Phytoconstituents assessment and development of standardization protocol for 'Nayopayam Kwatha', a polyherbal Ayurvedic formulation.

BACKGROUND: Nayopayam kwatha (NK) is a well-known polyherbal formulation widely used to cure respiratory ailments, heart problems, and postnatal difficulties. Literature suggests that so far no standardization protocol was developed for NK to validate its quality and purity. OBJECTIVE(S): To develop a standardization protocol for NK based on the marker phytoconstituents present in the individual herbs of the formulation. MATERIALS AND METHODS: The roots of bala [Sida cordifolia (B1) and Sida retusa (B2)], seeds of jeeraka (Cuminum cyminum), and rhizomes of nagara (Zingiber officinale) were the ingredients of NK. Since there were two source plants for bala, two sets of NK (NKB1 and NKB2) were prepared in the ratio 3:2:1 as per Vaidya Manorama and 10:1:1 as per Arogyaraksha Kalpadruma along with 1:1:1 as per the general way of Ayurvedic polyherbal decoctions. Both the individual herbs and the kwatha (decoction) prepared were analyzed in terms of pharmacognostical, organoleptic, and physcicochemical parameters as per the standard methods. Phytochemical analysis of the individual herbs resulted in the isolation of major phytoconstituents and the kwatha was quantified in terms of marker compounds with the aid of HPLC. RESULTS: HPLC quantification suggests that appreciable amount of marker phytoconstituents of individual herbs are present in the kwatha. Thus, the isolated compounds luteolin (C. cyminum), 6-gingerol (Z. officinale), ß-sitosterol (S. retusa), and ecdysterone (S.cordifolia) can be used as markers to standardize NK. CONCLUSION: Characteristics of NK, as well as its individual drugs, were well-established. The present study of NK with respect to its phytochemistry revealed that the classical drug ratios of the polyherbal formulation are of utmost importance rather than the ingredients in equal proportion. The characterization parameters of individual herbs and kwatha described in this study may serve as a standard reference for quality control analysis of NK and the method developed in this study can be used as a reliable technique for standardization of NK to ensure the purity and quality of raw drugs used.

Validation of a glaucoma knowledge assessment in glaucoma patients.

SUMMARY: To develop metrics to identify knowledge deficits and barriers to learning in glaucoma patients, this study seeks to validate a glaucoma knowledge assessment to use in the evaluation of knowledge in glaucoma patients. PURPOSE: Glaucoma treatment adherence appears to improve when patients demonstrate a greater knowledge of the disease and its treatment. This study seeks to validate a glaucoma knowledge assessment in a glaucoma patient population to assist in patient educational assessments and interventions. PATIENTS AND METHODS: The National Eye Health Education Program's (NEHEP) glaucoma knowledge assessment has previously been suggested as a useful measure to assess glaucoma patient's knowledge. This questionnaire was administered in glaucoma patients along with a more comprehensive 49-question examination. Demographic data and health literacy were assessed. Statistical analyses were performed to assess the validity of the assessments. RESULTS: A total of 12 glaucoma patients completed the knowledge assessments. The mean ± standard deviation age of the patients was 69±14 years, and the duration of glaucoma was 14±13 years. The participants' mean score on the NEHEP assessment was 7.3±0.8 (of 10, 73% correct) vs 29.3±7.3 (of 49, 60% correct) on the comprehensive assessment. The value of coefficient α was 0.592 for NEHEP and 0.872 for the cumulative assessment. The P-value (proportion of examinees answering correctly) ranged from 0 to 1 for individual questions. Item point-biserial correlation values for each question ranged from -0.402 to 0.813. DISCUSSION: The NEHEP quiz may be a good starting point for the development of a reliable knowledge assessment tool to measure and monitor glaucoma knowledge, due to its concise nature and reasonable level of difficulty. This study suggests that questions included in the currently available questionnaires vary widely in difficulty and ability to differentiate knowledge level, which may ultimately compromise reliability and utility of existing examinations. Further examination of individual questions and teaching points included in the current assessments may help to construct increasingly reliable and useful knowledge assessments in the future.

Utility of two methodologies in the clinical assessment of oral dryness in postmenopausal women.

