How Should Mechanical Circulatory Support Be Deactivated for Patients With Depression at the End of Life?

Mechanical circulatory support (MCS) is an increasingly frequent treatment option for managing end-stage heart failure. Devices are implanted either as destination therapy or as bridge to transplant. Patients undergoing this treatment can experience significant symptoms of depression in addition to stresses associated with chronic illness. After implantation, some patients may decide that the burdens of an MCS device outweigh the benefits. Physician asked to assist in deactivating MCS devices in the face of depression must ensure appropriate assessment, informed consent, and multidisciplinary involvement to minimize suffering and maximize patient quality of life.

Psychosocial Challenges in Solid Organ Transplantation.

Organ transplantation is often a life-saving surgery for individuals with end-stage organ disease. However, for most types of solid organ transplant, the demand for organs outweighs the supply, resulting in the need to institute a waiting list for suitable patients who cannot immediately receive an organ. Individuals who need transplants must undergo an assessment process that includes medical, surgical, and psychosocial evaluations. The transplant psychosocial evaluation considers whether surgical candidates are able and willing to care for the transplanted organ for many years. The evaluation must also consider a number of psychosocial risk factors that can lead to complications, which may cause premature loss of the graft. Some of these risk factors include a history of poor medical adherence, psychopathology (including substance use disorders), poor social support, and cognitive dysfunction. This article briefly summarizes the assessment of each of these risk factors and how they can be mitigated to ensure the best outcomes for patients and their families.

Partner burden in irritable bowel syndrome.

BACKGROUND & AIMS: Studies have described the burden experienced by caregivers and next of kin to patients with diseases such as cancer. However, the burden of functional gastrointestinal disorders on partners of patients has not been determined. We aimed to quantify the degree of burden to partners of patients with irritable bowel syndrome (IBS), to describe the factors that affect the burden perceived, and to identify the areas of relationship that are affected. METHODS: We surveyed 152 patients diagnosed with IBS at a tertiary gastrointestinal clinic, on the basis of Rome III criteria, and their partners. Their partners completed questionnaires including the Zarit Burden Interview (ZBI), Relationship Satisfaction Scale, and questions on sexual relationships. Patients with IBS were rated for disease severity by using the Functional Bowel Disease Severity Index. We compared findings with those from 39 partners of healthy individuals (controls). RESULTS: There were no significant demographic differences between the partners of patients with IBS and controls; demographics had no effect on burden. Burden was significantly higher among partners of IBS patients (mean ZBI score, 22.1) than controls (mean ZBI score, 11.5) (P = .0002). The degree of burden was directly related to IBS severity (P < .0001). There were inverse relationships between partners' rating of burden (ZBI) and relationship quality (R = -0.60; P < .001) and sexual satisfaction (R = -0.56; P < .0001). There was no difference in the Relationship Satisfaction Scale scores (4.25 vs 4.19; P = .78) or sexual relationship (6.47 vs 6.21; P = .64) between partners of IBS patients and controls, respectively. CONCLUSIONS: Partners of patients with IBS have a significant burden (on the basis of ZBI score), compared with partners of healthy individuals. Perceived burden increases with IBS severity and poorer sexual and relationship satisfaction.

Diagnosis, characterization, and 3-month outcome after detoxification of 39 patients with narcotic bowel syndrome.

