Pneumococcal Conjugate Vaccines and Otitis Media: An Appraisal of the Clinical Trials

Streptococcus pneumoniae is the predominant otitis media pathogen and its prevention through effective vaccination could diminish childhood illness and antibiotic use. This paper reviews 5 pneumococcal conjugate vaccine (PCV) trials that used otitis media as an endpoint: Northern California Kaiser Permanente (NCKP; vaccine, 7-valent PCV [PCV7]-CRM); Finnish Otitis Media (FinOM; vaccines, PCV7-CRM or PCV7-OMPC); Native American Trial (vaccine, PCV7-CRM); Pneumococcal Otitis Efficacy Trial (POET; vaccine, 11-valent PCV [PCV11]-PD). For the microbiological endpoint, vaccine efficacy against vaccine-serotype pneumococcal otitis media was about 60% across trials. Against the clinical endpoint of all episodes, vaccine efficacy was 7% (PCV7-CRM/NCKP), 6% (PCV7-CRM/FinOM), −1% (PCV7-OMPC/FinOM), and −0.4% (PCV7-CRM/Native American Trial); 34% against first episodes of ear, nose, and throat specialist-referral cases (PCV11-PD/POET). Both follow-up through 2 years of age, for the 5 trials, and long-term follow-up, for PCV7-CRM/NCKP and PCV7-CRM/FinOM, demonstrated greater vaccine efficacy against recurrent AOM and tympanostomy-tube placement, suggesting that vaccination against early episodes of AOM may prevent subsequent episodes of complicated otitis media. Although study designs varied by primary endpoint measured, age at follow-up, source of middle-ear fluid for culture, case ascertainment, and type of randomization, each clinical trial demonstrated vaccine efficacy against microbiological and/or clinical otitis media

An Evaluation of Farmer Applications of Deer Damage Controls

Damage to agricultural crops caused by white-tailed deer (Odocoileus virginianus) continues to be a significant concern of farmers in Michigan and elsewhere in the United States. Policy changes that promise to reduce deer numbers may be long in coming, but better application of available damage control techniques may be an immediate alternative for farmers awaiting relief. Conversations with farmers, extension agents, and wildlife professionals suggest that some damage control techniques are underutilized by Michigan farmers, whereas other techniques are applied with little success despite promising field trials. We investigated producers’ practices to identify common weaknesses in how deer damage controls were being applied so that Michigan Department of Natural Resources and Cooperative Extension personnel could develop programs to improve the effectiveness of these applications. In January 1997, a 6-page questionnaire was mailed to 250 agricultural producers who indicated that they used some form of deer damage control to protect their crops. Producers were queried about specific methods employed, intensity and frequency of applications, fence maintenance, hunting and shooting techniques, deer harvest ratios, integration of techniques, and the perceived effectiveness of controls and/or combinations of techniques. Recreational hunting, shooting permits, and block permits were the control methods used most frequently by respondents. Although 84% of respondents expressed a desire to reduce the deer herd in the vicinity of their farm, most were not contributing effectively to achieving such a reduction through their own hunter management and deer harvest. Results suggest that educational and management opportunities do exist to encourage producers to more systematically apply and integrate available deer damage controls in Michigan

What comprises a good outcome in spinal surgery? A preliminary survey among spine surgeons of the SSE and European spine patients

Standardized and validated self-administered outcome-instruments are broadly used in spinal surgery. Despite a plethora of articles on outcome research, no systematic evaluation is available on what actually comprises a good outcome in spinal surgery from the patients' and surgeons' perspective, respectively. However, this is a prerequisite for improving outcome instruments. In performing a cross-sectional survey among spine patients from different European regions and spine surgeons of the SSE, the study attempted (1) to identify the most important domains determining a good outcome from a patients' as well as a surgeon's perspective, and (2) to explore regional differences in the identified domains. For this purpose, a structured interview was performed among 30 spine surgeons of the SSE and 353 spine surgery patients (representing Northern, Central and Southern Europe) to investigate their criteria for a good outcome. A qualitative and descriptive approach was used to evaluate the data. Results revealed a high agreement on what comprises a good outcome among surgeons and patients, respectively. The main parameters determining good outcome were achieving the patients' expectations/satisfaction, pain relief, improvement of disability and social reintegration. Younger patients more often expected a complete pain relief, an improved work capacity, and better social life participation. Patients in southern Europe more often wanted to improve work capacity compared to those from central and northern European countries. No substantial differences were found when patients' and surgeons' perspective were compared. However, age and differences in national social security and health care system ("black flags”) have an impact on what is considered a good outcome in spinal surger

A prospective cohort study of surgical treatment for back pain with degenerated discs; study protocol

BACKGROUND: The diagnosis of discogenic back pain often leads to spinal fusion surgery and may partly explain the recent rapid increase in lumbar fusion operations in the United States. Little is known about how patients undergoing lumbar fusion compare in preoperative physical and psychological function to patients who have degenerative discs, but receive only non-surgical care. METHODS: Our group is implementing a multi-center prospective cohort study to compare patients with presumed discogenic pain who undergo lumbar fusion with those who have non-surgical care. We identify patients with predominant low back pain lasting at least six months, one or two-level disc degeneration confirmed by imaging, and a normal neurological exam. Patients are classified as surgical or non-surgical based on the treatment they receive during the six months following study enrollment. RESULTS: Three hundred patients discogenic low back pain will be followed in a prospective cohort study for two years. The primary outcome measure is the Modified Roland-Morris Disability Questionnaire at 24-months. We also evaluate several other dimensions of outcome, including pain, functional status, psychological distress, general well-being, and role disability. CONCLUSION: The primary aim of this prospective cohort study is to better define the outcomes of lumbar fusion for discogenic back pain as it is practiced in the United States. We additionally aim to identify characteristics that result in better patient selection for surgery. Potential predictors include demographics, work and disability compensation status, initial symptom severity and duration, imaging results, functional status, and psychological distress

