Outcomes Of Clinical Interventions Research Articles

(081) Enhancing Treatment for Patients with Medically Unresolved Persistent Sexual Dysfunction: What can be Learnt from Mixed Methodology Evaluation-Research?

Abstract Introduction Introduction: In adult healthcare delivery worldwide, medically unresolved persistent physical symptoms (uPPS) are of significant concern (Bermingham et al., 2010; Sumathipala, 2007), with patients often requiring an enhanced therapeutic approach (Nimnuan et al., 2001; Dwamena, et al., 2009). When routine medical care is not achieving desired patient outcomes for Unresolved Persistent Sexual Symptoms (uPSS) (erectile dysfunction (ED), rapid ejaculation (RE), genital pain and diminished sexual desire), the evidence for the best practice is limited. More research is needed in this area and whilst RCTs remain the gold standard in evidence-based medicine, there are limitations. At present there is no international consensus on the use of mixed method research parameters in studies involving patients with uPPS. Sexual Medicine teams are ideally placed to develop an enhanced approach to their own uPSS sufferers. We share our experience of an evaluation-research process and report its use, adaptations, and important findings. Objective Objectives: To present our experience of Realist Evaluation methodology in developing a cross-modality consultation model: Engaging the adult patient with uPSS. Methods Methods: Following NHS ethical approval using RAMESES standards (Wong et al., 2013), we conducted mixed method data comparisons by 3 stages: 1. A wide scoping of the literature, 1990–2014, 2. A Realist Literature Synthesis (2001–2014) of efficacy or effectiveness of Short-term Psychodynamic Psychotherapy (STPP), compared through common themes of engagement with Cognitive Behavioural Therapy (CBT) for uPPS. 3. Demographics, referral sources, length of history and clinical intervention outcomes were extracted from an established NHS psychosexual service. The comparative literature findings were used to develop a common-factor thematic analysis of 24 full transcripts from four adult prospective consecutive cases. Validated measures of wellbeing and symptoms severity with goal attainment measures supported further. Results Main Results: A synthesis of the literature from stages 1. and 2., supported by clinical experience, led to a succinct definition for the majority of adult uPPS sufferers within which the uPSS cohort is embraced. A Realist equation, ‘Context plus Mechanism = Outcomes’, developed across the case data showed the simple means of discovering the unique precipitating, predisposing, and perpetuating factors of the individual’s uPSS (an approach potentially transferrable to other uPPS). Further, the extraction of common factors perpetuating the uPSS over time plus an accessible set of collaborative principles of engagement for disabling these, substantiated the consultation model. Of the measures, personal goal attainment improvements over time in therapy were the most aligned to the transcript analyses showing improved subjective outcomes and personal satisfaction. Conclusions Conclusions: The literature synthesis revealed the paucity of high-quality mixed method research into uPPS talking therapy interventions and none for heterogenous uPSS. This was the first use of an enhanced evaluation-research methodology in this context. Due to the data emerging from the embedded cases it was possible to construct the foundational cross-modality consultation model. At the time of the study, the lack of available clinical service comparator limits the generalisation of our findings to uPPS. Our experience shows from the systematically developed outcome data that realist evaluation can be used appropriately, requiring further research. Disclosure No.

Using Within-Group Effect Size Benchmarks to Evaluate the Implementation and Outcome of Clinical Interventions in Service-Oriented Agencies

ABSTRACT In recent years a number of benchmarking studies have evolved that can be used to augment the value of one-group outcome evaluations of clinical interventions in social service agencies. The benchmarks are derived from using meta-analytic techniques to calculate aggregate within-group effect sizes separately for the treatment and control groups in the replicated RCTs providing strong research support for various clinical interventions. The purpose of the benchmarking studies was to help decision makers in social service agencies assess whether their clinicians are implementing research supported clinical interventions with adequate fidelity. This article summarizes the seven benchmarking studies that have been completed so far. It reports their aggregate within-group effect sizes and discusses how those data can be used to improve the value of outcome evaluations of clinical interventions in social service agencies where the previous benchmarking studies are not applicable.

