bluuebunny/crossref_metadata_2025_split huggingface dataset:
Patients’ perspectives on tapering programmes for prescription opioid use disorder: a qualitative study
Authors: Davies Lisa Eveline Maria , Koster Ellen S , Damen Katinka FM , Beurmanjer Harmen , van Dam Vivienne WT , Bouvy Marcel L , Schellekens Arnt FA 
Published: December 2023

ObjectivesApproximately 10% of chronic pain patients who receive opioids develop an opioid use disorder (OUD). Tapering programmes for these patients show high drop-out rates. Insight into chronic pain patients’ experiences with tapering programmes for prescription OUD could help improve such programmes. Therefore, we investigated the perspectives of chronic pain patients with prescription OUD to identify facilitators and barriers to initiate and complete a specialised OUD tapering programme.DesignA qualitative study using semi-structured interviews on experiences with initiation and completion of opioid tapering was audio recorded, transcribed and subject to directed content analysis.SettingThis study was conducted in two facilities with specialised opioid tapering programmes in the Netherlands.ParticipantsTwenty-five adults with chronic pain undergoing treatment for prescription OUD participated.ResultsParticipants indicated that tapering is a personal process, where willingness and motivation to taper, perceived (medical) support and pain coping strategies have an impact on the tapering outcome. The opportunity to join a medical-assisted tapering programme, shared decision-making regarding tapering pace, tapering location, and receiving medical and psychological support facilitated completion of an opioid tapering programme.ConclusionsAccording to patients, a successful treatment of prescription OUD requires a patient-centred approach that combines personal treatment goals with shared decision-making on opioid tapering. Referral to a specialised tapering programme that incorporates opioid rotation, non-judgmental attitudes, and psychological support can create a safe and supportive environment, fostering successful tapering and recovery.
Methodological guidelines and publications of benefit–risk assessment for health technology assessment: a scoping review protocol
Authors: De Oliveira Ascef Bruna , Gabriel Franciele Cordeiro , Suzumura Erica Aranha , Maia Fernando Henrique de Albuquerque , Bortoluzzi Aline Frossard Ribeiro , Farias Natalia Santos , Jahn Beate , Siebert Uwe , De Soarez Patricia Coelho 
Published: December 2023

BackgroundBenefit–risk assessment (BRA) is used in multiple phases along the health technology’s life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA’s application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.Methods and analysisThis scoping review protocol was developed following the framework proposed by Arksey and O’Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.Ethics and disseminationThis review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.Trial registration numberOpen Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).
Pharmacological and non-pharmacological interventions to prevent delirium after cardiac surgery: a protocol for a systematic review and meta-analysis
Authors: Cottuli de Cothi Elizabeth , Perry Rachel , Kota Rahul , Walker-Smith Terrie , Barnes Jonathan David , Pufulete Maria , Gibbison Ben 
Published: December 2023

IntroductionDelirium is a syndrome characterised by a disturbance in attention, awareness and cognition as a result of another physical condition. It occurs in up to 50% of patients after cardiac surgery and is associated with increased mortality, prolonged intensive care and hospital stay and long-term cognitive dysfunction. Identifying effective preventive interventions is important. We will therefore conduct a systematic review to identify all randomised controlled studies that have tested a pharmacological or non-pharmacological intervention to prevent delirium.Methods and analysisWe will search electronic databases (CDSR (Reviews), CENTRAL (Trials), MEDLINE Ovid, Embase Ovid, PsycINFO Ovid) as well as trial registers (clinicaltrials.gov and ISCRTN) for randomised controlled trials of both pharmacological and non-pharmacological interventions designed to prevent delirium after cardiac surgery in adults. Screening of search results and data extraction from included articles will be performed by two independent reviewers using Rayyan. The primary outcome will be the incidence of delirium. Secondary outcomes include: duration of postoperative delirium, all-cause mortality, length of postoperative hospital and intensive care stay, postoperative neurological complications other than delirium, health-related quality of life and intervention-specific adverse events. Studies will be assessed for risk of bias using the Cochrane RoB2 tool. A narrative synthesis of all included studies will be presented and meta-analysis (if appropriate network meta-analysis) will be undertaken where there are sufficient studies (three or more) for pooling results. Results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.Ethics and disseminationNo ethical approval is required. This review will be disseminated via peer-reviewed manuscript and conferences.PROSPERO registration numberCRD42022369068.
Acceptance of the Advocacy Core Group approach in promoting integrated social and behaviour change for MNCH+N in Nigeria: a qualitative study
Authors: Adetunji Adetayo , Adediran Mayokun , Etim Eno-Obong E , Bazzano Alessandra N 
Published: December 2023

