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International Journal of Radiation... Sep 2014The radiation oncology community has witnessed growing interest in observational research conducted using large-scale data sources such as registries and claims-based... (Review)
Review
The radiation oncology community has witnessed growing interest in observational research conducted using large-scale data sources such as registries and claims-based data sets. With the growing emphasis on observational analyses in health care, the radiation oncology community must possess a sophisticated understanding of the methodological considerations of such studies in order to evaluate evidence appropriately to guide practice and policy. Because observational research has unique features that distinguish it from clinical trials and other forms of traditional radiation oncology research, the International Journal of Radiation Oncology, Biology, Physics assembled a panel of experts in health services research to provide a concise and well-referenced review, intended to be informative for the lay reader, as well as for scholars who wish to embark on such research without prior experience. This review begins by discussing the types of research questions relevant to radiation oncology that large-scale databases may help illuminate. It then describes major potential data sources for such endeavors, including information regarding access and insights regarding the strengths and limitations of each. Finally, it provides guidance regarding the analytical challenges that observational studies must confront, along with discussion of the techniques that have been developed to help minimize the impact of certain common analytical issues in observational analysis. Features characterizing a well-designed observational study include clearly defined research questions, careful selection of an appropriate data source, consultation with investigators with relevant methodological expertise, inclusion of sensitivity analyses, caution not to overinterpret small but significant differences, and recognition of limitations when trying to evaluate causality. This review concludes that carefully designed and executed studies using observational data that possess these qualities hold substantial promise for advancing our understanding of many unanswered questions of importance to the field of radiation oncology.
Topics: Checklist; Comparative Effectiveness Research; Databases, Factual; Diffusion of Innovation; Health Care Costs; Health Services Research; Health Surveys; Insurance Claim Review; Medicare; Neoplasms; Nomograms; Observational Studies as Topic; Professional Practice; Propensity Score; Publication Bias; Radiation Oncology; Rare Diseases; Registries; Research Design; SEER Program; United States
PubMed: 25195986
DOI: 10.1016/j.ijrobp.2014.05.013 -
BMJ Open Aug 2021Mechanical ventilatory is a crucial element of acute brain injured patients' management. The ventilatory goals to ensure lung protection during acute respiratory failure...
INTRODUCTION
Mechanical ventilatory is a crucial element of acute brain injured patients' management. The ventilatory goals to ensure lung protection during acute respiratory failure may not be adequate in case of concomitant brain injury. Therefore, there are limited data from which physicians can draw conclusions regarding optimal ventilator management in this setting.
METHODS AND ANALYSIS
This is an international multicentre prospective observational cohort study. The aim of the 'multicentre observational study on practice of ventilation in brain injured patients'-the VENTIBRAIN study-is to describe the current practice of ventilator settings and mechanical ventilation in acute brain injured patients. Secondary objectives include the description of ventilator settings among different countries, and their association with outcomes. Inclusion criteria will be adult patients admitted to the intensive care unit (ICU) with a diagnosis of traumatic brain injury or cerebrovascular diseases (intracranial haemorrhage, subarachnoid haemorrhage, ischaemic stroke), requiring intubation and mechanical ventilation and admission to the ICU. Exclusion criteria will be the following: patients aged <18 years; pregnant patients; patients not intubated or not mechanically ventilated or receiving only non-invasive ventilation. Data related to clinical examination, neuromonitoring if available, ventilator settings and arterial blood gases will be recorded at admission and daily for the first 7 days and then at day 10 and 14. The Glasgow Outcome Scale Extended on mortality and neurological outcome will be collected at discharge from ICU, hospital and at 6 months follow-up.
ETHICS AND DISSEMINATION
The study has been approved by the Ethic committee of Brianza at the Azienda Socio Sanitaria Territoriale-Monza. Data will be disseminated to the scientific community by abstracts submitted to the European Society of Intensive Care Medicine annual conference and by original articles submitted to peer-reviewed journals.
TRIAL REGISTRATION NUMBER
NCT04459884.
