Community, facility and individual level impact of integrating mental health screening and treatment into the primary healthcare system in Sehore district, Madhya Pradesh, India.

INTRODUCTION: Programme for Improving Mental Health Care (PRIME) designed a comprehensive mental healthcare plan (MHCP) for Sehore district, Madhya Pradesh, India. The objective of this paper is to describe the findings of the district-level impact evaluation of the MHCP. METHODS: Repeat community-based CS were conducted to measure change in population-level contact coverage for depression and alcohol use disorders (AUD), repeat FDS were conducted to assess change in detection and initiation of treatment for depression and AUD, and the effect of treatment on patient outcomes was assessed using disorder-specific prospective cohort studies. RESULTS: PRIME MHCP did not have any impact on contact coverage/treatment seeking for depression (14.8% at the baseline and 10.5% at the follow-up) and AUD (7.7% at the baseline and 7.3% at the follow-up) and had a small impact on detection and initiation of treatment for depression and AUD (9.7% for depression and 17.8% for AUD compared with 0% for both at the baseline) in the health facilities. Patients with depression who received care as part of the MHCP had higher rates of response (52.2% in the treatment group vs 26.9% in the comparison/usual care group), early remission (70.2% in the treatment group vs 44.8% in the comparison/usual care group) and recovery (56.1% in the treatment group vs 28.5% in the comparison/usual care group), but there was no impact of treatment on their functioning. CONCLUSIONS: While dedicated human resources (eg, Case Managers) and dedicated space for mental health clinics (eg, Mann-Kaksha) strengthen the 'formal' healthcare platform, without substantial additional investments in staff, such as Community Health Workers/Accredited Social Health Activists to improve community level processes and provision of community-based continuing care to patients, we are unlikely to see major changes in coverage or clinical outcomes.

Maternal mental health in primary care in five low- and middle-income countries: a situational analysis.

BACKGROUND: The integration of maternal mental health into primary health care has been advocated to reduce the mental health treatment gap in low- and middle-income countries (LMICs). This study reports findings of a cross-country situation analysis on maternal mental health and services available in five LMICs, to inform the development of integrated maternal mental health services integrated into primary health care. METHODS: The situation analysis was conducted in five districts in Ethiopia, India, Nepal, South Africa and Uganda, as part of the Programme for Improving Mental Health Care (PRIME). The analysis reports secondary data on the prevalence and impact of priority maternal mental disorders (perinatal depression, alcohol use disorders during pregnancy and puerperal psychosis), existing policies, plans and services for maternal mental health, and other relevant contextual factors, such as explanatory models for mental illness. RESULTS: Limited data were available at the district level, although generalizable data from other sites was identified in most cases. Community and facility-based prevalences ranged widely across PRIME countries for perinatal depression (3-50 %) and alcohol consumption during pregnancy (5-51 %). Maternal mental health was included in mental health policies in South Africa, India and Ethiopia, and a mental health care plan was in the process of being implemented in South Africa. No district reported dedicated maternal mental health services, but referrals to specialised care in psychiatric units or general hospitals were possible. No information was available on coverage for maternal mental health care. Challenges to the provision of maternal mental health care included; limited evidence on feasible detection and treatment strategies for maternal mental disorders, lack of mental health specialists in the public health sector, lack of prescribing guidelines for pregnant and breastfeeding women, and stigmatising attitudes among primary health care staff and the community. CONCLUSIONS: It is difficult to anticipate demand for mental health care at district level in the five countries, given the lack of evidence on the prevalence and treatment coverage of women with maternal mental disorders. Limited evidence on effective psychosocial interventions was also noted, and must be addressed for mental health programmes, such as PRIME, to implement feasible and effective services.

Development and piloting of a plan for integrating mental health in primary care in Sehore district, Madhya Pradesh, India.