ObjectiveThis paper examines the acceptance of the Advocacy Core Group (ACG) programme, a social and behaviour change intervention addressing maternal, newborn, child health and nutrition (MNCH+N) in Bauchi and Sokoto states, with an additional focus on the perceived endorsement of health behaviours by social networks as a potential factor influencing acceptance.DesignThis study used the qualitative social network analysis approach and used in-depth interviews to collect data from 36 participants across Bauchi and Sokoto states.SettingThis study was conducted in selected communities across Bauchi and Sokoto states.ParticipantsA purposive sample of 36 participants comprised of men and women aged 15–49 years who have been exposed to the ACG programme.ResultsProgramme beneficiaries actively engaged in various ACG-related activities, including health messaging delivered through religious houses, social gatherings, home visits, community meetings and the media. As a result, they reported a perceived change in behaviour regarding exclusive breast feeding, antenatal care visits, family planning and malaria prevention. Our findings indicated consistent discussions on health behaviours between programme beneficiaries and their network partners (NPs), with a perceived endorsement of these behaviours by the NPs. However, a potential negative factor emerged, whereby NPs exhibited perceived disapproval of key behaviours, which poses a threat to behaviour adoption and, consequently, the success of the ACG model.ConclusionsWhile findings suggest the successful implementation and acceptance of the model, it is important to address possible barriers and to further explore the socially determined acceptance of MNCH+N behaviours by NPs. Interventions such as the ACG model should mobilise the networks of programme participants, particularly those with decision-making power, to improve the uptake of health behaviours.
Measuring supply-side service disruption: a systematic review of the methods for measuring disruption in the context of maternal and newborn health services in low and middle-income settings
Authors: McGowan Catherine R , Gokulakrishnan Dhikshitha , Monaghan Emily , Abdelmagid Nada , Romig Laura , Gallagher Meghan C , Meyers Janet , Cummings Rachael , Cardinal Laura J 
Published: December 2023

ObjectivesDuring the COVID-19 pandemic, most essential services experienced some level of disruption. Disruption in LMICs was more severe than in HICs. Early reports suggested that services for maternal and newborn health were disproportionately affected, raising concerns about health equity. Most disruption indicators measure demand-side disruption, or they conflate demand-side and supply-side disruption. There is currently no published guidance on measuring supply-side disruption. The primary objective of this review was to identify methods and approaches used to measure supply-side service disruptions to maternal and newborn health services in the context of COVID-19.DesignWe carried out a systematic review and have created a typology of measurement methods and approaches using narrative synthesis.Data sourcesWe searched MEDLINE, EMBASE and Global Health in January 2023. We also searched the grey literature.Eligibility criteriaWe included empirical studies describing the measurement of supply-side service disruption of maternal and newborn health services in LMICs in the context of COVID-19.Data extraction and synthesisWe extracted the aim, method(s), setting, and study outcome(s) from included studies. We synthesised findings by type of measure (ie, provision or quality of services) and methodological approach (ie, qualitative or quantitative).ResultsWe identified 28 studies describing 5 approaches to measuring supply-side disruption: (1) cross-sectional surveys of the nature and experience of supply-side disruption, (2) surveys to measure temporal changes in service provision or quality, (3) surveys to create composite disruption scores, (4) surveys of service users to measure receipt of services, and (5) clinical observation of the provision and quality of services.ConclusionOur review identified methods and approaches for measuring supply-side service disruption of maternal and newborn health services. These indicators provide important information about the causes and extent of supply-side disruption and provide a useful starting point for developing specific guidance on the measurement of service disruption in LMICs.
Potential drug–drug interaction and its determinants among patients with cancer receiving chemotherapy in oncology centres of Northwest Ethiopia: an institutional-based cross-sectional study
Authors: Wondm Samuel Agegnew , Tamene Fasil Bayafers , Gubae Kale , Dagnew Samuel Berihun , Worku Asres Agegnehu , Belachew Eyayaw Ashete 
Published: December 2023

