Registry Record Research Articles

Comparing the effect of childbirth preparation courses delivered both in-person and via social media on pregnancy experience, fear of childbirth, birth preference and mode of birth in pregnant Iranian women: A quasi-experimental study.

Rates of cesarean section in Iran are unnecessarily high largely due to fear of childbirth (FOC), yet this may be reduced through education. Iranian women are keen to obtain information about pregnancy and birth online though sources may not be reliable. Consequently, the present study aimed to compare the effect of childbirth preparation courses delivered both online via the social media platform 'Telegram' and in-person on pregnancy experience, FOC, birth preference, and mode of birth. This quasi-experimental study included 165 primiparous pregnant women referred to the prenatal clinic in Tehran, Iran. Convenience sampling was used to recruit participants, who were subsequently divided into three groups; (A) social media-based educational intervention (n = 53); (B) in-person educational intervention (n = 52), and (C) a control group who received no prenatal education (n = 50). During the 18th and 20th weeks of pregnancy, demographic questions along with the pregnancy experience scale (PES), and version A of the Wijma delivery expectancy/experience questionnaire (WDEQ‑A) were completed. In the 36th and 38th weeks of pregnancy, the PES and WDEQ‑A questionnaires, as well as birth preference form were further completed. Mode of birth was recorded in the first few days of postpartum. The Fisher's exact test, along with ANOVA and Chi-square tests were used to determine associations between variables. A paired t-test was used to examine within-group comparisons. The Kruskal-Wallis non-parametric test was used to investigate the intervening effect of economic status. Post intervention, the mean score of pregnancy experience and FOC did not differ significantly between the three groups. Also, 86.8% of participants in group A, 90.4% of participants in group B, and 62% of participants in the control group preferred to give birth vaginally, which was statistically significant (p = 0.001). Moreover, 66% of participants in group A, 61.5% of participants in group B, and 50% of participants in the control group ultimately gave birth vaginally. None of the participants in group A underwent an elective cesarean section, while this rate was 7.7% and 24% for groups B and control, respectively (p = 0.002). Despite the non-significant differences identified between the three groups in terms of pregnancy experience and FOC, prenatal education delivered via social media may be usefully offered to Iranian women keen to receive education flexibly online. Name of the Registry: Iranian Registry of Clinical Trials. Trial registration number: IRCT20180427039436N2. Date of registration: 15/06/2018. URL of trial registry record: https://www.irct.ir/trial/30890.

Mastering linked datasets: The future of emergency health care research

Objectives The aim of this work is to describe routine integration of prehospital emergency health records into a health master linkage file, delivering ongoing access to integrated patient treatment and outcome information for ambulance-attended patients in Queensland. Methods The Queensland Ambulance Service (QAS) data are integrated monthly into the Queensland Health master linkage file (MLF) using a linkage algorithm that relies on probabilistic matches in combination with deterministic rules based on patient demographic details, date, time, and facility identifiers. Each ambulance record is assigned an enduring linkage key (unique patient identifier) and further processing determines whether each record matches with a corresponding hospital emergency department, admission, or death registry record. In this study, all QAS electronic ambulance report form (eARF) records from October 2016 to December 2018 where at least one key linkage variable was present (n = 1,771,734) were integrated into the MLF. Results The majority of records (n = 1,456,502; 82.2%) were for transported patients, and 90.1% (n = 1,312,176) of these transports were to public hospital facilities. Of these transport records, 93.9% (n = 1,231,951) matched to ED records and 59.3% (n = 864,394) also linked to admitted patient records. Of ambulance non-transport records integrated into the MLF, 23.6% (n = 74,311) matched with ED records. Conclusion This study demonstrates robust linkage methods, quality assurance processes, and high linkage rates of data across the continuum of care (prehospital/emergency department/admitted patient/death) in Queensland. The resulting infrastructure provides a high-quality linked dataset that facilitates complex research and analysis to inform critical functions such as quality improvement, system evaluation, and design.

Association of Anesthesiologist Staffing Ratio With Surgical Patient Morbidity and Mortality

