Inadequate Documentation Research Articles

Knowledge, Aptitudes and Practice on Traditional Medicinal Plant use in Bafanji Village (Ngoketunjia Division, North West Region, Cameroon)

Bafanji village harbors a plethora of plants used in the treatment of several ailments. Alarmingly, traditional knowledge is quickly declining due to inadequate documentation and limited cross-generational transfer of knowledge. In this study indigenous medicinal plans were documented for their use, management and the threats affecting them. The study was carried out in Bafanji village between August 2015 and March 2016. Semi-structured questionnaires, interviews and field trips were used for data collection. Sample specimens were collected and identified. This study revealed that 6.06% of the population relied solely on medicinal plants for their health care while 15.14% do not use medicinal plants directly and 78.8% rely on both modern and traditional medicine for the treatment of their ailments. 92 plant species belonging to 51 families and 83 genera were documented. Family Asteraceae was the most represented (14.1%). More than one plant species is used to treat various ailments with the highest number of species (19) for malaria. Among the medicinal plant species recorded from the study area, the majority (55.4%) which were mainly herbs (70.7%) were collected from the wild. The leaves were the most commonly used plant part (44.5%). The principal method of remedy preparation was reported to be decoction. Oral administration was the most preferred mode. Knowledge of the use of plants as medicines was found to be confined to traditional healers and older folk. Documenting the eroding indigenous knowledge of medicinal plants and spurring youths to acquire traditional medicinal knowledge is recommended.

Mastering the Patient Handoff

Mastering the Patient Handoff

Transfer pricing tools for adjusting the company’s profitability

The article examines the tools for adjusting the company’s profitability, which can be used in transfer pricing. In recent decades, countries have adopted various rules to combat tax evasion and tax avoidance. Among such rules, it is advisable to single out the rules of transfer pricing and the rules of controlled foreign companies. These efforts have gained significant attention considering the G20 and OECD BEPS initiative. The regulations on transfer pricing contain regulations on the implementation of the «arm's length» principle. The regulations define the methods that can be used to calculate transfer prices, define documentation requirements, include in your application various special requirements necessary to confirm the transfer prices used, and establish penalties for detection of incorrect pricing or inadequate documentation. According to the legal and regulatory norms, the profitability of the controlled operation can be within the range and outside the price range. Depending on the type of controlled transaction, the company may not take any action (if all regulations are met) or may have to make an independent price adjustment. To determine profitability, it is necessary to sample prices and financial indicators of similar comparable operations on the market. The article discusses methods of transfer pricing: comparative uncontrolled price, resale price, «cost plus», net profit, distributed profit. The reasons for the drop in profitability have been identified. A credit note is defined as an effective tool for adjusting profitability. This tool allows for quality control and minimizing possible credit risks. International practice indicates the effectiveness of using the credit note mechanism to adjust profitability in transfer pricing. It was established that in Ukraine the legal status of a credit note is not defined in the legislative framework. This situation creates problems when using this tool and does not contribute to its wider use.

