestern University Feinberg School of Medicine Institutional Review Board. Deidentified datasets will be shared via the BioLINCC repository following the completion of the project. Biospecimen samples from the study that are not being analysed can be made available to qualified investigators on review and approval by study investigators. Requests that do not lead to participant burden or that conflict with the primary aims of the study will be reviewed by the study investigators.

Tiza-Titre increase and enhanced immunity through an adjuvanted, recombinant herpes zoster subunit vaccine in patients with liver cirrhosis and post-liver transplantation: a study protocol for a prospective cohort study

Por: Vollmer-Raschdorf · S. · Rashidi-Alavijeh · J. · Voigt · S. · Hengel · H. · Borchardt · B. · Huzly · D. · Hüssler · E.-M. · in der Schmitten · J. · Halenius · A. · Willuweit · K. · Botzenhardt · S. · Trilling · M. · Boettler · T. · Dehnen · D.
Introduction

Shingrix, an effective adjuvanted, recombinant herpes zoster vaccine (RZV), has been available since 2018. Immunocompromised patients are known to be predisposed to vaccine failure. In-vitro testing of immunological surrogates of vaccine protection could be instrumental for monitoring vaccination success. So far, no test procedure is available for vaccine responses to RZV that could be used on a routine basis.

Methods and analysis

This is a single-centre, three-arm, parallel, longitudinal cohort study aspiring to recruit a total of 308 patients (103 with a liver cirrhosis Child A/B, 103 after liver transplantation (both ≥50 years), 102 immunocompetent patients (60–70 years)). Blood samples will be taken at seven data collection points to determine varicella zoster virus (VZV) and glycoprotein E (gE)-specific IgG and T cell responses. The primary study outcome is to measure and compare responses after vaccination with RZV depending on the type and degree of immunosuppression using gE-specific antibody detection assays. As a secondary outcome, first, the gE-specific CD4+ T cell response of the three cohorts will be compared and, second, the gE-VZV antibody levels will be compared with the severity of possible vaccination reactions. The tertiary outcome is a potential association between VZV immune responses and clinical protection against shingles.

Ethics and dissemination

Ethical approval was issued on 07/11/2022 by the Ethics Committee Essen, Germany (number 22-10805-BO). Findings will be published in peer-reviewed open-access journals and presented at local, national and international conferences.

Trial registration number

German Clinical Trials Registry (number DRKS00030683).

Acute care nurse managers' definitions of and barriers to well‐being: A thematic analysis of open‐ended survey questions

Abstract

Background

During the COVID-19 pandemic, acute care nurse managers functioned in a critical role by helping to advance the mission and goals of their organization while navigating a rapidly evolving healthcare landscape. This resulted in high levels of ongoing job-related stress which is linked to negative physical, psychological, and job-related outcomes. Little is known about the perceptions regarding their own professional well-being during this time.

Aim

The aim of this study was to qualitatively describe acute care nurse managers' perceptions of and barriers to their professional well-being.

Methods

Using a qualitative descriptive approach, nurse managers from a hospital system in the southwestern United States responded to two short-answer, survey-based questions in 2022: (1) “Describe the definition of nurse-manager well-being in your own words” and (2) “What do you feel is your biggest barrier to professional well-being?” Reflexive thematic analysis was utilized to analyze participant responses (N = 80).

Results

Professional well-being is a complex concept influenced by the nurse manager's ability to navigate work–life balance; care for their own physical, emotional, and spiritual selves; give and receive support from stakeholders; and manage feelings of thriving vs. struggling in the role. Barriers most cited as influencing well-being included having too little time to get things done coupled with increasing workloads, feeling stuck in the middle among stakeholders, and coping with ongoing staffing challenges.

Linking Evidence to Action

The definition of and barriers to well-being are influenced by the specific needs and experiences of the nurse manager. While not all barriers can be immediately removed, the identification of individual and organization-specific barriers needs to be taken seriously, reviewed by those who can promote change, and evidence-based solutions for improvement piloted or implemented when feasible.

Effect of different catheter pathways on wounds after minimally invasive radical prostatectomy: A meta‐analysis

