ANALISIS KINERJA BADAN LINGKUNGAN HIDUP PROVINSI JAWA TENGAH (STUDI PENGAMATAN DI BIDANG PENGENDALIAN PENCEMARAN LINGKUNGAN HIDUP)

“Future randomized controlled studies are needed” is a conclusion all too familiar to readers of scientific articles. This statement, distributed liberally in the literature, has come to signify little more than an obligatory admission of a study’s deficiencies. It simultaneously seeks to absolve the authors of any fault from potentially exaggerating the importance of their statistical findings while leaving it to the reader to decide how to apply and disseminate the novel information. The statement also implies that higher quality studies could and should be devised and points to salvation by way of the randomized controlled trial (RCT), the pinnacle of evidence-based medicine.1 Despite this, historical and present-day data show that RCTs are undertaken less frequently in surgery than in other areas of medicine.2–4 This raises concerns about the quality of surgical research, but what can surgeons do about it? Surveys have demonstrated a preponderance of cohort studies and case series in surgical journals, with RCTs accounting for fewer than 10% of publications.5,6 Reasons for lack of quality surgical research have been attributed to unique methodologic, practical, and ethical considerations in evaluating surgical procedures, and surgeon reluctance and lack of experience with surgical trials.3,7,8 Although high-quality RCTs are something to strive for, it is also clear that not all problems in surgery can be evaluated in an RCT. Solomon and McLeod studied 250 research questions in gastrointestinal surgery and concluded that, under ideal conditions, only 38.8% could have been answered with an RCT.9 Rather than attempting to answer every question with an RCT, surgeons should focus on using the best research design for their clinical questions. A variety of study designs can shed important insights if they are applied to the correct problem and conducted with methodologic rigor. The idea, development, exploration, assessment, and long-term study (IDEAL) model is a five-stage framework developed to guide best research practices throughout progressive stages of surgical innovation (Table 1).10,11 Early stages focus on refining the technique and its safety profile, whereas later stages are generally amenable to higher levels of scientific inquiry. With consideration for the stage of development of the surgical technique being investigated, a simple stepwise approach can be applied using the highest feasible level of evidence when choosing a study design. In this article, we outline important concepts and discuss various study designs—RCTs, observational studies with control groups, and case series—with a focus on minimizing biases. We consider various practical and methodologic issues specific to surgical research throughout. Table 1. - IDEAL Stages of Surgical Innovationa Stage Objectives Study Methods 1. Idea Initial technical description of new surgical procedure or technology Case reports, case series 2a. Development Description of early experience with new procedure or technology, including technical modifications and short-term/safety-related outcomes Prospective case series, observational studies 2b. Exploration Larger exploratory study to better define the relevant comparator groups and outcomes, and evaluate feasibility of a future RCT Prospective observational studies, RCTsb 3. Assessment Definitive comparative evaluation against the standard of care RCTs, large prospective observational studiesc 4. Long-term study Collect data for surveillance in real-world practice, identify new complications, and revise indications as needed Registry-based prospective cohort studies or case-control studies, rare case reports aDeveloped from initial description of IDEAL framework by McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374:1105–1112.bPerformed when feasible at this stage.cAppropriate when ethical or practical factors preclude performing an RCT. DESIGNING A SURGICAL RESEARCH STUDY A 1994 commentary entitled “The Scandal of Poor Medical Research” was a heated outcry for higher quality research to be performed for a purpose greater than expanding the researcher’s curriculum vitae.12 It pointed to a variety of factors plaguing medical research, including flawed designs, inadequate samples, inappropriate statistical analyses, and misleading interpretation of results. At the heart of the problem was the combination of the “publish or perish” research climate together with a “general failure to appreciate the basic principles underlying scientific research.” Although it is not the goal of this article to review these principles in detail, the concepts of validity, bias, and statistics warrant consideration for our subsequent discussion. Once a question and hypothesis have been established, choosing the study design is the next step. The process should consider ways to maximize validity and minimize bias. Internal validity refers to the accuracy with which the findings reflect true variation in the outcomes measured in the study sample, whereas external validity refers to the extent to which the findings are generalizable to clinical populations encountered in practice.13 The interplay between these concepts is complex. By way of selective inclusion and exclusion criteria, RCTs ensure that groups of patients compared are equivalent in almost all aspects, other than the treatment administered, in striving to achieve a high level of internal validity. This can come at the expense of external validity. For instance, surgeons in real-world practice encounter patients who would not meet the strict inclusion and exclusion criteria of such studies. Biases refer to factors outside of the surgical intervention that systematically influence the results of a study.14 They detract directly from the validity of the study and can occur during study design and preparation, data