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.

Growth through adversity: posttraumatic growth in anonymous living liver donors.

PURPOSE: Post-traumatic growth (PTG) is positive change that occurs after struggling with challenging life crises. Research on PTG has typically been limited to oncology populations, first-responders, and individuals in warzones. We report the experience of PTG amongst a sample of 26 anonymous live liver donors. METHODS: Anonymous donors were those with no biological connection or prior relationship with recipients. Twenty-six participants participated in a semi-structured qualitative interview examining their experience with, and outcomes of donation. Interview transcripts were analyzed for themes about PTG using the constant comparison method. RESULTS: While some donors indicated that donation had little lasting impact on their life, most cited significant personal and interpersonal changes resulting from the experience. The most common positive changes included deepened bonds with others, appreciation for personal strength, clearer life direction, legacy-building, and a connection to the transplant community. CONCLUSION: Despite the short-term physical trauma of living donor surgery, the act of anonymous donation appeared to be a catalyst for positive long-term psychological growth. These findings help to bolster the ethical argument in favour of anonymous donation.IMPLICATIONS FOR REHABILITATIONThere is a shortage of organ donors for recipients in need, and anonymous living liver donors can successfully reduce wait times and mortality rates for those on wait lists.There are some questions about the ethics of anonymous donation due to possible negative physical and psychological effects of donation surgery on donors.In a qualitative study, this study shows that donors ascribe significant meaning to, and derive many psychological benefits from, their donation experience.These findings provide insights about how to best support anonymous donors through and after their donation experience.

The psychological burden of waiting for procedures and patient-centred strategies that could support the mental health of wait-listed patients and caregivers during the COVID-19 pandemic: A scoping review.

BACKGROUND: Waiting for procedures delayed by COVID-19 may cause anxiety and related adverse consequences. OBJECTIVE: To synthesize research on the mental health impact of waiting and patient-centred mitigation strategies that could be applied in the COVID-19 context. METHODS: Using a scoping review approach, we searched 9 databases for studies on waiting lists and mental health and reported study characteristics, impacts and intervention attributes and outcomes. RESULTS: We included 51 studies that focussed on organ transplant (60.8%), surgery (21.6%) or cancer management (13.7%). Most patients and caregivers reported anxiety, depression and poor quality of life, which deteriorated with increasing wait time. The impact of waiting on mental health was greater among women and new immigrants, and those of younger age, lower socio-economic status, or with less-positive coping ability. Six studies evaluated educational strategies to develop coping skills: 2 reduced depression (2 did not), 1 reduced anxiety (2 did not) and 2 improved quality of life (2 did not). In contrast, patients desired acknowledgement of concerns, peer support, and periodic communication about wait-list position, prioritization criteria and anticipated procedure date. CONCLUSIONS: Findings revealed patient-centred strategies to alleviate the mental health impact of waiting for procedures. Ongoing research should explore how to optimize the impact of those strategies for diverse patients and caregivers, particularly in the COVID-19 context. PATIENT OR PUBLIC CONTRIBUTION: Six patients and four caregivers waiting for COVID-19-delayed procedures helped to establish eligibility criteria, plan data extraction and review a draft and final report.

The Meaning Behind the Scar: Anonymous Live Liver Donors' Perceptions of Their Surgical Scars.

BACKGROUND: Scarring can greatly impact quality of life for individuals (ie, causing depression posttraumatic stress disorder and body image issues). Those who wish to be anonymous live liver donors are warned of the potential negative psychological impacts associated with the large scar left from liver donation surgery. Given the unique degree of autonomy that these patients have over their surgery, we explore whether a sample of 26 anonymous live liver donors experience a unique relationship with their scar. METHODS: Anonymous donors participated in a semistructured qualitative interview examining their experience with donation. Interviews were audio-recorded, transcribed, and analyzed using the constant comparison method for themes pertaining, to participants' perception of their scar. RESULTS: Five main themes were identified-a marker of satisfaction about the donation experience, a physical reminder of donation, a trigger for recipient-related thoughts, an awareness tool, and a potential threat to anonymity. Donors did not voice any body image or cosmetic concerns due to their scars. Instead, discussions about the negative aspects of scarring centered around the identifying nature of their scar. CONCLUSIONS: These findings help underscore the distinctiveness of anonymous living liver donors as a patient population. Preparing anonymous living liver donors for different types of cosmetic issues relating to their scar (ie, as a possible threat to their desired anonymity) may be more appropriate than preparing them in the same way as other donor populations.

