Establishing the Top 10 Research Priorities for Adolescent and Young Adult (AYA) Cancer in Canada: A Protocol for a James Lind Alliance Priority Setting Partnership.

Adolescents and young adults (AYAs; 15-39 years) diagnosed with cancer have unique medical and psychosocial needs. These needs could be better addressed through research that is focused on the topics that matter most to them. However, there is currently no patient-oriented research agenda for AYA cancer in Canada. This manuscript describes the early development and project protocol for a priority-setting partnership (PSP) for establishing the top 10 research priorities for AYA cancer in Canada. This project follows the PSP methodology outlined by the James Lind Alliance (JLA) to engage patients, caregivers, and clinicians in research prioritization. The steps of a JLA PSP include establishing a steering group and project partners, gathering uncertainties, data processing and verifying uncertainties, interim priority setting, and a final priority setting workshop. The AYA cancer PSP will result in a top 10 list of research priorities identified by Canadian AYA patients, caregivers, and clinicians that will be published and shared broadly with the research community. The first steering group meeting was held in April 2023, and the project is ongoing. The establishment of a patient-oriented research agenda for AYA cancer will catalyze a long-term and impactful research focus and ultimately improve outcomes for AYA patients with cancer in Canada.

Assessment of complementary health approaches use in pediatric oncology: Modification and preliminary validation of the "Which Health Approaches and Treatments Are You Using?" (WHAT) questionnaires.

OBJECTIVE: Complementary Health Approaches (CHA) are commonly used by children with cancer; however, a few health care providers (HCPs) inquire about the use of CHA. A standardized questionnaire could facilitate such clinical discussions. We aimed to adapt and determine the face and content validity of the "Which Health Approaches and Treatments are you using?" (WHAT) child and parent-report questionnaires in pediatric oncology. METHODS: An electronic Delphi survey that included children with cancer (8-18 years), parents, and HCPs and CHA researchers was conducted to reach consensus on the content of the WHAT questionnaires in pediatric oncology. Children and parents from the Hospital for Sick Children (SickKids), and HCPs and researchers from the International Society of Pediatric Oncology and Pediatric Complementary and Alternative Medicine Research and Education Network completed the survey. To determine the face and content validity of the questionnaires, two iterative cycles of individual interviews were conducted with purposive samples of children (8-18 years), parents, and HCPs from SickKids. RESULTS: Consensus was reached on all domains and items of the original WHAT questionnaires after one Delphi cycle (n = 61). For face and content validity testing, the first cycle of interviews (n = 19) revealed that the questionnaires were mostly comprehensive and relevant. However, the paper-based format of the original WHAT was not user-friendly, and generic items were vague and not aimed at facilitating clinical dialogues about CHA use. The WHAT questionnaires were then modified into electronic cancer-specific self- and proxy-report questionnaires including 13 and 15 items, respectively. The second cycle (n = 21) showed no need for further changes. CONCLUSIONS: The modified electronic cancer-specific WHAT questionnaires showed adequate face and content validity. The next step is to determine inter-rater reliability, construct validity, and feasibility of administration of the modified WHAT questionnaires in pediatric oncology.

Exploring the use of social media and online methods to engage persons with lived experience and healthcare professionals in creating research agendas: Lessons from a pediatric cancer research priority-setting partnership.

Social media is increasingly used to engage persons with lived experience and healthcare professionals in research, however, there remains sparse guidance on how to effectively use social media to engage these groups in research agenda-setting. Here we report our process and experience utilizing a social media campaign to engage Canadians within the pediatric cancer community in a research priority-setting exercise. Following the James Lind Alliance method, we launched a priority-setting partnership (PSP) to develop a child with cancer-, survivor-, family member-, and healthcare professional-based Canadian pediatric cancer research agenda. Social media-based strategies were implemented to recruit participants for two PSP surveys, including preparatory activities, developing a website, launching graphics and advertisements, and engaging internal and external networks. Descriptive statistics of our data and analytics provided by the platforms are used presently to report our process. The framework we implemented involved preparing for social media use, identifying a target audience, developing campaign content, conducting the campaign, refining the campaign as needed, and evaluating its success. Our process resulted in a substantial social media-based reach, good survey completion rates, and a successfully developed pediatric cancer community-specified research agenda. Social media may represent a useful approach to engage persons with lived experience and healthcare professionals in research agenda development. Based on our experience, we present strategies to increase social media campaign engagement that may be useful to those seeking to conduct health research priority-setting exercises.