collection, analysis, and interpretation of results.13,14 Biases are categorized conceptually in terms of their overarching similarities.15 Important conceptual categories are selection biases, observation biases, and confounders (Table 2). Selection biases occur during design of a study and result in unintended differences between comparison groups. They are attributable to systematic flaws in the methodology used to select patients. For instance, in a nonrandomized study investigating a novel surgical procedure compared with nonoperative treatment, patients selected to undergo surgery would likely be healthier, more compliant, and have better access to care than patients treated nonoperatively. These baseline factors stack the odds in favor of surgical outcomes. Observation biases occur during data collection and can be attributed to flaws in the measurement tools used, effects of the study environment on patient behavior, or deferential attitudes of surgeons toward one of the groups. For example, surgeons may be more invested in obtaining favorable outcomes and minimizing complications of surgically treated patients, unintentionally providing better follow-up care. A confounder is any unaccounted for “third variable” responsible for the causal relationship observed in the study. This could be a patient factor, such as smoking, in a study comparing infection rates after different wound care regimens, or a treatment-related factor, such as asymmetry in the duration of postoperative immobilization, in a study comparing different interventions for fractures. Such factors could be more pertinent than the treatments themselves to the outcomes being investigated. Table 2. - Examples of Biases in Surgical Research Bias Description Means of Minimization Selection biases Nonrespondent bias Patients declining to participate in the study differ systematically from those who take part Optimizing communication of objectives, limiting burden of participating Referral bias Patients referred to clinician and recruited to study have more severe disease Predefined and evidence-based inclusion criteria Channeling bias Patients assigned to interventions based on prognostic factors Randomized studies with allocation concealment, stratification in nonrandomized studies Chronology bias Intervention group compared with historical cohort Using concurrent comparison groups Observation biases Recall bias Inaccurate reporting of treatment response by patients Using prospective design and objective outcome measurements Hawthorne effect Change in behavior as a result of participation in a study Randomization, blinding Performance bias Results influenced by variability in surgical technique or expertise Standardized protocols, different surgeons for different procedures, stratification by surgeon level of expertise Transfer bias Patients lost to follow-up differ from those who completed study By maintaining up-to-date contact information, limiting study burden, issuing reminders Detection bias Outcomes not measured uniformly in comparison groups Concurrent comparison groups, blinding, predefined objective outcomes Conflict of interest Competing interests or secondary gain influence outcomes Mandatory disclosure, randomized blinded designs Misuse of statistics and inappropriate interpretation of statistical findings are other common culprits of poor surgical research. The majority of these issues are attributable to unintentional oversights, but a small proportion are caused by deliberate fraud.16,17 Common statistical errors include inadequate power, selection of inappropriate statistical tests, and inappropriate subgroup analysis.18–20 Complex statistical techniques are often relied on to make up for deficiencies in the study design, such as lack of randomization. Studies also tend to focus on statistical differences without considering clinically important thresholds, leading to exaggeration of the findings. Like strategies to minimize bias, the use of statistics should be planned when designing the study, with primary and secondary outcome variables and the statistical plan specified a priori. A well-designed study can also simplify the statistical methods needed. A thorough understanding of validity, bias, and statistical methods is critical when selecting any of the specific study designs discussed below. RANDOMIZED CONTROLLED TRIALS Now suppose that you have formulated a novel and structurally sound research question and have the resources at your institution to conduct the ideal study. A logical approach would be to start atop the pyramid of evidence and determine whether an RCT could be devised before considering other study types at lower levels of evidence.21 RCTs are generally most appropriate in the exploration or assessment stage of surgical innovation, once the technical aspects and safety profile of the procedure are established. Conducting an RCT requires intensive devotion of resources and time. The Wrist and Radius Injury Surgical Trial, led by the senior author (K.C.C.) to evaluate outcomes of treatments for distal radius fractures, took 10 years to complete and required funding from two National Institutes of Health grants.22 Compared with other types of studies, the same factors that make the RCT a coveted entity can also make it unwieldy in surgical research. Ethical and Practical Considerations A variety of ethical and practical considerations pose challenges for surgical RCTs. Like other comparative studies, RCTs are designed to evaluate a null hypothesis, which requires a control group. Unlike pharmaceutical trials, a methodologically equivalent control in surgery, such as a placebo, is rarely possible. One might be tempted to consider nonoperative treatment to be analogous to the placebo. This common view has been the basis of many surgical trials but is often misguided. In reality, nonoperative treatments are highly variable and difficult to control. They can be interventions such as activity