Does the patch fit the stoma? A study on peristoma geometry and patch use in laryngectomised patients

Clin. Otolaryngol. 2011, 36 , 235–241 Objective: To determine the geometry of (peri)stomas of laryngectomised patients in relation to patch use. This data will enable improvement of tracheostoma interfaces, specifically addressing patients currently unable to use stoma patches. The low use of Heat‐and‐Moisture‐Exchange (HME) filters and (hands‐free) speech valves, although very important to the quality of life of laryngectomised patients, is mainly attributed to poor fit of the adhesive patches to the stoma site. Current patch shapes are not based upon an objective (peri)stoma geometry because this geometry is unknown. Design: Observational anthropometric study of the (peri)stoma of laryngectomised patients. Setting: Ten hospitals or institutes in eight countries. Participants: About 191 laryngectomised patients, at least 1 year post operative. Main outcome measures: (Peri)stomas were photographed and measured. Patients completed a questionnaire on patch‐use. Concavity of commercially available patches was measured. Results: In countries with a financial reimbursement system 58% of the patients use patches, compares to only 9% in other countries. Patches stay in situ for an average of 33.3 h. Patch and non‐patch users differ on five out of ten measured geometrical parameters. Most striking differences are that patch users have much shallower peristomas (13 versus 18 mm), and stomas far more parallel to the anterior neck plane. The deepest commercially available patch is only 7 mm deep. Conclusions: This study provides detailed (peri)stoma geometry data of a divers population, and for the first time in relation to patch‐use. It reveals a serious mismatch between patients and patches. With these data new patches can be developed that could dramatically improve rehabilitation after laryngectomy.     

Currarino triad: Characteristic appearances on magnetic resonance imaging and plain radiography

The Currarino triad is a complex anomaly consisting of an anorectal malformation, a sacral bone defect and a presacral mass. It was first described in 1981 and since then, approximately 250 cases have been reported. Radiology has an important part to play in the diagnosis of this entity, as the imaging features are characteristic. We report a case of Currarino triad in an infant who presented with intractable constipation and discuss relevant MRI and plain radiography findings.     

Loss of tumor-promoting activity of unleaded gasoline in N- nitrosodiethylamine-initiated ovariectomized B6C3F1 mouse liver

Unleaded gasoline (UG) vapor (2056 ppm) increased the incidence of liver tumors in a chronic bioassay and exhibited tumor-promoting activity in N-nitrosodiethylamine (DEN)-initiated female mouse liver. Estrogen inhibited mouse liver tumor development and the hepatocarcinogenic and tumor-promoting dose of UG produced uterine changes suggestive of estrogen antagonism. To directly test the hypothesis that UG-induced tumor-promoting ability is secondary to its interaction with the mouse liver tumor inhibitor, estrogen, we compared the tumor-promoting ability of UG in ovariectomized (Ovex) mice with the hepatic tumor-promoting ability of UG in intact mice. Ovaries were surgically removed at 4 weeks of age. Exposure to wholly vaporized UG (2018 ppm) under bioassay and tumor-promoting conditions began at 8 weeks of age. After 4 months of exposure, UG increased relative liver weight and hepatic microsomal cytochrome P450 pentoxyresourfin-O- dealkylase and ethoxyresorufin-O-deethylase activity to a similar extent in intact and Ovex mice. Non-focal hepatocyte proliferation, as measured by the incorporation of bromo-deoxyuridine, was not changed by UG exposure and was similar in all treatment groups. After 4 months of exposure to DEN-initiated mice, UG significantly increased the volume fraction of liver occupied by foci (three-fold) as compared to control intact mice. As expected, volume of foci was elevated in DEN/Ovex/control mice as compared to DEN/intact/control mice. In DEN/Ovex mice UG did not significantly increase the focal volume fraction. Thus, the tumor promoting activity of UG, as demonstrated by increased volume fraction of liver occupied by hepatic foci in intact mice, is greatly attenuated in Ovex mice. The volume fraction data in Ovex mice support the hypothesis that the tumor promoting activity of UG is dependent upon the interaction of UG with ovarian hormones. These data also indicate that hepatic microsomal cytochrome P450 PROD and EROD induction, hepatomegaly and non-focal hepatic LI are not specific markers of hepatic tumor promoting activity of UG.      

