The latest medical research on Medical Administration
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Complementary medicines advertising policy Part II: unethical conduct in the Australian market after July 2018.Australian Health Review
ObjectiveTo assess the effects of Australian complementary medicines advertising policy after major changes in 2018. These included a legally enfor...
Complementary medicines advertising policy Part I: unethical conduct in the Australian market before July 2018.Australian Health Review
ObjectiveThis study assessed the effects of complementary medicines advertising policy before major changes in 2018.MethodsThe study consisted of a...
PREventive effect of FENestration with and without clipping on post-kidney transplantation lymphatic complications (PREFEN): study protocol for a randomised controlled trial.BMJ Open
ClinicalTrials.gov Registry (NCT03682627).
This trial has been initiated in July 2019 and is expected to last for 2 and a half years. All patients older than 18 years, who receive kidneys from deceased donors, will be included. The kidney recipients will be randomly allocated to either a control arm (small fenestration alone) or an intervention arm (small fenestration with clipping). All fenestrations will be round, maximum 2 cm, and close to the kidney hilum. Clipping will be performed with eight metal clips around the peritoneal window (360°) in every 45° in an oblique position. The primary endpoint is the incidence of symptomatic post-KTx lymphatic complications, which require interventional treatment within 6 months after KTx. Secondary endpoints are intraoperative and postoperative outcomes, including blood loss, operation time, severity grade of lymphocele/lymphorrhea and relative symptoms.
This protocol study received approval from the Ethics Committee of the University of Heidelberg (Registration Number S-318/2017). A Standard Protocol Items: Recommendations for Interventional Trials checklist is available for this protocol. The results will be disseminated through peer-reviewed journals and conference presentations.
Uncovering the high burden of hypertension and its predictors among adult population in Hosanna town, southern Ethiopia: a community-based cross-sectional study.BMJ Open
Hypertension is a global public health problem, with its burden increasing particularly in developing countries. However, it has not yet received due attention in Ethiopia. The aim of this study was to determine the prevalence and associated factors of hypertension among adult population in Hosanna town, southern Ethiopia.
A face-to-face interview using structured questionnaire was carried out by trained nurses. Anthropometry and blood pressure were measured following standard procedures. Hypertension status was defined as systolic blood pressure ≥140 mm Hg and/or diastolic blood pressure ≥90 mm Hg in two separate measurements or reported use of prescribed antihypertensive drugs for raised blood pressure. Factors associated with hypertension were identified by multivariable binary logistic regression analysis.
The overall prevalence of hypertension was found to be 17.2% (19.3% and 14.2% among men and women, respectively). About 40% were unaware that they were hypertensive prior to the study. Older age ≥35 years (adjusted OR=3.9, 95% CI: 1.4 to 10.8), alcohol use (adjusted OR=3.4, 95% CI: 1.4 to 8.3), consumption of saturated oil (adjusted OR=6.5, 95% CI: 1.5 to 17.5) and unspecified different types of oil (adjusted OR=8.2, 95% CI: 1.9 to 25.1) and overweight/obesity (adjusted OR=2.9, 95% CI: 1.9 to 4.6) were found to be independently associated with hypertension.
The prevalence of both diagnosed and undiagnosed hypertension is alarmingly high in the town. These findings underscore the need to design health information provision systems on the risk factors of hypertension and promote good health practices. Blood pressure screening programmes at community levels to identify and treat undiagnosed hypertension should be considered.
Effect of clindamycin and a live biotherapeutic on the reproductive outcomes of IVF patients with abnormal vaginal microbiota: protocol for a double-blind, placebo-controlled multicentre trial.BMJ Open
ICH-GCP monitored trial, EudraCT 2016-002385-31; Pre-results.
