Linking health technology assessment to practice. Interview by Abi Berger.
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Humans↗
Biomedical subjects
R Rosen
Publications and source records attributed to R Rosen.
Circadian rhythm of motor restlessness and sensory symptoms in the idiopathic restless legs syndrome.
STUDY OBJECTIVES: To determine if motor restlessness in the Restless Legs Syndrome (RLS) shows a circadian rhythm with maximum at night, as previously found for subjective discomfort and periodic limb movements (PLMs), and to correlate RLS peak intensity with the core temperature cycle. DESIGN: Subjects underwent two days of normally timed wakefulness and sleep followed by a night and subsequent day of sleep deprivation. Activity was standardized through modified suggested immobilization tests (mSITs). SETTING: The study was conducted in a laboratory environment with a bedroom equipped for polysomnography during sleep and the mSITs. PATIENTS: Nine patients (mean age 59.8+/-11.3 years [range: 33-72]; 4 males, 5 females) with clinically severe idiopathic RLS. INTERVENTIONS: Patients were monitored with continuous ambulatory activity and core temperature recording. The mSITs were performed every three hours while subjects were awake. During the mSITs, subjective discomfort was measured every 15 minutes while motor restlessness was assessed through activity monitoring. MEASUREMENTS AND RESULTS: Subjective discomfort and motor restlessness increased from a trough in the morning to a maximum at night in the hours following midnight. Peak intensity was found on the falling phase of the core temperature cycle, whose circadian rhythm appeared to be within the normal range for age. CONCLUSIONS: An independent circadian factor modulates the intensity of RLS, which seems to peak on the falling phase of the core temperature cycle. Therefore, the diagnostic criteria that RLS occurs with rest and during the night have independent bases. Furthermore, RLS may be partially controlled by some process or substance whose level varies with the normal circadian rhythm.
Adult↗
Clinical governance. Thin on the ground.
Clinical governance is being led by two people, usually a GP and a nurse, in most of the PCGs that responded to the survey. A fifth of the leads for clinical governance had no experience of working on quality issues. Nearly a third of respondents felt that their health authority had provided poor support or none at all. Only 10 PCGs had identified a clinical governance budget. No PCG was working with a finance manager to develop clinical governance and only five were working with an information manager.
Data Collection↗
Evaluating NHS direct. Early findings raise questions about expanding the service.
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Evaluation Studies as Topic↗
Effects of tonsillectomy and/or adenoidectomy on vocal function: laryngeal, supralaryngeal and perceptual characteristics.
A prospective, non-randomized study evaluated the effects of tonsillectomy and/or adenoidectomy (T +/- A) on acoustic and perceptual aspects of vocal function. Thirty-one children, ranging in age from 4 to 15 years participated and measurements were made prior to and 3 months following surgery. Twenty-three children had T +/- A and eight had adenoidectomy alone. Quantitative acoustic measures included: laryngeal (vocal fundamental frequency, FO) and supralaryngeal characteristics of sustained vowels (F1 and F2 formants, formant bandwidths, two-dimensional measures of vowel space) and temporal properties of consonant-vowel productions (diadochokinetic syllable rates). Perceptual measures were based on samples of continuous speech, using the Buffalo voice profile (BVP) and parental interviews/questionnaires were used to evaluate other aspects of surgery (i.e. subjective speech changes, protracted pain, difficulty swallowing, bleeding, etc.). Based on ANOVA, no significant post-surgical changes were detected for the majority of acoustic speech measures studied (vocal F0, formant bandwidths, measures of vowel space or diadochokinetic rates). However, the F2 formant frequency for vowels /i/ and /a/ increased and F1 decreased for /o/ following surgery. These changes had the largest effect on the structure of vowel /i/, which became more acute and diffuse following surgery. Furthermore, of the majority of perceptual measured studied with the BVP, 92% showed no change postoperatively. However, in the category of resonance, a significant decrease in hyponasality was detected. These results demonstrate that removing soft tissue from the oropharynx has only minimal impact on quantitative or qualitative (perceptual) aspects of vocal function, when measurements are made approximately 15 weeks post surgery.
Adenoidectomy↗
Quality-of-life changes among patients with obsessive-compulsive disorder in a partial hospitalization program.
