A multi-centre study on quality of life and absenteeism in patients with CRS referred for endoscopic surgery.

AIMS: This study summarises the health-related quality of life (HRQOL) scores and absenteeism caused by sinus problems in patients awaiting surgery with the diagnoses recurrent acute rhinosinusitis (RARS), chronic rhinosinusitis with nasal polyps (CRS+NP) or CRS without nasal polyps (CRS-NP), in a prospective multi-centre study. METHODOLOGY: Two hundred and seven patients with RARS, CRS+NP or CRS-NP were enrolled. EP3OS definitions of CRS and NP were used. The patients completed the 22 Sinonasal Outcome Test (SNOT-22), the short-form 36-item questionnaire (SF-36), the Hospital Anxiety and Depression Scale (HAD) and a total Visual Analogue Scale (VAS) regarding rhinosinusitis symptoms. RESULTS: SNOT-22 and VAS scores indicated severe disease. Comparison of the HRQOL scores in the three rhinosinusitis subgroups showed statistical differences in nine of the SNOT-22 items and in the SF-36 subscale of bodily pain. Mean scores of SF-36 were significantly lower than that of the normal Swedish population. According to the HAD scores, 28% of the patients had probable or possible anxiety or depression disorder. Fifty-seven percent of the patients reported absenteeism from work due to sinus problems. CONCLUSIONS: RARS, CRS+NP and CRS-NP significantly decrease HRQOL. Some statistically significant differences in HRQOL were found between the three rhinosinusitis subgroups. Absenteeism due to chronic sinus conditions is considerable.

Characteristics and implications of attrition in health-related quality of life studies in palliative care.

In a longitudinal study of 297 palliative care patients, 280 patients were followed from inclusion to death. Characteristics and health-related quality of life (HRQL) of the participants and those who later dropped out were compared at inclusion, and 3 and 2 months before their death. At inclusion, the dropouts were older (P = 0.001), had reduced Karnofsky performance score (P < 0.001), received more help from the local authority (P = 0.004) and had reduced HRQL compared with patients who continued in the study and completed the next questionnaire. There were no differences in any of the HRQL parameters between participants and dropouts 3 months before death. Two months before death, differences in HRQL were found, but in favour of the dropouts. Data from patients close to death may be representative of a larger group of patients, whereas initial dropouts may lead to a positive bias of reported HRQL.

Quality of life in head and neck cancer patients: validation of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-H&N35.

PURPOSE: The aim of this study was to define the scales and test the validity, reliability, and sensitivity of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-H&N35, a questionnaire designed to assess the quality of life of head and neck (H&N) cancer patients in conjunction with the general cancer-specific EORTC QLQ-C30. PATIENTS AND METHODS: Questionnaires were given to 500 H&N cancer patients from Norway, Sweden, and the Netherlands as part of two prospective studies. The patients completed the questionnaires before, during (Norway and Sweden only), and after treatment, yielding a total of 2070 completed questionnaires. RESULTS: The compliance rate was high, and the questionnaires were well accepted by the patients. Seven scales were constructed (pain, swallowing, senses, speech, social eating, social contact, sexuality). Scales and single items were sensitive to differences between patient subgroups with relation to site, stage, or performance status. Most scales and single items were sensitive to changes, with differences of various magnitudes according to the site in question. The internal consistency, as assessed by Cronbach's alpha coefficient, varied according to assessment point and within subsamples of patients. A low overall alpha value was found for the speech and the senses scales, but values were higher in assessments of patients with laryngeal cancer and in patients with nose, sinus, and salivary gland tumors. Scales and single items in the QLQ-H&N35 seem to be more sensitive to differences between groups and changes over time than do the scales and single items in the core questionnaire. CONCLUSION: The QLQ-H&N35, in conjunction with the QLQ-C30, provides a valuable tool for the assessment of health-related quality of life in clinical studies of H&N cancer patients before, during, and after treatment with radiotherapy, surgery, or chemotherapy.

