Compliance Protocol Research Articles

The Impact of Traditional Chinese Medicine QingreHuoxue Treatment and the Combination of Methotrexate and Hydroxychloroquine on the Radiological Progression of Active Rheumatoid Arthritis: A 52-Week Follow-Up of a Randomized Controlled Clinical Study.

Traditional Chinese medicine (TCM) has been used successfully to treat rheumatoid arthritis (RA). QingreHuoxue treatment (QingreHuoxue decoction [QRHXD]/QingreHuoxue external preparation [QRHXEP]) is a Chinese medicine treatment for RA. To date, very few studies have compared the long-term effects of QRHXD with those of conventional disease-modifying antirheumatic drugs on RA disease activity and radiological progression. QRHXD delayed the radiological progression and showed long-term clinical efficacy of RA. In clinical experiments, the clinical evidence of delaying the radiological progression of RA patients was obtained. A portion of the patients who participated in the “Traditional Chinese Medicine QingreHuoxue Treatment vs. the Combination of Methotrexate and Hydroxychloroquine for Active Rheumatoid Arthritis” study were followed up for 52 weeks, and intention-to-treat (ITT) and compliance protocol (PP) analyses were used to collect and compare the clinical indicators and imaging data between baseline and week 52. Two radiologists who were blind to treatment scored the images independently. Of the 468 subjects, 141 completed the 52-week follow-up. There were no significant differences among the three groups: the traditional Chinese medicine comprehensive treatment group, the Western medicine treatment group, and the integrated traditional Chinese and Western medicine treatment group. There were no differences in the total Sharp score, joint space stenosis score, and joint erosion score at baseline or 52 weeks. In the comparison of the estimated annual radiographic progression (EARP) and the actual annual Sharp total score changes among the three groups, the actual changes were much lower than the EARP at baseline. The radiological progress in all three groups was well controlled. Results of the ITT and PP data sets showed that the disease activity score 28 level of the three groups at 52 weeks was significantly lower than that at baseline. During the 52-week treatment period, the clearance of heat and promotion of blood circulation controlled disease activity and delayed the radiological progress of active RA.

Regulatory compliance under enforcement gaps

Analyses in the literature on regulatory enforcement usually assume that regulatory agencies know all of the entities subject to regulation. But constant entry and exit of firms create gaps in agencies’ knowledge of regulated entities. This paper conducts a theoretical and empirical analysis of firms’ compliance strategy when such enforcement gaps are present. Our theoretical analysis indicates that a firm with a sufficiently low probability of being subject to enforcement action will delay compliance. We analyze the effect of enforcement gaps on the compliance protocol development component of regulations empirically in the context of nutrient management regulations in Maryland. The Maryland Department of Agriculture (MDA), which enforces this regulation, relies on a registry of farms that includes less than half of the farm operations in the state. We conduct an econometric analysis using farm-level survey data combined with county-level enforcement data. Our econometric model indicates that the probability of being included in the MDA farm registry is associated with a statistically significant and economically meaningful increase in the probability of being in compliance with nutrient management regulations. This result suggests that enforcement gaps can have a significant effect on the performance of environmental regulations.

Improvement Frequency of Information Access and Anxious, Impact on The High Level of Compliance Protocol Prevention COVID-19 in Nurse Candidates

The spread of the COVID-19 virus which has become a pandemic is thought to cause changes in health behavior in nurse candidates. The purpose of this study is to identify changes in health behavior of nursing students in the form of seeking health information and increasing anxious about the possibility of contracting the virus, which is thought to have an impact on increasing compliance with health behavior. This type of research is an online survey with cross-sectional design. Data collected from nursing students in their late teens were statistically analyzed by the correlation test. The results showed that increasing literacy in seeking information about COVID-19 cases from social media and a fairly high increase in anxious had an impact on increasing compliance with preventing the spread of the virus. However, it was found that exposure to case information did not increase anxious in respondents. The conclusion of this study is the need for increased health literacy to create compliance with the COVID-19 virus prevention protocol at the same time as an increase in anxious.

