Satisfactory Response Rate Research Articles

Meropenem Monotherapy for the Treatment of Hospital- Acquired Pneumonia: Results of a Multicenter Trial

The efficacy and tolerability of meropenem as empirical treatment in patients with hospital-acquired pneumonia was determined in a prospective, open-label, non-randomized trial. Patients from 28 centers in the USA received meropenem 1 g every 8 h intravenously. Of 255 patients enrolled, 111 were evaluable for efficacy, including 60 patients with ventilator-associated pneumonia. At end of treatment 74% of patients had a satisfactory clinical response and 64% had this response at follow-up, which could last up to 28 days after treatment. In patients with ventilator- associated pneumonia, a satisfactory clinical response was observed in 68% at the end of treatment and 63% at follow-up. The overall satisfactory response rate for individual pretreatment pathogens ranged from 65% to 100%. This study demonstrates that meropenem monotherapy is effective and well tolerated for patients with hospital-acquired pneumonia, including a subgroup of patients with ventilator-associated pneumonia.

Use of CA-125 in clinical trial evaluation of new therapeutic drugs for ovarian cancer.

##### Ovarian Cancer Incidence and Mortality Rates. Ovarian cancer is the fourth leading cause of death from cancer in women and accounts for the highest mortality rate of all of the gynecological cancers [(1)][1] . Despite aggressive treatment via radical surgery, radiotherapy, or chemotherapy,

A pilot study of neoadjuvant chemotherapy with mitomycin C, etoposide, cisplatin, and epirubicin for adenocarcinoma of the cervix

To evaluate the efficacy and toxicity of the combination of mitomycin C, etoposide, cisplatin, and epirubicin (MEPA) as neoadjuvant therapy for patients with cervical adenocarcinoma. Fourteen patients with cervical adenocarcinoma received neoadjuvant MEPA therapy followed by radical hysterectomy. The International Federation of Gynecology and Obstetrics stage was: IB1 in 2 patients, IB2 in 5, and IIB in 7. The MEPA regimen consisted of mitomycin C (15 mg/m2) on day 1, etoposide (70 mg/m2) on days 1 to 3, cisplatin (15 mg/m2) on days 1 to 5, and epirubicin (30 mg/m2) on day 1, with this course being repeated every 4 weeks. After two or three courses of chemotherapy, all patients underwent radical hysterectomy. Postoperative radiotherapy was given to 6 patients who showed risk factors at surgery. Of the 14 patients, 7 had complete remission (CR) clinically, 6 had partial remission, and only 1 showed no change. Examination of surgical material revealed no residual disease in 6 patients, and microscopic residual disease (<5 mm) in 2 patients. The patients who had no residual disease or microscopic disease in their hysterectomy specimens showed a significantly longer survival than those with macroscopic residual disease (P = 0.012). The dose-limiting toxicity was myelosuppression. Of the 33 treatment cycles administered, leukopenia of grade 3 or more occurred in 70%,and thrombocytopenia of grade 3 or more occurred in 79%. There were no therapy-related deaths. Although severe myelosuppression was also observed, there was a satisfactory response rate to MEPA therapy, which showed a good pathological CR rate.

A Comparison of the Efficacy of Telithromycin versus Cefuroxime Axetil in the Treatment of Acute Bacterial Maxillary Sinusitis

Telithromycin, a new ketolide, exhibits potent activity against respiratory pathogens, including resistant strains. Five days of telithromycin (800 mg once daily) was compared with 10 days of cefuroxime axetil (250 mg twice daily) in subjects (n = 593) with acute bacterial maxillary sinusitis (ABMS). Bacteriologic sampling was accomplished by sinus puncture or nasal endoscopy. The primary efficacy variable was clinical outcome at the posttherapy/test-of-cure evaluation in clinically evaluable patients. Clinical cure was achieved in 85.2% of telithromycin patients and 82.0% of cefuroxime axetil patients (difference in proportions, 3.2%; 95% confidence interval, -7.1-13.4%). Satisfactory bacteriologic response rates were comparable. Treatment-emergent adverse events for both drugs were mild or moderate. The most frequently reported treatment-emergent adverse events were nausea and diarrhea. Once-daily telithromycin for 5 days was equivalent in efficacy to twice-daily cefuroxime axetil for 10 days in patients with ABMS. Telithromycin is a suitable option for short-course therapy of ABMS.

Non-response bias as a likely cause of the association between young maternal age at the time of delivery and the risk of cancer in the offspring.