Thirty treatment-resistant patients with a primary DSA-IV diagnosis of obsessive-compulsive disorder were assessed at admission to and discharge from a partial hospitalization program to determine whether improvement in symptoms of the disorder was associated with improvements in patients' quality of life. Symptom severity was measured using the Yale-Brown Obsessive Compulsive Scale (YBOCS). Quality of life was measured using Lehman's Quality of Life (QOL) scale, which includes several objective and subjective indexes. YBOCS scores significantly improved with treatment, as did scores on the majority of the QOL subjective indexes and on the objective social, health, and activity indexes. No significant association between changes in YBOCS scores and QOL scores was found.
Adult↗
Pilot open-label study of nefazodone in panic disorder.
Ten patients meeting DSM-IV criteria for non-comorbid panic disorder or panic disorder with agoraphobia were treated in a 12-week open-label, flexible dosage trial of nefazodone. Dosages ranged from 50 to 400 mg per day. Clinical assessment utilized several recently developed scales of panic disorder severity, as well as the clinical global impression scale. At the conclusion of the study, 9 out of 10 patients were rated much improved with 7 of the patients rated as panic free and in full remission. Significantly improved scores were reflected by all of the scales. Low sample size and absence of placebo control indicate the need for a large placebo-controlled trial. The results of this pilot study suggest that nefazodone may be promising in the treatment of panic and justify further research.
Adult↗
High altitude living: genetic and environmental adaptation.
High altitude (HA) living produces physiological changes for adaptation to chronic hypobaric-hypoxemic conditions. Although much is known about these physiologic adaptations, no clear separation has been made regarding what is "native" or "genetic" adaptation and what is "acquired." In this review, we describe the genetic vs. acquired adaptation and only include studies performed in a population native to HA and not in an acclimatized population or trekkers. The changes encountered in animals and humans living at HA in terms of hematology, muscular, respiratory, cerebral, cardiovascular, hormonal, fluid and electrolytes and reproduction, strongly suggest that genetics play a very important role in HA adaptation. Unfortunately, the characteristic physiology of HA natives has not been systematically defined to established specific measurable parameters of adaptation in comparison to the acquired ambient adaptation of the non-native population. Once the parameters are established, we can compare non-native populations exposed to HA that must emulate the HA physiology for a definite adaptation to be present. With measurable parameters, especially in the management of fluids and electrolytes, we can define how long it will take for a sea level native to adapt to an HA altitude. Until these studies are performed, speculation will continue and no rational medical intervention can be offered to HA newcomers who may experience HA difficulties.
Adaptation, Physiological↗
The Taskforce 2000 survey on medical education in sleep and sleep disorders.
Previous research has shown evidence of a widening gap between scientific research and clinical teaching in sleep and sleep disorders. To address the deficiencies in current medical education in sleep, the Taskforce 2000 was established by the American Sleep Disorders Association. The present study was undertaken to assess the teaching activities, needs and interests of the membership of the two largest professional sleep societies (American Sleep Disorders Association and Sleep Research Society). Survey instruments included a brief, 5-item postcard survey, which was mailed to all members, followed by an in-depth, 34-item questionnaire, which was completed by 158 respondents from the intitial postcard survey (N = 808). Results indicated that the majority of respondents (65.2%) are currently involved in teaching sleep to medical students or postgraduate trainees, although the average amount of teaching time was only 2.1 hours for undergraduate and 4.8 hours for graduate education in sleep. Teaching of sleep laboratory procedures and clinical evaluation of sleep-disordered patients is limited at either an undergraduate or postgraduate level. The major deficiencies noted were the lack of time in the medical curriculum and the need for better resources and teaching facilities. A large majority of respondents indicated their willingness to be involved in sleep education for physicians, and rated this a high priority for the professional organization.
Curriculum↗
High-resolution ultrasound biomicroscopy of the pars plana and peripheral retina.
OBJECTIVE: This study aimed to evaluate the ability and role of ultrasound biomicroscopy in imaging the peripheral retina, pars plana, and anterior choroid. DESIGN: The study design was a case series. PARTICIPANTS: Seventeen eyes of 17 patients with a variety of clinical diagnoses involving the anterior portion of the posterior segment were studied. INTERVENTION: High-frequency (50 MHz), high-resolution (50 microns) ultrasound biomicroscopy was performed. RESULTS: Ultrasound biomicroscopy was capable of imaging the peripheral retina, pars plana, and anterior choroid. Images had features consistent with known histopathology. Retinoschisis consisted of one thin hyper-reflective echo and could be differentiated from a retinal detachment, which was thicker and formed a bilayered echo. A choroidal effusion could be identified as an echolucent space within the suprachoroidea, whereas a choroidal hemorrhage was moderately echodense. Inflammatory diseases, such as a sarcoid granuloma, pars planitis, and Harada's disease, were characterized by different forms of uveal thickening. A ciliochoroidal nevus was internally hyporeflective and could be measured accurately and localized. CONCLUSIONS: Imaging of the peripheral retina, pars plana, and anterior choroid is possible with ultrasound biomicroscopy and may aid in the diagnosis and management of pathology involving this region.
