Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis.

Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a disabling long-term condition of unknown cause. The National Institute for Health and Care Excellence (NICE) published a guideline in 2021 that highlighted the seriousness of the condition, but also recommended that graded exercise therapy (GET) should not be used and cognitive-behavioural therapy should only be used to manage symptoms and reduce distress, not to aid recovery. This U-turn in recommendations from the previous 2007 guideline is controversial.We suggest that the controversy stems from anomalies in both processing and interpretation of the evidence by the NICE committee. The committee: (1) created a new definition of CFS/ME, which 'downgraded' the certainty of trial evidence; (2) omitted data from standard trial end points used to assess efficacy; (3) discounted trial data when assessing treatment harm in favour of lower quality surveys and qualitative studies; (4) minimised the importance of fatigue as an outcome; (5) did not use accepted practices to synthesise trial evidence adequately using GRADE (Grading of Recommendations, Assessment, Development and Evaluations trial evidence); (6) interpreted GET as mandating fixed increments of change when trials defined it as collaborative, negotiated and symptom dependent; (7) deviated from NICE recommendations of rehabilitation for related conditions, such as chronic primary pain and (8) recommended an energy management approach in the absence of supportive research evidence.We conclude that the dissonance between this and the previous guideline was the result of deviating from usual scientific standards of the NICE process. The consequences of this are that patients may be denied helpful treatments and therefore risk persistent ill health and disability.

When is lack of scientific integrity a reason for retracting a paper? A case study.

OBJECTIVE: The journal received a request to retract a paper reporting the results of a triple-blind randomized placebo-controlled trial. The present and immmediate past editors expand on the journal's decision not to retract this paper in spite of undisputable evidence of scientific misconduct on behalf of one of the investigators. METHODS: The editors present an ethical reflection on the request to retract this randomized clinical trial with consideration of relevant guidelines from the Committee on Publication Ethics (COPE) and the International Committee of Medical Journal Editors (ICMJE) applied to the unique contextual issues of this case. RESULTS: In this case, scientific misconduct by a blinded provider of a homeopathy intervention attempted to undermine the study blind. As part of the study, the integrity of the study blind was assessed. Neither participants nor homeopaths were able to identify whether the participant was assigned to homeopathic medicine or placebo. Central to the decision not to retract the paper was the fact that the rigorous scientific design provided evidence that the outcome of the study was not affected by the misconduct. The misconduct itself was thought to be insufficient reason to retract the paper. CONCLUSION: Retracting a paper of which the outcome is still valid was in itself considered unethical, as it takes away the opportunity to benefit from its results, rendering the whole study useless. In such cases, scientific misconduct is better handled through other professional channels.

Evaluation of intramuscular olanzapine and ziprasidone in the medically ill.

INTRODUCTION: Despite the paucity of studies evaluating short-acting parenteral second-generation antipsychotics in the medically ill, their use in this population has increased. The purpose of this study was to characterize the use of IM olanzapine and ziprasidone in the medically ill at an academic medical center. METHODS: This is a retrospective medical record review of all patients who received IM olanzapine or ziprasidone on nonpsychiatric inpatient units at a large academic medical center from August 1, 2015 to July 31, 2017. The primary endpoint characterized the indication for use. Secondary endpoints included safety, effectiveness, and prescribing patterns. RESULTS: After exclusion criteria, a total of 100 patients were included in this study, predominantly white males with a mean age of 56 years. Seventy-four percent of patients received IM ziprasidone and 26% received IM olanzapine. The most common indications for use were agitation of nonpsychotic origin (40%) and delirium (33%). Patients received IM olanzapine and ziprasidone when their use was contraindicated (26.9% vs 9.5%, respectively). DISCUSSION: Intramuscular second-generation antipsychotics are increasingly being used in the medically ill for delirium and agitation. Our study confirms these were the most common indications for IM second-generation antipsychotic use in this population. Additionally, their use appeared to be well-tolerated, and no patient developed Torsades de Pointes even when combined with other agents that putatively increase QTc. Given the retrospective, single-center, nonrandomized design of this study, the safety and effectiveness of these parenteral second-generation antipsychotics in common causes of acute agitation should continue to be further evaluated.

Use of psychotropic drugs in the dermatology patient: When to start and stop?