Topics: Adult; Brain; Brain Ischemia; Humans; Intensive Care Units; Lung; Multicenter Studies as Topic; Observational Studies as Topic; Prospective Studies; Respiration, Artificial; Stroke
PubMed: 34380722
DOI: 10.1136/bmjopen-2020-047100 -
Haematologica Mar 2020Plasminogen deficiency is an ultra-rare multisystem disorder characterized by the development of fibrin-rich pseudomembranes on mucous membranes. Ligneous... (Review)
Review
Plasminogen deficiency is an ultra-rare multisystem disorder characterized by the development of fibrin-rich pseudomembranes on mucous membranes. Ligneous conjunctivitis, which can result in vision impairment or loss, is the most frequent symptom reported. Affected systems may also include the respiratory tract, oropharynx, female reproductive tract, gingiva, middle ear, renal collecting system, skin and central nervous system. Untreated, plasminogen deficiency may result in significant reduction in quality of life and morbidity with potential life-threatening complications. Non-specific therapies are inadequate and plasminogen concentrates are not commercially available. The current understanding of plasminogen deficiency and management of disease symptoms and its progression are based on case reports/series and two small clinical trials. To date there has never been a comprehensive, international study to examine the natural history or optimal therapeutic intervention; knowledge gaps include identification of contributing factors and triggers of disease manifestations, inability to predict disease course, and insufficient real-world data for use of therapeutics. We have created an international, observational study (HISTORY) in a large cohort of persons with plasminogen deficiency and first-degree family members to address these gaps and to advance knowledge and care. HISTORY will build upon the established relationship between the Indiana Hemophilia and Thrombosis Center and the Fondazione Angelo Bianchi Bonomi, IRCCS Ca' Granda Ospedale Maggiore Policlinico - University of Milan and will utilize a modified version of the Prospective Rare Bleeding Disorders Database (PRO-RBDD). A biorepository containing samples from subjects with plasminogen deficiency will be established. This article describes the rationale behind the study and efforts towards its goals.
Topics: Conjunctivitis; Humans; Observational Studies as Topic; Plasminogen; Prospective Studies; Quality of Life; Registries
PubMed: 32001536
DOI: 10.3324/haematol.2019.241158 -
Epilepsy & Behavior : E&B May 2023This study aimed to systematically review the published literature evaluating the association between physical activity and cognitive function in people with epilepsy... (Review)
Review
BACKGROUND
This study aimed to systematically review the published literature evaluating the association between physical activity and cognitive function in people with epilepsy (PWE).
METHODS
A comprehensive search of PubMed, Cochrane, Embase, and PsychInfo was performed on June 20, 2022. Studies were excluded if they were not available in the English language, contained animal data only, did not include any original data, were not peer-reviewed, or did not include PWE as a discrete group. PRISMA guidelines were followed. The GRADE scale was used to assess the risk of bias.
RESULTS
Six studies were identified with a total of 123 participants. These included one observational study and five interventional studies, only one of which was a randomized controlled trial. In all studies, there was a positive association between physical activity and cognitive function in PWE. Both interventional studies showed improvement in at least one domain of cognitive functioning, though there was heterogeneity in the outcome measures used.
CONCLUSIONS
There is a potential positive association between physical activity and cognitive function in PWE, but available data is limited by heterogeneity, small sample size, and an overall lack of published studies in this area of research. There is a need for more robust studies to be performed in larger samples of PWE.
Topics: Animals; Exercise; Cognition; Epilepsy; Randomized Controlled Trials as Topic; Observational Studies as Topic
PubMed: 36940504
DOI: 10.1016/j.yebeh.2023.109170 -
Current Hypertension Reports Nov 2020E-cigarettes (e-cigs) release toxic chemicals known to increase blood pressure (BP) levels. The effects of e-cigs on BP, however, remain unknown. Studying BP may help... (Review)
Review
PURPOSE OF REVIEW
E-cigarettes (e-cigs) release toxic chemicals known to increase blood pressure (BP) levels. The effects of e-cigs on BP, however, remain unknown. Studying BP may help characterize potential cardiovascular risks of short- and long-term e-cig use. We summarized published studies on the association of e-cig use with BP endpoints.
