Core information set for informed consent to surgery for oral or oropharyngeal cancer: A mixed-methods study.

OBJECTIVES: To develop a core information set for informed consent to surgery for oral/oropharyngeal surgery. A core information set is baseline information rated important by patients and surgeons and is intended to improve patients' understanding of the intended procedure. DESIGN: A mixed-methods study. Systematic reviews of scientific and written healthcare literature, qualitative interviews and observations, Delphi surveys, and group consensus meetings identified information domains of importance for consent. SETTING: A regional head and neck clinic in the United Kingdom. Questionnaire participants were recruited from around the UK. PARTICIPANTS: Patients about to undergo, or who had previously undergone, surgery for oral/oropharyngeal cancer. Healthcare professionals involved in the management of head and neck cancer. MAIN OUTCOME MEASURES: The main outcome was a core information set. RESULTS: Systematic reviews, interviews and consultation observations yielded 887 pieces of information that were categorised into 87 information domains. Survey response rates were 67% (n = 50) and 71% (n = 52) for patient and healthcare professional groups in round one. More than 90% responded in each group in the second round. Healthcare professionals were more likely to rate information about short-term or peri-operative events as important while patients rated longer term issues about survival and quality of life. The consensus-building process resulted in an agreed core information set of 13 domains plus two procedure-specific domains about tracheostomy and free-flap surgery. CONCLUSION: This study produced a core information set for surgeons and patients to discuss before surgery for oral/oropharyngeal cancer. Future work will optimise ways to integrate core information into routine consultations.

Mammary analogue secretory carcinoma of the salivary glands: a diagnostic dilemma.

Mammary analogue secretory carcinoma (MASC) is a recently identified salivary gland neoplasm that can mimic other salivary gland tumours such as acinic cell carcinoma and cystadenocarcinoma. It is distinguished from these by differences in immunohistochemical profile and the identification of an ETV6-NTRK3 translocation (12;15)(p13;q25), which is also found in secretory carcinomas of the breast. Previous publications have suggested that MASC tumours have similar biological behaviour to acinic cell carcinoma. We report two cases of MASC that affected the upper lip, and showed an infiltrative and locally aggressive growth pattern that required several operations to ensure clearance of microscopic tumour cells.

Isolated submandibular metastasis from a contralateral thyroid papillary microcarcinoma: an unusual case.

Papillary carcinoma is the most common form of thyroid cancer. It is a relatively indolent disease, which commonly remains clinically silent until its incidental histological diagnosis in surgical material or at autopsy. A tumour less than 10 mm in size is termed a papillary microcarcinoma. Papillary microcarcinoma may present with clinical symptoms, most commonly jugulodigastric and pretracheal lymphadenopathy with or without palpable thyroid nodules. Isolated submandibular metastases are rare. We present the case of a submandibular metastasis arising from a solitary 3 mm papillary microcarcinoma of the thyroid on the contralateral side in a 46-year-old woman. We describe the ultrasound and MRI characteristics of the submandibular mass. The ultrasound findings in particular were suggestive of a thyroid malignancy and prompted detailed examination of the thyroid gland. Clinical and radiological examination of the thyroid was normal. To the best of our knowledge, we present the first report of a papillary microcarcinoma of the thyroid presenting as a contralateral and isolated submandibular mass.

Cyclin A expression and its diagnostic value in pleomorphic adenoma and carcinoma expleomorphic adenoma of the parotid gland.

AIMS: To investigate cyclin A expression in pleomorphic adenoma (PA) and carcinoma expleomorphic adenoma (CXPA) of the parotid gland with a view to assessing its potential value as a diagnostic marker for CXPA. METHODS AND RESULTS: Cyclin A expression in PA and CXPA was studied using semiquantitative immunohistochemistry. The epithelial component of the tumours expressed cyclin A in a statistically significantly (P < 0.005) higher number of CXPA cases (86%) compared with the PA cases (39%). Cyclin A was not expressed in normal salivary tissues of PA and CXPA. CONCLUSIONS: High cyclin A expression is a useful marker for the pathological diagnosis of CXPA.

A revised anchored version of the BPRS-C for childhood psychiatric disorders.