This is a drug intervention study where IVF patients will be screened for AVM, using a qPCR assay targeting Atopobium vaginae and Gardnerella vaginalis. If positive, patients will be randomised to one of the three study arms. The first arm consists of clindamycin 300 mg ×2 daily for 7 days followed by vaginal Lactobacillus crispatus CTV-05 until clinical pregnancy scan week 7-9. The second arm consists of clindamycin and placebo L. crispatus CTV-05, whereas patients in the third arm will be treated with placebo/placebo. We used a superiority design to estimate that active treatment in both arms will increase the primary outcome, clinical pregnancy rate per embryo transfer, from 20% to 40%. A potential difference between the two active arms was considered exploratory. With a power of 80% and an alpha at 5%, the sample size is estimated to be 333 patients randomised. A pre-planned interim analysis is scheduled at 167 patients randomised.
All patients have to give informed consent. Dissemination of results is ensured in clinical trial agreements whether they be positive or not. Ethics committee, Central Denmark Region approved this protocol.
Prescribing trends over time by non-medical independent prescribers in primary care settings across Wales (2011-2018): a secondary database analysis.BMJ Open
As of 2015, as part of the implementation of the Welsh Government primary care plan and primary care clusters, the Welsh Government has encouraged non-medical healthcare professionals working in primary care to train as independent prescribers (IPs).
This research aimed to identify the number of NMIPs in primary care in Wales and describe their prescribing trend of items between 2011 and 2018, in order to compare their prescribing pattern before and after the implementation of primary care clusters for Wales.
Retrospective secondary data analysis and interrupted time series analysis in order to compare prescribing by non-medical independent prescribers (NMIPs) preimplementation and postimplementation of primary care clusters across Wales.
Over the study period, 600 NMIPs (nurses n=474 and pharmacists n=104) had prescribed at least one item. The number of nurse IPs increased by 108% and pharmacists by 325% (pharmacists had the largest increase between July 2015 and March 2018). The number of items prescribed by NMIPs increased over time by an average of 1380 per month (95% CI 904 to 1855, p<0.001) after the implementation of primary care clusters compared with 496 (95% CI 445 to 548, p<0.001) prior its implementation. Approximately one-third of the items prescribed by NMIPs was within Betsi Cadwaladr University Health Board (HB) with only 4% in Powys Teaching HB.
The number of NMIPs and their volume of prescribing in primary care in Wales has increased following the implementation of primary care clusters in 2015. This suggests that the Government's recommendations of using NMIPs in primary care have been implemented. Future studies should focus on efficiency and quality of prescribing by NMIPs in primary care.
Patient-reported experiences with general practitioners: a randomised study of mail and web-based approaches following a national survey.BMJ Open
The standard data-collection procedure in the Norwegian national patient experience survey programme is post-discharge mail surveys, which include a pen-and-paper questionnaire with the option to answer electronically. A purely electronic protocol has not previously been explored in Norway. The aim of this study was to compare response rates, background characteristics, data quality and main study results for a survey of patient experiences with general practitioners (GPs) administered by the standard mail data-collection procedure and a web-based approach.
Response rates, background characteristics, data quality and main study results.
The response rate was markedly higher for the mail survey (42.6%) than for the web-based survey (18.3%). A few of the background variables differed significantly between the two groups, but the data quality and patient-reported experiences were similar.
Web-based surveys are faster and less expensive than standard mail surveys, but their low response rates and coverage problems threaten their usefulness and legitimacy. Initiatives to increase response rates for web-based data collection and strategies for tailoring data collection to different groups should be key elements in future research.
Haemorrhage rates of ruptured and unruptured brain arteriovenous malformation after radiosurgery: a nationwide population-based cohort study.BMJ Open
The present nationwide population-based cohort study aims to assess the effectiveness of gamma knife radiosurgery (GKS) on ruptured and unruptured brain arteriovenous malformations (AVMs) by evaluating the haemorrhage rates.
An observational study of 1515 patients who were diagnosed with brain AVMs between 1997 and 2013 from the Taiwan NHIRD.
We performed a survival analysis using the Kaplan-Meier method. Multivariate Cox proportional hazards regression models were used to explore the relationship between treatment modalities (GKS vs non-GKS) and haemorrhage, adjusted for age and sex.
