BMJ Open最新文献

Introduction: Maintaining haemodynamic stability is crucial but challenging during the induction and maintenance of general anaesthesia (GA) in patients undergoing off-pump coronary artery bypass grafting (OPCABG). Remimazolam tosylate is a novel ultra-short-acting benzodiazepine with minimal cardiovascular depression. Currently, non-inferior studies comparing the haemodynamic changes induced by remimazolam and etomidate are limited. This study aims to assess the efficacy and safety of remimazolam tosylate for the induction and maintenance of GA in patients undergoing OPCABG.

Method and analysis: This two-armed non-inferiority randomised controlled trial will include 88 patients aged 18-75 years who are scheduled for OPCABG. Patients will be randomly assigned in a 1:1 ratio to receive either remimazolam tosylate or etomidate and propofol for anaesthesia induction and maintenance. The primary outcome will be the fluctuation of mean artery pressure during anaesthesia induction. Secondary outcomes will include adverse events, adverse drug reactions, the cumulative dosage of vasoactive drugs, vital signs and bispectral index values at different time points, lengths of postoperative mechanical ventilation and tracheal intubation, lengths of intensive care unit stay and hospital stay and hospital mortality. Analyses will be conducted using both the intention-to-treat approach and the per-protocol approach.

Ethics and dissemination: This study was approved by the Ethics Committee of Zibo Central Hospital (No. 2024001). The trial results will be submitted to an international peer-reviewed journal.

Trial registration number: ChiCTR.gov.cn: ChiCTR2400079615.

Pain is one of the most debilitating symptoms of cancer, substantially diminishing one's quality of life. The level of pain experienced is eventually determined by the pain coping strategies adopted by patients individually. The awareness of the 'self-coping methods of pain' of individual patients would be beneficial for the multidisciplinary pain team to consider such methods when planning future interventions to manage pain.

Objectives: This study explores the pain perception and coping strategies used by patients with cancer pain in Sri Lanka.

Design: A descriptive qualitative study.

Setting: Pain management unit, Apeksha Hospital, Maharagama, Sri Lanka.

Participants: The study was conducted among purposively selected patients with cancer and registered at the pain management unit. 21 semi-structured interviews were conducted until data saturation. Data were analysed using Graneheim and Lundman's content analysis method.

Results: Most participants were between 51 and 60 years old and identified as Sinhalese Buddhists. The study's findings revealed two subthemes under 'Understanding pain', namely 'Physical and emotional impact' and 'Cultural and spiritual interpretations', and five subthemes under 'Coping strategies for living with pain', namely 'Medication and self-control', 'Seeking spiritual support', 'Receiving social support', 'Exploring alternative treatments' and 'Adapting daily life'.

Conclusion: Coping strategies were adopted especially in achieving essential life aspirations and participating in preferred activities. Goals or activities were often adjusted to fall within their health limits. Acceptance and progress in life were considered more important than pain control. We recommend giving due consideration to the 'self-coping strategies' of individual patients in designing interventions to mitigate cancer pain.

Background: Metabolic dysfunction-associated fatty liver disease (MAFLD) is the most common chronic liver disease in the world and carries an increased risk of liver-related events, but no approved medicine. Electroacupuncture has been used to treat non-alcoholic fatty liver disease, but its effect was uncertain because of the poor quality of prior studies. We designed this trial to evaluate the efficacy and safety of electroacupuncture for MAFLD.

Methods/design: This is a multicentre, randomised, sham acupuncture-controlled, patient-blinded clinical trial. Participants will take part in a total of 20 weeks of study, containing three phases: a 4-week run-in period, 12-week treatment (36 sessions of acupuncture) and 4-week follow-up. A total of 144 eligible patients diagnosed with MAFLD will be randomly allocated to the electroacupuncture or sham acupuncture groups. The primary outcome is the percentage of relative liver fat reduction on the MRI proton density fat fraction from baseline to 12 weeks. Secondary outcomes include magnetic resonance elastography, liver and metabolic biomarkers, anthropometry parameters, blinding assessment, credibility and expectancy, and adverse events. All patients who receive randomisation will be included in the intent-to-treat analysis.