Transfusion Trend in a Community-Academic Center

Introduction: Transfusion of blood and blood products is the most common medical intervention in the developed world, with someone requiring blood transfusion once every 2 seconds. With nearly 16 million units of blood products being transfused in the US annually, it is important to reflect on the transfusion trend and formulate strategies to reduce transfusion when not clinically indicated. A study was done at a community-academic center in Florence, Alabama to assess the trend of transfusion and formulate appropriate strategies to minimize transfusions that are not clinically indicated. Methodology: The blood management team was formed by the hospital to trend the transfusion of blood and blood products. This team consisted of hospitalists, resident physicians, nurses, blood bank personnel, and administrative personnel. The team met regularly once every month to analyze the blood transfusion trend and to calculate the rate of compliance to clinical indications for transfusion. Data from August 2021 to July 2022 were analyzed to compute the rate of noncompliance. In March 2022 a prompt was introduced in the electronic medical record (EMR) system to assist with additional documentation for the ordering physician to document the indication for transfusion when the most recent hemoglobin was more than 7gm/dL. Compliance was defined as meeting one of the clinical indications for transfusion such as hemoglobin less than 7gm/dL, active bleeding, coronary artery disease, surgery, and symptomatic anemia. Noncompliance was defined as a transfusion that did not meet these criteria. Results Data from August 2021 to July 2022 revealed the average number of red blood cells transfused per month to be 293 units. Indications for each of these transfusions were reviewed individually to classify them as being compliant or noncompliant with clinical indications for transfusion. Analysis revealed an average rate of 14.4% of noncompliance from the month of August 2021 to March 2022. Following the introduction of the EMR prompt in March 2022, the documentation of the indication improved, revealing the difference between actual noncompliance and observed non-compliance. From April 2022 to July 2022, the average noncompliance rate was reduced to 10.4% Conclusion: The decision to transfuse often involves complex decision-making with an analysis of the risk-benefit ratio. Laboratory data needs to be correlated with the clinical scenario. Often what is considered noncompliance to clinical indication for transfusion may be a result of inadequate documentation as revealed by the data from our study. Our study serves to highlight that by utilizing simple tools on EMR, goal-directed transfusion can be achieved. In addition, the results of this study can also be generalized to other practice settings. We intend to trend the data over subsequent months to ensure further improvement. Plans are underway to display the results of this study in various areas within the clinical workspace with easy access to physicians as a reminder for appropriate and adequate documentation while ordering blood and blood products. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Improving the provision of accurate driving advice to cardiac inpatients on discharge – a matter of both public and patient safety

Abstract Background/Introduction Cardiovascular disease can have a significant impact on an individual's ability to drive. The Driver and Vehicle Licensing Agency (DVLA) provides clear guidance on the legal obligation and limitations of drivers with cardiac conditions and the General Medical Council (GMC) sets out the responsibility of physicians' in providing and documenting this advice clearly. Failure to adhere to these requirements has safety implications for both patients and the public, and medico-legal implications for practitioners. Purpose We sought to audit the percentage of patients receiving the correct driving advice on discharge and improve any inadequacies found through a two-stepped intervention in a tertiary cardiac centre Methods A retrospective analysis of the clinical notes of patients discharged from cardiac wards over a 3-week period was conducted and documentation of accurate driving advice was assessed. Using Plan-do-study-act (PDSA) methodology, two cycles of change were implemented. During PDSA cycle 1, a poster outlining cardiology specific DVLA advice was created. The poster was displayed throughout all cardiac wards to educate and encourage healthcare workers to communicate and document driving advice to patients. During PDSA cycle 2 a teaching session highlighting relevant DVLA advice and the importance of documenting this advice was delivered to all healthcare workers within the Cardiology department. The poster was also integrated into the department's staff induction booklet. Results The baseline audit showed that only 2.5% (1/40) of discharge documentation included accurate driving advice. After the second PDSA cycle, there was a statistically significant improvement to 52.5% (21/40) (P<0.0001). Qualitative feedback was obtained in the form of questionnaires and it was found that confidence and knowledge of driving advice improved amongst the junior doctor cohort. Conclusion This study highlights the medico-legal implications for physicians and the risks to patient and public from inadequate documentation of driving advice in cardiac patients. We have demonstrated a quick and effective method to improve documentation of driving advice in cardiology patients which is easily reproducible in different settings. Funding Acknowledgement Type of funding sources: None.

A cross-sectional study in three German hospitals regarding oxygen therapy characteristics

Oxygen (O2) therapy is one of the most commonly applied medications in German hospitals and rescue services. Both hypoxemia and hyperoxemia can be associated with complications. There is currently a lack of reliable data on the use, documentation and surveillance of O2-therapy in German hospitals. We conducted a cross-sectional study on the use of O2 in three hospitals in Hannover, Germany. Of 343 patients included in this study, 20 % received O2 therapy. Twenty-nine percent of patients receiving O2 were at increased risk for hypercapnia. A standard operating procedure (SOP) for O2 therapy was available in only 68 % of patients. In 22 % patients the applied O2-therapy was appropriate in the context of the documented vital parameters. A complete documentation of vital parameters was conducted in only 30 % of all patients and 41 % of patients receiving O2-therapy. A surveillance of O2-therapy using capillary or arterial blood gas analysis was performed in 76 % of patients. Here, 64 % of patients showed normoxemia, 17 % showed hyperoxemia and 19 % of patients showed hypoxemia. The only identifiable predictor for an adequate O2-therapy was a previous invasive ventilation. Our data point towards and inadequate prescription, application and documentation of O2 therapy. The recently released German S3-guideline should be used to increase awareness among physicians and nursing staff regarding the use of O2-therapy to improve O2 therapy and consequently patient safety.