modification, immobilization, physical therapy, injections, or a combination thereof. Patients may also implement their own individualized lifestyle changes, such as specialized diets and fitness regimens. Even if the nonoperative treatment is tightly and reliably controlled, the natural history of the patient’s condition may confound outcomes. In surgical trials, the true equivalent of a placebo would be sham surgery, a notion that transgresses ethical boundaries except in the most selective circumstances.23 In most cases, the use of an RCT to evaluate a surgical procedure mandates clinical equipoise between the surgical treatment being investigated and some other treatment.8 Nevertheless, even the existence of true clinical equipoise does not guarantee the feasibility of an RCT. Randomization and allocation concealment can be difficult to execute.7,8 These attributes strip the patient and physician of the opportunity for shared decision-making. Patients may be uncomfortable with randomized treatment selection without input from the surgeon, or with the notion of being part of an experiment. Patients often arrive at the surgeon’s office with a preference for a particular treatment.24 Even when all of these factors are accounted for, patients who agree to participate in an RCT may differ from patients who do not consent, introducing selection bias.3 Ethical considerations are not limited to the patient. Surgeons conducting the study must strive to treat participants equally to avoid unduly influencing the results of the treatment groups. However, surgeons often have their own preferences for one procedure over another.25 If the same surgeon is performing multiple procedures in the study, he or she may also be more facile in one of the procedures, creating potential for performance bias. This brings forth the issue of blinding, which is generally easier to accomplish in medical trials than in surgical trials. Clearly, the surgeon performing the operation cannot be blinded, but it is also difficult to ensure that patients are blinded to the treatment that they received. Patients may become aware of the surgery that was performed based on the shape of a scar, length of time spent in the operating room, or some other discernible feature. The ethics of withholding information about the surgery from the patient and examiners at follow-up visits are controversial, particularly if difficulties with recovery or complications arise. Cost and challenges recruiting patients and ensuring they return to follow-up are other factors that can make the RCT unfeasible.26 Given some of the ethical and practical factors associated with RCTs, other study designs discussed below may be better options. Minimizing Bias in RCTs Good design is crucial for maximizing validity and minimizing bias. Alarmingly, analyses of all RCTs published in The Journal of Bone and Joint Surgery between 1998 and 2013 showed that trials evaluating surgical procedures (as opposed to nonoperative or medical interventions) and with surgeons as first authors scored significantly lower in quality.27,28 To illustrate features of a well-designed surgical RCT, consider a landmark trial investigating open reduction and internal fixation versus casting for minimally displaced scaphoid waist fractures (the Scaphoid Waist Internal Fixation for Fractures Trial).29 This study sought to answer a timely question that has been a longstanding area of clinical equipoise. Allocation concealment and randomization were used with a remote randomization service that stratified patients based on their pattern of fracture displacement, further minimizing confounders. Sample size was determined based on a priori power analysis, and statistical analyses were performed by a blinded statistician following a strict prespecified plan. Primary and secondary outcomes were stated from the outset, and potentially subjective radiologic tests were evaluated independently by two musculoskeletal radiologists and a surgeon. Instead of blinding patients and surgeons, the surgical technique and postoperative protocols were left to the discretion of the surgeons, allowing patient-centered care and accounting for differences in surgeons’ technical preference and skill. This practical approach sought to minimize bias while also maximizing external validity, which was important for a trial aiming to inform clinical practice on an international scale. Empiric data support the importance of sound study design on the results of an RCT. Colditz et al. found that the likelihood of an improved outcome from an experimental treatment increased significantly in the absence of randomization.30,31 In a study analyzing 250 controlled trials, treatment effects were increased by 41% when allocation concealment was inadequate and 30% when the extent of concealment was unclear.32 Trials that were not double-blinded yielded treatment effects 17% greater than double-blinded trials. Methodologic problems like these can lead to inaccurate interpretation of findings and distort knowledge found in the published literature. They can be avoided with use of validated quality checklists such as the Consolidated Standards of Reporting Clinical Trials guidelines when planning a study.33 Such frameworks serve as an important quality safeguard and should be familiar to surgeons undertaking RCTs. Grading systems specific to plastic surgery have also been developed.34 OBSERVATIONAL STUDIES WITH A CONTROL GROUP Many questions in surgery cannot be addressed with an RCT but are amenable to other study designs. A nonrandomized study with a control group should be considered when one of the ethical or practical factors discussed above precludes an RCT. Commonly used designs are cohort studies and case-control studies (Fig. 1).15 Although cohort studies are in a higher tier of evidence, both designs have specific indications, methodologic considerations, and biases.Fig. 1.: Observational study designs.Like RCTs, cohort studies