BACKGROUND: The large treatment gap for mental disorders in India underlines the need for integration of mental health in primary care. AIMS: To operationalise the delivery of the World Health Organization Mental Health Gap Action Plan interventions for priority mental disorders and to design an integrated mental healthcare plan (MHCP) comprising packages of care for primary healthcare in one district. METHOD: Mixed methods were used including theory of change workshops, qualitative research to develop the MHCP and piloting of specific packages of care in a single facility. RESULTS: The MHCP comprises three enabling packages: programme management, capacity building and community mobilisation; and four service delivery packages: awareness for mental disorders, identification, treatment and recovery. Challenges were encountered in training primary care workers to improve identification and treatment. CONCLUSIONS: There are a number of challenges to integrating mental health into primary care, which can be addressed through the injection of new resources and collaborative care models.

Challenges for Transformation: A Situational Analysis of Mental Health Care Services in Sehore District, Madhya Pradesh.

The proportion of individuals with mental disorders receiving evidence based treatments in India is very small. In order to address this huge treatment gap, programme for improving mental health care is being implemented in Sehore district of Madhya Pradesh, India. The aim of this study was to complete the situational analysis consisting of two parts; document review of Sehore district mental health programme followed by a qualitative study. The findings suggest that there are major health system challenges in developing and implementing the mental health care plan to be delivered through primary health care system in Sehore district.

In-vitro thrombogenicity assessment of polymer filament modified and native platinum embolic coils.

BACKGROUND: Embolic coils have been used to treat intracranial aneurysms using an endovascular approach for more than two decades. However, significant aneurysm recanalization rates have been reported specifically in large and giant aneurysms. Adding filaments to bare Platinum coils is considered a modification and has been proposed to achieve higher aneurysm occlusion rates as compared to bare Platinum coils. Quantitative information - in terms of thrombin generation potential of these modifications - is however lacking. OBJECTIVE: We report here in vitro thrombogenicity of Platinum coils containing Nylon (Axium™ MicroFx™ Nylon coil) and PGLA (Axium™ MicroFx™ PGLA coil) filaments and compare them with equivalent bare Platinum Axium™ coils. METHOD: We utilize a quantitative method that tracks the formation of thrombin upon exposure of the test samples to human platelet rich plasma using a slow binding fluorogenic substrate. RESULTS: We report a significant increase in the total thrombin turnover, the peak thrombin amount and the rate of thrombin generation for the Axium™ MicroFx™ coils and filaments compared to the Axium™ coils and Platinum wire. CONCLUSION: Nylon and PGLA filaments added to bare Platinum coils increase thrombogenicity of coils. This study offers a robust quantitative method to compare thrombus formation efficacy of embolic coils under static conditions.

Genetic risk factors in recurrent venous thromboembolism: A multilocus, population-based, prospective approach.

BACKGROUND: Recurrent venous thromboembolism (VTE) is a common, complex disorder; however, genetic factors have been suggested to play a role in the disease development. We therefore conducted a multi-locus genetic study examining the potential associations of candidate gene variants in inflammation, thrombosis, coagulation, and lipid metabolism pathways, individually or interactively, with risk of recurrent VTE. METHODS: Using DNA samples collected at baseline in the Prevention of Recurrent Venous Thromboembolism trial (PREVENT), we genotyped 86 candidate genes polymorphisms among 43 individuals who subsequently developed recurrent VTE and among 396 individuals who remained free of recurrent event over a mean follow-up period of 2.1 years to prospectively determine whether these gene polymorphisms contribute to the risk of recurrent VTE. RESULTS: Using a single-marker 'uncorrected' analysis, CCR5 A(-2459)G [rs1799864], MMP3 5A(-1171)6A [rs3025058] and PON1 gln192arg [rs662] gene variants were associated with increased risk, and CETP C(-629)A [rs1800775] gene variant with reduced risk of recurrent VTE, respectively. Furthermore, potentially important gene-gene-interactions were detected by the Monte Carlo Markov chain Logic Regression method. CONCLUSIONS: Although the present findings are hypothesis-generating and require confirmation in an independent investigation, our study provides a practical example of detecting epistasis in common, complex diseases.

Evaluation of efficacy and safety of fixed dose combination of ceftazidime-tobramycin in comparison with ceftazidime in lower respiratory tract infections.

