Auto-titrating continuous positive airway pressure treatment for obstructive sleep apnoea after acute quadriplegia (COSAQ): study protocol for a randomized controlled trial

BACKGROUND: Quadriplegia is a severe, catastrophic injury that predominantly affects people early in life, resulting in lifelong physical disability. Obstructive sleep apnoea is a direct consequence of quadriplegia and is associated with neurocognitive deficits, sleepiness and reduced quality of life. The usual treatment for sleep apnoea is nasal continuous positive airway pressure (CPAP); however, this is poorly tolerated in quadriplegia. To encourage patients to use this therapy, we have to demonstrate that the benefits outweigh the inconvenience. We therefore propose a prospective, multinational randomized controlled trial of three months of CPAP for obstructive sleep apnoea after acute quadriplegia. METHODS/DESIGN: Specialist spinal cord injury centres across Australia, New Zealand, the UK and Canada will recruit medically stable individuals who have sustained a (new) traumatic quadriplegia (complete or incomplete second cervical to first thoracic level lesions). Participants will be screened for obstructive sleep apnoea using full, portable sleep studies. Those with an apnoea hypopnoea index greater than 10 per hour will proceed to an initial three-night trial of CPAP. Those who can tolerate CPAP for at least 4 hours on at least one night of the initial trial will be randomized to either usual care or a 3-month period of auto-titrating CPAP. The primary hypothesis is that nocturnal CPAP will improve neuropsychological functioning more than usual care alone. The secondary hypothesis is that the magnitude of improvement of neuropsychological function will be predicted by the severity of baseline sleepiness measures, sleep fragmentation and sleep apnoea. Neuropsychological tests and full polysomnography will be performed at baseline and 3 months with interim measures of sleepiness and symptoms of autonomic dysfunction measured weekly. Spirometry will be performed monthly. Neuropsychological tests will be administered by blinded assessors. Recruitment commenced in July 2009. DISCUSSION: The results of this trial will demonstrate the effect of nocturnal CPAP treatment of obstructive sleep apnoea in acute quadriplegia. If CPAP can improve neurocognitive function after injury, it is likely that rehabilitation and subsequent community participation will be substantially improved for this group of predominantly young and severely physically disabled people. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN1260500079965

Association between mental health conditions and rehospitalization, mortality, and functional outcomes in patients with stroke following inpatient rehabilitation

<p>Abstract</p> <p>Background</p> <p>Limited evidence exists regarding the association of pre-existing mental health conditions in patients with stroke and stroke outcomes such as rehospitalization, mortality, and function. We examined the association between mental health conditions and rehospitalization, mortality, and functional outcomes in patients with stroke following inpatient rehabilitation.</p> <p>Methods</p> <p>Our observational study used the 2001 VA Integrated Stroke Outcomes database of 2162 patients with stroke who underwent rehabilitation at a Veterans Affairs Medical Center.</p> <p>Separate models were fit to our outcome measures that included 6-month rehospitalization or death, 6-month mortality post-discharge, and functional outcomes post inpatient rehabilitation as a function of number and type of mental health conditions. The models controlled for patient socio-demographics, length of stay, functional status, and rehabilitation setting.</p> <p>Results</p> <p>Patients had an average age of 68 years. Patients with stroke and two or more mental health conditions were more likely to be readmitted or die compared to patients with no conditions (OR: 1.44, p = 0.04). Depression and anxiety were associated with a greater likelihood of rehospitalization or death (OR: 1.33, p = 0.04; OR:1.47, p = 0.03). Patients with anxiety were more likely to die at six months (OR: 2.49, p = 0.001).</p> <p>Conclusions</p> <p>Patients with stroke with pre-existing mental health conditions may need additional psychotherapy interventions, which may potentially improve stroke outcomes post-hospitalization.</p

Physician reported perception in the treatment of high blood pressure does not correspond to practice

