bluuebunny/crossref_metadata_2025_split huggingface dataset:
Busting contraception myths and misconceptions among youth in Kwale County, Kenya: results of a digital health randomised control trial
Authors: Gichangi Peter , Gonsalves Lianne , Mwaisaka Jefferson , Thiongo Mary , Habib Ndema , Waithaka Michael , Tamrat Tigest , Agwanda Alfred , Sidha Hellen , Temmerman Marleen , Say Lale 
Published: January 2022

ObjectivesThe objective of this randomised controlled trial in Kenya was to assess the effect of delivering sexual and reproductive health (SRH) information via text message to young people on their ability to reject contraception-related myths and misconceptions.Design and settingA three-arm, unblinded randomised controlled trial with a ratio of 1:1:1 in Kwale County, Kenya.Participants and interventionsA total of 740 youth aged 18–24 years were randomised. Intervention arm participants could access informational SRH text messages on-demand. Contact arm participants received once weekly texts instructing them to study on an SRH topic on their own. Control arm participants received standard care. The intervention period was 7 weeks.Primary outcomeWe assessed change myths believed at baseline and endline using an index of 10 contraception-related myths. We assessed change across arms using difference of difference analysis.ResultsAcross arms, <5% of participants did not have any formal education, <10% were living alone, about 50% were single and >80% had never given birth. Between baseline and endline, there was a statistically significant drop in the average absolute number of myths and misconceptions believed by intervention arm (11.1%, 95% CI 17.1% to 5.2%), contact arm (14.4%, 95% CI 20.5% to 8.4%) and control arm (11.3%, 95% CI 17.4% to 5.2%) participants. However, we observed no statistically significant difference in the magnitude of change across arms.ConclusionsWe are unable to conclusively state that the text message intervention was better than text message ‘contact’ or no intervention at all. Digital health likely has potential for improving SRH-related outcomes when used as part of multifaceted interventions. Additional studies with physical and geographical separation of different arms is warranted.Trial registration numberISRCTN85156148.
The relationship between mental health and risk of active tuberculosis: a systematic review
Authors: Hayward Sally E , Deal Anna , Rustage Kieran , Nellums Laura B , Sweetland Annika C , Boccia Delia , Hargreaves Sally , Friedland Jon S 
Published: January 2022

ObjectivesTuberculosis (TB) and mental illnesses are highly prevalent globally and often coexist. While poor mental health is known to modulate immune function, whether mental disorders play a causal role in TB incidence is unknown. This systematic review examines the association between mental health and TB disease risk to inform clinical and public health measures.DesignSystematic review, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.Search strategy and selection criteriaMEDLINE, PsycINFO and PsycEXTRA databases were searched alongside reference list and citation searching. Inclusion criteria were original research studies published 1 January 1970–11 May 2020 reporting data on the association between mental health and TB risk.Data extraction, appraisal and synthesisData were extracted on study design and setting, sample characteristics, measurement of mental illness and TB, and outcomes including effect size or prevalence. Studies were critically appraised using Critical Appraisal Skills Programme (CASP) and Appraisal Tool for Cross-Sectional Studies (AXIS) checklists.Results1546 records published over 50 years were screened, resulting in 10 studies included reporting data from 607 184 individuals. Studies span across Asia, South America and Africa, and include mood and psychotic disorders. There is robust evidence from cohort studies in Asia demonstrating that depression and schizophrenia can increase risk of active TB, with effect estimates ranging from HR=1.15 (95% CI 1.03 to 1.28) to 2.63 (95% CI 1.74 to 3.96) for depression and HR=1.52 (95% CI 1.29 to 1.79) to RR=3.04 for schizophrenia. These data align with evidence from cross-sectional studies, for example, a large survey across low-income and middle-income countries (n=242 952) reports OR=3.68 (95% CI 3.01 to 4.50) for a depressive episode in those with TB symptoms versus those without.ConclusionsIndividuals with mental illnesses including depression and schizophrenia experience increased TB incidence and represent a high-risk population to target for screening and treatment. Integrated care for mental health and TB is needed, and interventions tackling mental illnesses and underlying drivers may help reduce TB incidence globally.PROSPERO registration numberCRD42019158071.
Association between initial opioid prescription diagnosis type and subsequent chronic prescription opioid use in Rhode Island: a population-based cohort study
Authors: Hallowell Benjamin D , Chambers Laura C , Barre Luke , Diao Nancy , Onyejekwe Collette , Banks Alexandra , Bratberg Jeffery , Weidele Heidi , Viner-Brown Samara , McDonald James 
Published: January 2022