Prognostic indicators for breast cancer patients with one to three regional lymph node metastases, with special reference to alterations in expression levels of bcl-2, p53 and c-erbB-2 proteins

Patients with primary breast carcinoma with one to three axillary lymph node metastases but without distant metastases (n1-3) in Japan have been shown to have a 10-year disease-free survival rate of > 60%. It would be reasonable to divide n1-3 Japanese breast cancer patients into groups with high- or low-risk for recurrence and to consider post-operative adjuvant therapy. In the present study, we analyzed 228 consecutive Japanese patients with n1-3 breast cancer who underwent radical mastectomy and were followed up for a median time of 11.0 years. The expression of bcl-2, p53 and c-erbB-2 proteins in the primary tumors was examined immunohistochemically and their prognostic roles were also analyzed along with conventional clinicopathologic indicators. bcl-2 expression was correlated with positive estrogen receptor status and inversely correlated with p53, c-erbB-2 and histologic grade. Univariate analysis showed that bcl-2, p53 and c-erbB-2 expression were prognostic indicators of the patient's group as well as node status, histologic grade, tumor size, age at diagnosis, menopausal status and estrogen receptor status. Cox's regression analysis demonstrated that the number of nodes involved, menopausal status, p53 and bcl-2 were independent predictors for overall survival and that histologic grade and the number of nodes involved were independent predictors for disease-free survival. These results suggest that bcl-2 expression in combination with p53 and c-erbB-2 expression, the number of lymph node metastases, histologic grade and menopausal status are useful in selecting subgroups of n1-3 breast cancer patients with good or poor prognoses.      

Risk factors for deaths in under-age-five children attending a diarrhoea treatment centre

Few case-control studies have examined possible risk factors for diarrhoeal deaths in under-age-five children in the developing countries. We analysed data from the surveillance system of our diarrhoea treatment centre/hospital for the period 1990-94 on 928 children less than 5 years of age. In univariate analysis, 11 factors were significantly associated with death: lack of breastfeeding, severe malnutrition, complicated diarrhoea, pneumonia, xerophthalmia, duration of diarrhoea 7-14 days, moderate or severe dehydration, recent history of measles, Shigella flexneri infection, maternal illiteracy, and very low household income. Rotavirus diarrhoea was negatively associated with fatal outcome. In the assessment of severe malnutrition, weight-for-height measurement discriminated mortality risk better than weight-for-age or height-for-age indices. Only two factors retained their significance, severe malnutrition and non-breastfeeding in the multivariate analysis with adjusted odds ratio (95% confidence interval) of 84.2 (9.1, 775.9) and 4.2 (1.3, 13.2) respectively.     

Short stay facilities: the future of efficient paediatric emergency services

OBJECTIVE: To assess the reactions of parents and their children to the request for a blood sample and an attempt to take blood. METHODS: 1859 children aged 1.5-4.5 years took part in a national survey of diet and nutrition. A retrospective inquiry of the parents' and children's reported reactions was carried out six to 18 months later by postal questionnaire sent only to the 1157 who had given consent for an attempt to take blood. RESULTS: 866 questionnaires were returned; 790 were from parents of children in whom an attempt to take blood had been successful. Thirteen per cent said that their child had given blood previously. About 30% discussed the request with the family doctor or nurse. Some 90% said that they were given enough information and that the phlebotomist was sympathetic. Attempting to take blood caused upset in over 50%, which, in most, lasted for less than five minutes. A substantial minority were upset for up to 30 minutes and a few much longer. Bruising or bleeding occurred in 20-27%. Degree and duration of upset were both adversely associated with a failed attempt to obtain blood. CONCLUSION: The majority of preschool children experienced no more than a little upset of short duration after an attempt to take blood, but a substantial minority exhibited a greater degree of upset. These responses should be taken into account when assessing the benefits and risks of the procedure. The best equipment and expertise should be employed for taking blood as successful attempts are less upsetting.     