Abstract

Prostate cancer is one of the most common malignancies worldwide and the fifth leading cause of cancer deaths in men. With the rapidly increasing surgical rate of minimally invasive radical prostatectomy, there is still controversy about how to use a urinary catheter post-operatively. Thus, we attempted to compare the post-operative wound-related outcomes through a meta-analysis of urethral catheterisation (UC) versus suprapubic catheterisation (SPC) after minimally invasive radical prostatectomy. As of August 2023, the authors conducted systematic searches in databases such as PubMed, Embase, Web of Science and the Cochrane Library. The authors reviewed the relevant literature separately to determine comparisons between SPC and UC treatment after radical prostatectomy. A total of 395 subjects were enrolled in the five trials, met the eligibility criteria and were included in the meta-analysis. Data collection and analysis revealed significant differences in catheter bother to patients for surgical trauma (MD, 0.98; 95% CI, 0.48, 1.48 p = 0.0001), with SPC causing less catheter bother to patients post-operatively; post-operative catheter-related problems (OR, 3.3; 95% CI, 0.03, 326.1 p = 0.61), the POD1 of the post-operative period (MD, − 0.09; 95% CI, −0.75, 0.94 p = 0.83) and the POD3 of the post-operative period (MD, −0.49; 95% CI, −0.99, 0.01 p = 0.06); there was no statistically significant difference in wound pain. Compared with UC, SPC patients had less post-operative catheter distress. Thus, SPC is more beneficial in reducing post-operative wound discomfort in patients. The validity of the results remains to be tested in more and better studies.

Laparoscopic vs. open surgery: A comparative analysis of wound infection rates and recovery outcomes

Por: Zhen Shi

Abstract

As medical technology continues to evolve, it becomes crucial to distinguish the outcomes of traditional versus modern surgical techniques. This was a retrospective cohort study, conducted to compare the wound infection rates and recovery outcomes between laparoscopic and open surgery (OS) in 180 patients. Participants were divided into laparoscopic (n = 105) and OS (n = 75) groups. Comprehensive data, including demographics, surgical details, and postoperative outcomes, were extracted. Wound infection rates, as measured by Wound Asepsis Score, were prioritized alongside recovery indicators such as duration of hospital stay and postoperative pain. The laparoscopic group had a mean operative time of 57.19 minutes, while the OS group required 85.10 ± 15.18 minutes (p < 0.05). Laparoscopic surgeries resulted in an average blood loss of 120.76 ± 13.3 mL compared to 170.01 ± 17.19 mL for OS (p < 0.05). The laparoscopic group had significantly reduced (p < 0.05) average hospital stays (2.1 ± 1.1 days) than the OS group (4.4 ± 2.1 days). Although the laparoscopic group had lower incidence of surgical site infection (4.76%) than the OS group (9.33%), this difference was not statistically significant (p > 0.05). On postoperative days 1, 3, and 7, the Visual Analog Scale assessment of pain in the laparoscopic group revealed significantly reduced pain (p < 0.05). Laparoscopic surgery appeared to offer distinct advantages over conventional open surgery, especially in terms of operative durations, recovery rates, and postoperative pain management. This study highlighted the potential of laparoscopic approaches for specific surgical interventions, as well as the importance of patient-specific surgical strategy decision-making.

Effects of rapid rehabilitation nursing model on surgical site wound infection and pain of patients with ovarian cancer: A meta‐analysis

Abstract

To explore the effect of rapid rehabilitation nursing model on surgical site wound infection and pain of patients with ovarian cancer. Computer searches were performed on randomised controlled trials (RCTs) of rapid rehabilitation nursing model applied to ovarian cancer patients in PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (SinoMed), VIP and Wanfang Database from the time each database was constructed to May 2023. Two researchers independently screened the literature, extracted data and completed an assessment of the quality of the literature based on the inclusion and exclusion criteria. Meta-analysis was performed using RevMan 5.4 software. The database was searched to obtain 255 articles, and 22 articles were finally included, containing 966 patients in the experimental group and 954 patients in the control group, for a total of 1920 patients. The results of the meta-analysis showed that, compared with other nursing models, the use of the rapid rehabilitation nursing model significantly reduced surgical site wound infections in patients with ovarian cancer (OR = 0.30, 95% CI: 0.15–0.61, p < 0.001) and the rate of post-operative complications (OR = 0.27, 95% CI: 0.19–0.38, p < 0.001) also reduced the patients' post-operative wound pain (MD = −0.70, 95% CI: −0.85 to −0.55, p < 0.001). The rapid rehabilitation nursing model applied to patients with ovarian cancer surgery can effectively reduce the rate of post-operative complications and wound infections, and it can also reduce the post-operative wound pain.

Development and validation of a multimorbidity risk prediction nomogram among Chinese middle-aged and older adults: a retrospective cohort study

Por: Zheng · X. · Xue · B. · Xiao · S. · Li · X. · Chen · Y. · Shi · L. · Liang · X. · Tian · F. · Zhang · C.
Objectives

The aim of this study is to establish a self-simple-to-use nomogram to predict the risk of multimorbidity among middle-aged and older adults.

Design

A retrospective cohort study.

Participants

We used data from the Chinese Longitudinal Healthy Longevity Survey, including 7735 samples.

