Outcomes in deprescribing implementation trials and compliance with expert recommendations: a systematic review.

BACKGROUND: Deprescribing, defined as discontinuing or reducing the dose of medications that are no longer needed or for which the risks outweigh the benefits is a way to reduce polypharmacy. In 2022, the US Deprescribing Research Network (USDeN) published recommendations concerning the measurement of outcomes for deprescribing intervention studies. The objectives of this systematic review were to identify the outcome categories used in deprescribing intervention trials and to relate them to the previously published recommendations. METHODS: We searched MEDLINE, Embase, PsychInfo, and the Cochrane library from January 2012 through January 2022. Studies were included if they were randomized controlled trials evaluating a deprescribing intervention. After data extraction, outcomes were categorized by type: medication outcomes, clinical outcomes, system outcomes, implementation outcomes, and other outcomes based on the previously published recommendations. RESULTS: Thirty-six studies were included. The majority of studies focused on older adults in nursing homes and targeted inappropriate medications or polypharmacy. In 20 studies, the intervention was a medication review; in seven studies, the intervention was educational or informative; and three studies based their intervention on motivational interviewing or patient empowerment. Thirty-one studies presented a medication outcome (primary outcome in 26 studies), 25 a clinical outcome, 18 a system outcome, and seven an implementation outcome. Only three studies presented all four types of outcomes, and 10 studies presented three types of outcomes. CONCLUSIONS: This review provides an update on the implementation of gold standard deprescribing studies in clinical practice. Implementation outcomes need to be developed and specified to facilitate the implementation of these practices on a larger scale and clinical outcome need to be prioritized. Finally, this review provides new elements for future real-life deprescribing studies.

Bicentre, randomized, parallel-arm, sham-controlled trial of transcranial direct-current stimulation (tDCS) in the treatment of palliative care patients with refractory cancer pain.

BACKGROUND: Pain is a common symptom in palliative care cancer patients and is often insufficiently relieved. In recent years, transcranial direct-current stimulation (tDCS) of the motor cortex has been shown to be effective to treat chronic pain, essentially neuropathic pain. We propose to test the efficacy of tDCS in patients experiencing cancer pain in the palliative care setting. METHOD/DESIGN: This article describes the protocol of a bicentre, randomized, parallel-arm, sham-controlled clinical trial evaluating tDCS in the treatment of palliative care patients with refractory cancer pain. Seventy patients between the ages of 18 and 80 years experiencing refractory pain with a pain score of 4/10 on a numerical rating scale (NRS) ranging from 0 to 10 will be enrolled in this trial. The main exclusion criteria are patients unable to fill in the various rating scales and life expectancy less than 3 weeks. Treatment consists of 5 consecutive tDCS sessions targeting the motor cortex (one daily session for 5 days) on the contralateral side to the pain. After randomization (1:1 ratio), 35 patients will receive active stimulation and 35 patients will receive sham stimulation. The primary endpoint is the NRS score and the primary objective is a significant improvement of this score between the baseline score recorded between D-3 and D-1 and the score recorded 4 days after stopping treatment (D8). The secondary objectives are to evaluate whether this improvement is maintained 16 days after stopping treatment (D21) and whether the following scores are improved on D14 and D21: Brief Pain Inventory, Edmonton Symptom Assessment System, Hospital Anxiety and Depression scale, State-Trait Anxiety Inventory and Medication Quantification Scale. DISCUSSION: Positive results of this trial would indicate that tDCS can improve pain and quality of life of cancer patients in the palliative care setting. Reduction of analgesic consumption and improvement of activities of daily living should allow many patients to return home with a decreased workload for caregivers.

Incidence and risk factors of prolonged grief in relatives of patients with terminal cancer in French palliative care units: The Fami-Life multicenter cohort study.