Nutritional factors and thalassaemia major

Abnormal growth is a common feature of thalassaemia major in children. In an attempt to determine whether it has a nutritional cause, 12 children aged 1 to 3 years with thalassaemia major were studied under metabolic ward conditions. Nutritional status was assessed by anthropometry and biochemistry before and after an intensive nutrition regimen. Five children had wasting or stunting on admission. As a result of the nutrition intervention, mean weight for height improved significantly. The mean height increase of 0.4 cm after one month was not significant. Plasma zinc, depressed in half the children on admission, improved, as did alpha tocopherol, while copper decreased. Plasma insulin-like growth factor-I also increased commensurate with improved growth. Fat absorption was normal in all children. Undernutrition is an important cause of associated growth disturbances in children with thalassaemia major. Malnutrition was primarily caused by inadequate nutrient intake, as indicated by the capacity to gain weight appropriately when provided with nutrition support, and by the absence of intestinal malabsorption. While long term studies are required to determine if nutritional support will prevent stunting, these results underscore its central role in preventing nutritional deficiencies and in promoting normal growth in thalassaemic children.     

Biofilm formation in vivo on perfluoro-alkylsiloxane-modified voice prostheses

OBJECTIVE: To study the influence of perfluoroalkylsiloxane (PA) surface modification of silicone rubber voice prostheses on biofouling. DESIGN: Placebo-controlled clinical trial. SETTING: Tertiary referral center, with specialization in head and neck cancer treatment. PATIENTS: Eighteen consecutive patients with laryngectomies and experienced in the use of a voice prosthesis who visited the outpatient clinic for prosthesis replacement. MATERIAL: Eighteen partially surface-modified voice prostheses (3 with short-chain PAs [1 fluorocarbon unit] and 15 with long-chain PAs [8 fluorocarbon units]) were inserted via the patients' tracheoesophageal shunts and remained in place for 2 to 8 weeks. INTERVENTION: Replacement of the prostheses. MAIN OUTCOME MEASURES: Evaluation of biofilm formation on short- and long-chain PA-modified and original silicone rubber surfaces on the esophageal side of the voice prosthesis. RESULTS: The planimetrical biofilm scores of the surfaces of all 3 short-chain PA-treated voice prostheses indicated more biofouling on the treated surfaces than on the untreated surfaces of the same prostheses. For the long-chain PA-treated prostheses, the planimetrical biofilm scores, as well as the numbers of colony-forming units per cm(-2) for bacteria and yeasts, indicated less biofouling on the treated side than on the control side for 9 of the 13 prostheses that could be analyzed (2 were lost to analysis). Identical fungal strains, mainly Candida sp, were isolated from biofilms on each side of the esophageal flange. CONCLUSIONS: Chemisorption of long-chain PAs by the silicone rubber used for voice prostheses reduces biofilm formation in vivo and therefore can be expected to prolong the life of these prostheses. Chemisorption of short-chain PAs by silicone rubber seems to have an adverse effect.     

Familial Cervical Cancer: Case Reports,Review and Clinical Implications

We report three Dutch families with familial clustering of (pre)neoplastic cervical disease, review the literature on familial risks of cervical intraepithelial neoplasia (CIN) and cervical cancer, and discuss possible practical guidelines for women with a family history of cervical cancer. Daughters and sisters of women with cervical cancer have been reported to have a relative risk of 1.5-2.3 to develop this type of cancer. From a practical clinical point of view, we suggest that as in women with an increased non-genetic risk to develop cervical cancer (e.g. because of immunosuppressive therapy) increased surveillance to detect this tumour should be considered in women with an increased risk based on family history. Cessation of smoking should be advised. As the use of condoms at least prevents HPV re-infection its use can be recommended as a way to lower the cervical cancer risk. Future studies to determine the genetic contribution to the development of cervical cancer should include the paternal family history of cancer and, because genetic predisposition might express itself as a higher risk to develop precursors of cervical cancer, carcinoma in situ and CIN grade II-III.     

Medical technology assessment: the use of the analytic hierarchy process as a tool for multidisciplinary evaluation of medical devices

Most types of medical technology assessment are performed only after the technology has been developed. Consequently, they have only minor effects on changes in clinical practice. Our study introduces a new method of constructive medical technology assessment that can change the development and diffusion of a medical device to improve its later clinical effectiveness. The method, based on Saaty's Analytic Hierarchy Process, quantitatively supports discussions between various parties involved in technological development and diffusion. We applied this method in comparing a new blood pump with two competitors based on technical, medical and social requirements. These discussions changed the evaluators' perspectives, reduced diasagreements, and ended in a reliable evaluation of the pump's performance. On the basis of these results, adaptations were derived which improved the design and diffusion of the blood pump. This application shows the adequate potential of our method to steer technological development and diffusion of artificial organs.