Parent and clinician perceptions and recommendations on a pediatric cancer pain management app: A qualitative co-design study.

Pain is one of the most prevalent and burdensome pediatric cancer symptoms for young children and their families. A significant proportion of pain episodes are experienced in environments where management options are limited, including at home. Digital innovations such as apps may have positive impacts on pain outcomes for young children in these environments. Our overall aim is to co-design such an app and the objective of this study was to explore the perceptions of children's parents about app utility, needed system features, and challenges. We recruited parents of young children with cancer and multidisciplinary pediatric oncology clinicians from two pediatric cancer care centers to participate in audio-recorded, semi-structured, co-design interviews. We conducted interviews structured around technology acceptance and family caregiving theories until data saturation was reached. Audio-recordings were then transcribed, coded, and analyzed using thematic analysis. Forty-two participants took part in the process. Participants endorsed the concept of an app as a useful, safe, and convenient way to engage caregivers in managing their young child's pain. Overall, the app was valued as a means to provide real-time, multimodal informational and procedural pain support to parents, while also reducing the emotional burden of pain care. Recommendations for intervention design included accessibility-focused features, comprehensive symptom tracking, and embedded scientific- and clinically-sound symptom assessments and management advice. Predicted challenges to app use included the workload burden it may place on parents and clinicians. The insights gathered will inform the design principles of our future childhood cancer pain digital research.

Inter-Rater Reliability, Construct Validity, and Feasibility of the Modified "Which Health Approaches and Treatments Are You Using?" (WHAT) Questionnaires for Assessing the Use of Complementary Health Approaches in Pediatric Oncology.

BACKGROUND: This study aimed to test the inter-rater reliability, construct validity, and feasibility of the modified "Which Health Approaches and Treatments Are You Using?" (WHAT) questionnaires in pediatric oncology; Methods: Parent-child dyads were invited to complete self- and proxy-report-modified WHAT, Pediatric Quality of Life Inventory, demographics, a diary of the child's recent use of CHA, and a questionnaire assessing the aspects of feasibility. Parents were asked to complete a satisfaction of their children's use of the CHA survey; Results: Twenty-four dyads completed the study. The mean weighted kappa showed strong inter-rater reliability (k = 0.77, SE = 0.056), and strong agreements between the modified WHAT and the diary (self-report [k = 0.806, SE = 0.046] and proxy-report [k = 0.894, SE = 0.057]). Significant relationships were found only between recent and non-recent CHA users in relation to the easy access to CHA (self-report [p = 0.02], proxy-report [p < 0.001]). The mean scores of the feasibility scale (out of 7.0) for the self- and proxy-report were 5.64 (SD = 0.23) and 5.81 (SD = 0.22), respectively, indicating the feasibility of the modified WHAT; Conclusions: The findings provide initial evidence of the reliability and validity of the modified WHAT and their feasibility. Further research is needed to test the theoretical relationships and further explore the validity and reliability of the modified WHAT.

Traumatic stress symptoms in family caregivers of patients with acute leukaemia: protocol for a multisite mixed methods, longitudinal, observational study.