OBJECTIVES: Psychological consequences of grief among relatives are insufficiently known. We reported incidence of prolonged grief among relatives of deceased patients with cancer. METHODS: Prospective cohort study of 611 relatives of 531 patients with cancer hospitalized for more than 72 hours and who died in 26 palliative care units was conducted. The primary outcome was prolonged grief in relatives 6 months after patient death, measured with the Inventory Complicated Grief (ICG > 25, range 0-76, a higher score indicates more severe symptoms) score. Secondary outcomes in relatives 6 months after patient death were anxiety and depression symptoms based on Hospital Anxiety and Depression Scale (HADS) score (range 0 [best]-42 [worst]), higher scores indicate more severe symptoms, minimally important difference 2.5. Post-traumatic stress disorder symptoms were defined by an Impact Event Scale-Revised score >22 (range 0-88, a higher score indicates more severe symptoms). RESULTS: Among 611 included relatives, 608 (99.5%) completed the trial. At 6 months, significant ICG scores were reported by 32.7% relatives (199/608, 95% CI, 29.0-36.4). The median (interquartile range ICG score) was 20.0 (11.5-29.0). The incidence of HADS symptoms was 87.5% (95% CI, 84.8-90.2%) at Days 3-5 and 68.7% (95% CI, 65.0-72.4) 6 months after patient's death, with a median (interquartile range) difference of -4 (-10 to 0) between these 2 time points. Improvement in HADS anxiety and depression scores were reported by 62.5% (362/579) relatives. SIGNIFICANCE OF RESULTS: These findings support the importance of screening relatives having risk factors of developing prolonged grief in the palliative unit and 6 months after patient's death.

Méthodologies de la recherche en soins palliatifs : les défis de l'interdisciplinarité.

AIM: This article aims to set some theoretical and practical milestones to better understand the challenges of interdisciplinary research in palliative care. METHOD: A theoretical perspective of the main challenges of interdisciplinary research is provided through a review of existing literature, supported by practical experiences learnt from the implementation of two research projects on the improvement of the organization of healthcare services in palliative care in France. RESULTS: Palliative care is historically and philosophically grounded in interdisciplinary culture. Implementation of interdisciplinary research in palliative care is particularly challenging as it implies engaging in a “paradigm dialogue” with different disciplines involved. Beyond the relational skills inherent in and required for actual interdisciplinary practice, interdisciplinary research calls for metacognitive skills such as the ability to search, identify, understand, connect and integrate theoretical and methodological perspectives of different disciplines. CONCLUSION: Addressing the challenges of interdisciplinary research in palliative care requires an educational program that integrates an interdisciplinary approach at the early stage of the medical and healthcare curriculum. Paradigm dialogue should also be encouraged in national research and innovation programs.

The Fami-life study: protocol of a prospective observational multicenter mixed study of psychological consequences of grieving relatives in French palliative care units on behalf of the family research in palliative care (F.R.I.P.C research network).

BACKGROUND: Grieving relatives can suffer from numerous consequences like anxiety, depression, post-traumatic stress disorder (PTSD) symptoms, and prolonged grief. This study aims to assess the psychological consequences of grieving relatives after patients' death in French palliative care units and their needs for support. METHODS: This is a prospective observational multicenter mixed study. Relatives of adult patients with a neoplasia expected to be hospitalized more than 72 h in a palliative care unit for end-of-life issues will be included within 48 h after patient admission. End-of-life issues are defined by the physician at patient admission. Relatives who are not able to have a phone call at 6-months are excluded. The primary outcome is the incidence of prolonged grief reaction defined by an ICG (Inventory Complicate Grief) > 25 (0 best-76 worst) at 6 months after patient' death. Prespecified secondary outcomes are the risk factors of prolonged grief, anxiety and depression symptoms between day 3 and day 5 and at 6 months after patients' death based on an Hospital Anxiety and Depression score (range 0-42) > 8 for each subscale (minimal clinically important difference: 2.5), post-traumatic stress disorder symptoms 6 months after patient' death based on the Impact of Events Scale questionnaire (0 best-88 worst) score > 22, experience of relatives during palliative care based on the Fami-Life questionnaire, specifically built for the study. Between 6 and 12 months after the patient's death, a phone interview with relatives with prolonged grief reactions will be planned by a psychologist to understand the complex system of grief. It will be analyzed with the Interpretative Phenomenological Analysis. We planned to enroll 500 patients and their close relatives assuming a 25% prolonged grief rate and a 6-month follow-up available in 60% of relatives. DISCUSSION: This study will be the first to report the psychological consequences of French relatives after a loss of a loved one in palliative care units. Evaluating relatives' experiences can provide instrumental insights for means of improving support for relatives and evaluation of bereavement programs. TRIAL REGISTRATION: NCT03748225 registered on 11/19/2018. Recruiting patients.