can be highly influential in their scope. Because of fewer upfront demands on participants and less stringent inclusion criteria, these studies lend themselves to broader investigations when more knowledge is needed before performing an RCT. For instance, a prospective cohort study was devised to evaluate the effectiveness and safety of immediate implant-based breast reconstruction with or without mesh following mastectomy (Implant Breast Reconstruction Evaluation study).35 This is a current topic of interest for many plastic surgeons, with recent trends toward immediate reconstruction following mastectomy.36 Although previous RCTs evaluating immediate breast reconstruction had been performed, their validity was questioned because of performance biases and low sample size.37–39 The Implant Breast Reconstruction Evaluation study addressed this gap in knowledge with an exploratory design that included more than 2000 patients from 81 participating centers. Patients underwent different variations of breast reconstruction at the discretion of the treating surgeon, eliminating concerns for patient preference that are a major hindrance to RCTs in breast surgery.40 Multiple predefined primary outcomes were evaluated and multivariable logistic regression was used to control for confounders. In addition to eliminating practical hurdles of RCTs, advantages of cohort studies illustrated in this example include obtaining larger samples, evaluating multiple exposures and outcomes at once, and generating new hypotheses for future studies through an exploratory approach. Surgeons must also be aware of the pitfalls of nonrandomized studies. Without randomization, cohort studies have limited ability to account for confounders. A causal relationship is inferred from the chronologic sequence of exposures and outcomes, which is most convincing in prospective studies. Without blinding or allocation concealment, cohort studies are also susceptible to selection biases. Recall bias is a limitation for retrospective cohort studies because of factors such as inaccurate patient recall and reliance on information from patient charts.41 Variability in documentation practices makes the fidelity of large databases particularly concerning. In case-control studies, the inference of causation is especially problematic because comparison groups are selected based on their outcomes and analyzed retrospectively for exposures. Designing an observational study with a control group requires paying special attention to these inherent limitations and must be individualized to the research question. Exposures, outcomes, inclusion criteria, and statistical methods should all be planned in advance, even for studies meant to be “exploratory” or hypothesis-generating. Observational studies should be evaluated using standardized guidelines such as the Strengthening the Reporting of Observational Studies in Epidemiology framework.42,43 Retrospective cohort studies lend themselves to studying rare conditions and procedures, particularly with the availability of large national databases. Vast amounts of data can be extracted and analyzed rapidly. Meanwhile, case-control studies are useful for investigating factors underlying rare outcomes or complications. When using a registry or database, its purpose, completeness, and accuracy should be carefully evaluated.44 If the question would be better suited for an RCT and there are no major practical or ethical barriers, a higher level of evidence design should be pursued. CASE SERIES An appraisal of articles published in the general surgery literature in 1996 compared the preponderance of case series, 46% of all studies, to “comic opera,” pointing to a necessary shift toward higher quality research.6 A similar survey conducted 10 years later found the proportion of case series had decreased to 34%, with 51% of publications being cohort studies.5 Case series, which typically involve a retrospective account of outcomes from a single procedure, often from a single institution and surgeon, remain a common avenue for publishing novel information. The absence of a control group is their primary flaw, as a hypothesis cannot be tested.44 Retrospective case series are also culprits of publication bias, as new procedures with poor outcomes are unlikely to be published.45–47 Furthermore, failure to favorable results of new techniques are unlikely to be concerns about the validity of a case series from a single Case series are for providing for subsequent hypothesis They should be undertaken with specific such as the safety of a novel procedure or rare or complications. The IDEAL model the use of a case series to be appropriate in the or development first with a new procedure are a and are to the surgical To some of the pitfalls discussed prospective series should be performed with protocols for the new procedure and in of conducting the study. studies should also be to publication The use of retrospective series should be but at a involve patients without and a standardized reporting in the case of RCTs and observational studies, validated checklists can be used to minimize bias when reporting novel surgical interventions in a case A simple approach can be used to the best research design for a surgical question. with consideration for the IDEAL stage of the surgery being investigated, the highest level of appropriate for that stage should be evaluated for feasibility before considering designs at lower levels of the evidence RCTs the highest level of but are not suited for many questions. such as observation studies and case series, to be when practical and ethical considerations preclude the use of an RCT. of the study surgical research should quality design and minimize bias. funding from the National Institutes of from and and a research from to study outcomes. has no interest to in to the of this The authors would like to for and to the development of this They appreciate the review and from of at the of

