BMJ Open

Mukherjee, Ankita; Yatirajula, Sandhya Kanaka; Kallakuri, Sudha; Paslawar, Srilatha; Lempp, Heidi; Raman, Usha; Kumar, Ashok; Essue, Beverley M; Sagar, Rajesh; Singh, Renu; Peiris, David; Norton, Robyn; Thornicroft, Graham; Maulik, Pallab Kumar

doi: 10.1136/bmjopen-2023-081844pmid: 38772584

IntroductionThere are around 250 million adolescents (10–19 years) in India. The prevalence of mental health-related morbidity among adolescents in India is approximately 7.3%. Vulnerable subpopulations among adolescents such as those living in slum communities are particularly at risk due to poor living conditions, financial difficulty and limited access to support services. Adolescents’ Resilience and Treatment nEeds for Mental Health in Indian Slums (ARTEMIS) is a cluster randomised controlled trial of an intervention that intends to improve the mental health of adolescents living in slum communities in India. The aim of this paper is to describe the process evaluation protocol for ARTEMIS trial. The process evaluation will help to explain the intervention outcomes and understand how and why the intervention worked or did not work. It will identify contextual factors, intervention barriers and facilitators and the adaptations required for optimising implementation.MethodsCase study method will be used and the data will include a mix of quantitative metrics and qualitative data. The UK Medical Research Council’s guidance on evaluating complex interventions, the Reach, Efficacy, Adoption, Implementation and Maintenance Framework and the Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Safety/Side Effects and, Equity criteria will be used to develop a conceptual framework and a priori codes for qualitative data analysis. Quantitative data will be analysed using descriptive statistics. Implementation fidelity will also be measured.DiscussionThe process evaluation will provide an understanding of outcomes and causal mechanisms that influenced any change in trial outcomes.Ethics and disseminationEthics Committee of the George Institute for Global Health India (project number 17/2020) and the Research Governance and Integrity Team, Imperial College, London (ICREC reference number: 22IC7718) have provided ethics approval. The Health Ministry’s Screening Committee has approved to the study (ID 2020-9770).Trial registration numberCTRI/2022/02/040307.

Ben, Ângela J; van der Vaart, Lisa R; E. Bosmans, Judith; Roovers, Jan-Paul W R; Lagro-Janssen, Antoinette L M; van der Vaart, Carl H; Vollebregt, Astrid

doi: 10.1136/bmjopen-2023-075016pmid: 38692718

ObjectiveTo evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.DesignEconomic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.Setting21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.Participants1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.InterventionsPessary therapy and surgery.Primary and secondary outcome measuresThe Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of −10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.ResultsFor the PGI-I, the mean difference between pessary therapy and surgery was −0.05 (95% CI −0.14; 0.03) and −0.03 (95% CI −0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=−€1807, 95% CI −€2172; −€1446 and mean difference=−€1850, 95% CI −€2349; −€1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between €0 and €20 000/QALY gained from both perspectives.ConclusionsNon-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.Trial registration numberNTR4883.

Pei, Dongliang; Wang, Shuyan; Sun, Chenmin

doi: 10.1136/bmjopen-2024-085044pmid: 38719285

BackgroundVenous access in patients with obesity presents significant challenges. The success of central venous catheterisation largely depends on the cross-sectional area (CSA) of the internal jugular vein (IJV). While techniques like the Trendelenburg position have been traditionally used to increase IJV CSA, recent studies suggest its ineffectiveness in patients with obesity. Conversely, the potential of the effect of passive leg raising (PLR) has not been thoroughly investigated in this group of patients.MethodsThis protocol outlines a planned randomised controlled trial to evaluate the effect of PLR on the CSA of the IJV in patients with obesity slated for central venous catheterisation. The protocol involves dividing 40 participants into two groups: one undergoing PLR and another serving as a control group without positional change. The protocol specifies measuring the CSA of the IJV via ultrasound as the primary outcome. Secondary outcomes will include the success rates of right IJV cannulation. The proposed statistical approach includes the use of t-tests to compare the changes in CSA between the two groups, with a significance threshold set at p<0.05.Ethics approvalThis study has been approved by the Institutional Review Board of Shanghai Tongren Hospital. All the participants will provide informed consent prior to enrolment in the study. Regarding the dissemination of research findings, we plan to share the results through academic conferences and peer-reviewed publications. Additionally, we will communicate our findings to the public and professional communities, including patient advocacy groups.Trial registration numberChiCTR: ChiCTR2400080513.