Penetration of loracarbef into the maxillary sinus: a pharmacokinetic assessment.

Loracarbef, a beta-lactam antibiotic of the carbacephem class, is active in vitro against pathogens associated with acute maxillary sinusitis. To study the extent and duration of maxillary sinus fluid penetration after administration of loracarbef, 20 patients (10 men, 10 women; average age, 41 +/- 13 years) with acute sinusitis were treated with loracarbef 400 mg every 12 hours for 10 days. A lavage catheter was inserted into the maxillary sinus, and 150-microL sinus fluid samples were obtained at 0 (baseline), 0.5, 1, 1.5, 2, and 2.5 hours after the first dose and at 24 and 48 hours (12 hours after the second and fourth doses, respectively). Venous blood samples were obtained at the same times. Maxillary fluid and serum samples were frozen immediately at -20 degrees C to -70 degrees C until later bioassay using a direct agar diffusion method. Excluding missing data or inappropriately timed samples, the mean (+/- SD) sinus fluid concentrations were 0.16 +/- 0.12 microgram/mL at baseline, 0.23 +/- 0.17 microgram/mL at 0.5 hour, 1.11 +/- 1.44 micrograms/mL at 1 hour, 1.63 +/- 2.07 micrograms/mL at 1.5 hours, 1.75 +/- 2.01 micrograms/mL at 2 hours, and 1.60 +/- 1.96 micrograms/mL at 2.5 hours after dose. The mean sinus fluid concentration before the third dose (approximately 12 hours after the second dose) was 1.01 +/- 0.89 microgram/mL and before the fifth dose (approximately 12 hours after the fourth dose) was 0.88 +/- 0.90 microgram/mL. Taking the highest sinus fluid concentration measured in each patient, the mean peak sinus fluid concentration was 2.12 +/- 1.98 micrograms/mL (range, 0 to 6.7 micrograms/mL). The pretherapy peripheral leukocyte count appeared to have a statistically significant association (P < 0.01) with loracarbef sinus fluid penetration as estimated by the sinus fluid area under the concentration-time curve at 0 to 2.5 hours. Loracarbef 400 mg twice daily achieved sinus fluid concentrations that appeared to exceed the minimum concentration required to inhibit 90% of relevant acute sinusitis pathogens throughout the 12-hour interdose interval in most patients with acute maxillary sinusitis.

A prospective study of quality of life in head and neck cancer patients. Part II: Longitudinal data.

OBJECTIVES: To evaluate the health-related quality of life (HRQL) of patients with head and neck cancer during and after treatment with radiotherapy, surgery, and chemotherapy. STUDY DESIGN: Prospective, descriptive study. METHODS: All new patients in four institutions in Norway and Sweden were asked to participate. Health-related quality of life was assessed at baseline and at 1, 2, 3, 6, and 12 months after start of treatment by means of the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire and the EORTC head and neck cancer-specific questionnaire. Baseline results are described elsewhere; longitudinal results are presented in the current article. Three hundred fifty-seven patients with cancer in the oral cavity, pharynx, larynx, nose, sinuses, and salivary glands and neck node metastases from unknown primaries filled in the questionnaires at baseline. RESULTS: Seventy-eight percent of the patients who were alive after 12 months filled in all questionnaires (218/280). The general trend was that HRQL deteriorated significantly during treatment, followed by a slow recovery until the 12-month follow-up with few exceptions (senses, dry mouth, and sexuality). Patients who later died reported worse HRQL at each assessment point compared with patients who filled in all six questionnaires, whereas those who dropped out of the study for other reasons were quite similar to patients who filled in all questionnaires. The patients with pharyngeal cancer in general reported worse HRQL compared with the other groups and did not reach pretreatment values in several domains. Stage was also an important factor for HRQL in patients with head and neck cancer. CONCLUSION: Detailed knowledge about the differences between groups and changes over time may aid us in the communication with patients and in the design of intervention studies focusing on improvement of the support and rehabilitation of patients with head and neck cancer.