Assessment of the lymphatic system by indirect lymphography in patients with post-thrombotic syndrome

ObjectiveAlterations in lower extremity lymph drainage caused by chronic venous obstruction (CVO) have not been well studied, partially because of a lack of standardized imaging modalities to assess the quality of lymphatic drainage in the lower extremities of patients with post-thrombotic syndrome (PTS). However, these changes are likely to have an impact on the severity of the disease and clinical outcomes of interventions. In the present study, we investigated the feasibility and diagnostic value of preintervention indirect lymphography in patients with CVO and their pre- and postintervention Villalta scores. MethodsA total of 17 patients (21 limbs) with iliofemoral and caval CVO were included in the study between 2017 and 2018. The deep and superficial lymphatic vessels in both legs were assessed before venous recanalization and stenting. The quality of lymphatic flow was compared between the legs with CVO and healthy legs. Moreover, the correlation between the lymphatic changes and clinical severity of PTS was evaluated using the Villalta score and CEAP (Clinical, Etiology, Anatomy, and Pathophysiology) classification. ResultsThe mean patient age was 44 ± 12 years, and 10 patients (59%) were women. The patients had undergone treatment at a mean of 25 ± 6 months after their first episode of deep vein thrombosis. Five patients (29%) had had recurrent deep vein thrombosis. The mean pre- and postinterventional Villalta score was 10.5 ± 1.46 and 9.27 ± 1.12, respectively (P = .0096). Using the CEAP classification, four legs were class 5, seven were class 4, and three each were class 3 and 2. The primary and secondary patency rate was 70.5% and 82.5% after a mean follow-up of 18 months, respectively. Indirect lymphography of the superficial and deep lymphatic systems was completed before intervention in both legs for all 17 patients (21 legs). According to the qualitative criteria, abnormal lymphatic vessel function was found in 35.2% of the superficial and 58.8% of the deep lymphatic vessels of the affected legs. Further analysis revealed abnormal function of the deep lymphatic vessels in all patients with moderate to severe PTS according to the Villalta score. ConclusionsIndirect lymphography is a feasible diagnostic tool to use for the evaluation of the function of lymphatic vessels. Impaired drainage of the deep lymphatic system was found in all our patients with moderate to severe PTS. The clinical significance of these lymphatic changes is not clear; however, an association between clinical severity and outcomes is possible.

Prevention of alcohol withdrawal seizure recurrence and treatment of other alcohol withdrawal symptoms in the emergency department: a rapid review

BackgroundPatients who experience harms from alcohol and other substance use often seek care in the emergency department (ED). ED visits related to alcohol withdrawal have increased across the world during the COVID-19 pandemic. ED clinicians are responsible for risk-stratifying patients under time and resource constraints and must reliably identify those who are safe for outpatient management versus those who require more intensive levels of care. Published guidelines for alcohol withdrawal are largely limited to the primary care and outpatient settings, and do not provide specific guidance for ED use. The purpose of this review was to synthesize published evidence on the treatment of alcohol withdrawal syndrome in the ED.MethodsWe conducted a rapid review by searching MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (1980 to 2020). We searched for grey literature on Google and hand-searched the conference abstracts of relevant addiction medicine and emergency medicine professional associations (2015 to 2020). We included interventional and observational studies that reported outcomes of clinical interventions aimed at treating alcohol withdrawal syndrome in adults in the ED.ResultsWe identified 13 studies that met inclusion criteria for our review (7 randomized controlled trials and 6 observational studies). Most studies were at high/serious risk of bias. We divided studies based on intervention and summarized evidence narratively. Benzodiazepines decrease alcohol withdrawal seizure recurrence and treat other alcohol withdrawal symptoms, but no clear evidence supports the use of one benzodiazepine over another. It is unclear if symptom-triggered benzodiazepine protocols are effective for use in the ED. More evidence is needed to determine if phenobarbital, with or without benzodiazepines, can be used safely and effectively to treat alcohol withdrawal in the ED. Phenytoin does not have evidence of effectiveness at preventing withdrawal seizures in the ED.ConclusionsFew studies have evaluated the safety and efficacy of pharmacotherapies for alcohol withdrawal specifically in the ED setting. Benzodiazepines are the most evidence-based treatment for alcohol withdrawal in the ED. Pharmacotherapies that have demonstrated benefit for treatment of alcohol withdrawal in other inpatient and outpatient settings should be evaluated in the ED setting before routine use.

Global Infectious Disease Surveillance and Case Tracking System for COVID-19: Development Study.

