Historical Comparison Group Research Articles

Graded exposure therapy for adults with persistent symptoms after mTBI: A historical comparison study

ABSTRACT Fear avoidance behaviour is associated with slow recovery from mild traumatic brain injury (mTBI). This study is a preliminary evaluation of graded exposure therapy (GET), which directly targets fear avoidance behaviour, for reducing post-concussion symptoms (PCS) and disability following mTBI. In a historical comparison design, we compared two groups from independent randomized trials. The GET + UC group (N = 34) received GET (delivered over 16 videoconference sessions) in addition to usual care (UC). The historical comparison group (N = 71) received UC only. PCS severity (Rivermead Post Concussion Symptoms Questionnaire; RPQ) and disability (World Health Organization Disability Assessment Schedule; WHODAS 2.0 12-item) were measured at clinic intake (M = 2.7, SD = 1.1 months after injury) and again at M = 4.9 (SD = 1.1) months after injury. Between-group differences were estimated using linear mixed effects regression, with a sensitivity analysis controlling for injury-to-assessment intervals. The estimated average change on the RPQ was −14.3 in the GET + UC group and −5.3 in the UC group. The estimated average change on the WHODAS was −5.3 in the GET + UC group and −3.2 in the UC group. Between-group differences post-treatment were −5.3 on the RPQ and −1.5 on the WHODAS. Treatment effects were larger in sensitivity analyses. Findings suggest that a randomized controlled trial is warranted.

Frequency of exposure incidents in hospital workers before and during the COVID-19 pandemic based on the hospital status and the use of personal protective equipment: a descriptive study with a historical comparison group

BackgroundAn occupational exposure, i.e. exposure incident (EI), is contact with potentially contaminated material that may contain bloodborne pathogens and that occurs during occupational activities inside or outside a health care facility, either during direct work with a patient or during contact with a patient’s body fluids and tissues. This study aimed to compare the frequency of EIs in a university hospital before and during the Coronavirus Disease 2019 (COVID-19) pandemic.MethodsThis was a descriptive study with a historical comparison group conducted at the Dubrava University Hospital (DUH) in Zagreb, Croatia. We compared the frequency of EIs among healthcare and non-healthcare workers before (from March 11, 2018, to March 10, 2020) and during (from March 11, 2020, to March 11, 2022) the COVID-19 pandemic, expressed as the number of EIs per number of hospitalized patients and the total number of hospital activities. We analyzed data based on the status of the hospital (a COVID-19 hospital or not) and the use of personal protective equipment (PPE) as recommended by the World Health Organization.ResultsDuring the total analyzed period, 241 EIs were reported in DUH. Before the pandemic, 128 EIs were reported, compared to 113 during the pandemic. Before the pandemic, 91% of EIs were recorded in healthcare workers, while during the pandemic, 96% of EIs were recorded in healthcare workers. Slightly more EIs were recorded during the period of mixed work form and de-escalation of PPE. The rate of EIs relative to the total number of hospital patients was significantly higher during the pandemic (3.9/1000) than in the pre-pandemic period (2.5/1000). The rate of EIs relative to the total number of hospital activities was significantly higher during the pandemic (0.4/1000) than in the pre-pandemic period (0.2/1000).ConclusionThe rate of EIs relative to the total number of hospitalized patients and the total number of hospital activities in DUH was significantly higher during the pandemic, and the rate of total EIs increased among healthcare workers during the COVID-19 pandemic. The results of this study show that it is necessary to constantly and effectively work on the prevention of EI.

Prospective Evaluation of the Kaiser Permanente Prostate Cancer Risk Calculator in Biopsy-Naïve Men With Mild PSA Elevations.