The Brief Psychiatric Rating Scale for Children (BPRS-C) is increasingly used as an outcome measure in research, managed care, and public sector child/adolescent clinical settings. The BPRS-C was developed to provide a descriptive profile of symptoms applicable to a broad range of child and adolescent psychiatric disorders. Its use frequently includes trained and untrained clinician raters with differing degrees of experience and training in child and adolescent disorders. Unfortunately, this latter approach leads to a large amount of variability in scores and consequently reduces its overall reliability. This study reports on a revised BPRS-C with the addition of clinical descriptive anchors designed to improve reliability and validity for both trained and untrained raters. A sample of 4,733 children and adolescents seen in 10 public sector facilities was administered the BPRS-C along with other standard clinical measures (Child Behavior Checklist and Global Assessment of Functioning). Additional reliability data were gathered in a University Medical Center child and adolescent research site with both trained and untrained raters. The data indicated improvement in overall reliability and validity scores, good internal consistency, and improved factor scores. The addition of an overall total severity score may prove to be a useful outcome measure for assessment of treatment response.

Clinician, parent, and child prediction of medication or placebo in double-blind depression study.

To evaluate how well a blind is maintained in a double-blind study. Clinicians (n = 66), parents (n = 62), and depressed child/adolescent subjects (n = 62) predicted whether the patient had been on either placebo or active medication at the end of an eight-week double-blind placebo versus fluoxetine trial. Clinician, patient and parents' guesses as to which treatment they had received were at a chance level based on an overall analysis. However, when clinical response and condition assignment were controlled, all were correctly predicting placebo treatment but not medication treatment. The finding that subjects, parents and clinicians predict at a chance level is important for double-blind study design integrity. However, clinicians, parents and subjects were accurately predicting placebo treatment when clinical response and the assigned condition were taken into account but not medication. Since they do not know condition however, all remain essentially blinded, and this is an important finding for design and analysis integrity for double-blind studies.

Toward a redefinition of psychiatric emergency.

OBJECTIVE: To compare three methods for rating legitimate use of psychiatric emergency services (PES) in order to develop criteria that can differentiate appropriate from inappropriate PES service requests. METHOD: Ratings of PES visits by treating physicians and ratings of the same visits made during review of medical records. STUDY DESIGN: Two previously used methods of identifying justified PES service use were compared with the treating physician's rating of the same: (1) hospitalization as visit outcome and (2) retrospective chart ratings of visit characteristics using traditional medico-surgical criteria for "emergent" illness episodes. DATA EXTRACTION METHODS: Data were extracted through use of a physician questionnaire, and medical and administrative record review. PRINCIPAL FINDINGS: Agreement between the methods ranged from 47.1 percent to 74.1 percent. A total of 21.7 percent of visits were rated as true health "emergencies" by the traditional definition, while 70.4 percent of visits were rated as "necessary" by treating physicians, and 21.0 percent resulted in hospitalization. Acuteness of behavioral dyscontrol and imminent dangerousness at the time of the visit were common characteristics of appropriate use by most combinations of the three methods of rating visits. CONCLUSIONS: The rating systems employed in similar recent studies produce widely varying percentages of visits so classified. However, it does appear likely that a minimum of 25-30 percent of visits are nonemergent and could be triaged to other, less costly treatment providers. Proposed criteria by which to identify "legitimate" psychiatric emergency room treatment requests includes only patient presentations with (a) acute behavioral dyscontrol or (b) imminent dangerousness to self or others.

Structured interview and uniform assessment improves diagnostic reliability.

OBJECTIVE: To compare a Childhood Uniform Assessment Package (CUAP), including a computerized structured diagnosis, with routine assessment and treatment in public mental health settings. DATA SOURCES/STUDY SETTINGS: Data was collected prospectively on 250 children and adolescents in both public mental health inpatient and outpatient settings in a large metropolitan area and a rural area. STUDY DESIGN: Subjects were randomized to either routine assessment and treatment as usual (ATU) or ATU plus an additional "gold standard" assessment battery Childhood Uniform Assessment Package (CUAP). Outcome measures were taken at admission (baseline), discharge, and again 6 months later. METHODS: The study was conducted at a State Hospital (CUAP, n = 75; ATU, n = 75) and a Community Mental Health center (CUAP, n = 50; ATU, n = 50). The "gold standard" diagnostic process was established at the Children's Medical Center-Dallas. Research focused on a comparison of the CUAP diagnostic process to the existing diagnostic process (ATU) and the service delivery system of an inpatient and outpatient public sector clinical treatment setting. PRINCIPAL FINDINGS: A bachelor's level individual can be trained to administer a highly reliable diagnostic battery to meet a "gold standard," suggesting a possible cost-effective way to assist in diagnostic evaluations. Higher reliability was found between this standardized assessment package (CUAP) and inpatient physicians than for outpatient physicians. The highest interrater reliabilities were found for attention deficit and substance abuse disorders, less so for the other behavior disorders. The use of CUAP results in more reliable diagnoses in public settings than those provided by typical clinical staff by identifying mood and anxiety disorders (disorders with the lowest reliability) with better reliability. The addition of "gold standard" diagnostic assessments (CUAP) did not appear to affect length of stay, number of medication changes, use of seclusion or restraints, and other behavioral interventions in the inpatient setting. Outpatient follow-up services did not differ for CUAP versus ATU either. CONCLUSIONS: A standard uniform assessment package that includes a structured diagnostic instrument can improve overall diagnostic reliability but may not have a significant overall impact in clinical treatment strategies or outcomes without additional intervention to assure proper use of the information. A well-trained bachelor's level assistant can administer such a battery.