Lee, Mangyeong; Kang, Danbee; Um, Yesol; Jo, Bokyung; Rhue, Jeong; Park, Sehhoon; Lee, Yoo-Young; Noh, Joseph J; Lee, Yun-Gyoo; Koo, Dong-Hoe; Park, Kyong-Hwa; Lee, Soohyeon; Ahn, Jin Seok; Oh, Dongryul; Cho, Juhee

doi: 10.1136/bmjopen-2023-080976pmid:

Yapi, Sopie Marielle; Boudrias, Marguerite; Tremblay, Alexandre; Belanger, Gabrielle; Sourial, Nadia; Boivin, Antoine; Sasseville, Maxime; Côté, André; Gartner, Jean-Baptiste; Taleb, Nadine; Lavoie, Marie-Eve; Trépanier, Emmanuelle; Vachon, Brigitte; Labelle, Marcel; Layani, Géraldine

doi: 10.1136/bmjopen-2023-080659

Munce, Sarah E. P.; Wong, Elliott; Luong, Dorothy; Rao, Justin; Cunningham, Jessie; Bailey, Katherine; John, Tomisin; Barber, Claire; Batthish, Michelle; Chambers, Kyle; Cleverley, Kristin; Crabtree, Marilyn; Diaz, Sanober; Dimitropoulos, Gina; Gorter, Jan Willem; Grahovac, Danijela; Grimes, Ruth; Guttman, Beverly; Hébert, Michèle L;

Mortelmans, Laura; Goossens, Eva; Dilles, Tinne

doi: 10.1136/bmjopen-2023-083129pmid: 38749699

IntroductionHealthcare providers usually manage medication for patients during hospitalisation, although patients are expected to self-manage their medication after discharge. A lack of self-management competencies is found to be associated with low adherence levels and medication errors harming patients’ health. Currently, patients seldom receive support or education in medication self-management. When self-management is allowed during hospitalisation, it is rarely provided using a structured, evidence-based format. Therefore, an in-hospital medication self-management intervention (ie, SelfMED) was developed based on current evidence. To date, empirical data demonstrating the effect of SelfMED on medication adherence are lacking. This study primarily aims to evaluate the effect of the SelfMED intervention on medication adherence 2 months postdischarge in polypharmacy patients, as compared with usual care.Methods and analysisA multicentre pre–post intervention study will be conducted. The study will start with a control phase investigating usual care (ie, medication management entirely provided by healthcare providers), followed by an intervention period, investigating the effects of the SelfMED intervention. SelfMED consists of multiple components: (1) a stepped assessment evaluating patients’ eligibility for in-hospital medication self-management, (2) a monitoring system allowing healthcare providers to follow up medication management and detect problems and (3) a supportive tool providing healthcare providers with a resource to act on observed problems with medication self-management. Polymedicated patients recruited during the control and intervention periods will be monitored for 2 months postdischarge. A total of 225 participants with polypharmacy should be included in each group. Medication adherence 2 months postdischarge, measured by pill counts, will be the primary outcome. Secondary outcomes include self-management, medication knowledge, patient and staff satisfaction, perceived workload and healthcare service utilisation.Ethics and disseminationThe ethics committee of the Antwerp University Hospital approved the study (reference no: B3002023000176). Study findings will be disseminated through peer-reviewed publications, conference presentations and summaries in layman’s terms.Trial registration number ISRCTN15132085.

Bruun-Jensen, Mikkel; Winther, Simon; Schmidt, Samuel Emil; Møller Dahl, Christian

doi: 10.1136/bmjopen-2023-076640pmid: 38760046

ObjectivesTo develop a risk assessment model (DAnish REgister Ischaemic Stroke Classifier, DARE-ISC) for predicting 1-year primary ischaemic stroke/systemic embolism (SE) in the general population. Secondly, to validate the accuracy DARE-ISC in atrial fibrillation (AF) patients where well-established models and risk scores exist.DesignRetrospective cohort study. DARE-ISC was developed using gradient boosting decision trees with information from 375 covariates including baseline information on relevant diagnoses, demographic characteristics, registered health-services, lifestyle-related covariates, hereditary stroke components, drug prescriptions and stress proxies.SettingDanish nationwide registries.ParticipantsAll Danish individuals aged ≥18 from 2010 to 2017 (n=35 519 348 person-years). The model was trained on the 2010–2016 cohorts with validation in the 2017 cohort.Primary and secondary outcome measuresModel optimisation and validation were performed through comparison of the area under the receiver operating characteristic curve (AUC) and average precision scores. Additionally, the relative importance of the model covariates was derived using SHAP values.ResultsDARE-ISC had an AUC (95% CI) of 0.874 (0.871 to 0.876) in the general population. In AF patients, DARE-ISC was superior to the GARFIELD-AF risk model and CHA2DS2-VASc score with AUC of 0.779 (95% CI 0.75 to 0.806), 0.704 (95% CI 0.674 to 0.732) and 0.681 (95% CI 0.652 to 0.709), respectively. Furthermore, in AF patients, DARE-ISC had an average threefold and fourfold higher ratio of correctly identified strokes compared with the GARFIELD-AF risk model and CHA2DS2-VASc score, as indicated by average precision scores of 0.119, 0.041 and 0.034, respectively.ConclusionsDARE-ISC had a very high stroke prediction accuracy in the general population and was superior to the GARFIELD-AF risk model and CHA2DS2-VASc score for predicting ischaemic stroke/SE in AF patients.

