Visceral Fat and Anastomotic Leakage After Colon Cancer Resection.

BACKGROUND: Visceral fat is considered a risk for postoperative complications in colon cancer surgery. However, the association with anastomotic leakage as the most worrisome complication is not clear mainly because of underpowered studies. OBJECTIVE: The purpose of this study was to analyze the effect of visceral fat as a continuous variable on anastomotic leakage in a large cohort of colon cancer resections. DESIGN: This was a retrospective, multicenter cohort study. SETTINGS: This study used data of the Dutch Surgical Colorectal Audit of the years 2011 through 2014 from 8 Dutch teaching hospitals. Visceral fat was assessed on the routine preoperative abdominal CT scan. PATIENTS: A total of 2370 patients underwent colon cancer resection with primary anastomosis. There were 2011 patients operated electively and 359 in an emergency setting. MAIN OUTCOME MEASURES: The effect of visceral fat on anastomotic leakage after multivariable analysis was measured. RESULTS: Visceral fat was associated with anastomotic leakage in the elective colon resection group (n = 2011) but not in emergency colon resections (n = 359). Significant confounding was found for type of resection, BMI, and sex. The association of male sex and BMI as previously reported risk factors for anastomotic leakage was explained by visceral fat. LIMITATIONS: The study was limited by its retrospective character and missing clinical data of known risk factors for anastomotic leakage, like smoking history and certain medication. CONCLUSIONS: The independent association of visceral fat with anastomotic leakage was confined to the elective colon cancer resection group. The previously reported associations of male sex and BMI with anastomotic leakage were explained by visceral fat. Visceral fat-associated comorbidities did not influence anastomotic leakage, suggesting that its effect on colon anastomotic healing is local rather than systemic. Future risk analysis for anastomotic leakage in colon cancer surgery should contain visceral fat values and consider subgroup differences. See Video Abstract at http://links.lww.com/DCR/B396. ADIPOSIDAD VISCERAL Y FUGA ANASTOMTICA EN CASOS DE RESECCIN DE CNCER DE COLON: ANTECEDENTES:La acumulación de grasa visceral se considera como un factor de riesgo en caso de complicaciones postoperatorias de cirugía de cáncer de colon. Sin embargo, la asociación con la fuga anastomótica como la complicación más preocupante no está clara principalmente debido a los estudios de bajo impacto disponibles.OBJETIVO:Analizar el efecto de la adiposidad visceral como una variable contínua sobre la fuga anastomótica en una gran cohorte de resecciones de cáncer de colon.DISEÑO:Estudio de cohorte multicéntrico retrospectivo.AJUSTES:Se utilizaron los datos de la Auditoría Colorrectal Quirúrgica Holandesa entre los años 2011 y 2014 en 8 hospitales de enseñanza de los Paises bajos. La grasa visceral fué evaluada por medio de la tomografía computada abdominal preoperatoria de rutina.PACIENTES:Un total de 2370 pacientes fueron sometidos a resección de cáncer de colon con anastomosis primaria. 2011 pacientes fueron operados electivamente y 359 en situación de emergencia.PRINCIPALES MEDIDAS DE RESULTADO:El efecto de la adiposidad visceral en la fuga anastomótica después del análisis multivariable.RESULTADOS:La grasa visceral se asoció con la fuga anastomótica en el grupo de resección electiva de colon (n = 2011) pero no en las resecciones de emergencia (n = 359). Se encontraron factores de confusión significativos para el tipo de resección, el índice de masa corporal y el género. La adiposidad visceral explica la asociación del género masculino y el índice de masa corporal como factores de riesgo reportados previamente en los casos de fugas anastomóticas.LIMITACIONES:Carácter retrospectivo del estudio y la falta de datos clínicos de factores de riesgo conocidos para la fuga anastomótica, como los antecedentes de tabaquismo y el consumo de ciertos medicamentos.CONCLUSIONES:La asociación independiente de la adiposidad visceral con la fuga anastomótica se limitó al grupo de resección electiva por cáncer de colon. Las asociaciones previamente reportadas de género masculino e índice de masa corporal con fuga anastomótica se explicaron por la grasa visceral. Las comorbilidades asociadas a la grasa visceral no influyeron en la fuga anastomótica, lo que sugiere que la cicatrisación anastomótica obedece más a un factor local que a un factor sistémico. Un análisis de riesgos previsibles para fugas anastomóticas en casos de resección de cáncer de colon deben involucrar los valores de la adiposidad visceral y considerar las diferencias entre subgrupos. Consulte Video Resumen en http://links.lww.com/DCR/B396. (Traducción-Dr Xavier Delgadillo).