ObjectiveTo identify initial diagnoses associated with elevated risk of chronic prescription opioid use.DesignPopulation-based, retrospective cohort study.SettingState of Rhode Island.ParticipantsRhode Island residents with an initial opioid prescription dispensed between 1 April 2019 and 31 March 2020.Primary outcome measureSubsequent chronic prescription opioid use, defined as receiving 60 or more days’ supply of opioids in the 90 days following an initial opioid prescription.ResultsAmong the 87 055 patients with an initial opioid prescription, 3199 (3.7%) subsequently became chronic users. Patients who become chronic users tended to receive a longer days’ supply, greater quantity dispensed, but a lower morphine milligram equivalents on the initial opioid prescription. Patients prescribed an initial opioid prescription for diseases of the musculoskeletal system and connective tissue (adjusted OR (aOR): 5.9, 95% CI: 4.7 to 7.6), diseases of the nervous system (aOR: 6.3, 95% CI: 4.9 to 8.0) and neoplasms (aOR: 5.6, 95% CI: 4.2 to 7.5) had higher odds of subsequent chronic prescription opioid use, compared with a referent group that included all diagnosis types with fewer than 15 chronic opioid users, after adjusting for confounders.ConclusionsBy focusing interventions and prescribing guidelines on specific types of diagnoses that carry a high risk of chronic prescription opioid use and diagnoses that would benefit equally or more from alternative management approaches, states and healthcare organisations may more efficiently decrease inappropriate opioid prescribing while improving the quality of patient care.
Additional offer of sigmoidoscopy in colorectal cancer screening in Germany: rationale and protocol of the decision-analytic modelling approach in the SIGMO study
Authors: Diedrich Leonie , Brinkmann Melanie , Dreier Maren , Schramm Wendelin , Krauth Christian 
Published: January 2022

IntroductionIn Germany, statutory insured persons are entitled to a stool test (faecal immunochemical test (FIT)) or colonoscopy for colorectal cancer (CRC) screening, depending on age and sex, yet participation rates are rather low. Sigmoidoscopy is a currently not available screening measure that has a strong evidence base for incidence and mortality reduction. Due to its distinct characteristics, it might be preferred by some, who now reject colonoscopy. The objective of this study is to estimate the economic consequences of the additional offer of sigmoidoscopy for CRC screening in Germany compared with the present screening practice while considering the preferences of the general population.Methods and analysisA decision-analytic modelling approach will be developed that compares the present CRC screening programme in Germany (FIT, colonoscopy) with a programme extended by sigmoidoscopy from a societal perspective. A decision tree and Markov model will be combined to assess both short-term and long-term effects, such as CRC and adenoma detection rates, the number of CRC cases, CRC mortality as well as complications. The incremental cost per quality-adjusted life year gained for each alternative will be calculated. The model will incorporate the general population’s preferences based on a discrete choice experiment. Further, input parameters will be taken from the literature, the German cancer registry and health insurance claims data.Ethics and disseminationEthical approval for the study was obtained from the Ethics Committee of Hannover Medical School (ID: 8671_BO_K_2019). The findings of the study will be published in peer-reviewed journals and presented at national and/or international conferences.Trial registration numberDRKS00019010.
Real-world data from expanded access programmes in health technology assessments: a review of NICE technology appraisals
Authors: Polak Tobias B , Cucchi David GJ , van Rosmalen Joost , Uyl-de Groot Carin A 
Published: January 2022