INTRODUCTION: The diagnosis, progression or recurrence of cancer is often highly traumatic for family caregivers (FCs), but systematic assessments of distress and approaches for its prevention and treatment are lacking. Acute leukaemia (AL) is a life-threatening cancer of the blood, which most often presents acutely, requires intensive treatment and is associated with severe physical symptoms. Consequently, traumatic stress may be common in the FCs of patients with AL. We aim to determine the prevalence, severity, longitudinal course and predictors of traumatic stress symptoms in FCs of patients with AL in the first year after diagnosis, and to understand their lived experience of traumatic stress and perceived support needs. METHODS AND ANALYSIS: This two-site longitudinal, observational, mixed methods study will recruit 223 adult FCs of paediatric or adult patients newly diagnosed with AL from two tertiary care centres. Quantitative data will be collected from self-report questionnaires at enrolment, and 1, 3, 6, 9 and 12 months after admission to hospital for initial treatment. Quantitative data will be analysed using descriptive and machine learning approaches and a multilevel modelling (MLM) approach will be used to confirm machine learning findings. Semi-structured qualitative interviews will be conducted at 3, 6 and 12 months and analysed using a grounded theory approach. ETHICS AND DISSEMINATION: This study is funded by the Canadian Institutes of Health Research (CIHR number PJT 173255) and has received ethical approval from the Ontario Cancer Research Ethics Board (CTO Project ID: 2104). The data generated have the potential to inform the development of targeted psychosocial interventions for traumatic stress, which is a public health priority for high-risk populations such as FCs of patients with haematological malignancies. An integrated and end-of-study knowledge translation strategy that involves FCs and other stakeholders will be used to interpret and disseminate study results.

The Symptom Experience in Pediatric Cancer: Current Conceptualizations and Future Directions.

PURPOSE OF REVIEW: We aimed to review the recent research on the childhood cancer symptom experience pertaining to socioeconomic factors, biology and genetics, growth and development, family psychosocial dynamics, and social and treating environments to begin to formulate recommendations for a personalized approach to symptom management. RECENT FINDINGS: Cancer symptoms are common and distressing in children and negatively impact child and family quality of life. Many interacting factors influence children's cancer symptoms experiences, including the assessment and management of such symptoms. This paper highlights several gaps in the research related to the cancer symptom experience including routine symptom assessment, the impact of socioeconomic, biological, and genetic factors on symptoms, and the establishment of effective symptom management partnerships with families. Based on our findings, we provide recommendations related to that research which is ready to be implemented into clinical practice and areas for needed future efforts.

Home-Based Pediatric Cancer Care: Perspectives and Improvement Suggestions From Children, Family Caregivers, and Clinicians.

PURPOSE: Although the hospital remains the dominant site for delivering most pediatric cancer care, home-based care is increasingly provided. To effectively deliver comprehensive, relevant, and acceptable care in children's homes, the voices of these key informants must be considered. We examined the views of children with cancer, their family caregivers, and clinicians on home-based cancer care to identify necessary strategies to improve the delivery of care. METHODS: Children with cancer, their family caregivers, and multiprofessional clinicians who provide care at a tertiary pediatric care center or in the community participated in audio-recorded, semistructured interviews in French and English. Interviews were conducted until data saturation in each participant group was achieved. Interviews were transcribed, coded, and analyzed using thematic analysis. RESULTS: Thirteen children, 20 family caregivers, and 22 clinicians participated. Home-based care was endorsed as a means to improve child health-, family social- and financial-, and system-level outcomes. The success of a home-based model is built on care that addresses child and family informational, treatment and care, material, and psychosocial needs. Mechanisms to improve care include enhanced homecare agency-hospital-family communication, training for homecare nurses in pediatric cancer care, virtual solutions, and an expanded breadth of services provided in-home. Child-, family-, and system-related factors affect the delivery of optimal home-based care. CONCLUSION: Children, families, and clinicians value a model of pediatric cancer care that incorporates home-based services. The insights of these key informants should be reflected in the principles that become the basis of home-based cancer care best practices.

Identification and Characteristics of the Three Subgroups of Pain in Chinese Children and Adolescents with Cancer.

