Medical cannabis or cannabinoids for chronic pain: a clinical practice guideline.

CLINICAL QUESTION: What is the role of medical cannabis or cannabinoids for people living with chronic pain due to cancer or non-cancer causes? CURRENT PRACTICE: Chronic pain is common and distressing and associated with considerable socioeconomic burden globally. Medical cannabis is increasingly used to manage chronic pain, particularly in jurisdictions that have enacted policies to reduce use of opioids; however, existing guideline recommendations are inconsistent, and cannabis remains illegal for therapeutic use in many countries. RECOMMENDATION: The guideline expert panel issued a weak recommendation to offer a trial of non-inhaled medical cannabis or cannabinoids, in addition to standard care and management (if not sufficient), for people living with chronic cancer or non-cancer pain. HOW THIS GUIDELINE WAS CREATED: An international guideline development panel including patients, clinicians with content expertise, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines using the GRADE approach. The MAGIC Evidence Ecosystem Foundation (MAGIC) provided methodological support. The panel applied an individual patient perspective. THE EVIDENCE: This recommendation is informed by a linked series of four systematic reviews summarising the current body of evidence for benefits and harms, as well as patient values and preferences, regarding medical cannabis or cannabinoids for chronic pain. UNDERSTANDING THE RECOMMENDATION: The recommendation is weak because of the close balance between benefits and harms of medical cannabis for chronic pain. It reflects a high value placed on small to very small improvements in self reported pain intensity, physical functioning, and sleep quality, and willingness to accept a small to modest risk of mostly self limited and transient harms. Shared decision making is required to ensure patients make choices that reflect their values and personal context. Further research is warranted and may alter this recommendation.

Medical cannabis or cannabinoids for chronic pain: a clinical practice guideline

Clinical question: What is the role of medical cannabis or cannabinoids for people living with chronic pain due to cancer or non-cancer causes? Current practice: Chronic pain is common and distressing and associated with considerable socioeconomic burden globally. Medical cannabis is increasingly used to manage chronic pain, particularly in jurisdictions that have enacted policies to reduce use of opioids; however, existing guideline recommendations are inconsistent, and cannabis remains illegal for therapeutic use in many countries. Recommendation: The guideline expert panel issued a weak recommendation to offer a trial of non-inhaled medical cannabis or cannabinoids, in addition to standard care and management (if not sufficient), for people living with chronic cancer or non-cancer pain. How this guideline was created: An international guideline development panel including patients, clinicians with content expertise, and methodologists produced this recommendation in adherence with standards for trustworthy guidelines using the GRADE approach. The MAGIC Evidence Ecosystem Foundation (MAGIC) provided methodological support. The panel applied an individual patient perspective. The evidence: This recommendation is informed by a linked series of four systematic reviews summarising the current body of evidence for benefits and harms, as well as patient values and preferences, regarding medical cannabis or cannabinoids for chronic pain. Understanding the recommendation: The recommendation is weak because of the close balance between benefits and harms of medical cannabis for chronic pain. It reflects a high value placed on small to very small improvements in self reported pain intensity, physical functioning, and sleep quality, and willingness to accept a small to modest risk of mostly self limited and transient harms. Shared decision making is required to ensure patients make choices that reflect their values and personal context. Further research is warranted and may alter this recommendation.

Tools to Assess the Trustworthiness of Evidence-Based Point-of-Care Information for Health Care Professionals: Systematic Review.

BACKGROUND: User-friendly information at the point of care should be well structured, rapidly accessible, and comprehensive. Also, this information should be trustworthy, as it will be used by health care practitioners to practice evidence-based medicine. Therefore, a standard, validated tool to evaluate the trustworthiness of such point-of-care information resources is needed. OBJECTIVE: This systematic review sought to search for tools to assess the trustworthiness of point-of-care resources and to describe and analyze the content of these tools. METHODS: A systematic search was performed on three sources: (1) we searched online for initiatives that worked off of the trustworthiness of medical information; (2) we searched Medline (PubMed) until June 2019 for relevant literature; and (3) we scanned reference lists and lists of citing papers via Web of Science for each retrieved paper. We included all studies, reports, websites, or methodologies that reported on tools that assessed the trustworthiness of medical information for professionals. From the selected studies, we extracted information on the general characteristics of the tools. As no standard, risk-of-bias assessment instruments are available for these types of studies, we described how each tool was developed, including any assessments on reliability and validity. We analyzed the criteria used in the different tools and divided them into five categories: (1) author-related information; (2) evidence-based methodology; (3) website quality; (4) website design and usability; and (5) website interactivity. The percentage of tools in compliance with these categories and the different criteria were calculated. RESULTS: Included in this review was a total of 17 tools, all published between 1997 and 2018. The tools were developed for different purposes, from a general quality assessment of medical information to very detailed analyses, all specifically for point-of-care resources. However, the development process of the tools was poorly described. Overall, seven tools had a scoring system implemented, two were assessed for reliability only, and two other tools were assessed for both validity and reliability. The content analysis showed that all the tools assessed criteria related to an evidence-based methodology: 82% of the tools assessed author-related information, 71% assessed criteria related to website quality, 71% assessed criteria related to website design and usability, and 47% of the tools assessed criteria related to website interactivity. There was significant variability in criteria used, as some were very detailed while others were more broadly defined. CONCLUSIONS: The 17 included tools encompass a variety of items important for the assessment of the trustworthiness of point-of-care information. Overall, two tools were assessed for both reliability and validity, but they lacked some essential criteria for the assessment of the trustworthiness of medical information for use at the point-of-care. Currently, a standard, validated tool does not exist. The results of this review may contribute to the development of such an instrument, which may enhance the quality of point-of-care information in the long term. TRIAL REGISTRATION: PROSPERO CRD42019122565; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=122565.