Some epidemiological studies have shown an association between young maternal age at the time of delivery and risk of cancer in the offspring. In a recent German case-control study, there was a twofold increase in the leukaemia risk for children whose mothers were aged < 20 years at the time of delivery. As the prevalence of younger mothers among control families was particularly low, data on maternal age distributions for the general population of Germany were obtained in order to examine the representativeness of the control sample. Despite the excellent sampling frame based on data from complete and up-to-date population registries and a satisfactory response rate among controls ( approximately 71%), there seemed to be a material deficit of young mothers in the control sample. The prevalence of young mothers in the control group was 1.4%[95% CI 0.8%, 2.0%] compared with 2.9% in the general population and 3.3%[1.8%, 4.8%] among leukaemia cases. The most likely cause of this deficit was non-participation. Non-participation bias is hard to identify if no information is available on non-responders and if it results from only small subgroups among the total control sample. Maternal age and childhood leukaemia are an example where differential non-participation creates a spurious moderate association for a relatively rare exposure situation. But nowadays, many epidemiological studies target the detection of small to moderate risk increases for rare exposures. Therefore, the choice of a representative control group as well as the achievement of an excellent response rate are of prime importance.

Combination gemcitabine and cisplatin chemotherapy for metastatic or recurrent nasopharyngeal carcinoma: report of a phase II study

BackgroundTo evaluate the efficacy and toxicity of combination gemcitabine plus cisplatin (GC) chemotherapy in metastatic or recurrent nasopharyngeal carcinoma (NPC). Patients and methodsForty-four patients of Chinese ethnicity with metastatic or recurrent NPC received ambulatory GC chemotherapy every 28 days (gemcitabine 1000 mg/m2 days 1, 8 and 15; cisplatin 50 mg/m2 days 1 and 8). There were 40 male and four female patients with a mean age of 47.4 years. More than half (54.5%) of the patients had received either prior platinum-based chemotherapy and/or radiotherapy to target lesions. ResultsThere were nine complete responses and 23 partial responses in the 44 patients, achieving an overallresponse rate of 73% (78% for the 41 assessable patients). The mean duration of response was 5.3 months. Improved subjective symptom-control scores were found in 78% of patients with pre-existing symptoms, while 64% of patients experienced improved general well-being scores. Toxicity was mainly hematological: grade III/IV anemia, granulocytopenia and thrombocytopenia were found in 11, 37 and 16% of cycles, respectively. With a median follow-up of 17.2 months, 62% survived 1 year while 36% were alive and progression free. ConclusionsGemcitabine plus cisplatin chemotherapy offers a satisfactory overall response rate, subjective patient improvement and safety profile for metastatic and recurrent NPC.

Determinants of patient satisfaction with services of the Vienna environmental medicine counseling center

Client satisfaction is a relevant aspect for assessing the efficiency of a Medical Advisory Board. The study presented here aimed at determining the factors that guarantee satisfaction. These findings are essential for the further development of the service of the Advisory Board of the City of Vienna for Environmental Medicine ("UMB"). To this end a brief anonymous questionnaire was sent to 245 clients. This comprised elements evaluating the degree of satisfaction with the consultant service of the Advisory Board, fulfillment rate of expectations, solutions offered for various problems, and whether--if necessary--the "UMB" Advisory Board would be consulted again. A satisfactory response rate of 43% was obtained. The results show a high degree of satisfaction among the clients with the consultations (= 78%) despite unresolved or only partly resolved problems (71%) and questions that remained open for discussion (38%). Approximately 90% of the clients would again consult "UMB" for advice. The reasons for consultation did not show any significant influence on the client satisfaction. However, satisfaction of clients depended on whether or not a solution was found in respect of their problem and on the action taken by "UMB" to solve it. Summarising the findings, the analyses show that apart from on-the-spot assessment and detailed inspection, comprehensive case histories and interviews are an important basis for further clarification of problems caused by environmental factors.

Conducting research in culturally diverse inner-city neighborhoods: some lessons learned.

Social, behavioral, and health research among disenfranchised groups in inner cities poses problems in collecting data. It is a challenge to achieve data of sufficient quantity and quality necessary to be scientifically usable. This article describes the experiences of a research team during two phases of data collection in a mental health intervention study in New York's South Bronx. Challenges in addressing human subject concerns, the formation of a fieldwork team, enrollment and retention of respondents, and administration of instruments are described and solutions are discussed. Emphasis is placed on researchers' approaches to the selection, orientation, and safety of interviewers, interviewer-respondent race and ethnic matching, contacts and rapport with respondents, and the handling of such interpersonal issues as distrust, poor cooperation, and family dynamics. The procedures developed took into consideration the culture and life conditions of the population to ensure a satisfactory response rate and high-quality data.