RECENT FINDINGS
Thirteen e-cig trials (12 cross-over designs) and 1 observational study evaluated systolic and diastolic blood pressure (SBP and DBP). All trials included at least one e-cig arm with nicotine, 6 a no-nicotine e-cig arm, and 3 a placebo arm. SBP/DBP increased in most nicotine e-cig arms, in some non-nicotine e-cig arms, and in none of the placebo arms. The observational study followed e-cig users and nonsmokers for 3.5 years with inconsistent findings. The use of e-cigs with and without nicotine may result in short-term elevations of both SBP and DBP. Prospective studies that investigate the long-term cardiovascular impact of e-cig use are needed.
Topics: Blood Pressure; Electronic Nicotine Delivery Systems; Humans; Hypertension; Observational Studies as Topic; Prospective Studies; Vaping
PubMed: 33230755
DOI: 10.1007/s11906-020-01119-0 -
BMC Oral Health Dec 2022Patient-reported outcome measures provide an essential perspective on the quality of health care provided. However, how data are collected, how providers value and make...
BACKGROUND
Patient-reported outcome measures provide an essential perspective on the quality of health care provided. However, how data are collected, how providers value and make sense of the data, and, ultimately, use the data to create meaningful impact all influence the success of using patient-reported outcomes.
OBJECTIVES
The primary objective is to assess post-operative pain experiences by dental procedure type through 21 days post-procedure as reported by patients following dental procedures and assess patients' satisfaction with pain management following dental surgical procedures. Secondary objectives are to: 1) assess post-operative pain management strategies 1 week following dental surgical procedures, as recommended by practitioners and reported by patients, and 2) evaluate practitioner and patient acceptance of the FollowApp.Care post visit patient monitoring technology (FollowApp.Care). We will evaluate FollowApp.Care usage, perceived usefulness, ease of use, and impact on clinical workload.
DESIGN AND METHODS
We describe the protocol for an observational study involving the use of the FollowApp.Care platform, an innovative mobile application that collects dental patients' assessments of their post-operative symptoms (e.g., pain). The study will be conducted in collaboration with the National Dental Practice-based Research Network, a collective Network of dental practices that include private and group practices, public health clinics, community health centers and Federal Qualified Health Centers, academic institutional settings, and special patient populations. We will recruit a minimum of 150 and up to 215 dental providers and up to 3147 patients who will receive push notifications through text messages FollowApp.Care on their mobile phones at designated time intervals following dental procedures. This innovative approach of implementing an existing and tested mobile health system technology into the real-world dental office setting will actively track pain and other complications following dental procedures. Through patients' use of their mobile phones, we expect to promptly and precisely identify specific pain levels and other issues after surgical dental procedures. The study's primary outcome will be the patients' reported pain experiences. Secondary outcomes include pain management strategies and medications implemented by the patient and provider and perceptions of usefulness and ease of use by patients and providers.
Topics: Humans; Cell Phone; Text Messaging; Patient Satisfaction; Pain, Postoperative; Dentistry; Observational Studies as Topic
PubMed: 36494795
DOI: 10.1186/s12903-022-02573-9 -
BMJ Open May 2023Considering the increasing complexity of care and workload for home care nurses due to the ageing of the population, it is crucial to describe the work environment and...
INTRODUCTION
Considering the increasing complexity of care and workload for home care nurses due to the ageing of the population, it is crucial to describe the work environment and the community care setting. The aim of this study protocol is to map the characteristics and identify gaps of home care in the community to design future interventions aimed at ensuring quality and safety.