Improving postoperative outcome in rectal cancer surgery: Enhanced Recovery After Surgery in an era of increasing laparoscopic resection.

PURPOSE: The Enhanced Recovery After Surgery (ERAS) protocol reduces complications and length of stay (LOS) in colon cancer, but implementation in rectal cancer is different because of neo-adjuvant therapy and surgical differences. Laparoscopic resection may further improve outcome. The aim of this study was to evaluate the effects of introducing ERAS on postoperative outcome after rectal cancer resection in an era of increasing laparoscopic resections. MATERIALS AND METHODS: Patients who underwent elective rectal cancer surgery from 2009 till 2015 were included in this observational cohort study. In 2010, ERAS was introduced and adherence to the protocol was registered. Open and laparoscopic resections were compared. With regression analysis, predictive factors for postoperative outcome and LOS were identified. RESULTS: A total of 499 patients were included. The LOS decreased from 12.3 days in 2009 to 5.7 days in 2015 (p = 0.000). Surgical site infections were reduced from 24% in 2009 to 5% in 2015 (p = 0.013) and postoperative ileus from 39% in 2009 to 6% in 2015 (p = 0.000). Only postoperative ERAS items and laparoscopic surgery were associated with an improved postoperative outcome and shorter LOS. CONCLUSIONS: ERAS proved to be feasible, safe, and contributed to improving short-term outcome in rectal cancer resections. The benefits of laparoscopic surgery may in part be explained by reaching better ERAS adherence rates. However, the laparoscopic approach was also associated with anastomotic leakage. Despite the potential of bias, this study provides an insight in effects of ERAS and laparoscopic surgery in a non-randomized real-time setting.

The Effect of Glycopyrrolate on Nocturnal Sialorrhea in Patients Using Clozapine: A Randomized, Crossover, Double-Blind, Placebo-Controlled Trial.

BACKGROUND: Nocturnal sialorrhea is one of the most frequent adverse events in clozapine treatment. Symptomatic management of sialorrhea usually consists of off-label treatment with anticholinergic agents. The aim of the current study is to evaluate the efficacy and safety of glycopyrrolate in patients using clozapine that experience sialorrhea. METHODS: In a double-blind randomized crossover trial, patients with nocturnal sialorrhea (n = 32) were randomized to treatment with glycopyrrolate 1 mg or placebo. This double-blinded phase was followed by an optional open label extension phase with glycopyrrolate 2 mg. Exposure periods consisted of 6 consecutive days and were separated with 1 washout week. The primary outcome was clinical improvement of nocturnal sialorrhea assessed by the Patient Global Impression of Improvement (PGI-I). RESULTS: The proportion of patients with a clinical improvement according to PGI-I did not significantly differ between 1 mg and placebo (18.8% vs 6.3%, P = 0.289); however, in patients using glycopyrrolate 2 mg once daily versus placebo, it did (43.5% vs 6.3%, P = 0.039). Glycopyrrolate was not associated with severe adverse events or worsening of cognitive adverse events. CONCLUSIONS: Glycopyrrolate 1 mg was not superior to placebo, whereas 2 mg showed a significant clinical improvement of nocturnal sialorrhea compared with placebo. Glycopyrrolate seemed to be a tolerable anticholinergic agent in the treatment of clozapine-associated sialorrhea.

Relation between duration of the prodromal phase and renal damage in ANCA-associated vasculitis.

