Drug utilization study of off-label drug use in outpatient department of psychiatry: a prospective study at a tertiary care teaching hospital

Background: In the absence of standard psychiatric prescribing information, physician often use drugs in an off-label way. Many studies have been published across the globe reporting different rates of off-label use. There is currently no study based on Indian Drug Formulary.Methods: After taking permission from Institutional Ethics Committee (IEC), a prospective study was conducted among 285 patients attending Psychiatry outpatient department for the period of 4 months. Data related to demographic parameters, diagnosis of psychiatry conditions and drugs details were collected directly from the patient's medical records and entered in Case Record Form (CRF).The off-label drugs were categorized as per National Formulary of India. Multivariate binary logistic regression model was used to determine the predictors of off- label drug prescribing. The data were statistically analyzed using SPSS version 19 and chi-square test.Results: A total of 285 patients (169 males, 116 females) were included in the study with mean age of 36.54±13.91 years. Most of the patients (n=65, 22.8%) were diagnosed as schizophrenic. Out of 285 patients, 133(46.6%) received at least one off-label drug. A total 841 drugs were prescribed out of which 167(19.85%) were off-label. The drug most frequently prescribed as off-label were trihexiphenidyl HCL 29 (10.2%), clozapine 23 (8.1%) and clonazepam 13 (4.6%).Conclusions: Off label drugs used among psychiatry patients was 19.85%. The most frequently used off-label drugs was trihexiphenidyl HCL. The use of off-label drugs in psychiatric patients has been reportedly increasing which warrant national drug regulatory authorities to review and revise safe administration such drugs

Evaluation of the nutritional quality of selected dietary ingredients for mud crab Scylla serrata of Suarashtra region in Gujarat, India

Mud crabs, or mangrove crabs, are one of the most valuable groups of crab species in the world. Several studies have been conducted to describe the nutrient requirements of mud crabs. Only preliminary studies have been conducted to define the nutritional ingredients requirements for growing out diets. Results of the analysis revealed the major components of seaweeds (Ulva reticulate and Sargassum cinctum) poultry waste, earth worms and fish meal with carbohydrate 57.18 % (Ulva reticulate) and 55.86 % (Sargassum cinctum), 31.07 %, 21.83 % and 2.89 %, followed by ash content of 21.3 % (U. reticulate) and 14.1 % (S. cinctum), 8.4 %, 12.0 % and 8.40 %, respectively. The crude protein component of fishmeal, soyabean meal, earthworms and seaweeds were obtained in little amount with 61.20 %, 48.3%, 36.2 % and 13.41 % (U. reticulate) and 10.67% (S. cinctum) and followed by crude lipid component of poultry waste 25.0%, seaweeds 13.41 % (U. reticulate) and 10.67 % (S. cinctum), earthworms 9.52% and fishmeal 9.20%  respectively. These results of nutritional composition indicated that poultry waste, earthworms and seaweeds have potential as a source of feed supplement and human nutrition

Effect of higher salinities on growth and survival of pacific white shrimp, Litopenaeus vannamei (Boone, 1931)

The growth and survival of Litopenaeus vannamei post larvae was measured in controlled different salinities condition 35ppt (T1), 40ppt (T2), 45ppt (T3) and 50ppt (T4) were maintained. Group of Shrimp post larvae (weight 0.032 g ± 0.002) were stocked at a density of 35 nos. /aquarium in above salinity ranges. Animals were fed with commercial feed (35% Crude Protein) @ 5% of body weight four times a day. The results indicate that higher SGR was observed in T2 (1.99±0.08) followed by T1 (1.75±0.07), T3 (1.54±0.06) and T4 (1.49±0.17). Highest survival (100 %) was recorded in T1 followed by T2 (96.42%), T3 (94.99%) and T4 (74.21%). From the results of the present study it could be seen that higher salinity significantly reduced the growth and survival of L. vannamei but will also open study area of physiological adaption of animal at higher saline water in performance of organisms

Effect of partial replacement of fishmeal with Eichhornia crassipes on growth and survival of Labeo rohita (Hamilton, 1822) juveniles

