This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study seeks to examine the impact of timing of social bowel continence, independent of surgical technique, upon the self-perception and social integration among children with anorectal malformations or Hirschsprung's Disease. The question is: among children with anorectal malformations or Hirschsprung's Disease, is there a difference in self-perception/social integration between those who achieve social bowel continence early and those who do so later? 'Social bowel continence' is defined as 'having daytime stool accidents or smelly smears fewer than once per month.' 'Early' is defined as 'prior to kindergarten entry.' The two study groups to be compared are: 1) those who achieved social bowel continence by entry to Kindergarten and 2) those who achieved social bowel continence sometime after kindergarten entry together with those who have never yet achieved social bowel continence. The study is a multi-centered, survey-data study using a measure of self-perception to compare the two groups of children with imperforate anus or Hirschsprung's Disease. Subjects will include children who, are ages 8-13years at the time of the study, carry a diagnosis of any severity of an anorectal malformation (imperforate anus or cloaca) or Hirschsprung's Disease , are grossly developmentally appropriate for age, able to assent for study participation, speak or read either English or Spanish. For each child subject, the study will include a corresponding parent or adult caregiver subject who is able to consent for study participation, speaks or reads either English or Spanish, and is a routine caregiver for the child subject. Child subjects (and their respective parent or caregiver) will be excluded who have a fecal diversion ostomy (ileostomy or colostomy) at the time of the study. This group of children cannot be described as socially continent or incontinent, so therefore could not be assigned to a study group. Further, their ostomy may be a confounding factor impacting their body image and self-perception. Additionally, child subjects will be excluded who are grossly developmentally delayed or mentally retarded, or who neither speak nor read English or Spanish. This group cannot complete the self-perception tool as written. Potential subjects for each site will be identified by searching the medical records / clinical databases of the 10 participating APSNA (American Pediatric Surgical Nurses Association) site coordinators, who work either in hospital-based departments of pediatric surgery, or in private offices of pediatric surgeons. ICD9 diagnosis codes for Hirschsprung's Disease and all variants of imperforate anus will be matched with birth dates to develop a list of potential subjects at each site who carry one of the study diagnoses and are of the appropriate age. The activities involved in identification of potential subjects (reviewing medical records for the exclusive purpose of identifying and recruiting potential research subjects) fall under the HIPPA privacy regulatory category of 'Activities Preparatory to Research.' In compliance with HIPPA privacy regulations and individual state law, the Seattle site coordinator will sign an Oath of Confidentiality prior to reviewing medical records. Site coordinators in other states with such laws will sign oaths accordingly. To enroll subjects in this study a study packet will then be sent by mail to the household of each potential subject on this list developed. The study packet will include an introduction letter (approach letter), a response form with self-addressed and stamped returned envelope, the Family Survey with demographic items, and copies of the consent and assent forms for review. The introduction letter begins by identifying the writer as a nurse from the office or clinic of the surgeon who performed surgery on the child in the past. The letter describes the nature of the study. The letter asks the adult to consider participation by thinking, reading the materials mailed, and talking with the child. The family is informed in this letter that reimbursement of $25 will be given to each family to help offset the cost of travel and the use of time. Regardless of choice to participate in the study, families will be encouraged should they have questions to contact the site coordinator or surgical clinical staff to discuss particulars of the bowel management program for the child. The letter concludes by asking the family to mail back the response form to the site coordinator. For those who check 'yes' a phone call will be made by the site coordinator or the data collector to schedule the appointment for data collection. For those who check 'no,' the child's name will be deleted form the list of potential subjects and no further contacts regarding the study will be made with that family. For those who do not return the response card or initiate phone contact with the site coordinator within two weeks of the mailing, a follow up phone call will be made by the site coordinator to clarify or answer any questions about the study, and to schedule the appointment for data collection if desired by the family. For families who wish to participate, the parent or caregiver will be asked to complete the Family Survey ahead of time, and to bring it to their scheduled appointment. A unique number code will be written on each Family Survey. These number codes are pre-written directly onto the Family Surveys but never written on the subject recruitment list, and therefore have no pre-assigned association with any specific subject. When the Family Survey is delivered by the family to the data collection staff at the time of the administration of the Harter tool, the same unique number code will then be written on the Harter tool score-sheets of the child subject and parent/caregiver so as to be linked for data analysis. These number codes will not be linked to the child's name, birth date, social security number or medical record number. Although each site coordinator will maintain a master-list of participant names derived from recruitment list, the participant list will not have number codes, and will therefore not be linked in any way to the number codes on the Family Survey or the Harter tool score sheets. The site coordinator will obtain consent and assent for participation during the scheduled appointment for data collection, prior to administration of the Harter tool. The Harter tool specifically addresses 6 domains: scholastic competence, social acceptance, athletic competence, physical appearance, behavioral conduct, and global self-worth. The Harter tool will be administered wherever possible through a CRC (Clinical Research Center) facility. The tools will never be administered by the site coordinator or by a member of the subject's usual clinical staff. Data collection will be undertaken for one subject at a time. The independent variable is the timing of achievement of social bowel continence, from which the two groups are derived: those who achieve social bowel continence early and those who do so later together with those who have not yet done so. Responses from the Family Survey items #8,#9,#10 and #11 will be utilized to assign each subject to one of those two groups. The primary outcome variable (dependent variable) will be the scores of the Harter Self-Perception Profile for Children: 36 items for each child subject and 15 items for each adult caregiver subject. Each of the participating sites will send the Family Surveys and Harter tool score sheets, by mail, to Seattle for central data entry and analysis. Scores of the Harter tool will be analyzed via ANOVA to identify any statistical differences between the two groups on the measures of self-perception. Once data collection begins, it is hoped to be completed within a 6-month timeframe. Data entry and analysis will be done at Children's Hospital and Regional Medical Center in Seattle, WA. The subjects are not expected to receive direct benefit from participation in this study. This fact is stated in the approach letter sent to potential subjects. The investigators hope the information learned about how children with bowel control problems view themselves will guide future care of this population and help influence the goal of social continence for children with anorectal malformations and Hirschsprung's disease prior to school entry. Information learned may support increased future vigilance among medical providers and family members, with earlier and more aggressive institution of bowel management programs when indicated.
Showing the most recent 10 out of 563 publications