<p>Abstract</p> <p>Background</p> <p>High blood pressure is a significant health problem world-wide. Physician factors play a significant role in the suboptimal control of hypertension in the United States. We sought to better understand primary care physician's opinions regarding use of hypertension guidelines, patient and physician related barriers to treatment and physician treatment decision making in the management of hypertension as part of a first step in developing research tools and interventions designed to address these issues.</p> <p>Methods</p> <p>An IRB approved survey pertaining to physician opinion regarding the treatment of hypertension. Items consisted of questions regarding: 1) knowledge of hypertension treatment guidelines; 2) barriers to hypertension control (physician vs. patient); and 3) self-estimation of physician treatment of hypertension. Descriptive Statistics were used to describe results.</p> <p>Results</p> <p>All physicians were board certified in family or general internal medicine (n = 28). Practices were located in urban (n = 12), suburban (n = 14) and inner city locations (n = 1). All physicians felt they did a good job of treating hypertension. Most physicians felt the biggest barrier to hypertension control was patient non-compliance. Half of physicians would fail to intensify treatment for hypertension when blood pressure was above recommended levels for all disease states studied (essential hypertension, heart disease, diabetes, and renal disease).</p> <p>Conclusion</p> <p>Physician ability to assess personal performance in the treatment of hypertension and physician opinion that patient noncompliance is the greatest barrier to optimal hypertension control is contradictory to reported practice behavior. Optimal blood pressure control requires increased physician understanding on the evaluation and management of blood pressure. These data provide crucial formative data to enhance the content validity of physician education efforts currently underway to improve the treatment of blood pressure in the primary care setting.</p

Educational outreach in an integrated clinical management tool for nurse-led non-communicable chronic disease management in primary care in South Africa: pragmatic cluster randomised controlled trial

Background: In many low-income countries, care for patients with non-communicable diseases (NCDs) and mental health conditions is provided by nurses. The benefits of nurse substitution and supplementation in NCD care in high income settings are well recognised, but evidence from low- and middle-income countries is limited. Primary Care 101 (PC101) is a programme designed to support and expand nurses’ role in NCD care, comprising a clinical management tool with enhanced prescribing provisions for nurses, and educational outreach. We evaluated the effectiveness of the programme on primary care nurses’ capacity to manage NCDs (ISRCTN20283604). Methods and findings: In a cluster randomised controlled trial design, 38 public sector primary care clinics in the Western Cape province, South Africa, were randomised. Nurses in the intervention clinics were trained to use the PC101 management tool during educational outreach sessions delivered by health department trainers and authorised to prescribe an expanded range of drugs for several NCDs. Control clinics continued use of the Practical Approach to Lung Health and HIV /AIDS in South Africa (PALSA PLUS) management tool and usual training. Patients attending these clinics with one or more of hypertension (3227), diabetes (1842), chronic respiratory disease (1157) or screened positive for depression (2466), totalling 4393 patients, were enrolled between March 2011 and October 2011. Primary outcomes were treatment intensification for hypertension, diabetes, and chronic respiratory disease cohorts, defined as the proportion of patients in whom treatment was escalated during follow-up over 14 months, and case detection in the depression cohort. Primary outcome data were analysed for 2110 (97%) intervention and 2170 (97%) control group patients. Treatment intensification rates in intervention clinics were not superior to those in the control group clinics [hypertension: 44% in the intervention group versus 40% in the controls, risk ratio (RR) 1.08 (95% CI: 0.94 to 1.24; p=0.252); diabetes: 57% v 50%, RR 1.10 (0.97 to 1.24;p=0.126); chronic respiratory disease: 14% v 12%, RR 1.08 (0.75 to 1.55; p=0.674); and case detection of depression: 18% v 24%, RR 0.76 (0.53 to 1.10; p=0.142)]. No adverse effects of the nurses’ expanded scope of practice were observed. Limitations of the study include dependence on self-reported diagnoses for inclusion in the patient cohorts, limited data on uptake of PC101 by users, reliance on process outcomes, and insufficient resources to measure important health outcomes, such as HbA1c, at follow-up. Conclusions: Educational outreach to primary care nurses through use of a management tool involving an expanded role in managing NCDs, is feasible and safe but was not associated with treatment intensification or case detection for index diseases. This notwithstanding, the intervention, with adjustments to improve its effectiveness, has been adopted for implementation in primary care clinics throughout South Africa