Recent studies have investigated the effect of overlapping surgeon responsibilities or nurse to patient staffing ratios on patient outcomes, but the association of overlapping anesthesiologist responsibilities with patient outcomes remains unexplored to our knowledge. To examine the association between different levels of anesthesiologist staffing ratios and surgical patient morbidity and mortality. A retrospective, matched cohort study consisting of major noncardiac inpatient surgical procedures performed from January 1, 2010, to October 31, 2017, was conducted in 23 US academic and private hospitals. A total of 866 453 adult patients (aged ≥18 years) undergoing major inpatient surgery within the Multicenter Perioperative Outcomes Group electronic health record registry were included. Anesthesiologist sign-in and sign-out times were used to calculate a continuous time-weighted average staffing ratio variable for each operation. Propensity score-matching methods were applied to create balanced sample groups with respect to patient-, operative-, and hospital-level confounders and resulted in 4 groups based on anesthesiologist staffing ratio. Groups consisted of patients receiving care from an anesthesiologist covering 1 operation (group 1), more than 1 to no more than 2 overlapping operations (group 1-2), more than 2 to no more than 3 overlapping operations (group 2-3), and more than 3 to no more than 4 overlapping operations (group 3-4). Data analysis was performed from October 2019 to October 2021. Undergoing a major inpatient surgical operation that involved an anesthesiologist providing care for up to 4 overlapping operations. The primary composite outcome was 30-day mortality and 6 major surgical morbidities (cardiac, respiratory, gastrointestinal, urinary, bleeding, and infectious complications) derived from International Classification of Diseases, Ninth Revision and International Statistical Classification of Diseases and Related Health Problems, Tenth Revision discharge diagnosis codes. In all, 578 815 adult patients (mean [SD] age, 55.7 [16.2] years; 55.1% female) were analyzed. After matching operations according to anesthesiologist staffing ratio, 48 555 patients were in group 1; 247 057, group 1-2; 216 193, group 2-3; and 67 010, group 3-4. Increasing anesthesiologist coverage responsibilities was associated with an increase in risk-adjusted surgical patient morbidity and mortality. Compared with patients in group 1-2, those in group 2-3 had a 4% relative increase in risk-adjusted mortality and morbidity (5.06% vs 5.25%; adjusted odds ratio [AOR], 1.04; 95% CI, 1.01-1.08; P = .02) and those in group 3-4 had a 14% increase in risk-adjusted mortality and morbidity (5.06% vs 5.75%; AOR, 1.15; 95% CI, 1.09-1.21; P < .001). This study's findings suggest that increasing overlapping coverage by anesthesiologists is associated with increased surgical patient morbidity and mortality. Therefore, the potential effects of staffing ratios in perioperative team models should be considered in clinical coverage efforts.

Assessing the meaningful change threshold of Quality of Life in Depression Scale using data from two phase 3 studies of esketamine nasal spray

BackgroundMajor depressive disorder (MDD) directly impacts patients’ lives including symptoms, functioning and health-related quality-of-life (HRQoL). Patient-reported outcomes can capture these impacts, however interpretation of clinical meaningfulness of these measurements are often not readily available. Meaningful change thresholds (MCTs) can be derived for clinical outcome assessments to quantify the change in symptoms that is meaningful to the patient following pharmacologic treatment or other interventions. The objective of this analysis was to determine the within-patient MCT of the self-reported Quality-of-Life in Depression Scale (QLDS) among patients with MDD and active suicidal ideation with intent (MDSI) using an anchor-based approach.MethodsData from 2 randomized phase-3 trials of esketamine nasal spray (ASPIRE I and ASPIRE II) were analyzed. The Montgomery–Åsberg Depression Rating Scale (MADRS) was the primary anchor with three different severity criteria. Other anchor variables utilized were Clinical Global Impression of Severity of Suicidality-revised version, Clinical Global Impression of Imminent Suicide Risk, and EuroQol Visual Analog Scale [EQ-VAS]. Spearman correlation coefficients between the change in QLDS and anchor variables were calculated. The mean change in QLDS score at Day 25 from baseline was calculated based on the categorical change in the anchor. Coefficient yield from linear regression of the mean changes in EQ-VAS and QLDS, and distribution-based approach with ½ SD of change in QLDS were considered.ResultsIn ASPIRE I, mean (SD) improvement in QLDS score among patients with one category improvement in MADRS from baseline to Day 25 was − 8.22 (8.87), − 8.30 (9.01), and − 8.20 (8.92) using severity criteria #1, #2, and #3, respectively. Patients who achieved a 7-point improvement (MCT) in EQ-VAS yielded a mean − 9.69-point improvement in QLDS at Day 25. The ½ SD of change in QLDS was 5.63. Similar results were obtained for ASPIRE II. The MCTs identified using multiple anchors across both trials ranged from − 11.4 to − 6.7 and had an overall mean of − 7.90 (ASPIRE I) and − 7.92 (ASPIRE II). Thus, an 8-point change was recommended as the MCT for QLDS.ConclusionThe recommended MCT will help quantify within-person changes in HRQoL using patient-reported QLDS and determine meaningful treatment benefit in an MDD patient population with acute suicidal ideation or behavior.Trial registration: Name of the registry: ClinicalTrials.gov. Trial registration number: ASPIRE I (NCT03039192), ASPIRE II (NCT03097133). Date of registration: February 01, 2017; March 31, 2017. URL of trial registry record: https://clinicaltrials.gov/ct2/show/NCT03039192; https://clinicaltrials.gov/ct2/show/NCT03097133.

