Research methodology
Participants
This study intends to target families and adolescents, who are capable of speaking and reading Arabic language; every eight year old to 19 year old child or adolescent diagnosed with type 1 diabetes mellitus and is due for a scheduled follow up in eastern Saudi Arabia for the next eight months. Family members and parent are invited through mail for and interview before the actual scheduled consultation. Whether the cohort in this current research is characteristic of Saudi Arabian children and adolescents diagnosed with diabetes will be evaluated by assessing demographic and medical characteristics in relation to the Saudi Arabian medical registry. It is assumed that almost 95% of all diagnosed cases of diabetes in children and adolescents are accurately documented and registered in the registry.
Instruments
DISABKIDS
The DISABKIDS is a chronic generic module (DCGM-37) is a list of questions in which evaluates the general HRQOL and the extent of distress brought about by a chronic illness, and can be complemented with condition-specific components for arthritis, asthma, cystic fibrosis, cerebral palsy, epilepsy, and diabetes(Bullinger, Schmidt & Petersen, 2002). The contraptions include a questionnaire to be filled out by the respondents aged 8 and 18 years, and a questionnaire to be filled out by their guardians and parent. In this study a four week recall period shall be employed to all items except item 11 concerning symptoms which is scheduled for recall after one year according to the diabetes specific module.
The DCGM-37 questionnaire contains 37 areas which survey six aspects of HRQOL (Petersen, Schmidt, Power & Bullinger, 2005; Simeoni, 2007). They include: mental independence which evaluates if the child feels self-assured about the future and is capable of living an independent life without deficiencies as a result of the condition; mental emotion deals with emotional responses, such as concerns, anger, worries and problems that may result from the child’s condition; social inclusion concentrates on positive sociocultural interactions and the comprehension of others; social exclusion refers to the sense of being left out and slurred; physical limitation deals with somatic limitations, resulting from the condition; and physical treatment evaluates the impact of using medication, and getting injections. Each individual item is scored on a five point Likert scale showing the frequency of conduct or feelings as (1=never, 2=seldom, 3=quite often, 4=very often, and 5=always). According to the manual, the scale of negatively worded items is reversed. In the calculation of total scores, missing values are replaced with the mean of items that are not missing only if a single item of the domain is missing. In the event that more than a single item is missing the domain is not scored. The total score of each domain is the total score of the single item scores. From the raw scores a final score may be calculated with a scope of 0 to 100 with the highest scores demonstrating a higher self-perceived HRQOL.
The diabetic specific instrument (DDM) is comprised of an impact and a treatment scale. The impact scale is concerned with emotional responses of blood glucose regulation and following diets in daily life, while the treatment scale is concerned with emotional responses to the planning of management and the burden of hauling equipment. DDMs 10 items are evaluated on a five point scale, and a score of 0 to 100 is computed for each sub scale (The DISABKIDS Group, 2000). The DCGM-37 and DDM-10 forms were subjected to translation from English to Arabic using the international scientific procedure (Schmidt, 2006). The aim of this translation process was to maintain the original meaning of the questionnaires and instantaneously to find the most suitable terms in the new language. The ultimate version was sanctioned by the DISABKIDS research group.
A standard guideline detailing the information gathering should be distributed to every participating health centre. In the recent past, presentations of HRQOL outcomes have been condemned for being unconceivable in relation to medical relevance (Leplège & Hunt, 1997). To tackle this critique, Osobo et al have implied that HRQOL outcomes should be meaningful in negative domains than as they hypothesized in positive statements (Chaplin, et al, 2009; Osoba, et al, 2006). As a result of this menta emotion is coined to inner strength, physical limitations to physical ability and social exclusion to social equality (Chaplin, et al, 2009).
Child health questionnaire
Complementary to the DISABKIDS questionnaires, the adolescents and children are required to fill a child health questionnaire form-87 (CHQ-CF87), and their guardians to fill the child health questionnaire parent form-50 (CHQ-PF-50). The CHQ-CF87 is a general HRQOL questionnaire formulated to evaluate emotional, physical, behavioural, and social welfare (Maruish & Landgraf , 1999). Respondents from 10 years and above are required to individually fill the questionnaire, while those under the age of 10, questions are to be read to them (Naar-King, Ellis, Frey & Ondersma, 2009; Raat, et al, 2002).