Deep continuous sedation at the patient's request until death in a palliative care unit: retrospective study.

OBJECTIVES: Limited descriptive data are available on continuous and deep sedation maintained until death (CDSUD) at the patient's request in palliative care units. This study aimed to describe such practices in the context of refractory suffering or after a request to stop life-sustaining treatment, evaluating the duration and dosage of sedative treatments used. METHODS: This retrospective observational study included consecutively hospitalised patients in a palliative care unit from January 2020 to December 2021. Data on patient profiles, reasons for the sedation request, duration of sedation and doses of sedatives were collected. RESULTS: Among 42 patients who underwent CDSUD, 79% occurred due to refractory suffering. In cases of sedation following a request to stop life support, high-dose corticosteroid therapy was the most commonly involved life-sustaining treatment. Midazolam was always the first-line sedative treatment. Chlorpromazine was added in 79% of cases, and propofol in 40%, to achieve a deep level of sedation. The mean maximum doses of midazolam, chlorpromazine and propofol were 7.6 mg/hour (±1.9), 3.3 mg/hour (±0.9) and 1.7 mg/kg/hour, respectively. The average duration of sedation was 37 hours. CONCLUSIONS: This study provides new descriptive elements on CDSUD. Notably, it highlights the use of second-line sedative molecules, such as propofol.

Are the deprescribing guidelines for proton pump inhibitors in palliative care applicable? A monocentric observational study.

OBJECTIVES: Proton pump inhibitors (PPIs) are among the most commonly prescribed medications. The aim of this study was to assess the appropriateness of prescribing PPIs in the palliative care unit on admission and during hospitalisation to determine the applicability of deprescribing recommendations. METHODS: A monocentric observational study was conducted over a 6-month period in 2020 in a university palliative care unit. Data on indication, starting date, dose and posology were collected at discharge from the medical record and by contacting the prescriber. A physician and a pharmacist evaluated PPI prescription appropriateness according to guidelines. RESULTS: 131 patients (mean age: 69.5 years; 82% with cancer) were included. Prior to admission, 41% (54/131) of patients were already prescribed PPIs. During hospitalisation, 50% of prescriptions were discontinued, while 12% were initiated. The indication was known for 50% of patients on admission and 59% during their stay. Among patients with PPI prescriptions, 56% had a relevant indication on admission, and 63% during their stay. The prevalence of potential drug interactions was low (<1/10). CONCLUSIONS: While PPIs remain essential for specific indications, this study highlights their excessive prescription even during palliative care. Implementing deprescribing recommendations in this population is crucial to optimise treatment plans.

Impact of the practice of touch-massage® by a nurse on the anxiety of patients with hematological disorders hospitalized in a sterile environment, a randomized, controlled study.