PURPOSE: Pain is a distressing symptom for children and adolescents with cancer and is experienced by individuals differently. This study sought to determine subgroups according to their pain experiences, and how demographic, clinical, and quality of life (QOL)-related characteristics might differ across subgroups. DESIGN AND METHODS: This cross-sectional study recruited 187 pediatric patients with cancer aged 8 to 17 years old and asked them to complete measures of pain intensity, pain duration, pain interference and pain control using the Chinese translation of the validated questionnaire from the Pain Squad app, as well as 7 PROMIS measures assessing QOL-related outcomes. Latent profile analysis (LPA) was used to identify latent subgroups. RESULTS: Three subgroups of children were identified: low-pain/low-duration (69.5%), moderate-pain/high-duration (19.8%), and high-pain/moderate-duration (10.7%). Hospitalized children were more likely to be in the moderate-pain/high-duration subgroup. Children in the high-pain/moderate-duration subgroup were more likely to be cared for by unemployed caregivers. Scores on depressive symptoms (p = 0.002), anger (p < 0.001), anxiety (p = 0.045), fatigue (p = 0.044), and mobility (p = 0.008) questionnaire were significantly worse in the high-pain/moderate-duration subgroup than the other two subgroup. PRACTICE IMPLICATIONS: This study provides a scientific foundation for further studies exploring predictive factors related to pain experiences. More targeted treatment strategies targeting the specific characteristics of each subgroup will help improve patients' QOL and use of medical resources. CONCLUSIONS: The 3 identified pain subgroups demonstrate the heterogeneity in pain experiences among pediatric patients with cancer. Knowledge of these subgroups can assist clinicians in better identifying and targeting pain treatment for children with cancer.

Quality of telephone-based cancer symptom management by nurses: a quality improvement project.

PURPOSE: To determine the quality of cancer symptom management when evidence from clinical practice guidelines are used in telephone-based oncology nursing services. METHODS: Guided by the Knowledge to Action Framework, we conducted a quality improvement (QI) project focused on "monitoring knowledge use" (e.g., use of practice guides) and "measuring outcomes." In 2016, 15 Pan-Canadian Oncology Symptom Triage and Remote Support (COSTaRS) practice guides that synthesize evidence from guidelines were implemented with training for all oncology nurses at a regional ambulatory oncology program. Eighteen months post-implementation, Symptom Management Analysis Tool (SMAT) was used to analyze audio-recorded calls and related documentation of cancer symptom management. RESULTS: Of 113 audio-recorded calls, 66 were COSTaRS symptoms (58%), 43 other symptoms (38%), and 4 medically complex situations (4%). Of 66 recorded calls, 63 (95%) were documented. Average SMAT quality score was 71% (range 21-100%) for audio-recordings and 63% (range 19-100%) for documentation of calls. COSTaRS practice guide use was documented in 33% calls. For these calls, average SMAT quality scores were 74% with COSTaRS versus 69% without COSTaRS for audio-recording and 73% (range 33-100%) with COSTaRS versus 58% without COSTaRS for documentation. Patient outcomes indicated symptom was resolved (38%), worse (25%), unchanged (3%), or unknown (33%). Eight patients (13%) had an ED visit within 14 days post that was related to the symptom discussed. CONCLUSIONS: Only a third of nurses indicated use of COSTaRS practice guides. There were higher quality symptom management scores when COSTaRS use was reported. Nurses documented less than what they discussed.

A Pilot Randomized Controlled Trial of Virtual Reality Distraction to Reduce Procedural Pain During Subcutaneous Port Access in Children and Adolescents With Cancer.

OBJECTIVES: We aimed to determine the feasibility of virtual reality (VR) distraction for children with cancer undergoing subcutaneous port (SCP) access. We also aimed to estimate preliminary treatment effects of VR compared with an active distraction control (iPad). MATERIALS AND METHODS: A single-site pilot randomized controlled trial comparing VR to iPad distraction was conducted. Eligible children and adolescents were aged 8 to 18 years undergoing treatment for cancer with upcoming SCP needle insertions. Intervention acceptability was evaluated by child, parent, and nurse self-report. Preliminary effectiveness outcomes included child-reported pain intensity, distress, and fear. Preliminary effectiveness was determined using logistic regression models with outcomes compared between groups using preprocedure scores as covariates. RESULTS: Twenty participants (mean age 12 y) were randomized to each group. The most common diagnosis was acute lymphocytic leukemia (n=23, 58%). Most eligible children and adolescents (62%) participated, and 1 withdrew after randomization to the iPad group. Nurses, parents, and children reported the interventions in both groups to be acceptable, with the VR participants reporting significantly higher immersion in the distraction environment (P=0.0318). Although not statistically significant, more VR group participants indicated no pain (65% vs. 45%) and no distress (80% vs. 47%) during the procedure compared with the iPad group. Fear was similar across groups, with ~60% of the sample indicating no fear. DISCUSSION: VR was feasible and acceptable to implement as an intervention during SCP access. Preliminary effectiveness results indicate that VR may reduce distress and distress compared with iPad distraction. These data will inform design of a future full-scale randomized controlled trial.