Discussion: The finding of this trial will provide evidence of the efficacy and safety of electroacupuncture for the treatment of MAFLD. The results of this study will be published in peer-reviewed journals.

Trial registration number: www.chictr.org.cn, ChiCTR2200060353. It was registered on 29 May 2022.

Introduction: Atrial fibrillation (AF) is the prevalent cardiac arrhythmia and can significantly impair the quality of life (QoL). Although catheter ablation (CA) is an established treatment for AF,post-procedural complications or perceived inadequate control of AF may diminish the QoL for some patients, potentially even to levels lower than pre-procedure. Preliminary findings from our previous pilot trial indicate that acupuncture may positively influence QoL in AF patients post-CA. This study aims to increase the sample size to evaluate the efficacy of acupuncture as an adjunctive treatment to conventional medical therapy in improving QoL of patients with AF after CA.

Methods and design: This multicentre randomised clinical trial will be conducted in China. A total of 146 eligible patients will be randomly assigned in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. All patients will receive standard postablation care and undergo 18 sessions of acupuncture/sham acupuncture within 12 weeks following CA, followed by a 9-month follow-up period. The primary outcome is the change in the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) summary score from baseline to months 6 after CA. Secondary outcomes include the changes in the AFEQT subscale scores at months 6, the AFEQT summary and subscale score at months 3 and 12, AF burden, AF recurrence, heart rate variability, number of cardioversions, repeat CA procedures, European Heart Rhythm Association score, number of arrhythmia-related hospitalisations, average heart rate, use of Six-Dimensional Health State Short Form to assess health status, costs incurred by disease treatment, Credibility/Expectancy Questionnaire and blinded assessments. Adverse events will also be meticulously recorded throughout the trial.

Ethics and dissemination: Ethics approval has been granted by the Ethics Committee of Beijing University of Traditional Chinese Medicine (approval no: 2020BZYLL0802) and seven other subcentres. The findings of the study results will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.

Trial registration number: ChiCTR2100049323.

Introduction: Recurrent shoulder dislocations often cause attrition of the labrum and progressive loss of the anterior bony contour of the glenoid. Treatment options for this pathology involve either soft tissue repair or bony augmentation procedure. The optimal management for patients with shoulder instability with subcritical bone loss remains unknown and current clinical practice is highly varied.

Methods and analysis: The Shoulder instability Trial comparing Arthroscopic stabilisation Benefits compared with Latarjet procedure Evaluation (STABLE) is an ongoing multicentre, randomised controlled trial of 114 patients diagnosed with recurrent anterior shoulder instability and subcritical glenoid bone loss (10%-20%, measured on 3D CT using circle of best fit technique). Patients are randomised either arthroscopic capsuloligamentous repair (Bankart repair+remplissage) or open or arthroscopic coracoid transfer (Latarjet procedure). The primary outcome of this trial will be the between-group difference in the change from baseline to 24 months postintervention in Western Ontario Shoulder Instability Index scores. Secondary outcomes include: (1) rates of recurrent shoulder dislocations and symptoms of instability up to 24 months' postsurgery; (2) clinical outcomes measured by American Shoulder and Elbow Society score, Shoulder Activity Scale, EQ-5D and Patient Satisfaction Scale; (3) physical examination (range of motion, stability); (4) return to previous level of activity/sport; (5) rate of shoulder-related complications and serious adverse events.

Ethics and dissemination: This protocol has been reviewed and approved by the Hamilton Integrated Research Ethics Board (HiREB; project number 15998) prior to commencement of the trial. Results from the study will be submitted for publication in a peer-reviewed journal regardless of whether there are statistically significant findings.

Trial registration number: NCT05705479; this study was prospectively registered on clinicaltrials.gov.

Background: Musculoskeletal joint complaints (MSCs) are the most common extraintestinal manifestation of inflammatory bowel disease (IBD). We aimed to investigate the effect of MSC on the health-related quality of life (QoL) in patients with IBD.

Design: A survey-based cross-sectional study among adult Dutch IBD patients.

Setting: Primary care, secondary care and patient association.

Participants: In total, 635 IBD patients were included. The mean age was 46.3 (SD 14.2) years, and 35% were male.

Outcome: MSC was defined as suffering from any joint complaints. QoL was measured using the IBD questionnaire and a 36-item short form health survey questionnaire.