Dermatologists often find themselves treating patients with psychiatric disorders, most commonly anxiety and depression, in the context of skin disease. The psychiatric condition may either be present before the skin condition developed and exacerbate it or, in some cases, even create it (eg, delusions of parasitosis). Alternatively, the psychiatric condition may occur subsequent to the development of the dermatologic condition. The treatment of psychodermatogic disorders requires collaboration between psychiatrists and dermatologists. Dermatologists should be able to recognize primary psychiatric disorders and refer patients to psychiatrists for appropriate treatment; however, the patient may encounter delays in accessing psychiatric care, and dermatologists should be familiar with the basic use of psychotropic drugs. This review describes common psychiatric disorders encountered in a dermatology practice and their treatment with psychotropic drugs. For each commonly used drug, dose range, side effects, and how to initiate and terminate treatment are described. Although psychotherapy is an important part of the treatment of most psychiatric disorders, we have limited our focus to psychotropic drugs in this review.

Somatic symptom disorder in dermatology.

Somatic symptom disorder (SSD) is defined by the prominence of somatic symptoms associated with abnormal thoughts, feelings, and behaviors related to the symptoms, resulting in significant distress and impairment. Individuals with these disorders are more commonly encountered in primary care and other medical settings, including dermatology practice, than in psychiatric and other mental health settings. What defines the thoughts, feelings, and behaviors as abnormal is that they are excessive, that is, out of proportion to other patients with similar somatic symptoms, and that they result in significant distress and impairment. SSD may occur with or without the presence of a diagnosable dermatologic disorder. When a dermatologic disorder is present, SSD should be considered when the patient is worrying too much about his or her skin, spending too much time and energy on it, and especially if the patient complains of many nondermatologic symptoms in addition. The differential diagnosis includes other psychiatric disorders, including depression, anxiety disorders, delusions of parasitosis, and body dysmorphic disorder. This paper describes SSD and its applicability in dermatologic practice, with illustrative cases.

Comorbidity, Pain, Utilization, and Psychosocial Outcomes in Older versus Younger Sickle Cell Adults: The PiSCES Project.

Background. Patients with SCD now usually live well into adulthood. Whereas transitions into adulthood are now often studied, little is published about aging beyond the transition period. We therefore studied age-associated SCD differences in utilization, pain, and psychosocial variables. Methods. Subjects were 232 adults in the Pain in Sickle Cell Epidemiology Study (PiSCES). Data included demographics, comorbidity, and psychosocial measures. SCD-related pain and health care utilization were recorded in diaries. We compared 3 age groups: 16-25 (transition), 26-36 (younger adults), and 37-64 (older adults) years. Results. Compared to the 2 adult groups, the transition group reported fewer physical challenges via comorbidities, somatic complaints, and pain frequency, though pain intensity did not differ on crisis or noncrisis pain days. The transition group utilized opioids less often, made fewer ambulatory visits, and had better quality of life, but these differences disappeared after adjusting for pain and comorbidities. However, the transition group reported more use of behavioral coping strategies. Conclusion. We found fewer biological challenges, visits, and better quality of life, in transition-aged versus older adults with SCD, but more behavioral coping. Further study is required to determine whether age-appropriate health care, behavioral, or other interventions could improve age-specific life challenges of patients with SCD.

Physicians' Perception of Sickle-cell Disease Pain.

The aim of this study was to evaluate the physician's perception of pain experienced by patients with sickle-cell disease (SCD). Pain experiences reported by patients were compared with physicians' perception of the patient's pain, and the treatment decision-making process was evaluated. Fifty-two patient-physician pairs were assessed. Before the clinic visit, the patients completed a 3-item on pain experienced 24 h prior to the visit and the PHQ-9. After the patient visit, the physicians completed a questionnaire assessing their perception of the patient's pain and a questionnaire on the factors taken into consideration when evaluating the patient's pain experience. The physicians rated the patients' pain as more intense than did the patients themselves; and there was agreement between pain intensity measurements (p < 0.05). The physicians' perception was influenced by the pain intensity reported by the patient, results of blood count at the time of the patient visit, and medication availability in the public health services. However, these factors were not predictive of the patient's pain intensity perceived by the physician. Patients' depressive symptoms were not predictive factor of the physicians' perception. Biochemical, genetic and symptomatic characteristics of SCD influenced the physicians' perception of the patient's pain experience, while psychosocial aspects did not.

Comparison of self-citation by peer reviewers in a journal with single-blind peer review versus a journal with open peer review.