Adolescent↗
The impact of the UK NHS purchaser-provider split on the 'rational' introduction of new medical technologies.
This article uses evidence from case studies of the introduction of three new medical technologies to explore the impact of the UK NHS purchaser--provider split on the diffusion of new medical technologies. A desirable policy objective is assumed to be the 'rational' diffusion of medical technologies according to evidence that they are clinically and cost effective. Theoretical mechanisms are identified through which diffusion could be controlled, and the case studies are used to explore the extent to which rational technology diffusion occurs in practice in the NHS. They illustrate the influence of purchasers and providers on the introduction and early use of new technologies and explore the extent to which research about clinical and cost effectiveness is used to inform decisions about technology adoption. The results demonstrate the limited influence of purchasers and the short term clinical and organisational objectives pursued by providers in relation to technology adoption. It is suggested that initiatives to promote rational technology diffusion might be most effective if they are focused on decision making in providers, and if they aim to balance the influence on decisions of administrative and financial information about the technologies with more systematic use of research about clinical and cost effectiveness.
Cost-Benefit Analysis↗
Ultrasound evaluation of endovascular repair of abdominal aortic aneurysms.
UNLABELLED: Endovascular repair of an abdominal aortic aneurysm (AAA) offers a minimally invasive alternative to an open surgical procedure in selected patients. The purpose of this study was to examine the usefulness of ultrasonography for evaluating the results of endovascular repair. METHODS: We studied 17 patients who underwent endovascular repair. In 10 patients a bifurcated prosthesis was positioned below the renal arteries with the bifurcated branches in the iliac arteries. The other 7 patients had a nonbifurcated infrarenal prosthesis. RESULTS: In each patient the AAA and the entire prosthesis, including its bifurcated branches, were visualized. The mean AAA diameter was 5.0 +/- 0.6 cm. The mean prosthesis body diameter was 2.2 +/- 0.3 cm, and the diameters of the bifurcated limbs were 1.0 to 1.2 cm. Color Doppler studies revealed blood flow limited to the prosthetic lumen and its bifurcation in 16 patients; the space between the prosthesis and the AAA wall was clotted in these patients. In 1 patient a communication was seen between the prosthesis and the AAA lumen through a dehiscence in the distal attachment. CONCLUSION: Ultrasonography is a simple, noninvasive tool for the evaluation of the results of endovascular repair of AAA and can detect complications of this procedure.
Aged↗
Controlling the introduction of new and emerging medical technologies: can we meet the challenge?
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Diffusion of Innovation↗
Successful treatment of a patient with severe refractory myasthenia gravis using mycophenolate mofetil.
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Adolescent↗
Partial renal resistance to arginine vasopressin as an adaptation to high altitude living.
BACKGROUND: The normal physiological response to high altitude (HA) is a decrease in total body water (TBW) and plasma and extracellular volume. The present investigation was designed to determine the mechanisms of the decrease in TBW with HA adaptation. METHOD: There were 10 men from the Southern Colombian Andes (2600 m) in Pasto, Colombia, who were compared to age-matched men from sea level (SL), Tampa, FL, in the U.S., with respect to their TBW, ability to handle a water load and response to exogenous arginine vasopressin (AVP). Measurements included circulating AVP, atrial natriuretic peptides [atrial natriuretic factor (ANF) and vessel dilator], and urinary excretion of the AVP sensitive water channel, aquaporin-2 (AQP2). RESULTS: The HA subjects had significantly (p < 0.01) lower TBW (29.37 +/- 0.98 vs 39.71 +/- 1.66 Kg), AQP2 excretion and vessel dilator circulating levels at baseline compared to SL subjects. ANF levels were not significantly different between the two groups. With water loading (20 ml.kg-1 in 15 min) there was a rapid increase in urine volume at 30 min with a decline thereafter in HA subjects while SL subjects had a gradual increment peaking at 120 min. There was a significant (p < 0.05) decrease in plasma AVP in the SL subjects within 30 min after the water load while the HA subjects had no significant decrease in AVP levels. Excretion of AQP2 decreased significantly after the water load only in the SL subjects. Administration of exogenous AVP increased AQP2 3- to 4-fold in the HA in comparison to SL subjects. CONCLUSIONS: Present data demonstrate the following adaptations to HA: decrease in TBW, better ability to handle a water load despite high levels of AVP, a significant decrease in the circulation of vessel dilator, and diminished excretion of AQP2 water channel. These findings indicate an insensitivity of the collecting duct of HA subjects to the actions AVP. However, exogenous administration of AVP caused a marked excretion of AQP2.