Main outcome measures

Samples’ demographic characteristics, modifiable lifestyles and depression were collected. Cox proportional hazard models and nomogram model were used to estimate the risk factors of multimorbidity.

Results

A total of 3576 (46.2%) participants have multimorbidity. The result showed that age, female (HR 0.80, 95% CI 0.72 to 0.89), chronic disease (HR 2.59, 95% CI 2.38 to 2.82), sleep time (HR 0.78, 95% CI 0.72 to 0.85), regular physical activity (HR 0.88, 95% CI 0.81 to 0.95), drinking (HR 1.27 95% CI 1.16 to 1.39), smoking (HR 1.40, 95% CI 1.26 to 1.53), body mass index (HR 1.04, 95% CI 1.03 to 1.05) and depression (HR 1.02, 95% CI 1.01 to 1.03) were associated with multimorbidity. The C-index of nomogram models for derivation and validation sets were 0.70 (95% CI 0.69 to 0.71, p=0.006) and 0.71 (95% CI 0.70 to 0.73, p=0.008), respectively.

Conclusions

We have crafted a user-friendly nomogram model for predicting multimorbidity risk among middle-aged and older adults. This model integrates readily available and routinely assessed risk factors, enabling the early identification of high-risk individuals and offering tailored preventive and intervention strategies.

The Canadian Study of Arterial Inflammation in Patients with Diabetes and Recent Vascular Events, Evaluation of Colchicine Effectiveness (CADENCE): protocol for a randomised, double-blind, placebo-controlled trial

Por: Boczar · K. E. · Shin · S. · deKemp · R. A. · Dowlatshahi · D. · Tavoosi · A. · Wiefels · C. · Liu · P. · Lochnan · H. · MacPherson · P. A. · Chong · A. Y. · Torres · C. · Leung · E. · Tawakol · A. · Ahmadi · A. · Garrard · L. · Lefebvre · C. · Kelly · C. · MacPhee · P. · Tilokee · E. · Ragg
Background

Inflammation is a key mediator in the development and progression of the atherosclerotic disease process as well as its resultant complications, like myocardial infarction (MI), stroke and cardiovascular (CV) death, and is emerging as a novel treatment target. Trials involving anti-inflammatory medications have demonstrated outcome benefit in patients with known CV disease. In this regard, colchicine appears to hold great promise. However, there are potential drawbacks to colchicine use, as some studies have identified an increased risk of infection, and a non-significant trend for increased all-cause mortality. Thus, a more thorough understanding of the underlying mechanism of action of colchicine is needed to enable a better patient selection for this novel CV therapy.

Objective

The primary objective of the Canadian Study of Arterial Inflammation in Patients with Diabetes and Recent Vascular Events, Evaluation of Colchicine Effectiveness (CADENCE) trial is to assess the effect of colchicine on vascular inflammation in the carotid arteries and ascending aorta measured with 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT in patients with type 2 diabetes mellitus (T2DM) or pre-diabetes who have experienced a recent vascular event (acute coronary syndrome (ACS)/MI, transient ischaemic attack (TIA) or stroke). Secondary objectives include determining colchicine’s effect on inflammatory biomarkers (high-sensitivity C reactive protein (hs-CRP) and interleukin-6 (IL-6)). Additionally, we will assess if baseline inflammation imaging or biomarkers are associated with a treatment response to colchicine determined by imaging. Exploratory objectives will look at: (1) the difference in the inflammatory response to colchicine in patients with coronary events compared with patients with cerebral events; (2) the difference in the inflammatory response to colchicine in different vascular beds; (3) the relationship of FDG-PET imaging markers with serum biomarkers and (4) assessment of quality-of-life changes.

Methods and design

CADENCE is a multicentre, prospective, randomised, double-blinded, placebo-controlled study to determine the effect of colchicine on arterial inflammation as assessed with imaging and circulatory biomarkers, specifically carotid arteries and aortic FDG uptake as well as hs-CRP and IL-6 among others. Patients with T2DM or pre-diabetes who have recently experienced a CV event (within 30–120 days after an ACS (ie, ST-elevation MI (STEMI) or non-STEMI)) or TIA/stroke with documented large vessel atherosclerotic disease will be randomised to treatment with either colchicine 0.6 mg oral daily or placebo. Participants will undergo baseline clinical evaluation including EQ5D assessment, blood work for inflammatory markers and FDG PET/CT scan of the ascending aorta and left and right carotid arteries. Patients will undergo treatment for 6 months and have repeat clinical evaluation including EQ5D assessment, blood work for inflammatory markers and FDG PET/CT scan at the conclusion of the study. The primary outcome will be the change in the maximum target to background ratio (TBRmax) in the ascending aorta (or carotid arteries) from baseline to follow-up on FDG PET/CT imaging.

