Lumbar fusion outcomes stratified by specific diagnostic indication

BACKGROUND: One of the primary difficulties in evaluating the effectiveness of lumbar fusion is that, with the exception of spondylolisthesis, specific diagnostic indications for surgery are poorly defined. Diagnostic specificity beyond the symptom of low back pain or the presence of lumbar degeneration needs to be delineated such that outcomes data can be effectively translated into clinical decision making or evidence-based guidelines. PURPOSE: The purpose of this study was to report on prospectively collected clinical outcome measures, stratified by diagnosis, among a series of patients with lumbar degenerative disease whose treatment included lumbar spine fusion. STUDY DESIGN: Demographics, diagnostic categorization, and clinical outcome measures were prospectively collected by six spine surgeons at a single tertiary spine center, as part of the surgeons' standard clinical practice. PATIENT SAMPLE: Four hundred and twenty-eight patients were enrolled in the study and complete 1- and 2-year Health-Related Quality of Life (HRQOL) data were available in 327 patients whose treatment included decompression and posterolateral lumbar fusion. OUTCOME MEASURES: The Oswestry Disability Index (ODI), Short Form-36 (SF-36), numeric rating scales for back pain and leg pain. METHODS: Preoperative diagnosis was classified, in the primary surgical cases, as disc pathology, spondylolisthesis, instability, stenosis, or scoliosis. In revision cases, the diagnosis was classified as nonunion, adjacent level degeneration, or postdiscectomy revision. Patient-reported outcomes at 1 and 2 years post-op were assessed based on diagnostic stratification. Statistical evaluation of clinical outcome was performed for both mean net change in outcome scores and the percentage of patients reaching a minimum clinically important difference (MCID) threshold for each outcome measure. RESULTS: Preoperative diagnosis was spondylolisthesis (n=80), scoliosis (n=17), disc pathology (n=33), instability (n=21), stenosis (n=46), postdiscectomy revision (n=67), adjacent level degeneration (n=40), or nonunion (n=23). Evaluation of 2-year post-op HRQOL measures by diagnostic subgroup revealed the most substantial improvement in ODI score for patients with spondylolisthesis (22.7 points) and scoliosis (21.2 points). Patients with the diagnosis of disc pathology (16.2 points), postdiscectomy revision (14.0 points), instability (12.7 points), stenosis (10.6 points), and adjacent level degeneration (9.5 points) demonstrated a progressively smaller magnitude of ODI improvement. The least ODI improvement at 2 years after surgery was seen in patients with nonunion of a prior fusion (5.5 points). The percentage of patients reaching MCID for ODI at 2 years post-op ranged from 71.0% in the spondylolisthesis subgroup to 34.8% in the nonunion subgroup. The greatest SF-36 physical component score improvement at 2-year follow-up was seen in patients with disc pathology (7.9 points) and spondylolisthesis (7.7 points), followed by scoliosis (6.6 points) and stenosis (6.5 points), instability (5.6 points), postdiscectomy revision (5.3 points) nonunion (3.1 points) and adjacent level degeneration (2.5 points). No significant changes from Year 1 to Year 2 were noted in any of the subgroups. For SF-36 physical component score, percentage of patients reaching MCID ranged from 63.6% in the disc pathology subgroup to 25% in the nonunion subgroup. CONCLUSIONS: This study supports the concept that added diagnostic specificity is a critical component in building an improved evidence base for lumbar fusion surgery. The magnitude of HRQOL improvement was not equal among diagnostic subgroups. The percentage of patients reaching an MCID level of improvement was also significantly influenced by diagnostic stratification. Without diagnostic specificity for entities beyond spondylolisthesis, the absence of well-defined study populations will continue to limit our ability to move toward evidence-based decision making.     

