bluuebunny/crossref_metadata_2025_split huggingface dataset:
Trends in healthcare utilisation of patients with migraine in South Korea: a retrospective observational study using Health Insurance Review and Assessment Service National Patient Sample data from 2010 to 2018
Authors: Lee Sookyung , Yeo Jiyoon , Lee Sook-Hyun , Lee Yoon Jae , Lee Sangkwan , Ha In-Hyuk 
Published: March 2023

ObjectiveThis study used 2010–2018 Health Insurance Review and Assessment Service National Patient Sample data to analyse the distribution and healthcare utilisation of patients with migraine in South Korea.DesignRetrospective, observational study using serial cross-sectional data.ParticipantsPatients with primary diagnosis of G43, a Korean Standard Classification of Diseases-10 code for migraine, were included in the analysis. The exclusion criteria were missing code information; code for dental, health centre or psychiatry; institution type specified as nursing hospital, psychiatric hospital, dental hospital, midwifery centre or health centre; blank entries for total cost or days of care. 453 246 records of patients and 117 157 patients corresponding to those records were identified.Outcome measuresPrimary outcome measures were medical service utilisation status, treatment methods and drug use status associated with migraine.ResultsCases and patients of migraine increased from 48 846 and 19 468 (2010) to 52 729 and 20 802 (2018), respectively, increases of 7.95% and 6.85%, respectively, compared with 2010. Total cost of care increased from $921 857.88 (2010) to $1 711 219.60 (2018). The most common age range of patients was 45–54 years, with 2.69 times more female than male patients. In Western medicine hospitals, subcutaneous or intramuscular injection therapy was used frequently, while in Korean medicine hospitals, acupuncture therapy was used. Among Western medicine outpatients, more than 50% of the therapeutics prescribed for acute migraine were simple analgesics or non-steroidal anti-inflammatory drugs. The number of prescriptions for the prevention of episodic migraine increased from 13 600 cases (2010) to 20 546 cases (2018), representing the steepest increase in drug utilisation.ConclusionsTreatments frequently used in Western and Korean medicine hospitals and their frequency of use and costs were identified. The findings of this study can be used as a basis for relevant health policy decisions.
Recording type 2 diabetes mellitus in a standardised central Saudi database: a retrospective validation study
Authors: Althunian Turki Abdulaziz , Alrasheed Meshael M , Alnofal Fatemah A , Tafish Rawan T , Mira Mahmood A , Alroba Raseel A , Kirdas Mohammed W , Alshammari Thamir M 
Published: March 2023

ObjectivesThis study was conducted to assess the validity of recording (and the original diagnostic practice) of type 2 diabetes mellitus at a hospital whose records were integrated to a centralised database (the standardised common data model (CDM) of the Saudi National Pharmacoepidemiologic Database (NPED)).DesignA retrospective single-centre validation study.SettingsData of the study participants were extracted from the CDM of the NPED (only records of one tertiary care hospital were integrated at the time of the study) between 1 January 2013 and 1 July 2018.ParticipantsA random sample of patients with type 2 diabetes mellitus (≥18 years old and with a code of type 2 diabetes mellitus) matched with a control group (patients without diabetes) based on age and sex.Outcome measuresThe standardised coding of type 2 diabetes in the CDM was validated by comparing the presence of diabetes in the CDM versus the original electronic records at the hospital, the recording in paper-based medical records, and the physician re-assessment of diabetes in the included cases and controls, respectively. Sensitivity, specificity, positive predictive value and negative predictive value were estimated for each pairwise comparison using RStudio V.1.4.1103.ResultsA total of 437 random sample of patients with type 2 diabetes mellitus was identified and matched with 437 controls. Only 190 of 437 (43.0%) had paper-based medical records. All estimates were above 90% except for sensitivity and specificity of CDM versus paper-based records (54%; 95% CI 47% to 61% and 68%; 95% CI 62% to 73%, respectively).ConclusionsThis study provided an assessment to the extent of which only type 2 diabetes mellitus code can be used to identify patients with this disease at a Saudi centralised database. A future multi-centre study would help adding more emphasis to the study findings.
Clinical–functional characteristics and risk of exacerbation and mortality among more symptomatic patients with chronic obstructive pulmonary disease: a retrospective cohort study
Authors: Song Qing , Lin Ling , Cheng Wei , Li Xue-Shan , Zeng Yu-Qin , Liu Cong , Deng Min-Hua , Liu Dan , Yu Zhi-Ping , Li Xin , Ma Li-Bing , Chen Yan , Cai Shan , Chen Ping 
Published: March 2023