CONTEXT: In addition to curative care, supportive care is beneficial in managing the anxiety symptoms common in patients in sterile hematology unit. We hypothesize that personal massage can help the patient, particularly in this isolated setting where physical contact is extremely limited. The main objective of this study was to show that anxiety could be reduced after a touch-massage® performed by a nurse trained in this therapy. METHODS: A single-center, randomized, unblinded controlled study in the sterile hematology unit of a French university hospital, validated by an ethics committee. The patients, aged between 18 and 65 years old, and suffering from a serious and progressive hematological pathology, were hospitalized in sterile hematology unit for a minimum of three weeks, patients were randomized into either a group receiving 15-minute touch-massage® sessions or a control group receiving an equivalent amount of quiet time once a week for three weeks. In the treated group, anxiety was assessed before and after each touch-massage® session, using the State-Trait Anxiety Inventory questionnaire with subscale state (STAI-State). In the control group, anxiety was assessed before and after a 15-minute quiet period. For each patient, the difference in the STAI-State score before and after each session (or period) was calculated, the primary endpoint was based on the average of these three differences. Each patient completed the Rosenberg Self-Esteem Questionnaire before the first session and after the last session. RESULTS: Sixty-two patients were randomized. Touch-massage® significantly decreased patient anxiety: a mean decrease in STAI-State scale score of 10.6 [7.65-13.54] was obtained for the massage group (p ≤ 0.001) compared with the control group. The improvement in self-esteem score was not significant. CONCLUSION: This study provides convincing evidence for integrating touch-massage® in the treatment of patients in sterile hematology unit. TRIAL REGISTRATION: NCT02343965.

Legalisation of euthanasia and assisted suicide: advanced cancer patient opinions - cross-sectional multicentre study.

OBJECTIVES: The French government voted a new law in February 2016 called the Claeys-Leonetti Law, which established the right to deep and continuous sedation, confirmed the ban on euthanasia and ruled out physician-assisted suicide. The aim of this work was to gather the opinion of patients on continuous sedation and the legalisation of medical assistance in dying and to explore determinants associated with favourable and unfavourable opinions. METHODS: This was a French national prospective multicentre study between 2016 and 2020. RESULTS: 331 patients with incurable cancer suffering from locally advanced or metastatic cancer in 14 palliative care units were interviewed. 48.6% of participants expressed a favourable opinion about physician-assisted suicide and 27.2% an unfavourable opinion about its legalisation. Regarding euthanasia, 52% of patients were in favour of its legalisation. In univariate analysis, the only factor determining opinion was belief in God. CONCLUSIONS: While most healthy French people are in favour of legalising euthanasia, only half of palliative care patients expressed this opinion. Medical palliative care specialists were largely opposed to euthanasia. The only determining factor identified was a cultural factor that was independent of the other studied variables. This common factor was found in other studies conducted on cohorts from other countries. This study contributes to the knowledge and thinking about the impact of patients' personal beliefs and values regarding their opinions about euthanasia and assisted suicide. TRIAL REGISTRATION NUMBER: NCT03664856.

The experience of being a caregiver of patients with digestive cancer, from patients and caregivers' perception: A mixed study.

BACKGROUNDS: Caregivers are essential in the care of a patient with digestive cancer. Considering their experience and needs is crucial. OBJECTIVES: To explore the experience of caregivers of patients with digestive cancer and to compare the perspectives of patients and caregivers. METHODS: A mixed-methods study with a cross-sectional prospective and a comprehensive qualitative dimension was performed in a medical oncology unit in a French tertiary hospital. Dyads made of patients with digestive cancer and their caregiver were recruited. The Caregiver Reaction Assessment (CRA) and the Supportive Care Needs Survey for Partners and Caregivers (SCNS-PC) questionnaires were distributed to caregivers. The CRA was used to measure the caregiver burden and the SCNS-PC was used to identify the unmet supportive care needs of caregivers. Semi-structured interviews with the dyads were conducted. Qualitative interviews addressed various dimensions of the caregiver's experience from each dyad's member perspective. RESULTS: Thirty-two caregivers completed the questionnaires. Responses showed high self-esteem, schedule burden, and a need for care and information services. Ten dyads participated in the interviews. Three themes emerged from the caregiver's interviews: illness is an upheaval; loneliness and helplessness are experienced; caring is a natural role with positive outcomes. Four themes emerged from patient's interviews: the caregiver naturally assumes the role and gets closer; he is the patient's anchor; his life is disrupted; anxiety and guilt accompany the desire to protect him. In comparing patient and caregiver data, the main theme of disagreement was their relationship. CONCLUSIONS: Caregiver care does not appear to be optimal, particularly in terms of their need for information. Patients have a fairly good representation of their experience, but the caregivers' opinion need to be considered.