Building stronger public health institutions (BIS) project: Deciphering the burden of air pollution in Ethiopia, (2021-2025)

Linking air pollution and health at a national level demands the use of a wide variety of data. The current state of science and practice recommends, countries to monitor pollutant concentrations in microenvironments and through satellite technologies. For this reason, countries with better policies and regulations are relentlessly assessing population exposure to air pollutants using air monitoring systems, from fixed atmospheric monitoring stations, atmospheric dispersion modelling, or spatial interpolation techniques for pollutant concentrations. Moreover, the use of systematic diseases surveillance system to document diseases distribution tandem with census data, administrative registers, and data on the patterns of the time-based activities at the individual scale, allowed them to better understand the burden of air pollution. Hitherto, Ethiopia has not established a national air pollution and health impact surveillance program or system to generate data that can be translated into policy or action. For this reason, the global burden of diseases lacks to present the full depiction of Ethiopia. This was ascribed to the dearth of information available on temporal and spatially representative ambient and indoor air quality monitoring efforts; inadequate documentation of population exposure, activity pattern, and diseases incidence to represent wide range of the social fabric. To this effect, the Norwegian public health institute (NIPH) through its four years program, building stronger public health institutions (BIS) (2021-2025), agreed to work with the Ethiopian public health institute (EPHI), to develop environmental epidemiological studies, to link air pollution and health. In doing so, establishing monitoring sites in collaboration with pertinent national authorities will be the first phase of the project. The second milestone will be identifying sentinel sites so as to track sex and age specific mortality and morbidity data of non-communicable diseases attributed to air pollution. Overall, the epidemiological studies will benefit Ethiopia to understand the burden of air pollution.

A double-edged weapon or commission forensic examination in civil trial on medical cases

BACKGROUND: A commission forensic medical examination is crucial for examining medical cases, and its conclusion is of fundamental importance to the court. However, experts often do not use their rights to the fullest extent, limiting themselves to the study of medical documentation. Such an approach negatively affects the quality of concrete conclusions, which is associated with legal risk in criminal and civil proceedings.
 CASE PRESENTATION: This review is devoted to a case report on moral damage compensation recovery from the hospital to the relatives of patient A., who died during medical care. A commission forensic medical examination could not establish death causation, citing inadequate medical documentation. The commission made no attempts to gather additional information on the case. The victims sued the two hospitals for a total of 2,500,000 rubles. The court of first instance dismissed the lawsuit, finding the defendants guilt unproven. The appellate court reversed this decision and indicated that the defendants must themselves prove their innocence; however, neither the available documentation nor the expert opinion was allowed to do this. The court ordered the defendants to pay 1,600,000 rubles.
 CONCLUSION: A commission forensic medical examination opinion must serve as evidence in the case. However, the court can interpret a formal approach to its performance against the defendants, sometimes even in cases where the medical care was potentially accurate and under accepted standards and recommendations.

