Relationship between performance status and satisfaction with fentanyl pectin nasal spray / Relación entre el estado de rendimiento medio con la escala ECOG y la satisfacción del paciente con el uso de fentanilo en pectina por vía nasal

Background: Patients with breakthrough pain in cancer (BTPc) experience impaired activities of daily living and quality of life. Both function and satisfaction with treatment can impact patients’ abilities to use products, and likely impact response to therapies. Objective: This exploratory analysis examined the relationship between functional status and satisfaction with ability to use fentanyl pectin nasal spray (FPNS) for BTPc. Methods: Treatment satisfaction data were analyzed from a multicenter, open-label, long-term study using FPNS for managing BTPc in patients with Eastern Cooperative Oncology Group (ECOG) grade ≤ 2. Satisfaction with ease of use, convenience, and reliability of FPNS were assessed on three-question, fourpoint scales (1 = not satisfied, 2 = not satisfied or dissatisfied, 3 = satisfied, 4 = very satisfied) at the end of 1, 4, 8, and 12 weeks. For each domain, percentage of patients who reported being "satisfied or very satisfied" (score 3 or 4) with FPNS was analyzed based on ECOG grade. Results: Overall, > 90 % of patients with ECOG 0-2 reported being satisfied or very satisfied with FPNS across all three domains. Differences in patient satisfaction with FPNS by ECOG grade were clinically small though statistically significant (ease of use: p = 0.0022, convenience: p = 0.0057, and reliability: p = 0.0012). Conclusion: The FPNS device was well accepted irrespective of ECOG grade (0-2). Statistically, patients with higher performance status (lower ECOG grades) reported higher satisfaction scores, though effect size was small. Results imply the FPNS device provides a high level of usability irrespective of functional status, which is likely to promote use and thus likelihood of success in controlling BTPc (AU)

Introducción: los pacientes con dolor irruptivo oncológico (BTPc) experimentan un deterioro de las actividades de la vida diaria y de la calidad de vida. Tanto la función como la satisfacción con el tratamiento pueden afectar a las capacidades de los pacientes para utilizar fármacos e impactar en sus respuestas a los mismos. Objetivo: este análisis exploratorio examina la relación entre el estado funcional y la satisfacción con la capacidad de usar el aerosol nasal de pectina de fentanilo (FPNS) para BTPc. Métodos: se analizaron datos de satisfacción del tratamiento de un estudio multicéntrico, abierto, a largo plazo usando FPNS para el tratamiento del BTPc en pacientes con Eastern Cooperative Oncology Group (ECOG) grado ≤ 2. Fueron evaluados la satisfacción con la facilidad de uso, comodidad y fiabilidad de FPNS en escalas tres preguntas y cuatro puntos (1 = nada satisfecho, 2 = no satisfecho o insatisfecho, 3 = satisfecho, 4 = muy satisfecho) al final de 1, 4, 8 y 12 semanas. Para cada dominio, el porcentaje de pacientes que informaron estar "satisfechos o muy satisfechos" (puntuación de 3 o 4) con FPNS se analizó basado en el grado ECOG. Resultados: en general, el 90 % de los pacientes con ECOG 0-2 dijo haber estado satisfecho o muy satisfecho con la FPNS en los tres dominios. Diferencias en la satisfacción del paciente con FPNS por grado ECOG fueron clínicamente pequeñas pero estadísticamente significativas (facilidad de uso: p = 0,0022, conveniencia: p = 0,0057 y fiabilidad: p = 0,0012). Conclusión: el dispositivo FPNS fue bien aceptado independientemente del grado ECOG (0-2). Estadísticamente, los pacientes con status de rendimiento superior (grados menores ECOG) informaron mayores puntuaciones de satisfacción, aunque el tamaño del efecto fue pequeño. Los resultados demuestran que el dispositivo FPNS proporciona un alto nivel de usabilidad independientemente del estado funcional, y que es probable que promover el uso y por lo tanto la probabilidad de éxito en el control de BTPc (AU)

Reliability of efficacy in men with erectile dysfunction treated with tadalafil once daily after initial success.

