Pulmonary Function Testing in Patients with Tracheostomies: Feasibility and Technical Considerations

Purpose

Pulmonary function testing (PFT) in patients with tracheostomies has been perceived as difficult to perform and clinically unreliable. We studied the feasibility, quality, repeatability and clinical significance of PFT.

Methods

Patients with tracheostomies that underwent PFT from January 1, 2010 to February 29, 2012 were identified. Clinical history and PFT data were reviewed retrospectively.

Results

Fifty patients (88% men) were identified. Forty-seven (94%) patients were able to perform PFT. Acceptable repeatability was obtained for FVC in 39 (83%) and for FEV1 in 41 (87%). Patients with tracheostomies showed difficulty in meeting ATS end-of-test criteria; only 9 (19%) met plateau criteria and 25 (53%) had exhalation times of greater than 6 s. Obstructive pattern was observed in 30 (64%) and restrictive pattern in 9 (19%). DLCO measurements were attempted in 43 patients and satisfactorily obtained in 34 (79%).

Conclusions

PFT can be performed with reliability in patients with tracheostomies, and they are useful for detecting and classifying types of lung dysfunction.

     

Results of irradiation in squamous cell carcinoma of the soft palate and uvula

Out of a series of 235 patients presenting with tumours of the soft palate at the Institut Curie, between 1958 and 1980, 146 cases were analysed to evaluate the results of radical radiation therapy. Seventy patients (48%) had advanced T3-T4 disease and 40 patients (27%) had clinically involved metastatic nodes. All patients had a minimum follow-up of 5 years. In 103 cases, megavoltage X-ray therapy was employed. For 43 patients, presenting with small or moderately advanced tumours, a combination of megavoltage and intra-oral orthovoltage X-rays was used. The local control rate at 3 years was 92% for T1, 70% for T2, 58% for T3 and 49% for T4 lesions. Nodal failure was seen in 19 patients. In 9 of these, it was not associated with failure at the primary site, 7 out of 9 occurring marginally or outside the treatment portals. Complications were observed in 16 patients, 7 requiring surgery. The crude 3 and 5 year survival rate was 52 and 40%, respectively, and the disease-free survival 59 and 53%.     

Assessment of the risk/benefit ratio of phase II cancer clinical trials by Institutional Review Board (IRB) members.

BACKGROUND: This study examined the assessment of risk/benefit ratios for phase II cancer clinical trials by Institutional Review Board (IRB) members. PATIENTS AND METHODS: Semi-structured interviews were conducted with 53 IRB members from six research hospitals and specialized cancer centers in The Netherlands. RESULTS: While the toxicity and side-effects of treatment were most often identified as risks associated with participating in a phase II trial, approximately two-thirds of IRB members also cited psychosocial and/or quality-of-life risks. Conversely, 68% of the respondents identified psychosocial benefits of trial participation, while 25% cited treatment effectiveness as a possible benefit. Between one-quarter and two-thirds of respondents indicated that trial protocols provide insufficient information regarding the likelihood, magnitude and duration of both risks and benefits. Between 15% and 34% of IRB members reported feeling less than fully competent at evaluating various aspects of phase II protocols (e.g. originality and feasibility of the study, adequacy of the methods and analysis procedures, etc.). This was particularly the case for non-physician IRB members. Few IRB members reported weighing risks and benefits in a systematic manner, but rather relied on global impressions or preferred to leave such matters to the IRB as a whole or to their patients. CONCLUSIONS: A substantial minority of IRB members believes that trial protocols provide too little information relevant to evaluating various cost/benefit and scientific issues, and feels less than fully competent in carrying out such evaluations. IRB members are more likely to identify psychosocial benefits than physical health benefits that may accrue to patients participating in phase II trials.     