Overview of the Epidemiology Methods and Applications: Strengths and Limitations of Observational Study Designs

Oil palm (Elaeis guineensis) is one of the most nutrient-intensive plantations in Malaysia. It requires many nutrients to reach its full potential and production stage. The main issue is that nutritional stress is a crop health issue caused by a lack of nutrient components to sustain crop growth requirements. We aimed to review the nutrient deficiency of oil palm based on an observation and literature study. The leaflet of the oil palm tree was analyzed for this study. The result showed that nutrient deficiency in oil palm is a common issue. Since oil palm is a heavy feeder plant that requires a well-balanced supply of nutrients, the continuous use of sustainable (eco-friendly) biofertilizers at a cost-effectively optimal level is necessary to achieve the maximum yield of oil palm. Though there are some inevitable causes of nutrient deficiencies, good management program should be carried out to lessen this problem and improve oil palm health and production.

Tuberculosis or TB is a type of infectious disease that is the center of world attention because it spreads very quickly and causes death. According to data from the Pekalongan Health Service, TB cases increase every year, in 2021 there were 347 cases, in 2022 there were 459 cases and in 2023 there were 505 cases. The research aims to determine the profile of TB cases, their characteristics based on age and gender and analyze the relationship between population density and the number of TB cases in Pekalongan Urban Area. The research design is an observational study on secondary data on the number of TB cases in 2021-2023 in Pekalongan Urban Areas. Using purposive sampling, the total research sample focused on four areas, namely North Pekalongan District, South Pekalongan District, East Pekalongan District and West Pekalongan District. Data collection techniques are observation and literature study. Descriptive data analysis and inferential analysis uses the Pearson Correlation Test. The research results explain that almost every sub-district in Pekalongan Urban Areas during 2021-2023 experienced an increasing trend in the number of TB cases. Based on age, the highest trend of TB cases occurs in productive age (15-65 years) compared to children. Based on gender, the highest number of TB cases occurs in men. On the other hand, no relationship was found between population density and the number of TB cases in Pekalongan Urban Areas (p value = 0.380 > 0.05). So, integrated preventive and promotive efforts are needed from the community.

Introduction: The implementation of occupational safety and health is one form of effort to create a safe, healthy and prosperous work environment, free from work accidents and occupational diseases, and free of environmental pollution towards increased productivity including the implementation of Occupational Safety and Health Management. Methods: This study aims to see an overview of occupational safety management. The research was conducted in the cutting process at the Warship Division of PT PAL Indonesia (Persero) in 2022. This research is an observational study. Data collection was carried out through observation, discussion, interviews and literature studies related to process flow and work environment measurements. Data analysis using the HIRADC method. Results: Based on the risk management of the cutting process in the Warship Division of PT PAL INDONESIA (Persero), there are 7 hazards that pose a risk. Risks have varying severity and frequency. The most frequent and severe type of risk is fire. Conclusion: The risk control that has been implemented is good, as evidenced by the decrease in the risk category in the residual risk, which is a low and medium risk category. PT PAL INDONESIA Warship Division is very committed in implementing risk control.

It is the most arduous and challenging task to observe and record the geological coordinates of earthquake precursor locations and the corresponding epicenter zones, in Indonesia - the largest archipelago in the world and Caribbean regions. For the convenience of observational earthquake prediction study, active seismological regions of Indonesia have been divided into 10 major epicenter zones- Northern Sumatra, Southern Sumatra, Sunda Strait, Jawa, Kalimantan, Northern Sulawesi, Southern Sulawesi, Maluku and Irian Jaya, Papua and Nusatenggara. Indonesia is in the Indian and Pacific Ocean, whereas the Caribbean regions are in the Atlantic Ocean side, though they are in three entirely different regions but all the seismically active regions are having the same generation process of all form of atmospheric weather and earthquakes, is the most significant findings in this observation study since 1985. This wonderful observation study over 35 years confirms strongly confirms the strong generational process scientific relation between atmospheric weather and seismic anomalies. Observational data for different Ocean regions simply identifies the impending earthquake locations based on rainfall locations.

Low Dose Ruxolitinib in Indian Haplo-Identical Transplant Patients with Steroid Refractory Acute Graft Versus Host Disease

A newly acquired spinal cord injury (SCI) has an impact on various aspects of a patients' functioning. Outcome measures represent an important component of initial rehabilitation to assess patients' overall status and their progress, simplify clinical communication and support clinical decision-making. The aim of this review was to create an evidence base for developing clinical practice guidelines using systematic literature review to evaluate assessment instruments used in acute/subacute SCI rehabilitation. PubMed, CINAHL, Cochrane Library and LIVIVO databases were searched using the MeSH terms and key words of the Spinal Cord Injury Research Evidence (SCIRE). Studies on outcome measures with patients in the acute/subacute phase of SCI, published in English or German from January 2013 until December 2018 were included. Two reviewers independently screened articles and when a consensus was not reached two further reviewers were consulted. To determine publication quality of systematic reviews, validation and observation studies, AMSTAR, COSMIN and STROBE checklists were applied. A total of 2533 records were retrieved, 71 potentially eligible articles identified, and 33 articles finally included. One validation and one observational study met all quality criteria. One systematic review received eight from a maximum of 11 points for publication quality (AMSTAR). Ten of 19 validation studies were deemed as "excellent" or "good" (COSMIN), but some were hampered by the low number of study participants. From the 29 reviewed assessments 28 were recommended and one was not. Seven of 13 observational studies received a rating equal or higher to 20 out of a maximum of 22 points (STROBE). Assessments covered neuro-musculoskeletal, sensory and pain, mental and skin structures and functions, as well as activity, participation and quality of life. In the field of initial SCI rehabilitation, scientifically sound assessments covering different aspects of the bio-psychosocial model of the ICF are available. According to COSMIN, validation studies struggled with quality, whereas observational studies and systematic studies performed well. The review results support the evidence-based selection of outcome measures for assessing the initial rehabilitation of patients with acute and subacute SCI. These results represent an update for recommendations for clinical guidelines on standardized rehabilitation outcome documentation.