Our goal was to assess the impact of providing prostate cancer risk estimates to patients and urologists among biopsy-naïve men with mild PSA elevations. This prospective intervention study was conducted in urology departments in Kaiser Permanente Northern California among biopsy-naïve men with mild PSA elevations (<10 ng/mL) between March 2021 and March 2023. The intervention was providing prostate cancer risk estimates for intermediate-/high-grade cancer (Grade Groups 2-5) and any cancer to patients and urologists using our previously validated risk calculator. Biopsy outcomes were compared to a historical comparison group biopsied between January 2016 and December 2019. Over 24 months, the risk calculator was used to estimate risk for 1962 men, of whom 1455 (74%) accepted the biopsy. The men who accepted the biopsy had higher predicted intermediate-/high-grade cancer risks (median 24%, interquartile range [IQR] 17%-31%, vs 20%, IQR 14%-29%; P < .0001) and higher predicted risks for any cancer (median 48%, IQR 40%-56%, vs 45%, IQR 37%-53%, respectively; P < .0001) than those who declined the biopsy. Compared to the historical group, use of the risk calculator resulted in a biopsy population enriched with intermediate-/high-grade cancer: 29% vs 25%; similar rates of low-grade cancer: 24% vs 24%; and fewer negative biopsies: 47% vs 51%, respectively; overall P = .013. In biopsy-naïve men with mild PSA elevations, use of this risk calculator resulted in a biopsy population that had more intermediate-/high-grade cancer and fewer negative biopsies compared to a historical group.

Are silver-coated megaprostheses superior to uncoated megaprostheses in managing chronic end-stage periprosthetic hip and knee infection?

Outcomes for silver coated megaprostheses (SC-MP) used in cases of end-stage periprosthetic joint infection (PJI) have not been clearly defined. Although attractive, concerns over implant longevity and the risk of infection relapse exist among the scientific community. Therefore, we sought to investigate the effect of silver coating in lower-extremity MPs used in such difficult-to-treat scenarios. The study's primary hypothesis was that the periprosthetic infection control rate would be higher in patients with silver-coated implants. Non-interventional retrospective study with a historical comparison group. We identified all consecutive end-stage hip and knee PJI cases at our center managed with exchange arthroplasty using a silver-coated megaprosthesis from January 2016 to March 2021, these cases were compared with a historical cohort of end-stage PJI cases managed with uncoated megaprostheses. The main outcome studied was infection control rate. Secondarily, we analyzed the short-to-medium-term survivorship of this type of silver-coated implant. Fifty-nine megaprostheses used in cases of end-stage PJI were included in this study. We identified 30 cases of chronic hip or knee PJI in which a silver-coated modular megaprosthesis was implanted. Our non-coated megaprosthesis (NC-MP) historical group included 29 patients. Both groups had similar demographic characteristics. We found no statistically significant differences in infection control rate (80% vs. 82.8%, p = 0.47) or implant survivorship (90% vs. 89.65%, p = 1) after a mean follow-up for SC-MP of 46.43months, and 48months for the non-coated MP group. In relapsed cases, there were no differences in infection eradication after DAIR (66% SC-MP vs. 60% NC-MP success rate, p = 1). During the follow-up we observed one case of skin argyria without further repercussion. We were unable to confirm our initial hypothesis that use of silver-coated implants in end-stage PJI scenarios may be associated with better outcomes in terms of infection control or implant survivorship.

Neurocognitive and psychosocial outcomes in survivors of childhood leukemia with Down syndrome.

The primary aim of this study was to assess the feasibility of a developmentally tailored neurocognitive assessment in survivors of childhood acute leukemia with Down syndrome (DS-leukemia). A secondary aim was to compare outcomes in the DS-leukemia group to a historical comparison group of individuals with DS and no history of childhood cancer. Survivors of DS-leukemia (n = 43; 56% male, mean [SD] age at diagnosis = 4.3 [4.5] years; age at evaluation = 15 [7.9] years) completed a neurocognitive assessment battery that included direct measures of attention, executive function, and processing speed, and proxy ratings of attention problems and executive dysfunction. Direct assessment outcomes were compared to a historical comparison cohort of individuals with DS and no history of childhood cancer (DS-control; n = 117; 56% male, mean [SD] age at evaluation = 12.7 [3.4] years). Rates of valid task completion ranged from 54% to 95%, suggesting feasibility for most direct assessment measures. Compared to the DS-control group, the DS-leukemia group had significantly lower completion rates on measures of executive function (p = 0.008) and processing speed (p = 0.018) compared to the DS-control group. There were no other significant group differences in completion rates. Compared to the DS-control group, the DS-leukemia group had significantly more accurate performance on two measures of executive function (p = 0.032; p = 0.005). Compared to the DS-control group, the DS-leukemia group had significantly more problems with executive function as identified on proxy ratings (6.5% vs. 32.6%, p = <0.001). Children with Down syndrome (DS) are at increased risk for developing acute leukemia compared to the general population but are systematically excluded from neurocognitive outcome studies among leukemia survivors. This study demonstrated the feasibility of evaluating neurocognitive late effects in leukemia survivors with DS using novel measures appropriate for populations with intellectual developmental disorder.