A prospective study of quality of life in head and neck cancer patients. Part I: at diagnosis.

PURPOSE: A Swedish and Norwegian study was designed to examine health-related quality of life (HQL) in patients with head and neck cancer (head and neck) at diagnosis and during treatment and rehabilitation. The overall aim was to examine the impact on HQL at diagnosis depending on tumor location, stage, sex, and age (part I) and to describe HQL longitudinally and determine for which patients and during which period HQL deteriorated most (part II). This article presents the results at diagnosis. METHOD: Patients with head and neck cancer at five hospitals in Sweden and Norway were consecutively requested to participate. They were asked to answer the EORTC QLQ-C30 and QLQ-H&N35 (the European Organization for Research and Treatment of Cancer, Core 30 questionnaire and head and neck cancer module) repeatedly during 1 year. A total of 357 patients (mean age, 63 y; 72% males) were included. RESULTS: Patients with different tumor locations all had their special problems at diagnosis, for example, those with tumors in the larynx with communication, those with oral tumors with pain, and those with pharyngeal tumors with nutrition and pain. The patients with hypopharyngeal cancer reported the worst HQL. Stage appeared to have the strongest impact on HQL. Patients with a more advanced tumor stage reported significantly worse HQL scores for 24 of 32 variables reflecting functioning or problems. The females scored worse than the males for some areas, in particular, emotional functioning. The older patients scored significantly better for emotional and social functioning than patients <65 years but worse for physical functioning and various symptoms. The traditional way of grouping the tumor locations into oral, pharyngeal, laryngeal, and "other" tumors (salivary gland, sinus and nose, and unknown primary) was tested from a HQL point of view and found to be consistent. CONCLUSIONS: The chosen questionnaires differentiated between different sites of head and neck cancer at diagnosis. Tumor stage had the most powerful impact on HQL score.

Effects of a cognitive-behavioral pain-management program.

A cognitive behavioral multidisciplinary pain management program was evaluated in two separate outcome studies; one controlled study (study I) and one study conducted on a consecutive sample with a long-term follow-up (study II). The 4-week inpatient treatment program included education sessions, goal setting, graded activity training, pacing, applied relaxation, cognitive techniques, social skills training, drug reduction methods, contingency management of pain behaviors, and planning of work return. The outcome of study I showed significant between-group differences in favor of the treatment group on measures of occupational training at 1-month follow-up, activity level in the sparetime at post-treatment and at follow-up, and decreased catastrophizing and pain behaviors at post-treatment. In study II significant improvements over time were found on measures of sick leave, pain intensity, pain interference, life control, affective distress, activity level in the sparetime, physical fitness and use of analgetics at 2-month follow-up and at 1-year follow-up. The results of the two outcome studies reported show that cognitive behavioral multidisciplinary pain management programs can successfully be applied to Swedish musculoskeletal pain patients.

Prospective, longitudinal quality-of-life study of patients with head and neck cancer: a feasibility study including the EORTC QLQ-C30.