Comparison of high-intensive and low-intensive electromechanical-assisted gait training by Exowalk® in patients over 3-month post-stroke

BackgroundThis study was conducted to assess the effect of electromechanical-assisted gait training intensity on walking ability in patients over 3-month post-stroke.MethodsData from two randomized controlled trials (RCTs) were collected under the same study design of assessment and intervention, excluding intervention time per session. After matching the inclusion criteria of two RCTs, the experimental groups of each RCT were defined as low-intensive (LI) and high-intensive (HI) group according to the intervention time per session. Primary outcome was the difference of the change in Functional Ambulatory Categories (FAC) between LI and HI gait training. Secondary outcomes were the difference of changes in mobility, walking speed, walking capacity, leg-muscle strength, balance and daily activity evaluated with Rivermead Mobility Index (RMI), 10 m walk test (10MWT), 6-min walk test (6MWT), Motricity Index (MI), Berg Balance Scale (BBS) and Modified Barthel Index (MBI) respectively.ResultsThe FAC improved after gait training in both groups. The secondary outcomes also improved in both groups except RMI and MI in HI group. The change of all outcomes were not different between groups except RMI. The change of RMI in the LI group was greater than that in the HI group statistically, but it did not meet minimal clinically important difference.ConclusionsThe improvement of walking ability after LI or HI gait training was not different if providing the same total gait training time. By providing the electromechanical gait training intensively, we could shorten the gait training period to improve walking ability and customize the training program according to the patient training abilities.Trial registrationName of the registry: Clinical Research Information Service. Trial registration number: No. KCT0002195(RCT1), No. KCT0002552(RCT2). Date of registration: 10/04/2016(RCT1), 10/05/2017(RCT2). URL of the trial registry record: https://cris.nih.go.kr/cris/search

A randomised controlled trial on the effects of a structural education module among women with polycystic ovarian syndrome on nutrition and physical activity changes

BackgroundPolycystic ovarian syndrome (PCOS) is a complex metabolic, endocrine and reproductive disorder that has a huge impact on the life of women. To ascertain the effectiveness of health education module among women with PCOS.MethodsThis single-centre, randomised controlled trial was conducted on female staff of the University Putra Malaysia who were diagnosed with PCOS. Subjects were randomly assigned into intervention (n = 34) and control group (n = 35). In the intervention group, they need to take part in 8 education sessions in total over 6 months, and feedback was collected at the end of the session.ResultsPrimary outcome was changes in knowledge, attitude and practise of nutrition. Secondary outcomes were eating attitude and behaviour as well as knowledge, attitude and practise towards physical activity. After 6-months of intervention, there was a significant difference observed in nutrition knowledge 1 score (p < 0.001) and nutrition knowledge 2 score (p = 0.01) between intervention and control groups. Similarly, there was a significant difference observed in international physical activity questionnaire score (p = 0.02) between intervention and control groups. However there was no significant changes for attitude and practice of nutrition, eating attitude as well as knowledge, attitude and practise of physical activity.ConclusionsOur study showed that 6-months of education intervention can improve nutrition and physical activity knowledge. Based on this study, the education module may be considered an effective intervention for women with PCOS.Trial registration: Name of the registry: Australian New Zealand Clinical Trials Registry (ANZCTR). Trial registration number: ACTRN12617000135314. Date of registration: 24/01/2017. URL of trial registry record: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372037

The Role of Recorded Volume of Cerebrospinal Fluid Output in Predicting Modified Rankin Scale Score at Discharge in Patients with Subarachnoid Hemorrhages (DROPSS)

Introduction. External ventricular drain (EVD) placement is common among aneurysmal subarachnoid hemorrhage (aSAH). Draining cerebrospinal fluid (CSF) from the EVD is also common, yet little is known about how much to drain, the length of time to drain, or how drainage impacts patient outcomes.&#x0D; Aim. The purpose of this study is to correlate amount of CSF drainage to patient outcomes, via modified Rankin Score (mRS).&#x0D; Material and Methods. This retrospective review of data located in a local hospital-based registry and electronic medical record. A linear mixed effects model was constructed to examine CSF drainage volume as a predictor of mRS at discharge.&#x0D; Results. Data from 82 patients was included in this analysis. There was no statistically significant relationship between CSF totals and mRS at hospital discharge (p = 0.3614, r² = 0.01). After controlling for age, Hunt and Hess score, and subject as random effect, there was still no significant relationship between CSF drained and mRS score at hospital discharge (p = .9042).&#x0D; Conclusions. There is no correlation between the total volume of CSF drained and mRS at discharge. Future research should explore CSF drainage documentation practices. (JNNN 2022;11(2):43–48)&#x0D; Key Words: acute care, aneurysmal subarachnoid hemorrhage, cerebrospinal fluid, external ventricular drain, patient outcomes