Risks of digestive diseases in long COVID: evidence from a population-based cohort study

BackgroundIn the post-pandemic era, a wide range of COVID-19 sequelae is of growing health concern. However, the risks of digestive diseases in long COVID have not been comprehensively understood. To investigate the long-term risk of digestive diseases among COVID patients.MethodsIn this large-scale retrospective cohort study with up to 2.6 years follow-up (median follow-up: 0.7 years), the COVID-19 group (n = 112,311), the contemporary comparison group (n = 359,671) and the historical comparison group (n = 370,979) predated the COVID-19 outbreak were built using UK Biobank database. Each digestive outcome was defined as the diagnosis 30 days or more after the onset of COVID-19 infection or the index date. Hazard ratios (HRs) and corresponding 95% confidence intervals (CI) were computed utilizing the Cox regression models after inverse probability weighting.ResultsCompared with the contemporary comparison group, patients with previous COVID-19 infection had higher risks of digestive diseases, including gastrointestinal (GI) dysfunction (HR 1.38 (95% CI 1.26 to 1.51)); peptic ulcer disease (HR 1.23 (1.00 to 1.52)); gastroesophageal reflux disease (GERD) (HR 1.41 (1.30 to 1.53)); gallbladder disease (HR 1.21 (1.06 to 1.38)); severe liver disease (HR 1.35 (1.03 to 1.76)); non-alcoholic liver disease (HR 1.27 (1.09 to 1.47)); and pancreatic disease (HR 1.36 (1.11 to 1.66)). The risks of GERD were increased stepwise with the severity of the acute phase of COVID-19 infection. Even after 1-year follow-up, GERD (HR 1.64 (1.30 to 2.07)) and GI dysfunction (HR 1.35 (1.04 to 1.75)) continued to pose risks to COVID-19 patients. Compared to those with one SARS-CoV-2 infection, reinfected patients were at a higher risk of pancreatic diseases (HR 2.57 (1.23 to 5.38)). The results were consistent when the historical cohort was used as the comparison group.ConclusionsOur study provides insights into the association between COVID-19 and the long-term risk of digestive system disorders. COVID-19 patients are at a higher risk of developing digestive diseases. The risks exhibited a stepwise escalation with the severity of COVID-19, were noted in cases of reinfection, and persisted even after 1-year follow-up. This highlights the need to understand the varying risks of digestive outcomes in COVID-19 patients over time, particularly those who experienced reinfection, and develop appropriate follow-up strategies.

Human Milk Fortifier After Neonatal Intensive Care Unit Discharge Improves Human Milk Usage Rates for Preterm Infants

BackgroundA common neonatal intensive care unit (NICU) discharge feeding strategy for preterm infants with growth failure who are fed exclusively expressed human milk (EHM) has been to enrich mother’s own milk with formula powder or supplement 2–3 feeds per day with formula. However, this strategy displaces human milk from the diet. Our NICU recently adopted the standard practice of adding commercial human milk fortifier (HMF) to human milk feedings after discharge. ObjectivesWe aimed to compare breastfeeding rates and growth using the aforementioned 2 strategies. MethodsPreterm infants (<34 wk of gestation at birth) exclusively feeding EHM fortified with HMF at 2 weeks before discharge were included in this retrospective study. The HMF group (n = 92) continued fortifying with HMF at home, whereas the historical comparison group (n = 35) received our previous guidance to enrich or supplement using postdischarge formula. ResultsRates of human milk exclusivity after discharge decreased significantly less in the HMF group than those in the historical comparison group (to 83% compared with 39% at the first outpatient visit and 27% compared with 6%, respectively, at the second outpatient visit). Rates of any EHM feedings were also significantly higher in the HMF group. Fenton z-scores for weight, length, and head circumference were not significantly different between the groups. ConclusionsContinuing EHM fortification with HMF after NICU discharge, rather than enriching or supplementing with postdischarge infant formula, increases rates of feeding EHM for ≥3 mo but does not affect growth.