ObjectivesThe Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 classified chronic obstructive pulmonary disease (COPD) patients into more and less symptomatic groups. This study aimed to analyze the clinical characteristics, risk of future exacerbation and mortality among patients in more symptomatic group.DesignA retrospective cohort study.SettingData were obtained from patients enrolled in a database setup by Second Xiangya Hospital of Central South University.Participants1729 stable COPD patients listed from September 2017 to December 2019 in the database. The patients were classified into more and less symptomatic groups based on GOLD 2017 report.OutcomesAll patients were followed up for 18 months. We collected baseline data and recorded the number of exacerbations and mortality during follow-up.ResultsThe more symptomatic patients were older, had higher Clinical COPD Questionnaire (CCQ) scores, more severe airflow limitation and higher number of exacerbations and hospitalizations in the past year (P< 0.05). Logistic regression showed that having more symptoms correlated with the CCQ scores and exacerbations in the past year (P< 0.05). After patients were followed up, there were higher numbers of exacerbations, hospitalizations and mortality rates in more symptomatic patients (P< 0.05). The multivariate model showed that age more than 65 years (OR = 2.047, 95% CI = 1.020-4.107) and COPD assessment test scores more than 30 (OR = 2.609, 95% CI = 1.339-5.085) were independent risk factors for mortality, whereas current smoker (OR = 1.565, 95% CI = 1.052-2.328), modified Medical Research Council scores (OR = 1.274, 95% CI = 1.073-1.512) and exacerbations in the past year (OR = 1.061, 95% CI = 1.013-1.112) were independent risk factors for exacerbation in more symptomatic patients (P< 0.05).ConclusionsMore symptomatic COPD patients have worse outcomes. In addition, several independent risk factors for exacerbation and mortality were identified. Therefore, clinicians should be aware of these risk factors and take them into account during interventions.
Budget impact analysis of a home-based colorectal cancer screening programme in Malaysia
Authors: Ngan Tran Thu , Ramanathan Kogila , Saleh Muhamad Raziq Bin Mohd , Schliemann Desiree , Ibrahim Tamin Nor Saleha Binti , Su Tin Tin , Donnelly Michael , O'Neill Ciaran 
Published: March 2023

ObjectivesThe 2020–2022 research project ‘Colorectal Cancer Screening Intervention for Malaysia’ (CRC-SIM) evaluated the implementation of a home-based CRC screening pilot in Segamat District. This budget impact analysis (BIA) assessed the expected changes in health expenditure of the Malaysian Ministry of Health budget in the scenario where the pilot programme was implemented nationwide vs current opportunistic screening.DesignBudget impact analysis. Assumptions and costs in the opportunistic and novel CRC screening scenarios were derived from a previous evaluation of opportunistic CRC screening in community health clinics across Malaysia and the CRC-SIM research project, respectively.SettingNational level (with supplement analysis for district level). The BIA was conducted from the viewpoint of the federal government and estimated the annual financial impact over a period of 5 years.ResultsThe total annual cost of the current practice of opportunistic screening was RM1 584 321 (~I$1 099 460) of which 80% (RM1 274 690 or ~I$884 587) was expended on the provision of opportunistic CRC to adults who availed of the service. Regarding the implementation of national CRC screening programme, the net budget impact in the first year was estimated to be RM107 631 959 (~I$74 692 546) and to reach RM148 485 812 (~I$103 043 589) in the fifth year based on an assumed increased uptake of 5% annually. The costs were calculated to be sensitive to the probability of adults who were contactable, eligible and agreeable to participating in the programme.ConclusionsResults from the BIA provided direct and explicit estimates of the budget changes to when implementing a population-based national CRC screening programme to aid decision making by health services planners and commissioners in Malaysia about whether such programme is affordable within given their budget constraint. The study also illustrates the use and value of the BIA approach in low-income and middle-income countries and resource-constrained settings.
Prevalence of taste and smell dysfunction in mild and asymptomatic COVID-19 patients during Omicron prevalent period in Shanghai, China: a cross-sectional survey study
Authors: Wang Jia , Chen Yan , Huang Jing , Niu Chenguang , Zhang Pengfei , Yuan Keyong , Zhu Xiaohan , Jin Qiaoqiao , Ran Shujun , Huang Zhengwei 
Published: March 2023