ObjectiveThe study was conducted to assess potential drug–drug interactions (PDDIs) and its determinants among patients with cancer receiving chemotherapy.Design and settingAn institutional-based cross-sectional study was used. This study was conducted from 1 June 2021 to 15 December 2021, in Northwest Ethiopia oncology centres.ParticipantsAll eligible patients with cancer received a combination of chemotherapy.OutcomesThe prevalence and severity of PDDIs were evaluated using three drug interaction databases. Characteristics of participants were presented, arranged and summarised using descriptive statistics. The predictors and outcome variables were examined using logistic regression. The cut-off point was a p value of 0.05.ResultsOf 422 patients included in the study, 304 patients were exposed to at least one PDDI with a prevalence of 72.1% (95 % CI: 68% to 76%) using three drug interaction databases. There were varied reports of the severity of PDDI among databases, but the test agreement using the kappa index was 0.57 (95% CI: 0.52 to 0.62, p=0.0001) which is interpreted as a moderate agreement among three databases. Patients aged ≥50 years old had the risk to be exposed to PDDI by odds of 3.1 times (adjusted OR (AOR)=3.1, 95% CI (1.8 to 5.3); p=0.001) as compared with patients <50 years old. Similarly, patients with polypharmacy and comorbidity were more likely to be exposed to PDDI than their counterparts (AOR=2.4, 95% CI (1.4 to 4.1); p=0.002 and AOR=1.9, 95% CI (1.1 to 3.4); p=0.02, respectively).ConclusionThe main finding of this study is the high prevalence of PDDI, signifying the need for strict patient monitoring for PDDIs among patients with cancer receiving chemotherapy. We suggest the use of at least three drug databases for quality screening. Patients with an age ≥50 years old, polypharmacy and comorbidity were significantly associated with PDDIs. The establishment of oncology clinical pharmacists and computerised reminder mechanisms for PDDIs through drug utilisation review is suggested.
Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK
Authors: Walsh Timothy Simon , Aitken Leanne M , McKenzie Cathrine A , Boyd Julia , Macdonald Alix , Giddings Annabel , Hope David , Norrie John , Weir Christopher , Parker Richard Anthony , Lone Nazir I , Emerson Lydia , Kydonaki Kalliopi , Creagh-Brown Benedict , Morris Stephen , McAuley Daniel Francis , Dark Paul , Wise Matt P , Gordon Anthony C , Perkins Gavin , Reade Michael , Blackwood Bronagh , MacLullich Alasdair , Glen Robert , Page Valerie J 
Published: December 2023

IntroductionAlmost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care.Methods and analysisAdult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of −2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40–50 UK ICUs.Ethics and disseminationThe Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines.Trial registration numberClinicalTrials.govNCT03653832.
Study protocol for a prospective, multicentre, phase II trial on endoscopic treatment using two fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy
Authors: Kawasaki Yuki , Hijioka Susumu , Nagashio Yoshikuni , Ohba Akihiro , Maruki Yuta , Takeshita Kotaro , Takasaki Tetsuro , Yagi Shin , Agarie Daiki , Hagiwara Yuya , Hara Hidenobu , Okamoto Kohei , Yamashige Daiki , Fukuda Souma , Kuwada Masaru , Kondo Shunsuke , Morizane Chigusa , Ueno Hideki , Okusaka Takuji 
Published: December 2023

IntroductionThe current endoscopic treatment for postoperative benign hepaticojejunostomy anastomotic stricture (HJAS) has a high technical success rate and is highly effective in the short term. However, long-term results have shown a high rate of stenosis recurrence, which indicates an insufficient response to treatment. Three prospective studies on fully covered self-expandable metallic stent (FC-SEMS) treatment for benign HJAS used the stenosis resolution rate as the primary endpoint, and no study has yet used the long-term non-stenosis rate (at 12 months) as the primary endpoint.Methods and analysisWe launched the ‘saddle-cross study’, which will be conducted as a multicentre, prospective intervention of endoscopic treatment using two modified FC-SEMSs (BONASTENT️ M-Intraductal) that have been improved for benign stenosis in patients with benign HJAS, with the long-term non-restenosis rate (at 12 months) as the primary endpoint. This study aims to evaluate the long-term non-restenosis rate (at 12 months) and safety of the saddle-cross technique for benign HJAS. We plan to enrol 50 participants.Ethics and disseminationThis study has been approved by the Certified Review Board of the National Cancer Center, Japan (CRB3180009). The results will be reported at various conferences and published in international peer-reviewed journals.
Assessing health impact of COVID-19 and associated household socioeconomic factors in Papua New Guinea: evidence from the Comprehensive Health and Epidemiological Surveillance System
Authors: Pham Bang Nguyen , Aga Tess , Emori Rebecca , Manong Doris , Maraga Seri , Degemba Billiam , Gabe Vicky , Berry Noel , Kobol Michael , Kue Lydia , Ainui Nanim , Jorry Ronny , Silas Vinson D , Abori Nora , Jaukae Gasowo S , Gende Guise , Ha Toan H , Okely Anthony D , Pomat William 
Published: December 2023