Critical Discourse Analysis on Name Shifting Practice among Millennial Muslims in the Indonesian Context

Name-giving is not merely a compilation of words to meet official record registration, yet the idea behind this has some socio-cultural values. Indonesian Muslim names have now experienced some changing from the past. This research aims at analyzing the discourse of millennial Muslim names in Indonesia. NVivo 12 Plus was used to analyze the nodes data of three categories—Pure Indonesian, Pure Arabic, and Mixing across its case—parents and children. Another analysis used was word frequency to picture the frequent word clouds used in parents' and children's naming practices. Results show a shift in Indonesian millennial Muslims' naming practice, as the Pure Arabic and Mixing categories have upward trends compared to the Pure Indonesian variety. This present research has shed a light that Indonesian Millennial Muslim parents want to pertain their children's identity as Muslims and want their children to be part of the global world.

Short term outcome after left atrial appendage occlusion with the AMPLATZER Amulet and WATCHMAN device: results from the ORIGINAL registry (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure)

BackgroundVarious randomized multicenter studies have shown that percutaneous left atrial appendage closure (LAAC) is not inferior in stroke prevention compared to vitamin K antagonists (VKA) and can be performed safely and effectively.AimsThe prospective multicenter ORIGINAL registry in the Free State of Saxony (saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure) investigated the efficiency and safety of LAAC with Watchman or Amulet device in a real word setting. A special focus was put on the influence of LAAC frequency on periprocedural efficiency and safety.Methods and resultsThe total of 482 consecutive patients (Abbott Amulet N = 93 and Boston Scientific Watchman N = 389) were included in the periinterventional analyses. After 6 weeks, 353 patients completed the first follow-up including transoesophageal echocardiography (TEE) (73.2%). Successful LAAC could be performed in more than 94%. The complication rate does not significantly differ between device types (p = 0.92) according to Fischer test and comprised 2.2% in the Amulet and 2.3% in the Watchman group. The kind of device and the frequency of LAAC per study center had no influence on the success and complication rates. Device related thrombus could be revealed more frequently in the Watchman group (4.5%) than in the Amulet group (1.4%) but this difference is still not significant in Fisher test (p = 0.14). Same conclusion can be made about residual leakage 1.1% versus 0% [not significant in Fisher test (p = 0.26)]. Dual antiplatelet therapy followed the intervention in 64% and 22% of patients were discharged under a combination of an anticoagulant (VKA/DOAC/Heparin) and one antiplatelet agent.ConclusionsThe ORIGINAL registry supports the thesis from large, randomized trials that LAAC can be performed with a very high procedural success rate in the everyday clinical routine irrespective of the used LAA device (Watchman or Amulet). The postprocedural antithrombotic strategy differs widely among the participating centers.Trial registration Name of the registry: "saxOnian RegIstry analyzinG and followINg left atrial Appendage cLosure", Trial registration number: DRKS00023803; Date of registration: 15/12/2020 'Retrospectively registered'; URL of trial registry record: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00023803.

The Influence of Depressive Mood on Mortality in Elderly with Different Health Status: Evidence from the Taiwan Longitudinal Study on Aging (TLSA).

Depression and related syndromes are well identified in older adults. Depression has been reported to increase the incidence of a multitude of somatic disorders. In older adults, the severity of depression is associated with higher mortality rates. The aim of the study is to examine whether the effect of depression screening on mortality is different between individuals with different physical health status. In order to meet this aim, we will first reprove the relationship between depression and mortality rate, and then we will set a subgroup analysis by using self-reported health (SRH) status. Our data source, Taiwan Longitudinal Study on Aging (TLSA), is a population-based prospective cohort study that was initiated by the Health Promotion Administration, Ministry of Health and Welfare, Taiwan. The depression risk was evaluated by 10-items Center for Epidemiologic Studies Depression (CES-D-10), we set 3 CES-D-10 cutting points (5, 10, and 12) and cut our subjects into four groups. Taking mortality as an end point, we use the Taiwan National Death Registry (TNDR) record from 1999 to 2012. Self-rated health (SRH) was taken as an effect modifier between depression and mortality in the elderly group, and stratification took place into three groups (good, fair, poor). The case numbers of 4 CES-D-10 groups were 2253, 939, 285 and 522, respectively. After dividing into 4 CES-D-10 groups, the mortality prevalence rose as the CES-D-10 level grew (40.7%, 47.82%, 54.39% and 67.62%, respectively). In the subgroup analysis, although the p-value of log-rank test showed <0.05 in three groups, as the SRH got worse the Hazard Ratio became more significant (p = 0.122, 0.033, <0.001, respectively). Kaplan–Meier (K-M) survival estimates for different CES-D groups in SRH were poor, and we can see the curves representing second and third CES-D group going almost together, which may suggest the cutting point of CES-D-10 in predicting depression risk should be adjusted in the relatively unhealthy elderly. The importance of the relationship between depression and mortality is re-emphasized in our study. Moreover, through joining SRH in our analysis, we can conclude that in self-rated poor health any sign of depression may lead to a rise in mortality. Therefore, we should pay attention to the old age group’s psychological status, and remember that depressive mood should be scrutinized more carefully in the elderly who feel themselves to be unhealthy.