Despite modern advances in the treatment of head and neck cancer, the survival rate fails to improve. Considering the different treatment modalities involved, quality of life has been thought of as an additional end point criterion for use in clinical trials. A Nordic protocol to measure the quality of life of head and neck cancer patients before, during, and after treatment was established. Before the study, a pilot study was done with this protocol. The main purpose of this pilot study was to find out whether this cancer population would answer quality-of-life questionnaires repeatedly (six times) over a 1-year period and whether the chosen questionnaires-a core questionnaire (European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)), a tumor-specific questionnaire, and a psychological distress measure (Hospital Anxiety and Depression scale (HAD))-were sensitive for changes to functions and symptoms during the study year. The results presented in this article all refer to the pilot study. Forty-eight consecutive patients agreed to participate in the study. The most common tumor locations were the oral cavity (17) and the larynx (12). Almost all patients received combined treatment: 45 of 48 radiation therapy, 18 of 48 chemotherapy, and 17 of 48 surgery. After the primary treatment, 40 patients had complete tumor remission. Four of the 48 patients did not answer any questionnaires and were therefore excluded from the study. Of the remaining 44 patients, 3 died during the study year, and another 6 withdrew for various reasons. Thirty-five (85%) of the 41 patients alive at the 1-year follow-up answered all six questionnaires and thus completed the study. Mailed questionnaires were used throughout the study. All questionnaires were well accepted and found to be sensitive to changes during the study year. The greatest variability was found for symptoms and functions related specifically to head and neck cancer. The symptoms were swallowing difficulties, hoarse voice, sore mouth, dry mouth, and problems with taste. They all showed the same pattern, with an increase of symptoms during and just after finishing the treatment. The HAD scale revealed a high level of psychological distress, with 21% probable cases of psychiatric morbidity at diagnosis. In conclusion, it was shown that the study design and questionnaires were feasible for the forthcoming prospective quality-of-life assessment of Swedish and Norwegian head and neck cancer patients.

Acute sinusitis in children--symptoms, clinical findings and bacteriology related to initial radiologic appearance.

In a series of 175 children with suspected sinusitis the symptoms and clinical signs were compared with the radiologic and bacteriologic findings. URI, purulent nasal secretion and pain were the main symptoms predicting radiologic changes. In 75% of the patients the presence of two or three of these symptoms was co-existent with major radiological changes. As assessed by nasopharyngeal culture Haemophilus influenzae seemed to be the major pathogen.

Studies on the maxillary ostial function in cases with maxillary pain, intrasinusal cysts and chronic sinusitis.

The maxillary ostial function, measured as pressure transmission capacity, ostial airway resistance, equivalent ostial diameter during nasal breathing and with a constant artificial air-flow of 16.7 cm3 X S-1 into the sinus, was compared in three groups of patients. One group consisted of 7 sinuses in 6 patients with maxillary pain but without any signs of sinusitis; a second group of 6 sinuses in 6 patients with intramaxillary cysts; and a third group of 6 sinuses in 5 patients with chronic maxillary sinusitis. No impairment of the ostial function was found in groups one and two. In the third group an increased airway resistance of the ostia and small equivalent ostial diameters were found in both sitting and recumbent positions. With the pressure recording technique, the ostium can be judged as patent, non-patent, or partially obstructed, but no further grading can be done. With the pressure-flow technique the ostial function can be evaluated as ostial resistance or equivalent ostial diameters under 'physiological conditions' when the ostium is patent. With a constant artificial air-flow into the sinus the equivalent ostial diameter can be estimated even in non-patent ostia but the equivalent ostial diameters obtained do not always reflect the true functional state of the ostium.

Patency of the maxillary sinus ostium in healthy individuals.

In a group of 20 healthy subjects the patency of the maxillary ostium has been evaluated in 35 maxillary sinuses with three different techniques: simultaneous pressure recording in the sinus and the ipsi- and contralateral nasal cavity; simultaneous recording of differential pressure between the sinus and the ipsilateral nasal cavity and air-flow through the ostium during nasal breathing; recording of the pressure rise in the sinus with an artificial air-flow of 1 litre per minute applied to the sinus. The tests were carried out in sitting and recumbent positions. In 5 persons (10 sinuses) a retest was performed after 2 months. These subjects were also tested with an inflatable neck cuff in order to obtain an increased venous pressure. Rhinomanometry at rest and after physical effort was also performed. The pressure relationship between the maxillary sinus and the ipsilateral nasal cavity was 1:1 in both the sitting and the recumbent position, but less than 1 when the contralateral nasal cavity was measured. Pressure recording alone gives no quantitative information about the patency of the ostium. Determination of the ostial resistance during nasal breathing could be performed in 13 sinuses, but in the remaining 22 the ostia were too wide to give a measurable resistance. The equivalent ostial diameter during inspiration could be estimated in 12 of the sinuses from a diagram constructed from known ostial diameters in model experiments. With an artificial air-flow applied into the sinus, the equivalent ostial diameters could be estimated from the diagram in all cases. No statistical difference was found in comparable cases between the mean equivalent ostial diameters estimated with the two methods. The equivalent ostial diameters showed a statistically significant reduction in the recumbent position and after application of the neck cuff. A statistically significant relationship was also found between the airway resistance of the nasal cavity and the equivalent diameter of the ostium in sitting and recumbent positions. Such a relationship could not be found between the equivalent ostial diameters measured at rest and the nasal resistance recorded after physical effort.