Canadian Cardiovascular Society/Canadian Cardiac Transplant Network Position Statement on Heart Transplantation: Patient Eligibility, Selection, and Post-Transplantation Care.

Significant practice-changing developments have occurred in the care of heart transplantation candidates and recipients over the past decade. This Canadian Cardiovascular Society/Canadian Cardiac Transplant Network Position Statement provides evidence-based, expert panel recommendations with values and preferences, and practical tips on: (1) patient selection criteria; (2) selected patient populations; and (3) post transplantation surveillance. The recommendations were developed through systematic review of the literature and using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. The evolving areas of importance addressed include transplant recipient age, frailty assessment, pulmonary hypertension evaluation, cannabis use, combined heart and other solid organ transplantation, adult congenital heart disease, cardiac amyloidosis, high sensitization, and post-transplantation management of antibodies to human leukocyte antigen, rejection, cardiac allograft vasculopathy, and long-term noncardiac care. Attention is also given to Canadian-specific management strategies including the prioritization of highly sensitized transplant candidates (status 4S) and heart organ allocation algorithms. The focus topics in this position statement highlight the increased complexity of patients who undergo evaluation for heart transplantation as well as improved patient selection, and advances in post-transplantation management and surveillance that have led to better long-term outcomes for heart transplant recipients.

Messy entanglements: research assemblages in heart transplantation discourses and practices.

The paper engages with a variety of data around a supposedly single biomedical event, that of heart transplantation. In conventional discourse, organ transplantation constitutes an unproblematised form of spare part surgery in which failing biological components are replaced by more efficient and enduring ones, but once that simple picture is complicated by employing a radically interdisciplinary approach, any biomedical certainty is profoundly disrupted. Our aim, as a cross-sectorial partnership, has been to explore the complexities of heart transplantation by explicitly entangling research from the arts, biosciences and humanities without privileging any one discourse. It has been no easy enterprise yet it has been highly productive of new insights. We draw on our own ongoing funded research with both heart donor families and recipients to explore our different perceptions of what constitutes data and to demonstrate how the dynamic entangling of multiple data produces a constitutive assemblage of elements in which no one can claim priority. Our claim is that the use of such research assemblages and the collaborations that we bring to our project breaks through disciplinary silos to enable a fuller comprehension of the significance and experience of heart transplantation in both theory and practice.

The Transplant Palliative Care Clinic: An early palliative care model for patients in a transplant program.

Although patients within a transplant program are awaiting or have received disease modifying or curative treatment, they are also facing advanced illness and the possibility of death. The involvement of specialized palliative care services for these patients may improve symptom management and facilitate advance care planning. However, patients in organ transplantation programs have difficulty accessing palliative care resources and often do so only sporadically in the inpatient setting. Currently, there is little access to ambulatory palliative care for these patients and there have been no descriptions of programs delivering such care in the medical literature. We outline the development and structure of a Transplant Palliative Care Clinic within the University Health Network's Multi-Organ Transplant Program, in Toronto, Canada. This information may be helpful for others aiming to provide early, integrated palliative care to patients awaiting and receiving organ transplantation.

Determining the need for team-based training in delirium management: A needs assessment of surgical healthcare professionals.

The high incidence of delirium in surgical units is a serious quality concern, given its impact on morbidity and mortality. While successful delirium management depends upon interdisciplinary care, training needs for surgical teams have not been studied. A needs assessment of surgical units was conducted to determine perceived comfort in managing delirium, and interprofessional training needs for team-based care. We administered a survey to 106 General Surgery healthcare professionals (69% response rate) with a focus on attitudes towards delirium and team management. Although most respondents identified delirium as important to patient outcomes, only 61% of healthcare professionals indicated that a team-based approach was always observed in practice. Less than half had a clear understanding of their role in delirium care, while just over half observed team communication of delirium care plans during handover. This is the first observation of clear gaps in perceived team performance in a General Surgery setting.

A framework for understanding international medical graduate challenges during transition into fellowship programs.

