Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study).

INTRODUCTION: Musculoskeletal (MSK) injuries are a frequent cause for emergency department (ED) visits in children. MSK injuries are associated with moderate-to-severe pain in most children, yet recent research confirms that the management of children's pain in the ED remains inadequate. Clinicians are seeking better oral analgesic options for MSK injury pain with demonstrated efficacy and an excellent safety profile. This study aims to determine the efficacy and safety of adding oral acetaminophen or oral hydromorphone to oral ibuprofen and interpret this information within the context of parent/caregiver preference. METHODS AND ANALYSIS: Using a novel preference-informed complementary trial design, two simultaneous trials are being conducted. Parents/caregivers of children presenting to the ED with acute limb injury will be approached and they will decide which trial they wish to participate in: an opioid-inclusive trial or a non-opioid trial. Both trials will follow randomised, double-blind, placebo-controlled, superiority-trial methodology and will enrol a minimum of 536 children across six Canadian paediatric EDs. Children will be eligible if they are 6 to 17 years of age and if they present to the ED with an acute limb injury and a self-reported verbal Numerical Rating Scale pain score ≥5. The primary objective is to determine the effectiveness of oral ibuprofen+oral hydromorphone versus oral ibuprofen+oral acetaminophen versus oral ibuprofen alone. Recruitment was launched in April 2019. ETHICS AND DISSEMINATION: This study has been approved by the Health Research Ethics Board (University of Alberta), and by appropriate ethics boards at all recruiting centres. Informed consent will be obtained from parents/guardians of all participants, in conjunction with assent from the participants themselves. Study data will be submitted for publication regardless of results. This study is funded through a Canadian Institutes of Health Research grant. TRIAL REGISTRATION NUMBER: NCT03767933, first registered on 07 December 2018.

The Initial Health Assessment: an intervention to identify the supportive care needs of cancer patients.

BACKGROUND: The first step in effective supportive care delivery is an assessment of patient needs. The Initial Health Assessment Form (IHA) was developed to aid clinicians in recognition and documentation of a patient's supportive care needs during their first visit to a comprehensive cancer centre. The purpose of this study was to determine the relative effectiveness of this instrument as compared to routine practice. METHODS: A before-after study was performed. Charts of consecutive patients with newly diagnosed cancer attending the Hamilton Regional Cancer Centre were selected randomly. Each chart was reviewed to determine the documentation at the initial patient assessment of 22 supportive care items under eight domains of need: physical, psychological, daily living, social, financial, informational, special needs and personal resources. The pre-intervention evaluation (T1) occurred over a 3-month period followed by the introduction of the IHA into clinical practice. Three months after its introduction, the post-intervention (T2) evaluation took place over the ensuing 3 months. RESULTS: A total of 306 charts were evaluated (153 each in T1 and T2). Patients from the two time periods were comparable with respect to background demographic variables. Introduction of the IHA increased the mean documentation of supportive care needs and resources from 26% in T1 to 49% in T2 ( p=0.001). Significant improvements were found in all domains of need. Despite improvements, documentation of assessment continued to remain low for daily living, social, financial, and informational needs. CONCLUSIONS: The IHA improved documentation of supportive care needs and resources. There is still room for improvement.

Shared treatment decision making: what does it mean to physicians?

PURPOSE: Physicians are urged to practice shared treatment decision making (STDM), yet this concept is poorly understood. We developed a conceptual framework describing essential characteristics of a shared approach. This study assessed the degree of congruence in the meanings of STDM as described in the framework and as perceived by practicing physicians. METHODS: A cross-sectional survey questionnaire was mailed to eligible Ontario medical and radiation oncologists and surgeons treating women with early-stage breast cancer. Open-ended and structured questions elicited physicians' perceptions of shared decision making. RESULTS: Most study physicians spontaneously described STDM using characteristics identified in the framework as essential to this concept. When presented with clinical examples in which the decision-making roles of physicians and patients were systematically varied, study physicians overwhelmingly identified example 4 as illustrating a shared approach. This example was deliberately constructed to depict STDM as defined in the framework. In addition, more than 85.0% of physicians identified as important to STDM specific patient and physician roles derived from the framework. These included the following: the physician gives information to the patient on treatment benefits and risks; the patient gives information to the physician about her values; the patient and physician discuss treatment options; both agree on the treatment to implement. CONCLUSION: Substantial congruence was found between the meaning of STDM as described in the framework and as perceived by study physicians. This supports use of the framework as a conceptual tool to guide research, compare different treatment decision-making approaches, clarify the meaning of STDM, and enhance its translation into practice.