ObjectivesTo quantify and characterise the usage of expanded access (EA) data in National Institute for Health and Care Excellence (NICE) technology appraisals (TAs). EA offers patients who are ineligible for clinical trials or registered treatment options, access to investigational therapies. Although EA programmes are increasingly used to collect real-world data, it is unknown if and how these date are used in NICE health technology assessments.DesignCross-sectional study of NICE appraisals (2010–2020). We automatically downloaded and screened all available appraisal documentation on NICE website (over 8500 documents), searching for EA-related terms. Two reviewers independently labelled the EA usage by disease area, and whether it was used to inform safety, efficacy and/or resource use. We qualitatively describe the five appraisals with the most occurrences of EA-related terms.Primary outcome measureNumber of TAs that used EA data to inform safety, efficacy and/or resource use analyses.ResultsIn 54.2% (206/380 appraisals), at least one reference to EA was made. 21.1% (80/380) of the TAs used EA data to inform safety (n=43), efficacy (n=47) and/or resource use (n=52). The number of TAs that use EA data remained stable over time, and the extent of EA data utilisation varied by disease area (p=0.001).ConclusionNICE uses EA data in over one in five appraisals. In synthesis with evidence from well-controlled trials, data collected from EA programmes may meaningfully inform cost-effectiveness modelling.
Implementation and initial analysis of Cardiff Model data collection procedures in a level I trauma adult emergency department
Authors: Nguyen Peter , Kohlbeck Sara A , Levas Michael , Hernandez-Meier Jennifer 
Published: January 2022

ObjectivesOur understanding of community violence is limited by incomplete information, which can potentially be resolved by collecting violence-related injury information through healthcare systems in tandem with prior data streams. This study assessed the feasibility of implementing Cardiff Model data collection procedures in the emergency department (ED) setting to improve multisystem data sharing capabilities and create more representative datasets.DesignInformation collection fields were incorporated into the ED electronic health record (EHR), which gathered additional information from patients reporting assaultive injuries. ED nurses were surveyed to evaluate implementation and feasibility of information collection. Logistic regression was performed to determine associations between missing location information and patient demographic data.Setting60-bed academic level I trauma adult ED in a large Midwestern city.Participants2648 patients screened positive for assault injuries between 2017 and 2020. 198 patients were omitted due to age outside the range served by this ED. Unselected inclusion of 150 ED nurses was surveyed.Main outcome measuresMain outcomes include nursing staff survey responses and ORs for providing complete injury information across various patient demographics.ResultsMost ED nurses believed that information collection aligned with the hospital’s mission (92%), wanted information collection to continue (88%), did not believe that information collection impacted their workflow (88%), and reported taking under 1 min to screen and document violence information (77%). 825 patients (31.2%) provided sufficient information for geospatial mapping. Likelihood of providing complete location information was significantly associated with patient gender, race, arrival means, accompaniment, trauma type and year.ConclusionsIt is feasible to implement information collection procedures about location-based, assault-related injuries through the EHR in the adult ED setting. Nurses reported being receptive to collecting information. Analyses suggest patient-level and time variables impact information collection completeness. The geospatial information collected can greatly improve preexisting law enforcement and emergency medical systems datasets.
Postoperative care in ICU versus non-ICU after head and neck free-flap surgery: a systematic review and meta-analysis
Authors: Mashrah Mubarak Ahmed , Aldhohrah Taghrid , Abdelrehem Ahmed , Sabri Bahia , Ahmed Hyat , Al-Rawi Natheer H , Yu Tian , Zhao Shiyong , Wang Liping , Ge Linhu 
Published: January 2022

ObjectiveAdmission to the intensive care unit (ICU) has long been considered as routine by most head and neck surgeons after microvascular free-flap transfer. This study aimed to answer the question ‘Is there a difference in the flap survival and postoperative complications rates between admission to intensive care unit (ICU) versus Non-ICU following microvascular head and neck reconstructive surgery?’.DesignSystematic review, and meta-analysis.MethodsThe PubMed, Embase, Scopus and Cochrane Library electronic databases were systematically searched (till April 2021) to identify the relevant studies. Studies that compared postoperative nursing of patients who underwent microvascular head and neck reconstructive surgery in ICU and non-ICU were included. The outcome variables were flap failure and length of hospital stay (LOS) and other complications. Weighted OR or mean differences with 95% CIs were calculated.ResultsEight studies involving a total of 2349 patients were included. No statistically significant differences were observed between ICU and non-ICU admitted patients regarding flap survival reported (fixed, risk ratio, 1.46; 95% CI 0.80 to 2.69, p=0.231, I2=0%), reoperation, readmission, respiratory failure, delirium and mortality (p>0.05). A significant increase in the postoperative pneumonia (p=0.018) and sepsis (p=0.033) was observed in patients admitted to ICU compared with non-ICU setting.ConclusionThis meta-analysis showed that an immediate postoperative nursing in the ICU after head and neck microvascular reconstructive surgery did not reduce the incidence of flap failure or complications rate. Limiting the routine ICU admission to the carefully selected patients may result in a reduction in the incidence of postoperative pneumonia, sepsis, LOS and total hospital charge.
Study protocol for a randomised, double-blinded, placebo-controlled phase III trial examining the add-on efficacy, cost–utility and neurobiological effects of low-dose naltrexone (LDN) in patients with fibromyalgia (INNOVA study)
Authors: Colomer-Carbonell Ariadna , Sanabria-Mazo Juan P , Hernández-Negrín Halbert , Borràs Xavier , Suso-Ribera Carlos , García-Palacios Azucena , Muchart Jordi , Munuera Josep , D'Amico Francesco , Maes Michael , Younger Jarred W , Feliu-Soler Albert , Rozadilla-Sacanell Antoni , Luciano Juan V 
Published: January 2022