BACKGROUND: Previous studies have highlighted unique needs of international medical graduates (IMG) during their transition into medical training programs; however, limited data exist on IMG needs specific to fellowship training. PURPOSES: We conducted the following mixed-method study to determine IMG fellow training needs during the transition into fellowship training programs in psychiatry and surgery. METHODS: The authors conducted a mixed-methods study consisting of an online survey of IMG fellows and their supervisors in psychiatry or surgery fellowship training programs and individual interviews of IMG fellows. The survey assessed (a) fellows' and supervisors' perceptions on IMG challenges in clinical communication, health systems, and education domains and (b) past orientation initiatives. In the second phase of the study, IMG fellows were interviewed during the latter half of their fellowship training, and perceptions regarding orientation and adaptation to fellowship in Canada were assessed. Survey data were analyzed using descriptive and Mann-Whitney U statistics. Qualitative interviews were analyzed using grounded theory methodology. RESULTS: The survey response rate was 76% (35/46) and 69% (35/51) for IMG fellows and supervisors, respectively. Fellows reported the greatest difficulty with adapting to the hospital system, medical documentation, and balancing one's professional and personal life. Supervisors believed that fellows had the greatest difficulty with managing language and slang in Canada, the healthcare system, and an interprofessional team. In Phase 2, fellows generated themes of disorientation, disconnection, interprofessional team challenges, a need for IMG fellow resources, and a benefit from training in a multicultural setting. CONCLUSIONS: Our study results highlight the need for IMG specific orientation resources for fellows and supervisors. Maslow's Hierarchy of Needs may be a useful framework for understanding IMG training needs.

Canadian Pain Society and Canadian Rheumatology Association recommendations for rational care of persons with fibromyalgia: a summary report.

OBJECTIVE: To summarize the development of evidence-based guidelines for the clinical care of persons with fibromyalgia (FM), taking into account advances in understanding of the pathogenesis of FM, new diagnostic criteria, and new treatment options. METHODS: Recommendations for diagnosis, treatment, and patient followup were drafted according to the classification system of the Oxford Centre for Evidence-Based Medicine, and following review were endorsed by the Canadian Rheumatology Association and the Canadian Pain Society. RESULTS: FM is a polysymptomatic syndrome presenting a spectrum of severity, with a pivotal symptom of body pain. FM is a positive clinical diagnosis, not a diagnosis of exclusion, and not requiring specialist confirmation. There are no confirmatory laboratory tests, although some investigation may be indicated to exclude other conditions. Ideal care is in the primary care setting, incorporating nonpharmacologic and pharmacologic strategies in a multimodal approach with active patient participation. The treatment objective should be reduction of symptoms, but also improved function using a patient-tailored treatment approach that is symptom-based. Self-management strategies combining good lifestyle habits and fostering a strong locus of control are imperative. Medications afford only modest relief, with doses often lower than suggested, and drug combinations used according to clinical judgment. There is a need for continued reassessment of the risk-benefit ratio for any drug treatment. Outcome should be aimed toward functioning within a normal life pattern and any culture of disablement should be discouraged. CONCLUSION: These guidelines should provide the health community with reassurance for the global care of patients with FM with the aim of improving patient outcome by reducing symptoms and maintaining function.

2012 Canadian Guidelines for the diagnosis and management of fibromyalgia syndrome: executive summary.

BACKGROUND: Recent neurophysiological evidence attests to the validity of fibromyalgia (FM), a chronic pain condition that affects >2% of the population. OBJECTIVES: To present the evidence-based guidelines for the diagnosis, management and patient trajectory of individuals with FM. METHODS: A needs assessment following consultation with diverse health care professionals identified questions pertinent to various aspects of FM. A literature search identified the evidence available to address these questions; evidence was graded according to the standards of the Oxford Centre for Evidence-Based Medicine. Drafted recommendations were appraised by an advisory panel to reflect meaningful clinical practice. RESULTS: The present recommendations incorporate the new clinical concepts of FM as a clinical construct without any defining physical abnormality or biological marker, characterized by fluctuating, diffuse body pain and the frequent symptoms of sleep disturbance, fatigue, mood and cognitive changes. In the absence of a defining cause or cure, treatment objectives should be patient-tailored and symptom-based, aimed at reducing global complaints and enhancing function. Healthy lifestyle practices with active patient participation in health care forms the cornerstone of care. Multimodal management may include nonpharmacological and pharmacological strategies, although it must be acknowledged that pharmacological treatments provide only modest benefit. Maintenance of function and retention in the workforce is encouraged. CONCLUSIONS: The new Canadian guidelines for the treatment of FM should provide health professionals with confidence in the complete care of these patients and improve clinical outcomes.

Financial, vocational, and interpersonal impact of living liver donation.

