Patient-reported outcome (PRO) results from the AGITG DOCTOR trial: a randomised phase 2 trial of tailored neoadjuvant therapy for resectable oesophageal adenocarcinoma.

BACKGROUND: AGITG DOCTOR was a randomised phase 2 trial of pre-operative cisplatin, 5 fluorouracil (CF) followed by docetaxel (D) with or without radiotherapy (RT) based on poor early response to CF, detected via PET, for resectable oesophageal adenocarcinoma. This study describes PROs over 2 years. METHODS: Participants (N = 116) completed the EORTC QLQ-C30 and oesophageal module (QLQ-OES18) before chemotherapy (baseline), before surgery, six and 12 weeks post-surgery and three-monthly until 2 years. We plotted PROs over time and calculated the percentage of participants per treatment group whose post-surgery score was within 10 points (threshold for clinically relevant change) of their baseline score, for each PRO scale. We examined the relationship between Grade 3+ adverse events (AEs) and PROs. This analysis included four groups: CF responders, non-responders randomised to DCF, non-responders randomised to DCF + RT, and "others" who were not randomised. RESULTS: Global QOL was clinically similar between groups from 6 weeks post-surgery. All groups had poorer functional and higher symptom scores during active treatment and shortly after surgery, particularly the DCF and DCF + RT groups. DCF + RT reported a clinically significant difference (-13points) in mean overall health/QOL between baseline and pre-surgery. Similar proportions of patients across groups scored +/- 10 points of baseline scores within 2 years for most PRO domains. Instance of grade 3+ AEs were not related to PROs at baseline or 2 years. CONCLUSIONS: By 2 years, similar proportions of patients scored within 10 points of baseline for most PRO domains, with the exception of pain and insomnia for the DCF + RT group. Non-responders randomised to DCF or DCF + RT experienced additional short-term burden compared to CF responders, reflecting the longer duration of neoadjuvant treatment and additional toxicity. This should be weighed against clinical benefits reported in AGITG DOCTOR. This data will inform communication of the trajectory of treatment options for early CF non-responders. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry (ANZCTR), ACTRN12609000665235 . Registered 31 July 2009.

Short bowel syndrome and the impact on patients and their families: a qualitative study.

BACKGROUND: Short bowel syndrome (SBS) is a malabsorptive condition that can result in intestinal failure (SBS-IF). Many patients with SBS-IF require home parenteral nutrition (PN) for survival. However, PN has profound effects on patients and their family members. The present study aimed to understand the lived experience of SBS-IF for patients and their families. METHODS: In-depth semi-structured qualitative interviews were conducted with 15 patients with SBS-IF and five adult family members living with someone with SBS-IF. A patient-centric approach was taken, with a patient steering group providing input and guidance to develop the interview guide. Key concepts were identified using thematic analysis of interview transcripts. RESULTS: Patients' lives were dominated by having SBS-IF. They described physical impacts that included patient-reported signs and symptoms and physical restrictions comprising of restrictions on daily life, actives of daily living and physical functioning. In addition, they encountered emotional impacts with a plethora of negative feelings and social impacts, such as difficulties socialising and maintaining relationships. Patients coped by adapting their life around SBS-IF, having support and adopting an attitude of gratitude and acceptance. Family members were also affected and, along with patients, appreciated the respite of a night off from infusions. CONCLUSIONS: Patients and families face many difficulties with SBS-IF. Healthcare professionals can support patients by facilitating them explore what others have found beneficial; adapting their life around PN, viewing PN with acceptance and trying to cultivate gratitude. Further research into the support required for families may be beneficial.

A survey of children's acute, recurrent, and chronic pain: validation of the pain experience interview.

The ultimate objective of our epidemiological research is to complete a longitudinal population-based study to document the prevalence and impact of acute, recurrent, and chronic pain in children and adolescents. As the first phase of our epidemiological research, we developed a comprehensive screening instrument for identifying children with acute, recurrent, and chronic pain, the Pain Experience Interview. We designed this interview to provide information about the lifetime and point prevalence of various pains, and also to provide information about the intensity, affect, duration, and frequency of children's pain. The primary objective of this study was to validate the Pain Experience Interview using the discriminant validation procedure of group differences. The secondary objectives of our study were to obtain descriptive data on children's acute, recurrent, and chronic pain experiences and to conduct exploratory analyses on age- and gender-related differences in children's pain experiences. We interviewed 187 children from five different health groups (arthritis, cancer, enuresis, recurrent headaches, and healthy) to provide distinct subsets of children with respect to their acute, recurrent, and chronic pain experience, and from four different age groups (5-7, 8-10, 11-13, and 14-16 years) to provide distinct subgroups with respect to children's developmental level. To test the interview we determined a priori several study predictions about children's pain experiences. These included four predictions about the common response patterns that we would expect to observe for all children based on our understanding of acute pain caused by trauma/disease, and six predictions about the distinct response patterns that we would expect to observe based on the known differences among children in their experiences of headache, acute treatment-related pain, recurrent pain, and chronic pain. All study predictions were confirmed, demonstrating that the Pain Experience Interview is a valid screening instrument for differentiating children with different types of pain problems. The interview can provide estimates for the lifetime and point prevalence of various pains in children, and data on the intensity, affect, duration, and frequency of their pain experiences.