OBJECTIVE: Some peer reviewers may inappropriately, or coercively request that authors include references to the reviewers' own work. The objective of this study was to evaluate whether, compared to reviews for a journal with single-blind peer review, reviews for a journal with open peer review included (1) fewer self-citations; (2) a lower proportion of self-citations without a rationale; and (3) a lower ratio of proportions of citations without a rationale in self-citations versus citations to others' work. METHODS: Peer reviews for published manuscripts submitted in 2012 to a single-blind peer review journal, the Journal of Psychosomatic Research, were previously evaluated (Thombs et al., 2015). These were compared to publically available peer reviews of manuscripts published in 2012 in an open review journal, BMC Psychiatry. Two investigators independently extracted data for both journals. RESULTS: There were no significant differences between journals in the proportion of all reviewer citations that were self-citations (Journal of Psychosomatic Research: 71/225, 32%; BMC Psychiatry: 90/315, 29%; p=.50), or in the proportion of self-citations without a rationale (Journal of Psychosomatic Research: 15/71, 21%; BMC Psychiatry: 12/90, 13%; p=.21). There was no significant difference between journals in the proportion of self-citations versus citations to others' work without a rationale (p=.31). CONCLUSION: Blind and open peer review methodologies have distinct advantages and disadvantages. The present study found that, in reasonably similar journals that use single-blind and open review, there were no substantive differences in the pattern of peer reviewer self-citations.

Daily home opioid use in adults with sickle cell disease: The PiSCES project.

BACKGROUND: Although opioid prescribing in sickle cell disease (SCD) can be controversial, little is published about patterns of opioid use. OBJECTIVE: To report on home opioid use among adults with SCD. DESIGN: Cohort study. PARTICIPANTS: Adults with SCD (n=219) who completed daily pain diaries for up to 6 months and had at least one home pain day. MAIN MEASURES: Use of long-acting or short-acting opioids, other analgesics, or adjuvants; the proportion of home days, home pain days, and home crisis days with opioid use; these two outcomes according to patient characteristics. KEY RESULTS: Patients used opioids on 12,311 (78 percent) of 15,778 home pain days. Eighty-five patients (38.8 percent) used long-acting opioids with or without short-acting opioids and 103 (47.0 percent) used only short-acting opioids. Twenty-one (9.6 percent) patients used only non-opioid analgesics and 10 (4.6 percent) used no analgesics. Both pain intensity and pain frequency were higher among opioid users (analysis of variance [ANOVA], p<0.0001). Opioid users used hydroxyurea more often than nonusers, even when controlling for mean pain on pain days. Among all patients, significant relationships were found between any opioid use and somatic symptom burden, SCD stress, negative coping, and physical and mental quality of life (QOL); the relationship with SCD stress and physical QOL remained when controlled for mean pain. Among opioid users, similar associations were found between frequency of opioid use and some disease-related and psychosocial variables. CONCLUSIONS: In this adult SCD sample, opioids were used by the majority of patients. Pain was the overwhelming characteristic associated with use, but disease-related and psychosocial variables were also associated.

The milestones for psychosomatic medicine subspecialty training.

BACKGROUND: The Accreditation Council of Graduate Medical Education Milestones project is a key element in the Next Accreditation System for graduate medical education. On completing the general psychiatry milestones in 2013, the Accreditation Council of Graduate Medical Education began the process of creating milestones for the accredited psychiatric subspecialties. METHODS: With consultation from the Academy of Psychosomatic Medicine, the Accreditation Council of Graduate Medical Education appointed a working group to create the psychosomatic medicine milestones, using the general psychiatry milestones as a starting point. RESULTS: This article represents a record of the work of this committee. It describes the history and rationale behind the milestones, the development process used by the working group, and the implications of these milestones on psychosomatic medicine fellowship training. CONCLUSIONS: The milestones, as presented in this article, will have an important influence on psychosomatic medicine training programs. The implications of these include changes in how fellowship programs will be reviewed and accredited by the Accreditation Council of Graduate Medical Education and changes in the process of assessment and feedback for fellows.

Readiness for behaviour change in non-alcoholic fatty liver disease: implications for multidisciplinary care models.

BACKGROUND & AIMS: Weight management is a cornerstone of treatment for overweight/obese persons with non-alcoholic fatty liver disease (NAFLD). This exploratory study sought to: (i) evaluate readiness to change weight-related behaviours; (ii) assess psychosocial characteristics that may interfere with weight loss; and (iii) evaluate how baseline psychosocial features associate with 6-month change in weight in persons with NAFLD receiving standard medical care. The purpose of this investigation was to develop hypotheses regarding relationships between psychosocial factors and weight for use in future fully powered studies and clinical interventions METHODS: Fifty-eight overweight/obese participants with NAFLD completed baseline measures of personality, psychiatric symptoms and readiness for behaviour change and were followed up for 6 months in standard care. RESULTS: One-third of participants (31.0%) were not interested in making weight-related behaviour changes; 58.6% were considering making a change, and 10.4% of individuals were actively working on or preparing to change. Six-month change in weight was non-significant and was not associated with baseline readiness for change. Depression, low conscientiousness and high neuroticism were associated with higher weight at 6-month follow-up with small to large effect sizes. CONCLUSIONS: Although participants received nutritional education and guidance, very few individuals presented in the active stage of change. Although readiness for change did not predict subsequent change in weight, personality factors and psychiatric symptoms were associated with weight outcomes. Integrated multidisciplinary approaches that address psychiatric needs and provide behavioural support for weight loss may help patients with NAFLD implement sustained lifestyle changes.

