- Northern Manhattan Hispanic Caregiver Intervention Effectiveness Study: protocol of a pragmatic randomised trial comparing the effectiveness of two established interventions for informal caregivers of persons with dementia. [Journal Article]
- BOBMJ Open 2016 Nov 25; 6(11):e014082
- The prevalence of dementia is increasing without a known cure, resulting in an increasing number of informal caregivers. Caring for a person with dementia results in increased stress and depressive s...
The prevalence of dementia is increasing without a known cure, resulting in an increasing number of informal caregivers. Caring for a person with dementia results in increased stress and depressive symptoms. There are several behavioural interventions designed to alleviate stress and depressive symptoms in caregivers of persons with dementia with evidence of efficacy. Two of the best-known interventions are the New York University Caregiver Intervention (NYUCI) and the Resources for Enhancing Alzheimer's Caregivers Health (REACH). The effectiveness of the NYUCI and REACH has never been compared. There is also a paucity of data on which interventions are more effective in Hispanics in New York City. Thus, we proposed the Northern Manhattan Hispanic Caregiver intervention Effectiveness Study (NHiCE), a pragmatic clinical trial designed to compare the effectiveness of adaptations of the NYUCI and the REACH in informal Hispanic caregivers of persons with dementia in New York City.
- Understanding the functions and operations of data monitoring committees: Survey and focus group findings. [Journal Article]
- CTClin Trials 2016 Nov 24
- CONCLUSIONS: Findings from the survey and focus groups provide a better understanding of contemporary data monitoring committee operations and insights regarding challenges and best practices. Overall, it was clear that increased training will be needed to prepare the next generation of qualified data monitoring committee members to meet the growing demand. These findings can be used by Clinical Trials Transformation Initiative and others to develop recommendations and tools to improve data monitoring committee operations and the overall quality of trial oversight.
- An Observational Registry of Carotid Endarterectomy and Carotid Artery Stenting in Brazil: Study Protocol. [Journal Article]
- JRJMIR Res Protoc 2016 Nov 23; 5(4):e226
- CONCLUSIONS: The analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of São Paulo, Brazil.
- Data and Safety Monitoring Board evaluation and management of a renal adverse event signal in TOPCAT. [Review]
- EJEur J Heart Fail 2016 Nov 21
- Clinical trial Data and Safety Monitoring Boards (DSMBs) have a primary obligation of ensuring study participant safety, while maintaining trial integrity. The role of DSMBs is expanding, and ideally...
Clinical trial Data and Safety Monitoring Boards (DSMBs) have a primary obligation of ensuring study participant safety, while maintaining trial integrity. The role of DSMBs is expanding, and ideally should include post-hoc reporting of deliberative processes related to clinically important safety issues or factors that could impact on future trial designs. We describe how the TOPCAT DSMB detected, investigated, and adjudicated an unexpectedly large renal adverse event signal midway through the trial, and offer general guidelines for dealing with similar unanticipated occurrences in future trials. The detection of a greater than expected incidence of deterioration in renal function, occurring in 6.1% of patients in the spironolactone arm compared with 3.9% in the placebo arm (P = 0.009), led to an in-depth DSMB review of associated study medication withdrawals and adverse events. The trial continued uninterrupted throughout the review, which reached the conclusions that spironolactone-associated renal dysfunction did not compromise overall patient safety or interfere with a perceived efficacy signal. Although no discrete mechanism for the spironolactone-associated renal adverse event signal was identified, likely possibilities are discussed. In clinical trials, DSMBs and co-ordinating centres should have the resources to detect, investigate, and adjudicate unexpected safety issues, with goals of ensuring patient safety and preserving the potential for detection of therapeutic effectiveness. In TOPCAT, spironolactone-associated renal dysfunction emerged as a potentially trial-threatening adverse event and, although clinically important, did not lead to compromise of patient safety, trial interruption, termination, or apparent loss of treatment effectiveness.
- Challenges in the Diagnosis and Management of Growth Hormone Deficiency in India. [Review]
- IJInt J Endocrinol 2016; 2016:2967578
- In clinical practice, every year approximately 150,000 children are referred with short stature (SS) based on a cut-off of fifth percentile. The most important endocrine and treatable cause of SS is ...
In clinical practice, every year approximately 150,000 children are referred with short stature (SS) based on a cut-off of fifth percentile. The most important endocrine and treatable cause of SS is growth hormone deficiency (GHD). The lack of reliable data on the prevalence of GHD in India limits estimation of the magnitude of this problem. The diagnosis and treatment of GHD are hurdled with various challenges, restricting the availability of growth hormone (GH) therapy to only a very limited segment of the children in India. This review will firstly summarize the gaps and challenges in diagnosis and treatment of GHD based on literature analysis. Subsequently, it presents suggestions from the members at advisory board meetings to overcome these challenges. The advisory board suggested that early initiation of the therapy could better the chances of achieving final adult height within the normal range for the population. Education and awareness about growth disorders among parents, regular training for physicians, and more emphasis on using the Indian growth charts for growth monitoring would help improve the diagnosis and treatment of children with GHD. Availability of an easy-to-use therapy delivery system could also be beneficial in improving adherence and achieving satisfactory outcomes.
- Leprosy Post-Exposure Prophylaxis (LPEP) programme: study protocol for evaluating the feasibility and impact on case detection rates of contact tracing and single dose rifampicin. [Journal Article]
- BOBMJ Open 2016 Nov 17; 6(11):e013633
- The reported number of new leprosy patients has barely changed in recent years. Thus, additional approaches or modifications to the current standard of passive case detection are needed to interrupt ...
