Real-world safety data for the Pfizer BNT162b2 SARS-CoV-2 vaccine: historical cohort study.

OBJECTIVE: The Pfizer BNT162b2 vaccine showed a reassuring safety profile in clinical trials, but real-world data are scarce. Bell's palsy, herpes zoster, Guillain-Barré syndrome (GBS) and other neurological complaints in proximity to vaccination have received special public attention. We compared their rates among vaccinated and unvaccinated individuals. METHODS: Individuals ≥16 years vaccinated with at least one dose of BNT162b2 were eligible for this historical cohort study in a health maintenance organization insuring 1.2 million citizens. Each vaccinee was matched to a non-vaccinated control by sex, age, population sector (general Jewish, Arab, ultra-orthodox Jewish) and comorbidities. Diagnosis of Covid-19 before or after vaccination was an exclusion criterion. The outcome was a diagnosis of Bell's palsy, GBS, herpes zoster or symptoms of numbness or tingling, coded in the visit diagnosis field using ICD-9 codes. Diagnoses of Bell's palsy and GBS were verified by individual file review. RESULTS: Of 406 148 individuals vaccinated during the study period, 394 609 (97.2%) were eligible (11 539 excluded). A total of 233 159 (59.1%) were matched with unvaccinated controls. Mean follow was 43 ± 15.14 days. In vaccinated and unvaccinated individuals there were 23 versus 24 cases of Bell's palsy (RR 0.96, CI 0.54-1.70), one versus zero cases of GBS, 151 versus 141 cases of herpes zoster (RR 1.07, CI 0.85-1.35) and 605 versus 497 cases of numbness or tingling (RR 1.22, CI 1.08-1.37), respectively. DISCUSSION: No association was found between vaccination, Bell's palsy, herpes zoster or GBS. Symptoms of numbness or tingling were more common among vaccinees. This study adds reassuring data regarding the safety of the BNT162b2 vaccine.

Reversible conductive hearing impediments among patients with severe brain injury.

Purpose: Rehabilitation of patients with severe traumatic brain injury may include auditory stimuli. Hampering the function of the external, middle ear or Eustachian tube generates a conductive auditory deficit up to 35 dB that may potentially hinder auditory rehabilitation. The objective was to evaluate the incidence of conductive hearing impediments among patients with severe brain injury.Methods: The cross-section study included adults with severe brain injury hospitalized in a rehabilitation center. The patients presented with a prolonged vegetative state, were dependent on mechanical ventilation and gastrostomy tube feeding. Assessment of external, middle ear and Eustachian tube included otoscopy, tympanometry, nasopharyngoscopy, gag reflex and soft palate evaluations.Results: Nineteen patients (38 ears) were evaluated: 14 males and 5 females, aged 18-93 years (average 59). All patients had a normal nasopharynx, lacked a gag reflex, palatal movements or supraglottic sensation. Eighteen ears (47%) had middle ear effusion, 26 (68%) ears had cerumen impaction, and 14 (37%) had both.Conclusions: Many patients with severe brain injury have reversible and treatable impairments that cause potential conductive hearing loss. Routine otoscopic examination and treatment if required, that is, removal of impacted cerumen or middle ear drainage, have rehabilitating and general health benefits.Implications for rehabilitationAuditory stimulation was suggested for rehabilitation in patients with severe traumatic brain injury.Many patients have cerumen and/or otitis media with effusion causing conductive hearing impairment as well as general health issues.Both aural impediments are diagnosed by routine otoscopy, are easily treated, and may affect rehabilitation.

Comparing assessment of diabetes-related quality of life between patients and their physicians.

BACKGROUND: Health-related quality of life (QoL) is a comprehensive, multidimensional construct encompassing physical and psychosocial wellbeing. Physicians frequently assess QoL as part of their decision making process without specifically asking their patients. This study examined the degree and predictors of concordance between physician and patient assessments of QoL among patients with diabetes in primary care and in multi-disciplinary diabetes clinics. METHODS: Patients completed a questionnaire regarding overall and diabetes-specific QoL before entering their physician's office. After the visit, the physician completed the same questionnaire in order to evaluate how he/she perceived that patient's QoL. In addition, medical data relating to the patient's health status were collected from the medical records. The concordance between patient-reported QoL and physician-estimated QoL was evaluated. Stepwise regression analysis was conducted to determine which factors contributed to the difference between physicians' and patients' assessment of QoL. RESULTS: A total of 136 patients and 39 treating physicians were surveyed. Patients' response rate was 95%. A strong concordance was found between patients' and physicians' ratings of current health status (r = 0.79, p < 0. 01); however, physicians perceived their patients' QoL as worse than the QoL assessed by the patients themselves. Primary care physicians were better at assessing their patients' overall wellbeing while diabetes-specialists were better at assessing their patients' diabetes-specific QoL. In addition, the longer the duration of diabetes, the more difficult is was for the physicians to accurately assess QoL. When entered in the regression analysis, familiarity did not explain physicians' ability to assess health-related QoL or diabetes-specific QoL. CONCLUSIONS: Physicians make reasonable assessments of their patients' QoL, however as the patients' disease progresses, it becomes harder for physicians to assess QoL. Primary care physicians are better at assessing overall well-being whereas diabetes specialists are better at assessing diabetes-specific QoL. TRIAL REGISTRATION NUMBER: Not registered. Assuta Medical Center institutional review board approval number 2009103.