BackgroundCOVID-19 has affected more than 180 countries and is the first known pandemic to be caused by a new virus. COVID-19’s emergence and rapid spread is a global public health and economic crisis. However, investigations into the disease, patient-tracking mechanisms, and case report transmissions are both labor-intensive and slow.ObjectiveThe pandemic has overwhelmed health care systems, forcing hospitals and medical facilities to find effective ways to share data. This study aims to design a global infectious disease surveillance and case tracking system that can facilitate the detection and control of COVID-19.MethodsThe International Patient Summary (IPS; an electronic health record that contains essential health care information about a patient) was used. The IPS was designed to support the used case scenario for unplanned cross-border care. The design, scope, utility, and potential for reuse of the IPS for unplanned cross-border care make it suitable for situations like COVID-19. The Fast Healthcare Interoperability Resources confirmed that IPS data, which includes symptoms, therapies, medications, and laboratory data, can be efficiently transferred and exchanged on the system for easy access by physicians. To protect privacy, patient data are deidentified. All systems are protected by blockchain architecture, including data encryption, validation, and exchange of records.ResultsTo achieve worldwide COVID-19 surveillance, a global infectious disease information exchange must be enacted. The COVID-19 surveillance system was designed based on blockchain architecture. The IPS was used to exchange case study information among physicians. After being verified, physicians can upload IPS files and receive IPS data from other global cases. The system includes a daily IPS uploading and enhancement plan, which covers real-time uploading through the interoperation of the clinic system, with the module based on the Open Application Programming Interface architecture. Through the treatment of different cases, drug treatments, and the exchange of treatment results, the disease spread can be controlled, and treatment methods can be funded. In the Infectious Disease Case Tracking module, we can track the moving paths of infectious disease cases. The location information recorded in the blockchain is used to check the locations of different cases. The Case Tracking module was established for the Centers for Disease Control and Prevention to track cases and prevent disease spread.ConclusionsWe created the IPS of infectious diseases for physicians treating patients with COVID-19. Our system can help health authorities respond quickly to the transmission and spread of unknown diseases, and provides a system for information retrieval on disease transmission. In addition, this system can help researchers form trials and analyze data from different countries. A common forum to facilitate the mutual sharing of experiences, best practices, therapies, useful medications, and clinical intervention outcomes from research in various countries could help control an unknown virus. This system could be an effective tool for global collaboration in evidence-based efforts to fight COVID-19.

Advancing the Delivery of Communication Sciences and Disorders Services Through Research: The Promise of Health Services Research

Purpose Traditional efficacy research, or research that studies interventions in controlled settings, can be difficult to translate to real-world clinical settings. In this article, we introduce the field of health services research (HSR) as 1 possible tool to aid this translation. HSR is a field of research that examines and intervenes in the use, cost, quality, delivery, organization, and outcomes of clinical interventions and services in the real-world setting. The complexity of the world outside the clinic walls is accounted for in HSR methods and data sources. As such, HSR often requires collaboration of stakeholders, including patients, caregivers, clinicians, and policy makers. These stakeholders are often engaged throughout the research process, from selecting research questions to disseminating results. HSR brings together researchers from multiple disciplines, including sociology, health economics, epidemiology, and implementation science, among others. The outcomes of HSR can inform policy changes both locally and nationally. To clarify the scope and impact of HSR, we present examples of HSR-based research on communication between patients with communication disorders and health care providers. Conclusions HSR is a critical tool for clinicians and researchers in the discipline of communication sciences and disorders who are committed to improving the lives and health of persons with communication disorders.

Roles of miRNAs in spinal cord injury and potential therapeutic interventions.

Spinal cord injury (SCI) affects approximately 200,000 individuals per year worldwide. There are more than 27 million people worldwide living with long-term disability due to SCI. Historically, it was thought that the central nervous system (CNS) had little ability for regeneration; however, more recent studies have demonstrated potential for repair within the CNS. Because of this, there exists a renewed interest in the discovery of novel approaches to promote regeneration in the CNS including the spinal cord. It is important to know the roles of the microRNAs (miRNAs) in modulation of pathogenesis in SCI and the potentials of the miRNA-based clinical interventions for controlling post-injury symptoms and improving functional recovery. The miRNAs, which are non-coding RNAs with an average of 22 nucleotides in length, are post-transcriptional gene regulators that cause degradation of the target mRNAs and thus negatively control their translation. This review article focuses on current research related to miRNAs and their roles in modulating SCI symptoms, asserting that miRNAs contribute to critical post-SCI molecular processes including neuroplasticity, functional recovery, astrogliosis, neuropathic pain, inflammation, and apoptosis. In particular, miR-96 provides a promising therapeutic opportunity to improve the outcomes of clinical interventions, including the way SCI injuries are evaluated and treated.

Acotec Drug-Coated Balloon Catheter: Randomized, Multicenter, Controlled Clinical Study inFemoropopliteal Arteries: Evidence From the AcoArtI Trial.