Treatment decisions in T3N0M0 glottic carcinoma.

PURPOSE: To analyze the results of T3N0M0 glottic carcinoma treated with radiotherapy, surgery, or both. METHODS AND MATERIALS: The records were retrospectively reviewed of 97 patients with this tumor subsite and stage seen for treatment at the Queensland Radium Institute over a 29-year period. The results for radiotherapy with surgical salvage of failure (XRT/SS) were compared to those with surgery with or without radiotherapy (SURG/SURG+XRT). For those treated initially with radiotherapy alone, the results for different ranges of biologically equivalent doses were compared. These results were compared to those of other published studies. RESULTS: The 5-year disease-specific survival rats for the XRT/SS and SURG/SURG+XRT groups were 50% and 58%, respectively; this difference is not significant. For the XRT/SS group, there was a trend towards improved 5-year recurrence-free survival (73%) and 5-year disease-specific survival (86%) in those treated to a dose equivalent to 60-64 Gy in 2 Gy fractions, when compared with higher or lower dose equivalents. CONCLUSION: A group of patients with T3N0M0 glottic carcinoma is specified for which the option of radiotherapy offers a similar chance of survival to those treated surgically. More than 50% of the XRT/SS survivors will retain their larynx.

Analgesic efficacy and safety of single-dose oral and intramuscular ketorolac tromethamine for postoperative pain.

The efficacy and safety of the analgesic drug ketorolac tromethamine in the treatment of moderate to very severe postoperative pain was assessed in five dose-ranging studies with single-dose, double-blind, randomized, parallel-group designs. The drug was administered orally (2.5-200 mg, 352 patients in three trials) and intramuscularly (5-90 mg, 395 patients in two trials), and compared with placebo and reference drugs. Patients subjectively evaluated pain intensity and relief using verbal categoric and visual analog scales; efficacy values included pain intensity difference (PID), summed PID, and total pain relief. Oral ketorolac 10, 12.5, 100, and 200 mg were each statistically significantly superior to placebo in all efficacy measurements, and 10 mg was equivalent to intramuscular morphine 10 mg. Intramuscular ketorolac 90 mg was superior to and 10 and 30 mg were similar to intramuscular morphine 12 mg, and all of these ketorolac doses were superior to intramuscular morphine 6 mg. Intramuscular ketorolac 10 and 30 mg were superior to intramuscular meperidine 50 and 100 mg. Ketorolac was well tolerated, with rates of adverse events generally lower than those of the opiate comparators. Ketorolac doses of 2.5 and 5 mg were less effective than higher doses; 10 mg or more resulted in faster onset of action and greater peak efficacy; 90 mg or more gave more prolonged analgesic effects.

Changes in residents' self-assessed competences during a two-year family practice program.

PURPOSE: To compare changes in self-assessed clinical confidence over a two-year residency between two groups of family practice residents, one starting in a family practice center and the other starting in a hospital. METHOD: All 44 entering residents at the University of Western Ontario in either 1984 or 1985 were eligible. Forty-two participated at baseline, and 24 (57%) provided completed responses after two years. Confidence regarding 177 topics in 19 general topic areas was assessed using self-completed questionnaires administered at baseline and after six, 12, and 24 months. The residents rotated every six months between sites, with approximately half starting in each site. Nonrandom assignment to starting site included consideration of the residents' stated preferences; hence self-selection bias was possible. Mean differences were evaluated using t-tests, and trends over time were assessed using repeated-measures analysis of variance. RESULTS: There was no difference between the groups' grand means at any time. In the 19 areas, five statistically significant differences were seen, four at six months and one at 12 months; four involved greater confidence by the center-start group. No difference was seen after two years, and both groups displayed substantial increases in confidence over two years. CONCLUSIONS: The few significant differences in confidence between the two groups suggest that their training might have been deficient if it had omitted one of the settings. However, because these differences had disappeared after the groups had each experienced 12 months in each setting, the initial site of training appears not to affect learning.