Discussion

Colchicine is an exciting potential new therapy for CV risk reduction. However, its use is associated with side effects and greater understanding of its underlying mechanism of action is needed. Importantly, the current study will determine whether its anti-inflammatory action is an indirect systemic effect, or a more local plaque action that decreases inflammation. The results will also help identify patients who will benefit most from such therapy.

Trial registration number

NCT04181996.

A survey of Indonesian nurses' educational experiences and self‐perceived capability to care for people with intellectual disability and/or autism spectrum disorder

Abstract

Aims

To describe Indonesian nurses' educational experience regarding care for people with intellectual disability and/or autism and to explore if these educational experiences are associated with their self-perceived confidence, comfort, knowledge and preparedness to care for these cohorts.

Design

Cross-sectional descriptive survey.

Methods

A descriptive survey tool utilized in a study of Australian registered nurses was replicated and adapted for this study. Following descriptive analysis, chi-square analyses were undertaken to explore associations between educational experiences, and self-rated measures of confidence, comfort and knowledge to work with people with intellectual disability and/or autism. Although there was no end-user involvement in the design of the study, the concepts explored have all been raised by those with lived insights of intellectual disability and/or autism as being critical to their healthcare experiences.

Results

There were 544 complete responses, and 51.7% were not exposed to any educational or clinical content relevant to caring for people with intellectual disability and/or autism. Moderate to low levels of self-perceived confidence, comfort, knowledge and preparedness to address healthcare needs of these cohorts were reported. Significant associations were identified between educational and clinical experiences during undergraduate training, and higher levels of self-perceived confidence, comfort and knowledge.

Conclusion

Mirroring international literature, the findings of this study highlight a large proportion of Indonesian nurses had little educational experience relevant to caring for people with intellectual disability and/or autism, and have relatively low levels of self-reported capability.

Impact

This study highlights gaps in the educational experiences, and self-perceived confidence, comfort, knowledge and preparedness of Indonesian nurses regarding caring for people with intellectual disability and/or autism. Given that internationally, people with intellectual disability and/or autism have disproportionately negative health outcomes and experiences, these findings have substantial implications for nursing curriculum, policy and professional development.

Improving post‐acute stroke follow‐up care by adopting telecare consultations in a nurse‐led clinic: Study protocol of a hybrid implementation‐effectiveness trial

Abstract

Aim

To evaluate the clinical effectiveness and implementation strategies of telecare consultations in post-stroke nurse-led clinics.

Background

Telecare consultations could be an alternative to conventional in-person consultations and improve continuity of care for stroke survivors following their discharge from hospital. Previous studies utilizing telecare consultations only focused on testing their clinical effectiveness on stroke survivors; the appropriateness and feasibility of adopting this new delivery modality in a real-world setting were not examined.

Design

A Type II hybrid effectiveness-implementation design will be adopted.

Methods

Eligible stroke survivor participants will be randomly assigned to the intervention group (telecare consultation) or control group (usual in-person clinic consultation). Both groups will receive the same nursing intervention but delivered through different channels. The Reach, Effectiveness, Adoption, Implementation, Maintenance framework will be used to evaluate the clinical effectiveness and implementation outcomes. The primary outcome is the non-inferiority of the degree of disability between the two groups at 3 months into the intervention and at 3 months post-intervention. The paper complies with the SPIRIT guidelines for study protocols adapted for designing and reporting parallel group randomized trials.

Conclusion

The findings of this study will provide key insights into the processes for implementing and adopting telecare consultations into long-term services for post-stroke patients.

Impact

This study contributes to the translation of telecare consultations for stroke survivors into real-life settings. If effective, this program may provide guidance for expanding telecare consultations to other post-stroke nurse-led clinics or to patients with other chronic diseases.

Trial Registration

This study has been registered at clinicaltrials.gov (identifier: NCT05183672). Registered on 10 January 2022.

Online search interest in long-term symptoms of coronavirus disease 2019 during the COVID-19 pandemic in Japan: Infodemiology study using the most visited search engine in Japan

by Kosuke Ishizuka, Taiju Miyagami, Tomoya Tsuchida, Mizue Saita, Yoshiyuki Ohira, Toshio Naito