UNLABELLED: OBFECTIVES: Narcotic bowel syndrome (NBS) is characterized by a paradoxical increase in abdominal pain associated with continued or escalating dosages of narcotics. This study evaluated the clinical and psychosocial features of patients with NBS and the response to detoxification treatment. METHODS: For 2 years, 39 patients seen by the GI consult service at the University of North Carolina at Chapel Hill (UNC) with presumed NBS were placed on a detoxification program. Clinical, psychosocial, health status, and outcome data were obtained before and after detoxification. Our aims were to: (i) clinically characterize patients with presumed NBS, (ii) assess the clinical response and adverse effects to detoxification, (iii) identify clinical and psychosocial predictors of treatment response, and (iv) determine the clinical outcome at 3 months after detoxification and the time frame for patients who revert back to narcotics. RESULTS: Of the 39 patients detoxified, 89.7% met predefined criteria. Patients were mostly well educated (14.5 ± 2.3 years of school), female (92.3%), and with a variety of diagnoses (21% irritable bowel syndrome IBS/functional, 37% inflammatory bowel disease and other structural, 29% fibromyalgia and other functional somatic, or orthopedic, and 13% postoperative or other). They reported high health-care use (15.3 ± 10.1 MD visits/6 months; 6.5 ± 6.1 hospitalizations/2 years, 6.4 ± 2.0 surgeries/lifetime), and 82.1% were jobless. Despite high dosages of narcotics (total intravenous (IV) morphine equivalent 75.3 ± 78.0 mg/day), pain scores were rated severe (52.9 ± 28.8 visual analog scale (VAS); 257.1 ± 139.6 functional bowel disorder severity index (FBDSI); 17.2 ± 10.2 (McGill Pain and greater than labor or postoperative pain). Multiple symptoms were reported (n = 17.8 ± 9.2) and rated as moderate to severe. Psychosocial scores showed high catastrophizing (19.9 ± 8.6); poor daily function (Short Form-36 (SF-36) physical 28.3 ± 7.7, mental 34.3 ± 11.0; worse than tetraplegia); 28.2% were clinically depressed and 33.3% anxious (Hospital Anxiety and Depression Scale (HADS)). Detoxification was successfully completed by 89.7%; after detoxification, abdominal pain was reduced by 35% (P < 0.03) and nonabdominal pain by 42% (P < 0.01) on VAS, and catastrophizing significantly improved (P < 0.01). Responder status was met in 56.4% with 48.7% achieving a ≥ 30% reduction in pain. By 3 months after detoxification, 45.8% had returned to using narcotics. For those who remained off narcotics at 3 months, the VAS abdominal pain score was 75% lower than pretreatment when compared with those who went back on narcotics (24% lower). Successful detoxification and a good clinical response was associated with low abuse potential (Current Opioid Misuse Measure (COMM) score < 9). CONCLUSIONS: Despite severe pain, poor coping, and poor health status, almost all patients with NBS undergoing detoxification were able to stop using narcotics and have significant improvement in pain and coping. However, almost ½ reverted to narcotic use at 3 months. Those who stayed off narcotics showed greater improvement in pain scores. This study provides a rationale for treating patients with NBS by detoxification in order to improve their clinical status. Further work is needed to understand the reasons for the high recidivism rate.

Development and validation of the irritable bowel syndrome satisfaction with care scale.

BACKGROUND & AIMS: Satisfaction with care is an important measure of quality, from the patients' perspective, and could also affect outcomes. However, there is no standard measure of patient satisfaction for irritable bowel syndrome (IBS) care; a multi-item, condition-specific instrument is needed. METHODS: Using standard qualitative methods, we conducted focus groups to identify items that patients associated with satisfaction in their care for IBS. These and additional items identified by experts were placed into a preliminary questionnaire, which was refined through pilot testing and cognitive debriefing by additional patients, as well as standard statistical methods. The resulting instrument and several external validation measures were administered to 300 adult US patients with IBS. Factor analysis was performed to identify clinically relevant subscales and then psychometric properties were assessed. RESULTS: We developed an IBS satisfaction with care scale (IBS-SAT) that has 38 items from 5 clinically relevant subscales (connection with provider, education, benefits of visit, office attributes, and access to care). This IBS-SAT had a high level of internal consistency (Crohnbach's α = .96). Convergent validity was established by correlations between the IBS-SAT and a single, global satisfaction with care question (r = 0.68; P < .001), and a generic, multi-item satisfaction scale (physician satisfaction questionnaire-18) (r = 0.75, P < .001). Discriminant validity (among known groups) was established across groups that were stratified based on IBS-quality of life (r = 0.34; P < .0001), IBS severity (functional bowel disorders severity index) (r = -0.21; P < .001), and number of unmet expectations (r = -0.38; P < .0001). CONCLUSIONS: The IBS-SAT is a validated measure of patient satisfaction with IBS care. As a new, condition-specific instrument, it is likely to be a useful tool for quality measurement, health services research, and clinical trials.

Characterization of episodes of irritable bowel syndrome using ecological momentary assessment.