Pure versus Complicated Vulvar Vestibulitis: A Randomized Trial of Fluconazole Treatment

Objective: To examine the effectiveness of a 6-month treatment consisting of a weekly oral dose of 150 mg fluconazole for women with vestibulitis, and to explore the causes of treatment failure. Methods: Forty women with vestibulitis were randomized to either of two treatment groups. One group received a 6-month low oxalate diet with calcium citrate complement, as a placebo, and the second group the same diet and calcium citrate with the addition of a weekly oral tablet of 150 mg fluconazole. The women were examined 3 months after completing treatment, for response to therapy. Results: The addition of intensive 6-month fluconazole treatment did not lead to an outcome better than that attained by maintaining a low oxalate diet with calcium citrate supplementation. The satisfactory response rate was 15 and 30%, respectively. The presence of ‘complicated vestibulitis’, candidiasis concomitant with vestibulitis, decreases the satisfactory response rate regardless of the type of treatment administered (odds ratio 19.9, 95% CI 1.6, 250). Conclusion: Prolonged oral fluconazole is an ineffective treatment of vestibulitis, whether pure or complicated by concomitant vulvovaginal candidiasis. The coexistence of candidiasis and vestibulitis – complicated vestibulitis – might represent a subset of vestibulitis that is resistant to the currently available medical therapy.

Meropenem versus imipenem/cilastatin as empirical monotherapy for serious bacterial infections in the intensive care unit

To compare the efficacy and tolerability of meropenem and imipenem/cilastatin as empirical monotherapy in intensive care unit (ICU) patients with serious bacterial infections. A multicenter, open-label, randomized, parallel-group trial was conducted in Belgium, evaluating empirical monotherapy with meropenem or imipenem/cilastatin (both 1 g/8 h intravenously) in ICU patients with one or more of the following infections caused by sensitive pathogens: lower respiratory tract infection (LRTI) in ventilated patients, intra-abdominal infection or sepsis. The overall satisfactory clinical response rate at the end of randomized treatment was 77.0% (67/87) with meropenem and 68.1% (62/91) with imipenem/cilastatin (difference 8.9%; 95% confidence interval -4.2% to 21.9%; P = 0.185). The two drugs produced similar satisfactory clinical response rates against LRTIs: 68.3% (41/60) with meropenem versus 68.6% (35/51) with imipenem/cilastatin. Meropenem appeared to be slightly more effective against intra-abdominal infections: 95.5% (21/22) versus 76.7% (23/30), respectively. All five meropenem recipients with sepsis had a satisfactory clinical response, compared to 40.0% (4/10) of those who received imipenem/cilastatin. The overall satisfactory bacteriologic response rate was 67.1% (49/73) with meropenem and 60.3% (44/73) with imipenem/cilastatin (difference 6.9%; 95% confidence interval -8.7% to 22.4%; P = 0.389). The predominant pathogens were Escherichia coli, Enterobacter spp. and Pseudomonas aeruginosa. No incidences of drug-related nausea and vomiting were reported, but one probable drug-related seizure occurred in the imipenem/cilastatin group. Meropenem is at least as efficacious (clinically and bacteriologically) as imipenem/cilastatin for the empirical monotherapy of serious bacterial infections in ICU patients, and it can therefore be considered a useful option in this setting. Moreover, meropenem is well tolerated and offers several potential advantages, including greater in vitro activity against Gram-negative pathogens and the option of bolus administration.

Strategic information systems planning: the IT strategy implementation matrix

The need for improved implementation of information technology (IT) strategy has been emphasised in both empirical and prescriptive research studies. In this study, ten content characteristics of formal information technology strategy are identified from the research literature as potential implementation predictors. These are descriptions of: (i) resources needed for the implementation; (ii) user involvement during the implementation; (iii) analyses of the organization; (iv) anticipated changes in the environment; (v) solutions to potential resistance during the implementation; (vi) information technology to be implemented; (vii) projects' relevance to the business plan; (viii) responsibility for the implementation; (ix) management support for the implementation; and (x) clarity of the documentation. An IT strategy implementation matrix is introduced to illustrate the relationship between the expired time horizon and the IT strategy implementation extent. The matrix can be used by organizations to monitor their IT strategy implementation performance over time. A survey was conducted in Norway whereupon the return of 471 completed questionnaires resulted in a satisfactory response rate of 43%. Formal IT strategy was reported in 40% of these organizations. The two significant predictors in the testing of hypotheses proved to be the description of responsibility for the implementation and the description of user involvement during the implementation.