Prone Positioning in Patients With COVID-19 and Non-COVID-19 Acute Respiratory Distress Syndrome.

Patients critically ill with COVID-19 develop acute respiratory distress syndrome (ARDS) and may undergo prone positioning. To compare the effects of prone positioning on oxygenation, intensive care unit length of stay, and intubation days in patients with COVID-19 ARDS and patients with non-COVID-19 ARDS. A convenience sample of intubated patients with COVID-19 and moderate to severe ARDS (per Berlin criteria) was compared with historical data from a retrospective, descriptive medical record review of patients with non-COVID-19 ARDS. The historical comparison group was age and sex matched. Differences in Po2 to fraction of inspired oxygen ratios between the COVID-19 ARDS group (n = 41) and the non-COVID-19 ARDS group (n = 6) during the first 7 days of prone positioning were significant at the end of prone positioning on day 1 (P = .01), day 3 (P = .04), and day 4 (P = .04). Wilcoxon signed-rank tests showed that prone positioning had a positive impact on Po2 to fraction of inspired oxygen ratios from day 1 through day 6 in the COVID-19 ARDS group and on day 2 in the non-COVID-19 ARDS group. This retrospective review found greater improvement in oxygenation in the COVID-19 ARDS group than in the non-COVID-19 ARDS group. This finding may be attributed to the assertive prone positioning protocol during the pandemic and teams whose skills and training were likely enhanced by the pandemic demand. Prone positioning did not affect intensive care unit length of stay or intubation days in either group.

Phase 2 trial of epidermal growth factor (EGF) vaccine CIMAvax in combination with pembrolizumab in first line and maintenance setting in advanced non–small cell lung cancer patients.

TPS2677 Background: CIMAvax-EGF is a novel growth-factor depleting immunotherapy consisting of human recombinant EGF conjugated to recombinant P64k derived from Neisseria meningitidis, that elicits an anti-EGF antibody response, resulting in reduction of circulating EGF levels. A randomized phase 3 study of CIMAvax-EGF administered as switch maintenance therapy after first-line platinum-based chemotherapy in patients with advanced NSCLC demonstrated overall survival (OS) advantage in comparison to best supportive care alone, particularly in patients with high baseline serum EGF levels. A phase 1 trial combining CIMAvax-EGF with nivolumab, an anti-PD1 immune checkpoint inhibitor, showed that the combination is safe and appears to induce higher rate of good anti-EGF antibody response within the first 8 weeks of therapy compared to historical comparison group receiving CIMAvax-EGF alone. CIMAvax-EGF is currently being investigated in combination with pembrolizumab in a multi-arm phase II trial as 1L therapy in combination with pembrolizumab for patients with EGFR/ALK wildtype NSCLC and PD-L1 &gt; 50% (Cohort C) and as maintenance therapy after completing 1L chemoimmunotherapy for patients with PD-L1 &lt; 50% (Cohorts D and E). Accrual to this trial is ongoing (NCT02955290). Methods: This is an open-label, non-randomized, multi-site, phase 2 basket trial. CIMAvax-EGF (2.4 mg IM every 2 weeks x 4 doses, then every 4 weeks thereafter) is being tested as first-line therapy in combination with pembrolizumab (200 mg IV every 4 weeks) in patients with advanced NSCLC with PD-L1 ≥ 50% (Cohort C), using a Simon two stage design (n up to 41). A safety lead-in consisting of the first 6 NSCLC patients was completed. There were no G3 or higher adverse events attributed to the combination within the first 4 weeks of protocol treatment. Patients with advanced squamous NSCLC (Cohort D, n=50) and non-squamous NSCLC (without EGFR/ALK/ROS-1/KRAS mutations; Cohort E, n=45) with PD-L1 expression &lt;50% and no evidence of progression of disease by RECIST 1.1 criteria after at least 4 cycles of induction platinum-based doublet with pembrolizumab, prior to initiation of standard of care maintenance therapy will be enrolled to receive protocol treatment with pembrolizumab in combination with CIMAvax-EGF as maintenance therapy. The primary endpoint is to evaluate objective response rate (Cohort C), and 12-month PFS in Cohorts D and E. Secondary endpoints include 12-month overall survival in all cohorts. Exploratory objectives include characterizing tissue-based immune and EGFR signaling profile as well as serum EGF levels, anti-EGF antibody levels and other blood-based biomarkers in relation to clinical outcomes. Clinical trial information: NCT02955290 .