Pouch volvulus-why adhesions are not always the enemy.

Minimally invasive approaches to proctocolectomy with ileal pouch anal anastomosis have become the standard of care with one benefit being the reduced risk of adhesion-related complications. However, a lack of pouch adherence to the pelvis can lead to increased mobility as well as volvulization, placing pouch viability at risk. We aimed to describe our institutional experience with pouch volvulus. Patients who presented with pouch volvulus from 1983 to 2020 were identified through a search of our pelvic pouch registry and enterprise-wide electronic medical record. Pouch volvulus was defined as a reducible rotation of the J-pouch on its mesenteric axis with evidence of a properly oriented ileo-anal anastomosis. Patients with 'twisted pouches' were excluded. In total, 5760 patients underwent ileal pouch anal anastomosis from 1983 to 2020. Six patients (five women) were identified with a diagnosis of 'pouch volvulus' consistent with our definition. The six pouches were constructed utilizing laparoscopic techniques and the mean time from construction to volvulus was 2.36 years. All patients underwent urgent surgery, with a paucity of adhesions noted in five. Reduction and pouch pexy was performed in three and pouch excision in three, with immediate pouch reconstruction in two and end ileostomy creation in one. At a median follow-up of 9months, pouch survival was 50%. Pelvic pouches constructed using minimally invasive techniques may be at risk of volvulus due to reduced adhesion development. A high index of suspicion is warranted in pouch patients with obstructive symptomatology. CT imaging may be diagnostic, and prompt surgical intervention may facilitate pouch salvage.

A case-control study of healthcare disparities in sex and gender minority patients with breast cancer.

6517 Background: Disparities in the quality of diagnosis and treatment of breast cancer in sex and gender minority (SGM) populations are largely undefined. Only 24% of studies funded by the National Cancer Institute capture data on sexual orientation, while only 10% capture data on gender identity. To address this gap, the National Academies 2020 Report calls for adding sexual orientation and gender identity (SOGI) to ongoing data collection efforts. This case-control study matching SGM patients with breast cancer to cisgender heterosexual controls is the result of linking SOGI data to the Stanford University Healthcare (SHC) Oncoshare breast cancer database, which integrates data from the electronic medical record (EMR) and California Cancer Registry. Methods: An initial database query across the SHC EMR was performed for charts containing SOGI terms in patients with breast cancer seen in SHC Oncology. 686 charts were identified for manual review and after eliminating false positives, the sample was reduced to 92 SGM patients, who were then matched by year of diagnosis, age, stage, ER-status, and HER-2 status to cisgender heterosexual controls within Oncoshare. Additional data on demographics, diagnosis, treatment, and relapse were then manually abstracted from the EMR. Results: The SGM cohort was comprised of 80% lesbians, 13% bisexuals and 6% transgender men. The median age at diagnosis across both groups was 49. SGM patients were 72% white, 4% Asian, 12% Black or Latinx 6% other compared to 63% white, 24% Asian, 6% Black or Latinx, 6% other in the controls (p = 0.0006). Thirteen percent and 32% of SGM patients engaged in risky alcohol and illicit drug use respectively, compared to 3% and 6% of controls (p = 0.028; p &lt; 0.0001). Estrogen exposure risk factors including median age of menarche, first delivery, menopause, and use of exogenous estrogens were balanced between the two groups, but SGM patients had fewer children (median 0 vs 2, p &lt; 0.0001). There was a delay in time to diagnosis from symptom onset in SGM patients versus controls (median 64 days vs 37 days, p = 0.043). There was no difference in surgical approach, use of post-lumpectomy radiation, or use of neoadjuvant chemotherapy for stage III disease. However, SGM patients were less likely to undergo chest reconstruction (55% vs 82%, p = 0.0098) and if ER+, to complete ≥5 years of ER-directed therapy (53% vs 72%, p = 0.048). SGM patients used more alternative medicine (46% vs 29%, p = 0.033) and had a higher rate of documented refusal of recommended oncologic treatments (38% vs 21%, p = 0.0088). Correspondingly, SGM patients experienced a higher recurrence rate (31% vs 14%, p = 0.0124). Conclusions: To our knowledge, this is the first study to examine quality of diagnosis and treatment of breast cancer in SGM patients. Several novel potential healthcare disparities are identified, which should be further evaluated in population-based studies to inform interventions.

