ARS - 2011

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Completeness of the consent forms in research proposals submitted to an ethics review committee
(University of Kelaniya, 2011) Abeysena, C.; Jayamanna, K.
The voluntary consent of human subjects is essential prior to any medical research. A consent form should provide all the information needed for an individual to make an informed decision. In order for that to occur, the consent form must be replete with all the necessary information to give a complete picture of the research study to the participant. The objective of this paper is to assess the completeness of consent forms submitted for ethical approval. This was a descriptive cross sectional study which analysed the consent forms submitted to the Ethics Review Committee of the Faculty of Medicine of the University of Kelaniya, Sri Lanka, between January 2007 and December 2008. The consent forms submitted with undergraduate research proposals were excluded. A record sheet was used to extract data. Of 145 consent forms reviewed, 94.5% (137) explained the purpose of the study, 77% (111) included a statement that participation was voluntary, 44% (64) refused participation and did not affect care, 65.5% (95) gave ability to withdraw consent at any time, 79% (115) stated that confidentiality of records would be maintained, and 45.5% (66) said further clarifications were possible. Thirty nine (75%) of 52 eligible consent forms described the potential benefits, and 19% (18) of 93 consent forms explained that there were no benefits to the participants. Twenty eight (59%) of 47 eligible consent forms described possible risks or discomfort to patients, and 30% (29) of 98 consent forms explained that there were no risks to the participants. Only 48% (15) of 31 eligible consent forms described the procedure of physical examination and 21% (31) used a separate section to assess the participant‟s understanding of her/his role. We conclude that essential elements of the consent forms were missing, and recommend that a checklist of compulsory elements to be included on forms be used, before proposals are submitted to the Ethics Review Committee.
Factor structure and reliability of the 12-item Sinhala version of general health questionnaires
(University of Kelaniya, 2011) Abeysena, C.; Jayawardana, P.; Peiris, U.
The General Health Questionnaire (GHQ) is widely used to detect psychiatric disorders. There are advantages of using GHQ 12 over other versions of GHQ, of which the former is brief, simple and less time consuming to administer. Therefore, it is easily used for both research purposes and in a busy clinical setting to screen patients. Even though GHQ 12 has been validated for many countries, psychometric properties in relation to the Sinhala speaking Sri Lankan population lack conclusive evidence. The objective of this study is to determine the factor structure and the reliability of the Sinhala version of GHQ 12. This was a descriptive study including 386 patients within the age range of 18 to 75 years, attending the Out Patient Department of the Colombo North Teaching Hospital during the period between June 2009 and September 2010. The Sinhala version of GHQ-12 was given to be completed by the participants. Each item of the GHQ was rated on a four-point scale (0-1-2-3). Factor analyses were performed by applying Generalized Least Squares method using oblimin rotation. The internal consistency was assessed by calculating Cronbach‟s  coefficient. The median age of the study population was 32.5 years (IQR= 21years) and the median GHQ score was 9 (IQR 7). GHQ 12 yielded two factor solutions. Factor I (Depression and Anxiety) accounts for 88% of the total explained variance and Factor II (Social dysfunction) 12%. Forty five percent (45 %) of the total variance can be explained by two extracted factors. There was a clear distinction between the items that loaded on the two factors. The correlation coefficient between factor I and II was 0.65. Cronbach's alpha of GHQ 12 was found to be 0.88, indicating satisfactory internal consistency. The conclusions of the study show that GHQ 12 displays adequate reliability and validity for use in the Sinhala speaking Sri Lankan population for assessing psychiatric disorders.
Validity of 30-item sinhala version of general health questionnaires
(University of Kelaniya, 2011) Abeysena, C.; Jayawardana, P.; Peiris, U.; Rodrigo, A.
The General Health Questionnaire (GHQ) is widely used to detect psychiatric disorders. The Sinhala translation of GHQ 30 has been widely used for research purposes in Sri Lanka, but details pertaining to the validation procedure have not been published. The objective of the study is to determine the criterion validity of the Sinhala version of GHQ-30. This was a descriptive cross-sectional study, including 374 patients within the age range of 18 to 75 years, attending the Out Patient Department of the Colombo North Teaching Hospital during the period between June 2009 and September 2010. The Sinhala version of GHQ-30 was given to be completed by the participants. Structured clinical examination was done blindly to the GHQ score by the Consultant Psychiatrist based on the ICD 10 classification of Depression/Anxiety as the reference standard. Threshold values for GHQ-30 were determined by applying Receiver Operation Characteristic (ROC) curves. The results show that according to the ROC curve, the optimal cutoff level was 5/6 of GHQ-30, with sensitivity of 67.5%, specificity of 80%. Subgroup analysis revealed that all the subgroups had an optimal cutoff level of 5/6 except for females which was 4/5. The GHQ-30 misclassified 26.1% of subjects either with false positives or negatives when the cutoff level was 5/6. With regard to stratum specific likelihood ratios, a value of > 1 was obtained only with a total score of 7 and above and for a cutoff level set at 6/7, sensitivity and specificity were 64% and 84% respectively with a misclassification rate of 25.9%. In conclusion, GHQ-30 is a useful method for assessing psychiatric disorders in the Sinhala speaking Sri Lankan population.