The Texas Children's Medication Algorithm Project: Report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Attention-Deficit/Hyperactivity Disorder. Part I. Attention-Deficit/Hyperactivity Disorder.

OBJECTIVES: Expert consensus methodology was used to develop evidence-based, consensually agreed-upon medication treatment algorithms for attention-deficit/hyperactivity disorder (ADHD) in the public mental health sector. Although treatment algorithms for adult mental disorders have been developed, this represents one of the first attempts to develop similar algorithms for childhood mental disorders. Although these algorithms were developed initially for the public sector, the goals of this approach are to increase the uniformity of treatment and improve the clinical outcomes of children and adolescents with ADHD in a variety of treatment settings. METHOD: A consensus conference of academic clinicians and researchers, practicing clinicians, administrators, consumers, and families was convened to develop evidence-based consensus algorithms for the pharmacotherapy of childhood ADHD. After a series of presentations of current research evidence and panel discussion, the consensus panel met and drafted the algorithms along with guidelines for implementation. RESULTS: The panel developed consensually agreed-upon algorithms for ADHD with and without specific comorbid disorders. The algorithms consist of systematic strategies for psychopharmacological interventions and tactics to ensure successful implementation of the strategies. While the algorithms focused on the medication management of ADHD, the conference emphasized that psychosocial treatments are often a critical component of the overall management of ADHD. CONCLUSIONS: Medication algorithms for ADHD can be developed with consensus. A companion article will discuss the implementation of these algorithms.

The Texas Children's Medication Algorithm Project: Report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Attention-Deficit/Hyperactivity Disorder. Part II: Tactics. Attention-Deficit/Hyperactivity Disorder.

OBJECTIVES: Expert consensus methodology was used to develop a medication treatment algorithm for attention-deficit/hyperactivity disorder (ADHD). The algorithm broadly outlined the choice of medication for ADHD and some of its most common comorbid conditions. Specific tactical recommendations were developed with regard to medication dosage, assessment of drug response, management of side effects, and long-term medication management. METHOD: The consensus conference of academic clinicians and researchers, practicing clinicians, administrators, consumers, and families developed evidence-based tactics for the pharmacotherapy of childhood ADHD and its common comorbid disorders. The panel discussed specifics of treatment of ADHD and its comorbid conditions with stimulants, antidepressants, mood stabilizers, alpha-agonists, and (when appropriate) antipsychotics. RESULTS: Specific tactics for the use of each of the above agents are outlined. The tactics are designed to be practical for implementation in the public mental health sector, but they may have utility in many practice settings, including the private practice environment. CONCLUSIONS: Tactics for psychopharmacological management of ADHD can be developed with consensus.

The nature of help-seeking during psychiatric emergency service visits by a patient and an accompanying adult.

Utilization rates for urban psychiatric emergency services remain high, and the decision to seek care in this setting is poorly understood. Three hundred individuals accompanying patients to a psychiatric emergency service were interviewed about their help seeking and choice of treatment setting. Twenty-three of the interviewees (7.7 percent) were caregivers accompanying patients with severe and persistent mental illness. They were significantly more likely than other interviewees to know the difference between psychiatric emergency services and services offered by other outpatient providers. More than half reported that the patient they accompanied was intermittently noncompliant, which required visiting either a walk-in service during a moment when the patient was cooperative or a facility equipped to provide involuntary treatment.

The Texas Children's Medication Algorithm Project: report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Major Depressive Disorder.