Scleral Lens Hygiene and Care

Scleral lenses (ScCLs) are developed using the same material as rigid gas permeable corneal lenses yet the care of scleral lenses differs from corneal lenses. These large diameter rigid gas permeable lenses necessitate hygiene, care and compliance protocol that is more complex compared with corneal lenses. Cleaning, disinfection, storing, rinsing and applying ScCL will be discussed. Practitioners will gain confidence in ScCL care which will provide patients with a better understanding of the steps involved in ScCL disinfection leading to increased patient compliance and increased success rates. In turn, patient education will lower the risk for infection and other complications associated with ScCL.

Regulated Firm Strategy under Uncertainty about Regulatory Status

The effectiveness of environmental regulation is limited by the extent to which those regulations are enforced. Profit-maximizing firms will comply with a regulation if the expected net benefits of compliance are greater than the expected net benefits of non-compliance given the limited enforcement capabilities regulators have at their disposal. Analyses in the literature usually assume that regulatory agencies know all of the entities subject to regulation. But constant entry and exit of firms create gaps in agencies’ knowledge of regulated entities. This paper conducts a theoretical and empirical analysis of firms’ compliance strategy when such enforcement gaps are present. Our theoretical analysis indicates that a firm with a sufficiently low probability of being subject to enforcement action will delay compliance. We analyze the effect of enforcement gaps on the compliance protocol development component of regulations empirically within the context of nutrient management regulations in Maryland. The Maryland Department of Agriculture (MDA), which enforces this regulation, relies on a registry of farms that includes less than half of the farm operations in the state. We conduct an econometric analysis using farm-level survey data combined with county-level enforcement data. Our econometric model indicates that the probability of being included in the MDA farm registry is associated with a statistically significant and economically meaningful increase in the probability of being in compliance with nutrient management regulations. This result suggests that enforcement gaps can have a significant effect on the performance of environmental regulations.

Neurological Favorable Outcomes Associated with EMS Compliance and On-Scene Resuscitation Time Protocol

Purpose: Korean national emergency care protocol for EMS providers recommends a minimum of 5 minutes of on-scene resuscitation before transport to hospital in cases of Out-of-Hospital Cardiac Arrest (OHCA). We compared survival outcome of OHCA patients according to scene time interval (STI)-protocol compliance of EMS. Methods: EMS treated adult OHCAs with presumed cardiac etiology during a two-year period were analyzed. Non-compliance was defined as hospital transport with STI less than 6 minutes without return of spontaneous circulation (ROSC) on scene. Propensity score for compliance with protocol was calculated and based on the calculated propensity score, 1:1 matching was performed between compliance and non-compliance group. Univariate analysis as well as multivariable logistic model was used to evaluate the effect of compliance to survival outcome. Results: Among a total of 28,100 OHCAs, EMS transported 7,026 (25.0%) cardiac arrests without ROSC on the scene with an STI less than 6 minutes. A total of 6,854 cases in each group were matched using propensity score matching. Overall survival to discharge rate did not differ in both groups (4.6% for compliance group vs. 4.5 for non-compliance group, p = 0.78). Adjusted odds ratio of compliance for survival to discharge were 1.12 (95% CI 0.92–1.36). More patients with favorable neurological outcome was shown in compliance group (2.5% vs. 1.7%, p < 0.01) and adjusted odds ratio was 1.91 (95% CI 1.42–2.59). Conclusions: Although survival to discharge rate did not differ for patient with EMS non-compliance with STI protocol, lesser patients survived with favorable neurological outcomes when EMS did not stay for sufficient time on scene in OHCA before transport.

Medication Compliance Protocol for Pediatric Patients With Severe Intellectual and Behavioral Disabilities

Pediatric nurses are well aware of patient medication refusal. For a variety of reasons, many pediatric patients are noncompliant with their medication regimen. Medication administration is even more difficult when the population has severe intellectual and behavioral disabilities. An inpatient unit composed of children with these diagnoses presented a unique challenge. To address this issue, the unit RNs devised a medication compliance protocol. Initial implementation resulted in a success rate of 83.3% for six patients, after 4 weeks. Despite the small sample size, the RNs experienced a positive outcome with medication administration through consistent application of a medication compliance protocol.