Acclimatization↗
Transscleral diode laser retinopexy in retinal detachment surgery: results of a multicenter trial.
PURPOSE: To evaluate the safety and efficacy of transscleral diode laser for retinopexy in rhegmatogenous retinal detachment surgery in a multicenter trial. METHODS: Seventy-two patients with primary rhegmatogenous retinal detachments were enrolled. No patient with chronic detachment, a retinal break greater than 90 degrees, history of uveitis or infectious retinopathy, or proliferative vitreoretinopathy was enrolled. RESULTS: Information from follow-up of 6 months or longer was available on 65 eyes. Retinas were attached at 6 months with a single operation in 58 (89%) of these eyes. Complications included apparent pinpoint breaks in Bruch's membrane in 15 eyes, scleral-thermal effect in 14 eyes, and limited hemorrhage, which was intraretinal in 10 eyes and extended into the vitreous in 3 eyes. In one case, hemorrhage was judged perhaps to have contributed to initial surgical failure. The other complications had no known adverse effects. Complications were significantly associated with the physician's experience in using transscleral laser retinopexy. CONCLUSIONS: In this multicenter study, transscleral diode laser retinopexy served as a safe and effective means of creating chorioretinal adhesion during retinal reattachment surgery. Minor complications were minimized by increasing experience with the technique.
Adolescent↗
High-dose chemotherapy and autologous peripheral blood stem cell transplantation in patients with multiple myeloma and renal insufficiency.
Six patients with multiple myeloma and chronic renal insufficiency (serum creatinine >3.0 mg/dl), including four on dialysis, received high-dose busulfan and cyclophosphamide (BUCY) followed by autologous peripheral stem cell transplantation. Peripheral blood stem cells were collected after priming with cyclophosphamide, etoposide and G-CSF. Patterns of engraftment and toxicities were not apparently different from those seen in myeloma patients with normal renal function. There was one toxicity-related death, resulting from a massive spontaneous subdural hematoma. One patient died of disease progression 6 months after transplant, while the remaining four patients are alive and free of myeloma progression 6 to 39 months after high-dose therapy. Two of these patients have remained in complete remission for 28 and 39 months. Our experience suggests that high-dose therapy with BUCY and autologous peripheral blood stem cell rescue is feasible in patients with multiple myeloma and renal failure.
Adult↗
Baseline correlates with quality of life among men and women with medication-controlled hypertension. The trial of nonpharmacologic interventions in the elderly (TONE).
OBJECTIVES: To examine Quality of Life (QOL) and its correlates among older adults with medication-controlled hypertension. DESIGN: Baseline data from the TONE clinical trial. MEASUREMENTS: Demographic variables (age, race, income), hypertension treatment (medication class, years treated), health status (obesity, physical symptoms), and QOL status (MOS-Short-Form 36, Jenkins Sleep Disturbance, and CES-D Depression). PARTICIPANTS: A total of 975 men and women, aged 60 to 81 years and free of major diseases and disability, with a screening blood pressure (BP) of < or = 145/85 mm Hg, treated medically for hypertension with antihypertensive medication. RESULTS: On average, TONE participants reported a QOL level on the SF-36 that was similar to or better than that reported by older adults in the general population. However, there was a strikingly high prevalence of physical complaints or symptoms: 90.3% of men and 93.3% of women experienced one or more physical symptoms or complaints, and nearly 50% reported that such symptoms had disrupted their daily functioning. Among variables-considered, only the physical symptoms index score, number of severe symptoms, and obesity status were correlated consistently with QOL among TONE men and women. Lower QOL scores were associated with higher symptom scores and with obesity. Neither medication class nor age were appreciably associated with QOL status. CONCLUSIONS: Physical symptoms, rather than medication class and age, were the strongest correlates of QOL in TONE. This underscores the importance of identifying the etiology of symptoms as a means to improve the QOL of order hypertensive persons rather than substituting medication. The association of poorer physical well-being with obesity suggests that weight reduction to manage BP may also improve QOL for some individuals.
Activities of Daily Living↗