The reported number of new leprosy patients has barely changed in recent years. Thus, additional approaches or modifications to the current standard of passive case detection are needed to interrupt leprosy transmission. Large-scale clinical trials with single dose rifampicin (SDR) given as post-exposure prophylaxis (PEP) to contacts of newly diagnosed patients with leprosy have shown a 50-60% reduction of the risk of developing leprosy over the following 2 years. To accelerate the uptake of this evidence and introduction of PEP into national leprosy programmes, data on the effectiveness, impact and feasibility of contact tracing and PEP for leprosy are required. The leprosy post-exposure prophylaxis (LPEP) programme was designed to obtain those data.
- Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline. [Journal Article]
- JCJ Clin Endocrinol Metab 2016; 101(11):3922-3937
- CONCLUSIONS: Continuous subcutaneous insulin infusion and continuous glucose monitoring have an important role in the treatment of diabetes. Data from randomized controlled trials are limited on the use of medical devices, but existing studies support the use of diabetes technology for a wide variety of indications. This guideline presents a review of the literature and practice recommendations for appropriate device use.
- Reporting on data monitoring committees in neonatal randomised controlled trials is inconsistent. [Journal Article]
- APActa Paediatr 2016 Sep 16
- CONCLUSIONS: While the majority of neonatal RCTs report on DMC involvement and interim analysis, there is still scope for improvement. Clear documentation of safety-related issues should be a central component of reporting in neonatal trials involving newborn infants.
- School Board Policies on Prevention and Management of Anaphylaxis in İstanbul: Where Do We Stand? [Journal Article]
- BMBalkan Med J 2016; 33(5):539-542
- CONCLUSIONS: Our survey demonstrated critical gaps in the organization of schools for the management of children at risk of anaphylaxis. Data derived from this study would provide the initiative for legislators to review the current situation of school health policies along with the relevant authorities to establish school anaphylaxis guidelines.
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- ME 02-3 EXTENDING SPRINT RESULTS TO DIABETICS. [Journal Article]
- JHJ Hypertens 2016; 34 Suppl 1 - ISH 2016 Abstract Book:e197
- The Systolic Blood Pressure Intervention Trial (SPRINT), sponsored by the National Heart, Lung and Blood Institute in the USA, allocated 9361 hypertensive patients (mean age 68 years) to two systolic...
The Systolic Blood Pressure Intervention Trial (SPRINT), sponsored by the National Heart, Lung and Blood Institute in the USA, allocated 9361 hypertensive patients (mean age 68 years) to two systolic blood pressure treatment targets (either < 120mmHg or < 140mmHg). Although SPRINT intended to enrol hypertensive patients at high cardiovascular risk, it specifically excluded patients with diabetes mellitus or prior stroke. SPRINT was stopped earlier than planned, after a mean follow-up of 3.26 years, on the recommendation of its data and safety monitoring board, and data were published on 9 November 2015. A mean systolic blood pressure reduction to 121.4 mmHg in the intense-treatment group, compared with a mean systolic blood pressure reduction to 136.2 mmHg, was reported to significantly decreasethe primary outcome (the composite of myocardial infarction, acute coronary syndrome, stroke, heart failure or death from cardiovascular disease) by 25% and all-cause mortality by 27%. Although the SPRINT trial provided important information, a number of criticisms has been raised regarding some results of the study. For example the patients included in SPRINT, although all had to have 'increased' cardiovascular risk, cannot be considered at a particularly high level of risk. Indeed, the group with standard treatment had an overall incidence of major cardiovascular events (inclusive of myocardial infarction, acute coronary syndrome, stroke, heart failure and cardiovascular death) just above 2% per year. In particular, incidence of death from cardiovascular disease was rather low (0.43% per year) and only about a quarter of all-cause death, against an expectation of about 50%. A further element of criticisms came from the evidence that the cause-specific event most importantly reduced by intense treatment in SPRINT appears to be heart failure (38 heart failure events prevented of a total of 76 cardiovascular events prevented; a marked reduction in sudden cardiac death, known to be particularly prevalent in heart failure patients). Heart failure is certainly a clinically relevant outcome, but at clear difference from myocardial infarction and stroke, not to say mortality, heart failure in trials is not defined by really 'hard' measures, but on the basis of symptoms diagnosed by hospital physicians the patients are referred to. Furthermore, of all cardiovascular outcomes, heart failure is the one that is not only influenced by blood pressure-lowering per se but also by the class of blood pressure-lowering drugs being used.With this critical background in mind this presentation will examine whether and to what extent the SPRINT trial results can be of help in the treatment of the diabetic hypertensive patients, well known to be characterized by a very high cardiovascular risk as well as by the need of obtaining an effective blood pressure control by antihypertensive treatment. This because international guidelines on hypertension recommend maintaining blood pressure below 140 mmHg systolic and 90 mmHg diastolic in the general hypertensive population up to the age of 80 years. A more aggressive blood pressure target is recommended when the hypertensive patient has an additional risk for cardiovascular disease, such as if the patient has diabetes, renal disease, or a prior history of cardiovascular disease. In these situations, guidelines encourage decreasing blood pressure below 130/80 mmHg to grant additional cardiovascular protection. The possibility that the SPRINT trial results might be applied in diabetic hypertensive patients will be critically examined by reviewing three sets of relevant studies: randomized trials, post-hoc analysis of prospective studies, and studies on organ damage.