BACKGROUND: In ANCA-associated vasculitis the acute phase of the disease is often preceded by prodromal symptoms. The aim of the present study was to analyze the relation between the duration of the prodromal phase and renal damage. METHODS: Patients with ANCA-associated vasculitis and renal involvement from a retrospective single-center cohort were divided into two equal groups based on the duration of the prodromal phase. The prodromal phase was defined as the time between first vasculitis related symptoms and the date of diagnosis. Clinical characteristics at diagnosis and renal items on the vasculitis damage index at 6 months were compared between the two groups. In addition, the relation between a long prodromal phase and 3-year end-stage renal disease and mortality as a composite outcome was studied. RESULTS: A total of 72 patients were included (age 64 ± 12 years; 74% male; 96% Caucasian). At diagnosis, in patients with a prodromal phase ≤22 weeks versus >22 weeks estimated glomerular filtration rate and proteinuria did not differ significantly (35 (interquartile range 50) versus 30 (50) ml/min p = 0.84; 75% versus 87%, p = 0.21 respectively). Furthermore, Birmingham Vasculitis Activity Scores were comparable (7 (3), p = 0.71). At 6 months, a long prodromal phase was associated with proteinuria (odds ratio 5.38, 95% confidence interval (CI) 1.47-19.62), but not with an estimated glomerular filtration rate ≤ 50 ml/min (odds ratio 0.89, 95% CI 0.33-2.37) in multivariable analyses. In addition, a long prodromal phase was associated with end-stage renal disease/mortality (hazard ratio 5.22, 95% CI 1.13-24.20). CONCLUSIONS: A long prodromal phase was associated with proteinuria and 3-year end-stage renal disease/mortality, but not with a reduced renal function at 6 months. These results underline the importance of an early diagnosis in ANCA-associated vasculitis patients in order to improve renal outcomes.

Risk of New-Onset Diabetes After Long-Term Treatment With Clozapine in Comparison to Other Antipsychotics in Patients With Schizophrenia.

It has been suggested that clozapine has one of the largest diabetic effects of all atypical antipsychotics. To confirm these findings, we examined retrospectively the risk of new-onset diabetes in long-term clozapine treatment compared to treatment with other antipsychotics in a matched control population with schizophrenia or schizoaffective disorder. Ninety-four adult patients with schizophrenia or schizoaffective disorder who had been treated with clozapine for 5 years or longer were matched on age, diagnosis, and sex to 94 patients without any use of clozapine. The groups were followed up for as long as 20 years. The cumulative incidence of new detection of diabetes in the clozapine group was 22.3% (mean follow-up, 12.3 years; absolute risk difference, 6.3%; 95% confidence interval, -4.9% to 17.5%). An additional rigorous analysis of the 83 matched pairs with normal glucose measurement before end point showed a significant risk difference between the 2 groups (21.7% compared with 8.4%) but may have been biased against clozapine. We conclude that definitive evidence showing a clinically significant larger risk for new-onset diabetes after long-term treatment with clozapine in comparison to other antipsychotics is lacking.

The effect of a preoperative erythropoietin protocol as part of a multifaceted blood management program in daily clinical practice (CME).

BACKGROUND: The effectiveness of a preoperative erythropoietin (EPO) protocol to reduce allogeneic blood transfusions (ABTs) in daily clinical practice has been insufficiently studied. This study evaluated the effect of such a protocol, as part of a multifaceted blood management program, in patients undergoing total hip arthroplasty (THA). STUDY DESIGN AND METHODS: This retrospective observational study was designed as an interrupted time series (1999-2010). The intervention was the introduction of an EPO protocol in THA patients in 2003. Patients were classified according to preoperative hemoglobin (Hb) level: 10 to 13 g/dL (eligible patients for EPO) and more than 13 g/dL. The primary outcome was the percentage of patients receiving an ABT. Segmented regression analysis was used to estimate changes in outcome after the intervention. RESULTS: A total of 4568 THA patients were included. The absolute reductions in ABTs after the intervention were 17% (95% confidence interval [CI], 6%-29%) for the total study population and 25% (95% CI, 11%-39%) and 8% (95% CI, -5% to 21%) for the Hb groups 10 to 13 and more than 13 g/dL, respectively. In the postintervention period, 46% of the eligible patients (Hb level, 10-13 g/dL) actually received EPO. The transfusion rate in the EPO group was lower compared to the non-EPO group: 14 and 50%, respectively (p < 0.01). CONCLUSION: Introduction of a preoperative EPO protocol reduced the transfusion rate in THA patients in daily clinical practice. The reduction must be seen as part of a multifaceted blood management program, in which increased awareness of blood transfusion contributes simultaneously and substantially to the reduction in transfusion rate.

Use of serotonergic antidepressants and bleeding risk in orthopedic patients.