OBJECTIVES: To develop consensus guidelines for medication treatment algorithms for childhood major depressive disorder (MDD) based on scientific evidence and clinical opinion when science is lacking. The ultimate goal of this approach is to synthesize research and clinical experience for the practitioner and to increase the uniformity of preferred treatment for childhood MDD. A final goal is to develop an approach that can be tested as to whether it improves clinical outcomes for children and adolescents with MDD. METHOD: A consensus conference was held. Participants included academic clinicians and researchers, practicing clinicians, administrators, consumers, and families. The focus was to review and use clinical evidence to recommend specific pharmacological approaches for treatment of MDD in children and adolescents. After a series of presentations of current research evidence and panel discussion, the consensus panel met, agreed on assumptions, and drafted the algorithms. The process initially addressed strategies of treatment and then tactics to implement the strategies. RESULTS: Consensually agreed-upon algorithms for major depressions (with and without psychosis) and comorbid attention deficit disorders were developed. Treatment strategies emphasized the use of selective serotonin reuptake inhibitors. The algorithm consists of systematic strategies for treatment interventions and recommended tactics for implementation of the strategies, including medication augmentation and medication combinations. Participants recommended prospective evaluation of the algorithms in various public sector settings, and many volunteered as sites for such an evaluation. CONCLUSIONS: Using scientific and clinical experience, consensus-derived algorithms for children and adolescents with MDD can be developed.

Prediction of response to fluoxetine and placebo in children and adolescents with major depression: a hypothesis generating study.

BACKGROUND: The results of multivariate analyses to identify potential predictors of response to fluoxetine or placebo separately in 96 child and adolescent outpatients with major depressive disorder from a recent controlled trial are presented. METHODS: A variety of clinical, demographic and laboratory factors were examined as possible predictors of response to fluoxetine or placebo using logistic regression models. RESULTS: No single variable or combination of variables strongly predicted response to fluoxetine. For the placebo group, a younger age, a shorter duration of depressive episode, and a lower socioeconomic status predicted response with an overall predictive power of 81%. CONCLUSIONS: This study is limited by the small sample size and should be considered hypothesis generating rather than confirming.

A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression.

BACKGROUND: Depression is a major cause of morbidity and mortality in children and adolescents. To date, randomized, controlled, double-blind trials of antidepressants (largely tricyclic agents) have yet to reveal that any antidepressant is more effective than placebo. This article is of a randomized, double-blind, placebo-controlled trial of fluoxetine in children and adolescents with depression. METHODS: Ninety-six child and adolescent outpatients (aged 7-17 years) with nonpsychotic major depressive disorder were randomized (stratified for age and sex) to 20 mg of fluoxetine or placebo and seen weekly for 8 consecutive weeks. Randomization was preceded by 3 evaluation visits that included structured diagnostic interviews during 2 weeks, followed 1 week later by a 1-week, single-blind placebo run-in. Primary outcome measurements were the global improvement of the Clinical Global Impressions scale and the Children's Depression Rating Scale--Revised, a measure of the severity depressive symptoms. RESULTS: Of the 96 patients, 48 were randomized to fluoxetine treatment and 48 to placebo. Using the intent to treat sample, 27 (56%) of those receiving fluoxetine and 16 (33%) receiving placebo were rated "much" or "very much" improved on the Clinical Global Impressions scale at study exit (chi 2 = 5.1, df = 1, P = .02). Significant differences were also noted in weekly ratings of the Children's Depression Rating Scale--Revised after 5 weeks of treatment (using last observation carried forward). Equivalent response rates were found for patients aged 12 years and younger (n = 48) and those aged 13 years and older (n = 48). However, complete symptom remission (Children's Depression Rating Scale--Revised < or = 28) occurred in only 31% of the fluoxetine-treated patients and 23% of the placebo patients. CONCLUSION: Fluoxetine was superior to placebo in the acute phase treatment of major depressive disorder in child and adolescent outpatients with severe, persistent depression. Complete remission of symptoms was rare.

Recurrence of major depressive disorder in hospitalized children and adolescents.

OBJECTIVE: To evaluate the outcome of a sample of children and adolescents hospitalized with major depressive disorder (MDD) and to assess different duration and severity criteria to define recovery and recurrence. METHOD: Fifty-nine of 70 children and adolescents were reevaluated 1 to 5 years later, and the intervening course of depression and other disorders was assessed using the Kiddie-Longitudinal interval Follow-up Evaluation (K-LIFE). RESULTS: Ninety-eight percent of subjects had recovered from their index MDD episode within 1 year of their initial evaluation, but 61% had at least one recurrence during the follow-up period. Of those with recurrences, 47.2% had a recurrence within 1 year and 69.4% by 2 years from the offset of the index episode. Changing the criteria for recovery by increasing the length of time required to define recovery resulted in decreases in the number of episodes of recurrence reported. CONCLUSION: MDD in children and adolescents is often an episodic disorder. Difference in definitions of recovery and recurrence affect the data reported. Consistent definitions of remission, recovery, relapse, and recurrence are needed. These data suggest that recovery may be defined after two consecutive months without symptoms and that episodes of MDD may be briefer, but more frequent, in children and adolescents than in adults.