Background: Trigeminal neuralgia (TN) is a pain appearing in the ophthalmic (V1), maxillary (V2), and mandibular (V3) trigeminal branches. Pharmacologic treatment is the first line for TN; however, many patients prefer to receive minimally invasive treatment rather than medicine because of intolerable side effects. Thermocoagulation radiofrequency (TRF) is a minimally invasive treatment that has been shown to effectively treat the maxillary (V2) and mandibular (V3) divisions, but the safety of TRF treatment of the ophthalmic (V1) division has been controversial. Objective: This study was to observe the effectiveness and safety of TRF treatment of the ophthalmic (V1) division of trigeminal branches in idiopathic TN patients. Study Design: An observational study. Setting: All of patients received temperature controlled TRF, the effectiveness and safety of TRF was assessed by VAS and complications. Methods: Eighty patients with ophthalmic division (V1) or ophthalmic division (V1) combined with maxillary (V2) or mandibular (V3) divisions of idiopathic TN were treated with step-increased temperature TRF for 6 minutes. At a pulse width of 20 ms, the temperature was titrated up 2 degrees from 60 degrees to 66 degrees every 60 seconds, and then another 66 degrees or 68 degrees for 2 minutes. Meanwhile, the tip of the cannula was turned 180 degrees with each temperature titration. Patients were assessed for pain relief and corneal reflex, numbness, and masticatory muscle weakness at one week, one month, and 3 months after the procedure. Results: Eighty patients were successfully treated with temperature controlled TRF for ophthalmic (V1) division. Excellent pain relief was achieved in 79 of 80 patients (98.75%) after one week, one month, and 3 months, and 78 of 80 patients (97.5%) patients experienced tolerable numbness. Only one patient lost the corneal reflex, 14 experienced a corneal reflex that was mildly decreased, and 2 patients felt a foreign body sensation in the ipsilateral eye after TRF, but there were no corneal ulcers, incidences of blindness, or other complications. Limitations: This study is limited by being an observation study and a non-prospective trial with a short-term follow-up period. Conclusion: Temperature controlled TRF to the ophthalmic division (V1) of the semilular ganglion is effectiveness and safe in TN. Key words: Thermocoagulation radiofrequency, pulsed radiofrequency, trigeminal neuralgia, ophthalmic division, trigeminal ganglion, pain, numbness, corneal reflex

The aim of this study was to evaluate whether bystanders with no training in triage can correctly prioritize three injured patients by using a triage instrument. An observational study was conducted. Participants performed a primary triage on three paper-based patient cases and answered 11 questions during a public event in the center of Stockholm, Sweden. A total of 69 persons participated in the study. The success rate among all the participants for correct triage of the three patient cases was 52 percent. The female participants and younger participants (<55 years of age) performed correct triage to a greater extent. The over-triage was 12.5 percent and under-triage was 6.3 percent. Participants with no prior knowledge of triage instruments may be capable of triaging injured patients with the help of an easy triage instrument. The over- and under-triage percentages were low, and this may indicate that the developed triage instrument is relatively easy to use. It may also indicate that bystanders can identify a severely injured patient. Nordberg M , Castrén M , Lindström V . Primary trauma triage performed by bystanders: an observation study. Prehosp Disaster Med. 2016;31(4):353-357.

Statement of purpose Bicycling is becoming a popular mode of transportation within the United States. Due to the increase of cyclists/vulnerable road users, laws and safety recommendations are being established to keep all road users safe. The purpose of this study was to observe bicycle safety behaviours and road law compliance of personal and bike share users at several high traffic intersections in Boston, MA. Methods/Approach This is a prospective observational study of safety and law compliance behaviours of bicyclists in downtown Boston. Investigators observed bicyclists for specific law and safety compliance behaviours including: wearing a helmet, riding in bike lanes, displaying reflectors at night, and obeying all road laws. The findings of this study were compared to other national and international studies that observed bike share and personal bike users. Results 1685 cyclists were observed. Of all observations, 74% of all bikers wore a helmet and 83% obeyed the road laws. 39% bike share riders and 78% of personal bikers were observed wearing a helmet (p = 0.0001). A sample of 680 cyclists was observed for obedience with mandated reflector laws at night and 39% were in compliance (p = 0.001). Conclusions Boston bicyclists were more compliant with helmet use and road law compliance as compared to prior studies in the US and Canada. The majority of cyclists demonstrated safe cycling practices, however other unsafe cycling behaviours were noted and merit further investigation (i.e. distracted biking). Bicycling is common mode of daily transportation, and more observational studies and interventional studies are needed to assess and mitigate emerging risks for bicyclists in today’s society. Significance and contribution to the field This is one of the first comprehensive bike observation studies in the city of Boston that provides data on multiple cycling safety behaviours. Based on our observations, the use of electronic devices while biking is widespread and requires further investigation.

