Development and validation of the disease-specific Short Bowel Syndrome-Quality of Life (SBS-QoL™) scale.

BACKGROUND & AIMS: Subjects with short bowel syndrome (SBS) have impaired quality of life (QoL). No disease-specific instrument has been available to measure treatment-induced changes in QoL over time. Therefore, the aim was to develop and validate an SBS-specific QoL scale. METHODS: Classical test theory and Food and Drug Administration (FDA) guidance were applied for development and validation of the SBS-QoL™. Procedures included item generation and raw scale construction. Factor analysis, construct validity and internal consistency were assessed in a non-interventional observation, test re-test reliability and responsiveness in a randomised clinical study. RESULTS: The SBS-QoL™ comprises 17 items including two subscales. Subjects assessed the scale as easy to handle and comprehensible. Good construct validity was shown by comparison with the Home Parenteral Nutrition-Quality Of Life questionnaire as an external scale, which yielded moderately high correlation (r ≥ 0.7). High internal consistency was demonstrated (Cronbach's alpha: 0.94). Also the test re-test reliability was high (r ≥ 0.95), indicating reliable reproducibility of results. The Responsiveness Index (1.84) indicated the ability of the scale to detect changes in QoL over time. CONCLUSIONS: The SBS-QoL™ is an easy to handle and comprehensible SBS-specific subject-reported QoL scale. It is valid, reliable and sensitive with excellent psychometric characteristics to measure treatment-induced changes in QoL over time in subjects with SBS.

Screening for psychosocial distress in patients with long-term home parenteral nutrition.

BACKGROUND & AIMS: Long-term home parenteral nutrition (HPN) may cause distress and negatively affect quality of life (QoL). The HPN version of the Distress Thermometer and Problem List (DT/PL) was developed to evaluate distress during HPN. This study validates the DT/PL, examines referral wish for additional care, assesses opinions on the DT/PL, and studies risk factors for distress and referral wish. METHODS: Dutch and Scottish patients completed questions on socio-demographic and HPN-related general characteristics, the DT/PL, referral wish, the Hospital Anxiety and Depression Scale, and opinions on the DT. RESULTS: The HPN version of the DT/PL seemed valid and the PL sufficiently reliable. Cut-off score appeared to be 6. Consequently, 45% of patients were diagnosed as clinically distressed. Fifty-three percent had a referral wish. Emotional and physical problems were most strongly associated with distress. Not being able to work related to elevated distress. Female gender and co-morbidity related to referral wish. Opinions on the DT were generally positive. CONCLUSION: The DT/PL appears to be a good instrument to regularly gain insight into distress and referral wish in HPN patients. Use of the DT/PL facilitates support to patients who most need and want it, thus improving quality of care and QoL.

Assessment of quality of life on home parenteral nutrition and after intestinal transplantation using treatment-specific questionnaires.

In order to investigate the quality of life on home parenteral nutrition and after intestinal transplantation using comparable questionnaires, the treatment-specific quality of life questionnaire for adult patients on home parenteral nutrition was adapted for intestinal transplant recipients. Both instruments were composed of 8 functional scales, 9 symptom scales, 3 global health status/quality of life scales and 2 single items. A preliminary cross-sectional study enrolling all the patients currently cared at the same hospital was carried out. Exclusion criteria were age ≥ 60 years and hospitalization at time of assessment. Thirty-three home parenteral nutrition patients (100% answered) and 22 intestinal transplant recipients (82% answered) were enrolled. Intestinal transplant recipients showed a better score in following scales: ability to holiday/travel (p < 0.001), fatigue (p = 0.022), gastrointestinal symptoms (p < 0.001), stoma management/bowel movements (p = 0.001) and global health status/quality of life (p = 0.012). A better score for ability to eat/drink (p = 0.070) and a worse score for sleep pattern (p = 0.100) after intestinal transplantation were also observed. The results of this preliminary study with specific instruments were consistent with the main expected improvement of the quality of life related to intestinal transplantation. Further studies in larger patient cohorts are required to confirm these data.

Muscle cramps are the commonest side effect of home parenteral nutrition.

BACKGROUND & AIMS: Complications resulting from home parenteral nutrition (HPN) reduce a patient's quality of life. The major complications of catheter-related sepsis, venous thrombosis and chronic liver disease are well recognised. This study aimed to determine if there were other minor, but common complications that caused patient distress. METHODS: All patients (45) from four HPN centres were asked if they had suffered any side effects of parenteral nutrition and whether these side effects related to the timings of the feed or required specific intervention. RESULTS: Muscle cramps were the most common minor side effect [12/45 (27%)]. A greater proportion of HPN patients (51%) suffered from muscle cramps than did a control group of patients with inflammatory bowel disease (24%) [p=0.0001]. In the HPN patients, no significant difference in serum electrolyte concentration or in feed composition was noted between those patients with and those without cramps in relation to feeds. Cramps were of sufficient severity to warrant pharmacological intervention in 9 of 12 patients who had cramps in relation to feeds, and parenteral nutrition administration was slowed in 2 of the 12. CONCLUSION: Muscle cramps have a high prevalence in patients receiving home parenteral nutrition.