Reducing opioid use for chronic non-cancer pain in primary care using an evidence-based, theory-informed, multistrategic, multistakeholder approach: a single-arm time series with segmented regression

BackgroundMany countries have high opioid use among people with chronic non-cancer pain. Knowledge about effective interventions that could be implemented at scale is limited. We designed a national intervention that...

Intrathecal Morphine Injection for Postoperative Analgesia Following Gender-Affirming Pelvic Surgery: A Retrospective Case-Control Study.

Background Gender-affirming pelvic surgery (GAPS) can be associated with significant postoperative pelvic pain. Given the lack of available peripheral nerve blocks to the perineum, intrathecal morphine (ITM) injection could offer a potent analgesic modality for this patient population. No prior studies to date have been performed examining the analgesic effects of intrathecal morphine for these patients. Methods This retrospective case-control study aims to understand the postoperative analgesic effects of intrathecal morphine for these patients with a historical comparison group of patients who did not receive intrathecal morphine. Results Fourteen patients presented for gender-affirming pelvic surgery over an eight-month period at a single institution and were offered intrathecal morphine for postoperative analgesia. Their analgesic results were compared to a similar historical group of 13 patients who were not offered or declined intrathecal morphine. Conclusions Intrathecal morphine injection is a potent analgesic modality for patients presenting for gender-affirming pelvic surgery.

Popliteal sciatic nerve block in the endovascular management of critical limb ischaemia: a UK single-centre experience

Objective: This study aims to assess the safety and efficacy of the use of popliteal nerve block (PNB) in the endovascular management of patients with critical limb threatening ischaemia. Design: Single-centre retrospective observational study. Methods: All patients with rest pain who received PNB from March 2018 to August 2021 were included. Pain scores were recorded before and after block using a visual analogue scale (VAS). Requirements for analgesia or sedation, complications related to nerve block, and level of intervention were recorded. Results were compared with a historical cohort of patients prior to implementation of nerve blocks. Results: 68 nerve blocks were performed in 63 patients (M:F 46:17) of mean age 71.7 years (range 43–91). All patients were Fontaine classification III–IV. Sonographically, all nerve blocks were technically successful. The mean VAS pain score was 8.2 pre-block, reducing to 0.3 (p&lt;0.0001) post-block. There were no complications related to the block. Four patients required supplementary analgesia for breakthrough ischaemic pain. Compared with the historical comparison group of patients (n=62), there was a statistically significant reduction in the requirement for conscious sedation (p=0.004) and no procedures were abandoned due to pain compared with three in the historical comparison group (p=0.034). Conclusion: Popliteal sciatic nerve block is safe and effective in patients with critical limb threatening ischaemia undergoing lower limb endovascular intervention, significantly reducing the need for conscious sedation and risk of procedural abandonment.