Prolonged symptoms that occur after COVID-19 (long-COVID) vary from mild, which do not interfere with daily life, to severe, which require long-term social support. This study assessed the secular trend in online searches on long-COVID in Japan. We conducted an observational study using data provided by Yahoo! JAPAN on the monthly search volume of query terms related to long-COVID from January 2020 to December 2022, including the search volume of the query “コロナ後遺症” (long-COVID in Japanese). The number of new cases of COVID-19 by month was used as a control for search trends, and the symptoms retrieved in conjunction with long-COVID were compared. Trends in online searches for each symptom of long-COVID were analyzed. The symptoms of long-COVID were classified according to “Component 1—Symptoms and Complaints” of the International Classification of Primary Care, 2nd edition (ICPC-2). Interest in long-COVID increased in response to peaks in the number of new cases of COVID-19 in Japan. The most frequent symptom searches with long-COVID were hair loss/baldness (3,530, 21,400, and 33,600 searches in 2020, 2021, and 2022, respectively), cough (340, 7,900 and 138,910 searches in 2020, 2021, and 2022, respectively), disturbance of smell/taste (230, 13,340, and 44,160 searches in 2020, 2021, and 2022, respectively), and headache (580, 6,180, and 42,870 searches in 2020, 2021, and 2022, respectively). In addition, the ranking of interest in “weakness/tiredness, general” in long-COVID increased each year (not in the top 10 in 2020, seventh in 2021, and second in 2022), and the absolute number of searches also increased. To our knowledge, this is the first study to investigate secular trends in online interest in long-COVID in the world. Continued monitoring of online interest in long-COVID is necessary to prepare for a possible increase in the number of patients with long-COVID.

Community perceptions matter: a mixed-methods study using local knowledge to define features of success for a community intervention to improve quality of care for children under-5 in Jigawa, Nigeria

Por: Iuliano · A. · Shittu · F. · Colbourn · T. · Salako · J. · Bakare · D. · Bakare · A. A. A. · King · C. · Graham · H. · McCollum · E. D. · Falade · A. G. · Uchendu · O. · Haruna · I. · Valentine · P. · Burgess · R.
Objectives

In this study, we used the information generated by community members during an intervention design process to understand the features needed for a successful community participatory intervention to improve child health.

Design

We conducted a concurrent mixed-methods study (November 2019–March 2020) to inform the design and evaluation of a community–facility linkage participatory intervention.

Setting

Kiyawa Local Government Area (Jigawa State, Nigeria)—population of 230 000 (n=425 villages).

Participants

Qualitative data included 12 community conversations with caregivers of children under-5 (men, older and younger women; n=9 per group), 3 focus group discussions (n=10) with ward development committee members and interviews with facility heads (n=3). Quantitative data comprised household surveys (n=3464) with compound heads (n=1803) and women (n=1661).

Results

We analysed qualitative data with thematic network analysis and the surveys with linear regression—results were triangulated in the interpretation phase. Participants identified the following areas of focus: community health education; facility infrastructure, equipment and staff improvements; raising funds to make these changes. Community involvement, cooperation and empowerment were recognised as a strategy to improve child health, and the presence of intermediate bodies (development committees) was deemed important to improve communication and solve problems between community and facility members. The survey showed functional community relations’ dynamics, with high levels of internal cohesion (78%), efficacy in solving problems together (79%) and fairness of the local leaders (82%).

Conclusions

Combining the results from this study and critical theories on successful participation identified community-informed features for a contextually tailored community–facility link intervention. The need to promote a more inclusive approach to future child health interventions was highlighted. In addition to health education campaigns, the relationship between community and healthcare providers needs strengthening, and development committees were identified as an essential feature for successfully linking communities and facilities for child health.

Trial registration number

ISRCTN39213655.

Longitudinal analysis of long-term outcomes of colorectal cancer after laparotomy and laparoscopic surgery: The Shizuoka study

by Noriko Kojimahara, Yasuto Sato, Yoko Sato, Fumihiro Kojimahara, Katsuyuki Takahashi, Eiji Nakatani

Background

Long-term cancer prognosis after initial surgical procedures is an unlikely endpoint for clinical trials. Medical claim databases may aid in addressing this issue regardless of limited information on disease and patient background. However, the long-term prognosis (especially regarding long-term care needs) following surgical procedures remains unclear. This study aimed to assess whether long-term outcomes, such as the exacerbation of long-term care needs and mortality, differ with surgical methods.

Methods

Using a longitudinal study with linkage between medical claim and long-term care database, patients with primary colorectal cancer who underwent initial colonoscopies were identified through anonymized data in Japan (Shizuoka Kokuho Database, 2012–2018). Odds ratios (ORs) for long-term outcomes (long-term care needs and all-cause mortality during a 6.5-year follow-up period) were analyzed using logistic regression to compare laparoscopy and endoscopic surgery to laparotomy.

Results

Overall, 3,744 primary colorectal cancer cases (822 laparotomies, 705 laparoscopies, and 2,217 endoscopic surgeries) were included. Compared to the laparotomy group, the crude OR for exacerbation of long-term care needs in the laparoscopic surgery group was 0.376 (95% confidence interval, 0.227, 0.624), while the OR for all-cause mortality was 0.22 (0.329, 0.532).