ObjectivesCOVID-19, which is caused by SARS-CoV-2, is a severe threat to human health and the economy globally. This study aimed to investigate the prevalence of taste and/or smell dysfunction and associated risk factors in mild and asymptomatic patients with Omicron infection in Shanghai, China.DesignThis was a questionnaire-based cross-sectional study.SettingCOVID-19 patients at the makeshift hospital in the Shanghai World Expo Exhibition and Convention Centre were recruited from March to April 2022.ParticipantsIn total, 686 COVID-19-infected patients who were defined as mild or asymptomatic cases according to the diagnostic criteria of New Coronavirus Pneumonia Prevention and Control Programme ninth edition (National Health Commission of China, 2022) were enrolled.MeasuresData to investigate taste and smell loss and to characterise other symptoms were collected by the modified Chemotherapy-induced Taste Alteration Scale and Sino-Nasal Outcome Test-22 questionnaires. The risk factors for the severity of taste/smell dysfunction were analysed by binary logistic regression models.Results379 males (379/686, 55.2%) and 307 females (307/686, 44.8%) completed the questionnaires to record recent changes in taste and smell ability. A total of 302 patients (44%) had chemosensory dysfunction with Omicron infection, of which 22.7% (156/686) suffered from both taste and smell dysfunction. In addition, cough (60.2%), expectoration (40.5%), fever (33.2%) and sore throat (32.5%) were common symptoms during Omicron infection. The quality-of-life-related indicators were negatively associated with participants’ self-reported taste and smell dysfunction.ConclusionsThe prevalence of taste or/and smell dysfunction in patients with Omicron infections was 44%. Individuals with chemosensory dysfunction had significantly higher rates of various upper respiratory influenza-like symptoms, xerostomia and bad breath. Moreover, smell dysfunction was a risk factor for the prevalence of taste dysfunction in patients with Omicron infection.Trial registration numberChiCTR 2200059097.
Protocol for the development of a core outcome set for studies on centralisation of healthcare services
Authors: Pfisterer-Heise Stefanie , Scharfe Julia , Kugler Charlotte Mareike , Shehu Eni , Wolf Tobias , Mathes Tim , Pieper Dawid 
Published: March 2023

IntroductionCentralisation defined as the reorganisation of healthcare services into fewer specialised units serving a higher volume of patients is a potential measure for healthcare reforms aiming at reducing costs while improving quality. Research on centralisation of healthcare services is thus essential to inform decision-makers. However, so far studies on centralisation report a variability of outcomes, often neglecting outcomes at the health system level. Therefore, this study aims at developing a core outcome set (COS) for studies on centralisation of hospital procedures, which is intended for use in observational as well as in experimental studies.Methods and analysisWe propose a five-stage study design: (1) systematic review, (2) focus group, (3) interview studies, (4) online survey, (5) Delphi survey. The study will be conducted from March 2022 to November 2023. First, an initial list of outcomes will be identified through a systematic review on reported outcomes in studies on minimum volume regulations. We will search MEDLINE, EMBASE, CENTRAL, CINHAL, EconLIT, PDQ-Evidence for Informed Health Policymaking, Health Systems Evidence, Open Grey and also trial registries. This will be supplemented with relevant outcomes from published studies on centralisation of hospital procedures. Second, we will conduct a focus group with representatives of patient advocacy groups for which minimum volume regulations are currently in effect in Germany or are likely to come into effect to identify outcomes important to patients. Furthermore, two interview studies, one with representatives of the German medical societies and one with representatives of statutory health insurance funds, as well as an online survey with health services researchers will be conducted. In our analyses of the suggested outcomes, we will largely follow the categorisation scheme developed by the Cochrane EPOC group. Finally, a two-round online Delphi survey with all stakeholder groups using predefined score criteria for consensus will be employed to first prioritise outcomes and then agree on the final COS.Ethics and disseminationThis study has been approved by the Research Ethics Committee at the Brandenburg Medical School Theodor Fontane (MHB). The final COS will be disseminated to all stakeholders involved and through peer-reviewed publications and conferences.
Public reporting of clinical trial findings as an ethical responsibility to participants: a qualitative study
Authors: Morrow Richard L , Mintzes Barbara , Gray Garry , Law Michael R , Garrison Scott , Dormuth Colin R 
Published: March 2023