Wearable Respiratory Monitoring and Feedback for Chronic Pain in Adult Survivors of Childhood Cancer: A Feasibility Randomized Controlled Trial From the Childhood Cancer Survivor Study.

PURPOSE: Approximately 40% of childhood cancer survivors experience chronic pain, with many also reporting pain-related disability. Given associations established in the general population among respiration, anxiety, and pain, continuous tracking and feedback of respiration may help survivors manage pain. METHODS: A feasibility, nonblinded, randomized controlled trial (RCT) comparing wearable respiratory monitoring with a control group examined feasibility, acceptability, and preliminary efficacy among survivors of childhood cancer with chronic pain who were ≥ 18 years of age, able to speak and read English, lived in the United States, and had access to a smartphone and the Internet. The primary outcomes were pain interference, pain severity, anxiety, negative affect, and perceived stress. The intervention group (n = 32) received a wearable respiratory monitor, used the device, and completed an in-application breathing exercise daily for 30 days. The control group (n = 33) received psychoeducation after completion of the study. RESULTS: Almost all participants in the intervention group (n = 31 of 32) and control group (n = 32 of 33) completed the study. Of those who completed the intervention, 90.3% wore the device for ≥ 50% of the trial. Posttreatment improvement for negative affect (Cohen d = 0.59; 95% CI, 0.09 to 1.10) was significantly greater in the intervention group compared with the control group. A follow-up study (n = 24) examined acceptability and feasibility of a second-generation device among those who completed the RCT. Most survivors (81.0%) wore the device daily during the trial and 85.7% reported satisfaction with the device and the application. CONCLUSION: The results of this pilot study support the acceptability and feasibility of wearable respiratory monitoring among survivors of childhood cancer. Larger randomized trials are needed to assess efficacy and maintenance of this intervention for chronic pain.

Questionnaires assessing the use of complementary health approaches in pediatrics and their measurement properties: A systematic review.

OBJECTIVES: To identify questionnaires assessing the use of complementary health approaches (CHA) in pediatrics, describe their content, and appraise the methodological quality of the studies and the measurement properties of the questionnaires. METHOD: Major electronic databases were searched from 2011 to 2020. Studies which aimed to assess the use of CHA and studies which reported developing and validating CHA questionnaires in pediatrics were included. Two reviewers independently screened the studies, extracted the data, and rated the methodological quality of the studies and measurement properties of the questionnaires using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. When consensus was not reached, a third reviewer was consulted. RESULTS: Thirty-eight studies were included. From these studies, 35 CHA questionnaires with a variety of different items were identified. Only two studies aimed to evaluate the measurement properties of two questionnaires. One questionnaire, available as a self- and proxy-report, was initially validated in children with juvenile idiopathic arthritis, and the other, available as an interviewer-administered questionnaire, was validated in children with cancer. According to the COSMIN, the methodological quality of both studies was inadequate or doubtful, and both questionnaires was not thoroughly validated. CONCLUSION: This systematic review showed a lack of a thoroughly validated CHA questionnaire in pediatrics. However, two questionnaires were found to hold promise. To address this gap, one of the existing questionnaires should be adapted and further validated.

Quality of telephone nursing services for adults with cancer and related non-emergent visits to the emergency department.

A quality improvement project was conducted to determine the quality of telephone nursing for patients with cancer symptoms. Eligible patients were ones who telephoned the nurse about cancer symptom(s) within four weeks prior to an emergency department (ED) visit not requiring hospital admission. Experienced oncology nurses extracting data indicated appropriateness of ED visits and opportunities for improvement. The Symptom Management Analysis Tool was used to analyze nurse documentation. For 77 patients, 87% ED visits occurred within four days of calls about symptoms (e.g., pain, breathlessness, constipation, diarrhea, nausea/vomiting) and 91% could have been managed by more complete telephone assessment and/or an urgent clinic visit. Quality of nurse documentation revealed few patients were assessed adequately (38%), received any symptom-specific medication review (49%), or were guided in self-care strategies (17%). There was low-quality telephone symptom management by nurses and a need for alternative options for patients requiring urgent face-to-face assessments. Our findings highlight a gap in use of guidelines for informing telephone symptom management.