Conclusion

This is the first study to analyze long-term prognosis after surgery for patients with colorectal cancer to combine medical and long-term needs data. As the national health insurance claim database rarely includes information on cancer stage and comorbidities, better prognosis on endoscopic surgery may need careful interpretation. Therefore, laparoscopy has superior outcomes in terms of long-term care needs and mortality compared to those of laparotomy.

Impact of PARP inhibitor maintenance therapy in newly diagnosed advanced epithelial ovarian cancer: A meta-analysis

by Banghyun Lee, Suk-Joon Chang, Byung Su Kwon, Joo-Hyuk Son, Myong Cheol Lim, Yun Hwan Kim, Shin-Wha Lee, Chel Hun Choi, Kyung Jin Eoh, Jung-Yun Lee, Dong Hoon Suh, Yong Beom Kim

Objectives

This meta-analysis was undertaken to systematically evaluate the effects of poly (ADP-ribose) polymerase inhibitor (PARPi) maintenance therapy on the survival of newly diagnosed advanced epithelial ovarian cancer (EOC) patients.

Methods/Materials

A systematic literature search revealed 3,227 studies. A subsequent selection process identified seven suitable randomized studies that assessed the survival outcomes in newly diagnosed advanced EOC patients administered PARPi (n = 1921; the PARPi group) or placebo (n = 1150; the placebo group). The survival outcomes were compared with respect to the PARPi treatment regardless of bevacizumab maintenance therapy. All adverse events ≥ grade 3 were analyzed. Review Manager Version 5.4.1 software was used for the meta-analysis.

Results

The two-year progression-free survival (PFS) was significantly better in the PARPi group than the placebo (Hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.41 to 0.68). Furthermore, patients in the PARPi group with the BRCA1/2 mutation (BRCAm), BRCA wild type, homologous-recombination deficiency (HRD), or HRD without BRCAm, but not with homologous-recombination proficiency had a significantly better two-year PFS than the patients in the placebo group. The five-year overall survival (OS) was comparable in the two groups, but patients in the PARPi group with BRCAm had a significantly better five-year OS than those in the placebo group (HR, 0.57; 95% CI, 0.44 to 0.74). In addition, the adverse event rate (≥ grade 3) was significantly higher in the PARPi group than in the placebo group (HR, 2.94; 95% CI, 1.13 to 7.63).

Conclusions

In patients with newly diagnosed advanced EOC, PARPi maintenance therapy was significantly more effective in terms of survival than no PARPi treatment. However, the risk of serious adverse events was higher for patients who received PARPi maintenance therapy.

Single-facility study of the effectiveness of rehabilitation therapy using wearable hybrid assistive limb for patients with bleeding disorders: study protocol for a randomised controlled trial

Por: Mawarikado · Y. · Sakata · A. · Inagaki · Y. · Shirai · D. · Tatsumi · K. · Nogami · K. · Tanaka · Y. · Kido · A. · Shima · M.
Introduction

Haemophilic arthropathy, a serious complication of haemophilia, results from recurrent joint bleeding, causing progressive joint damage and severely impacting patient quality of life. Rehabilitation therapy (RT) effectively addresses declining physical function due to joint degradation, but pain during RT can hinder its success. Therefore, an effective pain-alleviating treatment method is required. The single-joint hybrid assistive limb (HAL-SJ), a powered exoskeleton, measures bioelectric potential during muscle contraction and provides motorised support, potentially alleviating pain.

Objective

This study outlines our protocol for a randomised, prospective, single-blind (evaluator) trial aimed to investigate the effects of HAL-SJ on pain reduction during RT, kinesiophobia and other physical functions in patients with haemophilia.

Methods and analysis

This two-group comparison intervention study will include 24 male patients aged 12–85 years diagnosed with a bleeding disorder necessitating RT for pain and physical function improvement. The primary outcome measures pain changes during the first and second RT session in patients receiving HAL-SJ-assisted RT compared with traditional RT without HAL-SJ. The secondary outcomes include kinesiophobia (Japanese version of the Tampa Scale for Kinesiophobia), standing position gait (zebris FDM-T treadmill), range of motion (manual goniometer) and body surface temperature (infrared thermography camera) during the study period of up to 3 months or until the end of 10 RTs. RT intensity remains below that required to move the affected joint against gravity, given HAL-SJ’s muscular support. The follow-up period extends to 1 month after the last RT. Intergroup study variables are compared by an unpaired t-test or Mann-Whitney test. Intragroup comparisons of secondary outcomes are analysed by a paired t-test or Wilcoxon signed-rank test.

Ethics and dissemination

This study was approved by the accreditation committee of Nara Medical University Hospital. The study results will disseminate through publication in a peer-reviewed journal.

Trial registration number

jRCTs052220076.

PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT): a prospective longitudinal study protocol investigating the prevalence, severity and determinants of atherosclerotic cardiovascular disease in the young adult Pakistani popu

Por: Hanif · B. · Sheikh · S. · Peerwani · G. · Cainzos-Achirica · M. · Javed · W. · Baqar · J. B. · Samad · Z. · Bashir · F. · S Virani · S. · Nasir · K. · Aijaz · S.
Introduction

Atherosclerotic cardiovascular disease (ASCVD) is a major cause of morbidity, mortality and health expenditures worldwide. Despite having higher ASCVD in the Pakistani population, data on subclinical coronary atherosclerosis in young Pakistanis remain scarce. The PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT) aims to assess the prevalence, severity and determinants of subclinical coronary atherosclerosis among Pakistani men (35–60 years) and women (35–65 years) free of clinically symptomatic ASCVD and will assess 5-year rates of ASCVD events.

Methods and analysis

PAK-SEHAT is an ongoing prospective cohort study with 2000 participants from all provinces of Pakistan who will be interviewed at the baseline along with phlebotomy, measurement of carotid intima-media thickness (CIMT) and coronary CT angiography (CCTA). Phlebotomy will be repeated at 2.5 years, whereas CIMT and CCTA will be repeated at 5 years. We will report the frequency of maximal coronary stenosis ≥50% and ≥70%, number of coronary vessels with plaque and the number of coronary segments affected per participant on CCTA. We will use Cox proportional hazards regression models to evaluate the association between baseline characteristics and incident ASCVD events during follow-up. These associations will be presented as HRs with 95% CIs.

Ethics and dissemination

The study protocol was approved by the Tabba Heart Institute Institutional Review Board (THI/IRB/FQ/22-09-2021/016). All study procedures are consistent with the principles of the Declaration of Helsinki. Findings of the study will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

NCT05156736.

Health-related quality of life and its changes of the Tibetan population in China: based on the 2013 and 2018 National Health Services Surveys

Por: Dou · L. · Shi · Z. · Cuomu · Z. · Zhuoga · C. · Li · C. · Dawa · Z. · Li · S.
Objective

Health-related quality of life (HRQoL) was an important health outcome measure for evaluating an individual’s overall health status. However, there was limited in the literature on HRQoL and its long-term changes of the Tibetan population. This study aimed to assess HRQoL of Tibetan and its changes over time, and explore the differences in HRQoL for residents at different altitudes.

Design

Data for the cross-sectional study were extracted from the fifth and sixth waves of the National Health Services Surveys which were conducted in 2013 and 2018. A multistage stratified cluster random sampling strategy was used to select representative participants.

Setting

Tibet Autonomous Region in China.

Participants

This study recruited 14 752 participants in 2013 and 13 106 participants in 2018, and after excluding observations with missing values for key variables, 10 247 in 2013 and 6436 in 2018 were included in the study analysis.

Primary and secondary outcome measures

The EQ-5D-3L was used to measure participants’ HRQoL.

Results

The mean health state utility scores of the participants were 0.969±0.078 and 0.966±0.077 in 2013 and 2018, respectively. Pain/discomfort was the most frequently prevalent issue reported in 18.1% and 17.9% of the participants in 2013 and 2018, respectively. Tibetans living 3500–4000 m altitude had the best HRQoL. Age, sex, employment status, educational attainment, chronic disease and weekly physical exercise were influencing factors associated with HRQoL.

Conclusions

The HRQoL of the Tibetan population was lower than the general Chinese population, and decreased over time between 5 years. There were differences in HRQoL among Tibetan at different altitudes, with residents living at 3500–4000 m having the best quality of life. More attention should be paid to those Tibetans who are older, female, unemployed and without formal education.

Elucidation of the needs for telecritical care services in Japan: a qualitative study

Por: Morimoto · M. · Nawa · N. · Okada · E. · Itsui · Y. · Kashimada · A. · Yamamoto · K. · Akaishi · Y. · Yamawaki · M.
Objective

To clarify the reasons for consultation, advice sought by frontline physicians and relationship between the patient’s pathology and the type of advice provided to guide the future development of telecritical care services.

Design

Secondary analysis of transcripts of telephone calls originally recorded for quality control purposes was conducted using a thematic content analysis. The calls were conducted between December 2019 and April 2021 (total cases: 70; total time: ~15 hour).

Settings

Intensivists provided consultation services to frontline physicians at secondary care institutions in the Kansai and Chubu regions.

Participants

Non-intensive care frontline physicians working in five secondary care institutions in the Kansai and Chubu regions and intensivists providing a consultation service (n=26).

Interventions

Not applicable.

Primary and secondary outcome measures

The main outcome was the themes emerging from the language used during telephone and video consultations, indicating the gap filled by the telecritical care service.