[EXECUTIVE FUNCTIONS AND DAILY FUNCTIONS, ROAD SIGN RECOGNITION AND DRIVING SELF-REPORT AMONG HEALTHY AND POST-STROKE DRIVERS].

INTRODUCTION: Driving is an essential part of occupational performance. In determining potential driving competence, there is a lack of screening tools to ascertain who should be referred for further assessment in Occupational Therapy or at the Medical Institute for Road Safety. AIMS: To assess the relationship between executive-function, daily-functions and driving behavior measures in unimpaired and neurologically impaired populations. BACKGROUND: Although the research findings were not statistically significant, the trend points to the correlation between executive-function measures and self-report driving ability. Road sign recognition tests and daily-functions were found to be potential screening tools for assessing driving potential, but a larger sample size is recommended to confirm results. METHODS: An exploratory study that included 19 subjects - 10 without neurological impairments - and 9 post-stroke. Self-report questionnaires on driving ability, executive-functions and daily-function were administered. Post-stroke subjects were also assessed on road sign recognition. RESULTS: The research hypothesis was not confirmed. Three moderately correlated but statistically insignificant correlations were found: in unimpaired subjects between the driving self-report and functional status; in post-stroke subjects - between the driving self-report and self-monitoring and behavioral-regulation skills and in the road sign recognition tests - between executive and daily-function measures. CONCLUSIONS: If the trends were strengthened in a larger sample size the use of driving behavior self-report questionnaires, executive-function, daily-function and road sign recognition tests as screening tools for the unimpaired and post-stroke populations would be effective/recommended. DISCUSSION: Present findings of correlations between self-report of driving skills and behavioral regulation skills confirm previous research findings.

[AN INVESTIGATION INTO THE ROLE OF A REHABILITATION HOSPITAL PHARMACIST IN DETERMINING DISCREPANCIES AND MEDICATION ERRORS DURING PATIENTS` ADMISSION].

INTRODUCTION: The importance of correcting medication errors at hospital admission is paramount for promoting error-free delivery and continuity of care. Recently stakeholders have paid considerable attention to patient safety in acute-care hospitals but less is known about discrepancies and medication errors during patients` admission in other health care settings, such as post-acute care providers. An increased understanding of errors that occur in rehabilitation hospitals, would better equip stakeholders in taking actions to improve the safety of patient care in this unique setting. AIMS: The primary aim of the current study, conducted in a rehabilitation health care setting, is to study the pharmacist's role in identifying and preventing unintended medication discrepancies at the time of their hospital admission. The lack of available information on medications errors associated with medicines' risk factors and patients' characteristics, led the researcher to her secondary objective: to study the source of error, type of discrepancy and class of medicine most frequently implicated during the transition of care from an acute to a rehabilitation hospital. METHODS: The researcher performed a retrospective investigation and study of 356 patients with 3071 prescription medications referred from an acute hospital. The inclusion criteria also included ventilated patients over the age of 18 who received more than five prescription-only medicines. Over a period of 12 months, the investigator ascertained what medications were used prior and post-admission stage and then compared these drugs. The discrepancies identified were discussed with the attending physician. Unintended discrepancies were classified as errors. RESULTS: Unexplained errors which resulted in physician changes affected 154 patients, 43% of the total number of the study participants. The findings show that the most common cause of error found during the reconciliation of medicines at the point of admission is the use of patients own medications in the process. The most accurate and up to date source of information during the reconciliation process is the medication list brought with the patient upon admission. The wrong route of administration was the most common type of error that was found. Errors were concerned with important drug categories such as cardiovascular and antidiabetic drugs. The average number of drugs per patient is 9, while each of the studied population had a mean of two or more errors in admission. Although men were treated with an average of 10 medicines and females received only 8, the number of discrepancies was higher in females. CONCLUSIONS: Pharmacists play an important role in determining discrepancies and medication errors during patients` admission. This study provides an insight into the discrepancies that occur in this unique setting. Stakeholders may wish to adopt the recommendations provided by the author and act in order to improve the patients' safety in rehabilitation hospitals. Some of the recommendations are also applicable to other health care settings.

[FALL PREDICTION AND FALL SEVERITY IN REHABILITATION HOSPITAL].