Generally health is evaluated from different dimensions that may include self esteem, mental health, parent impact time, parent impact-emotional, behaviour of family activities, family cohesion, emotional and behavioural functioning, bodily pain, and social-physical functioning. The outcomes are supposed to be recorded on a 4 to 6 point Likert scale defining the level of correlation to a specific categorical phrase such as ‘’not at all’’ or ‘’very often’’. The outcomes within each domain are totalled, and the raw figures are changed to a score ranging from 0 and 100, with the highest values illustrating good functional health and social welfare. Detailed researches on the psychometric feature of the CHQ-CF87 and the CHQ-PF50 imply strong internal uniformity, construct validity and content validity. Various translations have been made into Arabic language, and the tools have already put in to use in various studies carried out on Saudi Arabian cohorts (Selvaag, et al, 2001; Vederhus, et al, 2010).
Generally a four week recall period is employed for all the grades except for the change in health and family cohesion components which refer to the previous year and the general health measurement that has no recall periods. The questionnaires are to be filled by the cooperating health institutions when the respondents make their follow up visits. As required for CHQ-87, health care professionals are supposed to be on call to explain the questions to children below the age group of 9 years, if and when required to do so. The adolescent/child and their guardian should fill the form separately from each other. The completed forms are to be subjected to electronic scanning, and scrutinised for scanning errors.
Clinical characteristics
HbA1c is to be evaluated at the exact time when the first questionnaires are completed by making use of Bayer DCA 2000. The occurrence of reported ketoacidosis and hypoglycaemia if it is very low may not permit the analysis of HRQOL outcomes in relation to clinical guidelines.
Ethical considerations
The parents, children and adolescents need to give their acceptance or consent to participate in the study in a written document. This is essential because it will safe guard the research team and health institutions from possible litigation from the respondents in the event of a fatality. Approval also has to be obtained from the respective government authorities that regulate the medical sector.
Statistical analysis
Outcomes will be shown as means with a uniform standard deviation (SD) or expressed as percentages (%). The floor and ceiling outcomes will be reported in the number of respondents with HQRL results of 0 and 100 respectively, with 0 representing the floor. Any percentage beyond and above 25% will be considered to be very high. Internal consistency insinuates to the extent to which the different items in a scale evaluate a similar construct. For the DISABKIDS questionnaires issue that concern reliability will be evaluated by examination of internal consistency of each of the sublevels and the overall total scores. When instruments are put into use for group level evaluation, the Cronbach alpha coefficients beyond 0.07 are widely viewed as acceptable (Crohnbach, 1951; Fayers & Machin, 2007). When dealing with short scales such as DCGM-37 and DDM-10 it is usually suitable to record the mean inter item correlations. The upper and lower limits are not fixed, they are subject to discussion, although some authors hold that values ranging from 0.2 and 0.4 are sufficient, whereas some argue that a mean inter item correlation constantly above0.70, might suggest redundancy (Ponteretto & Ruckdeschel, 2007). In this proposal we are going to peg mean inter item correlation range from 0.2 and 0.7 as being adequate.
The divergent and convergent authenticity of the DISABKIDS questionnaires DCGM-37 and DDM-10 will be assessed in relation to the generic questionnaires CHQ-CF87 and CHQ-PF50, correspondingly, making use of Pearson correlation modified for age and gender. Any correlation coefficient level exceeding 0.5 between measures of construct associated to each other should be regarded as high and a coefficient ranging from 0.3 and 0.5 should be regarded as moderate convergence, whereas values are not to be regarded as having any correlation if they are below 0.3 (Fayers & Machin, 2007). The DISABKIDS bias validity in regard to gender, age, duration of diabetes, metabolic controls, and the method of insulin delivery is to be evaluated using multiple regression analysis. Paired sample t-tests will be made use of to evaluate correlations between scores generated by the children and their guardians. The significance is to be described by p<0.05. Analysis will be done using the SPSS 18th version (SPSS IBM< NY< USA).
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