The ability to inform prospective donors of the psychosocial risks of living liver donation is currently limited by the scant empirical literature. The present study was designed to examine donor perceptions of the impact of donation on financial, vocational, and interpersonal life domains and identify demographic and clinical factors related to longer recovery times and greater life interference. A total of 143 donors completed a retrospective questionnaire that included a standardized measure of life interference [Illness Intrusiveness Rating Scale (IIRS)] and additional questions regarding the perceived impact of donation. Donor IIRS scores suggested that donors experience a relatively low level of life interference due to donation [1.60 +/- 0.72, with a possible range of 1 ("not very much" interference) to 7 ("very much" interference)]. However, approximately 1 in 5 donors reported that donating was a significant financial burden. Logistic regression analysis revealed that donors with a psychiatric diagnosis at or prior to donation took longer to return to their self-reported predonation level of functioning (odds ratio = 3.78, P = 0.016). Medical complications were unrelated to self-reported recovery time. Multiple regression analysis revealed 4 independent predictors of greater life interference: less time since donation (b = 0.11, P < 0.001), income lower than CAD$100,000 (b = 0.28, P = 0.038), predonation concerns about the donation process (b = 0.24, P = 0.008), and the perception that the recipient is not caring for the new liver (b = 0.12, P = 0.031). In conclusion, life interference due to living liver donation appears to be relatively low. Donors should be made aware of risk factors for greater life disruptions post-surgery and of the potential financial burden of donation.

The impact of thyroid cancer and post-surgical radioactive iodine treatment on the lives of thyroid cancer survivors: a qualitative study.

BACKGROUND: Adjuvant treatment with radioactive iodine (RAI) is often considered in the treatment of well-differentiated thyroid carcinoma (WDTC). We explored the recollections of thyroid cancer survivors on the diagnosis of WDTC, adjuvant radioactive iodine (RAI) treatment, and decision-making related to RAI treatment. Participants provided recommendations for healthcare providers on counseling future patients on adjuvant RAI treatment. METHODS: We conducted three focus group sessions, including WDTC survivors recruited from two Canadian academic hospitals. Participants had a prior history of WDTC that was completely resected at primary surgery and had been offered adjuvant RAI treatment. Open-ended questions were used to generate discussion in the groups. Saturation of major themes was achieved among the groups. FINDINGS: There were 16 participants in the study, twelve of whom were women (75%). All but one participant had received RAI treatment (94%). Participants reported that a thyroid cancer diagnosis was life-changing, resulting in feelings of fear and uncertainty. Some participants felt dismissed as not having a serious disease. Some participants reported receiving conflicting messages from healthcare providers on the appropriateness of adjuvant RAI treatment or insufficient information. If RAI-related side effects occurred, their presence was not legitimized by some healthcare providers. CONCLUSIONS: The diagnosis and treatment of thyroid cancer significantly impacts the lives of survivors. Fear and uncertainty related to a cancer diagnosis, feelings of the diagnosis being dismissed as not serious, conflicting messages about adjuvant RAI treatment, and treatment-related side effects, have been raised as important concerns by thyroid cancer survivors.

Preoperative use of statins is associated with reduced early delirium rates after cardiac surgery.

BACKGROUND: Delirium is an acute deterioration of brain function characterized by fluctuating consciousness and an inability to maintain attention. Use of statins has been shown to decrease morbidity and mortality after major surgical procedures. The objective of this study was to determine an association between preoperative administration of statins and postoperative delirium in a large prospective cohort of patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: After Institutional Review Board approval, data were prospectively collected on consecutive patients undergoing cardiac surgery with cardiopulmonary bypass from April 2005 to June 2006 in an academic hospital. All patients were screened for delirium during their hospitalization using the Confusion Assessment Method in the intensive care unit. Multivariable logistic regression analysis was used to identify independent perioperative predictors of delirium after cardiac surgery. Statins were tested for a potential protective effect. RESULTS: Of the 1,059 patients analyzed, 122 patients (11.5%) had delirium at any time during their cardiovascular intensive care unit stay. Administration of statins had a protective effect, reducing the odds of delirium by 46%. Independent predictors of postoperative delirium included older age, preoperative depression, preoperative renal dysfunction, complex cardiac surgery, perioperative intraaortic balloon pump support, and massive blood transfusion. The model was reliable (Hosmer-Lemeshow test, P = 0.3) and discriminative (area under receiver operating characteristic curve = 0.77). CONCLUSIONS: Preoperative administration of statins is associated with the reduced risk of postoperative delirium after cardiac surgery with cardiopulmonary bypass.

Effect of depression on five-year mortality after an acute coronary syndrome.