Pneumonia: The Impact of Risk Factors on the Outcome of Treatment with Meropenem and Ceftazidime

This analysis comprises data pooled from two clinical trials of meropenem (0.5 g 8-hourly) versus ceftazidime (1 g 8-hourly) in hospitalized patients with community-acquired pneumonia. The clinical and bacteriological responses to treatment were assessed in relation to a range of risk factors previously linked to a poor clinical outcome. 393 patients (198 meropenem, 195 ceftazidime) were clinically evaluable while 230 (113 meropenem, 117 ceftazidime) were bacteriologically evaluable. Meropenem was highly effective, independent of associated risk factors, producing overall satisfactory clinical and bacteriological response rates at the end of therapy of 91.4% and 94.7%, respectively, similar to those produced by ceftazidime (90.3% and 92.3%, respectively). Clinical and bacteriological treatment outcome were similar in patients with up to three of the following key risk factors: age >65 years, male gender, serum urea >7 mmol/L, serum albumin <35 g/L and difficult-to-treat pathogens. Meropenem also achieved high clinical (85.7%) and bacteriological (89.3%) success rates in patients requiring ventilation, as did ceftazidime (81.6% and 87.1%, respectively). Both agents were highly effective against both Gram-negative and Gram-positive causative pathogens, including those organisms normally considered difficult to treat and typical of nosocomial pneumonia (e.g. Enterobacteriaceae, Staphylococcus aureus, Pseudomonas aeruginosa). Thus, meropenem and ceftazidime were highly effective in patients hospitalized with community-acquired pneumonia, irrespective of a number of concurrent risk factors (including those regarded as key risk factors). Furthermore, the analysis points to a role for meropenem 0.5 g 8-hourly in the treatment of nosocomial pneumonias that do not require intensive care unit admission and/or mechanical ventilation. Overall, this novel analysis of trial data suggests that incorporation of key risk factor endpoints into the initial design of pneumonia studies may prove to be a useful approach in defining appropriate antibiotic treatment for specific patient groups.

Researching the sexual behaviour of older people: a methodological challenge

Although it is known that older people are diagnosed with sexually transmitted diseases (STDs), including HIV (PHLS, 1998) and attend genitourinary medicine (GUM) clinics (Gott et al. 1998, Gott et al. 1998, Rogstad and Bigneil 1991, Openeye 1991, Kohiyar 1983), little is known about the sexual health of older people who do not present at health care services. This paper discusses methodological issues pertinent to designing such a study and presents the example of a two-phase postal questionnaire survey based upon the electoral register which elicited a satisfactory response rate from an older sample. This indicates that the perceived difficulties of researching sexual health issues with older populations may have been over-estimated.

A comparative study of meropenem and ceftazidime in the treatment of patients hospitalized with community-acquired pneumonia

This multicenter, open-label, randomized clinical trial compared the efficacy and tolerability of intravenous (IV) meropenem 0.5 g every 8 hours (n = 147) and IV ceftazidime 1 g every 8 hours (n = 148) as empiric monotherapy for 295 patients hospitalized with community-acquired pneumonia. Seventy-four meropenem recipients and 81 ceftazidime recipients with pneumonia were assessable both clinically and bacteriologically. In these patients, no statistically significant differences were reported in the satisfactory clinical (95% with meropenem vs 90% with ceftazidime) or bacteriologic (95% with meropenem vs 93% with ceftazidime) response rates with the two agents at the end of treatment. High satisfactory clinical (95% with meropenem vs 92% with ceftazidime) and bacteriologic (97% with meropenem vs 89% with ceftazidime) response rates were maintained at follow-up (2 to 4 weeks later). In 90 patients who were clinically assessable but bacteriologically unassessable (no pretreatment pathogen isolated), both agents produced a satisfactory clinical response rate of 87% at the end of therapy. Streptococcus pneumoniae was the most frequently isolated pretreatment pathogen (28%), but nosocomial-type pathogens such as Escherichia coli (5%), Pseudomonas aeruginosa (11%), and Klebsiella pneumoniae (6%) were also frequently isolated. Both medications were well tolerated, and the types of treatment-related adverse events were similar in the two treatment groups. These findings indicate that meropenem 0.5 g every 8 hours is a useful option for the empiric treatment of patients hospitalized with community-acquired pneumonia.