Cost effectiveness of disc prosthesis versus lumbar fusion in patients with chronic low back pain: randomized controlled trial with 2-year follow-up

This randomized controlled health economic study assesses the cost-effectiveness of the concept of total disc replacement (TDR) (Charité/Prodisc/Maverick) when compared with the concept of instrumented lumbar fusion (FUS) [posterior lumbar fusion (PLF) /posterior lumbar interbody fusion (PLIF)]. Social and healthcare perspectives after 2 years are reported. In all, 152 patients were randomized to either TDR (n = 80) or lumbar FUS (n = 72). Cost to society (total mean cost/patient, Swedish kronor = SEK, standard deviation) for TDR was SEK 599,560 (400,272), and for lumbar FUS SEK 685,919 (422,903) (ns). The difference was not significant: SEK 86,359 (−45,605 to 214,332). TDR was significantly less costly from a healthcare perspective, SEK 22,996 (1,202 to 43,055). Number of days on sick leave among those who returned to work was 185 (146) in the TDR group, and 252 (189) in the FUS group (ns). Using EQ-5D, the total gain in quality adjusted life years (QALYs) over 2 years was 0.41 units for TDR and 0.40 units for FUS (ns). Based on EQ-5D, the incremental cost-effectiveness ratio (ICER) of using TDR instead of FUS was difficult to analyze due to the “non-difference” in treatment outcome, which is why cost/QALY was not meaningful to define. Using cost-effectiveness probabilistic analysis, the net benefit (with CI) was found to be SEK 91,359 (−73,643 to 249,114) (ns). We used the currency of 2006 where 1 EURO = 9.26 SEK and 1 USD = 7.38 SEK. It was not possible to state whether TDR or FUS is more cost-effective after 2 years. Since disc replacement and lumbar fusion are based on different conceptual approaches, it is important to follow these results over time

Validity of rating scale measures of voice quality

The validity of perceptual measures of vocal quality has been neglected in studies of voice, which focus more commonly on rater reliability. Validity depends in part on reliability, because an unreliable test does not measure what it is intended to measure. However, traditional measures of rating reliability only partially represent interrater agreement, because they cannot reflect variations or patterns of agreement for specific voice samples. In this paper the likelihood that two raters would agree in their ratings of a single voice is examined, for each voice in five previously gathered data sets. Results do not support the continued assumption that traditional rating procedures produce useful indices of listeners' perceptions. Listeners agreed very poorly in the midrange of scales for breathiness and roughness, and mean ratings in the midrange of such scales did not represent the extent to which a voice possesses a quality, but served only to indicate that listeners disagreed. Techniques like analysis by synthesis or judgment of similarity avoid decomposing quality into constituent dimensions, and do not require a listener to compare an external stimulus to an unstable internal representation, thus decreasing the error in measures of quality. Modeling individual differences in perception can increase the variance accounted for in models of quality, further reducing the error in perceptual measures. Thus such techniques may provide valid alternatives to current approaches

Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD). To date, there is no convincing evidence that these devices provide any patient benefits.</p> <p>Methods/Design</p> <p>The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off").</p> <p>Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually.</p> <p>Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI). In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration), postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided.</p> <p>Discussion</p> <p>New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these topping off systems. High quality data is required to evaluate the benefits and drawbacks of topping off devices. If only because these devices are quite expensive compared to conventional fusion implants, nonessential use should be avoided. In fact, these high costs necessitate efforts by health care providers to evaluate the effects of these implants. Randomized clinical trials are highly recommended to evaluate the benefits or harm to the patient.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01224379">NCT01224379</a></p

Evaluating rehabilitation following lumbar fusion surgery (REFS): study protocol for a randomised controlled trial

BACKGROUND: The rate of lumbar fusion surgery (LFS) is increasing. Clinical recovery often lags technical outcome. Approximately 40% of patients undergoing LFS rate themselves as symptomatically unchanged or worse following surgery. There is little research describing rehabilitation following LFS with no clear consensus as to what constitutes the optimum strategy. It is important to develop appropriate rehabilitation strategies to help patients manage pain and recover lost function following LFS. METHODS/DESIGN: The study design is a randomised controlled feasibility trial exploring the feasibility of providing a complex multi-method rehabilitation intervention 3 months following LFS. The rehabilitation protocol that we have developed involves small participant groups of therapist led structured education utilising principles of cognitive behavioral therapy (CBT), progressive, individualised exercise and peer support. Participants will be randomly allocated to either usual care (UC) or the rehabilitation group (RG). We will recruit 50 subjects, planning to undergo LFS, over 30 months. Following LFS all participants will experience normal care for the first 3 months. Subsequent to a satisfactory 3 month surgical review they will commence their allocated post-operative treatment (RG or UC). Data collection will occur at baseline (pre-operatively), 3, 6 and 12 months post-operatively. Primary outcomes will include an assessment of feasibility factors (including recruitment and compliance). Secondary outcomes will evaluate the acceptability and characteristics of a limited cluster of quantitative measures including the Oswestry Disability Index (ODI) and an aggregated assessment of physical function (walking 50 yards, ascend/descend a flight of stairs). A nested qualitative study will evaluate participants' experiences. DISCUSSION: This study will evaluate the feasibility of providing complex, structured rehabilitation in small groups 3 months following technically successful LFS. We will identify strengths and weakness of the proposed protocol and the usefulness and characteristics of the planned outcome measures. This will help shape the development of rehabilitation strategies and inform future work aimed at evaluating clinical efficacy. TRIAL REGISTRATION: ISRCTN60891364, 10/07/2014