ObjectiveTo understand how the experiences and views of trial participants, trial investigators and others connected to clinical trial research relate to whether researchers have a duty to participants to publicly report research findings.DesignQualitative interview study.SettingSemistructured interviews held in person or by telephone between March 2019 and April 2021 with participants in the Canadian provinces of Alberta, British Columbia and Ontario.Participants34 participants, including 10 clinical trial participants, 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators and 3 research ethics board members.AnalysisWe conducted a thematic analysis, including qualitative coding of interview transcripts and identification of key themes.Main outcome measuresKey themes identified through qualitative coding of interview data.ResultsMost clinical trial participants felt that reporting clinical trial results is important. Accounts of trial participants suggest their contributions are part of a reciprocal relationship involving the expectation that research will advance medical knowledge. Similarly, comments from trial investigators suggest that reporting trial results is part of reciprocity with trial participants and is a necessary part of honouring informed consent. Accounts of trial investigators suggest that when drug trials are not reported, this may undermine informed consent in subsequent trials by withholding information on harms or efficacy relevant to informed decisions on whether to conduct or enroll in future trials of similar drugs.ConclusionThe views of trial participants, trial investigators and others connected to clinical trial research in Canada suggest that researchers have an obligation to participants to publicly report clinical trial results and that reporting results is necessary for honouring informed consent.
Efficacy of indocyanine green systemic administration for bile leak detection after hepatectomy: a protocol for a prospective single-arm clinical trial with a historical control group
Authors: Hanaki Takehiko , Goto Keisuke , Tokuyasu Naruo , Endo Yusuke , Sunada Hiroshi , Noma Hisashi , Sunaguchi Teppei , Murakami Yuki , Matsunaga Tomoyuki , Yamamoto Manabu , Sakamoto Teruhisa , Hasegawa Toshimichi , Fujiwara Yoshiyuki 
Published: March 2023

IntroductionBile leakage (BL) after hepatectomy cannot always be detected with conventional methods; moreover, BL cannot be completely prevented. Recently, navigation procedures with indocyanine green (ICG) have been reported. Furthermore, we previously reported the possibility of detecting BLs with high sensitivity during hepatectomy by administering ICG into the bloodstream, which is quickly excreted in the bile. This study aims to verify whether detecting and addressing ICG leakage from the hepatic dissection plane using an ICG camera can reduce the bilirubin concentration in the drainage fluid, and consequently, the incidence of BL.Methods and analysisThis prospective single-centre non-randomised single-arm trial will be conducted with historical controls. Overall, 85 patients will be enrolled, including 40 and 45 in the ICG and historical control groups, respectively. In the ICG group, 10 mg/2 mL of ICG will be transvenously or transportally administered during liver surgery. After its uptake by liver cells and excretion into bile, it will be visualised using a camera following the completion of hepatectomy, and the site of ICG leakage will be sutured. Moreover, we will record the number of bile leak spots detected by the naked eye and ICG camera. The primary endpoint of the study will be the total bilirubin concentration in the drain fluid on postoperative day 3, and we will determine whether the concentration differs significantly between the ICG and historical control groups. The results of our study will be used to suggest whether intraoperative ICG administration and evaluation at the hepatic dissection plane can be widely used in liver surgery for more reliable detection of BL and consequent reduction of biliary fistula.Ethics and disseminationThe protocol was approved by the Certified Review Board of Tottori University Hospital (approval number: 21C002). Findings from this trial will be published in peer-reviewed journals and presented at academic conferences.Trial registration numberjRCTs061210043.
Patients’ perceptions of self-administered dosing to opioid agonist treatment and other changes during the COVID-19 pandemic: a qualitative study
Authors: Scott Gemma , Turner Sophie , Lowry Natalie , Hodge Annette , Ashraf Waniya , McClean Katie , Kelleher Mike , Mitcheson Luke , Marsden John 
Published: March 2023