AIMS: We tested whether the Farmer questionnaire is valid for fall risk assessment in Hebrew. We tested whether NDNQI (National Database of Nursing Quality Indicators) is valid for fall severity evaluation in Hebrew. Finally, we tested whether the Farmer and NDNQI are correlated. BACKGROUND: Patients in rehabilitation hospitals are exposed to fall-risking conditions. Falls with severe outcomes can extend the hospitalization, and increase the workload on health systems. Fall risk assessment at the beginning of hospitalization is crucial for making supportive and preventive adjustments. The Israel Ministry of Health obliges using fall risk assessment at hospitalization. Nonetheless, fall risk assessment has not been validated in Hebrew, and has not been tested for prediction power of fall severity outcome. METHODS: Farmer measurement was validated in 1187 patients retrospectively, out of whom 288 had fallen during hospitalization. Twenty-five fall cases with varying severities were ranked by 47 staff members for their fall severity score. Non-parametric Spearman's correlation was tested between Farmer and NDNQI measurements. RESULTS: Mean Farmer value of the falling group was larger than the mean Farmer value of the non-falling group (F=9.5, pv=0.002). Variability between raters was smaller than variability between conditions in NDNQI (ICC(2,1)=0.75). Farmer index was not correlated with NDNQI score (ρ=0.092, pv=0.118). CONCLUSIONS: Farmer measurement is a valid tool for fall risk assessment in Hebrew. NDNQI is a valid tool for evaluation of fall severity. Farmer index is not predictive of fall severity. DISCUSSION: There is a need for predictive measures of fall severity outcomes. We recommend using fall severity scores for ranking the intervention's success.

The Middle Ear Cleft Status in a "Natural" Cohort With Eustachian Tube Dysfunction.

BACKGROUND: The Eustachian tube (ET) has a major role in the middle ear (ME) pressure homeostasis. ET dysfunction is the accepted paradigm for pressure-related ME disorders. We studied the ME status in patients with severely diminished ET opening abilities, and anticipated to find ME disorders in most of them. PATIENTS AND METHODS: ME status was evaluated in unconscious adults, who were hospitalized in a rehabilitation center with severe brain damage, requiring tracheotomy and gastrostomy. These patients were unable to swallow, produce valsalva, yawn, and needed oral suctioning. Examination included fiberoptic nasopharyngoscopy, gag reflex and soft palate assessments, otoscopy, and tympanometry. RESULTS: Nineteen patients (38 ears) were evaluated: 14 men and 5 women, aged 18 to 93 years (average 59). Duration of gastrostomy and tracheotomy were between 3 months and 18 years. All the patients lacked gag reflex, palatal movements, or supraglottic sensation. Eighteen ears (47%) had otitis media with effusion (OME) (versus ∼3% in the general population, p = 0.00001), none had significant tympanic membrane atelectasis, but 20 (53%) ears were normal. Twenty-two ears (59%) had tympanometry types B/C and 16 (41%) had type A. Cerumen impaction incidence (26 ears, 68%) was significantly higher than in normal adults (10%), mentally retarded (36%), and nursing homes residents (57%). CONCLUSIONS: A dysfunctional ET predisposed ME disorders. Yet, ∼50% of the ears were normal, in contrast to the current paradigm. This implies that ME pressure homeostasis is maintained by factors that can compensate for ET dysfunction. Treating cerumen impaction and OME may be beneficial for rehabilitation.

Computerized energy balance and complications in critically ill patients: an observational study.

BACKGROUND AND AIMS: An accurate energy balance is difficult to achieve in hospitalized patients. The aim of the study was to measure the daily cumulative energy balance in critically ill patients receiving mechanical ventilation using a bedside computerized information system (CIS), and to assess its impact on outcome. METHODS: Fifty intensive care unit (ICU) patients (33 male, 17 female, mean age 59 +/- 18 years) were prospectively followed. Mean body mass index was 26.85 +/- 5.23 kg/m2 and mean APACHE II score, 23.1 +/- 7.7. Resting energy expenditure was measured daily with indirect calorimetry (Deltatrac II, Datex-Ohmeda, Finland), and daily macronutrient intake was measured with a bedside CIS (iMDsoft, Israel) connected to all caloric sources. End-point measures were morbidity (acquired organ dysfunction, pressure sores, need for surgery) and mortality. One- and two-way analysis of variance and stepwise logistic regression for predicted probability were used for statistical analysis. RESULTS: Mean energy intake was 1512 kcal/day and mean cumulative energy balance for an overall ICU stay of 566 days was -4767 kcal (range +4747 to -17,274). A strong association of maximum negative energy balance with adult respiratory distress syndrome (P = 0.0003), sepsis (P = 0.0035), renal failure (P = 0.0001), pressure sores (P = 0.013), need for surgery (P = 0.023), and total complication rate (P = 0.0001), but not with length of ventilation, ICU stay, or hospitalization, or mortality. CONCLUSIONS: Negative energy balance may be correlated with the occurrence of complications in the ICU. The bedside CIS provides accurate information on energy balance in critically ill patients and may allow for early detection and prevention of severe negative energy balance and complications.