A hundred cases of parasuicide: V. validation of the amharic version of hopelessness scale at St. Paul's General specialized referral hospital, AA, Ethiopia

Background: Hopelessness is an important variable in parasuicide and suicide. The need for a valid and reliable Amharic version (AV) of Hopelessness Scale (HS) for clinical screening is obvious. Objective: To test the validity and the reliability of the AV of HS. Methods: 100 consecutive parasuicide cases arriving at the OPD were included in this `retrospective descriptive clinical case study'. Self-rated AV of HS and interviewer-rated Expanded BPRS was administered. The AV of HS was validated against the corres- ponding item/items on the Expanded BPRS. Reliability test was also performed. Results: Concurrent validity: Yule's Q; between AV of HS and Expanded BPRS depression and suicidality items were 0.66265; p=0.00052 and 0.55585; p=0.04144 respectively. Construct validity: It was shown that cases with the intention `to die' had significantly higher (p=0.0028) HS scores than those without the intention. The association between the dichotomous measures of AV of HS and intention `to die' was very highly positive and significant (Yule's Q=0.89563; P=0.00011). No such relationships between the AV of HS scores and other 9 endorsed intentions/`reasons' for parasuicidal act with different themes. These findings indicate that the AV of HS has an acceptable construct validity to measure Hopelessness. Reliability: in item-total correlation test; only item no. 5 was eliminated due to low correlation coefficient (0.0370; p=0.715). Three more items were eliminated in factor analysis which yielded 3 factors similar to Beck's finding. Conclusion: The AV of HS has acceptable validity; reliability and factor loading. Items recommended to be discarded have to be re-translated/re-written to keep the meaning as close to the original (eng version) as possible. Further validation studies are advisable to be done. In the meantime; the AV of HS has to be applied clinically in vulnerable groups

A hundred cases of parasuicide: IV validation of the Amharic Version of IDA-Scale at St. Paul's General Specialised Referral Hospital; AA; Ethiopia

Background: There is a need for a valid and reliable Amharic version (AV) of IDA-Scale whose sub-scales measure irritability (inward and outward directed); depression and anxiety. Irritability which had emerged to be an important distinguishing characteristic of parasuicide cases can be easily tapped with IDA- Scale which is cost-effective andquickly administered. Objective: To test the validity and the reliability of each sub-scale. Methods: Retrospective and prospective data were collected from a cohort of 100 consecutive parasuicide cases and each followed for a period of five years. Self-rated AV of IDA-Scale and interviewer-rated Expanded BPRS (Brief Psychiatric Rating Scale) were administered. Each sub-scale was validated against the corresponding item/items on the Expanded BPRS. ROC curves were plotted for sub-scales to select the efficient cut-off scores. Reliability and validity tests were performed for each sub-scale. Results: The coefficient of association (Yule's Q) between depression; anxiety; extropunitiveness and intropunitiveness sub-scales and the corresponding item/items on Expanded BPRS were 0.83333 (p=0.0000); 0.72680 (p=0.00021); 0.49116 (p=0.01702) and 0.61821 (p=0.00029) respectively (all 2-tailed). One of the items of extropunitiveness sub-scale; IDA12; has low item-total correlation. This sub-scale; at its cut-off point; lacks the desired discriminating ability and could not manifest the expected relationship between PV+; specificity or positivity criterion. Its factor loading was also insignificant. Conclusion : Depression; anxiety and intropunitiveness sub-scales showed acceptable validity and reliability. IDA12 has to be re-translated/re-written to keep the meaning as close to the original (eng version) as possible and to ensure that terms are understood. Further validation of extropunitiveness sub-scale is advisable. In the meantime; the AV of IDA-Scale has to be applied clinically in vulnerable groups

Validation of a model to predict all-cause in-hospital mortality in vascular surgical patients : cardiovascular topic

Objective : To develop and validate a pre- and postoperative model of all-cause in-hospital mortality in South African vascular surgical patients. Methods : We carried out a retrospective cohort study. A multivariate analysis using binary logistic regression was conducted on a derivation cohort using clinical, physiological and surgical data. Interaction and colinearity between covariates were investigated. The models were validated using the Homer-Lemeshow goodness-of-fit test. Results : Independent predictors of in-hospital mortality in the pre-operative model were : (1) age (per one-year increase) [odds ratio (OR) 1.03, 95% confidence interval (CI) 1.0-1.06), (2) creatinine > 180 µmol.l-1 (OR 6.43, 95% CI: 3.482-11.86), (3) chronic beta-blocker therapy (OR 2.48, 95% CI: 1.38-4.48), and (4) absence of chronic statin therapy (OR 2.81, 95% CI: 1.15-6.83). Independent predictors of mortality in the postoperative model were: (1) age (per one-year increase) (OR 1.05, 95% CI: 1.02-1.09), (2) creatinine > 180 µmol.l-1 (OR 5.08, 95% CI: 2.50-10.31), (3) surgery out of hours without statin therapy (OR 8.27, 95% CI: 3.36-20.38), (4) mean daily postoperative heart rate (HR) (OR 1.02, 95% CI: 1.0-1.04), (5) mean daily postoperative HR in the presence of a mean daily systolic blood pressure of less than 100 beats per minute or above 179 mmHg (OR 1.02, 95% CI: 1.01-1.03) and (6) mean daily postoperative HR associated with withdrawal of chronic beta-blockade (OR 1.02, 95% CI: 1.01-1.03). Both models were validated. Conclusion : The pre-operative model may predict the risk of in-hospital mortality associated with vascular surgery. The postoperative model may identify patients whose risk increases as a result of surgical or physiological factors

Method Development and Validations: Characterization of Critical Elements in the Development of Pharmaceuticals

Although a thorough validation cannot rule out all potential problems; the process of method development and validation should address the most common ones. Examples of typical problems that can be minimized or avoided are synthesis impurities that co-elute with the analyte peak in an HPLC assay; a particular type of column that no longer produces the separation needed because the supplier of the column has changed the manufacturing process; an assay method that is transferred to a second laboratory where they are unable to achieve the same detection limit; and a quality assurance audit of a validation report that finds no documentation on how the method was performed during the validation. Problems increase as additional people; laboratories; and equipment are used to perform the method. When the method is used in the developer's laboratory; a small adjustment can usually be made to make the method work; but the flexibility to change it is lost once the method is transferred to other laboratories or used for official product testing. This is especially true in the pharmaceutical industry; where methods are submitted to regulatory agencies and changes may require formal approval before they can be implemented for official testing. The best way to minimize method problems is to perform adequate validation experiments during development