The reliability of response to treatment is an important component of erectile dysfunction (ED) treatment. This study examined the reliability of tadalafil once daily (that is, successful attempts/total attempts) following initial successful intercourse. Data pooled from two randomized, double-blind, placebo-controlled trials of men with ED who received tadalafil 2.5 mg (N=96), tadalafil 5 mg (N=206) or placebo (N=148) once daily were analyzed to determine the first-attempt success rate and subsequent reliability of response. The first-attempt success rate (Sexual Encounter Profile question 3 (SEP3)) was significantly higher among men taking tadalafil 2.5 mg (45.7%) and 5 mg (55.2%) compared to placebo (28.5%; P<0.05 and P<0.001, respectively). Furthermore, following initial success, men taking tadalafil 5 mg had a significantly greater proportion of successful intercourse (SEP3) on subsequent attempts (85.9%, P<0.001) compared to men taking placebo (70.2%). Overall, men with ED taking tadalafil once daily experienced a high rate of reliability of efficacy.

Further evidence of the reliability and validity of the premature ejaculation diagnostic tool.

This study details the further validation of the Premature Ejaculation Diagnostic Tool (PEDT), a five-item tool, developed to systematically apply the Diagnostic and Statistical Manual of Mental Disorders, revised version 4 (DSM-IV-TR), criteria in diagnosing presence or absence of premature ejaculation (PE). A total of 102 men completed the PEDT and were then interviewed by one of the seven clinical experts, who made a diagnosis of presence or absence of PE. The diagnoses from these two methods were compared to assess the convergent validity of PEDT. Retest reliability was also assessed, by men completing the PEDT a second time, approximately 2 weeks after the first administration. The level of agreement between clinical expert and PEDT diagnoses was very high (kappa-statistic=0.80 (95% CI=0.68-0.92)), and retest reliability was very good - Intraclass correlation coefficient=0.88. In summary, the PEDT is extensively validated, self-report measure that can systematically assess DSM-IV-TR criteria to provide accurate diagnoses of PE/no-PE.

Phosphodiesterase type 5 inhibitors' extended duration of response as a variable in the treatment of erectile dysfunction.

The phosphodiesterase type 5 (PDE5) inhibitors, sildenafil, tadalafil and vardenafil, are a class of medications that are safe and effective in treating erectile dysfunction (ED). Yet, resuming sexual activity following a period of abstinence in response to ED may be anxiety-provoking for the man, his partner and their relationship, causing the sexual encounter to become a stressful event. The differences between PDE5 inhibitors in terms of duration of action can be successfully utilized by healthcare professionals to mitigate some of the psychosocial barriers that interfere with treating ED. PDE5 inhibitors with a longer duration of responsiveness provide some men with ED and their partners, a treatment option that may offer greater flexibility and potentially less anxiety surrounding the resumption of sexual activity. Shorter-acting PDE5s may be preferred by men/couples with predictable sexual scripts, excellent communication strategies and concerns regarding the duration of side effects.

Lipoid pneumonia: a preventable form of drug-induced lung injury.

We report a case where recurrent "pneumonia" was eventually diagnosed as lipoid pneumonia in an elderly patient with cerebrovascular disease. The discontinuation of paraffin oil laxative led to clinical improvement. Lipoid pneumonia, a foreign body-type reaction to the presence of lipid within lung parenchyma, is probably underdiagnosed and underreported, and paraffin oil laxative is the main causative agent. Paraffin oil is marketed as a food additive, and no information about its hazards is provided to clinicians or patients. We suggest that a change in paraffin oil licensing may decrease the incidence of lipoid pneumonia.

Health issues of men: prevalence and correlates of erectile dysfunction.

PURPOSE: The Cross-National Survey on Men's Health Issues was a population based, international survey of men using the health care systems of participating countries. The prevalence of erectile dysfunction (ED) and its correlation with patient age, overall health and comorbidities were assessed. MATERIALS AND METHODS: Men who were 20 to 75 years old in the United States, Germany, United Kingdom, France, Italy and Spain were recruited to participate in the study. During visits to physician offices participants completed a screening questionnaire about their overall health, and problems with prostate, urination and penile erection. Men who reported ED completed a followup questionnaire. RESULTS: A cohort of 28,691 men completed the screening questionnaire and provided their age. Respondents in the oldest age group (70 to 75 years) were at 14-fold higher relative risk for ED than respondents in the youngest age group (20 to 29 years). ED correlated positively with poor overall health, and prostate and urinary problems. The prevalence of comorbid conditions increased with ED severity. Only a small percent of men with ED (2% to 8%) were using nitrates for comorbid cardiac disorders. Approximately 10% to 20% of men were on beta-blockers. CONCLUSIONS: The results of this survey are consistent with those of other population based reports showing a high correlation between ED prevalence and patient age, and ED and lower urinary tract symptoms. The prevalence of comorbidities, such as vascular conditions, increased with ED severity, which may indicate that ED is a prognostic marker of overall health and an important medical condition.