Patients' preferences in therapeutic decision-making in digestive oncology: a single centre cross-sectional observational study.

Considering the preferences in Shared Decision Making (SDM) of patients with Digestive Cancer (DC) is crucial to ensure the quality of care. To date, there is limited information on preferences in SDM of patients with DC. The objectives of this study were to describe digestive cancer patients' preference for involvement in therapeutic decision-making and to identify variables associated with these preferences. An observational prospective study in a French university cancer center has been conducted. Patients completed two questionnaires to qualify and quantify their preference for involvement in therapeutic decision-making: the Control Preference Scale (CPS) and the Autonomy Preference Index (API), which is composed of the Decision Making (DM) score and the Information Seeking (IS) score. Associations between these scores and socio-demographic data, disease-related data, coping strategies (Brief-COPE), physical (QLQ-C30) and psychological (HADS) quality of life were tested. One-hundred fifteen patients returned the questionnaires. The majority of patients reported a passive (49.1%) or a collaborative (43.0%) CPS status. The mean DM score was 39.4 Variables associated with decision-making preferences were occupational status and time since diagnosis. The identification of variables associated with patients' preferences for involvement in decision-making can help make clinicians aware of patients' needs and wishes. However, it can only be determined by interviewing the patient individually.

[Feelings of cancer patients in exclusive palliative care: Towards a general practitioner, oncologist pairing?] / Ressenti des patients atteints de cancer en soins palliatifs exclusifs: vers un binôme médecin généraliste, cancérologue?

INTRODUCTION: In palliative care, cancer patients' thoughts about support given by their general practitioner are poorly described in the literature. General practitioners are involved in the management of cancer patients in palliative care, but when contact with the oncologist become less frequent, the place of the patient's different doctors becomes difficult to define. The objective of our work is to analyze the patient's perception of the place and role of the general practitioner. METHODS: Qualitative study by individual semi-directed interviews, with voluntary patients with solid cancer in palliative care. Patients were selected by palliative care physicians. A thematic analysis was performed on the basis of the patients' verbatim transcripts. RESULTS: Seventeen patients were interviewed and four main themes were highlighted: a perception of abandonment, a resignation to call the general practitioner, an omnipresence of the oncologist who seems not to leave the place to the general practitioner and a search for global support. The general practitioner did not appear to be empathetic nor supportive enough and was not available enough. DISCUSSION: Patients are looking for empathy and for their doctors to listen. Our work shows a certain disappointment of the patients regarding the place and role of their general practitioner. This disappointment reflects the insufficient coordination between hospital and community care setting. While the early integration of palliative care is becoming a standard of care, the patients' testimony commits us to improve the articulation between the oncologist and the general practitioner.

Interaction between CYP2D6 inhibitor antidepressants and codeine: is this relevant?

INTRODUCTION: Co-occurring pain impairs depression's prognosis. Selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs) are first-line pharmacotherapies for depression and inhibit many cytochrome 2D6 enzymes. Codeine is a first-line treatment for pain and needs to be metabolized into morphine by cytochrome 2D6 to exert its analgesic effect. Concomitant prescription of both pharmacotherapies leads to inadequate analgesia. Areas covered: We performed a systematic review of the literature to amalgamate the current knowledge regarding the clinical effect of this association and quantified its prevalence in clinical practice in the French Pays de la Loire area using a retrospective observational cohort study design. Expert opinion: The literature review highlighted that antidepressants with moderate-to-strong inhibition of CYP2D6 should be avoided in patients receiving codeine. However, 0.44% of the 12,296 sampled patients received concomitant codeine and CYP2D6 inhibitor between January 2015 and June 2015. Switching drugs in both painful and depressive patients depends on the pain and depression subtypes. Promising drugs that both show an effect on pain and depression are currently being studied but are not usable in clinical practice. Until then, tailored communication reinforcement toward health-care professionals is needed to prevent these problematic occurrences of concomitant prescription administration.