IntroductionThere is evidence that low-dose naltrexone (LDN; <5.0 mg/day) reduces pain and improves the quality of life of people with fibromyalgia syndrome (FMS). However, no randomised controlled trials with long-term follow-ups have been carried out. The INNOVA study will evaluate the add-on efficacy, safety, cost–utility and neurobiological effects of LDN for reducing pain in patients with FMS, with a 1-year follow-up.Methods and analysisA single-site, prospective, randomised, double-blinded, placebo-controlled, parallel design phase III trial will be performed. Eligibility criteria include being adult, having a diagnosis of FMS and experiencing pain of 4 or higher on a 10-point numerical rating scale. Participants will be randomised to a LDN intervention group (4.5 mg/day) or to a placebo control group. Clinical assessments will be performed at baseline (T0), 3 months (T1), 6 months (T2) and 12 months (T3). The primary endpoint will be pain intensity. A sample size of 60 patients per study arm (120 in total), as calculated prior to recruitment for sufficient power, will be monitored between January 2022 and August 2024. Assessment will also include daily ecological momentary evaluations of FMS-related symptoms (eg, pain intensity, fatigue and sleep disturbance), and side effects via ecological momentary assessment through the Pain Monitor app during the first 3 months. Costs and quality-adjusted life years will be also calculated. Half of the participants in each arm will be scanned with MRI at T0 and T1 for changes in brain metabolites related to neuroinflammation and central sensitisation. Inflammatory biomarkers in serum will also be measured.Ethics and disseminationThis study has been approved by the Ethics Committee of the Fundació Sant Joan de Déu. The results will be actively disseminated through peer-reviewed journals, conference presentations, social media and community engagement activities.Trial registration numberNCT04739995.
Development of strategies to support home-based exercise adherence after stroke: a Delphi consensus
Authors: Mahmood Amreen , Deshmukh Anagha , Natarajan Manikandan , Marsden Dianne , Vyslysel Glade , Padickaparambil Sebastian , TS Shwetha , Direito Artur , Kumaran Senthil , N Girish , Sachdev Harpreet , Kumar Veluswamy Sundar , Karthikbabu Suruliraj , Unnikrishnan B , English Coralie , Solomon John M 
Published: January 2022

ObjectiveTo develop a set of strategies to enhance adherence to home-based exercises after stroke, and an overarching framework to classify these strategies.MethodWe conducted a four-round Delphi consensus (two online surveys, followed by a focus group then a consensus round). The Delphi panel consisted of 13 experts from physiotherapy, occupational therapy, clinical psychology, behaviour science and community medicine. The experts were from India, Australia and UK.ResultsIn round 1, a 10-item survey using open-ended questions was emailed to panel members and 75 strategies were generated. Of these, 25 strategies were included in round 2 for further consideration. A total of 64 strategies were finally included in the subsequent rounds. In round 3, the strategies were categorised into nine domains—(1) patient education on stroke and recovery, (2) method of exercise prescription, (3) feedback and supervision, (4) cognitive remediation, (5) involvement of family members, (6) involvement of society, (7) promoting self-efficacy, (8) motivational strategies and (9) reminder strategies. The consensus from 12 experts (93%) led to the development of the framework in round 4.ConclusionWe developed a framework of comprehensive strategies to assist clinicians in supporting exercise adherence among stroke survivors. It provides practical methods that can be deployed in both research and clinical practices. Future studies should explore stakeholders’ experiences and the cost-effectiveness of implementing these strategies.
Health service costs of treating venous leg ulcers in the UK: evidence from a cross-sectional survey based in the north west of England
Authors: Urwin Sean , Dumville Jo C , Sutton Matt , Cullum Nicky 
Published: January 2022