Development of an electronic health record registry to facilitate collection of Commission on Cancer (CoC) metrics for patients undergoing surgery for breast cancer.

1549 Background: Accurate and efficient data collection is a challenge for quality improvement initiatives and clinical research. We describe the development of a custom electronic health record (EHR) based registry to automatically extract structured Commission on Cancer (CoC) axillary surgery specific metrics from a custom synoptic note template included in the operative reports for breast cancer patients undergoing surgery. Methods: The “Smart” functionality of our enterprise-based EHR system was leveraged to create a custom Smart phrase to capture axillary surgery specific variables. A multidisciplinary team developed structured data elements correlating to each axillary surgery-specific variable. These data elements were then included in a note template for the operative report. Each variable could be aggregated and converted into a single flat database through the EHR’s reporting workbench and serve as a live, prospective registry for all users within the EHR. Results: The final axillary surgery-specific note template in a synoptic format allowed for efficient and easy entry and automatic collection of breast cancer specific metrics. From initial adoption in February 2021 through December 2021, there were 1,254 patients who underwent breast surgery with axillary surgery. The operative notes allowed for automatic capture of metrics from 60.5% (n = 759) of patients. Data capture improved from 37.6% in the initial adoption period of six months to 86.2% in the last five months. Capture rate in December 2021 was 98%. Conclusions: We were able to demonstrate successful implementation of provider driven structured data entry into EHR systems that permits automatic data capture. The end result is a custom synoptic note template and a real-time, prospective registry of breast cancer-specific CoC metrics that are robust enough to use for quality improvement initiatives and clinical research.

Evaluation of Inaccuracy Analysis of Returning Inpatient Medical Record Documents at “X” Hospital in Malang City

This study uses a qualitative method, the data collection is in the form of interview and observation techniques on medical record Assembling officers, registration officers, verification officers, distribution officers and nurses at RS "X" Malang City. Thus, the qualitative method in this study was used to find out what factors caused the inaccuracy in the time of providing and distributing medical record files to the assembling section in terms of input, process and output factors. The results showed that the causes of the delay in returning Medical Record Documents (DRM) included patients who registered in 2 polyclinics until no medical records were found, and a missfile where the medical record file was still in inpatient because the data had not been filled out completely by the doctor in charge of the patient and had not been completed and returned to the medical record installation section, so this will slow down in finding the medical record file.

Rationale and design of a prospective, multicenter, phase II clinical trial of safety and efficacy evaluation of long course neoadjuvant chemoradiotherapy plus tislelizumab followed by total mesorectal excision for locally advanced rectal cancer (NCRT-PD1-LARC trial)

BackgroundLong course radiotherapy plus neoadjuvant chemotherapy followed by resection (total mesorectal excision, TME) has accepted widespread recognized in the treatment of locally advanced rectal cancer (LARC). Tislelizumab, an anti-PD1 humanized IgG4 monoclonal antibody, has been demonstrated with clinical activity and is approved for treating recurrent/refractory classical Hodgkin lymphoma and locally advanced/metastatic urothelial carcinoma in China. However, the safety and efficacy of long course (neoadjuvant chemoradiotherapy, NCRT) plus tislelizumab followed by TME for LARC is still uncertain.MethodsThis NCRT-PD1-LARC trial will be a prospective, multicenter and phase II clinical trial designed to evaluate the safety and efficacy of LARC patients treated with long course NCRT plus tislelizumab followed by TME. This trial will consecutively enroll 50 stage II/III LARC patients (cT3N0M0 and cT1-3N1-2M0) with the tumor distal location ≤ 7 cm from anal verge at 7 centers in China. The enrolled patients will receive long course radiotherapy (50 Gy/25 f, 2 Gy/f, 5 days/week) and three 21-day cycles capecitabine (1000 mg/m2, bid, po, day1-14) plus three 21-day cycles tislelizumab (200 mg, iv.gtt, day8), followed by TME 6–8 weeks after the end of radiotherapy. The primary efficacy endpoint will be the pathological complete response (pCR) rate, which is defined as absence of viable tumor cells in the primary tumor and lymph nodes.DiscussionTo our knowledge, this trial is the first multicenter clinical trial in China to assess the safety and efficacy of NCRT plus anti-PD1 therapy followed by TME to treat patients with LARC. NCRT followed by TME was recognized as the most recommended treatment against LARC while could not be completely satisfied in clinic. This study expects to provide a solid basis and encouraging outcomes for this promising combination of radiotherapy, chemotherapy and immunotherapy in LARC.Trial registrationName of the registry: ClinicalTrials.gov. Trialregistration number: NCT04911517. Date of registration: 23 May 2021. URL oftrial registry record: https://www.clinicaltrials.gov/ct2/show/NCT04911517?id=BFH-NCRTPD&draw=2&rank=1.

