Detection of Difficulties and Improvement Compliance to Growth Hormone Treatment
Detection of Difficulties and Improvement Compliance to Growth Hormone Treatment
In the last 50 years the use of growth hormone (rhGH, somatropin) has become commonly to
 treat problems such as GH deficiency, chronic renal failure and Turner syndrome and
 Prader-Willi. Giving the hormone in childhood and adolescence is designed to accelerate
 growth to close the gap in the average population and reach a final height is normal, while
 minimizing risks and costs.

 Noncompliance to treatment with GH is common; Other estimates are that one third to one half
 of patients do not comply with the provisions as require. This may result in linear growth
 depreciation, unnecessary diagnostic tests, unnecessary change of dosage and treatment and
 higher costs.

 Many studies have been devoted to locating factors make it difficult to adhere to their
 chronic diseases in children, including conditions that require treatment with GH.

 Pain is the primary cause for difficulties. In recent decades, many resources were devoted to
 research and development of ways of dealing with pain in all aspects.

 In order to implement all of the information collected, appropriate interventions medium
 should be found; In this study we intend to use the method of playback. Playback define that
 improvisation as a theater facilitator asks the audience to share moments, feelings and
 stories of his daily life, and a group of actors improvise their stories in front of the
 stage as a kind of "play-back". Unlike hobbies such as sports or singing, the method allows
 not only to unload the tensions but also communication and collaboration. It is very
 reminiscent of psychodrama, but unlike, is not considered a therapeutic tool.

 Assumption:

 Intervention of two playback meetings during the year will uncover the difficulties and
 engage ways of dealing with pain. That will reduce the difficulties caused by GH injections
 and improve compliance to treatment.
In the last 50 years the use of growth hormone (rhGH, somatropin) has become commonly to
 treat problems such as GH deficiency, chronic renal failure and Turner syndrome and
 Prader-Willi. Giving the hormone in childhood and adolescence is designed to accelerate
 growth to close the gap in the average population and reach a final height is normal, while
 minimizing risks and costs.

 Noncompliance to treatment with GH is common; Other estimates are that one third to one half
 of patients do not comply with the provisions as require. This may result in linear growth
 depreciation, unnecessary diagnostic tests, unnecessary change of dosage and treatment and
 higher costs.

 GH therapy in all non-yielding satisfactory results, it is recommended first of all to
 consider noncompliance before turning to look for other causes.

 Many studies have been devoted to locating factors make it difficult to adhere to their
 chronic diseases in children, including conditions that require treatment with GH.

 Pain is the primary cause for difficulties. Despite the pain seems fairly simple phenomenon,
 it is actually very complex. Untreated pain is manifested prominently course and immediate
 distress to the child and the parent, but it has other deep effects; It seems that pain not
 receiving treatment at early stages in children's lives adversely affects the central nervous
 system development. This assumption is supported by various studies.

 Pain is a force in shaping behavior; In recent decades, many resources were devoted to
 research and development of ways of dealing with pain in all aspects.

 In order to implement all of the information collected, appropriate interventions medium
 should be found; In this study we intend to use the method of playback. Playback define that
 improvisation as a theater facilitator asks the audience to share moments, feelings and
 stories of his daily life, and a group of actors improvise their stories in front of the
 stage as a kind of "play-back". Unlike hobbies such as sports or singing, the method allows
 not only to unload the tensions but also communication and collaboration. It is very
 reminiscent of psychodrama, but unlike, is not considered a therapeutic tool.

 Assumption:

 Intervention of two playback meetings during the year will uncover the difficulties and
 engage ways of dealing with pain. That will reduce the difficulties caused by GH injections
 and improve compliance to treatment.

 Study Population:

 1. This is a pilot study in with a total of 200 participants treated with GH therapy.

 2. Intervention group - 100 participants that will be participating in the Play Back
 meetings.

 3. Control group - 100 participants with similar demographic s that will not participate in
 the play back meetings.

 Patients will be divided randomly into groups. The following data will be collected-

 -  Height (SDS)

 -  Growth rate (SDS)

 -  IGF-1 (by SDS) - a sample taken on the first visit (time 0 and the last visit six months
 later).

 -  Accountability - empty ampoules of growth hormone (collected on a visit to No. 3 - After
 three months and the last visit, after six months).