The aim of this study was to investigate the efficacy and safety of a new paclitaxel-coated balloon catheter in the treatment of stenotic or occluded femoropopliteal arteries. The incidence of restenosis can be reduced by the use of drug-coated balloons. However, dose, coating composition, and technology are decisive for efficacy. Two hundred Chinese patients with peripheral arterial occlusive disease were prospectively randomized to treatment with new paclitaxel-coated or standard uncoated balloon catheters. The primary endpoint was angiographic late lumen loss at 6 months, measured by a blinded core laboratory. Secondary angiographic endpoints (6 months) andspecific clinical endpoints (1 year) were binary restenosis, ankle-brachial index, Rutherford stage, clinically driven target lesion revascularization, and amputation. Patients' mean age was 66 years, 74% were men, 31% were smokers, and 55% had diabetes. Patients were in Rutherford stages 2 through 5, with a mean lesion length of 150 mm; 25% had in-stent restenosis, 55% had occlusion or partial occlusion, and 20% underwent provisional stenting. Late lumen loss at 6 months was available for 89%, and clinical follow-up was available for >95% per group. Mean late lumen loss was 0.05 ± 0.73 mm with coated balloons and 1.15 ± 0.89 mm with uncoated balloons (p< 0.001). Correspondingly, the rates of restenosis were 22.5% and 70.8% (p< 0.001). After 1 year, the rates of target lesion revascularization were 7.2% and 39.6% (p< 0.001), and Rutherford class and ankle-brachial index improved more markedly in the coated group (p< 0.046 and p= 0.023, respectively). One major amputation was recorded in the control group. No coating-related adverse events were observed for doses of up to 43 mg paclitaxel per patient. In this medium-sized trial with long superficial femoral artery lesions, the use of paclitaxel-coated balloon catheters markedly improved angiographic and clinical outcomes of interventions despite advanced disease in the majority of patients.

A Psychologist's Response to the Case Study: Application of Theory and Measurement

This article represents a psychologist's perspective on the case study of Doris, a middle-aged woman with metastatic breast cancer who is initially referred to Chaplain Rhonda for assistance with death anxiety. In the field of psychology, it has long been accepted that good clinical research is informed by theory. As such, Chaplain Rhonda's intervention with Doris will be examined through the lens of object relations theory. Specifically, we will see how Rhonda's relationship and interaction with Doris improves her image of God and, by doing so, decreases her death anxiety. In psychological research, it is also important to accurately measure the effects or outcomes of clinical interventions. In this light, several suggestions are offered for the measurement of constructs relevant to the case of Doris, namely God image and death anxiety. Finally, a simple case study research design, applying the aforementioned theory and measurement, is provided as a suggested starting point for research on the efficacy of chaplaincy interventions.

Twin Pregnancies Complicated by a Single Malformed Fetus: Chorionicity, Outcome and Management

The objective of this study was to evaluate the impact of one abnormal fetus in a twin pregnancy, to compare impact of chorionicity and clinical outcome of intervention and expectant management. Thirty-seven dichorionic (DC) twins and 18 monochorionic (MC) twins complicated with one malformed fetus were evaluated for gestational age, birthweight and perinatal outcome. Six hundred and forty-two twin pregnancies were evaluated in the database. The control groups consisted of 429 DC and 86 MC twins without anomalous fetus. Mean birthweight and gestational age at birth for DC control group were (n = 429; 2137g and 34.71 weeks), DC study group, n = 37; 2117g (p = .338) and 33.97 weeks (p = .311), and DC study group with major malformations, n = 30; 2019g (p = .289) and 33.3 weeks (p = .01), and showed only significance for gestational age. There was no statistical significance between MC control group, n = 86; 2097g and 34.93 weeks, and MC study group, n = 18; 2237g (p = .338), and 34.42 weeks (p = .502). Because of limited data, the preliminary evaluation for expectant management and intervention, and survival of at least one normal fetus showed no impact. We conclude that, although, all DC twin pregnancies have a risk for preterm delivery, DC twins complicated with major malformation of one twin, have a lower mean gestational age at birth. Preliminary results for intervention does not improve fetal outcome for DC and MC twins and needs further evaluation with greater studies of impact or review.

Biological markers as outcome measures for Alzheimer's disease interventions – real problems and future possibilities

Because the biological pathological process is observed decades years before the clinical onset of Alzheimer's disease (AD), there is a theoretical ad-vantage in using biological markers for the early diagnosis of AD. Neuro-psychological test batteries, brain imaging and biological markers are expected to be used for screening and differential diagnosis of dementia and also for evaluation of the efficacy of early intervention. No single biological marker can serve all the purposes of screening, differential diagnosis and measurement of severity. Biological markers that reflect molecular stress, such as oxidative, ribotoxic, and nitroso stress, need to be developed, particularly for measuring the clinical outcomes of interventions. As well as providing a better understanding of the molecular pathogenesis of AD, there is a possibility of finding a surrogate marker of AD, which might fulfill the requirement of sufficient sensitivity and specificity for AD diagnosis, as well as indicating the disease-modifying activity of interventions. In this study we examine whether the mechanism of secretase activity will offer a new surrogate marker of AD.