BACKGROUND: Selective serotonin reuptake inhibitors have been associated with an increased bleeding tendency. Information on the impact of a possible impaired hemostasis associated with the perioperative use of selective serotonin reuptake inhibitors is limited. This study aimed to determine the association between the perioperative use of selective serotonin reuptake inhibitors and the amount of blood loss during surgery and perioperative transfusion requirements. METHODS: The authors conducted a retrospective cohort study among patients who underwent elective primary total hip arthroplasty in two hospitals from the period of July 1, 2004 until July 1, 2008. The index group included all users of both serotonergic and nonserotonergic antidepressants. The reference group included a random sample (ratio 1:3) of nonusers. The primary outcome was the amount of intraoperative blood loss. The requirement for blood transfusion was a secondary outcome. The outcomes were adjusted for confounding factors (comorbidity and comedication) using regression techniques. RESULTS: The index group included 66 users of serotonergic and 29 users of nonserotonergic antidepressants, and the reference group included 285 patients. After adjustment for confounding factors, mean blood loss during surgery was significantly higher in the users of selective serotonin reuptake inhibitors when compared with the reference group: 95 ml (95% CI 9-181). Mean blood loss in the users of nonserotonergic antidepressants did not differ from the reference group. Users of antidepressants did not have a higher risk for transfusion. CONCLUSIONS: Patients undergoing total hip arthroplasty who continue the use of serotonergic antidepressants show a significantly higher, but clinically unimportant, intraoperative blood loss, without an increase in perioperative transfusion requirements.

Visceral obesity, muscle mass and outcome in rectal cancer surgery after neo-adjuvant chemo-radiation.

BACKGROUND: Preoperative chemoradiation has become a routine modality in the treatment of rectal carcinoma that may impair a patients general condition. In these patients, it is important to identify factors that influence postoperative recovery. Visceral obesity(VO) as a metabolic risk factor was studied in rectal cancer patients receiving preoperative chemoradiation. AIM: The impact of VO on post-operative outcome in rectal carcinoma surgery after preoperative chemoradiation was studied. In addition, the effect of chemoradiation on body composition was studied. METHOD: The visceral fat area(VFA), total fat area(TFA) and skeletal muscle area(SMA) were measured on cross-sectional CT-slides in 74 patients who underwent rectal cancer surgery after chemoradiation. CT-scans taken before and after chemoradiation were analysed. Associations between VFA, per- and postoperative complications were studied. A VFA of 100 cm(2) and 130 cm(2) was used to differentiate between non-VO and VO. RESULTS: Using a VO cut-off point of a VFA of 100 cm(2), the VO patients had more per-operative blood loss(471 mL vs 271 mL p = 0.020), a higher complication rate(10% vs 49% p = 0.001), more ileus(2% vs 28% p = 0.027) and a longer length of stay(9.7days vs 13days p = 0.027). When a VFA of 130 cm(2) was used, VO patients showed more complications(17% vs 55%, p = 0.001) and ileus(10% vs 32% p = 0.017). During chemoradiation the SMA increased(Mean difference: 2.2 cm(2) p = 0.024), while the VFA showed no change. CONCLUSION: It appears that VO is associated with co-morbidity and poor outcome in rectal cancer patients. Using different cutoff values for VO different associations with outcome were found. SMA increased during chemoradiation, a phenomenon that remains to be explained.

Risk of anastomotic leakage with nonsteroidal anti-inflammatory drugs within an enhanced recovery program.

INTRODUCTION: Anastomotic leakage is a serious complication after colorectal resection. Recent studies suggest that nonsteroidal anti-inflammatory drugs may increase the risk of anastomotic leakage. We investigated this association in our enhanced recovery population. MATERIAL AND METHODS: Patients undergoing an elective colon or rectal resection with primary anastomosis because of malignancy and treated within our enhanced recovery program were included. Univariable and multivariable logistic regression analyses were used to study risk factors for anastomotic leakage. RESULTS: Between 2006 and 2013, 856 patients were included. The anastomotic leakage rate was significantly higher in the group that received nonsteroidal anti-inflammatory drugs compared to patients who did not: 9.2 vs. 5.3%, p = 0.038. This higher rate was only seen in patients receiving diclofenac: for colonic resections, 11.8 vs. 6.0%, p = 0.016; for rectal resections, 13.1 vs. 0%, p = 0.017. Only male sex (odds ratio 2.20, p = 0.005) was also independently associated with anastomotic leakage. CONCLUSION: The results of this study are in line with other comparable studies in the literature, showing an increased risk for anastomotic leakage with diclofenac. The use of diclofenac in colorectal surgery can no longer be recommended. Alternatives for postoperative analgesia need to be explored within an enhanced recovery program.