Sex coaching for physicians: combination treatment for patient and partner.

Physicians dealing with sexual dysfunction (SD) must consider the psychological and behavioral aspects of their patient's diagnosis and management, as well as organic causes and risk factors. Integrating sex therapy and other psychological techniques into their office practice will improve effectiveness in treating SD. This presentation provides information about the psychological forces of patient and partner resistance, which impact patient compliance and sex lives beyond organic illness and mere performance anxiety. Four key areas are reviewed: (1). 'Sex coaching for physicians' uses the 'Cornell Model' for conceptualizing and treating SD. A 5-min 'sex status,' manages 'time crunch' by rapidly identifying common causes of sexual dysfunction (insufficient stimulation, depression, etc). (2). Augmenting pharmacotherapy with sex therapy when treating erectile dysfunction (ED) specifically, or SD generally is stressed. Sex therapy is useful as a monotherapy or an adjunctive treatment and is often the 'combination therapy' of choice when treating SD. The following therapeutic integrations are highlighted: modifying patient's initial expectations; sexual pharmaceuticals use as a therapeutic probe; 'follow-up' to manage noncompliance and improve outcome; relapse prevention. (3). Issues specific to the role of the partner of the ED patient are described. The physician must appreciate the role of couple's issues in causing and/or exacerbating the ED and the impact of the ED on the patient/partner relationship. Successful treatment requires a supportive available sexual partner, yet partner cooperation may be independent of partner attendance during the office visit. Preliminary data from a survey of SMSNA members practice patterns, regarding partner issues, is presented and discussed. The importance of evoking partner support and cooperation independent of actual attendance during office visits is emphasized. (4). Finally, the need for more patient and partner educational materials to assist the physician in overcoming a patient/partner's emotional barriers to sexual success in a time efficient manner are discussed.

Pulmonary-renal syndrome in systemic sclerosis.

BACKGROUND AND OBJECTIVE: Renal failure, pulmonary hypertension, and interstitial lung disease are major causes of morbidity and mortality in systemic sclerosis (SSc). However, the concomitant occurrence of pulmonary hemorrhage associated with acute renal failure in SSc has been rarely described. The present study is the first analysis of pulmonary-renal syndrome in SSc. PATIENT AND METHODS: We present a 44-year-old woman with SSc who died of a fulminant course of acute renal failure associated with diffuse alveolar hemorrhage. We termed this uncommon and fatal complication of SSc scleroderma-pulmonary-renal syndrome (SPRS). A search of the English-written literature yielded reports of 10 additional similar cases. These patients, together with our present case, form the basis of the present analysis. RESULTS: The average age of the patients with SPRS was 46 years. The majority of the patients (80%) were women, and most had diffuse SSc. SPRS occurred an average of 6.4 years after disease onset and was associated with prior fibrosing alveolitis and/or D-penicillamine treatment. Interestingly, normotensive renal failure seems to characterize the scleroderma patients, because 9 of 11 (82%) had normal blood pressure. SPRS bears a poor prognosis: all of the 11 patients (100%) died within 12 months of admission. However, only 60% of the 5 patients for whom we have treatment data received corticosteroids. CONCLUSIONS: Pulmonary-renal syndrome is a rare but fatal complication of SSc. Because the treatment data are scarce and the prognosis is poor, aggressive treatment with pulse corticosteroids, cyclophosphamide, and possibly plasmapheresis is suggested.

Identification of rifampin-resistant Mycobacterium tuberculosis strains by hybridization, PCR, and ligase detection reaction on oligonucleotide microchips.