The objective of the study was to find out the effect of partial replacement of fish meal in the diet of Labeo rohita juveniles. In this experiment, the data pertaining to growth, survival rate, feed conversion ratio, protein efficiency ratio of L. rohita at partial replacement of fishmeal with E. crassipes were evaluated. For that purpose fry of approximately equal weight (57.97mg ± 1.25) were distributed in groups of 15 to each four aquaria at 0% (T1), 10% (T2), 20% (T3), 30% (T4) and 40% (T5) inclusion levels of aquatic macrophyte, Eichhornia crassipes. Maximum mean weight gain (235.25 ± 11.04 mg) was observed in T1 and minimum (165.06 ± 10.93 mg) was observed in T5 at the end of the experiment. Among the treatments tested, the highest survival (89.99% ± 1.93) was recorded in treatment T1 and minimum was found in T4 (79.99% ± 2.72). Lowest FCR was recorded in treatment T3 (2.02 ± 0.39) and highest was found in T5 (3.08 ± 0.59). Higher SGR was observed in treatment T1 (297.15 ± 18.78%) and minimum was observed in T5 (182.74 ± 18.45%). The study revealed a decrease in the growth performance indices as the percentage of water hyacinth increases. In present study also there was not much difference in growth rate upto 20% incorporation of E. crassipes in the diet. Also, significant difference was observed among treatments with respect to feed utilization (P<0.05)

Problems persist in reporting of methods and results for the WOMAC measure in hip and knee osteoarthritis trials

Purpose The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a commonly used outcome measure for osteoarthritis. There are different versions of the WOMAC (Likert, visual analogue or numeric scales). A previous review of trials published before 2010 found poor reporting and inconsistency in how the WOMAC was used. This review explores whether these problems persist. Methods This systematic review included randomised trials of hip and/or knee osteoarthritis published in 2016 that used the WOMAC. Data were extracted on the version used, score range, analysis and results of the WOMAC, and whether these details were clearly reported. Results This review included 62 trials and 41 reported the WOMAC total score. The version used and item range for the WOMAC total score were unclear in 44% (n = 18/41) and 24% (n = 10/41) of trials, respectively. The smallest total score range was 0–10 (calculated by averaging 24 items scored 0–10); the largest was 0–2400 (calculated by summing 24 items scored 0–100). All trials reported the statistical analysis methods but only 29% reported the between-group mean difference and 95% confidence interval. Conclusion Details on the use and scoring of the WOMAC were often not reported. We recommend that trials report the version of the WOMAC and the score range used. The between-group treatment effect and corresponding confidence interval should be reported. If all the items of the WOMAC are collected, the total score and individual subscale scores should be presented. Better reporting would facilitate the interpretation, comparison and synthesis of the WOMAC score in trials

Better Outcomes for Older people with Spinal Trouble (BOOST) Trial: a randomised controlled trial of a combined physical and psychological intervention for older adults with neurogenic claudication, a protocol

Introduction Neurogenic claudication due to spinal stenosis is common in older adults. The effectiveness of conservative interventions is not known. The aim of the study is to estimate the clinical and cost-effectiveness of a physiotherapist-delivered, combined physical and psychological intervention. Methods and analysis This is a pragmatic, multicentred, randomised controlled trial. Participants are randomised to a combined physical and psychological intervention (Better Outcomes for Older people with Spinal Trouble (BOOST) programme) or best practice advice (control). Community-dwelling adults, 65 years and over, with neurogenic claudication are identified from community and secondary care services. Recruitment is supplemented using a primary care-based cohort. Participants are registered prospectively and randomised in a 2:1 ratio (intervention:control) using a web-based service to ensure allocation concealment. The target sample size is a minimum of 402. The BOOST programme consists of an individual assessment and twelve 90 min classes, including education and discussion underpinned by cognitive behavioural techniques, exercises and walking circuit. During and after the classes, participants undertake home exercises and there are two support telephone calls to promote adherence with the exercises. Best practice advice is delivered in one to three individual sessions with a physiotherapist. The primary outcome is the Oswestry Disability Index at 12 months. Secondary outcomes include the 6 Minute Walk Test, Short Physical Performance Battery, Fear Avoidance Beliefs Questionnaire and Gait Self-Efficacy Scale. Outcomes are measured at 6 and 12 months by researchers who are masked to treatment allocation. The primary statistical analysis will be by ‘intention to treat’. There is a parallel health economic evaluation and qualitative study

Computerized clinical decision support systems for therapeutic drug monitoring and dosing: A decision-maker-researcher partnership systematic review