Visceral obesity, body mass index and risk of complications after colon cancer resection: A retrospective cohort study.

BACKGROUND: The aim of our study was to assess the influence of visceral obesity (VO), as measured by preoperative abdominal CT scan, in relation to body mass index (BMI) on the incidence of postoperative complications and duration of hospital stay after colon cancer surgery. METHODS: Patients who underwent elective resection for colon cancer between January 1, 2006, and December 31, 2013, and had a preoperative CT scan were entered in the study. Visceral fat area (VFA) was determined by using the preoperative CT scan at the L3-L4 level. The effect of VO, defined as a VFA of >100 cm², on postoperative complications and duration of hospital stay was analyzed. RESULTS: Of 564 included patients, 65% had VO. VO was associated with more anastomotic leakage (P = .04), pneumonia (P = .02), wound infection (P = .03), reoperations (P = .04), and longer duration of hospital stay (P = .05). Of patients with a BMI < 25 kg/m², 44% had VO. In this group, VO was associated significantly with postoperative complications, cardiac (P < .01) and pulmonary (P = .01) comorbidity, hypertension (P < .01), and diabetes (P < .01). In the overweight (BMI 25-30 kg/m²) and obese (BMI > 30 kg/m²) groups, the rate of VO was much higher (81% and 90%, respectively), but was not associated significantly with complications or comorbidity, except for cardiac comorbidity (P < .02) in the BMI = 25-30 kg/m² group. After multivariable analysis, VO was shown to be an independent predictor of anastomotic leakage and wound infection. CONCLUSION: The association of VO with worse outcome after colon cancer surgery is most pronounced in patients with a BMI < 25 kg/m².

The new Body Mass Index as a predictor of postoperative complications in elective colorectal cancer surgery.

BACKGROUND & AIMS: A new Body Mass Index (BMI) formula has been developed for a better approximation of under and overweight. The aim of this study was to investigate the predictive value of this newly proposed BMI formula for postoperative complications in elective colorectal cancer surgery compared with the conventional BMI formula. METHODS: A digital database of patients undergoing elective colorectal cancer surgery was prospectively maintained in three centers and retrospectively analyzed. Data consisted of patient characteristics, surgical procedure, length of hospital stay (LOS), postoperative complications, mortality, reoperation and readmission. The BMI was calculated using both the conventional and new BMI formula. Patients were divided into four groups (BMI <20, 20-25, 25-30, ≥30 kg/m(2)). RESULTS: A total of 1614 patients were included. There was no significant difference in mean BMI between males and females using the conventional BMI formula (26.0 versus 26.2, p = 0.347), whereas a trend was observed using the new BMI formula (26.3 versus 25.6, p = 0.071). The proportion of overweight (BMI ≥25) male patients was significantly higher compared with the proportion of overweight female patients using the conventional formula (58.9% versus 51.0%, p = 0.021), whereas a non-significant difference was observed using the new formula (51.7% versus 53.4%, p = 0.515). Neither the conventional nor the new BMI were associated with postoperative complications and LOS. Higher age, higher ASA classification, male gender, and conventional surgery were independent predictors of the occurrence of postoperative complications. A longer LOS was also independently predicted by higher age, higher ASA classification and conventional surgery. CONCLUSIONS: This study showed no superiority of the new BMI formula in predicting postoperative complications after colorectal cancer surgery. Confirmation of the results in a larger cohort is desirable.

QT interval prolongation in users of selective serotonin reuptake inhibitors in an elderly surgical population: a cross-sectional study.