Patency tests of the maxillary ostium--model experiments.

The function of the maxillary ostia (phi 0.22-4.7 mm) has been evaluated in experiments on a nose-sinus model with variable sinusal volumes. A piston-pump producing to-and-fro volumes of 467 cm3 of air per revolution was used at a speed of 10 and 20 revolutions per minute (rpm). Three different techniques were used: simultaneous pressure recording in the sinus and the nose (Method I); simultaneous recording of the differential pressure between nose and sinus and the air-flow through the ostium (Method II); recording of the pressure rise inside the sinus upon the application of a constant artificial air-flow of 16,7 cm3 . s-1 or 2.0 cm3 . s-1 (Method III). All variables were recorded on an ink-jet recorder and onto tape when using methods I and II for later analysis on an x-y recorder. A pressure relationship of 1 : 1 was found between nose and sinus, independently of ostial diameters, sinusal volumes and piston-pump rates. The first method did not permit an isolated determination of the ostial function as the pressure values recorded are affected by ostial diameters, sinusal volumes and piston-pump rates. The pressure-flow relationship recorded with the second method was found to be dependent only on the ostial diameters. Hysteresis was observed at ostial diameters less than or equal to 1.63 mm. This is due to ostial diameter, sinusal volume and the rate of the nasal pressure changes. This method is suitable for an isolated determination of the ostial resistance, from which the equivalent ostial diameter can be calculated. With the third method using static air-flows and pressures the results are independent of the sinusal volume. This method is suitable for estimation of the ostial airway resistance and the equivalent ostial diameter. A striking similarity was observed between the results obtained with the last two methods in estimating equivalent ostial diameters.

Effects of phenylpropanolamine on ostial and nasal airway resistance in healthy individuals.

Ostial airway resistance (OAR) of 11 maxillary ostia and the airway resistance of the nasal cavity (NAR) in 6 healthy persons were tested before and after administration of phenylpropanolamine (Ppa) and placebo. The effects of physical exercise were also tested. After logarithmic transformation, the resistance values showed a normal distribution. Significant effects on the ostial resistance in relation to initial values were found after Ppa medication. The effect was more pronounced in recumbency than in the sitting position. Physical exercise also gave a significant reduction of ostial resistance while placebo treatment was without effect. On comparison of the Ppa- and placebo-groups in an extended statistical analysis, more striking differences were found both for OAR and NAR. In this model study, Ppa thus showed effects in healthy individuals.

Ostial and nasal patency in chronic maxillary sinusitis. A long-term post-treatment study.

In a long-term follow-up study (mean 3.5 years) after treatment of chronic maxillary sinusitis of either rhinogenous or dental origin, 72 sinuses in 66 patients were examined with respect to maxillo-ostial and nasal resistance. In sinusitis of rhinogenous etiology, the mean equivalent ostial diameter was pathologically narrowed (0.89 mm, in patients treated conservatively) whereas it was normal (2.51 mm) in sinusitis of dental etiology (dental treatment in combination with local sinus surgery). In the former group, all sinuses were diseased, compared with 3 out of 23 in the dental group. In order to distinguish between functional and organic ostial stenosis, the patients were also tested after physical exercise. The functional ostial diameter in healthy sinuses was significantly increased in contrast to the diseased sinuses. In one patient the narrow ostium was due to mucosal swelling only, but in the other cases was caused mainly by an organic stenosis. In sinusitis of rhinogenous etiology, a pathologically increased nasal resistance was found in 14.3%, while the corresponding figure in the dental group was 4.3%. Improved sinusal and nasal ventilation, achieved either pharmacologically or, preferably by surgical intervention, seems necessary for successful treatment of chronic maxillary sinusitis.

