Lynn S. Walker

Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations

UNLABELLED Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents. Consensus was refined by consultation with the international pediatric pain community through announcement of our recommendations on the Pediatric Pain List and inviting and incorporating comments from external sources. There was consensus that investigators conducting pediatric acute pain clinical trials should consider assessing outcomes in pain intensity; global judgment of satisfaction with treatment; symptoms and adverse events; physical recovery; emotional response; and economic factors. There was also agreement that investigators conducting pediatric clinical trials in chronic and recurrent pain should consider assessing outcomes in pain intensity; physical functioning; emotional functioning; role functioning; symptoms and adverse events; global judgment of satisfaction with treatment; sleep; and economic factors. Specific measures or measurement strategies were recommended for different age groups for each domain. PERSPECTIVE Based on systematic review and consensus of experts, core domains and measures for clinical trials to treat pain in children and adolescents were defined. This will assist in comparison and pooling of data and promote evidence-based treatment, encourage complete reporting of outcomes, simplify the review of proposals and manuscripts, and facilitate clinicians making informed decisions regarding treatment.

Functional assessment of pediatric pain patients: Psychometric properties of the Functional Disability Inventory

Abstract The Functional Disability Inventory (FDI; Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol 1991;16:39–58) assesses activity limitations in children and adolescents with a variety of pediatric conditions. This study evaluated the psychometric properties of the FDI in pediatric pain patients. Participants included 596 patients with chronic abdominal pain, ages 8–17, and a subset of their parents (n = 151) who completed the FDI and measures of pain, limitations in school activities, and somatic and depressive symptoms at a clinic visit. Test–retest reliability was high at 2 weeks (child report, .74; parent‐report, .64) and moderate at 3 months (child report, .48; parent report, .39). Internal consistency reliability was excellent, ranging from .86 to .91. Validity was supported by significant correlations of child‐ and parent‐report FDI scores with measures of school‐related disability, pain, and somatic symptoms. Study results add to a growing body of empirical literature supporting the reliability and validity of the FDI for functional assessment of pediatric patients with chronic pain.

Psychosocial correlates of recurrent childhood pain: a comparison of pediatric patients with recurrent abdominal pain, organic illness, and psychiatric disorders.

Pediatric patients with recurrent abdominal pain (RAP) were compared with patients with peptic disease, patients with emotional disorders, and well children with regard to (a) emotional and somatic symptoms and (b) theoretically derived variables, including negative life events, competence, family functioning, and the modeling and encouragement of illness behavior. RAP patients had levels of emotional distress and somatic complaints higher than those of well children and lower than those of psychiatric patients, but not different from those of patients with peptic disease. RAP patients had fewer negative life events, better family functioning, and higher competence than children with emotional disorders. In comparison with well children and psychiatric patients, both RAP and peptic disease patients had a higher incidence of illness in other family members and perceived greater parental encouragement of illness behavior for abdominal symptoms.

Somatization Symptoms in Pediatric Abdominal Pain Patients: Relation to Chronicity of Abdominal Pain and Parent Somatization

Symptoms of somatization were investigated in pediatric patients with recurrent abdominal pain (RAP) and comparison groups of patients with organic etiology for abdominal pain and well patients. Somatization scores were higher in RAP patients than well patients at the clinic visit, and higher than in either well patients or organic patients at a 3- month followup. Higher somatization scores in mothers and fathers were associated with higher somatization scores in RAP patients, but not in organic or well patients. Contrary to the findings of Ernst, Routh, and Harper (1984), chronicity of abdominal pain in RAP patients was not significantly associated with their level of somatization symptoms. Psychometric information about the Childrens Somatization Inventory is presented.

Chronic Abdominal Pain In Children: A Technical Report of the American Academy of Pediatrics and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition: Aap Subcommittee and Naspghan Committee on Chronic Abdominal Pain

Chronic abdominal pain, defined as long-lasting intermittent or constant abdominal pain, is a common pediatric problem encountered by primary care physicians, medical subspecialists and surgical specialists. Chronic abdominal pain in children is usually functional-that is, without objective evidence of an underlying organic disorder. The Subcommittee on Chronic Abdominal Pain of the American Academy of Pediatrics and the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition has prepared this report based on a comprehensive, systematic review and rating of the medical literature. This report accompanies a clinical report based on the literature review and expert opinion. The subcommittee examined the diagnostic and therapeutic value of a medical and psychologic history, diagnostic tests, and pharmacological and behavioral therapy. The presence of alarm symptoms or signs (such as weight loss, gastrointestinal bleeding, persistent fever, chronic severe diarrhea and significant vomiting) is associated with a higher prevalence of organic disease. There was insufficient evidence to state that the nature of the abdominal pain or the presence of associated symptoms (such as anorexia, nausea, headache and joint pain) can discriminate between functional and organic disorders. Although children with chronic abdominal pain and their parents are more often anxious or depressed, the presence of anxiety, depression, behavior problems or recent negative life events does not distinguish between functional and organic abdominal pain. Most children who are brought to the primary care physicians office for chronic abdominal pain are unlikely to require diagnostic testing. Pediatric studies of therapeutic interventions were examined and found to be limited or inconclusive.