Reducing pain and distress related to needle procedures in children with cancer: A clinical practice guideline.

BACKGROUND: Children with cancer often undergo long treatment trajectories involving repeated needle procedures that potentially cause pain and distress. As part of a comprehensive effort to develop clinical practice guidelines (CPGs) to address pain prevention and management in children with cancer, we aimed to provide recommendations on the pharmacological and psychological management of procedure-related pain and distress. METHODS: Of the international inter-disciplinary CPG development panel (44 individuals), two working groups including 13 healthcare professionals focused on procedural pain and distress. Grading of Recommendations Assessment, Development and Evaluation methodology was used, including the use of systematic literature reviews to inform recommendations and the use of evidence to decision frameworks. At an in-person meeting in February 2018, the guideline panel discussed these frameworks and formulated recommendations which were then discussed with a patient-parent panel consisting of 4 survivors and 5 parents. RESULTS: The systematic reviews led to the inclusion of 48 randomised controlled trials (total number of participants = 2271). Quality of evidence supporting the recommendations ranged from very low to moderate. Strong recommendations were made for the use of topical anesthetics in all needle procedures, for offering deep sedation (DS)/general anesthesia (GA) to all children undergoing lumbar puncture, for the use of DS/ GA in major procedures in children of all ages, for the use of hypnosis in all needle procedures and for the use of active distraction in all needle procedures. CONCLUSION: In this CPG, an evidence-based approach to manage procedure-related pain and distress in children with cancer is presented. As children with cancer often undergo repeated needle procedures during treatment, prevention and alleviation of procedure-related pain and distress is of the utmost importance to increase quality of life in these children and their families.

Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial.

INTRODUCTION: Pain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes. METHODS AND ANALYSIS: This will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed. ETHICS AND DISSEMINATION: This trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing. TRIAL REGISTRATION NUMBER: NCT03632343 (ClinicalTrials.gov).

Digital Process Innovation for Patient Centred Cancer Symptom Management.

Digital process innovation in healthcare enables us to enhance functionality beyond what is enabled in physical process execution. However, the movement from paper artifacts and manual processes to the use of information and communication technologies (ICTs) to support healthcare delivery is challenging because system design requirements for digital processes can be much less structured and more difficult to define than for physical processes. This paper addresses the above issue and presents on our research in converting paper-based cancer symptom management practice guides to digital format for use by patients. We provide an overall architecture and three system design considerations for digital process innovation to support patient centered cancer symptom management.

Electronic Versus Traditional Data Collection: A Multicenter Randomized Controlled Perioperative Pain Trial.

Background: Electronic data collection is increasingly available as a means to collect pain-related clinical trial data; however, effectiveness and costs relative to traditional data collection are uncertain. Aims: The aim of this study was to evaluate data quality, protocol adherence, satisfaction, and resource requirements of electronic data collection (i.e., Internet-based electronic submission) compared to traditional data collection methods (i.e., paper-based diaries and telephone interviews) in a perioperative factorial randomized controlled trial. Methods: This study was an open-label two-arm parallel randomized controlled trial. Women (18-75 years) undergoing breast cancer surgery were allocated to either electronic or traditional data collection and completed pain-related questionnaires at baseline, postoperative period, and 3-month follow-up (NCT02240199). Results: We acquired outcome data at all time points from 78 randomized patients, 38 in the electronic group and 40 in the traditional group. The number of data queries (e.g., erroneously entered data) per patient was higher in the electronic data group (4.92 [SD = 4.67] vs. 1.88 [SD = 1.51]; P < 0.001). No between-group differences were observed for compliance with medications, data completeness, loss to follow-up, or patient or research assistant satisfaction. More research assistant time per patient was spent collecting data in the traditional group (42.6 min [SD = 12.8] vs. 9.92 min [SD = 7.6]; P < 0.001); however, costs per patient were higher in the electronic group ($176.85 [SD = 2.90] vs. $16.33 [SD = 4.90]; P < 0.001). Conclusion: Electronic data collection is feasible for perioperative pain clinical trials. Additional trials, including different surgical populations, are needed to confirm our findings and optimize use of electronic data capture methods.