Lower respiratory tract infections are major cause of morbidity and mortality. Objectives were to evaluate efficacy and safety of fixed dose combination (FDC) of Ceftazidime and Tobramycin in comparison with Ceftazidime alone in patients with lower respiratory tract infections. Patients (n=240) were randomly distributed in two arms: one arm was treated with Ceftazidime(1g)-Tobramycin(120mg) and other arm was treated with Ceftazidime (1g) alone. Patients were clinically, radiologically and bacteriologically evaluated. Clinically successful outcome was seen in 88.4% of the patients in Ceftazidime-Tobramycin treated group as compared to 61.2% in Ceftazidime alone treated group. In Ceftazidime-Tobramycin treated group, majority of pathogen isolated were H.inflenzae (35%), P. aeruginosa (24.16%), K. pneumoniae (16.66%) and M. catarrhalis (24.16%), whereas in Ceftazidime alone treated group majority of pathogen isolated were H.inflenzae (33.33%), P. aeruginosa (20%), K. pneumoniae (18.33%) and M. catarrhalis (28.33%). In Ceftazidime-Tobramycin treated group (98%), a significantly higher bacterial eradication was observed than Ceftazidime alone treated group (79%). Radiological improvement was also superior in Ceftazidime-Tobramycin treated group. No major adverse events were observed. Results showed that fixed dose combination of Ceftazidime Tobramycin is superior than Ceftazidime alone in the treatment of lower respiratory tract infections.

A novel high performance liquid chromatographic method for simultaneous determination of ceftriaxone and sulbactam in sulbactomax.

An isocratic liquid chromatographic method with UV detection at 220 nm is described for simultaneous determination of ceftriaxone sodium and sulbactam sodium in Sulbactomax. Chromatographic separation of two drugs was achieved on a Hypersil ODS C-18 column using a mobile phase consisting of a binary mixture of acetonitrile and tetrabutyl ammonium hydroxide adjusted to pH7.0 with orthophosphoric acid in ratio 70:30. The developed Liquid Chromatographic method offers symmetric peak shape, good resolution and reasonable retention time for both drugs. Linearity, accuracy and precision were found to be acceptable over the concentration range of 125-750 ppm for ceftriaxone sodium and 62.5-375 ppm for sulbactam sodium. The LC method can be used for the quality control of formulated products containing ceftriaxone and sulbactam.

Systematic review: D-dimer to predict recurrent disease after stopping anticoagulant therapy for unprovoked venous thromboembolism.

BACKGROUND: The optimal duration of anticoagulation for a first episode of unprovoked venous thromboembolism (VTE) is uncertain. Methods for predicting risk for recurrence may identify low-risk patients who are less likely to benefit from prolonged anticoagulation. PURPOSE: To synthesize evidence evaluating the value of D-dimer as a predictor of recurrent disease in patients who have stopped anticoagulant therapy after a first unprovoked VTE. DATA SOURCES: The MEDLINE, EMBASE, CINAHL, and Cochrane databases were searched until March 2008 without language restrictions. The strategy was supplemented with manual review of reference lists and contact with content experts. STUDY SELECTION: Randomized, controlled trials or prospective cohort studies that measured D-dimer after anticoagulant therapy in patients who received at least 3 months of anticoagulant treatment of unprovoked VTE. DATA EXTRACTION: Two authors independently reviewed articles and extracted data. DATA SYNTHESIS: Seven studies, totaling 1888 patients with a first unprovoked VTE, were eligible for analysis. During 4500 person-years of follow up, annual rates of recurrent VTE differed statistically significantly: 8.9% (95% CI, 5.8% to 11.9%) in patients with positive D-dimer results and 3.5% (CI, 2.7% to 4.3%) in patients with negative D-dimer results. LIMITATION: The duration of anticoagulation, timing of D-dimer testing, and D-dimer assay varied across studies. CONCLUSION: In patients who have completed at least 3 months of anticoagulation for a first episode of unprovoked VTE and after approximately 2 years of follow-up, a negative D-dimer result was associated with a 3.5% annual risk for recurrent disease, whereas a positive D-dimer result was associated with an 8.9% annual risk for recurrence. These rates should inform decisions about the balance of risks and benefits of prolonging anticoagulation.