Developing low-achieving medical students’ self-regulated learning using a combined learning diary and explicit training intervention

Introduction The development of self-regulated learning (SRL) is an essential educational component of remediation for low-achieving students. The aim of this study was to design, implement, and evaluate a longitudinal SRL intervention combining both a structured learning diary and explicit SRL training in a cohort of low-achieving undergraduate medical students. Materials and methods A mixed methods quasi-experimental study was conducted, with a pretest–posttest study in the intervention group and comparison of the GPA and course grade of the intervention group with a historical comparison group. A questionnaire and focus group explored the participants’ perceptions about the intervention. Results The SRL scores (total and rehearsal, organization, critical thinking, metacognitive regulation, time management and environment management) and course grade of participants were significantly improved in the intervention group. The course grade of participants was significantly higher than the comparison group but the GPA was not significantly different. Overall, the participants were positive about the intervention. Conclusions This study was the first in medical education to evaluate the effectiveness and user acceptability of an SRL intervention that combined a structured learning diary and explicit SRL training in low-achieving medical students. Further research is recommended in different contexts and with larger number of students.

Enhancing community integration after incarceration: findings from a prospective study of an intensive peer support intervention for veterans with an historical comparison group

BackgroundThe transition to the community after incarceration presents challenges for returning citizens, including the immediate need to secure housing, employment, and income. Additionally, health care is essential for this population due to high rates of chronic physical health and mental health problems and substance use disorders. There is growing recognition of the need for interventions that support returning citizens as they navigate community reintegration while simultaneously tending to physical and behavioral health needs. We developed and pilot tested a peer support intervention designed to provide social, emotional, and logistic support and promote linkage and engagement in healthcare for returning citizens. We tested the intervention with US military veterans in Massachusetts who were being released from prison and jail. Outcomes related to linkage to and engagement in healthcare were evaluated using an historical comparison group. Engagement in peer support, housing status, and reincarceration rates were monitored for the intervention group.ResultsThere were 43 veterans in the intervention group, and 36 in the historical comparison group. For linkage to primary care within 90 days of release, there were no statistically significant differences between the intervention and comparison groups (58% versus 67%). Intervention participants were significantly more likely to receive substance use treatment than the comparison group (86% versus 19%, p < .0001) and the mean monthly substance use visits was greater in the intervention group (0.96 versus 0.34, p < .007). Engagement in mental health services was greater for the intervention group than the comparison group (93% versus 64%, p < .003). There were no significant differences between groups for emergency department use and hospitalization. At the end of the study period, the majority of intervention participants who had been released for over a year were living in permanent housing (84%). Recidivism among the was low, with 7% re-arrested during the study period.ConclusionsAugmenting reentry support through intensive peer support appears to have substantial benefits for veterans in terms of engaging them in health care and contributing to their longer-term stability, including housing and recidivism. Flexible reentry support such as this intervention may be well suited to meet the widely varying needs of returning citizens.

Identifying appropriate comparison groups for health system interventions in the COVID-19 era.

IntroductionCOVID‐19 has created additional challenges for the analysis of non‐randomized interventions in health system settings. Our objective is to evaluate these challenges and identify lessons learned from the analysis of a medically tailored meals (MTM) intervention at Kaiser Permanente Northwest (KPNW) that began in April 2020.MethodsWe identified both a historical and concurrent comparison group. The historical comparison group included patients living in the same area as the MTM recipients prior to COVID‐19. The concurrent comparison group included patients admitted to contracted non‐KPNW hospitals or admitted to a KPNW facility and living outside the service area for the intervention but otherwise eligible. We used two alternative propensity score methods in response to the loss of sample size with exact matching to evaluate the intervention.ResultsWe identified 452 patients who received the intervention, 3873 patients in the historical comparison group, and 5333 in the concurrent comparison group. We were able to mostly achieve balance on observable characteristics for the intervention and the two comparison groups.ConclusionsLessons learned included: (a) The use of two different comparison groups helped to triangulate results; (b) the meaning of utilization measures changed pre‐ and post‐COVID‐19; and (c) that balance on observable characteristics can be achieved, especially when the comparison groups are meaningfully larger than the intervention group. These findings may inform the design for future evaluations of interventions during COVID‐19.

Risk of Death in Nursing Home Residents After COVID-19 Vaccination.