Systematic screening and assessment of psychosocial well-being and care needs of people with cancer.

BACKGROUND: Receiving a diagnosis of cancer and the subsequent related treatments can have a significant impact on an individual's physical and psychosocial well-being. To ensure that cancer care addresses all aspects of well-being, systematic screening for distress and supportive care needs is recommended. Appropriate screening could help support the integration of psychosocial approaches in daily routines in order to achieve holistic cancer care and ensure that the specific care needs of people with cancer are met and that the organisation of such care is optimised. OBJECTIVES: To examine the effectiveness and safety of screening of psychosocial well-being and care needs of people with cancer. To explore the intervention characteristics that contribute to the effectiveness of these screening interventions. SEARCH METHODS: We searched five electronic databases in January 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, PsycINFO, and CINAHL. We also searched five trial registers and screened the contents of relevant journals, citations, and references to find published and unpublished trials. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and non-randomised controlled trials (NRCTs) that studied the effect of screening interventions addressing the psychosocial well-being and care needs of people with cancer compared to usual care. These screening interventions could involve self-reporting of people with a patient-reported outcome measures (PROMs) or a semi-structured interview with a screening interventionist, and comprise a solitary screening intervention or screening with guided actions. We excluded studies that evaluated screening integrated as an element in more complex interventions (e.g. therapy, coaching, full care pathways, or care programmes). DATA COLLECTION AND ANALYSIS: Two review authors independently extracted the data and assessed methodological quality for each included study using the Cochrane tool for RCTs and the Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool for NRCTs. Due to the high level of heterogeneity in the included studies, only three were included in meta-analysis. Results of the remaining 23 studies were analysed narratively. MAIN RESULTS: We included 26 studies (18 RCTs and 8 NRCTs) with sample sizes of 41 to 1012 participants, involving a total of 7654 adults with cancer. Two studies included only men or women; all other studies included both sexes. For most studies people with breast, lung, head and neck, colorectal, prostate cancer, or several of these diagnoses were included; some studies included people with a broader range of cancer diagnosis. Ten studies focused on a solitary screening intervention, while the remaining 16 studies evaluated a screening intervention combined with guided actions. A broad range of intervention instruments was used, and were described by study authors as a screening of health-related quality of life (HRQoL), distress screening, needs assessment, or assessment of biopsychosocial symptoms or overall well-being. In 13 studies, the screening was a self-reported questionnaire, while in the remaining 13 studies an interventionist conducted the screening by interview or paper-pencil assessment. The interventional screenings in the studies were applied 1 to 12 times, without follow-up or from 4 weeks to 18 months after the first interventional screening. We assessed risk of bias as high for eight RCTs, low for five RCTs, and unclear for the five remaining RCTs. There were further concerns about the NRCTs (1 = critical risk study; 6 = serious risk studies; 1 = risk unclear).Due to considerable heterogeneity in several intervention and study characteristics, we have reported the results narratively for the majority of the evidence.In the narrative synthesis of all included studies, we found very low-certainty evidence for the effect of screening on HRQoL (20 studies). Of these studies, eight found beneficial effects of screening for several subdomains of HRQoL, and 10 found no effects of screening. One study found adverse effects, and the last study did not report quantitative results. We found very low-certainty evidence for the effect of screening on distress (16 studies). Of these studies, two found beneficial effects of screening, and 14 found no effects of screening. We judged the overall certainty of the evidence for the effect of screening on HRQoL to be very low. We found very low-certainty evidence for the effect of screening on care needs (seven studies). Of these studies, three found beneficial effects of screening for several subdomains of care needs, and two found no effects of screening. One study found adverse effects, and the last study did not report quantitative results. We judged the overall level of evidence for the effect of screening on HRQoL to be very low. None of the studies specifically evaluated or reported adverse effects of screening. However, three studies reported unfavourable effects of screening, including lower QoL, more unmet needs, and lower satisfaction.Three studies could be included in a meta-analysis. The meta-analysis revealed no beneficial effect of the screening intervention on people with cancer HRQoL (mean difference (MD) 1.65, 95% confidence interval (CI) -4.83 to 8.12, 2 RCTs, 6 months follow-up); distress (MD 0.0, 95% CI -0.36 to 0.36, 1 RCT, 3 months follow-up); or care needs (MD 2.32, 95% CI -7.49 to 12.14, 2 RCTs, 3 months follow-up). However, these studies all evaluated one specific screening intervention (CONNECT) in people with colorectal cancer.In the studies where some effects could be identified, no recurring relationships were found between intervention characteristics and the effectiveness of screening interventions. AUTHORS' CONCLUSIONS: We found low-certainty evidence that does not support the effectiveness of screening of psychosocial well-being and care needs in people with cancer. Studies were heterogeneous in population, intervention, and outcome assessment.The results of this review suggest a need for more uniformity in outcomes and reporting; for the use of intervention description guidelines; for further improvement of methodological certainty in studies and for combining subjective patient-reported outcomes with objective outcomes.