OBJECTIVES: Patients with irritable bowel syndrome (IBS) report that symptoms occur as episodes. The nature and frequency of episodes have not been well studied. METHODS: Using modified ecological momentary assessment (EMA), we examined clinical factors attributed to IBS symptom episodes and compared them with nonsymptom episode periods in patients with IBS-D (N=21), IBS-C (N=18), or IBS-M (N=19), and healthy controls (N=19). Symptoms were rated over 14 days on a visual ordinal scale (VOS: 0-10) randomly in morning, midday, and evening, and at wake up, bedtime, prebowel movement, and postbowel movement. Scores were evaluated for total group and across subgroups and between EMA and daily diary cards on the same day. RESULTS: Subjects (n=57/59) reported symptom episodes 34% of the time. Episodes showed significantly higher pain levels (3.6 vs. 1.64, P<0.0001), bloating (4.57 vs. 3.02, P<0.0001), stress (3.54 vs. 2.59, P<0.0001), and decreased well-being (5.29 vs. 6.16, P<0.0001). Episode frequency/2 weeks was greatest for IBS-D (10.7±7.05) than IBS-C (8.4±5.76) and IBS-M (7.1±4.45) (P=nonsignificant). IBS-D also had shorter episodes (9 h 23 min) compared with IBS-M (15 h 01 min) and IBS-C (15 h 25 min) (P<0.04). Stool frequency and looser consistency were greater with IBS-D and similar between IBS-C and IBS-M. Abdominal pain was the greatest predictor of episode status. Diary card ratings of pain and stool frequency overestimate levels reported by EMA. CONCLUSIONS: Episodes of IBS are associated with greater pain (strongest relationship), bloating, and stress scores, and poorer global well-being. Compared with IBS-D, IBS-C and IBS-M are similar in clinical features. Patients overreport pain and stool frequency by diary compared with EMA.

Cognitive factors affect treatment response to medical and psychological treatments in functional bowel disorders.

OBJECTIVES: For clinical trials in functional bowel disorders (FBD), the definition of a responder, one who meets the predefined criteria for a clinical response, is needed. Factors that determine clinical response aside from treatment itself are unknown. The aim of this study was to determine what baseline and post-treatment factors affect treatment response. METHODS: Females (n=397) with FBD entering a 12-week, four-arm, randomized NIH treatment trial (desipramine (DES), CBT, pill placebo, and education) were studied at baseline and after treatment. Demographic, clinical, psychosocial, and physiological variables were considered in the analysis. A responder was defined as a patient obtaining a score>3.5 on an averaged eight-item, five-point satisfaction-with-treatment questionnaire. Baseline and post-treatment logistic regressions were performed for each treatment condition to predict the responder outcome variable. RESULTS: Similar cognitive features predisposed participants to treatment response across the treatment conditions: sense of control over the condition, positive relationship with therapist or study coordinator, confidence in treatment, improvement in maladaptive cognitions, and quality of life during treatment. Demographic and clinical variables studied were not predictive. Some treatment-specific effects predicting responder status were noted, including a reduction in stool frequency with DES treatment and lack of abuse history in the placebo group. CONCLUSIONS: For medication, psychological, and placebo treatment in FBD, satisfaction with treatment depends on cognitive factors of confidence in treatments, perceived control over illness and symptoms, and reduction in negative cognitions related to symptom experience. Addressing these issues among patients with FBD may enhance treatment response to a variety of treatments.

International survey of patients with IBS: symptom features and their severity, health status, treatments, and risk taking to achieve clinical benefit.

BACKGROUND: Although clinicians generally make treatment decisions in irritable bowel syndrome (IBS) related to the type of symptoms, other factors such as the perceived severity and the risks patients are willing to tolerate for effective treatment are also important to consider. These factors are not fully understood. OBJECTIVE: To describe among patients with IBS their symptoms and severity, quality of life and health status, medications taken, and the risk that they would take to continue medications for optimal relief. METHODS: Adult patients diagnosed with IBS who accessed the websites of the International Foundation for Functional GI Disorders or the University of North Carolina Center for Functional GI Disorders filled out questionnaires to address the study aims. RESULTS: The 1966 respondents (83% female, 91% white, 78% US/Canada) reported impaired health status: restricting on average 73 days of activity in a year, having poor health-related quality of life particularly with dietary restrictions, mood disturbance, and interference with daily activity, and 35% reported their symptoms as severe defined primarily as pain, bowel difficulties, bloating, and eating/dietary restrictions). These symptoms were reported in some combination by over 90%, and 35.1% endorsed all 4 items. To receive a treatment that would make them symptom free, patients would give up 25% of their remaining life (average 15 y) and 14% would risk a 1/1000 chance of death. Most of the medications being taken were for pain relief and 18% were taking narcotics. Complementary and alternative treatments were used by 37%. CONCLUSIONS: Patients accessing IBS informational websites report moderate-to-severe impairments in health status, and would take considerable risk to obtain symptom benefit. There is an unmet need to find effective treatments for patients with IBS and regulatory agencies might consider raising risk-benefit ratios when approving new medications for IBS.