Neuromuscular features in Marfan syndrome

Marfan syndrome is a clinically and allelic heterogeneous, heritable connective tissue disorder with infrequently reported neuromuscular features. This study is the first to delineate these symptoms in a non-selected population. Neuromuscular involvement was evaluated in 10 Marfan patients through a standardized questionnaire, physical examination, nerve conduction study (NCS), needle electromyography (EMG), muscle ultrasound, laboratory investigation, and muscle biopsy. Existing neuroimages were screened for dural ectasia and spinal meningeal cysts. Twenty healthy controls with similar age distribution completed the questionnaire.
The results showed that various neuromuscular symptoms occur more frequently in the patients. Four older patients reported muscle weakness, five patients had a mild-to-moderate reduction in vibration sense, and all older patients mentioned mild functional impairments. NCS showed axonal polyneuropathy in four and EMG myopathic and neurogenic changes in all patients. Increased echo intensity and atrophy on muscle ultrasound was found in more than half of the patients. Muscle biopsies obtained in two patients showed myopathic changes in the older, female patient.
In conclusion, the majority of Marfan patients exhibited neuromuscular symptoms characterized as myopathy or polyneuropathy or both, and signs of lumbosacral radiculopathy, with symptoms being most pronounced in the older patients. Although meriting corroboration, these findings indicate a need to further the awareness of neuromuscular involvement in this population.     

Who has access to counseling and testing and anti-retroviral therapy in Malawi – an equity analysis

Background  

The HIV and AIDS epidemic in Malawi poses multiple challenges from an equity perspective. It is estimated that 12% of Malawians are living with HIV or AIDS among the 15-49 age group. This paper synthesises available information to bring an equity lens on Counselling and Testing (CT) and Antiretroviral Therapy (ART) policy, practice and provision in Malawi.     

The disutility of restenosis �C the impact of repeat percutaneous coronary intervention on quality of life

BACKGROUND:

Percutaneous coronary intervention (PCI) with coronary stenting is a common medical procedure that is used to treat the symptoms of both stable angina and acute coronary syndromes. Drug-eluting stents (DES) decrease restenosis and repeat revascularization procedures but are more expensive than bare-metal stents. A proper cost-effectiveness analysis of DES requires an understanding of the health value patients place on the avoidance of restenosis accompanied by a repeat PCI.

OBJECTIVE:

To estimate quality-of-life (QoL) benefits ascribed to avoiding the return of coronary symptoms and the need for a repeat revascularization procedure.

METHODS:

A prospective, single-centre study was conducted involving PCI patients. A time trade-off (TTO) question, based on a hypothetical restricted lifespan of 10 years, was used to estimate the QoL benefits patients attach to the avoidance of recurrent symptoms and a repeat PCI. This was accomplished by interviewing the patients by telephone, two weeks post-PCI. The TTO question was also administered to the catheterization laboratory staff.

RESULTS:

Between January and March 2007, and between April and June 2008, 103 interviews were completed. The median TTO was zero weeks (interquartile range zero to 1.7 weeks). Six interventional cardiologists and eight cardiac catheterization nurses reported a similar median disutility.

CONCLUSION:

Despite acknowledgement of the substantial clinical benefits of DES, the results of the present study suggest that patients do not place a great disutility on avoiding restenosis, thereby providing little QoL justification for the large incremental cost associated with this technology.     

Evaluating a streamlined clinical tool and educational outreach intervention for health care workers in Malawi: the PALM PLUS case study