METHODS AND ANALYSIS
This is a national cross-sectional descriptive observational study using the survey method. Nurses from all participating community care centres will be recruited through convenience sampling by the coordinators of each centre, who will act as facilitators for this study. All community care recipients and their informal carers during the study period will be invited to complete a survey.To map the characteristics and identify gaps of home care in the community, three sources of data will be collected: (1) organisational characteristics, professional satisfaction, intention to leave and burn-out; (2) experience of care recipients and their informal carers and (3) improper access to the emergency department, readmission to hospital, comorbidities, services offered and users' level of autonomy, and main and secondary diagnoses.Considering the total Italian nursing population of approximately 450 000 registered nurses, a sample size of 1% of this population, equal to approximately 4600 nurses, was hypothesised.This study started in July 2022 and is planned to end in December 2023.Data will be analysed using descriptive and inferential statistics.
ETHICS AND DISSEMINATION
This study protocol was approved by the Liguria Regional Ethics Committee in November 2022. Informed consent will be obtained from participants and confidentiality will be ensured. Data collected for this study will be kept anonymised in a protected database.The results of the study will be disseminated mainly through conferences, publications and meetings with government representatives.
Topics: Humans; Cross-Sectional Studies; Hospitals; Research Design; Sample Size; Home Care Services; Observational Studies as Topic; Multicenter Studies as Topic
PubMed: 37202129
DOI: 10.1136/bmjopen-2022-071155 -
BMJ Open Aug 2023Acute mesenteric ischaemia (AMI) is a life-threatening condition with short-term mortality of up to 80%. The diagnosis of AMI has remained troublesome due to the...
Diagnostic potential of plasma biomarkers and exhaled volatile organic compounds in predicting the different stages of acute mesenteric ischaemia: protocol for a multicentre prospective observational study (TACTIC study).
INTRODUCTION
Acute mesenteric ischaemia (AMI) is a life-threatening condition with short-term mortality of up to 80%. The diagnosis of AMI has remained troublesome due to the non-specific clinical presentation, symptoms and laboratory findings. Early unambiguous diagnosis of AMI is critical to prevent progression from reversible to irreversible transmural intestinal damage, thereby decreasing morbidity and improving survival. The present study aims to validate a panel of plasma biomarkers and investigate volatile organic compound (VOC) profiles in exhaled air as a tool to timely and accurately diagnose AMI.
METHODS AND ANALYSIS
In this international multicentre prospective observational study, 120 patients (>18 years of age) will be recruited with clinical suspicion of AMI. Clinical suspicion is based on: (1) clinical manifestation, (2) physical examination, (3) laboratory measurements and (4) the physician's consideration to perform a CT scan. The patient's characteristics, repetitive blood samples and exhaled air will be prospectively collected. Plasma levels of mucosal damage markers intestinal fatty acid-binding protein and villin-1, as well as transmural damage marker smooth muscle protein 22-alpha, will be assessed by ELISA. Analysis of VOCs in exhaled air will be performed by gas chromatography time-of-flight mass spectrometry. Diagnosis of AMI will be based on CT, endovascular and surgical reports, clinical findings, and (if applicable) verified by histopathological examination.
ETHICS AND DISSEMINATION
The study protocol was approved by the Medical Research Ethics Committee (METC) of Maastricht University Medical Centre+ and Maastricht University (METC azM/UM), the Netherlands (METC19-010) and the Ethics Committee Research UZ/KU Leuven, Belgium (S63500). Executive boards and local METCs of other Dutch participating centres Gelre Ziekenhuizen (Apeldoorn), Medisch Spectrum Twente (Enschede), and University Medical Centre Groningen have granted permission to carry out this study. Study results will be disseminated via open-access peer-reviewed scientific journals and national/international conferences.
TRIAL REGISTRATION NUMBER
NCT05194527.