AimMaintaining neonatal resuscitation skills among health workers in low resource settings will require continuous quality improvement efforts. We aimed to evaluate the effect of skill drills and feedback on neonatal resuscitation and the optimal number of skill drills required to maintain the ventilation skill in a simulated setting.MethodsAn observational study was conducted for a period of 3 months in a referral hospital of Nepal. Sixty nursing staffs were trained on Helping Babies Breathe (HBB) 2.0 and daily skill drills using a high-fidelity manikin. The high-fidelity manikin had different clinical case scenarios and provided feedback as “well done” or “improvement required” based on the ventilation performance. Adequate ventilation was defined as bag-and-mask ventilation at the rate of 40–60 breaths per minute. The effective ventilation was defined as adequate ventilation with a “well done” feedback. We assessed the correlation of number skill drills and clinical case scenario with adequate ventilation rate using pearson’s correlation. We assessed the correlation of number of skill dills performed by each participant with effective ventilation using Mann Whitney test.ResultsAmong the total of 60 nursing staffs, all of them were competent with an average score of 12.73 ± 1.09 out of 14 (p < 0.001) on bag-and-mask ventilation skill checklist. Among the trained staff, 47 staffs participated in daily skill drills who performed a total of 331 skill drills and 68.9% of the ventilations were done adequately. Among the 47 nursing staffs who performed the skill drills, 228 (68.9%) drills were conducted at a ventilation rate of 40–60 breathes per minute. There was no correlation of the adequate ventilation with skill drill category (p = 0.88) and the level of skill performed (p = 0.28). Out of 47 participants performing the skill drills, 74.5% of them had done effective ventilation with a mean average of 8 skill drills (SD ± 4.78) (p-value- 0.032).ConclusionIn a simulated setting, participants who had an average skill drill of 8 in 3 months had effective ventilation. We demonstrated optimal skill drill sessions for maintain the neonatal resuscitation competency. Further evaluation will be required to validate the findings in a scale up setting.

A Prospective, Observational Study on the Safety and Effectiveness of Rituximab Plus Chemotherapy As the First-Line Treatment of Diffuse Large B-Cell Lymphoma