Incidence of Facial Canal Dehiscent Noted Intraoperatively in Unsafe Chronic Suppurative Otitis Media: A Retrospective Study

Background: Dehiscence of the facial canal is a matter of great concern for an otologist as one of the most dreaded complications of mastoid surgery is injury to the facial nerve study was carried to determine the intra operative presence of facial canal dehiscence in primary and revision cholesteatoma surgery in a tertiary care centre. And also, our second goal was to identify association between FCD and other intra-operative pathological findings such as labyrinthine fistula, Dural plate dehiscence, sinus plate dehiscence in a group of patients with cholesteatoma surgery. Methods: A retrospective study was carried out in the department of Otorhinolaryngology in a tertiary referral hospital, Gujarat among 302 patients. The study’s inclusion criterion was primary and revision CWU and CWD tympano-mastoidectomy in patients who suffered from (CSOM) with cholesteatoma and exclusion criterion was charts with inadequate documentation. In addition, tympanoplasty cases were excluded as the study evaluated both tympanic and mastoid segments of facial nerve canal. Pre-operative clinical data and intra-operative findings were documented in a formatted questionnaire. Results: It was found that the incidence of FCD in our study of unsafe CSOM surgery was 21.22%. Conclusions: The surgeon should keep in mind during the procedures performed in the middle ear could potentially traumatize or damage the facial nerve at the site of dehiscence. A longer duration and more extensive cholesteatoma increase the chance of finding a dehiscent facial nerve. To this, we can prevent facial nerve paralysis and other complications in post-operative period and reduce the rate of morbidity.

Does the Levasseur-Merrill Retractor Provide Reliable In Vivo Guidance for the Intraoral Vertical Ramus Osteotomy?

Levasseur-Merrill retractor (LMR) utilization during the intraoral vertical ramus osteotomy (IVRO) helps initiate the osteotomy approximately 7mm from the posterior border of the mandible, preventing damage to the inferior alveolar nerve. The purpose of this invivo study is to evaluate the IVRO placement and the risk of neurosensory deficit (NSD) while using the LMR. This prospective case series was conducted at a single tertiary care center. Medical records were reviewed for medical and demographic information. Inclusion criteria were as follows: underwent the IVRO procedure by a single provider from June 2020 to June 2022 and postoperative cone beam computed tomography images. Exclusion criteria were as follows: age less than 16 years, previous mandibular osteotomies, inadequate clinical documentation, or follow-up. The primary outcome variables included the proximal segment width and proximity of the IVRO to the inferior alveolar foramen. The secondary outcome variable was NSD as measured subjectively by 2-point discrimination, sharp versus dull touch, and light touch with von Frey filaments. The 26 subjects (42 operated sides) were 96% female, with an average age of 30.1years (range 17-54years). The mean proximal segment width was 10.3±1.7mm (95% confidence interval: 9.77, 10.83). The mean distance from the posterior border of the inferior alveolar foramen (IAF) to the osteotomy was -0.89±1.7mm (95% confidence interval: -1.43, -0.35), with negative numbers indicating violation of the IAF. IAF and full bony canal violation occurred in 61.9% and 4.8% of operated sides, respectively. NSD at 6months postoperatively occurred in the 2 sides that experienced full bony canal violation. The LMR did not consistently guide the IVRO position within 7mm from the posterior border of the mandible as previously thought and allows for frequent violation of the IAF. Long-term NSD of the inferior alveolar nerve was infrequent and correlated with violation of the full bony canal.

Reevaluating Gendered Language in Surgery.

Reevaluating Gendered Language in Surgery.

A cross-sectional study in three German hospitals regarding oxygen therapy characteristics