ObjectivesTo estimate and examine the direct healthcare costs of treating people with open venous leg ulcers in the UK.DesignCost-of-illness study.SettingA cross-sectional survey of nine National Health Service community locales over 2-week periods in 2015/2016.MethodsWe examined the resource use and prevalence of venous leg ulcer treatment in the community. Examination of variation in these obtained costs was performed by ordinary least squares regression. We used additional resource use information from a randomised control trial and extrapolated costs to the UK for an annual period.ResultsThe average 2-week per person cost of treating patients where a venous leg ulceration was the primary (most severe) wound was estimated at £166.39 (95% CI £157.78 to £175.00) with community staff time making up over half of this amount. Costs were higher where antimicrobial dressings were used and where wound care was delivered in the home. Among those with any recorded venous leg ulcer (primary and non-primary), we derived a point prevalence of 3.2 per 10 000 population and estimated that the annual prevalence could be no greater than 82.4 per 10 000 population. We estimated that the national cost of treating a venous leg ulcer was £102 million with a per person annual cost at £4787.70.ConclusionOur point prevalence figures are in line with the literature. However, our annual prevalence estimations and costs are far lower than those reported in recent literature which suggests that the costs of treating venous leg ulcers are lower than previously thought. Movement towards routinely collected and useable community care activity would help provide a transparent and deeper understanding of the scale and cost of wound care in the UK.
Expression and possible role of Smad3 in postnecrotizing enterocolitis stricture
Authors: Chen Rui , Lv Chengjie , Zhao Xiaoxia , Ma Dong , Lai Dengming , Zhao Yun , Zhang Luyin , Tou Jinfa 
Published: January 2022

ObjectiveTo investigate the expression of Smad3 (mothers against decapentaplegic homolog 3) protein in postnecrotizing enterocolitis stricture and its possible mechanism of action.MethodsWe used immunohistochemistry to detect the expression characteristics of Smad3 and nuclear factor kappa B (NF-κB) proteins in human postnecrotizing enterocolitis stricture. We cultured IEC-6 (crypt epithelial cells of rat small intestine) in vitro and inhibited the expression of Smad3 using siRNA technique. Quantitative PCR, western blotting, and ELISA were used to detect the changes in transforming growth factor-β1 (TGF-β1), NF-κB, tumor necrosis factor-α (TNF-α), vascular endothelial growth factor (VEGF), and zonula occludens-1 (ZO-1) messenger RNA (mRNA) and protein expressions in IEC-6 cells. CCK8 kit and Transwell cellular migration were used to detect cell proliferation and migration. Changes in epithelial–mesenchymal transition (EMT) markers (E-cadherin and vimentin) in IEC-6 cells were detected by immunofluorescence technique.ResultsThe results showed that Smad3 protein and NF-κB protein were overexpressed in narrow intestinal tissues and that Smad3 protein expression was positively correlated with NF-κB protein expression. After inhibiting the expression of Smad3 in IEC-6 cells, the mRNA expressions of NF-κB, TGF-β1, ZO-1, and VEGF decreased, whereas the mRNA expression of TNF-α did not significantly change. TGF-β1, NF-κB, and TNF-α protein expressions in IEC-6 cells decreased, whereas ZO-1 and intracellular VEGF protein expressions increased. IEC-6 cell proliferation and migration capacity decreased. There was no significant change in protein expression levels of EMT markers E-cadherin and vimentin and also extracellular VEGF protein expression.ConclusionsWe suspect that the high expression of Smad3 protein in postnecrotizing enterocolitis stricture may promote the occurrence and development of secondary intestinal stenosis. The mechanism may be related to the regulation of TGF-β1, NF-κB, TNF-α, ZO-1, and VEGF mRNA and protein expression. This may also be related to the ability of Smad3 to promote epithelial cell proliferation and migration.