PATTERN OF PSYCHIATRIC REFERRALS IN A TERTIARY CARE PUBLIC SECTOR HOSPITAL OF KARACHI

Objective: To observe the frequency and pattern of Psychiatric referrals by Emergency and In-patient Departments (IPD) of tertiary care public sector hospital of Karachi. Methodology: A comparative cross-sectional study was conducted in the referred cases of Emergency (ER) and In-patient Department (IPD) for Psychiatric consultation from December 2019 to May 2020. The available medical records and International Classification of Diseases (ICD-10) diagnostic criteria were used for assessment and the record register was maintained on regular basis for data collection. The Data was analyzed to compare the findings in both ER and IPD. Results: There was a total of 281 referrals recorded in the register during six months. Among those112 (39.9%) were made from ER while 169 (60.1%) were from IPD. Most of them were young (33.4±13.5 years) and were almost equally distributed in both genders [Male=141 (50.2%) and Female=140 (49.8%)]. Altered or disorganized behavior, 88 (31.3%) followed by unexplained somatic complaints, 36 (12.8%,) and past psychiatric history, 25 (8.9%) were the most frequent reason for a referral from IPD. Suicide and deliberate self-harm were more common in ER (12, 4.3%) than that in IPD (6, 2.1%). Conclusion: Overall the frequency of Psychiatric referrals was low in comparison to the patient population and most of those were from the inpatient department than the ER.

The Global Open Source Severity of Illness Score (GOSSIS).

To develop and demonstrate the feasibility of a Global Open Source Severity of Illness Score (GOSSIS)-1 for critical care patients, which generalizes across healthcare systems and countries. A merger of several critical care multicenter cohorts derived from registry and electronic health record data. Data were split into training (70%) and test (30%) sets, using each set exclusively for development and evaluation, respectively. Missing data were imputed when not available. Two large multicenter datasets from Australia and New Zealand (Australian and New Zealand Intensive Care Society Adult Patient Database [ANZICS-APD]) and the United States (eICU Collaborative Research Database [eICU-CRD]) representing 249,229 and 131,051 patients, respectively. ANZICS-APD and eICU-CRD contributed data from 162 and 204 hospitals, respectively. The cohort included all ICU admissions discharged in 2014-2015, excluding patients less than 16 years old, admissions less than 6 hours, and those with a previous ICU stay. Not applicable. GOSSIS-1 uses data collected during the ICU stay's first 24 hours, including extrema values for vital signs and laboratory results, admission diagnosis, the Glasgow Coma Scale, chronic comorbidities, and admission/demographic variables. The datasets showed significant variation in admission-related variables, case-mix, and average physiologic state. Despite this heterogeneity, test set discrimination of GOSSIS-1 was high (area under the receiver operator characteristic curve [AUROC], 0.918; 95% CI, 0.915-0.921) and calibration was excellent (standardized mortality ratio [SMR], 0.986; 95% CI, 0.966-1.005; Brier score, 0.050). Performance was held within ANZICS-APD (AUROC, 0.925; SMR, 0.982; Brier score, 0.047) and eICU-CRD (AUROC, 0.904; SMR, 0.992; Brier score, 0.055). Compared with GOSSIS-1, Acute Physiology and Chronic Health Evaluation (APACHE)-IIIj (ANZICS-APD) and APACHE-IVa (eICU-CRD), had worse discrimination with AUROCs of 0.904 and 0.869, and poorer calibration with SMRs of 0.594 and 0.770, and Brier scores of 0.059 and 0.063, respectively. GOSSIS-1 is a modern, free, open-source inhospital mortality prediction algorithm for critical care patients, achieving excellent discrimination and calibration across three countries.