Recurrent abdominal pain: A potential precursor of irritable bowel syndrome in adolescents and young adults

OBJECTIVES To assess symptoms of irritable bowel syndrome (IBS) in patients with recurrent abdominal pain (RAP) 5 years after their initial evaluation, to identify the relation of IBS symptoms to functional disability and health service use, and to determine the extent to which IBS symptoms are associated with life stress and poor psychosocial adjustment. METHODS Patients with RAP (n = 76) and control subjects (n = 49) completed a telephone interview; measures included the Bowel Disease Questionnaire, the Functional Disability Inventory, the Life Events Questionnaire, the Family Inventory of Life Events, the Center for Epidemiological Studies Depression Scale, the Self-Perception Profile for Adolescents, and the Health Resources Inventory. RESULTS Five years after the initial evaluation, patients with RAP reported significantly more episodes of abdominal pain than did control subjects, as well as significantly higher levels of functional disability, school absence, and clinic visits for abdominal distress. Female patients with RAP were more likely than female control subjects to meet the Manning criteria for IBS. Among patients with RAP, higher levels of IBS symptoms were associated with significantly greater functional disability, more clinic visits, more life stress, higher levels of depression, and lower academic and social competence. CONCLUSION Female patients with a history of RAP may be at increased risk of IBS during adolescence and young adulthood. Among adolescents and young adults with a history of RAP, IBS symptoms are likely to be associated with high levels of disability and health service use.

Recurrent Abdominal Pain in Children: Psychiatric Diagnoses and Parental Psychopathology

Approximately 12% of children report recurrent episodes of abdominal pain. In only about 10% of these cases, however, can an organic etiology be identified, and therefore it often is assumed that these children have emotional problems. To test this hypothesis, children with recurrent abdominal pain (RAP) with no identifiable organic cause were compared to children with an organic diagnosis for their abdominal pain, children with psychiatric disorders, and healthy controls. Both groups of children with abdominal pain had significantly more psychiatric disorders (predominantly anxiety and depression) than did the healthy group. Both RAP and psychiatric children had significantly higher Child Behavior Checklist internalizing scores; psychiatric children were rated as significantly more maladjusted on the Childrens Global Assessment Scale. Mothers of RAP children were significantly more anxious than mothers of organic pain and healthy children. Psychiatric children were significantly more likely than the other three groups to underreport their psychiatric symptoms relative to their mothers.

Recurrent abdominal pain : Symptom subtypes based on the Rome ii Criteria for Pediatric functional gastrointestinal disorders

Objectives Recurrent abdominal pain (RAP) is a common childhood complaint rarely associated with organic disease. Recently, the Pediatric Rome Criteria were developed to standardize the classification of pediatric functional gastrointestinal disorders (FGIDs) using a symptom-based approach. The authors tested the hypothesis that most patients with childhood RAP could be classified into one or more of the symptom subtypes defined by the Pediatric Rome Criteria. Methods Using a prospective longitudinal design, new patients with RAP (n = 114) were studied at a tertiary care childrens medical center. Before the medical evaluation, parents completed a questionnaire about their child, assessing symptoms defined by the Pediatric Rome Criteria. Results Of the 107 children for whom medical evaluation revealed no organic etiology for pain, 73% had symptom profiles consistent with the Pediatric Rome Criteria for one of the FGIDs associated with abdominal pain (irritable bowel syndrome, 44.9%; functional dyspepsia,15.9%; functional abdominal pain, 7.5%; abdominal migraine, 4.7%) Conclusions This study provides the first systematic empirical evidence that RAP, originally defined by Apley, includes children whose symptoms are consistent with the symptom criteria for several FGIDs defined by the Rome criteria. The pediatric Rome criteria may be useful in clinical research to (1) describe the symptom characteristics of research participants who meet Apleys broad criteria for RAP, and (2) select patients with particular symptom profiles for investigation of potential biologic and psychosocial mechanisms associated with pediatric FGIDs.

The relation of daily stressors to somatic and emotional symptoms in children with and without recurrent abdominal pain.

Prior investigations of the relation between stressors and symptoms in children with recurrent abdominal pain (RAP) have focused on major negative life events. This study used consecutive daily telephone interviews to assess daily stressors and symptoms in 154 pediatric patients with RAP and 109 well children. Results showed that patients with RAP reported more frequent daily stressors than well children reported both at home and at school. Idiographic (within-subject) analyses indicated that the association between daily stressors and somatic symptoms was significantly stronger for patients with RAP than for well children. In contrast, the relation between daily stressors and negative affect did not differ between the groups. The relation between daily stressors and somatic symptoms was stronger for patients with RAP who had higher levels of trait negative affectivity.

Validation of the pediatric Rome II criteria for functional gastrointestinal disorders using the questionnaire on pediatric gastrointestinal symptoms.

Objective: To validate the pediatric Rome II criteria for functional gastrointestinal disorders (FGIDs) using the Questionnaire on Pediatric Gastrointestinal Symptoms (QPGS). Methods: Subjects were 315 consecutive new patients, 4 to 18 years of age, seen in a tertiary care clinic and classified by pediatric gastroenterologists as having a functional problem. Patients and parents separately completed the QPGS before medical consultation. Diagnoses were derived using computer algorithms reflecting the Rome II criteria for pediatric FGIDs. Convergent validity was assessed by prevalence of diagnoses and internal validity using factor analysis to confirm symptom clusters of the criteria. Separate analyses were performed for 4 to 9 and 10 to 18 year olds, and for diagnoses based on parent and child reports. Results: In both age groups, the most prevalent diagnoses were irritable bowel syndrome (IBS) (22.0%, 35.5%), functional constipation (19.0%, 15.2%), and functional dyspepsia (FD) (13.6%, 10.1%). Parent-child concordance on diagnoses was generally poor. Factor analyses supported the internal validity of FD and of IBS symptoms except for relief with defecation. Although functional abdominal pain syndrome and abdominal migraine occurred rarely, symptom clustering within each diagnosis supports their validity. Among patients with abdominal pain, duration was of at least 3 months in most, and pain was of long duration and severe in at least one third. Conclusion: More than half of patients classified as having a functional problem met at least one pediatric Rome II diagnosis for FGIDs. This study offers initial support for the validity of several of the criteria.