Methods: A univariate analysis was performed to estimate the impact of various factors, such as demographic characteristics, setting, type of IBD and fatigue, which was followed by a multiple regression analysis to adjust for the confounding factors.

Results: Of the 635 IBD patients, 332 suffered from Crohn's disease (CD) and 303 from ulcerative colitis (UC). After adjusting for confounding factors, MSC was independently associated with reduced QoL among IBD patients (β=-10.6, 95% CI -15.2 to -6.1), both in CD (β=-8.3, 95% CI -14.6 to -2.1) and UC (β=-13.9, 95% CI -20.5 to -7.3). 11% of the IBD patients had a rheumatological diagnosis. QoL in these patients was significantly lower compared with IBD patients with non-rheumatological MSC.

Conclusions: IBD patients with MSC are associated with a lower QoL, explicitly in patients with a rheumatological diagnosis. Prospective research is necessary to evaluate the causality and suitable interventions to increase QoL in these multimorbid patients.

Objective: To understand if presbyopia correction could empower older craftswomen entrepreneurs living in Zanzibar.

Design: Mixed-method, before-after intervention study.

Setting: Unguja and Pemba islands, Zanzibar.

Participants: 209 craftswomen (weaving, tailoring and sewing, pottery and producing oil and making soaps) 40 years and older with correctable presbyopia, with no other ocular morbidities.

Intervention: Eye health assessment and near vision spectacle correction for 6 months.

Primary and secondary outcomes: Change in economic, social, psychological and political empowerment (4-point Likert scale responses) before and after correction. Odds ratios were calculated to determine the likelihood of upward movement on the Likert scale. Five focus group interviews were conducted to explore the craftswomen's daily experiences concerning vision correction and empowerment, and subsequently, narrative analysis was conducted.

Results: Of the 209 craftswomen who completed the baseline survey from 4 to 21 April 2022, 157 (75.1%) were successfully followed up from 6 to 27 October 2022. Craftswomen reported significantly greater economic, social, psychological and political empowerment in 14 out of 18 statements (77.8%) (p<0.05). Qualitative responses showed that after correction, craftswomen reported having greater autonomy in running the business and improved income, better decision-making power for their business and children, greater independence and confidence and greater participation in problem-solving for the community and appointing leaders. We did not observe a significant change in the following: ability to make decisions for their family, understanding their capabilities, ability to be elected as a leader and ability to advise government leaders.

Conclusion: The correlation between presbyopia correction and empowerment among older Zanzibari craftswomen is mostly positive. Some aspects of empowerment require further investigation with an extended timeframe.

Objective: Treatment compliance among psychiatric patients is related to disease outcomes. How to assess patient compliance remains a concern. Here, we established a predictive model for medication compliance in patients with psychotic disorders to provide a reference for early intervention in treatment non-compliance behaviour.

Design: Clinical information for 451 patients with psychotic disorders was downloaded from the Dryad database. The Least Absolute Shrinkage and Selection Operator regression and logistic regression were used to establish the model. Bootstrap resampling (1000 iterations) was used for internal validation and a nomogram was drawn to predict medication compliance. The consistency index, Brier score, receiver operating characteristic curve and decision curve were used for model evaluation.

Setting: 35 Italian Community Psychiatric Services.

Participants: 451 patients prescribed with any long-acting intramuscular (LAI) antipsychotic were consecutively recruited, and assessed after 6 months and 12 months, from December 2015 to May 2017.

Results: 432 patients with psychotic disorders were included for model construction; among these, the compliance rate was 61.3%. The Drug Attitude Inventory-10 (DAI-10) and Brief Psychiatric Rating Scale (BPRS) scores, multiple hospitalisations in 1 year and a history of long-acting injectables were found to be independent risk factors for treatment noncompliance (all p<0.01). The concordance statistic of the nomogram was 0.709 (95% CI 0.652 to 0.766), the Brier index was 0.215 and the area under the ROC curve was 0.716 (95% CI 0.669 to 0.763); decision curve analysis showed that applying this model between the threshold probabilities of 44% and 63% improved the net clinical benefit.