An Attributional Style Questionnaire for General Use

Explanatory style is a cognitive personality variable with diverse correlates reflecting good versus bad adaptation. It is usually measured with the Attributional Style Questionnaire (ASQ), but existing versions of this instrument can be difficult for research participants to complete without close supervision. We describe a new version of the ASQ and its use in a mail survey of 146 college students. Results support its efficiency, reliability, and validity. A satisfactory response rate of 70%o was attained. Very few items were omitted among the questionnaires returned (1.3%). Subscale reliabilities were satisfactory (alphas &gt; .70), and the new ASQ correlated with reports of depressive symptoms ( rs &gt; .28), suggesting its appropriateness for general use with adults, including survey research.

A subjective health indicator for follow-up. A randomised trial after treatment of displaced intracapsular hip fractures

We report a randomised prospective trial of the early results of three types of treatment for displaced intracapsular hip fractures. We used a questionnaire sent to patients at about six months (Nottingham Health Profile, NHP) in addition to clinical assessments. There was a 67.4% usable response to the questionnaire, similar to that in other studies using the NHP. There were more responders from younger patients, those walking independently before injury and those with higher mental test scores on admission. In the younger group (65 to 79 years) we found a trend for better scores in most NHP indices after the use of a bipolar prosthesis rather than a unipolar prosthesis or internal fixation, particularly for social function, pain and physical mobility. Postal assessment using the NHP gave a satisfactory response rate even in the elderly, and can provide an extra assessment to complement or replace hospital follow-up in some circumstances.

Multi-investigator evaluation of the efficacy and safety of cefprozil, amoxicillin-clavulanate, cefixime and cefaclor in the treatment of acute otitis media

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

A randomized trial of chemotherapy followed by pelvic radiation therapy in stage IIIB carcinoma of the cervix.

Because of the poor results in stage III B carcinoma of the cervix with standard treatment using radiotherapy alone, we designed a randomized trial to determine whether administration of chemotherapy before pelvic irradiation would improve survival. Between May 1984 and August 1986, 107 patients with previously untreated squamous cell carcinoma were randomly assigned, after stratification by age (less than 50 v greater than 50 years), extent of parametrial involvement (unilateral v bilateral), and lymphangiographic findings (negative v positive) to pelvic radiotherapy (RT; arm A) or three cycles of chemotherapy (CT; bleomycin, vincristine, mitomycin, and cisplatin [BOMP]), followed by the same radiotherapy regimen (CT + RT; arm B). The groups were balanced by age, performance status, extent of parametrial involvement, bulkiness of cervical disease, nodal involvement, and presence of hydronephrosis. Minimal follow-up is 34 months. A complete local response was observed in 32.5% of the patients in arm A and in 47% of the patients in arm B (P = .19). Overall 5-year survival rates were 39% for the RT arm and 23% for the CT + RT approach (P = .02). Toxicity was severe in arm B and included fatal pulmonary toxicity in four patients. Locoregional and distant failures were similar in both groups. We conclude that, despite a satisfactory response rate, neoadjuvant BOMP chemotherapy adversely affects survival in stage III B cervical cancer and is associated with unacceptable toxicity.

Possible factors affecting response to postal questionnaires: findings from a study of general practitioner services

Poor response rates affect the validity of results from postal questionnaires. The effect of three controllable factors upon response rates was examined in a recent study of patients' experiences and views of general practitioner services. The factors studied were the institution from which questionnaires were dispatched, the length of the questionnaire and the inclusion of a potentially sensitive question about ethnic origin. Questionnaires sent out by local Family Practitioner Committees were more likely to be returned than those sent out by a London-based independent research unit, but there were no differences in the nature of replies obtained. Neither the length of the questionnaire nor the inclusion of the potentially sensitive question affected response rates. The results of the study indicate that Family Practitioner Committees wishing to carry out postal surveys of users of general practitioner services can obtain satisfactory response rates.

Superselective Intra-arterial Chemotherapy of Advanced Paranasal Sinus Tumors

Twenty-four patients with advanced paranasal sinus tumors were treated with combined superselective intra-arterial and systemic chemotherapy, yielding an immediate satisfactory tumor response rate of 91%, significantly better than previously reported. Eight patients had craniofacial surgery circumvented because of complete or near complete response. Repetitive uncomplicated catheterization of the pterygoid segment of the internal maxillary artery using a coaxial system is the cornerstone of successful induction chemotherapy. Strenuous screening of medical status is mandatory for this aggressive introduction chemotherapy.