Potentially coercive self-citation by peer reviewers: a cross-sectional study.

OBJECTIVE: Peer reviewers sometimes request that authors cite their work, either appropriately or via coercive self-citation to highlight the reviewers' work. The objective of this study was to determine in peer reviews submitted to one biomedical journal (1) the extent of peer reviewer self-citation; (2) the proportion of reviews recommending revision or acceptance versus rejection that included reviewer self-citations; and (3) the proportion of reviewer self-citations versus citations to others that included a rationale. METHODS: Peer reviews for manuscripts submitted in 2012 to the Journal of Psychosomatic Research were evaluated. Data extraction was performed independently by two investigators. RESULTS: There were 616 peer reviews (526 reviewers; 276 manuscripts), of which 444 recommended revision or acceptance and 172 rejection. Of 428 total citations, there were 122 peer reviewer self-citations (29%) and 306 citations to others' work (71%). Self-citations were more common in reviews recommending revision or acceptance (105 of 316 citations; 33%) versus rejection (17/112; 15%; p<0.001). The percentage of self-citations with no rationale (26 of 122; 21%) was higher than for citations to others' work (15 of 306; 5%; p<0.001). CONCLUSIONS: Self-citation in peer reviews is common and may reflect a combination of appropriate citation to research that should be cited in published articles and inappropriate citation intended to highlight the work of the peer reviewer. Providing instructions to peer reviewers about self-citation and asking them to indicate when and why they have self-cited may help to limit self-citation to appropriate, constructive recommendations.

Clinical use of amyloid-positron emission tomography neuroimaging: Practical and bioethical considerations.

Until recently, estimation of ß-amyloid plaque density as a key element for identifying Alzheimer's disease (AD) pathology as the cause of cognitive impairment was only possible at autopsy. Now with amyloid-positron emission tomography (amyloid-PET) neuroimaging, this AD hallmark can be detected antemortem. Practitioners and patients need to better understand potential diagnostic benefits and limitations of amyloid-PET and the complex practical, ethical, and social implications surrounding this new technology. To complement the practical considerations, Eli Lilly and Company sponsored a Bioethics Advisory Board to discuss ethical issues that might arise from clinical use of amyloid-PET neuroimaging with patients being evaluated for causes of cognitive decline. To best address the multifaceted issues associated with amyloid-PET neuroimaging, we recommend this technology be used only by experienced imaging and treating physicians in appropriately selected patients and only in the context of a comprehensive clinical evaluation with adequate explanations before and after the scan.

Emergent use of mechanical circulatory support devices: ethical dilemmas.

PURPOSE OF REVIEW: Mechanical Circulatory Support (MCS) devices are 'life-sustaining devices' placed as a bridge to decision, either recovery, transplantation or a lifetime tether with the device. Cardiogenic shock may compromise patient autonomy, or the right for an individual patient to determine his own care. This review addresses an ethical dilemma in the context of complex clinical medical decision-making, during marked uncertainty for outcomes. RECENT FINDINGS: The language in an advanced directive is often imprecise and may not provide clear guidance, especially for emergent decisions related to MCS devices. Despite improving outcomes, application of MCS in critical illness is associated with excessive morbidity and quality of life-limiting adverse outcomes. Several cohort experiences now exist that define deactivation of Left Ventricular Assist Devices (LVADs) in futility as now deemed as morally and ethically appropriate. In contradistinction to euthanasia, deactivation of an LVAD does not introduce new intervention or an additional surgical injury, thereby allowing the patient to die from their original disorder. SUMMARY: Clinicians must maintain the principle of patient autonomy, ensure the viability of an appropriate informed consent process and facilitate surrogate judgment. An interdisciplinary team-based approach is required, and, in some cases, assisted by formal ethics consultations in vexing situations.

Ethical issues concerning the recruitment of university students as research subjects.

OBJECTIVE: To discuss the ethical issues in the recruitment of university students as research subjects. METHODS: Narrative review and discussion. RESULTS: The recruitment and inclusion of students in university research projects raise ethical issues specific to this population. Students may be required or coerced to participate, receive course credits for their participation, and their privacy may be violated. Some ethically questionable procedures are standard practice at some universities, and endorsed by their institutional review boards and faculties. Some changes will not be easy to achieve because this implies a change of organization of research and will affect funding and output. CONCLUSION: The authors call for international standards to be set for research with students, that are in line with applicable standards in research with other subjects, such as medically ill patients, on which researchers, members of institutional review boards and editors can base their policies, opinions and decisions.