Three new molecular approaches were developed to identify drug-resistant strains of Mycobacterium tuberculosis using biochips with oligonucleotides immobilized in polyacrylamide gel pads. These approaches are significantly faster than traditional bacteriological methods. All three approaches-hybridization, PCR, and ligase detection reaction--were designed to analyze an 81-bp fragment of the gene rpoB encoding the beta-subunit of RNA polymerase, where most known mutations of rifampin resistance are located. The call set for hybridization analysis consisted of 42 immobilized oligonucleotides and enabled us to identify 30 mutant variants of the rpoB gene within 24 h. These variants are found in 95% of all mutants whose rifampin resistance is caused by mutations in the 81-bp fragment. Using the second approach, allele-specific on-chip PCR, it was possible to directly identify mutations in clinical samples within 1.5 h. The third approach, on-chip ligase detection reaction, was sensitive enough to reveal rifampin-resistant strains in a model mixture containing 1% of resistant and 99% of susceptible bacteria. This level of sensitivity is comparable to that from the determination of M. tuberculosis drug resistance by using standard bacteriological tests.

The impact of the new sexual pharmaceuticals on sex therapy.

Since the March 27, 1998 introduction of sildenafil, opportunities for sex therapists have expanded, primarily in three ways: 1) public education, 2) colleague education, and 3) treatment. Primary care physicians and urologists learned that incorporating sex therapy techniques improved the effectiveness of sildenafil; furthermore, sex therapists discovered that integrating adjunctive use of sildenafil with sex therapy accelerated the therapy process and improved outcome. As new pharmaceuticals are developed and approved for men and women, opportunities for medical and nonmedical sex therapists will only increase. In fact, sex therapists are playing an increasingly important consultative role to industry in the research and development of new sexual pharmaceuticals. However, optimism for nonphysician sex therapists is tempered by recognition of the continuing trend toward medicalization of sexual dysfunction.

The effects of prolonged cryopreservation on the biomechanical properties of bone allografts: a microbiological, histological and mechanical study.

Bone allografting is the most common form of allotransplantation in modern medicine. Bone banking is usually the major part of most tissue banks throughout the world. Several years ago, many standards of bone banking were set empirically, and have never been evaluated. One particular parameter or standard was outdating graft materials after 5 years of storage. This study was conducted to evaluate the effect of prolonged cryopreservation on the biomechanical properties of bone allografts and establish whether graft materials become contaminated during long-term storage.Proximal humeral bone allografts were obtained from the bone bank after 1, 3 and 5 years of -80 degrees C cryopreservation. Samples of each humeral head, i.e., cartilage, subchondral bone and spongy bone were histologically examined for inter- and intra-cellular changes. A three-point mechanical bending test was used on identical pieces of cortical bone to compare fresh and cryopreserved materials. Fresh-retrieved cortical bone using identically-sized segments, served as a control. Cultures were taken from each respective sample to determine contamination or sterility.Results of both the histological and mechanical testing showed that there were no significant, qualitative histological, or quantitative mechanical differences among the samples. All the cultures were negative. Therefore, based on this study's parameters, bone allografts can safely be used after a cryopreservation period of over 5 years and should not be discarded.

Pulmonary manifestations of early schistosome infection among nonimmune travelers.

PURPOSE: The clinical aspects of acute pulmonary schistosomiasis among nonimmune patients have not been well characterized. METHODS: We evaluated 8 patients who presented with pulmonary symptoms and abnormal chest radiographs after recent travel to Africa. Diagnosis was based on the detection of schistosomal eggs or positive serology. RESULTS: Of 60 patients evaluated in our center for schistosomiasis during a 3-year period, 8 (6 with Schistosoma hematobium, 2 with S. mansoni) had pulmonary symptoms. These symptoms appeared 3 to 6 weeks after exposure and consisted of dry cough and shortness of breath without concurrent fever. The mean (+/- SD) eosinophil count was 4020 +/- 1400 per micromL. Chest radiography revealed multiple small nodules in 7 patients; in 1 patient, a diffuse interstitial infiltrate was also seen. Computerized tomographic scans of the chest were obtained in 4 patients; the scans confirmed the nodular pattern and detected a greater number of nodules. A transbronchial biopsy in 1 patient revealed eosinophilic pneumonia without detection of larva or eggs. CONCLUSION: Pulmonary manifestations during the early stage of schistosomal infection may occur with either S. hematobium or S. mansoni infection. These manifestations may represent an immunologic process, as is thought to be responsible for the febrile systemic response (Katayama fever) to acute infection.