Craven, Eleanor May; Luck, Gemma; Whitney, David; Dodhia, Hiten; Foster, Shaneka; Stanke, Carla; Seed, Paul T; Crompton, James; Brown, Kerry Ann

doi: 10.1136/bmjopen-2023-082253pmid: 38803264

ObjectivesThis study identifies the most common recorded reason for attendance to primary care for children under 5 years old, including a breakdown via age, ethnicity, deprivation quintile and sex.DesignCross-sectional.Setting39 of 40 general practices in Lambeth, London, UK.Participants22 189 children under 5 years who had attended primary care between the 1 April 2017 and 31 March 2020 and had not opted out of anonymous data sharing within Lambeth DataNet.Outcome measureThe primary objective was to identify the most frequently recorded complaint in general practice for children under 5 years old. The secondary objective was to understand how presenting complaint differs by age, ethnicity, sex and deprivation level. The third objective was to create a multivariate logistic regression with frequent attendance as the outcome variable.ResultsNine conditions formed over 50% of all patient interactions: the most common reason was upper respiratory tract infections (14%), followed by eczema (8%) and cough (7%). While there was some variation by ethnicity and age, these nine conditions remained dominant. Children living in the most deprived area are more likely to be frequent attenders than children living in the least deprived area (adjusted OR (AOR) 1.27 (95% CI 1.14 to 1.41)). Children of Indian (AOR 1.47 (1.04 to 2.08)), Bangladeshi (AOR 2.70 (1.95 to 3.74)) and other white (AOR 1.18 (1.04 to 1.34)) ethnicities were more likely to be frequent attenders, compared with those of white British ethnicity.ConclusionsMost reasons for attendance for children under 5 years to primary care are for acute, self-limiting conditions. Some of these could potentially be managed by increasing access to community care services, such as pharmacies. By focusing on the influence of the broader determinants of health as to why particular groups are more likely to attend, health promotion efforts have the opportunity to reduce barriers to healthcare and improve outcomes.

Arnaout, Ahmad Yamen; Nerabani, Yaman; Sawas, Mohamad Nabhan; Alhejazi, Tala Jouma; Farho, Mohamad Ali; Arnaout, Khaled; Alshaker, Hassan; Shebli, Baraa; Helou, Mostafa; Mobaied, Bashir Badawi; Mouti, Mohamad Bassel; Kady, Fares; Aljarad, Ziad

doi: 10.1136/bmjopen-2023-082385pmid: 38702080

ObjectivesThe aim of this study is a descriptive presentation of cases of acute watery diarrhoea (AWD) that were presented to Aleppo University Hospital (AUH) during the recent cholera outbreak in Syria.DesignProspective, observational, cohort study.Setting and participantsA total of 1061 patients with AWD were admitted to AUH during the timeframe of 20 September 2022 to 20 October 2022. The data collection was done through a structured questionnaire. This includes comprehensive clinical observation, laboratory analyses, therapeutic interventions and holistic case evaluations.ResultsThe analysis has revealed notable insights: a predominant proportion of patients (58.6%) were residents from urban areas and 40.3% were residents from rural areas. Intriguingly, a diverse range of potential infection sources emerged from patient data within our hospital, including uncontrolled well water, vegetables and faecal-oral transmission through contaminated street/fast food. At discharge, most patients were in good health (79.7%), followed by moderate health (17.6%) and poor health (2.3%), with a minimal percentage dying before discharge (0.4%). The most common complications reported at admission and during hospitalisation included electrolyte imbalance (28.2%), followed by severe dehydration (16.3%). In the follow-up period, the majority of patients exhibited good health (81.0%). Older patients (>60 years) had poorer outcomes, with 8.4% having poor health and 4.2% death rate.ConclusionsThe study found results consistent with previous AWD outbreaks in developing countries like Yemen, Nigeria and Lebanon. Preventative measures like improving water sanitation and hygiene practices are essential to prevent future outbreaks and ease the strain on healthcare systems. Therefore, future studies must investigate the risk factors that increase the spread and the severity of the disease and investigate the best management method.