A very low-carbohydrate diet improves symptoms and quality of life in diarrhea-predominant irritable bowel syndrome.

BACKGROUND & AIMS: Patients with diarrhea-predominant irritable bowel syndrome (IBS-D) anecdotally report symptom improvement after initiating a very low-carbohydrate diet (VLCD). This study prospectively evaluated a VLCD in IBS-D. METHODS: Participants with moderate to severe IBS-D were provided a 2-week standard diet, then 4 weeks of a VLCD (20 g carbohydrates/d). A responder was defined as having adequate relief of gastrointestinal symptoms for 2 or more weeks during the VLCD. Changes in abdominal pain, stool habits, and quality of life also were measured. RESULTS: Of the 17 participants enrolled, 13 completed the study and all met the responder definition, with 10 (77%) reporting adequate relief for all 4 VLCD weeks. Stool frequency decreased (2.6 +/- 0.8/d to 1.4 +/- 0.6/d; P < .001). Stool consistency improved from diarrheal to normal form (Bristol Stool Score, 5.3 +/- 0.7 to 3.8 +/- 1.2; P < .001). Pain scores and quality-of-life measures significantly improved. Outcomes were independent of weight loss. CONCLUSIONS: A VLCD provides adequate relief, and improves abdominal pain, stool habits, and quality of life in IBS-D.

Atypical antipsychotic quetiapine in the management of severe refractory functional gastrointestinal disorders.

Management of severe refractory functional gastrointestinal disorders (FGIDs) is difficult. Quetiapine, an atypical antipsychotic, may benefit patients by mitigating associated anxiety and sleep disturbances, augmenting the effect of antidepressants, and providing an independent analgesic effect. Outpatient records from a university-based FGID clinic were reviewed, and 21 patients with refractory symptoms who received quetiapine were identified and interviewed. Outcomes included global relief of symptoms, treatment efficacy questionnaire, and change in gastrointestinal (GI) and psychological symptoms. Eleven of 21 patients continued therapy at the time of interview. Six of 11 demonstrated global relief of symptoms, and 9 were satisfied with treatment. The remaining 10 of 21 discontinued therapy because of somnolence and lack of GI benefits. Quetiapine in low doses appeared beneficial in more than half of the adults with severe FGIDs who stayed on treatment. This response in otherwise refractory patients suggests quetiapine might augment the effectiveness of antidepressants in severe FGIDs.

Botulinum toxin a in the treatment of chronic tension-type headache with cervical myofascial trigger points: a randomized, double-blind, placebo-controlled pilot study.

OBJECTIVE: To evaluate the efficacy of botulinum toxin A (BT-A) as a prophylactic treatment for chronic tension-type headache (CTTH) with myofascial trigger points (MTPs) producing referred head pain. BACKGROUND: Although BT-A has received mixed support for the treatment of TTH, deliberate injection directly into the cervical MTPs very often found in this population has not been formally evaluated. METHODS: Patients with CTTH and specific MTPs producing referred head pain were assigned randomly to receive intramuscular injections of BT-A or isotonic saline (placebo) in a double-blind design. Daily headache diaries, pill counts, trigger point pressure algometry, range of motion assessment, and responses to standardized pain and psychological questionnaires were used as outcome measures; patients returned for follow-up assessment at 2 weeks, 1 month, 2 months, and 3 months post injection. After 3 months, all patients were offered participation in an open-label extension of the study. Effect sizes were calculated to index treatment effects among the intent-to-treat population; individual time series models were computed for average pain intensity. RESULTS: The 23 participants reported experiencing headache on a near-daily basis (average of 27 days/month). Compared with placebo, patients in the BT-A group reported greater reductions in headache frequency during the first part of the study (P = .013), but these effects dissipated by week 12. Reductions in headache intensity over time did not differ significantly between groups (P = .80; maximum d = 0.13), although a larger proportion of BT-A patients showed evidence of statistically significant improvements in headache intensity in the time series analyses (62.5% for BT-A vs 30% for placebo). There were no differences between the groups on any of the secondary outcome measures. CONCLUSIONS: The evidence for BT-A in headache is mixed, and even more so in CTTH. However, the putative technique of injecting BT-A directly into the ubiquitous MTPs in CTTH is partially supported in this pilot study. Definitive trials with larger samples are needed to test this hypothesis further.