Hand effect on head specific absorption rate (SAR) exposed by two realistic phone models

There have been some reports about possible effect of the hand presence on the head SAR if hand phantom is included in the measurements of the head SAR compliance assessment procedure. The objective of this computational study was to examine the reported effect by using realistic head models and realistic CAD based phone models. A commercially available FDTD based EM solver was used to carry out the computational work. Based on the results of this study considering the SAR values without hand phantom as reference, following conclusions can be made: 1. In general presence of the hand lead to significantly less conservative SAR values in the head for large majority of cases 2. For lower band GSM frequencies the presence of the hand decreases the head SAR up to ~70%. 3. For the upper band GSM frequencies the presence of the hand decreases the head SAR up to ~55%. Based on the results of this study the present SAR compliance protocol where hand phantom is not included leads to more conservative head SAR results compared to the cases where hand is included.

A (F)UTILE INTERSESSIONAL PROCESS?

During its thirty-five years, the Biological Weapons Convention (BWC) has been scarred by treaty violations, failed compliance negotiations, and ambiguous treaty language. Essentially a bruised paper tiger, the BWC adds no clarification to its distinction between biological activities for peaceful versus hostile purposes and has amplified—rather than lessened—mistrust in states' biological research and development potential. For the past two decades, these circumstances have generated multilateral annual discussions on BWC issues. From 2003 to 2010, intersessional talks centered on less controversial topics in an attempt to save the treaty from spiraling political tensions. States generally agree that this intersessional process was not futile and that it cooled some of the negative effects of the failed negotiations over a compliance protocol. At the upcoming Seventh BWC Review Conference this December, treaty members will weigh the utility of extending the process and its accompanying administrative Implementation Support Unit. The challenge will be to stimulate the evolution of the BWC beyond its hollow characterization to strengthen and inspire confidence in the treaty regime. This article examines the BWC's ambiguous language and how it has affected diplomacy, reflects on intersessional discussions, acknowledges the (limited) scope of appropriate peaceful activities that can be identified under the BWC, and addresses ways in which to reinvigorate the treaty.

Pediatric functional magnetic resonance neuroimaging: tactics for encouraging task compliance

BackgroundNeuroimaging technology has afforded advances in our understanding of normal and pathological brain function and development in children and adolescents. However, noncompliance involving the inability to remain in the magnetic resonance imaging (MRI) scanner to complete tasks is one common and significant problem. Task noncompliance is an especially significant problem in pediatric functional magnetic resonance imaging (fMRI) research because increases in noncompliance produces a greater risk that a study sample will not be representative of the study population.MethodIn this preliminary investigation, we describe the development and application of an approach for increasing the number of fMRI tasks children complete during neuroimaging. Twenty-eight healthy children ages 9-13 years participated. Generalization of the approach was examined in additional fMRI and event-related potential investigations with children at risk for depression, children with anxiety and children with depression (N = 120). Essential features of the approach include a preference assessment for identifying multiple individualized rewards, increasing reinforcement rates during imaging by pairing tasks with chosen rewards and presenting a visual 'road map' listing tasks, rewards and current progress.ResultsOur results showing a higher percentage of fMRI task completion by healthy children provides proof of concept data for the recommended tactics. Additional support was provided by results showing our approach generalized to several additional fMRI and event-related potential investigations and clinical populations.DiscussionWe proposed that some forms of task noncompliance may emerge from less than optimal reward protocols. While our findings may not directly support the effectiveness of the multiple reward compliance protocol, increased attention to how rewards are selected and delivered may aid cooperation with completing fMRI tasksConclusionThe proposed approach contributes to the pediatric neuroimaging literature by providing a useful way to conceptualize and measure task noncompliance and by providing simple cost effective tactics for improving the effectiveness of common reward-based protocols.