OBJECTIVE: To investigate the association between the use of a selective serotonin reuptake inhibitor (SSRI) and the occurrence of QT interval prolongation in an elderly surgical population. METHOD: A cross-sectional study was conducted among patients (> 60 years) scheduled for outpatient preanesthesia evaluation in the period 2007 until 2012. The index group included elderly users of an SSRI. The reference group of nonusers of antidepressants was matched to the index group on sex and year of scheduled surgery (ratio, 1:1). The primary outcome was the occurrence of QT interval prolongation shown on electrocardiogram. The QT interval was corrected for heart rate (QTc interval). The secondary outcome was the duration of the QTc interval. The outcomes were adjusted for confounding by using regression techniques. RESULTS: The index and reference groups included 397 users of an SSRI and 397 nonusers, respectively. QTc interval prolongation occurred in 25 (6%) and 19 (5%) index and reference patients, respectively. After adjustment for confounding, users of an SSRI did not have a higher risk for QTc interval prolongation compared to nonusers: OR = 1.1 (95% CI, 0.5 to 2.0). The adjusted mean QTc interval length in users of an SSRI and nonusers was comparable (difference of 1.5 milliseconds [95% CI, -1.8 to 4.8]). Use of the most frequently used SSRIs citalopram and paroxetine was not associated with a higher risk of QTc interval prolongation nor with lengthening of the QTc interval duration. CONCLUSIONS: The use of an SSRI by elderly surgical patients was not associated with the occurrence of QT interval prolongation.

Selective serotonin reuptake inhibitors and intraoperative blood pressure.

BACKGROUND: The influence of selective serotonin reuptake inhibitors (SSRIs) on blood pressure is poorly understood. We hypothesized that if SSRIs have an influence on blood pressure, this might become manifest in changes in intraoperative blood pressure. We aimed to study the association between perioperative use of SSRIs and changes in intraoperative blood pressure by measuring the occurrence of intraoperative hyper- and hypotension. METHODS: We conducted a retrospective observational follow-up study among patients who underwent elective primary total hip arthroplasty. The index group included users of SSRIs. The reference group included a random sample (ratio 1:3) of nonusers of an antidepressant agent. The outcome was the occurrence of intraoperative hypo- and hypertensive episodes (number, mean and total duration, and area under the curve (AUC)). The outcome was adjusted for confounding factors using regression techniques. RESULTS: The index group included 20 users of an SSRI. The reference group included 60 nonusers. Users of SSRIs showed fewer intraoperative hypotensive episodes, a shorter mean and total duration, and a smaller AUC when compared to the reference group. After adjustment for confounders, SSRI use was associated with a significantly shorter total duration of hypotension: mean difference of -29.4 min (95% confidence interval (CI) -50.4 to -8.3). Two users of an SSRI and two patients in the reference group had a hypertensive episode. CONCLUSIONS: Continuation of treatment with SSRIs before surgery was associated with a briefer duration of intraoperative hypotension.

Antidepressive treatment with monoamine oxidase inhibitors and the occurrence of intraoperative hemodynamic events: a retrospective observational cohort study.

OBJECTIVE: To investigate the occurrence of intraoperative hemodynamic events when antidepressive treatment with monoamine oxidase inhibitors (MAOIs) was continued during anesthesia. METHOD: A retrospective observational cohort study was conducted among patients who were admitted for elective surgery requiring anesthesia in 8 Dutch hospitals (2004-2010). The index group included current users of irreversible (tranylcypromine) and reversible (moclobemide) MAOIs. The reference group included a sample of nonusers matched to the index group on hospital, type and period of surgery, and type of anesthesia (ratio 1:3). The outcome of interest was the occurrence of the following intraoperative hemodynamic events: hypotension or hypertension and tachycardia or bradycardia. RESULTS: Approximately 280,000 surgical procedures were performed in the participating hospitals in the total observational period of 33 years. The index group included 26 and 25 users of tranylcypromine and moclobemide, respectively. The reference groups included 149 nonusers. Intraoperative hypotension occurred less frequently in users of tranylcypromine (46%) than in nonusers (73%) (P = .01). The occurrence of hypertension, bradycardia, and tachycardia during anesthesia was not different between users of tranylcypromine (27%, 50%, and 12%, respectively) and those in the reference group (35%, 61%, and 26%, respectively). The occurrence of hypotension, hypertension, bradycardia, and tachycardia was not different between users of moclobemide and the reference group. CONCLUSIONS: Severe adverse hemodynamic events, such as hypertension and tachycardia, did not occur more frequently in users of both the irreversible MAOI tranylcypromine and the reversible MAO-A inhibitor moclobemide compared to nonusers. These findings suggest that there is no longer much justification to discontinue these MAOIs before surgery, with the considerable risk of compromising patients' psychiatric status.