OBJECTIVE: The aim of this study was to assess the oral dryness in postmenopausal women and to correlate the salivary flow rate determined by sialometry with the clinical oral dryness score (CODS) obtained from Challacombe Scale. To correlate between subjective and objective oral dryness and relationship of salivary flow rate with that of the duration of menopause. MATERIALS AND METHODS: Sixty postmenopausal women were questioned regarding their oral dryness status and the duration of menopause. Patients complaining of xerostomia formed the case group and rest formed the control group. CODS was assessed based on the 10 features of oral dryness. Unstimulated whole salivary (UWS) flow rate was assessed by sialometry for 5 min. RESULTS: Highly significant negative correlation was observed between UWS and CODS (r = -0.651), low negative correlation was noted between the duration of menopause and UWS flow rates (r = -0.159), and no significant correlation was found between subjective oral dryness with that of UWS flow rates (P = 0.0964). There was no statistically significant difference between case and control group with regard to CODS (P = 0.525). CONCLUSION: A good correlation of CODS with sialometry scores indicates that CODS can be utilized for semiquantitative assessment of oral dryness. It appears that UWS has poor correlation with duration of menopause. Xerostomia and UWS were not significantly related.

Box-Behnken study design for optimization of bicalutamide-loaded nanostructured lipid carrier: stability assessment.

Bicalutamide (BCM) is an anti-androgen drug used to treat prostate cancer. In this study, nanostructured lipid carriers (NLCs) were chosen as a carrier for delivery of BCM using Box-Behnken (BB) design for optimizing various quality attributes such as particle size and entrapment efficiency which is very critical for efficient drug delivery and high therapeutic efficacy. Stability of formulated NLCs was assessed with respect to storage stability, pH stability, hemolysis, protein stability, serum protein stability and accelerated stability. Hot high-pressure homogenizer was utilized for formulation of BCM-loaded NLCs. In BB response surface methodology, total lipid, % liquid lipid and % soya lecithin was selected as independent variable and particle size and %EE as dependent variables. Scanning electron microscopy (SEM) was done for morphological study of NLCs. Differential scanning calorimeter and X-ray diffraction study were used to study crystalline and amorphous behavior. Analysis of design space showed that process was robust with the particle size less than 200 nm and EE up to 78%. Results of stability studies showed stability of carrier in various storage conditions and in different pH condition. From all the above study, it can be concluded that NLCs may be suitable carrier for the delivery of BCM with respect to stability and quality attributes.

Do some trusts deliver a consistently better experience for patients? An analysis of patient experience across acute care surveys in English NHS trusts.

INTRODUCTION: Data were used from inpatient, outpatient and accident and emergency surveys in acute trusts in England to examine consistency in patient-reported experience across services, and factors associated with systematic variations in performance. METHODS: Standardised mean scores for six domains of patient experience were constructed for each survey for 145 non-specialist acute trusts. Hierarchical cluster analysis was used to investigate whether and how trust performance clusters. Multilevel regression analysis was used to determine trust characteristics associated with performance. RESULTS: Cluster analysis identified three groups: trusts that performed consistently above (30 trusts) or below (six trusts) average, and those with mixed performance. All the poor performing trusts were in London, none were foundation trusts or teaching hospitals, and they had the highest mean deprivation score and the lowest proportion of white inpatients and response rates. Foundation and teaching status, and the proportion of white inpatients, were positively associated with performance; deprivation and response rates showed less consistent positive associations. No regional effects were apparent after adjusting for independent variables. CONCLUSION: The results have significant implications for quality improvement in the NHS. The finding that some NHS providers consistently perform better than others suggests that there are system-wide determinants of patient experience and the potential for learning from innovators. However, there is room for improvement overall. Given the large samples of these surveys, the messages could also have relevance for healthcare systems elsewhere.

Pulse-plethysmographic variables in hemodynamic assessment during mannitol infusion.

Plethysmographic signal using pulse oximetry may be used to assess fluid status of patients during surgery as it resembles arterial pressure waveform. This will avoid placement of invasive arterial lines. This study was designed to find out whether intravascular volume changes induced by mannitol bolus in neurosurgical patients are detected by variations in arterial pressure and plethysmographic waveforms and also to assess the strength of correlation between different variables derived from these two waveforms. The time difference between the onset of arterial and plethysmographic waveforms as means of significant hemodynamic changes was also evaluated. Forty one adult ASA I and II neurosurgical patients requiring mannitol infusion were recruited. Arterial line and plethysmographic probe were placed in the same limb. Digitized waveforms were collected before, at the end, and 15, 30 and 60 min after mannitol infusion. Using MATLAB, the following parameters were collected for three consecutive respiratory cycles,-systolic pressure variation (SPV), pulse pressure variation (PPV), plethysmographic peak variation (Pl-PV), plethysmographic amplitude variation (Pl-AV) and blood pressure-plethysmographic time lag (BP-Pleth time lag). Changes in above parameters over the study period were studied using repeated measure analysis of variance. Correlation between the parameters was analysed. SPV and Pl-PV showed significant increase at 15, 30 and 60 min compared to end of mannitol infusion (P < 0.01 for SPV; P < 0.05 for Pl-PV). PPV and Pl-AV showed significant increase only at 30 min (P < 0.05). The correlation between ∆SPV-∆Pl-PV, ∆PPV-∆Pl-AV and ∆SPV-∆BP-Pleth time lag were significant (r = 0.3; P < 0.01). SPV and time lag had no significant interaction. Pl-PV correlates well with SPV following mannitol infusion and can be used as an alternative to SPV. (BP-Pleth) time-lag promises to be an important parameter in assessing the state of peripheral vascular resistance and deserves further investigation.