ObjectivesIn the first months of 2021, the Dutch COVID-19 vaccination campaign was disturbed by reports of death in Norwegian nursing homes (NHs) after vaccination. Reports predominantly concerned persons >65 years of age with 1 or more comorbidities. Also, in the Netherlands adverse events were reported after COVID-19 vaccination in this vulnerable group. Yet, it was unclear whether a causal link between vaccination and death existed. Therefore, we investigated the risk of death after COVID-19 vaccination in Dutch NH residents compared with the risk of death in NH residents prior to the COVID-19 pandemic.DesignPopulation-based longitudinal cohort study with electronic health record data.Setting and ParticipantsWe studied Dutch NH residents from 73 NHs who received 1 or 2 COVID-19 vaccination(s) between January 13 and April 16, 2021 (n = 21,762). As a historical comparison group, we included Dutch NH residents who were registered in the same period in 2019 (n = 27,591).MethodsData on vaccination status, age, gender, type of care, comorbidities, and date of NH entry and (if applicable) discharge or date of death were extracted from electronic health records. Risk of death after 30 days was evaluated and compared between vaccinated residents and historical comparison participants with Kaplan-Meier and Cox regression analyses. Regression analyses were adjusted for age, gender, comorbidities, and length of stay.ResultsRisk of death in NH residents after one COVID-19 vaccination (regardless of whether a second vaccination was given) was decreased compared with historical comparison participants from 2019 (adjusted HR 0.77, 95% CI 0.69-0.86). The risk of death further decreased after 2 vaccinations compared with the historical comparison group (adjusted HR 0.57, 95% CI 0.50-0.64).Conclusions and ImplicationsWe found no indication that risk of death in NH residents is increased after COVID-19 vaccination. These results indicate that COVID-19 vaccination in NH residents is safe and could reduce fear and resistance toward vaccination.

Characterizing patients with multiple same-sided ureteric stones.

Patients presenting with multiple same-sided ureteric stones (MSSUS) are a unique population with nuanced prognostic and treatment considerations, which have yet to be characterized in the literature. Therefore, our purpose was to examine outcomes of patients with MSSUS vs those with single ureteric stones (SUS). A retrospective review of prospectively collected patients included adults (> 18yo) with [Formula: see text] 2 ipsilateral ureteral stones without prior treatment for their current stone burden. A historical comparison group was used as a control population. Univariate logistic regression analyses and descriptive statistics were performed with SPSS® 20.0 (p < 0.05). Seventy-nine MSSUS patients were compared to 101 SUS patients. MSSUS patients had 2.21 [Formula: see text] 0.66 ureteric stones and had significantly smaller lead stones (MSSUS 6.4mm vs SUS 7.2mm, p = 0.03). MSSUS patients were more likely to have had prior stones (66 vs 42%) and 5.9 times more likely to have had prior stone procedures. Conservative management was successful in 30% MSSUS vs 19% SUS (p = 0.073), and there were no differences in resolution time (p = 0.44). For patients proceeding to intervention, (MSSUS n = 52, SUS n = 78), ureteroscopy was performed on 58% MSSUS vs 51% SUS patients (p = 0.302), and shockwave lithotripsy in 10% MSSUS vs 26% SUS (p = 0.01). MSSUS were more likely to spontaneously pass a stone prior to planned intervention (OR = 41.1; 95% CI = 12.0-140.7; p = 0.0001). MSSUS patients are more likely recurrent stone formers with extensive stone histories and current stone burdens. Conservative management appears as successful between groups, with no difference in resolution time. When employed, ureteroscopy outcomes do not different between cohorts.