Findings

We analysed 70 cases and approximately 15 hours of anonymised audio data. We identified the following reasons for consultation: ‘lack of competence in treatment and diagnostic testing’ and ‘lack of access to consultation in their own hospital’. Frontline physicians most often sought advice related to ‘treatment’, followed by ‘patient triage and transfer’, ‘diagnosis’ and ‘diagnostic testing and evaluation’. Regarding the relationship between the patient’s pathology and type of advice provided, the most commonly sought advice by frontline physicians varied based on the patient’s pathology.

Conclusion

This study explored the characteristics of 70 telecritical sessions and identified the reasons for and nature of the consultations. These findings can be used to guide the future provision and scale up of telecritical services.

Dietary replacement of soybean meal with black soldier fly larvae meal in juvenile <i>Labeo rohita</i> and <i>Catla catla</i>: Effects on growth, nutritional quality, oxidative stress biomarkers and disease resistance

by Shafaq Fatima, Ayesha Afzal, Hamna Rashid, Saba Iqbal, Rosheen Zafar, Komal Khalid, Ayman Rauf, Maryam Majeed, Aqsa Malik, Chris G. Carter

This experiment aimed to investigate the effects of partial substitution of crude protein from soybean meal (SBM) with black soldier fly (Hermetia illucens) larvae meal (BSFLM) in juvenile rohu (Labeo rohita) and catla (Catla catla). Four isonitrogenous diets (23% crude protein) were formulated to replace 0% (T0), 40% (T40), 80% (T80) and 100% (T100) crude protein from SBM with BSFLM. Triplicate groups of each species (10 fish per replicate) were fed in an eight week growth experiment. After final sampling (n = 20 fish per dietary group), the remaining fish were exposed to bacterial (Staphylococcus aureus) challenge (0.80 CFU/ml) for 15 days. Rohu fed with BSFLM substituted diets showed significantly higher growth and feed conversion ratio as compared to those in T0. Catla fed with BSFLM substituted diets showed slightly higher growth indices. The growth response of rohu to BSFLM substitution was better than that noted in catla in all groups. The chemical composition, amino acids and fatty acids profile, haematological and biochemical parameters, levels of liver function enzymes measured in T0, T40, T80 and T100 were similar between four dietary groups in both species. However, the maximum value of cholesterol and triglycerides were noted in T100 both in catla and rohu. The values of lauric acid, α-linolenic acid, decosahexanoic acid, n3:n6 fatty acids ratio progressively increased with dietary increase of BSFLM in both species. At end of the growth experiment, the levels of catalase, superoxide dismutase and lysozyme increased linearly with the inclusion of BSFLM in both species while malondialdehyde showed similar values between different groups. However, catalase, and superoxide dismutase increased (T0

Lifestyle behaviours and associated factors among people with type 2 diabetes attending a diabetes clinic in Ningbo, China: A cross-sectional study

by Naomi Carter, Jialin Li, Miao Xu, Li Li, Shengnan Xu, Xuelan Fan, Shuyan Zhu, Prit Chahal, Kaushik Chattopadhyay

The burden of type 2 diabetes (T2DM) in China is significant and growing, and this is reflected in high rates of T2DM in the city of Ningbo, China. Consequent impacts on morbidity, mortality, healthcare expenditure, and health-related quality of life, make this a problem of the utmost importance to address. One way to improve T2DM outcomes is to address lifestyle behaviours that may affect prognosis and complications, such as physical activity levels, dietary habits, smoking status, and alcohol intake. A cross-sectional survey was undertaken to describe the prevalence of being physically active, having a healthy diet, currently smoking, and currently drinking alcohol among people living with T2DM attending a diabetes clinic in Ningbo, China. Regression analysis was used to determine the factors associated with these lifestyle behaviours. We found a high prevalence of a healthy diet (97.8%, 95% CI 96.5–98.7%). Prevalence of being physically active (83.4%, 95% CI 80.6–85.9%), smoking (21.6%, 95% CI 18.8–24.6%), and alcohol drinking (32.9%. 95% CI 29.6–36.2%) appeared in keeping with those of the general population. Marked associations were demonstrated between male sex and smoking (OR 41.1, 95% CI 16.2–139.0), and male sex and alcohol drinking (OR 4.00, 95% CI 2.62–6.20). Correlation between lifestyle factors was demonstrated including between alcohol drinking and smoking, and between physical activity and reduced smoking. General diabetes self-management education programmes that address multiple lifestyle risk factors simultaneously may be beneficial in this population. Specific interventions targeting smoking cessation and reduction in alcohol drinking may be of benefit to men living with T2DM attending a diabetes clinic in Ningbo.
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