Is the new NHS outcomes framework fit for purpose?

The coalition government's new NHS outcomes framework aims to refocus the NHS on improving outcomes for patients, avoiding the 'bureaucracy' and 'clinical distortions' of previous target-based approaches. The authors argue that its implementation will need a wider focus than on outcomes alone if the underlying goals of the NHS reforms--improving healthcare quality and outcomes in England--are to be achieved.

Root cause analysis of transfusion error: identifying causes to implement changes.

BACKGROUND: As part of ongoing efforts to improve transfusion safety, an error reporting system was implemented in our hospital-based transfusion medicine unit at a tertiary care medical institute. This system is based on Medical Event Reporting System-Transfusion Medicine (MERS-TM) and collects data on all near miss, no harm, and misadventures related to the transfusion process. Root cause analyses of one such innocuous appearing error demonstrate how weaknesses in the system can be identified to make necessary changes to achieve transfusion safety. STUDY DESIGN AND METHODS: The reported error was investigated, classified, coded, and analyzed using MERS-TM prototype, modified and adopted for our institute. RESULTS: The consequent error was a "mistransfusion" but a "no-harm event" as the transfused unit was of the same blood group as the patient. It was a high event severity level error (level 1). Multiple errors preceded the final error at various functional locations in the transfusion process. Human, organizational, and patient-related factors were identified as root causes and corrective actions were initiated to prevent future occurrences. CONCLUSION: This case illustrates the usefulness of having an error reporting system in hospitals to highlight human and system failures associated with transfusion that may otherwise go unnoticed. Areas can be identified where resources need to be targeted to improve patient safety.

Relationship between physical activity measured using accelerometers and energy expenditure measured using doubly labelled water in Indian children.

BACKGROUND/OBJECTIVES: To test the association between physical activity measured using accelerometer counts (Actigraph) and energy expenditure (EE) measured using the doubly labelled water (DLW) method in free-living children in India. The aim of this study was to explore the usefulness of Actigraphs in estimating EE. SUBJECTS/METHODS: Total EE (TEE) was measured in 58 children aged 8-9 years over a period of 2 weeks using the DLW technique. Physical activity level (PAL) was estimated from TEE, and the basal metabolic rate was predicted from weight. Physical activity was measured simultaneously using the Actigraph accelerometers (MTI AM7164 and GT1M). TEE was also calculated from the Actigraph counts using a published equation. RESULTS: TEE (mean: 6.6 vs 5.7 MJ, P=0.04) and Actigraph counts (counts/minute: 557 vs 465, P=0.02; total counts: 445 534 vs 354 748, P=0.004) were higher in boys than in girls. There were no significant correlations between either total Actigraph counts (r=0.15, P=0.3) or counts/minute (r=0.18, P=0.2), and TEE estimated using DLW. Similarly, there were no significant correlations between Actigraph counts and PAL (r=0.10, P=0.5; r=0.17, P=0.2, respectively). The Bland-Altman analysis showed poor agreement between TEE estimated using the DLW method and TEE derived from the Actigraph equation. CONCLUSIONS: Activity measured using Actigraph accelerometers was not related to TEE and PAL derived using the DLW technique in children in Mysore. Actigraphs may not be useful in predicting EE in this setting, but may be better used for judging activity patterns.

Ethnic variations in the experiences of mental health service users in England: results of a national patient survey programme.

BACKGROUND: Minority ethnic groups in the UK are reported to have a poor experience of mental health services, but comparative information is scarce. AIMS: To examine ethnic differences in patients' experience of community mental health services. METHOD: Trusts providing mental health services in England conducted surveys in 2004 and 2005 of users of community mental health services. Multiple regression was used to examine ethnic differences in responses. RESULTS: About 27 000 patients responded to each of the surveys, of whom 10% were of minority ethnic origin. In the 2004 survey, age, living alone, the 2004 survey, age, living alone, detention and hospital admissions were stronger predictors of patient experience than ethnicity. Self-reported mental health status had the strongest explanatory effect. In the 2005 survey, the main negative differences relative to the White British were for Asians. CONCLUSIONS: Ethnicity had a smaller effect on patient experience than other variables. Relative to the White British, the Black group did not report negative experiences whereas the Asian group were most likely to respond negatively. However, there is a need for improvements in services for minority ethnic groups, including access to talking therapies and better recording of ethnicity.