From the ancient period to the current day, each cultural area has had their distinctive dietary pattern (combinations of dietary components, such as food or nutrients, to summarize a total diet) to adapt to their lifestyle and environments, such as a Western style diet (American style), Mediterranean diet and Asian diet (Japanese style). In recent years, chronic diseases such as diabetes, obesity, atherosclerosis, cardiovascular disease, and hypertension incidence and prevalence rate, have rapidly increased and have become a burden of public health management. Because lifestyle modification is the only confirmed preventive method for the rapid increase of these patients, several methods are recommended, such as nutritional modification and diverse exercise without drug therapy. In these lifestyle modification methods, dietary modification is extremely important for chronic disease prevention and management. So many dietary recommendations released by the international scientific committees and organizations state that a diet should be moderately low in caloric content, low in fat and carbohydrate content, and high in protein and fiber. These diets emphasize the reduction of carbohydrate intake and thereby encourage high protein intake, given that, in Western countries, high fat diets are also generally avoided. Many diets are low in carbohydrates and high in protein, such as the Atkins diet. Very low-carbohydrate diets typically contain <10% carbohydrates, 25–35% proteins and 55–65% lipids. For comparison, the average American diet contains 50% carbohydrates (275 g/day), 15% protein (83 g/day) and 35% lipids (85 g/day). In the UK, the mean intake, as a percentage of total energy, is approximately 48% carbohydrates, 17% protein and 35% lipids1. Hession et al.2 suggest that low-carbohydrate, high-protein diets were associated with a slightly greater increase in high-density lipoprotein cholesterol and to a slightly greater decrease in triglycerides. In contrast, these diets were associated with a slightly greater increase in low-density lipoprotein cholesterol. Recently, low-carbohydrate and high-protein diets have become extremely popular with consumers and patients. However, concerns have been expressed about the health effects of low-carbohydrate and high-protein diets3, 4, even though little documented information exists about the long-term health consequences of low-carbohydrate and high-protein diets. Also these methods have not been fully confirmed for their benefit and usefulness by long-term, large, randomized clinical trials, but have only been found by short-term, small, randomized clinical trials and meta-analysis. Last year in Annals of Internal Medicine, Fung et al.5 published a very interesting article about all cause and cause-specific mortality in a Nurses’ Health Study and Health Professionals’ Follow-up Study cohort. They examined the relationships of animal based or vegetable based fat and protein mixed low-carbohydrate diets with cardiovascular and cancer mortality over 20-years prospective follow up in two cohorts. They used a low-carbohydrate score, which was based on the percentage of energy as carbohydrate, fat and protein. They concluded that a low-carbohydrate diet based on animal sources was associated with higher all-cause cardiovascular and cancer mortality in both men and women, whereas a vegetable-based low-carbohydrate diet was associated with lower all-cause and cardiovascular disease mortality rates5. Another three long-term observational studies on the effects of a long-term low-carbohydrate diet on mortality were carried out1, 6. In a long-term cohort study of Swedish women6, decreasing carbohydrate or increasing protein intake by one decile were associated with an increase in total mortality by 6% (95% CI 0, 12) and 2% (95% CI −1, 5), respectively. So, they concluded that low carbohydrate and high protein intake was associated with increased total and, particularly, cardiovascular mortality amongst women. During 10 years of follow up in Greek participants of the European Prospective Investigation Cancer and Nutrition study1, higher intake of carbohydrates was associated with a significant reduction of total mortality, whereas higher intake of protein was associated with a non-significant increase of total mortality. Positive associations of low-carbohydrate and high-protein score were noted with respect to both cardiovascular and cancer mortality. Therefore, they suggested that prolonged consumption of diets low in carbohydrates and high in protein is associated with an increase in total mortality. In an elderly Swedish cohort study6 for 10.2-year median follow up, adjusted hazard ratios for the Mediterranean diet score were 0.71 (95% CI 0.55, 0.92) for all-cause mortality and 0.63 (95% CI 0.42, 0.96) for cardiovascular mortality, and the carbohydrate restricted diet scores were 1.19 (95% CI 0.97, 1.45) for all-cause mortality and 1.44 (95% CI 1.03, 2.02) for cardiovascular mortality. They concluded that adherence to a Mediterranean dietary pattern decreased mortality, but adherence to a carbohydrate-restricted dietary pattern increased mortality in elderly Swedish men. Another Asian population-based cohort study7 was divided into three major dietary patterns (vegetable-rich, fruit-rich and meat-rich) and followed up for 5.7 years. They reported that the meat-rich diet was associated with increased risk of diabetes (HR = 1.18; 95% CI 0.98, 1.42) and a slightly elevated risk of total mortality, whereas the fruit-rich diet lowered mortality. From the aforementioned four studies’ results, low-carbohydrate and high-protein diets didn’t show favorable effects for cardiovascular and cancer mortality. On the contrary, adverse effects have not been reported for the long-term consumption of Mediterranean-type diets, low-glycemic index/glycemic load diets or low-carbohydrate, high vegetable protein diets. Are all kinds of low-carbohydrate high-protein diets sustainable and safe for very long periods? Are all low-carbohydrate high-protein from vegetable origin diets really beneficial to specific disease mortality? No definitive answer exists. Future studies will need to address the long-term safety of low carbohydrate high-vegetable protein diets. How did we interpret and understand these results? All forms of low-carbohydrate and high-protein diets did not have adverse long-term effects. Therefore, frequently recommended dietary patterns that indiscriminately focus on low intake of carbohydrates and high intake of proteins in general, should be considered for effectiveness. However, large population-based, long-term intervention studies analyzing the impact of specific dietary patterns on the mortality of specific diseases are not feasible. The results of the study by Fung et al.5 must be confirmed by well-designed, large, population-based, long-term interventional studies. Until now, observational trials remain a major source of evidence for differential effects of the quantity and quality of carbohydrates and protein on the risk and mortality of specific diseases. In observational studies for dietary pattern, many researchers use exploratory and hypothesis-oriented approaches (Table 1). Therefore, these epidemiological observation studies have many limitations, such as the selective under-reporting of nutritional intake possibly being related to specific diseases and the conscious awareness of the relationship between food intake and specific diseases. These limitations are of particular concern for cross-sectional studies and less pertinent for prospective studies addressing disease outcomes, such as cardiovascular disease and cancer. So, simultaneous consideration for the prospective epidemiological evidence linking diet to the subsequent development of outcome was very important. In conclusion, each dietary pattern reflects the specific traditional cultures and environments where the population lives. Therefore, frequently recommended dietary pattern modification to prevent specific disease development and adverse outcomes should be considered seriously before being applied to the whole population. Dietary pattern modification must be evaluated for its efficacy and adverse effects, not by an observational study, but a prospective epidemiological intervention study.

An assessment of community health workers’ ability to screen for cardiovascular disease risk with a simple, non-invasive risk assessment instrument in Bangladesh, Guatemala, Mexico, and South Africa: an observational study