Healthcare professionals' perspectives on the prevalence, barriers and management of psychosocial issues in cancer care: A mixed methods study.

This cross-sectional mixed methods survey explores healthcare professionals' perspective on their management of cancer patients' psychosocial concerns, and barriers to integrate the psychosocial approach in their work. An invitation for participation was sent to 4,965 inpatient and outpatient working professionals, of which 583 responded (12% response rate), and 368 fully completed the survey. The majority of respondents does not use a systematic approach to discuss patients' psychosocial concerns, 37.5% use the general question "How are you?," and 65.0% spontaneously addresses various psychosocial aspects. Most psychosocial topics are "sometimes" or "regularly" discussed. Sexuality and return to work are rarely mentioned. About half of the respondents are convinced that they pay enough attention to the psychosocial well-being of cancer patients: by listening, engaging in a deeper conversation, providing advice and through referral. Mostly, patients are referred to a psychologist, a general practitioner, a social worker, a specialised nurse or a centre for well-being and mental health. The barriers experienced, when providing psychosocial support, can be attributed to the patients, to themselves or other healthcare professionals, and to policy restrictions. These barriers should be addressed in order to enable healthcare professionals to improve the integration of the psychosocial approach in cancer care.

An explorative study on systematic assessment of QOL and care needs with the CARES-SF in the early follow-up of patients with digestive cancer.

PURPOSE: Systematic assessment of QOL and care needs was applied in two gastroenterology departments to support "Cancer Care for the Whole Patient." METHODS: Patients with digestive cancer were asked to complete the Cancer Rehabilitation Evaluation System-Short Form (CARES-SF) at the start of treatment and 3 months later. Both times CARES data were processed, and summary reports on the retained insights were sent to the reference nurse for use in further follow-up of the patient. Patients' and reference nurse's experiences with the systematic CARES-assessment were explored with several survey questions and semi-structured interviews, respectively. RESULTS: The mean age of the 51 participants was 63 years (SD11.17), 52.9% was male. With the CARES-SF, a large variety of problems and care needs was detected. Problems most frequently experienced, and most burdensome for QOL are a mix of physical complaints, side effects from treatment, practical, relational, and psychosocial difficulties. Only for a limited number of experienced problems a desire for extra help was expressed. All patients positively evaluate the timing and frequency of the CARES-assessment. The majority believes that this assessment could contribute to the discussion of problems and needs with healthcare professionals, to get more tailored care. Reference nurses experienced the intervention as an opportunity to systematically explore patients' well-being in a comprehensive way, leading to detection and discussion of specific problems or needs in greater depth, and more efficient involvement of different disciplines in care. CONCLUSIONS: Systematic QOL and needs assessment with the CARES-SF in oncology can contribute to more patient-centeredness and efficiency of care.

Qualitative research on the Belgian Cancer Rehabilitation Evaluation System (CARES): An evaluation of the content validity and feasibility.