Efficacy and safety evaluation of fixed dose combination of cefepime and amikacin in comparison with cefepime alone in treatment of nosocomial pneumonia patients.

Nosocomial pneumonia is the most frequent and leading cause of morbidity and mortality. Pseudomonas aeruginosa, the most frequent causative agent, is intrinsically resistant to most antibiotics. The study was aimed at comparing the efficacy and safety of fixed dose combination (FDC) of Cefepime and Amakacin with that of Cefepime alone in treatment of patients suffering from nosocomial pneumonia. Patients suffering from nosocomial pneumonia participated in an open-labeled, two-arm, randomized, comparative, multicentric trial. One group (n=100) of patients were treated with intravenous injection of Cefepime and Amakacin FDC 2.5g b.i.d and other group (n=100) were treated with intravenous injection of Cefepime alone 2.0g b.i.d, for 7-10 days. Outcome of therapy was evaluated on the basis of clinical and bacteriological evaluation. Clinical and bacteriological successful outcomes were significantly higher in the patients treated with Cefepime and Amakacin FDC than Cefepime alone treated patients. Analysis of patients infected with Pseudomonas aeruginosa amongst the two treatment arms indicated that clinical and bacteriological success is significantly higher in Cefepime and Amakacin FDC treated patients than Cefepime alone treated group. No major adverse events with observed in both the treatment arms. In conclusion, fixed dose combination of Cefepime and Amakacin was more effective in the treatment of nosocomial pneumonia than Cefepime alone.

Efficacy and safety study of fixed-dose combination of ceftriaxone-vancomycin injection in patients with various infections.

Pathogens can infect almost all tissues and cause serious infections. Objective was to evaluate efficacy and safety of fixed-dose combination of Ceftriaxone-Vancomycin in patients with various infections. Patients (n=305) suffering from different bacterial infections (serious respiratory tract disease, bronchitis, gastrointestinal tract infections, urinary tract infection, cellulites and meningitis) were enrolled. Patients were randomized into two groups depending on severity of illness. Group A (n=106) and Group B (n=199) patients were given intravenous dose of fixed-dose combination 1.5 g B.D. and 3.0 g B.D. respectively for 3-10 days. Hemoglobin, total leukocyte count, erythrocyte sedimentation rate, urea, creatinine levels serum glutamyl oxaloacetic transaminase and glutamyl pyruvic transaminase activities were recorded before and on completion of the treatment. Most of patients (70%) were cured in seven or less than seven days of the treatment. Significant decrease in total leukocyte count, erythrocyte sedimentation rate levels were observed indicating patients were cured from the infections. No significant alterations were observed in hemoglobin, serum urea, creatinine levels, glutamyl oxaloacetic transaminase and glutamyl pyruvic transaminase activities on completion of treatment. The fixed-dose combination of Ceftriaxone-Vancomycin, is found to be effective in treating various bacterial infections without any toxic effect on liver and kidney. Patients well tolerated the drug without major adverse effects.

Fracture of self-expanding nitinol stents stressed in vitro under simulated intravascular conditions.