Implementing Personal Digital Assistant Documentation of Pharmacist Interventions in a Military Treatment Facility

To describe the use of personal digital assistants (PDAs) in documenting pharmacists' clinical interventions. Evans Army Community Hospital (EACH), a 78-bed military treatment facility, in Colorado Springs. Pharmacists on staff at EACH. All pharmacists at EACH used PDAs with the pilot software to record interventions for 1 month. The program underwent final design changes and then became the sole source for recording pharmacist interventions. The results of this project are being evaluated every 3 months for the first year and yearly thereafter. Visual CE (Syware Inc. Cambridge, Mass.) software was selected to develop fields for the documentation tool. This software is simple and easy to use, and users can retrieve reports of interventions from both inpatient and outpatient sections. The software needed to be designed so that data entry would only take a few minutes and ad hoc reports could be produced easily. Number of pharmacist interventions reported, time spent in clinical interventions, and outcome of clinical intervention. Implementing a PDA-based system for documenting pharmacist interventions across ambulatory, inpatient, and clinical services dramatically increased reporting during the first 6 months after implementation (August 2004-February 2005). After initial fielding, clinical pharmacists in advanced practice settings (such as disease management clinic, anticoagulation clinic) recognized a need to tailor the program to their specific activities, which resulted in a spin-off program unique to their practice roles. A PDA-based system for documenting clinical interventions at a military treatment facility increased reporting of interventions across all pharmacy points of service. Pharmacy leadership used these data to document the impact of pharmacist interventions on safety and quality of pharmaceutical care provided.

Ethical requirements that must be met before the introduction of new procedures.

For orthopaedic care of patients to continue to improve, new approaches, both diagnostic and therapeutic, must be continually developed. To verify that a new approach actually provides improved outcomes, these innovations must be subjected to rigorous scientific study. However, because outcomes of clinical interventions only can be studied in human subjects, these studies must not only meet scientific criteria, they also must meet strict ethical criteria. The Declaration of Helsinki, a document prepared by the World Medical Association that originally was written in 1964, revised substantially in 1975, and most recently revised in 1996, provides guidelines for such studies. In addition to satisfying ethical requirements, clinical investigators also face various complex issues that must be dealt with in the performance of clinical research studies. One of the most difficult issues is the conflict between a physician's concern for the well-being of his or her patients and the need for protocol driven trials. No matter how enthusiastic surgeons may be about a new therapeutic approach, they must recognize that they are responsible to scientifically validate their innovative approach with a well controlled clinical trial using valid functional outcome measures.

Cost drivers in diabetes care: the problems they present and potential solutions

Diabetes mellitus is a chronic disease that affects many aspects of the lives of diagnosed patients and their families, the health care industry, and society. The majority of the economic literature on diabetes addresses the cost of treating diabetes but not the outcomes of clinical interventions. The primary cost of treating diabetes is related to short-term care to achieve euglycemia and long-term care associated with complications of the disease. The short-term costs of achieving euglycemia can be overshadowed by the decreased risk of long-term complications. The difficulty of providing care for a chronic disease such as diabetes arises from the high short-term costs of clinical interventions, the positive benefits of which may not be realized for many years. The results of the Diabetes Control and Complications Trial show a correlation between the intensive treatment of diabetes and a decreased risk of the development of long-term complications. Whether intensive treatment is practical, effective, and cost-effective in a real-world setting is a topic for further study. In the meantime, health care providers with a good knowledge of the clinical and economic elements of available therapeutic options can develop individualized care regimens for their patients with diabetes that are high quality and cost-effective

The Adenoma-carcinoma Sequence in Colorectal Neoplasia

In this article the epidemiologic, pathologic, molecular, and clinical evidence for the adenoma-carcinoma sequence is reviewed. The authors describe the morphologic evolution of the precursor adenomas, from the earliest discernible abnormality of the colon to adenomas with advanced pathologic features, the factors that determine the risk of progression of adenomas to adenocarcinoma, the molecular events that parallel or underlie the morphologic changes, the outcome of clinical interventions that have tested this hypothesis, and the time frame within which this progression is likely to occur.