Development and evaluation of a decision aid for patients with stage IV non‐small cell lung cancer

Although guidelines for treating stage IV non‐small cell lung cancer suggest that the patient’s values should be considered in decision‐making, there are no practical tools available to assist them with their decision‐making.

Objective

To develop and evaluate a decision aid that incorporates patient values.

Design and sample

(1) Before/after evaluation with patients referred to a regional cancer centre. (2) Mailed survey of thoracic surgeons and respirologists in Ontario.

Intervention

An audio‐tape guided individuals to review a booklet describing stage IV non‐small cell lung cancer, its impact and possible coping strategies, treatment options, benefits and risks, and examples of the decision‐making of others. Patients then used a worksheet to consider and communicate personal issues involved in the choice, including: personal values using a ‘weigh‐scale’; questions; preferred role in decision‐making; and predisposition.

Measures

(1) Patient questionnaires eliciting knowledge, the decision, decisional conflict and acceptability of the decision aid. (2) Physician questionnaires eliciting attitudes toward the decision aid.

Results

(1) Twenty of 30 patients used the aid in decision‐making. Users thought that the aid was acceptable and significantly improved their knowledge about options and outcomes (P < 0.001), and reduced their decisional conflict (P < 0.001). (2) The majority of the 29 physicians who reviewed the decision aid found it acceptable, were comfortable providing it to patients and said that they were likely to use it.

Conclusion

The decision aid is a useful and acceptable adjunct to personal counselling.

     

A comparison of methods for limited-sampling strategy design using data from a phase I trial of the anthrapyrazole DuP-941

The pharmacokinetics of a drug in individual patients can be estimated using plasma samples collected at a limited number of time points. However, different methods for a limited-sampling strategy (LSS) design exist and the optimal method has not yet been defined. Plasma concentration data were available from 27 of 74 courses in a phase I study (dose range, 5–55 mg m^-2) of the novel anthrapyrazole DuP-941. Three approaches to LSS development were compared. Firstly, forward stepwise regression (FSR) was used to derive equations to predict the DuP-941 area under the concentration-time curve (AUC) based on plasma concentrations measured at specified times. LSSs were developed using 14 randomly chosen data sets and were validated using the remaining 13 data sets. Secondly, “all subsets” regression (ASR) was used to develop LSSs. A jack-knife technique was also used to allow model development utilising 26 data sets and validation on the 27th data set. Thirdly, an LSS was developed using optimal sampling theory (OST), and the LSS was used in conjuction with a Bayesian algorithm. Selected sampling times for four-point LSSs were 10, 65, 185 and 485 min (FSR) and 10, 45, 200 and 480 min (OST). Ten candidate LSSs were developed using the ASR approach. ASR- and OST/Bayesian-derived four-point LSSs gave more precise (P<0.05) estimates of AUC [mean absolute percentage of difference (MAD%)  ± SD: ASR, 6.4±3.7%; OST/Bayesian, 6.8±4.6%] than did FSR (MAD%=15.1±9.9%). The OST/Bayesian approach is recommended because it allows estimation of all model parameters and is more flexible with regard to sample collection time and design variables. Received: 23 January 1995/Accepted: 22 May 1995     

Oral and written language abilities of XXY boys: implications for anticipatory guidance

Previous studies of XXY boys suggest that they are at risk for certain communication disorders involving oral and written language. In this study, the language, reading, and spelling skills of a group of 14 XXY boys identified during neonatal cytogenetic screening were compared with those of a group of 15 control children. The two groups were matched for age, grade, race, parity, birth weight, parental age and education, and socioeconomic status. The mean age of the XXY group was 9 years 7 months and that of the control group was 9 years 3 months. The mean academic grade level for both groups was at the transition between third and fourth grade. There was selective reduction in verbal IQ scores for the XXY group and no significant differences apparent between groups for performance IQ scores. The decrease in verbal IQ was associated with a reduced full-scale IQ and also with significant problems in expressive language, auditory processing abilities, and auditory memory. Word-finding difficulties and problems in the production of syntax were major components of the specific expressive language deficit. Except for difficulties in the understanding of complex sentence structures, the receptive language skills of XXY boys did not differ significantly from those of the control group. These reductions in speech and language abilities correlated with decreased achievement by the XXY group on a variety of reading and spelling tasks. These results suggest that difficulty learning how to read and spell may be due to a preexistent language disability. Early attention to such expressive language problems may be essential to ameliorate secondary maladaptive behaviors due to chronic language-related learning disabilities.     