Thirty-four patients with carcinoma of the cervical esophagus treated with chemoradiation therapy.

OBJECTIVE: To review the experience of 2 institutions in the management of localized carcinoma of the cervical esophagus with chemoradiation therapy. DESIGN: A series of 34 patients received chemoradiation therapy for a 5-year period. All patients were treated with curative intent. Three different regimens were used, all involving concomitant chemotherapy and high-dose radiation therapy. Data relating to toxic effects, local control of disease, and disease-free and overall survival were prospectively collected. SETTING: Two combined clinics at separate major hospitals where multidisciplinary care is the standard practice for this disease. PATIENTS: Patients with biopsy-proved carcinoma of the cervical esophagus. INTERVENTIONS: Patients received 3 different chemotherapy regimens. Two of the regimens used a combination of cisplatin and fluorouracil. The high-dose cisplatin regimen was a large dose of cisplatin (80 mg/m2) given on days 1 and 22 followed by a 96-hour infusion of fluorouracil (800 mg/m2) from days 2 to 5 and from days 23 to 26. The low-dose cisplatin regimen was cisplatin, 20 mg/m2, from days 1 to 5 and from days 22 to 26 and the same 96-hour infusion of fluorouracil. The third regimen used fluorouracil alone. The mean radiation dose administered was 61.2 Gy in 29.6 fractions during 41.8 days using 4- or 6-mV photons and a shrinking field technique. RESULTS: The results of treatment have shown a high rate of local control, although some patients developed metastases. The local complete response rate following treatment was 91%, and the rate of local control of disease was 88%. The projected actuarial 5-year survival rate was 55%. Death from other causes was common. The acute toxic effects of the treatment were acceptable, with only 5 patients requiring nasogastric feeding or gavage. Two patients died of complications related to strictures. CONCLUSION: Concomitant chemoradiation therapy, should be the treatment of choice for carcinoma of the cervical esophagus.

Improving problem oriented medical records through self-audit.

In a teaching family medical center a strategy was sought to improve the quality of medical record keeping. A study was undertaken to determine the usefulness of a standardized form for self-audit. Validity and reliability of the form were established and it was shown that there was a significant improvement in the study group three weeks after the exposure period, as compared to a control group. Improvements occurred particularly in the recording of drugs prescribed and in the linkage of progress notes to the problem list. Despite this improvement, linkage to the problem list was seen to occur in only half of the studied charts. With modification the self-audit form appears to be a useful stimulus to good record keeping.

An information system for family practice. Part 4: encounter data and their uses.

This paper describes the ways in which encounter data from the family practice teaching units of the Department of Family Medicine, University of Western Ontario, have been used for teaching, service, and research. The fact that family physicians may deal with several problems at one visit is emphasized, as is the need to report morbidity in terms of the population at risk, so that comparisons can be made with other work. The value of encounter data in studies of patient utilization and resident experience is noted. The validity of the data has been examined and the extent of underrecording assessed. The system has helped to encourage the spirit of inquiry in its users.

An information system for family practice. Part 3: gathering encounter data.

This paper describes the development of a system for recording encounter data in family practice. The system has been developed by the Department of Family Medicine, University of Western Ontario, and came about as a natural addition to a previously reported method for describing and defining a practice population. The system gathers information on each encounter and includes data concerning the patient, the provider, the location, and certain other details concerning the encounter, including all problems dealt with on that occasion. The storage and analysis of these data are carried out by a computer. The uses of such data are many, and some of them will be dealt with in the fourth and last paper in this series.

An information system for family practice. Part 1: Defining the practice population.

Information systems for family practice are vital in its development as an academic discipline, in the teaching and learning process which ultimately improves the quality of care, and in the planning processes which must be used to rationalize the distribution of scarce resources in the health-care field. The provision of sufficient data for these purposes demands a flexible system, generally one based on the computer as a data storing and analyzing tool. Such a system has been developed in the teaching practices of the Department of Family Medicine, University of Western Ontario; the methods employed and the uses for that system are to be described in a series of four papers. This first paper describes the methods developed for gathering demographic information on the practice population.

An information system for family practice. Part 2: The value of defining a practice population.

The gathering of information on the practice population is essential for practice monitoring, preventive medicine, and research. The minimum necessary information is the age and sex of individuals cared for in the practice. This allows the expression of age-sex specific morbidity rates for the at-risk population. In the Department of Family Medicine, University of Western Ontario, practice census information has been used to determine the suitable size for a teaching practice, the representativeness of our practices in terms of age, sex, residence location, and morbidity, and for the production of at-risk registers based on age and sex.

