Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre,randomised, controlled trial

Background  

Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect.     

Iatrogenic newborn weight loss: knowledge translation using a study protocol for your maternity setting

Background

WHO and UNICEF believe that both antenatal and maternity care organizations are in an excellent position to protect and, if necessary, reinstate a culture that promotes breastfeeding, and that they are responsible for doing so. In Sweden, the number of breastfeeding women has been decreasing annually since 1996. Thus the aim of this study is to identify, describe and analyze the attitude midwives have towards the mother, child and breastfeeding when infant formula is given.

Methods

From the theoretical standpoint of Buber's I-Thou and I-It concept, the different attitudes during breastfeeding consultations are interpreted. By using a phenomenographic approach based on 101 accounts of varying lengths from 39 midwives, different attitudes or approaches were identified.

Results

Four different approaches are distinguished in the breastfeeding consultation. The first is the family as a whole, the second is mother and child as separate and equal, the third views the mother as superior and the fourth views the child as superior.

Conclusions

The approach of the midwife is related to how she defines the overall perspective of the mother-child relationship and how she looks upon her relationship to the mother-child dyad. Her approach varies depending on whether she meets the mother and child as a subject, similar to herself, or whether she sees one of them as an object. A midwife may also take an outside position, as an object, thus excluding a genuine relationship with the mother. The results also indicate that health care professionals focus on parts of the whole instead of maintaining a holistic perspective.     

Evaluation of the efficacy and effectiveness of a structured disorder tailored psychotherapy in ADHD in adults: study protocol of a randomized controlled multicentre trial

ADHD is a serious risk factor for co-occurring psychiatric disorders and negative psychosocial consequences in adulthood. Previous trials on psychotherapeutic concepts for adult ADHD are based on behavioural (cognitive behavioural and dialectical behavioural) psychotherapeutic approaches and showed significant effects. The aim of our study group (COMPAS) is to carry out a first randomized and controlled multicentre study to evaluate the effects of a disorder tailored psychotherapy in adult ADHD compared to clinical management in combination with psychopharmacological treatment or placebo. A total of 448 adults with ADHD according to DSM-IV will be treated at seven university sites in Germany. In a four-arm design, patients are randomized to a manualized dialectical behavioural therapy (DBT) based group programme plus methylphenidate or placebo or clinical management plus methylphenidate or placebo with weekly sessions in the first 12 weeks and monthly sessions thereafter. Therapists are graduated psychologists or physicians. Treatment integrity is established by independent supervision. Primary endpoint (ADHD symptoms measured by the Conners Adult Rating Scale) is rated by interviewers blind to the treatment allocation. Intention-to-treat analysis will be performed within a linear regression model (Current Controlled Trials ISRCTN54096201). The trial is funded by the German Federal Ministry of Research and Education (01GV0606) and is part of the German network for the treatment of ADHD in children and adults (ADHD-NET).     

The optimized acupuncture treatment for neck pain caused by cervical spondylosis: a study protocol of a multicentre randomized controlled trial

ABSTRACT: BACKGROUND: Neck pain is one of the chief complains of patients with cervical spondylosis (CS). Both in China and worldwide, acupuncture is a well-accepted and widely used complementary therapy for the management of neck pain caused by CS. In this paper, we present a protocol designed for a multi-centre, randomised, controlled trial to evaluate the effects of optimised acupuncture treatment for CS neck pain. The study aims to evaluate the effects of the optimised acupuncture treatment in real practice compared with sham and shallow acupuncture therapy. Methods/design This trial uses a multicentre, three-group, randomised, sham acupuncture and shallow acupuncture, controlled single-blind design. Nine hospitals are involved as trial centres. The sample size is calculated based on the formula for a three-group parallel design with a 0.05 significance level and a power of 0.9. A total of 105 cases in a single centre, and a total of 315 cases per each arm are required across all 9 centres. Patients who meet inclusion criteria are randomly assigned to receive optimised acupuncture treatment, sham acupuncture or shallow acupuncture by a computerised central randomisation system. The interventions last for 4 weeks with 8 to 10 treatments. The group allocations and interventions are concealed to patients and statisticians. The Northwick Park Neck Pain Questionnaire (NPQ) is used as the primary outcome measure, and the McGill Pain Questionnaire (MPQ) and The Short Form (36) Health Survey (SF-36) are applied as secondary outcome measures. The evaluation is performed at baseline, at the end of the intervention, and at the end of the first month and the third month during follow-up. The statistical analyses will include baseline data comparison and repeated measures of analysis of variance (ANOVA) for primary and secondary outcomes of group and time differences. Adverse events (AEs) will be reported if they occur. DISCUSSION: This trial is a multicentre randomised control trial (RCT) on the efficacy of acupuncture for CS neck pain and has a large sample size and central randomisation in China. It will strictly follow the CONSORT statement and STRICTA extension guideline to report high-quality study results. By setting the control groups as sham and shallow acupuncture, this study attempts to reveal the effects of real acupuncture versus placebo or non-classic acupuncture therapy and evaluate whether classic Chinese medical acupuncture is effective on CS neck pain. This study will provide evidence for the effects of acupuncture on CS neck pain. Trial Registration: Chinese Clinical Trial Registry: ChiCTR-TRC-00000184.     