The GKS and non-GKS groups included 317 and 1198 patients, respectively. Patients in the GKS group (mean±SD, 33.08±15.48 years of age) tended to be younger than those in the non-GKS group (37.40±17.62) (p<0.001). The 15-year follow-up revealed that the rate of bleeding risk was lower in the GKS group than in the non-GKRS group (adjusted HR (aHR) 0.61; 95% CI 0.40 to 0.92). The bleeding risk of ruptured AVMs was significantly lower in GKS group than in the non-GKS group (aHR 0.34; 95% CI 0.19 to 0.62). On the other hand, the bleeding risk of unruptured AVMs was higher in the GKS group than in the non-GKS group (aHR 1.95; 95% CI 1.04 to 3.65). In the unruptured AVM group, the incidence of bleeding was significantly higher among patients in the GKS group that were of >40 years of age (aHR 3.21; 95% CI 1.12 to 9.14).
GKS is safe and it reduces the risk of haemorrhage in patients with ruptured AVMs. The administration of GKS to patients with unruptured AVMs who are above the age of 40 years old male might increase the risk of haemorrhage.
Digital telemedicine interventions for patients with multimorbidity: a systematic review and meta-analysis.BMJ Open
To determine the effectiveness of digital telemedicine interventions designed to improve outcomes in patients with multimorbidity.
MEDLINE, EMBASE, The Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and the Database of Abstracts of Reviews of Effectiveness and hand searching. The search included articles from inception to 19 April 2019 without language restrictions. The search was updated on 7 June 2020 without additional findings.
Prospective interventional studies reporting multimorbid participants employing interventions with at least one digital telemedicine component were included. Primary outcomes were patient physical or mental health outcomes, health-related quality of life scores and the utilisation of health services.
Out of 5865 studies initially identified, 7 articles, reporting on 6 studies were retained (total of 699 participants). Four of these studies reported interventions including integration with usual care, two studies had interventions with no links to usual patient care. Follow-up periods lasted between 2 and 6 months. Among the studies with links to usual care, the primary outcomes were systolic blood pressure (SBP) (three studies), haemoglobin A1c (HbA1c) (three studies), total cholesterol (two studies) and self-perceived health status (one study). The evidence ranged from very low to moderate certainty. Meta-analysis showed a moderate decrease in SBP (8 mm Hg (95% CI 4.6 to 11.4)), a small to moderate decrease in HbA1c (0.46 mg/dL (95% CI 0.25 to 0.67)) and moderate decrease in total cholesterol (cholesterol 16.5 mg/dL (95% CI 8.1 to 25.0)) in the intervention groups. There was an absence of evidence for self-perceived health status. Among the studies with no links to usual care, time to hospitalisation (median time to hospitalisation 113.4 days intervention and 104.7 days control group, absolute difference 12.7 days) and the Minnesota Living with Heart Failure Questionnaire (intervention group 35.2 score points, control group 23.9 points, absolute difference 11.3, 95% CI 5.5 to 17.1) showed small reductions. The Personal Health Questionnaire (PHQ-8) showed no evidence of improvement (intervention 7.6 points, control 8.6 points, difference 1.0 points, 95% CI -22.9% to 11.9%).
Digital telemedicine interventions provided moderate evidence of improvements in measures of disease control but little evidence and no demonstrated benefits on health status. Further research is needed with clear descriptions of conditions, interventions and outcomes based on patients' and healthcare providers' preferences.
Perioperative intravenous lignocaine infusion for postoperative pain control in patients undergoing surgery of the spine: protocol for a systematic review and meta-analysis.BMJ Open
Intravenous lignocaine is an amide local anaesthetic known for its analgesic, antihyperalgesic and anti-inflammatory properties. Administration of intravenous lignocaine has been shown to enhance perioperative recovery parameters. This is the protocol for a systematic review which intends to summarise the evidence base for perioperative intravenous lignocaine administration in patients undergoing spinal surgery.