RATIONALE, AIMS, AND OBJECTIVES: The systematic assessment of cancer patients well-being and care needs is internationally recommended to optimize comprehensive cancer care. The Cancer Rehabilitation Evaluation System (CARES) is a psychometrically robust quality of life and needs assessment tool of US origin, developed in the early 1990s. This article describes Belgian patients' view on the content validity and feasibility of the CARES for use in current cancer care. METHODS: Participants were cancer patients recruited through media. Data were gathered in 4 focus groups (n = 26). The focus group discussions were facilitated with key questions. A moderator and an observer conducted and followed up the discussion. The audio file was transcribed verbatim and afterwards analyzed thematically. RESULTS: Participants experience concerns and needs in a wide range of life domains such as physical, emotional, cognitive, social, relational, sexual, financial, and work-related and in the interaction with care professionals. According to participants, the items of the CARES are all relevant to capture the possible life disruption that cancer patients and survivors experience. One important theme is missing in the CARES, namely, the well-being of loved ones. The completion time of the CARES was judged to be feasible, and according to participants, only a few items need a reformulation. CONCLUSIONS: In general, the results of this study support the content validity and feasibility of the CARES. However, little adjustments in formulation and a few extra items are needed. The instrument can be used to obtain a comprehensive assessment of a cancer patients' overall well-being and care needs to take dedicated action in care.

Validation of the flemish CARES, a quality of life and needs assessment tool for cancer care.

BACKGROUND: The Cancer Rehabilitation Evaluation System (CARES) is a quality of life (QOL) and needs assessment instrument of US origin that was developed in the 90's. Since November 2012 the copyright and user fee were abolished and the instrument became publicly available the present study aims to reinvestigate the psychometric properties of the CARES for the Flemish population in Belgium. METHODS: The CARES was translated into Flemish following a translation-back translation process. A sample of 192 cancer patients completed the CARES, concurrent measures, and questions on socio-demographic and medical data. Participants were asked to complete the CARES a second time 1 week later, followed by some questions on their experiences with the instrument. Internal consistency, test-retest reliability, content validity, construct validity, concurrent validity and feasibility of the CARES were subsequently assessed. RESULTS: The Flemish CARES version demonstrated excellent reliability with high internal consistency (range .87-.96) and test-retest ratings (range .70-.91) for all summary scales. Factor analysis replicated the original factor solution of five higher order factors with factor loadings of .325-.851. Correlations with other instruments ranging from |.43|-|.75| confirmed concurrent validity. Feasibility was indicated by the low number of missing items (mean 2.3; SD 5.0) and positive feedback of participants on the instrument. CONCLUSIONS: The Flemish CARES has strong psychometric properties and can as such be a valid tool to assess cancer patients' QOL and needs in research, for example in international comparisons. The positive feedback of participants on the CARES support the usefulness of this tool for systematic assessment of cancer patients' well-being and care needs in clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02282696 (July 16, 2014).

Assessing cancer patients' quality of life and supportive care needs: Translation-revalidation of the CARES in Flemish and exhaustive evaluation of concurrent validity.

BACKGROUND: The prevalence of cancer increases every year, leading to a growing population of patients and survivors in need for care. To achieve good quality care, a patient-centered approach is essential. Correct and timely detection of needs throughout the different stages of the care trajectory is crucial and can be supported by the use of screening and assessment in a stepped-care approach. The Cancer Rehabilitation Evaluation System (CARES) is a valuable and comprehensive quality of life and needs assessment instrument. For use in Flemish research and clinical practice, the CARES tool was translated for the Dutch-speaking part of Belgium (Flanders) from its original English format. This protocol paper describes the translation and revalidation of this Flemish CARES version. METHODS: After forward-backward translation of the CARES into Flemish we aim to recruit 150 adult cancer patients with a primary cancer diagnosis (stage I, II or III) for validation. In this study with a combination of qualitative and a quantitative approach, qualitative data will be collected through focus groups and supplemented by two phases of quantitative data collection: i) an initial patient survey containing questions on socio-demographic and medical data, the CARES and seven concurrent instruments; and ii) a second survey administered after 1 week containing the CARES and supplementary questions to explore their impressions on the content and the feasibility of the CARES. DISCUSSION: With this extensive data collection process, psychometric validity of the Flemish CARES can be tested thoroughly using classical test theory. Internal consistency of summary scales, test-retest reliability, content validity, construct validity, concurrent validity and feasibility of the instrument will be examined. If the Flemish CARES version is found reliable, valid and feasible, it will be used in future research and clinical practice. Comprehensive assessment with the CARES in a stepped-care approach can facilitate timely identification of cancer patients' psychosocial concerns and care needs so it can contribute to efficient provision of patient-centered quality care. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02282696 (July 16, 2014).