Previous research has established a relation between depression at the time of cardiac hospitalization and patient mortality. The objective of this study was to examine the role of depressive history and symptomatology during hospitalization on 5-year all-cause mortality after admission for an acute coronary syndrome. We recruited 750 patients who had unstable angina pectoris and myocardial infarction from 12 coronary care units between 1997 and 1999. Measurements included sociodemographic and clinic data and the Beck Depression Inventory (BDI). Data were linked to an administrative database to determine 5-year all-cause mortality. Survival data were adjusted using a Cox's proportional hazards model. One hundred seventy-four participants (23.2%) self-reported a history of depressed mood for >2 weeks, 235 (31.3%) had elevated BDI scores at index hospitalization, with 105 (14.0%) reporting persistent depressive symptomatology. One hundred fifteen participants (15.3%) died by 5 years after hospitalization. After adjusting for prognostic indicators, such as cardiac disease severity, medical history, and smoking, depressive symptomatology during hospitalization was significantly predictive of mortality, but depressive history was not. Hazard ratios associated with BDI scores <10 versus those > or =10 at hospitalization ranged from 1.90 (95% confidence interval 1.12 to 3.24) at 2 years to 1.53 (95% confidence interval 1.04 to 2.24) at 5 years. In conclusion, the significance of depressive symptomatology at the time of, but not before, hospitalization underlines the need for early identification of increased distress and renews calls to identify treatments that not only improve quality of life but also decrease the risk of mortality.

Prospective examination of anxiety persistence and its relationship to cardiac symptoms and recurrent cardiac events.

BACKGROUND: The current study builds on previous research demonstrating a link between anxiety and inhospital recurrent ischemic and arrhythmic events, by examining the effects of persistent anxiety on recurrent events 1 year later. METHODS: 913 patients with unstable angina (UA) and myocardial infarction (MI) from 12 coronary care units were recruited, and follow-up data were collected at 6 and 12 months after the event. Measures included cardiac symptomatology, healthcare utilization, the anxiety subscale of the Primary Care Evaluation of Mental Disorders , the phobic anxiety subscale of the Middlesex Hospital Questionnaire, and the Beck Depression Inventory. RESULTS: Over one third of participants with UA and MI experienced elevated anxiety at the time of the ischemic event, and these symptoms persisted for 1 year in 50% of anxious participants. Although participants with anxiety reported more atypical cardiac symptomatology, the prevalence of typical cardiac symptoms such as chest pain did not differ based on anxiety. After controlling for the severity of the coronary event, family income, sex, diabetes, and smoking, the following variables were significantly predictive of self-reported recurrent cardiac events at 6 months or 1 year: older age, family history of cardiovascular disease, greater depressive symptomatology at baseline, and anxiety at 6 months. Only 38% of anxious patients were asked about such symptoms, indicating underutilization of effective psychotherapeutic treatment. CONCLUSIONS: Over and above the effects of depressive symptomatology (among other confounding variables), nonphobic anxiety appears to have a negative effect on self-reported outcome following an ischemic coronary event. Anxiety symptomatology is underrecognized and undertreated, and examination of effects of treatment on secondary prevention must be pursued.

Prevalence and incidence of chronic fatigue syndrome in Wichita, Kansas.

BACKGROUND: Chronic fatigue syndrome (CFS) is a debilitating illness with no known cause or effective therapy. Population-based epidemiologic data on CFS prevalence and incidence are critical to put CFS in a realistic context for public health officials and others responsible for allocating resources and for practicing physicians when examining and caring for patients. METHODS: We conducted a random digit-dialing survey and clinical examination to estimate the prevalence of CFS in the general population of Wichita, Kan, and a 1-year follow-up telephone interview and clinical examination to estimate the incidence of CFS. The survey included 33 997 households representing 90 316 residents. This report focuses on 7162 respondents aged 18 to 69 years. Fatigued (n = 3528) and randomly selected nonfatigued (n = 3634) respondents completed telephone questionnaires concerning fatigue, other symptoms, and medical history. The clinical examination included the Diagnostic Interview Schedule for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, laboratory testing, and a physical examination. RESULTS: The overall weighted point prevalence of CFS, adjusted for nonresponse, was 235 per 100,000 persons (95% confidence interval, 142-327 per 100,000 persons). The prevalence of CFS was higher among women, 373 per 100,000 persons (95% confidence interval, 210-536 per 100,000 persons), than among men, 83 per 100,000 persons (95% confidence interval, 15-150 per 100,000 persons). Among subjects nonfatigued and fatigued for less than 6 months, the 1-year incidence of CFS was 180 per 100,000 persons (95% confidence interval, 0-466 per 100,000 persons). CONCLUSIONS: Chronic fatigue syndrome constitutes a major public health problem. Longitudinal follow-up of this cohort will be used to further evaluate the natural history of this illness.