Outcomes from a hybrid implementation-effectiveness study of the living well during pregnancy Tele-coaching program for women at high risk of excessive gestational weight gain

BackgroundExcess gestational weight gain (GWG) is associated with short-term perinatal complications and longer term cardiometabolic risks for mothers and their babies. Dietitian counselling and weight gain monitoring for women at risk of high pregnancy weight gain is recommended by clinical practice guidelines. However, face-to-face appointments, during a time with high appointment burden, can introduce barriers to engaging with care. Telephone counselling may offer a solution. The Living Well during Pregnancy (LWdP) program is a dietitian-delivered telephone coaching program implemented within routine antenatal care for women at risk of excess GWG. This program evaluation used a hybrid implementation-effectiveness design guided by the RE-AIM framework to report on the primary outcomes (reach, adoption, implementation, maintenance) and secondary outcomes (effectiveness) of the LWdP intervention.MethodsThe LWdP program evaluation compared data from women participating in the LWdP program with a historical comparison group (pregnant women receiving dietetic counselling for GWG in the 12 months prior to the study). The primary outcomes were described for the LWdP program. Between group comparisons were used to determine effectiveness of achieving appropriate GWG and pre and post intervention comparisons of LWdP participants was used to determine changes to dietary intake and physical activity.ResultsThe LWdP intervention group (n = 142) were compared with women in the historical comparison group (n = 49). Women in the LWdP intervention group attended 3.4 (95% CI 2.9–3.8) appointments compared with 1.9 (95% CI, 1.6–2.2) in the historical comparison group. GWG was similar between the two groups, including the proportion of women gaining weight above the Institute of Medicine recommendations (70% vs 73%, p = 0.69). Within group comparison showed that total diet quality, intake of fruit and vegetables and weekly physical activity were all significantly improved from baseline to follow-up for the women in LWdP, while consumption of discretionary food and time spent being sedentary decreased (all p < 0.05).ConclusionThe LWdP program resulted in more women accessing care and positive improvements in diet quality, intuitive eating behaviours and physical activity. It was as effective as face-to-face appointments for GWG, though more research is required to identify how to engage women earlier in pregnancy and reduce appointment burden.

A community partnership to evaluate the feasibility of addressing food insecurity among adult patients in an urban healthcare system

BackgroundFood insecurity (FI) is a significant public health problem. Possible sequelae of prolonged food insecurity include kidney disease, obesity, and diabetes. Our objective was to assess the feasibility of a partnership between Henry Ford Health System (HFHS) and Gleaners Community Foodbank of Southeastern Michigan to implement and evaluate a food supplementation intervention initiated in a hospital outpatient clinic setting.MethodsWe established a protocol for using the Hunger Vital Signs to screen HFHS internal medicine patients for food insecurity and established the data sharing infrastructure and agreements necessary for an HFHS-Gleaners partnership that would allow home delivery of food to consenting patients. We evaluated the food supplementation program using a quasi-experimental design and constructing a historical comparison group using the electronic medical record. Patients identified as food insecure through screening were enrolled in the program and received food supplementation twice per month for a total of 12 months, mostly by home delivery. The feasibility outcomes included successful clinic-based screening and enrollment and successful food delivery to consenting patients. Our evaluation compared healthcare utilization between the intervention and historical comparison group during a 12-month observation period using a difference-in-differences (DID) analysis.ResultsOf 1691 patients screened, 353 patients (20.9%) met the criteria for FI, of which 340/353 (96.3%) consented, and 256/340 (75.3%) were matched and had data sufficient for analysis. Food deliveries were successfully made to 89.9% of participant households. At follow-up, the intervention group showed greater reductions in emergency department visits than the comparison group, −41.5% and −25.3% reduction, respectively. Similar results were observed for hospitalizations, −55.9% and −17.6% reduction for intervention and control groups, respectively. DID regression analysis also showed lower trends in ED visits and hospitalizations for the intervention group compared to the comparison group.ConclusionsResults suggest that community-health system partnerships to address patient-reported food insecurity are feasible and potentially could reduce healthcare utilization in these patients. A larger, randomized trial may be the next step in fully evaluating this intervention, perhaps with more outcomes (e.g., medication adherence), and additional covariates (e.g., housing insecurity and financial strain).

Risk of persistent and new clinical sequelae among adults aged 65 years and older during the post-acute phase of SARS-CoV-2 infection: retrospective cohort study

ObjectiveTo characterize the risk of persistent and new clinical sequelae in adults aged ≥65 years after the acute phase of SARS-CoV-2 infection.DesignRetrospective cohort study.SettingUnitedHealth Group Clinical Research Database: deidentified administrative...