BACKGROUND: Nearly 3 million people in resource-poor countries receive antiretrovirals for the treatment of HIV/AIDS, yet millions more require treatment. Key barriers to treatment scale up are shortages of trained health care workers, and challenges integrating HIV/AIDS care with primary care. THE RESEARCH: PALM PLUS (Practical Approach to Lung Health and HIV/AIDS in Malawi) is an intervention designed to simplify and integrate existing Malawian national guidelines into a single, simple, user-friendly guideline for mid-level health care workers. Training utilizes a peer-to-peer educational outreach approach. Research is being undertaken to evaluate this intervention to generate evidence that will guide future decision-making for consideration of roll out in Malawi. The research consists of a cluster randomized trial in 30 public health centres in Zomba District that measures the effect of the intervention on staff satisfaction and retention, quality of patient care, and costs through quantitative, qualitative and health economics methods. RESULTS AND OUTCOMES: In the first phase of qualitative inquiry respondents from intervention sites demonstrated in-depth knowledge of PALM PLUS compared to those from control sites. Participants in intervention sites felt that the PALM PLUS tool empowered them to provide better health services to patients. Interim staff retention data shows that there were, on average, 3 to 4 staff departing from the control and intervention sites per month. Additional qualitative, quantitative and economic analyses are planned. THE PARTNERSHIP: Dignitas International and the Knowledge Translation Unit at the University of Cape Town Lung Institute have led the adaptation and development of the PALM PLUS intervention, using experience gained through the implementation of the South African precursor, PALSA PLUS. The Malawian partners, REACH Trust and the Research Unit at the Ministry of Health, have led the qualitative and economic evaluations. Dignitas and Ministry of Health have facilitated interaction with implementers and policy-makers. CHALLENGES AND SUCCESSES: This initiative is an example of South-South knowledge translation between South Africa and Malawi, mediated by a Canadian academic-NGO hybrid. Our success in developing and rolling out PALM PLUS in Malawi suggests that it is possible to adapt and implement this intervention for use in other resource-limited settings.     

NeuroAIDS in Africa

In July 2009, the Center for Mental Health Research on AIDS at the National Institute of Mental Health organized and supported the meeting “NeuroAIDS in Africa.” This meeting was held in Cape Town, South Africa, and was affiliated with the 5th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Presentations began with an overview of the epidemiology of HIV in sub-Saharan Africa, the molecular epidemiology of HIV, HIV-associated neurocognitive disorders (HANDs), and HAND treatment. These introductory talks were followed by presentations on HAND research and clinical care in Botswana, Cameroon, Ethiopia, The Gambia, Kenya, Malawi, Nigeria, Senegal, South Africa, Uganda, and Zambia. Topics discussed included best practices for assessing neurocognitive disorders, patterns of central nervous system (CNS) involvement in the region, subtype-associated risk for HAND, pediatric HIV assessments and neurodevelopment, HIV-associated CNS opportunistic infections and immune reconstitution syndrome, the evolving changes in treatment implementation, and various opportunities and strategies for NeuroAIDS research and capacity building in the region.     

Pharmacological modulation by celecoxib of cachexia associated with experimental arthritis and atherosclerosis in rabbits

BACKGROUND AND PURPOSE

Non-steroidal anti-inflammatory drugs improve inflammatory cachexia in several conditions. Thus, we have explored inhibition of cyclooxygenase-2 (COX-2) in an experimental model of rheumatoid cachexia in rabbits.

EXPERIMENTAL APPROACH

Chronic arthritis was induced in immunized rabbits by repeated intra-articular injections of ovalbumin. To increase the degree of systemic inflammation and also to induce atherosclerotic lesions, the animals were fed a hyperlipidaemic diet (2% cholesterol and 6% peanut oil) and were given an endothelial injury of the femoral artery. Rabbits were randomized to receive the COX-2 inhibitor celecoxib (10 mg·kg⁻¹·day⁻¹) or no treatment. After 4 weeks, sera, peripheral mononuclear cells and vessel specimens were collected.

KEY RESULTS

Inhibition of COX-2 by celecoxib modulated the systemic inflammatory response and increased total cholesterol and triglyceride levels. Celecoxib also minimized weight loss and prevented serum albumin fall. At a vascular level, celecoxib reduced COX-2 protein in the femoral arterial wall, but did not modify size or the macrophage infiltration of femoral lesions nor the percentage of rabbits with spontaneous aortic plaques.

CONCLUSIONS AND IMPLICATIONS

Our animal model induced a severe inflammatory cachexia, comparable to that of persistently active rheumatoid arthritis. The inhibition of COX-2 by celecoxib improves this state, suggesting that COX products play an important role in its development, without affecting the development or the progression of vascular lesions. Overall, these results suggest that celecoxib might be considered as a new therapeutic tool for the treatment of rheumatoid cachexia.