ZusammenfassungEinleitung Sauerstoff (O2) ist eines der am häufigsten angewendeten Arzneimittel in deutschen Krankenhäusern und im Rettungswesen. Sowohl eine Hypoxämie als auch eine Hyperoxämie sind mit Komplikationen vergesellschaftet. In Deutschland fehlen bislang belastbare Daten zur Anwendung, Dokumentation und Überwachung der O2-Therapie. Methoden Eine Querschnittsstudie zur Sauerstoff-Anwendung wurde in 3 Krankenhäusern der maximalen bzw. supramaximalen Versorgung in Hannover im Herbst 2020 durchgeführt. Ergebnisse Von 343 erfassten Patienten erhielten 20 % eine O2-Therapie. Bei 29 % der Patienten mit O2-Therapie bestand ein Hyperkapnie-Risiko. Lediglich bei 68 % Patienten mit einer O2-Therapie lag eine SOP zur O2-Anwendung auf den jeweiligen Stationen vor und nur bei 22 % entsprach die gegebene O2-Therapie dem tatsächlichen Bedarf des Patienten. Nur bei 30 % des Gesamtkollektivs und 41 % der Patienten mit O2-Therapie erfolgte eine vollständige Dokumentation der Vitalparameter. Eine Überwachung der O2-Therapie mittels arterieller oder kapillärer Blutgasanalyse (BGA) erfolgte bei 76 % der O2-Patienten. Hier zeigte sich bei 64 % der Patienten eine Normoxämie, bei 17 % eine Hyperoxämie und bei 19 % eine Hypoxämie. Der einzige identifizierbare Prediktor für eine adäquate O2-Therapie war eine vorangegangene Beatmungstherapie. Diskussion Insgesamt zeigt sich eine suboptimale Indikationsstellung, Anwendung und Kontrolle der Sauerstofftherapie. Schulungen des pflegerischen und ärztlichen Personals zur Verbesserung der Anwendung der O2-Therapie und resultierend auch der Patientensicherheit sind dringend notwendig.

Analisis Manajemen Risiko pada Penerapan Sistem Informasi Pembangunan Daerah (SIPD) Menggunakan IEC/ISO 31010:2019

The purpose of this study was to analyze the risk of information technology in the application of the Regional Development Information System (SIPD) on the development planning menu at the Department of Communication, Information, Statistics and Encoding (DKISP) of Rote Ndao Regency using the IEC/ISO 31010:2019 standard. Risk management in this study includes the stages of communication and consultation, setting context, risk assessment, including the process of risk identification, risk analysis, risk evaluation, and risk treatment. The results of the study found that there were 17 possible risks in the SIPD application on the regional development planning menu. Of the 17 possible risks, there are three high-level risks, namely financial transaction failure, data leakage, misuse of accounts in the database system. Two risks at a moderate level are unreliable data and information and inadequate application documentation, as well as 12 risks with a low level, namely abuse of access rights, proposal submission being cancelled, database system error, proposal verification failure, users not understanding the function of the SIPD application menu, error in inputting prices in shopping accounts, data input for double development planning activities, failure to input income data, expenditure data not in accordance with programs, activities and sub-programs, system failure to archive deleted data, error in inputting validation ceilings, and sources of funds not having valid information. complete in accordance with SIPD features. The results of the risk management analysis are documented in the form of a risk register for management

1064 THINK STOOL CHART

Abstract Introduction Bowel care is an important part of care for older people. This quality improvement project (QIP) was carried out on the Older Person’s Assessment Unit at Arrowe Park Hospital which is a 24 bed acute frailty unit. Locally we found inadequate documentation of stool charts. This had the potential to cause problems related to constipation such as pain, increased use of catheters, delirium, bowel obstruction, thereby increasing length of hospital stay. Our aim was that all our patients would have a completed stool chart. Method Three Plan Do Study Act (PDSA) cycles were designed with input from the medical team, ward charge nurse and QIP lead. The first intervention was to discuss the importance of stool charts at board round. The second intervention included displaying a Bristol stool chart poster. The final intervention involved discussion with the clinical support workers and notices were displayed. Baseline audit data was collected and the audit repeated following each intervention. 12 patients were selected per cycle using alternate even and odd bed numbers. Data included if the amount, colour and stool type had been documented on the chart or the notes. Data was collected and presented using Google Sheets and Slides. Results Baseline data showed 40% of patients had a completed stool chart. Following the first intervention this improved to 50%. Data collected in PDSA cycle 2 showed the worst results with 25% of charts documented. After the final intervention stool charts were completed for 42% of patients. This information was less frequently documented in the notes. Staff experience and workload were likely factors affecting documentation. Conclusion The first intervention of active discussion with the multi-disciplinary team was most effective. Passive interventions such as displaying a poster was much less effective. There remains room for improvement and further PDSA cycles are planned.