<p>Abstract</p> <p>Background</p> <p>Some drugs have a narrow therapeutic range and require monitoring and dose adjustments to optimize their efficacy and safety. Computerized clinical decision support systems (CCDSSs) may improve the net benefit of these drugs. The objective of this review was to determine if CCDSSs improve processes of care or patient outcomes for therapeutic drug monitoring and dosing.</p> <p>Methods</p> <p>We conducted a decision-maker-researcher partnership systematic review. Studies from our previous review were included, and new studies were sought until January 2010 in MEDLINE, EMBASE, Evidence-Based Medicine Reviews, and Inspec databases. Randomized controlled trials assessing the effect of a CCDSS on process of care or patient outcomes were selected by pairs of independent reviewers. A study was considered to have a positive effect (<it>i.e.</it>, CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.</p> <p>Results</p> <p>Thirty-three randomized controlled trials were identified, assessing the effect of a CCDSS on management of vitamin K antagonists (14), insulin (6), theophylline/aminophylline (4), aminoglycosides (3), digoxin (2), lidocaine (1), or as part of a multifaceted approach (3). Cluster randomization was rarely used (18%) and CCDSSs were usually stand-alone systems (76%) primarily used by physicians (85%). Overall, 18 of 30 studies (60%) showed an improvement in the process of care and 4 of 19 (21%) an improvement in patient outcomes. All evaluable studies assessing insulin dosing for glycaemic control showed an improvement. In meta-analysis, CCDSSs for vitamin K antagonist dosing significantly improved time in therapeutic range.</p> <p>Conclusions</p> <p>CCDSSs have potential for improving process of care for therapeutic drug monitoring and dosing, specifically insulin and vitamin K antagonist dosing. However, studies were small and generally of modest quality, and effects on patient outcomes were uncertain, with no convincing benefit in the largest studies. At present, no firm recommendation for specific systems can be given. More potent CCDSSs need to be developed and should be evaluated by independent researchers using cluster randomization and primarily assess patient outcomes related to drug efficacy and safety.</p

Negative-pressure wound therapy compared with standard dressings following surgical treatment of major trauma to the lower limb: the WHiST RCT.

BACKGROUND: Major trauma is the leading cause of death in people aged  72 hours after injury and inability to complete questionnaires. INTERVENTIONS: Incisional negative-pressure wound therapy (n = 785), in which a non-adherent absorbent dressing covered with a semipermeable membrane is connected to a pump to create a partial vacuum over the wound, versus standard dressings not involving negative pressure (n = 763). Trial participants and the treating surgeon could not be blinded to treatment allocation. MAIN OUTCOME MEASURES: Deep surgical site infection at 30 days was the primary outcome measure. Secondary outcomes were deep infection at 90 days, the results of the Disability Rating Index, health-related quality of life, the results of the Patient and Observer Scar Assessment Scale and resource use collected at 3 and 6 months post surgery. RESULTS: A total of 98% of participants provided primary outcome data. There was no evidence of a difference in the rate of deep surgical site infection at 30 days. The infection rate was 6.7% (50/749) in the standard dressing group and 5.8% (45/770) in the incisional negative-pressure wound therapy group (intention-to-treat odds ratio 0.87; 95% confidence interval 0.57 to 1.33; p = 0.52). There was no difference in the deep surgical site infection rate at 90 days: 13.2% in the standard dressing group and 11.4% in the incisional negative-pressure wound therapy group (odds ratio 0.84, 95% confidence interval 0.59 to 1.19; p = 0.32). There was no difference between the two groups in disability, quality of life or scar appearance at 3 or 6 months. Incisional negative-pressure wound therapy did not reduce the cost of treatment and was associated with a low probability of cost-effectiveness. LIMITATIONS: Owing to the emergency nature of the surgery, we anticipated that some patients who were randomised would subsequently be unable or unwilling to participate. However, the majority of the patients (85%) agreed to participate. Therefore, participants were representative of the population with lower-limb fractures associated with major trauma. CONCLUSIONS: The findings of this study do not support the use of negative-pressure wound therapy in patients having surgery for major trauma to the lower limbs. FUTURE WORK: Our work suggests that the use of incisional negative-pressure wound therapy dressings in other at-risk surgical wounds requires further investigation. Future research may also investigate different approaches to reduce postoperative infections, for example the use of topical antibiotic preparations in surgical wounds and the role of orthopaedic implants with antimicrobial coatings when fixing the associated fracture. TRIAL REGISTRATION: Current Controlled Trials ISRCTN12702354 and UK Clinical Research Network Portfolio ID20416. FUNDING: This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 38. See the NIHR Journals Library for further project information

The subchondral bone in articular cartilage repair: current problems in the surgical management

As the understanding of interactions between articular cartilage and subchondral bone continues to evolve, increased attention is being directed at treatment options for the entire osteochondral unit, rather than focusing on the articular surface only. It is becoming apparent that without support from an intact subchondral bed, any treatment of the surface chondral lesion is likely to fail. This article reviews issues affecting the entire osteochondral unit, such as subchondral changes after marrow-stimulation techniques and meniscectomy or large osteochondral defects created by prosthetic resurfacing techniques. Also discussed are surgical techniques designed to address these issues, including the use of osteochondral allografts, autologous bone grafting, next generation cell-based implants, as well as strategies after failed subchondral repair and problems specific to the ankle joint. Lastly, since this area remains in constant evolution, the requirements for prospective studies needed to evaluate these emerging technologies will be reviewed