IntroductionThe COVID-19 pandemic had an unprecedented impact on the health and well-being of populations worldwide. Few studies have used household data to explore the health risks associated with COVID-19 in low-income and middle-income countries. This study assessed population vulnerability to COVID-19 by examining household socioeconomic factors related to COVID-19 health risks in Papua New Guinea (PNG).MethodsUsing household socioeconomic surveillance data from 2020, encompassing 37 880 residents living within the catchment areas of the Comprehensive Health and Epidemiological Surveillance System, the study assessed COVID-19 health risks based on the socioeconomic demographic characteristics of the surveillance population. Multinomial logistic regression analyses were conducted to determine associated factors and to estimate predictors of COVID-19 health risks.ResultsAmong the surveillance population, more than 9% reported experiencing COVID-19 health risks, including home-based quarantine (9.6%), centre-based quarantine (0.5%), positive COVID-19 test (0.1%), hospitalisation due to COVID-19 (0.3%) and death from COVID-19 (0.3%). People living in semimodern houses (OR 1.47 (95% CI 1.35 to 1.61)) (verse permanent houses), individuals living in houses with 1–2 bedrooms (OR 1.12 (95% CI 1.01 to 1.25)) (verse houses with 4+ bedrooms) and those belonging to the poorest wealth quintile (OR 1.16 (95% CI 1.024 to 1.314)) (verse the richest) were more susceptible to COVID-19 health risks. Protective factors against COVID-19 health risks included urban residence (OR 0.65 (95% CI 0.59 to 0.71)) (verse rurality), aged 0–4 years (OR 0.76 (95% CI 0.64 to 0.91)) (verse aged 55+ years), households with 7–8 members (OR 0.84 (95% CI 0.74 to 0.96)) (verse 10+ members), handwashing with soap (OR 0.3 (95% CI 0.28 to 0.33)) (verse without soap).ConclusionsThe study provides insights into the susceptibility to COVID-19 health risks across socioeconomic groups in PNG. These findings have implications for development of public health policies and interventions that can be extrapolated to similar settings for enhancing preparedness for future public health emergencies.
FIT negative clinic as a safety net for low-risk patients with colorectal cancer: impact on endoscopy and radiology utilisation–a retrospective cohort study
Authors: Nigam Gaurav B , Meran Laween , Bhatnagar Ishita , Evans Sarah , Malik Reem , Cianci Nicole , Pakpoor Julia , Manganis Charis , Shine Brian , James Tim , Nicholson Brian D , East James E , Palmer Rebecca M 
Published: December 2023

BackgroundFaecal immunochemical testing (FIT) is recommended by the National Institute for Health and Care Excellence to triage symptomatic primary care patients who have unexplained symptoms but do not meet the criteria for a suspected lower gastrointestinal cancer pathway. During the COVID-19 pandemic, FIT was used to triage patients referred with urgent 2-week wait (2ww) cancer referrals instead of a direct-to-test strategy. FIT-negative patients were assessed and safety netted in a FIT negative clinic.MethodsWe reviewed case notes for 622 patients referred on a 2ww pathway and seen in a FIT negative clinic between June 2020 and April 2021 in a tertiary care hospital. We collected information on demographics, indication for referral, dates for referral, clinic visit, investigations and long-term outcomes.ResultsThe average age of the patients was 71.5 years with 54% female, and a median follow-up of 2.5 years. Indications for referrals included: anaemia (11%), iron deficiency (24%), weight loss (9%), bleeding per rectum (5%) and change in bowel habits (61%). Of the cases, 28% (95% CI 24% to 31%) had endoscopic (15%, 95% CI 12% to 18%) and/or radiological (20%, 95% CI 17% to 23%) investigations requested after clinic review, and among those investigated, malignancy rate was 1.7%, with rectosigmoid neuroendocrine tumour, oesophageal cancer and lung adenocarcinoma.ConclusionA FIT negative clinic provides a safety net for patients with unexplained symptoms but low risk of colorectal cancer. These real-world data demonstrate significantly reduced demand on endoscopy and radiology services for FIT-negative patients referred via the 2ww pathway.