Medicinal plant use, conservation, and the associated traditional knowledge in rural communities in Eastern Uganda

BackgroundThe global consumption of herbal medicine is increasing steadily, posing an extinction risk to medicinal plants. Uganda is among the top ten countries with a high threat of herbal medicine extinction, and Traditional Medicinal Knowledge (TMK) erosion. This might be attributed to the inadequate documentation, plus many more unclear hindrances. In this study, plant species used to treat human diseases in Butaleja district in Eastern Uganda and their associated TMK were documented. The conservation methods for medicinal plants were also evaluated. The rationale was to support the preservation of ethnopharmacological knowledge.MethodsData were collected from 80 herbalists using semi-structured questionnaires, from July 2020 to March 2021. Additionally, guided field walks and observations were conducted. Quantitative indices such as, use categories and informant consensus factor (ICF) were evaluated to elucidate the importance of the medicinal plants. Data were analyzed using STATA version-15.0 software.ResultsIn total, 133 species, belonging to 34 families and 125 genera were identified. Fabaceae (65%), and Solanaceae (29%) were the dominant families. Leaves (80%), and roots (15%), were the commonest parts used in medicinal preparations; mostly administered orally as decoctions (34.6%) and infusions (16%). The commonest illnesses treated were cough (7.74%), gastric ulcers (7.42%), and malaria (4.52%). The informant consensus factor was high for all disease categories (≥ 0.8), indicating homogeneity of knowledge about remedies used. Only 73% of the respondents made efforts to conserve medicinal plants. The commonest conservation strategy was preservation of forests with spiritually valued species (100%), while compliance with government regulations was the rarest (4.5%). Overall, efforts to stop the extinction of medicinal plants and TMK were inadequate.Conclusion and recommendationsThere was enormous dependency on a rich diversity of medicinal plant species and TMK for healthcare and income generation. The potential for medicinal plant biodiversity loss was evident due to habitat destruction. Inclusion of traditional cultural norms in conservation strategies, and laboratory-based efficacy tests for the species identified are necessary, to promote the conservative and utilization of validated herbal medicines and TMK in rural settings.

Lessons Learned When Discharging Older Adults to Skilled Nursing Facilities

Background: When patients transition from an inpatient hospital stay to a skilled nursing facility (SNF), the information that is sent with them is essential to proper care in the facility. Methods: Records of hospital-to-SNF transfer were reviewed for opportunities for improvement in providing accurate or complete information. SNF staff were asked about their experiences caring for these patients and the effects that the inadequate documentation had on the patient’s medical care. Results: Four cases were identified that exhibit key errors that make the transition from the inpatient setting to the SNF setting difficult and potentially unsafe for patients and providers. These included: (1) inaccurate medication reconciliation on discharge, (2) incomplete medication instructions on discharge, (3) lack of information about the inpatient course and diagnoses and (4) missing instructions for follow-up care and procedures. Conclusions: Education for hospital-based providers has the potential to decrease the risks associated with transitioning patients from inpatient to SNF care settings. Structural and systemic changes could reduce the role of human error in this process and decrease the time requirements on overburdened hospital staff.

Improving the weekend spinal ward round at a major trauma centre.

Documentation is key for communicating between members of the multidisciplinary team, allowing for better care, but documentation for spinal patients in the authors' centre was poor. Every ward round encounter was analysed for six weekends. Data were analysed and presented to the department. A weekend ward round proforma was designed to help improve ward-round documentation. Ward round entries were then re-audited over four weekends to assess the usefulness of the new proforma. A total of 69 patient encounters were analysed in cycle 1, 58 in cycle 2 and 92 in cycle 3. In cycle 1, 80% of encounters had inadequate documentation. Following introduction of the ward round proforma there was a significant improvement in documentation in six out of fields, which was maintained in four out of seven fields 2 years later. The authors believe that this improvement may avoid adverse effects on patient care, streamline doctors' time and reduce medicolegal consequences.

A single centre audit: repeat pre-operative colonoscopy.