Performance of the new SmartCardia wireless, wearable oximeter: a comparison with arterial SaO2 in healthy volunteers

BackgroundOur goal was to evaluate the performance of a new wearable arm located pulse oximeter.MethodsTwelve volunteers were monitored with three pulse oximeters and underwent desaturation to 70% SaO2.We compared the accuracy of SpO2 reading from the SmartCardia system with SpO2 using two well established devices (Masimo and Nellcor) as reference.Oximetry was performed at different level of oxygen saturation varying from 70 to 100%. Bias, ARMS and precision were evaluated using Bland-Altman plots.ResultsThe mean (SD) differences between SaO2 compared to SpO2 and the devices were as follows: SaO2 versus Masimo 2,12 ± 1,01% (95% CI 1,45 to 2,79), SaO2 versus Nellcor 0,78 ± 0,58% (95% CI − 0,29 to 1,65) and SaO2 versus SmartCardia 0,42 ± 0,24% (95% CI − 0,64 to 1,46). The bias between SmartCardia, Masimo, Nellcor devices and SaO2 was 0.16 (95% CI 0.05 to 0.33) and LoA (level of agreements) 2.96 (95% CI − 2,68 to 2,89) for SmartCardia, 2,02 (95% CI 1,49 to 2,54) and LoA − 6 to 11 for Masimo, and 0,76 (95% CI 0,5 to − 1) and LoA − 3,5 to 5,0 for Nellcor. ARMS for the 70–100% SaO2 range was 1,4 for SmartCardia, 5,0 for Masimo and 2,31 for Nellcor.ConclusionsThe new wireless SmartCardia SpO2 measurement system demonstrated in-line results, bias, ARMS and precision in healthy volunteers, when compared with the gold standard SaO2 and with two well established systems, Masimo and Nellcor.Trial registrationThe present trial was prospectively registered at UCSF record (registration number:10–00437), on March 8, 2021.

Demographic Characteristics of Spinal Cord Injury Patients Referred for Rehabilitation in Miri Hospital

Background and aim: Miri is the second-largest city in Sarawak, and Miri hospital is the main referral hospital in Northern Sarawak that serves other hospitals such as Bintulu, Marudi, Limbang and Lawas hospitals. The rehabilitation medicine service in Miri hospital started on 14th February 2019. This study aims to explore the demographic characteristics among the referrals for the spinal cord injury populations. Methods: This is a retrospective descriptive study among inpatient referrals to the rehabilitation department taken from the patient’s registry record from 15th February 2019 to 13th April 2021. The descriptive statistical analysis described the demographic characteristics of the spinal cord injury patients. Results: A total of 70 patients were analysed in the study. Non-traumatic spinal cord injury comprises 2/3 of the total cases, with 65% being of infective origin. Most (77.1%) of the patients were referred to rehabilitation within the first 2 weeks of admission, with the average days from admission to the referral of 10 ± 10 days. The duration for co-management of the rehabilitation team with the primary team during inpatient stay was short, with an average of 6 ± 8 days. Rehabilitation management for most of the patients (67.1%) had to be carried out within a week of admission, whereas another 24.3% of the patients were given additional stay up to 2 weeks. From the functional aspect, the mean SCIM scored 29 ± 14, and the mean MBI scored 30 ± 20, indicating a high dependency level among the patients. Conclusion: Due to bed limitations in the hospital setting, the spinal cord injury patients at the high level of dependency were given early supported discharge plans. Identifying the demographic characteristics of the spinal cord population in Miri enables the ongoing development of spinal cord rehabilitation service that meets the need of the local population.

Association Between First-Trimester Maternal Cytomegalovirus Infection and Stillbirth: A Prospective Cohort Study.

BackgroundGiven that the time lag between cytomegalovirus (CMV) screening and diagnosed testing, a better knowledge of the association between pregnant women with CMV screening test positive and stillbirth in an epidemiological perspective was required to assist people being counseled reframe their pregnancy and birth plans based on the magnitude of the risk.MethodsThis study recruited 44048 eligible pregnant women from March 13, 2013 to December 31, 2019. Serological tests including CMV-specific IgM and IgG, and IgG avidity index were used to screen for maternal CMV infection and were measured by automated chemiluminescence immunoassay. The association was assessed using the inverse probability of group-weighted multivariate-adjusted log-binomial models.ResultsA total of 540 infants ended with a stillbirth (12.3 per 1000 pregnancies), and 2472 pregnancies with maternal CMV infection were screened out (56.1 per 1000 pregnancies) among all eligible pregnancies. In the comparison analysis, 326 infants ended with a stillbirth (86.6 per 1000 pregnancies) in the maternal CMV infection group compared with 214 infants (7.8 per 1000 pregnancies) in the group where mothers were not infected with CMV (RR 12.17; 95% CI 9.43–15.71). After excluding the pregnancies of stillbirth with birth defects, a strong association between the two groups was still observed (RR 9.38; 95% CI 6.92–12.70).ConclusionOur findings quantified the risk of a woman having a baby with stillbirth if she had a positive serologic CMV screening test in her first trimester, and supported the value of using CMV serologic tests as part of regular testing in pregnant women.Trial registrationRegistered in Chinese Clinical Trial Registry Center; registration number, ChiCTR1800016635; registration date, 06/14/2018 (Retrospectively registered); URL of trial registry record, https://www.chictr.org.cn/showproj.aspx?proj=28300.