Effects of phenylpropanolamine on ostial and nasal patency in patients treated for chronic maxillary sinusitis.

Ostial and nasal patency were measured in different body positions and after phenylpropanolamine (Ppa) treatment in 12 patients earlier treated for chronic unilateral maxillary sinusitis of varying severity. Six of the sinuses were of normal appearance on sinoscopy. Phenylpropanolamine in a single dose of 100 mg was found to increase the equivalent ostial diameter significantly in the sitting and recumbent positions. The drug also reduced the nasal airway resistance. The Ppa effect might be of benefit in patients treated for chronic maxillary sinusitis.

Patency tests of the maxillary ostium in health and disease.

Three different maxillary ostial function tests (simultaneous pressure recording in nose and sinus; simultaneous differential pressure and flow recording across the ostium; pressure recording at a constant artificial air-flow into the sinus) have been evaluated on healthy subjects and used in clinical materials. No quantitative evaluation of the ostial function was possible when using the simultaneous nasosinusal pressure recording method. The ostial function can be expressed as ostial resistance or as corresponding equivalent ostial diameter with the pressure-flow and the constant artificial air-flow methods. An isolated determination of the ostial function in both sinu-nasal and naso-sinusal directions during nasal breathing was only possible with the pressure-flow method. No impaired ostial function was found in cases with maxillary pain and intrasinusal cysts, but in chronic sinusitis the ostial function was considerably deteriorated. In cases with impaired ostial function the constant artificial air-flow method does not mirror the true functional state due to the non-physiological air-flow level used. Thus, the pressure-flow method seems to be the most physiological one.

Antileukoprotease in patients with maxillary sinusitis.

Antileukoprotease, an inhibitor of leukocyte elastase, was studied in paired sera from 12 patients with maxillary sinusitis. The serum concentration of antileukoprotease was increased at the day of admission to hospital, compared with the serum concentration in convalescence sera. In purulent maxillary sinus secretions antileukoprotease was found in complex with leukocyte elastase, as shown by gel filtration. The findings suggest a local protective function of antileukoprotease in maxillary sinus.

Ultrasonography of the paranasal sinuses. A new computerized equipment using LCD-display and capture mode.

Ultrasonography of the paranasal sinuses is a well established method. However, no technical development in this field has taken place during the last five years. In order to improve the method a new computerized equipment with a graphic liquid crystal display (LCD) and capture mode has been designed.

The pulsed ultrasound method adapted for examination of paranasal sinuses.

Three different ultrasonic display systems for examination of paranasal sinuses (oscilloscope; light emitting diodes; gas discharge display) have been evaluated in model experiments, on healthy subjects and in clinical materials. With the three different ultrasonic display systems air could be separated from other types of sinusal contents in model experiments. The detectable amount of saline solution in normal sinuses was 1-5 ml with all display units. The different display units showed the same screening capacity as radiography. The oscilloscope display system was significantly more efficient than the other display systems in separating different pathological conditions. Also regarding radiography the oscilloscope display was significantly more efficient in detecting secretion, but no difference was found in the capacity of predicting intrasinusal cysts. Thus, the oscilloscope display seems to be the most useful for both clinical and scientific purposes.

A new administration form of the nasal decongestant oxymetazoline: a study on the change of ostial patency in healthy individuals.

A new administration form of the nasal decongestant oxymetazoline and the effect on patency of the maxillary ostium was investigated in five healthy volunteers. Registration and comparison of the equivalent diameter after administration of placebo spray and oxymetazoline spray, placebo solution and oxymetazoline solution were performed. It is our impression that administration of solution with the new spring-bellows container compared to spray oxymetazoline, is a more effective way of increasing the equivalent diameter of the maxillary ostium.