Repeat colonoscopy may be required for tumour localisation. The aim of the study is to explore the clinical settings it was used and benchmark the quality of initial colonoscopy against standardized guidelines for tumour localisation, tattooing and colonoscopy reporting amongst clinicians. A retrospective study from 2016 to 2021 has been performed on patients who underwent elective colorectal cancer resections at the Northern Hospital. Patient demographics, colonoscopic and operative details were retrieved from the Bi-National Colorectal Cancer Audit (BCCA) Registry database and hospital medical records. changes in operative approach and delays to operation. reasons for a repeat colonoscopy and complications from repeat colonoscopy. A total of 339 patients were included in this study. 94 (28.6%) underwent a repeat colonoscopy. Re-scoping rate was 29.6% for surgeons, and 26.2% for non-operating endoscopists. Surgeons had a 5.9% localisation error rate, and non-operating endoscopist 6.95% (p= 0.673). Surgeons did not have a lower rate of repeat colonoscopy (p= 0.462). Repeat endoscopy was associated with a longer time to definitive operation (p < 0.001). No complications were associated with a repeat colonoscopy. There was no difference in localisation error rates or repeat colonoscopy amongst surgeons (29.6%) and non-operating endoscopists (26.2%) (p= 0.462). This could be explained by the standardized endoscopy training in Australia governed by a common training board. Lack of tattooing at index colonoscopy and inadequate documentation often led to a repeat endoscopy, which was associated with a longer time to definitive operation. Standardized guidelines in tattooing of lesions and colonoscopy reporting should be implemented.

An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period.

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year period and compare it with two similar earlier audits. WLs were reviewed and classified as per stakeholders and further categorised as per predefined violation themes. The chi-square test was performed for trend analysis of WLs. A total of 62 WLs were issued to the three stakeholders. The maximum number of WLs were issued to the clinical investigators (36/62, 58.06%), followed by sponsors (19/62, 30.64%), and least to the IRBs (7/62, 11.29%). Among sponsors, lack of standard operating procedures for the monitoring, receipt, evaluation and reporting of post-marketing adverse drug events was the most common violation theme (8/19, 42.1%). Among clinical investigators, deviation from investigational plan was the most common violation theme (31/36, 86.11%.). For IRBs, inadequate documentation was the most common violation theme (6/7, 85.71%). We saw an overall reduction in the number of WLs issued to the stakeholders. Thus, we identified multiple areas on which each stakeholder should work for improvement.

Comparing skin surface temperature to clinical documentation of skin warmth in emergency department patients diagnosed with cellulitis.

ObjectiveTo compare clinical documentation of skin warmth to patient report and quantitative skin surface temperatures of patients diagnosed with cellulitis in the emergency department (ED).MethodsAdult patients (≥18 years) presenting to the ED with an acute complaint involving visible erythema of the lower extremity were prospectively enrolled. Those diagnosed with cellulitis were included in this analysis. Participant report of skin warmth was recorded and skin surface temperature values were obtained from the affected and corresponding unaffected area of skin using thermal cameras. Average temperature (Tavg) was extracted from each image and the difference in Tavg between the affected and unaffected limb was calculated (Tgradient). Clinical documentation of skin warmth was compared to patient report and measured skin warmth (Tgradient >0°C).ResultsAmong 126 participants diagnosed with cellulitis, 110 (87%) exhibited objective warmth (Tgradient >0°C) and 58 (53%) of these cases had warmth documented in the physical examination. Of those with objective warmth, 86 (78%) self‐reported warmth and 7 (6%) had warmth documented in their history of present illness (HPI) (difference = 72%, 95% confidence interval [CI]: 62%–82%; P < 0.001). A significant difference was observed for Tavg affected when warmth was documented (32.1°C) versus not documented (31.0°C) in the physical examination (difference = 1.1°C, 95% CI: 0.29–1.94; P = 0.0083). No association was found between Tgradient and patient‐reported or HPI‐documented warmth.ConclusionsThe majority of ED‐diagnosed cellulitis exhibited objective warmth, yet significant discordance was observed between patient‐reported, clinician‐documented, and measured warmth. This raises concerns over inadequate documentation practices and/or the poor sensitivity of touch as a reliable means to assess skin surface temperature. Introduction of objective temperature measurement tools could reduce subjectivity in the assessment of warmth in patients with suspected cellulitis.