 Inclusion criteria:

 1. Patients diagnosed with a growth hormone deficiency

 2. Patients treated with growth hormone for at least two years.

 3. The patient and parent signing an inform consent in the mother tongue.

 4. Patients speakers and readers of Hebrew.

 5. Age range: Boys 7 years to 12 years, Girls 7 years to 11 years.

 Exclusion criteria:

 1. Patients receiving growth hormone for other reasons.

 2. Patients with comorbidities (celiac disease, hypothyroidism).

 3. Children who began signs of puberty (Tanner 2 or higher).

 4. Patients who completed growth, closed epiphysis.

 The information collected in the study will be typed in encoder. The list that links the
 subject and the code given to them will be kept in the ISF, that will be be accessible only
 to the study team. The questionnaires of the participants will be identified through a
 personal code given to each of the participants and will be stored in a dedicated research
 folder in the Endocrinology and diabetes at Soroka Medical Center.

 The intervention protocol:

 Visit no.1:

 1. Parents and patient will sign the ICF.

 2. Patients will be randomized.

 3. Height and Weight will be measured.

 4. Patient / parent will answer questionnaires regarding their compliance to GH treatment,
 their difficulties and the way the deal with pain - if patient is below age of 8, his
 parent will complete the questionnaire.

 5. IGF-1 blood sample will be collected.

 6. Patients and parents will be guided to bring their empty ampoules for the next study
 visit and also to the last visit.

 7. Patients that randomized to the intervention group will meet the Play Back team for the
 first session.

 Visit no.2:

 This visit will take place one month after the first visit. Patients that randomized to the
 intervention group will meet the Play Back team for the first session.

 The meeting will be divided for 2 age groups: the first for 7-9 years old participants, and
 the second one for 10-12 years old participants.

 Visit no.3:

 This visit will take place 3 months after the first visit. Patients that randomized to the
 intervention group will meet the Play Back team for the second session.

 Visit no.4:

 This visit will take place 6 months after the first visit.

 1. Height and Weight will be measured.

 2. IGF-1 blood sample will be collected.

 3. Patient / parent will answer questionnaires regarding their compliance to GH treatment,
 their difficulties and the way the deal with pain - if patient is below age of 8, his
 parent will complete the questionnaire.

 4. Drug accountability. System analysis and processing results Descriptive statistics
 quantitative variables (such as age)that distribute normally are shown as averages ± SD.
 Quantitative variables that do not show normal distribution (the number of days of
 hospitalization) will be presented as median values between quarterly domain.
 Categorical variables (such as gender) will be out of proportion.

 Univariate analyzes

 Comparison of different variables between groups will be carried out according to the
 following rules:

 Quantitative variables (such as age)that distribute normally will be compared using the t
 test for independent samples.

 Variables that do not show normal distribution as the number of days of hospitalization
 between the two groups will be compared using the Mann-Whitney test. Categorical variables
 such as sex, will be compared using the chi-squared test.

 Analysis of correlations between different variables will be using Pearson and Spearman
 correlations based on the distribution and type of data.

 Weight and height data IGFI will be compared between subgroups according to a change in HtSDS
 since the start of growth hormone therapy to baseline.

 A multivariate model Checking the compliance level logistic regression model was constructed
 multivariate where the dependent variable will be high responsiveness and low responsiveness
 dichotomous variable (if the patient has more than 80% response variable will receive the 1
 or not (less than 80%) then receives a value of 0). Independent variables will be different
 risk factors which have passed the initial data analysis phase.

 All statistical tests of significance level will alpha = 0.05 two-sided unless stated
 otherwise. All pv values shall be rounded to two decimal places.

 Data analysis will be performed in Microsoft SPSS version 22.
Inclusion Criteria:

 1. Patients diagnosed with a growth hormone deficiency

 2. Patients treated with growth hormone for at least two years.

 3. The patient and parent signing an inform consent in the mother tongue.

 4. Patients speakers and readers of Hebrew.

 5. Age range: Boys 7 years to 12 years, Girls 7 years to 11 years.

 Exclusion Criteria:

 1. Patients receiving growth hormone for other reasons.

 2. Patients with comorbidities (celiac disease, hypothyroidism).

 3. Children who began signs of puberty (Tanner 2 or higher).

 4. Patients who completed growth, closed epiphysis.