Efficiency and Safety of a Standardized Protocol for Intravenous Insulin Therapy in ICU Patients with Neurovascular or Head Injury

To evaluate the safety and efficiency of a protocol for glycemic control in intensive care unit (ICU) patients with neurovascular or head injury. Two cohorts of 50 consecutive patients admitted to the ICU with an admission diagnosis of neurovascular or head injury before and after protocol implementation were evaluated. All patients in the interventional cohort received insulin using a standardized intravenous insulin infusion protocol targeting blood glucose levels of 7-9 mmol/l. Efficiency (time to reach and time within target range), safety (hypoglycemia), and nursing compliance (protocol violations) were evaluated. The median time to reach the target blood glucose range was shorter in the interventional cohort than the conventional cohort (5.0 h [0.5-20.5 h] vs. 12.9 h [1.3-90.3 h]; P < 0.001). More time was spent within target range in the interventional cohort than in the conventional cohort (36.4 +/- 16.3% vs. 27.1 +/- 19.0%; P < 0.001). The median prevalence of mild (<4.9 mmol/l) hypoglycemia (0 [0-1.11]% vs. 0.58 [0-2.79]%; P < 0.001) and moderate (<3.9) hypoglycemia (0[0-0.55]% vs. 0 [1-1.25]%; p < 0.001) was significantly lower in the interventional cohort. The intravenous insulin infusion protocol improved the safety and efficiency of glycemic control for ICU patients with neurovascular or head injury.

WHILE WAITING FOR THE PROTOCOL

The Biological Weapons Convention (BWC) regime currently suffers from a lack of effective compliance procedures. Because a legally binding compliance protocol to the BWC is not available, other measures are needed to stabilize the regime against the risk of violations of its rules. The Treaty on the Non-Proliferation of Nuclear Weapons, the Chemical Weapons Convention, and the experiences of UN inspection teams show that among the necessary components of effective compliance mechanisms are an intermediary level between bilateral consultations of states parties and involvement of the UN Security Council as well as independent assessment capabilities. This article suggests that the UN Secretary General could assume such an intermediary function and, using the authority contained in Article 99 of the UN Charter, could investigate not only alleged use of biological weapons but also alleged breaches of the BWC. A standing expert unit in the Department for Disarmament Affairs could provide the independent expertise necessary for such investigations. Such a compliance mechanism could provisionally help stabilize the BWC regime until a permanent compliance system can be agreed.

The ALSOS Mission, 1943–1945: A Secret U.S. Scientific Intelligence Unit

The Biological and Toxin Weapons Convention (BTWC), which entered into force on 26 March 1975, has no verification mechanism. 1 An ad hoc group in Geneva is currently drafting a compliance protocol...

Validity of assessments of youth access to tobacco: the familiarity effect.

We examined the standard compliance protocol and its validity as a measure of youth access to tobacco. In Study 1, youth smokers reported buying cigarettes in stores where they are regular customers. In Study 2, youths attempted to purchase cigarettes by using the Standard Protocol, in which they appeared at stores once for cigarettes, and by using the Familiarity Protocol, in which they were rendered regular customers by purchasing nontobacco items 4 times and then requested cigarettes during their fifth visit. Sales to youths aged 17 years in the Familiarity Protocol were significantly higher than sales to the same age group in the Standard Protocols (62.5% vs. 6%, respectively). The Standard Protocol does not match how youths obtain cigarettes. Access is low for stranger youths within compliance studies, but access is high for familiar youths outside of compliance studies.

Strengthening the effectiveness of the BTW control regime – feasibility and options

The article raises the question of the feasibility of strengthening the effectiveness of the BTW control regime and compares two different approaches to achieve this end: the proposed Compliance Protocol to the BTWC and an alternative set of measures. After outlining the conceptual framework, the article discusses the characteristics of the BTW control regime and its current level of effectiveness. It then provides an analysis of the Compliance Protocol negotiated from 1995–2001 and the increase of regime effectiveness from the Protocol, had it been agreed upon. The impact on regime effectiveness of an alternative set of measures, based on proposals by the US government is assessed subsequently. It is concluded that the Protocol would have led to a greater increase in regime effectiveness. The alternative measures either do not lead to rules and procedures for state behaviour that are linked to and thus do not support the norms of the regime, or threaten to lead to an unequal regime strengthening that could lead to polarization among regime members and fragmentation of the overall BTW control regime.