Levels of oxytocin-like activity and progesterone in follicular fluid from in vitro fertilization cycles

Oxytocinlike immunoreactivity, estradiol, and progesterone were measured in follicular fluid collected during oocyte collection in an in vitro fertilization program in which clomiphene citrate was used to stimulate follicular development. Follicles which yielded morphologically normal embryos after fertilization of the oocyte had oxytocin concentrations ranging from <10 to 600 ng/liter. Oxytocin concentrations did not differ between follicles from 12 pregnancy cycles (median, 169; N=21 and follicles from 12 nonpregnancy cycles (median, 110; N= 18). Oxytocin concentrations were correlated negatively with progesterone concentrations (Spearman's rank correlation coefficient r=–0.50; P=0.001). In cycles with some follicles having progesterone concentrations <10 and some >10 mol/liter, oxytocin concentrations were higher in the less progestogenic follicles in 15 of 16 cases.     

Radiation therapy in primary carcinoma of the vagina

A retrospective analysis of 32 patients with carcinoma of the vagina treated with curative radiotherapy between 1965 and 1981 is presented. Squamous cell carcinoma was the most common histologic type, found in 78% of the patients. Patients were staged according to the FIGO system. Stage I and II disease was found in 8 and 18 patients, respectively. Six patients had either Stage III or IV disease. The absolute survival rate was 100% for Stage I and 72% for Stage II patients. The pattern of failure was analyzed. All patients who failed had done so within 14 months of completion of treatment. Treatment failure in the pelvis occurred only in 16% of the patients with early disease (Stages I and II) while 81% of the patients with late stage had failed in the pelvis.     

Clinical and Biochemical Evaluation of Patients with Hirsutism

Summary: Patients with moderate to severe hirsutism presenting over an 18-month period to an endocrine clinic were assessed by clinical evaluation and hormone measurements. Hair growth rate was estimated by a photographic technique and the severity of hirsutism graded using an objective scale. Of 43 patients, 9 had polycystic ovaries and the remainder were considered to have idiopathic hirsutism. The most severely affected group had significantly increased hair growth rates compared with less clinically affected subjects, and 47% of this group showed objective features of virilization. However, apart from a significantly higher 24-hr urine 17-ketosteroid excretion all other hormonal patterns were not significantly different between severely and mildly affected patients. Serum levels of testosterone (T), sex hormone-binding globulin (SHBG), free T (calculated from T and SHBG values), and androstenedione (A) were abnormal in 44%, 51%, 60% and 60% of patients respectively, whereas plasma levels of the specific adrenal androgen DHAS were increased in 40% of patients. There was an overlap between patients with elevated hormone levels, although isolated elevation of T, A or DHAS were seen in 9%, 19% and 3% of patients respectively. In 19% of patients all serum androgen measurements were normal. Gonadotrophin levels were significantly lower in the more severely affected group. Thus androgen levels in patients with idiopathic hirsutism or polycystic ovaries, show considerable overlap with measurements in normal subjects, and elevated plasma androgens may be of adrenal (DHAS) or combined adrenal/ovarian (T, A) origin.     

Right atrial thrombus and superior vena cava syndrome in a child

Complications of central venous catheterization are well described. They include right atrial thrombosis and superior vena cava syndrome resulting from impaired venous drainage. Such complications are normally observed while the catheter is in place. They are often transient, resolving upon catheter removal. A patient with recurrent signs of superior vena caval obstruction 1 1/2 years after removal of the central venous catheter is described. The obstruction was determined to be intermittent and functionally related to elevated cardiac output due, in turn, to anemia. This patient was also found to have a calcific right atrial thrombus which was not obstructive.     

Gamma-carboxyglutamate in normal and pathological human middle ear bones

Summary The presence of the amino acid -carboxyglutamate (GLA) was established in human middle ear bones. Proteins containing GLA have been described as being associated with normal as well as pathological calcifications. The GLA content of human incus, malleus, and stapes with 1–2 nmol/mg bone is in the range previously reported for a variety of bone. A limited number of samples with middle ear pathology, including otosclerosis, did not show altered GLA levels.