ObjectivesDuring the COVID-19 pandemic, addiction treatment services received official guidance asking them to limit face-to-face contact with patients and to prescribe opioid agonist treatment (OAT) medication flexibly. With the aim for most patients to receive take-home supplies for self-administration rather than attendance for observed daily dosing.DesignThis was a theory-driven, clinically applied qualitative study, with data for thematic analysis collected by semi-structured, audio-recorded, telephone interviews.ParticipantsTwenty-seven adults (aged ≥18 years) enrolled in sublingual (tablet) buprenorphine and oral (liquid) methadone OAT.SettingCommunity addictions centre in the London Borough of Lambeth operated by South London and Maudsley NHS Trust.ResultsThree major themes were identified: (1) dissatisfaction and perceived stigma with OAT medication dispensing arrangements before the pandemic; (2) positive adaptations in response to COVID-19 by services; (3) participants recommended that, according to preference and evidence of adherence, OAT should be personalised to offer increasing medication supplies for self-administration from as early as 7 days after commencement of maintenance prescribing.ConclusionsIn an applied qualitative study of patients enrolled in OAT during the COVID-19 pandemic, participants endorsed their opportunity to take medication themselves at home and with virtual addiction support. Most patients described a preference for self-administration with increased dispensing supplies, from as early as 7 days into maintenance treatment, if they could demonstrate adherence to their prescription.
Volunteer responder provision of support to relatives of out-of-hospital cardiac arrest patients: a qualitative study
Authors: Kragh Astrid Rolin , Grabmayr Anne Juul , Tjørnhøj-Thomsen Tine , Zinckernagel Line , Gregers Mads Christian Tofte , Andelius Linn Charlotte , Christensen Anders Korsgaard , Kjærgaard Jesper , Folke Fredrik , Malta Hansen Carolina 
Published: March 2023

ObjectivesSmartphone dispatch of volunteer responders for out-of-hospital cardiac arrest (OHCA) is implemented worldwide. While basic life support courses prepare participants to provide CPR, the courses rarely address the possibility of meeting a family member or relative in crisis. This study aimed to examine volunteer responders’ provision of support to relatives of cardiac arrest patients and how relatives experienced the interaction with volunteer responders.DesignIn this qualitative study, we conducted 16 semistructured interviews with volunteer responders and relatives of cardiac arrest patients.SettingInterviews were conducted face to face and by video and recorded and transcribed verbatim.ParticipantsVolunteer responders dispatched to cardiac arrests and relatives of cardiac arrest patients were included in the study. Participants were included from all five regions of Denmark.ResultsA thematic analysis was performed with inspiration from Braun and Clarke. We identified three themes: (1) relatives’ experiences of immediate relief at arrival of assistance, (2) volunteer responders’ assessment of relatives’ needs and (3) the advantage of being healthcare educated.ConclusionsRelatives to out-of-hospital cardiac arrest patients benefited from volunteer responders’ presence and support and experienced the mere presence of volunteer responders as supportive. Healthcare-educated volunteer responders felt confident and skilled to provide care for relatives, while some non-healthcare-educated volunteer responders felt they lacked the proper training and knowledge to provide emotional support for relatives. Future basic life support courses should include a lesson on how to provide emotional support to relatives of cardiac arrest patients.