Our primary outcomes include: postoperative pain scores at rest and movement at predefined early, intermediate and late time points and adverse events. Other outcomes of interest include perioperative opioid consumption, composite morbidity, surgical complications and hospital length of stay. We will include randomised controlled trials, which compared intravenous lignocaine infusion vs standard treatment for perioperative analgesia. We will search electronic databases from inception to present; MEDLINE, EMBASE and Cochrane Library (Cochrane Database of Systematic Reviews and CENTRAL). Two team members will independently screen all citations, full-text articles and abstract data. The individual study risk of bias will be appraised using the Cochrane risk of bias tool. We will obtain a risk ratio or mean difference (MD) from the intervention and control group event rates based on the nature of data. We will correct for the variable measurement tools by using the standardised MD (SMD). We will use a random-effects model to synthesise data. We will conduct five subgroup analysis: major versus minor surgery, emergency versus elective surgery, patients with chronic pain conditions versus patients without, duration of lignocaine infusion and adult versus paediatric. Confidence in cumulative evidence for will be classified according to the Grading of Recommendations, Assessment, Development and Evaluation system. We will construct summary of findings tables supported detailed evidence profile tables for predefined outcomes.
Formal ethical approval is not required as primary data will not be collected. The results will be disseminated through a peer-reviewed publication.
Dance for people with chronic respiratory disease: a qualitative study.BMJ Open
To explore the experiences and perceived impact on health and well-being related to participation in a dance group for people with chronic respiratory disease (CRD).
Weekly community dance sessions designed for people with breathlessness, lasting 75 min, led by a trained community dance leader.
Convenience sample of eight participants, six females, aged 57-87 years (mean 75), with a median 2-year attendance at weekly dance sessions. Long-term attendance was driven by strongly held beliefs regarding the health and well-being benefits of participation. Four key themes were identified: dance as (1) a holistically beneficial activity, with physical and psychosocial health benefits including improved or maintained physical fitness and psychological well-being, and reduced need for healthcare; (2) an integral part of their life; (3) an enjoyable activity; and (4) a source of deep social cohesion.
Dance group participants perceived a broad range of health benefits of relevance to the biopsychosocial impacts of their respiratory disease. The themes identified are useful in the ongoing planning and evaluation of dance as a holistic complex intervention for people with CRD. Further research is required to assess the extent of health impacts identified, and how dance might be most effectively placed as an option in the management of CRD.
Association between hyperemesis gravidarum and psychological symptoms, psychosocial outcomes and infant bonding: a two-point prospective case-control multicentre survey study in an inner city setting.BMJ Open
To assess if there is any association between hyperemesis gravidarum (HG), psychological morbidity and infant bonding and to quantify any psychosocial consequences of HG.
Pregnant women at ≤12 completed weeks gestation recruited consecutively over 2 years. Women with HG were recruited at the time of admission; controls recruited from a low risk antenatal clinic. 106 women were recruited to the case group and 108 to the control. Response rates at antenatal data collection were 87% and 85% in the case and control groups, respectively. Postnatally, the response rate was 90% in both groups.
Primary outcomes were psychological morbidity in the antenatal and postnatal periods, infant bonding in the postnatal period and psychosocial implications of HG. Secondary outcomes were the effects of severity and longevity of HG and assessment of correlation between Edinburgh Postnatal Depression Scale scores and maternal-to-infant bonding scores.
Antenatally, 49% of cases had probable depression compared with 6% of controls (OR 14.4 (5.29 to 39.44)). Postnatally, 29% of cases had probable depression versus 7% of controls (OR 5.2 (1.65 to 17.21)). There was no direct association between HG and infant bonding. 53% of women in the HG group reported needing four or more weeks of sick leave compared with 2% in the control group (OR 60.5 (95% CI 8.4 to 2535.6)).
Long-lasting psychological morbidity associated with HG was evident. Significantly more women in the case group sought help for mental health symptoms in the antenatal period, however very few were diagnosed with or treated for depression in pregnancy or referred to specialist perinatal mental health services. HG did not directly affect infant bonding. Women in the case group required long periods off work, highlighting the socioeconomic impact of HG.