Tuberculosis in Russia.

Various aspects of tuberculosis in Russia, including epidemiology, means of prevention, diagnosis and treatment, have been widely discussed in the last few years in the medical literature and by the general media. A certain amount of controversy has been generated on some of these subjects. This review is an attempt to objectively analyze the true situation of tuberculosis in Russia, including the issues of control measures, as viewed by the public health authorities and by the majority of Russian tuberculosis specialists. The data presented and their analysis reflect the official position of the Russian Federation Ministry of Health. These views became a basis for the concept of the national anti-tuberculosis program to serve the needs of the population, which was approved by the Scientific Council of the Ministry of Health of Russia in February 2000.

Revision hip arthroplasty in patients with a history of previous malignancy.

BACKGROUND AND OBJECTIVES: The potential association between implants and malignancy has been discussed in the literature, but never as a cause of loosening of joint arthroplasty. METHODS: The records of all patients who underwent revision arthroplasty at our institution between 1992 and 1995 were reviewed. RESULTS: Among 93 patients who underwent revision hip arthroplasties, 11 (11.8%) had a history of previous malignancy. At surgery, in 2 of these patients, metastasis was found to be the cause of loosening in the affected hip. CONCLUSIONS: When revision hip arthroplasty is considered, patients with a history of malignancy require attenuated pre-, intra-, and postoperative workup. Management algorithm in such cases is proposed.

Pulmonary alveolar proteinosis in Israel: ethnic clustering.

BACKGROUND: Pulmonary alveolar proteinosis is a rare disease in which a surfactant-like phospholipid-rich protein accumulates in the lungs. The disease is amenable to effective therapy by total lung lavage. OBJECTIVES: To investigate the prevalence, ethnic distribution and course of PAP in Israel. METHODS: A countrywide survey was conducted during which pulmonologists were questioned about patients with PAP. The patients were examined and their charts, radiological images, pathological slides and physiological data were reviewed. RESULTS: The survey yielded 15 patients (8 females) during the period 1976-98 (14 in the last decade), giving a prevalence of 3.7 x 10(6) and an incidence of 0.36 x 10(6)/year. Mean age of the patients was 33 +/- 13 years (range 0.5-46 years). Seven patients were North African (two were siblings), four were from Iraq and two were Arabs; there was only one Ashkenazi Jew (a child). Symptoms at the onset were dyspnea and chest pain. Spontaneous remission occurred in at least 3 patients, and 10 patients required 1-4 bronchoalveolar lavage treatments. The subjective and physiological response was favorable, but there was less consistent radiological improvement. CONCLUSION: The prevalence of PAP in Israel is approximately 3.7 x 10(6). Most cases occurred in Jews who had immigrated from North Africa or Iraq, and two were siblings. The prevalence among the Arab population appears to be similar. This clustering suggests the existence of a genetic predisposition. The course of the disease appears to be similar to that reported elsewhere.

Commentary: pharmacological agents for erectile dysfunction and the human sexual response cycle.

Public interest following the approval of sildenafil (Viagra), for the treatment of erectile dysfunction (ED), provides sex therapists with an unprecedented opportunity to educate both lay and professional audiences about the importance of psychosocial factors in the evaluation and treatment of sexual dysfunction. My commentary here briefly summarizes how all four phases of the Human Sexual Response (HSR) cycle are affected by sildenafil.

Littoral cell angioma: a vascular tumor mimicking a solid tumor on a Tc-99m-red blood cell spleen scan.

A splenic space occupying lesion, in a 45-year-old woman, was negative in a Tc-99m-RBC spleen scan. A diagnostic splenectomy was performed and the lesion was found to be a vascular tumor, lately identified as littoral cell angioma. The histological and immunohistochemical findings are discussed in correlation with the imaging results.

[Pulmonary alveolar microlithiasis presenting with prolonged cough].

A 40-year-old man had been followed in the pulmonary clinic for prolonged cough. Chest X-ray showed bilateral diffuse interstitial infiltrates with accentuation toward the bases. CT-scan demonstrated a fine diffuse reticulonodular pattern. Transbronchial lung biopsy showed pulmonary alveolar microlithiasis, a rare disease characterized by the presence of concentric calcifications within the pulmonary alveoli. This is the second case of the disease reported in Israel.