Contexte: La collecte électronique de données est de plus en plus disponible en tant que moyen de recueillir les données dans le cadre d'essais cliniques liés à la douleur; toutefois, l'efficacité et le coût de cette méthode, comparativement à la collecte de données traditionnelle, sont incertains.But: Évaluer la qualité des données, le respect du protocole, la satisfaction et les ressources requises dans le cadre de la collecte électronique de données (i.e. la transmission électronique par Internet) comparativement aux méthodes de collecte de données traditionnelles (c.-à.-d les cahiers papier et les entrevues téléphoniques) dans un essai randomisé contrôllé factoriel périopératoire.Méthodes: Cette étude était un essai contrôlé randomisé ouvert parallèle à deux volets. Des femmes (de 18 à 75 ans) subissant une chirurgie pour traiter un cancer du sein ont été réparties en deux groupes, soit celui de la collecte életronique de données et celui de la collecte traditionnelle de données. Elles ont ensuite répondu à des questionnaires liés à la douleur au départ, pendant la période post-opératoire et au bout de trois mois (NCT02240199).Résutats: Nous avons receuilli les données de 78 patientes randomisées à chaque point dans le temps : 38 patientes dans le groupe électronique et 40 patientes dans le groupe traditionnel. Le nombre de questions relatives aux données (ex.: données saisies de manière erronée) par patiente était plus élevé dans le groupe de données électroniques (4,92, É.-T. 4,67 comparativement à 1,88, É.-T. 1,51; p < 0,001). Aucune différence n'a été observée entre les groupes en ce qui concerne l'observance du traitement médicamenteux, l'exhaustivité des données, le nombre de patientes perdues de vue et la satisfaction des patientes ou des assistantes de recherche. Les assistants de recherche ont passé plus de temps par patiente pour recueillir les données dans le groupe traditionnel (42,6 minutes É.-T. 12,8 comparativement à 9,92 minutes É.-T. 76; p < 0,001); toutefois, le coût par patiente était plus élevé dans le groupe électronique (176,85 $ É.-T. 2,90 comparativement à 16,33 $ É.-T. 4,90; p < 0,001).Conclusion: La collecte électronique de données est réalisable dans le cadre d'essais cliniques portant sur la douleur périopératoire. Des essais supplémentaires, y compris auprès de différentes populations de patients chirurgicaux, sont nécessaires pour confirmer nos résultats et optimiser l'utilisation de méthodes éectroniques de saisie de données.

The Implementation Effectiveness of a Freely Available Pediatric Cancer Pain Assessment App: A Pilot Implementation Study.

BACKGROUND: Pain Squad is an evidence-based, freely available iOS app designed to assess pain in children with cancer. Once research-based technologies such as Pain Squad are validated, it is important to evaluate their performance in natural settings to optimize their real-world clinical use. OBJECTIVE: The objective of this study was to evaluate the implementation effectiveness of Pain Squad in a natural setting. METHODS: Parents of 149 children with cancer (aged 8-18 years) were contacted to invite their child to participate. Participating children downloaded Pain Squad on their own iOS devices from the Apple App Store and reported their pain using the app twice daily for 1 week. Participants then emailed their pain reports from the app to the research team and completed an online survey on their experiences. Key implementation outcomes included acceptability, appropriateness, cost, feasibility, fidelity, penetration, and sustainability. RESULTS: Of the 149 parents contacted, 16 of their children agreed to participate. More than a third (6/16, 37.5%) of participating children returned their pain reports to the research team. Adherence to the pain assessments was 62.1% (mean 8.7/14 assessments). The 6 children who returned reports rated the app as highly feasible to download and use and rated their overall experience as acceptable. They also reported that they would be willing to sustain their Pain Squad use over several weeks and that they would recommend it to other children with cancer, which suggests that it may have potential for penetration. CONCLUSIONS: While Pain Squad was well received by the small number of children who completed the study, user uptake, engagement, and adherence were significant barriers to the implementation of Pain Squad in a natural setting. Implementation studies such as this highlight important challenges and opportunities for promoting the use and uptake of evidence-based technologies by the intended end-users.