Late effects of radiotherapy on hearing

Summary The effect of radiotherapy on hearing was studied in 30 patients who were treated by surgery and radiotherapy for a parotid neoplasm. Functions of the irradiated ear were compared with those of the non-irradiated ear in the same patient. Tympanometry showed a small but significant reduction of static compliance on the irradiated side when compared with the non-irradiated side. Audiometry showed a significant increase in hearing loss in the 1–2, 4–8 and 10–20 kHz ranges that increased with frequency. This hearing loss was mainly sensorineural in contrast to hearing loss at 250–500 Hz, where it was more of a conductive type. There appeared to be a significant dose-effect relation in sound perception at 4–8 kHz. Doses to the cochlea of less than 55 Gy seldom caused a hearing loss, in contrast to doses exceeding 65 Gy. Overall, radiotherapy was found to cause significant, mainly sensorineural hearing losses, which were partly dose-dependent.     

Malaria in the Nuba Mountains of Sudan: baseline genotypic resistance and efficacy of the artesunate plus sulfadoxine-pyrimethamine and artesunate plus amodiaquine combinations

Both northern and southern Sudan are deploying artemisinin-based combinations against uncomplicated Plasmodium falciparum malaria (artesunate+sulfadoxine-pyrimethamine [AS+SP] in the north, artesunate+amodiaquine [AS+AQ] in the south). In 2003, we tested the efficacy of 3 day AS+SP and AS+AQ regimens in vivo in the isolated, seasonally endemic Nuba Mountains region (the first study of AS combinations in southern Sudan). We also analysed pre-treatment blood samples for mutations at the P. falciparum chloroquine transporter (Pfcrt) gene (associated with CQ resistance), and at the dihydrofolate reductase (Dhfr) gene (associated with pyrimethamine resistance). Among 161 randomized children under 5 years, PCR-corrected cure rates after 28 days were 91.2% (52/57, 95% CI 80.7-97.1) for AS+SP and 92.7% (51/55, 95% CI 82.4-98.0) for AS+AQ, with equally rapid parasite and fever clearance. The Pfcrt K76T mutation occurred in 90.0% (144/160) of infections, suggesting CQ would work poorly in this region. Overall, 82.5% (132/160) carried mutations at Dhfr (N51I, C59R or S108N, but not I164L), but triple mutants (more predictive of in vivo SP failure) were rare (3.1%). CQ use should be rapidly discontinued in this region. SP resistance may propagate rapidly, and AS+AQ is likely to be a better long-term option, provided AQ use is limited to the combination.     

The development of a prognostic score for patients with parotid carcinoma

BACKGROUND: Understanding of prognostic factors in parotid carcinoma has grown considerably. In particular, clinical tumor staging and histologic classification have been found to be prognostically important. Univariate and multivariate analyses have indicated that other variables, such as age, pain, skin invasion, and facial nerve impairment, are important predictors as well. In an actual patient, some of these factors are present and others are absent. However, a clinical tool incorporating this information, resulting in an individualized prognosis based on the combined effects of present adverse prognostic factors, has never been devised. METHODS: Of a cohort of 168 patients, 151 were evaluated to assess the prognostic value of clinical and pathologic factors in a multivariate proportional hazards analysis. Follow-up ranged from 1 to 278 months (median, 37 months). The end point was tumor recurrence. Identified prognostic factors and their hazard ratios were combined into prognostic scores. RESULTS: Clinical T classification, clinical N classification, pain, age at diagnosis, skin invasion, facial nerve dysfunction, perineural growth, and positive surgical margins acted as major factors predicting recurrence. A prognostic score (PS), generated by the weighted combination of the factors present in the individual patient, placed the patient in one of four subgroups with markedly different prognoses. In the subgroups based on the preoperative prognostic score, 5-year recurrence free percentages ranged from 92% (in the group PS1=1) to 23% (in PS1=4). In the subgroups based on the postoperative prognostic score, which took into account the histologic details of the resected specimen, 5-year recurrence free percentages ranged from 95% (in the group PS2=1) to 42% (in PS2=4). CONCLUSIONS: The proposed subgrouping, which is based on the combined effects of key prognostic preoperative and postoperative factors, provides a practical prognostic grouping system for the clinician treating patients with parotid carcinoma.