The physician's actions and the outcome of illness in family practice.

The outcome of new episodes of common nonrespiratory tract symptoms was studied in 193 patients attending family physicians. After controlling for demographic, psychological, and social variables, the only element of the process of care that was related to resolution of the patient's symptom at one month was physician-patient agreement about the nature of the problem. Patients with unresolved symptoms were followed for an additional two months. Late resolution was associated with the physician's recording of attention to psychosocial problems. These results have implications both for the provision and audit of primary care.

Multiple choice questions for continuing education in family medicine.

Multiple choice questions used in continuing medical education may require characteristics different from those used in tests and examinations. The questions of three continuing education exercise were assessed by 48 board certified family physicians. Each physician answered one third of the questions and then judged them on usefulness in patient management, as discriminators of quality of medical care, and on educational value. The relevance of each question was determined by a composite index based on these factors. The content of each question was independently analyzed by three physicians. Relevant questions tended to be those concerned with surgery, symptoms, and management, and those requiring more than simple factual recall. Questions on office management or concerning specific diagnoses were considered less relevant. Neither the manner of asking the question nor the severity of the illness appeared to influence relevance. This information should benefit those developing continuing education programs for family physicians, especially those designed for self-administered individual learning.

Symptomatology of urinary tract infection.

Patients with urinary symptoms are commonly seen in family practice. This study reports the rate of urinary symptoms in three teaching practices over one year. The response of the physician to such patients is described. The predictive value of urinary symptoms in the diagnosis of urinary tract infection is examined.

A full factorial analysis of nine factors influencing in vitro antagonistic screens for potential biocontrol agents.

The effect of nine factors on the outcome of classic in vitro screens testing the antagonistic action of endophytic bacterial isolates from grape vines against virulent Agrobacterium vitis has been examined. These factors were (i) the strain of A. vitis, (ii) the strain of endophyte, (iii) the growth medium of the pathogen, (iv) the growth medium of the endophyte, (v) the temperature of growth of the pathogen, (vi) the temperature of growth of the endophyte, (vii) the pH of growth of the pathogen, (viii) the pH of growth of the endophyte, and (ix) the medium of the assay plate. Analyses of variance of the full factorial design incorporating main effects and two- and three-way interactions accounted for 66% of the variance. All nine factors had a significant effect on the diameter of inhibition zones (p < 0.001). An examination of the three-way interactions revealed that generalizations were difficult to draw; each target agrobacterium had a specific response to a given antagonistic isolate. It was possible to determine that the growth history of bacterial strains, before they were administered to an assay plate to test for antagonism (especially the composition of the growth medium and the temperature of growth), had a profound effect on the outcome of the test. Generally the more chemically defined media produced less inhibition whereas the lower growth temperature of 15 degrees C produced more inhibition. These findings could be relevant to in situ inhibitory activity. The method used to conduct the inhibitory screen (order of strain application and the medium of the assay plate) had a profound influence on the results. These influences add to the caution necessary in the use of in vitro antagonistic screens for finding successful biocontrol agents.

Strontium and samarium therapy for bone metastases from prostate carcinoma.

A review was performed of all patients who received strontium-89 chloride or samarium-153 ethylenediamine-tetramethylenephosphonate for prostate cancer metastatic to bone at the Royal Brisbane Hospital between 1992 and 1997. There were 57 patients, 38 treated with strontium-89 and 19 with samarium-153. Forty patients had radionuclide therapy alone, and 28/40 (or 70%) responded in terms of experiencing a beneficial effect on pain. In the other 17 patients, the effect of the radionuclide on pain could not be assessed because they received external beam radiotherapy concomitant with a therapeutic radionuclide. There was no difference in response rates between the samarium and strontium groups as measured by the effect on pain or in the time to progression. The median time to progression for all patients was 2-3 months. The present study confirms that following administration of a therapeutic radionuclide, a high proportion of patients experienced improvement of pain, but the time to progression is not long, so that the overall degree of benefit is modest.

Does memory of childhood determine parenting? Correlation in family practice.

The authors studied 46 eldest or only children under school age and their parents to determine the relationship between parents' recollections of their own childhoods and the way they use their family physician for care of their children. The parents completed a questionnaire that measured the caring and overprotection dimensions of the parenting they themselves remember. Positive correlations were found between perceptions of maternal overprotection and the frequency of children's visits. Negative correlations were found between perceptions of parental affection and children's visits and non-routine diagnoses. Neuroticism was found to be a confounding variable that slightly weakened the relationship between maternal caring and children's visits.