Topics: Humans; Mesenteric Ischemia; Volatile Organic Compounds; Academic Medical Centers; Biomarkers; Ethics Committees, Research; Observational Studies as Topic; Multicenter Studies as Topic
PubMed: 37643848
DOI: 10.1136/bmjopen-2023-072875 -
Sexual and Reproductive Health Matters 2021Promoting sexual health is a World Health Organization (WHO) priority. Lubricants are widely available and used to improve sexual pleasure and reduce pain during... (Review)
Review
Promoting sexual health is a World Health Organization (WHO) priority. Lubricants are widely available and used to improve sexual pleasure and reduce pain during intercourse. To inform WHO's self-care interventions guideline, we conducted a systematic review of the peer-reviewed literature to answer the question: does use of lubricants during or prior to sex result in improved sexual health and well-being. We searched PubMed, CINAHL, LILACS and EMBASE on 8 July 2020 for effectiveness, values and preferences, and cost data related to commercially available vaginal and anal lubricants. Data were systematically extracted and qualitatively synthesised. Effectiveness evidence was summarised in GRADE evidence profiles. Seven studies met the effectiveness review criteria. Two randomised trials found lubricant use led to improved female sexual well-being and had no impact on incidence of human papillomavirus (moderate certainty evidence). One observational study with gay and bisexual men showed lubricants were associated with increased reports of pain during receptive intercourse and no difference in pain during insertive intercourse, but a reduced degree of pain in both types of intercourse (low/very low certainty evidence). One observational study with female breast cancer survivors found better outcomes of vaginal dryness and dyspareunia with lubricant use (very low certainty evidence). Twenty-one values and preferences studies from diverse populations globally found that most individuals supported lubricant use for reasons of comfort/reduced pain and sexual pleasure. No cost studies were identified. Although evidence is limited, lubricants appear to offer an acceptable approach to improving sexual health and well-being.
Topics: Bisexuality; Coitus; Female; Humans; Lubricants; Male; Observational Studies as Topic; Sexual Behavior; Sexual Health
PubMed: 35315312
DOI: 10.1080/26410397.2022.2044198 -
Clinical Drug Investigation Aug 2023Numerous biologic drugs, including etanercept and adalimumab, are administered subcutaneously. This study reviewed the evidence on the usability and preference of... (Review)
Review
Healthcare Professional (HCP) and Patient Usability Evaluation and Preferences of Two Auto-injector Devices for Self-Injection of Biosimilars, SB4 and SB5: A Literature Review.
BACKGROUND
Numerous biologic drugs, including etanercept and adalimumab, are administered subcutaneously. This study reviewed the evidence on the usability and preference of self-injection devices of SB4 and SB5 compared with the reference product injectors.
METHODS
A systematic search was conducted in PubMed using the search string "(Imraldi OR Hadlima OR SB5 OR Benepali OR Brenzys OR SB4) AND (preference) AND (device)" covering the period from 28 January 2016 (first introduction of SB4) to 31 May 2022. Only articles and abstracts on usability or preference-rating of SB4 and SB5 autoinjectors (AI) written in English were selected. Additional papers identified via manual search supplemented the retrieved papers.
RESULTS
A total of nine articles and one conference poster were selected (seven surveys, one observational study, and two phase II studies). Overall, participants of the studies included nurses and rheumatologists, as well as patients who were from three medical specialties where these medicines are most commonly used (rheumatology, gastroenterology, and dermatology). The majority of patients and healthcare professionals rated ease of use and ease of grip as the most important device attributes. SB4/Pen and SB5/Pen were mostly preferred over their prefilled syringes (PFS), Enbrel/Pen, and Humira/Pen.
CONCLUSION
The analyzed data on usability and device preference indicate that SB4/Pen and SB5/Pen were preferred over the other reference product autoinjectors, thanks to their button-free design, auditory and visual injection feedback, and overall ease of use. Therefore, they were preferred over the other reference product autoinjectors. Because user-friendly devices can improve treatment adherence, pharmaceutical companies should consider patient convenience when developing medical devices.
Topics: Humans; Adalimumab; Biosimilar Pharmaceuticals; Delivery of Health Care; Dietary Supplements; Etanercept; Observational Studies as Topic
PubMed: 37615857
DOI: 10.1007/s40261-023-01284-5