Conclusion: A low DAI-10 score, a high BPRS score, multiple hospitalisations in 1 year and the previous use of long-acting injectable drugs were independent risk factors for medication noncompliance in patients with psychotic disorders. Our nomogram for predicting treatment adherence behaviour in psychiatric patients exhibited good sensitivity and specificity.

Objectives: To estimate thresholds for defining meaningful within-patient improvement from baseline to weeks 13-24 and interpreting meaningfulness of between-group difference for the non-transfusion-dependent beta-thalassaemia patient-reported outcome (NTDT-PRO) tiredness/weakness (T/W) and shortness of breath (SoB) scores. A secondary objective was to determine the symptom severity threshold for the NTDT-PRO T/W domain to identify patients with symptomatic T/W.

Design: Pooled blinded data from the phase 2, double-blind, placebo-controlled, randomised BEYOND trial in NTDT (NCT03342404) were used. Anchor-based analyses supplemented with distribution-based analyses and empirical cumulative distribution function (eCDF) curves were applied. Distribution-based analyses and receiver operating characteristic curves were used to estimate between-group difference and symptomatic thresholds, respectively.

Setting: Greece, Italy, Lebanon, Thailand, the UK and the USA.

Participants: Adults (N=145; mean age 39.9 years) with NTDT who were transfusion-free ≥8 weeks before randomisation.

Measures: Score changes from baseline to weeks 13-24 in PROs used as anchors (correlation coefficient ≥0.3): NTDT-PRO T/W and SoB scores, Patient Global Impression of Severity, Functional Assessment of Chronic Illness Therapy-Fatigue (Fatigue Subscale, item HI12 and item An2) and Short Form Health Survey version 2.

Results: The eCDF curves support the use of estimates from the improvement by one level group for all anchors to determine the threshold(s) for meaningful within-patient improvement. Mean (median) changes from these groups and estimates from distribution-based analyses suggest that a ≥1-point reduction in the NTDT-PRO T/W or SoB domains represents a clinically meaningful improvement. Meaningful between-group difference threshold ranges were 0.53-1.10 for the T/W domain and 0.65-1.15 for the SoB domain. The optimal symptomatic threshold for the T/W domain (by maximum Youden's index) was ≥3 points.

Conclusions: The thresholds proposed may support the use of NTDT-PRO in assessing and interpreting treatment effects in clinical studies and identifying patients with NTDT in need of symptom relief.

Objectives: Worldwide, a number of studies have been conducted to assess the prevalence of adherence to secondary antibiotic prophylaxis and to identify the associated factors (reasons) for poor adherence among patients with rheumatic heart disease or acute rheumatic fever (RHD/ARF). However, results were highly inconsistent with a prevalence ranging from 10% to 93%; and the reported reasons or associated factors have not been systematically reviewed. Therefore, this study aimed to assess the prevalence of adherence to secondary antibiotic prophylaxis among patients with RHD/ARF; and to review the associated factors (reasons) for poor adherence.

Design: Systematic review and meta-analysis.

Data sources: PubMed/Medline, Google Scholar, Cochrane Review and African Journals Online databases.

Eligibility criteria: Articles published in English from 1 January 2005 to 1 December 2022 and reported the prevalence of adherence using ≥80% cut-off points were included.

Data extraction and synthesis: Data were extracted using the Microsoft Excel and analysed by STATA V.11.0. A meta-analysis was conducted using the weighted inverse-variance random-effects model. Reasons for poor adherence were identified through thematic analysis.

Results: 33 articles with a total sample size of 7158 patients were included. The pooled prevalence of adherence to secondary antibiotic prophylaxis among patients with RHD/ARF was found to be 58.5% (95% CI: 48.2% to 68.7%; I²=99.2%; p<0.001). Rural residency, lack of money, distance from the health institutions, inaccessibility, poor counselling, forgetting schedules, lack of disease knowledge and fear of injection pain were the reported factors or reasons for poor adherence.

Conclusion: About 41.5% of patients with RHD/ARF were found to have poor adherence. Long distance from health institutions, forgetting schedules, poor counselling and lack of knowledge and skill among healthcare workers were some of the modifiable reasons for poor adherence. Therefore, decentralisation of the follow-up care, creating schedule reminding systems and providing targeted health education might help to improve adherence.