The new system of review by multicentre research ethics committees: prospective study

ObjectiveTo assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed.DesignProspectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited.SettingA single multicentre research ethics committee and 125 local ethics committees from six regions of England.ResultsOnly 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested.ConclusionsThe new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.     

Endemic goitre: a research protocol elaboration for eradication

The iodine deficiency (ID), which affects 1 person out of 6, is relatively neglected by the responsible of Public Health Service, particularly in developing countries. Consequences of ID are far from being negligible: mental retardation, hypofertility, hyperplasia, carcinoma, early ageing and, in very exposed areas, endemic cretinism. Nevertheless, eradication is easy and cheap but it requires rigorous protocols and control of results. The elaboration of these protocols is complex because it must be adapted to environment, population and financial possibilities of concerned countries. Based on our experience in this field, we propose a combined protocol, between the Public Health too liberal approach and that of too expensive research, which can be adapted to several situations.     

Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

Background

Recent attention has focused on strategies to combat the forecast epidemic of type-2 diabetes (T2DM) and its major vascular sequelae. Metabolic syndrome (MetS) comprises a constellation of factors that increase the risk of cardiovascular disease (CVD) and T2DM. Our study aims to develop a structured self-management education programme for people with MetS, which includes management of cardiovascular and diabetes risk factors, and to determine its impact. This paper describes the rationale and design of the TRIMS study, including intervention development, and presents baseline data.

Methods

Subjects recruited from a mixed-ethnic population with MetS were randomised to intervention or control arms. The intervention arm received structured group education based on robust psychological theories and current evidence. The control group received routine care. Follow-up data will be collected at 6 and 12 months. The primary outcome measure will be reversal of metabolic syndrome in the intervention group subjects compared to controls at 12 months follow-up.

Results

82 participants (44% male, 22% South Asian) were recruited between November 2009 and July 2010. Baseline characteristics were similar for both the intervention (n = 42) and control groups (n = 40). Median age was 63 years (IQR 57 - 67), mean waist size 106 cm (SD ± 11), and prescribing of statins and anti-hypertensives was 51% in each case.

Conclusion

Results will provide information on changes in diabetes and CVD risk factors and help to inform primary prevention strategies in people with MetS from varied ethnic backgrounds who are at high risk of developing T2DM and CVD. Information gathered in relation to the programme's acceptability and effectiveness in a multi-ethnic population would ensure that our results are widely applicable.

Trial registration

The study is registered at ClinicalTrials.gov, study identifier: NCT01043770.     

Manipulation in treatment of low back pain: a multicentre study.

In a multicentre trial 456 selected patients with low back pain were randomly allocated to one of four treatments-manipulation, definitive physiotherapy, corset, or analgesic tablets. Patients were reassessed clinically after three weeks'' treatment and again after a further three weeks. Questionnaires were used to find out the patients'' condition three months and one year after admission to the trial. There were never any important differences among the four groups of patients. A few patients responded well and quickly to manipulation, but there was no way of identifying such patients in advance. The response to a corset was slow, but the long-tern effects were at least as good as those of the other treatments. Patients treated only with analgesics fared marginally worse than those on the other three treatments. There is no strong reason, however, for recommending manipulation over physiotherapy or corset.     

Developing a set of guidelines for your research field: a practical approach

Since 2008, the autophagy community has periodically published a set of guidelines, currently titled “Guidelines for the Use and Interpretation of Assays for Monitoring Autophagy.” The newest version of the guidelines was published in 2016. There are many reasons for establishing a set of guidelines in a given research field. This Perspective explores some of these reasons, including standardizing nomenclature for better communication, improving reproducibility, and making it easier for newcomers to enter the field. It also includes the approach I have used to generate and update the guidelines that are now widely used in the autophagy field. The suggestions are not meant to be formulaic, and the method is certainly not perfect. Instead, this should be viewed as a starting set of, well, guidelines.     

Tailoring your bee sampling protocol: Comparing three methods reveals the best approaches to capturing bees

1. Bees are prolific, vital pollinators in agricultural and natural settings, but some taxa are declining. Surveying bees is crucial to understand the needs of these taxa; however, we lack a fine-grained understanding of assemblages associated with different sampling methods that would enable us to analyse data range-wide.
2. Here we examine the difference in abundance and richness of bees (bee bowls and vane traps only) and bumble bees (genus Bombus; bee bowls, blue vane traps and target netting) sampled with these methods from mixed-grass prairie to alpine habitats in Wyoming, USA.
3. We collected four times more bees and twice as many genera of bees in vane traps than bee bowls. Vane traps captured more individuals of abundant genera than bee bowls.
4. Bombus species abundance did not vary between vane traps and target netting; however, richness was higher in vane traps. Bee bowls captured few Bombus species.
5. Overall, we recommend using vane traps to sample most bees, and a combination of vane traps and target netting to collect bumble bees. We evaluated how three sampling techniques perform when surveying for wild bees, which will aid in identifying declining species as well as monitoring species of conservation concern.