The Scottish home parenteral nutrition managed clinical network: one year on.

The purpose of home parenteral nutrition (HPN) is to allow patients with intestinal failure a reasonable quality of life and to facilitate independence from hospital. A managed clinical network (MCN) has been established for the organisation of HPN. This multi-professional group works towards optimal patient management by adoption of nationally agreed, evidence standards and protocols, to allow equity of access to quality care. A coordinator has identified patients and practice. A MCN exists to ensure that quality care can be delivered near to the patient's home. An audit of the organisation of HPN has been completed. The aims of this study were to identify the numbers of patients receiving this treatment and to assess management practices. Data was collected from 16 centres between July 2000 and August 2001. This paper discusses the practicalities of setting up the network and presents data from the first full year of audit. This will act as the baseline for continuous audit and a basis for revision of documentation.

A randomised controlled trial evaluating the use of enteral nutritional supplements postoperatively in malnourished surgical patients.

BACKGROUND: Patients who undergo surgery are at risk of malnutrition due to periods of starvation, the stress of surgery, and subsequent increase in metabolic rate. There are limited data on nutritional outcome of surgical patients. AIMS: To investigate changes in nutritional status and the influence of oral supplements on nutritional status, morbidity, and quality of life in postoperative surgical patients. METHODS: Entry was determined by the presence of malnutrition, as defined by a body mass index (BMI) < or =20 kg/m(2), anthropometric measurements < or =15th percentile on admission, or initiation of oral diet postoperatively and/or a weight loss of 5% or more during the operative period. We studied 101 patients: 52 were randomised to the treatment group (TG) and prescribed a 1.5 kcal/ml nutritional supplement; 49 patients were randomised to the control group (CG) and continued with routine nutritional management. Nutritional status was assessed by weight, anthropometry, and grip strength, with measurements taken at two weekly intervals for 10 weeks. Complications, namely wound infection, chest infection, and antibiotic use were documented. Quality of life (QOL) was assessed using the UK SF-36 questionnaire. RESULTS: Patients in the control group lost a maximum mean (SD) of 5.96 (4.21) kg in weight over a period of eight weeks while patients in group TG lost less weight overall (maximum mean (SD) 3.40 (0.89) kg (p<0.001) occurring at four weeks and progressively regained weight from week 4). Anthropometry, grip strength, and QOL were similarly significantly different between groups (p<0.001). Fewer patients in the treatment group (7/52) required antibiotic prescriptions compared with the control group (15/49). CONCLUSIONS: Nutritional status declined for two months after discharge. Postoperative nutritional supplementation improved nutritional status, QOL, and morbidity in these patients.

Problems of nutritional assessment in the acute setting.

Surveys have shown that 20-50% of hospital admissions suffer from nutritional depletion and that there is failure to recognize its existence and significance. More emphasis must be placed in clinical medicine on identifying subjects who are at high risk of developing disease-related malnutrition. There is a need to screen patients on admission to hospital to identify those at risk of nutrition-related complications. More formal determination of nutritional status should be carried out to define the nutritional status of the patient and to monitor changes in nutritional status during nutritional support. The most frequently used tests of nutritional status include dietary, anthropometric, biochemical and functional indices of nutritional status. It is important, and indeed is the skill of the nutritional care team (particularly the dietitian) to be able to evaluate these measurements, as many of them are affected by non-nutritional factors. There is no consensus on the best method for the accurate assessment of nutritional status. Practical difficulties arise with individual measurements and in their interpretation in the acute setting. The aim of the present paper is to identify the most relevant variables to measure in clinical medicine, and to discuss the limitations of their use in the acute setting.

Manganese requirement and toxicity in patients on home parenteral nutrition.

Two patients who were receiving home parenteral nutrition complained of vague neurological symptoms of such severity that they underwent full clinical appraisal. The only positive finding was that plasma manganese concentrations were greater than twice the upper 95% confidence interval of normal (7-27|nmol/l). In the light of this result all nine patients receiving home parenteral nutrition underwent evaluation for possible manganese toxicity. One other patient had serum manganese concentrations exceeding twice the upper limit (127|nmol/l). The three patients with elevated serum Mn had evidence of manganese deposition in the brain on magnetic resonance imaging scanning. In contrast two patients with normal plasma results had negative scans. Patient susceptibility appears very variable. We suggest that current amounts of trace elements provided in nutrition solutions may be a potential source of nutrient activity. The fine tuning of supply and demand may be difficult on account of a limited range of commercially available trace element solutions.