Commentary: sociocultural factors in medicine and gastrointestinal research.

(Table is included in full-text article.)The authors examine the work by Gerson et al., with respect to the role of cultural factors in clinical gastrointestinal practice and research. These often underappreciated factors play an important role in the diverse populations that clinicians work with in westernized countries and internationally. This study argues for the importance of addressing culture when examining the perception of symptoms and the roles of physician and patient. Research questions as well as treatment decisions can be compromised if a patient's cultural belief systems are not accommodated. Sociocultural factors affect physician-patient interactions and particularly affect how symptoms are reported and treated. An understanding of specific cultural contributions to symptom experience can enhance the clinician's ability to engage in more effective research and treatment.

Medication Quantification Scale Version III: update in medication classes and revised detriment weights by survey of American Pain Society Physicians.

UNLABELLED: The Medication Quantification Scale (MQS) is an instrument with potential clinical and research applications for quantifying medication regimen use in chronic pain populations. The MQS was developed in 1992 and updated in 1998 (MQS II) as a tool to co-quantify 3 relevant aspects of medications prescribed for chronic nonmalignant pain: drug class, dosage, and detriment (risk). This 2003 version (MQS III) is the third iteration of the scale, featuring new detriment weights determined by surveying all physician members of the American Pain Society in the United States via mail. A total of 248 physicians (18%) responded with their opinion as to the detriment of 22 mechanistically distinct medication classes. Overall, the physician ratings of detriment weight were relatively consistent (alpha = .84). The increased number of survey responses encompassed a wide range of disciplines, thus reducing discipline bias and introducing several important changes to MQS scoring. Some medication classes previously rated with low detriment weights (eg, nonsteroidal anti-inflammatory drugs) increased in detriment weight (from 2 to 3.4), whereas other classes previously given high weights (eg, "strong" opioids) received lower detriment ratings (from 5 to 3.4) in this survey. The MQS III must now be validated in clinical and research applications. PERSPECTIVE: The MQS is a tool to objectively quantify pain. It computes a single numeric value for a patient's pain medication profile. This number can be used by both clinicians and researchers to track pain levels through a treatment course or research study.

Biofeedback in the treatment of phantom limb pain: a time-series analysis.

Phantom limb pain (PLP) is a noxious, painful sensation that is perceived to occur in an amputated limb. It has been reported to occur in up to 85% of amputees. This pilot study examined the effectiveness of biofeedback in the treatment of nine individuals with PLP who received up to seven thermal/autogenic biofeedback sessions over the course of 4-6 weeks. Pain was assessed daily using the visual analog scale (VAS), the sum of the sensory descriptors, and the sum of the affective descriptors of the McGill short form. Interrupted time-series analytical models were created for each of the participants, allowing biofeedback sessions to be modeled as discrete interventions. Analyses of the VAS revealed that a 20% pain reduction was seen in five of the nine patients in the weeks after session 4, and that at least a 30% pain reduction (range: 25-66%) was seen in six of the seven patients in the weeks following session 6. Sensory descriptors of pain decreased more than the affective pain descriptors. These preliminary results provide some support for the use of biofeedback in the treatment of PLP and indicate the need for further, definitive study.

A preliminary analysis of EMG variance as an index of change in EMG biofeedback treatment of tension-type headache.

The effectiveness of EMG biofeedback training for tension headache has been well established. Previous studies evaluating changes in an average EMG activity score from pre- to posttreatment have not consistently found a relationship between a reduction in average EMG activity and headache improvement at posttreatment. The current study is a preliminary analysis of the utility of EMG variance as another possible mechanism of change. Frontalis EMG average activity and variances from 6 chronic tension-type headache sufferers who demonstrated significant improvement in headache activity at posttreatment (at least 70%) and 6 chronic tension-type headache sufferes who did not demonstrate improvement (less than 30%) were examined across 6 sessions of biofeedback treatment. The improved group demonstrated larger time-specific EMG variance in relation to mean EMG amplitudes during all treatment sessions. A dramatic decline in time-specific variance was observed during the later treatment sessions for improved participants; this pattern was not observed in the group who demonstrated little or no improvement. Results from the current study suggest that the inclusion of both average EMG activity and EMG variance may provide a more comprehensive measure to evaluate possible physiological changes responsible for improvement in headache activity following EMG biofeedback training.