OBJECTIVE: The use of intravascular stents in the superficial femoral artery (SFA) continues to be controversial due to the potential for compression and fracture in the tortuous physical environment of the adductor canal. The purpose of this study was to (1) characterize the types and ranges of stent distortion theoretically produced by extremity movement and (2) use these ranges as parameters for in vitro long-term fatigue testing of commercially available self-expanding nitinol stents. METHODS: Nitinol self-expanding stents were placed in the SFAs of cadavers and lateral view radiographs were obtained with the limb in various degrees of hip and knee flexion. The measured degrees of axial shortening and bending of the stent were estimated by planimetry and used for in vitro fatigue testing, which was undertaken using specially designed equipment. Six different commercially available nitinol self-expanding stents-Protégé EverFlex (EV3, Minneapolis, Minn), S.M.A.R.T. Control (Cordis/Johnson & Johnson, Miami Lakes, Fla), Luminexx (C.R. Bard, Murray Hill, NJ), LifeStent FlexStar (Edwards Lifesciences, Irvine, Calif), and Xceed and Absolute (Abbott Vascular, Santa Clara, Calif)-were mounted in elastic silicone tubing, bathed in phosphate buffered saline at 37 degrees +/- 2 degrees C, and examined for fracture after 10 million cycles of chronic deformation. RESULTS: For unstented arteries, the distal SFA/proximal popliteal artery exhibited the greatest axial compression (23%) vs the middle SFA (9%) or popliteal artery (14%) at 90 degrees /90 degrees knee/hip flexion. For stented arteries, the popliteal artery exhibited the most axial compression (11%) vs the middle SFA (3%) or distal SFA/proximal popliteal artery (6%) at 90 degrees /90 degrees knee/hip flexion. Axial compression of the stented popliteal artery at 70 degrees /20 degrees knee/hip flexion was 6% with a deflection angle of 33 degrees . These parameters were used for chronic in vitro fatigue testing, which produced a range of responses in commercially available stents. Chronic 5% axial compression resulted in high rates of fracture of Luminexx (80%) and LifeStent FlexStar (50%), with lower fracture rates for Absolute (3%), Protégé EverFlex (0%), and S.M.A.R.T. Control stents (0%). Chronic 48 degrees bending deformation resulted in high rates of fracture in Protégé EverFlex (100%), S.M.A.R.T. Control (100%), and Luminexx stents (100%), with lower rates in Absolute (3%) and LifeStent FlexStar (0%). CONCLUSION: Nitinol self-expanding stents undergo both axial and bending deformation when implanted into the superficial femoral and popliteal arteries. Commercially available stents exhibit a variable ability to withstand chronic deformation in vitro, and their response is highly dependent on the type of deformation applied.

Symptomatic peripheral arterial disease in women: nontraditional biomarkers of elevated risk.

BACKGROUND: Most investigations of novel biomarkers for prediction of cardiovascular disease pertain to coronary artery disease. Few large-scale prospective studies have critically assessed plasma-based factors as predictors of peripheral arterial disease (PAD), and comparative data between individual biomarkers and lipid levels are sparse, especially among women. METHODS AND RESULTS: We evaluated the relationship between baseline levels of several novel biomarkers and confirmed incident symptomatic PAD (n=100) in a prospective cohort study (median follow-up, 12.3 years) involving 27,935 US female health professionals > or = 45 years of age without diagnosed vascular disease at baseline. Biomarkers assessed were high-sensitivity C-reactive protein, fibrinogen, soluble intercellular adhesion molecule-1 (sICAM-1), homocysteine, lipoprotein(a), hemoglobin A1c, creatinine, and conventional lipid levels. In univariate analyses, levels of high-sensitivity C-reactive protein, fibrinogen, sICAM-1, homocysteine, lipoprotein(a), creatinine clearance, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, and the ratio of total cholesterol to HDL-C (TC:HDL-C) were significantly related to PAD (all P<0.05). However, after multivariable adjustment, risk associations were significant only for high-sensitivity C-reactive protein (adjusted hazard ratio [HR] extreme tertiles, 2.1; 95% confidence interval, 1.2 to 3.7), sICAM-1 (adjusted HR, 4.0; 95% confidence interval, 1.9 to 8.6), HDL-C (adjusted HR, 0.4; 95% confidence interval, 0.3 to 0.8), and TC:HDL-C (adjusted HR, 2.2; 95% confidence interval, 1.2 to 3.9). In a model simultaneously controlling for traditional risk factors plus these significant biomarkers, sICAM-1 remained independently predictive of PAD (adjusted HR in each tertile, 1.0 [reference], 2.3, and 3.5). CONCLUSIONS: Among a broad range of biomarkers of cardiovascular risk, only 4 factors, sICAM-1, high-sensitivity C-reactive protein, HDL-C, and TC:HDL-C, were significantly associated with incident symptomatic PAD in women. Findings pertaining to novel biomarkers provide clinical confirmation of a prominent role of endothelial activation and leukocyte recruitment in lower-extremity arterial disease.