Ethics of university research, biotechnology and potential military spin-off.

The paper provides a brief introduction to the biotechnology revolution and its impact upon biological research relevant to military uses. It describes the status of biological weapon today, and current efforts to strengthen the Biological Weapons Convention with a legally binding compliance protocol. Specific modifications of micro-organisms that may be of military use are discussed. There examples of dual-use research activities are then used to highlight issues and dilemmas in ethical decision making.

U.S. Searches For Way To Say No

The European Union (EU) has notified the U.S. that it is in the best interest of world security to finalize a binding compliance protocol to the 1975 Biological Weapons Convention (BWC) this year. If the U.S. does not sign on to the compromise text developed over the past six years, the EU sees no chance of renegotiating a new mandate with a more 'restricted' approach. The U.S. wants to limit the protocol to declarations and challenges. The U.S. will have to announce its position either during negotiations later this month or in November, when the Fifth Review Conference meets in Geneva. The official Bush Administration position is that no high-level decision has yet been made, though an interagency policy review has recommended that the compromise text be rejected, C&EN has learned. Adverse fallout from the U.S.'s decision to bow out of the Kyoto protocol on global warming has the Administration ...

Strengthening the biological weapons convention.

An international treaty banning the development of biological weapons has been in effect since 1975 but lacks an effective compliance protocol for visits and inspections of facilities that might be engaged in these activities. The U.S. biopharmaceutical industry has been reluctant to subject itself to such visits. We believe that it is far more important to strengthen the treaty than to create hypothetical barriers to a compliance regime.

Using experiential training to enhance health professionals' awareness of patient compliance issues.

To educate health care practitioners about medication compliance by having them play the role of patients who have been placed on a medication regimen. In 1988, ten physicians and ten nurses working in the Acquired Immune Deficiency Syndrome Clinical Trials Unit of Tulane University and Louisiana State University participated in a compliance protocol designed to enable them to better understand the experience of their patients, who were involved in a three-year controlled trial of azidothymidine (zidovudine) for asymptomatic persons infected with the human immunodeficiency virus. Over the three-year trial, the patients were expected to take three pills five times a day at four-hour intervals every day. To gain experiential understanding of this prolonged, intensive medication regimen, the physicians and nurses agreed to follow their patients' pill-taking schedule by using placebos for seven days, and they kept diaries of their reactions to the seven-day experience. Two years later, a follow-up assessment was done to ascertain the participants' opinions about whether the seven-day experience had had a lasting, positive influence on the way they addressed compliance issues with patients. The primary barriers to medication compliance recorded by the participants were time-related difficulties in following such a strict, unvarying schedule (e.g., frustration at having to repeat the pill-taking five times a day at regular intervals). Other frequently recorded difficulties were social barriers to public pill-taking (e.g., being stigmatized as ill or different). The follow-up results indicated that the participants felt that the seven-day experience was a relatively fast, painless, and helpful means of educating themselves about the problems their patients face. By playing the role of patients, the physicians and nurses learned to recognize sources of patient noncompliance with medication regimens, and, as the follow-up indicated, they were able to generalize the role-playing experiences to later interactions with patients.

A compliance protocol: psychiatric emergency services and brief encounters.

The documented high rates of noncompliance by psychiatric clients to their disposition plans following psychiatric emergency room treatment are a problem for psychiatric nurses. A compliance protocol is presented that approaches compliance as an interactive collaborative process based on an assumption that clients can participate in the compliance process with varying degrees of responsibility. The protocol includes an organizing system for assessment, nursing diagnoses, and interventions. The components of the protocol, mutuality, decision making, supporting systems, and intentionality are adapted from the Health Belief Model.