Missing science: A scoping study of COVID-19 epidemiological data in the United States.

Systematic approaches to epidemiologic data collection are critical for informing pandemic responses, providing information for the targeting and timing of mitigations, for judging the efficacy and efficiency of alternative response strategies, and for conducting real-world impact assessments. Here, we report on a scoping study to assess the completeness of epidemiological data available for COVID-19 pandemic management in the United States, enumerating authoritative US government estimates of parameters of infectious transmission, infection severity, and disease burden and characterizing the extent and scope of US public health affiliated epidemiological investigations published through November 2021. While we found authoritative estimates for most expected transmission and disease severity parameters, some were lacking, and others had significant uncertainties. Moreover, most transmission parameters were not validated domestically or re-assessed over the course of the pandemic. Publicly available disease surveillance measures did grow appreciably in scope and resolution over time; however, their resolution with regards to specific populations and exposure settings remained limited. We identified 283 published epidemiological reports authored by investigators affiliated with U.S. governmental public health entities. Most reported on descriptive studies. Published analytic studies did not appear to fully respond to knowledge gaps or to provide systematic evidence to support, evaluate or tailor community mitigation strategies. The existence of epidemiological data gaps 18 months after the declaration of the COVID-19 pandemic underscores the need for more timely standardization of data collection practices and for anticipatory research priorities and protocols for emerging infectious disease epidemics.

Use of a dual-layer amniotic membrane in the treatment of diabetic foot ulcers: an observational study.

BACKGROUND: Despite advances in the treatment, fewer than half of diabetic foot ulcers (DFUs) heal in 12 weeks and 85% of non-traumatic amputations follow the development of a DFU. The search for treatment options continues. Placental-derived products have shown promise in the treatment of DFUs. This study investigates Artacent (Tides Medical, US), a unique amniotic patch containing two layers of amnion and its potential to increase growth factor delivery. METHOD: This observational analysis included patients with DFUs with documented failure to heal by >50% after the protocol-defined run-in period (either two or four weeks) of standard of care (SOC), and who had been randomised in a larger clinical trial that had been discontinued earlier for logistical reasons. Patients were randomised to either weekly or biweekly application of the dual-layer amniotic membrane (DLAM) plus SOC and were included in per-protocol effectiveness analyses. Descriptive statistics were chosen for this analysis. Primary endpoint was complete closure at 12 weeks. RESULTS: A total of 26 patients were included in the analysis. Examination of baseline patient characteristics revealed that the ulcers were larger than in most DFU clinical trials (4.65±4.89cm2). For the primary endpoint, 17/26 (65%, 95% CI: 44-83%) of the combined treatment arms achieved complete closure. The small sample size precluded a meaningful comparison of healing between weekly and biweekly DLAM applications. CONCLUSION: The observations taken from the discontinued clinical trial suggest that the DLAM promotes healing of DFUs. The healing rates are similar to those in other placental-based tissue studies. In addition, the relatively larger size of the ulcers suggests that the DLAM may be effective in ulcers that are more resistant to standard of care. In the future, a revised clinical trial with a greater sample size is planned.

Treatment of atrial fibrillation with antiarrhythmic drugs or radiofrequency ablation: two systematic literature reviews and meta-analyses.

BACKGROUND: Although radiofrequency catheter ablation (RFA) has evolved from an experimental procedure to an important treatment option for atrial fibrillation, the relative safety and efficacy of catheter ablation relative to that of antiarrhythmic drug (AAD) therapy has not been established. METHODS AND RESULTS: Two separate systematic reviews were conducted: one on RFA and the other on AAD to provide accurate and broadly representative estimates of the clinical efficacy and safety of both therapies in the treatment of atrial fibrillation. Electronic searches were conducted in EMBASE and MEDLINE from 1990 to 2007. For the RFA review, all study designs were accepted. For the AAD review, articles were limited to prospective studies on the following drugs of interest: amiodarone, dofetilide, sotalol, flecainide, and propafenone. Data were extracted by 1 reviewer, with a second reviewer performing independent confirmation of extracted data. Sixty-three RFA and 34 AAD studies were included in the reviews. Patients enrolled in RFA studies tended to be younger (mean age, 55 versus 62 years), had longer duration of atrial fibrillation (6.0 versus 3.1 years), and had failed a greater number of prior drug trials (2.6 versus 1.7). The single-procedure success rate of ablation off AAD therapy was 57% (95% CI, 50% to 64%), the multiple procedure success rate off AAD was 71% (95% CI, 65% to 77%), and the multiple procedure success rate on AAD or with unknown AAD usage was 77% (95% CI, 73% to 81%). In comparison, the success rate for AAD therapy was 52% (95% CI, 47% to 57%). A major complication of catheter ablation occurred in 4.9% of patients. Adverse events for AAD studies, although more common (30% versus 5%), were less severe. CONCLUSIONS: Studies of RFA for treatment of atrial fibrillation report higher efficacy rates than do studies of AAD therapy and a lower rate of complications.

Meta-analysis of ablation of atrial flutter and supraventricular tachycardia.

The purpose of this study was to perform a systematic review and meta-analysis to evaluate the safety and efficacy of radiofrequency ablation (RFA) of typical atrial flutter (AFL) and atrioventricular node-dependent supraventricular tachycardia (SVT) in adult patients. Medline and EMBASE were searched (1990 to 2007) for all study design trials of RFA. Data relating to single- and multiple-procedure success, arrhythmia recurrence, repeat ablation, adverse events, and death were extracted. For RFA in AFL, 18 primary studies with 22 treatment arms and 1,323 patients were identified. Single-procedure success for AFL was 91.7% (95% confidence interval [CI] 88.4% to 94.9%). Multiple-procedure success was 97.0% (95% CI 94.7% to 99.4%). Postablation arrhythmia was noted in 13.2% of patients (95% CI 7.5% to 18.9%), while repeat ablation was reported in 8% (95% CI 4.5% to 11.4%). For RFA of SVT, 39 primary studies with 49 treatment arms in 7,693 patients with accessory pathways and atrioventricular nodal reentrant tachycardia were identified. Single-procedure success for SVT was 93.2% (95% CI 90.8% to 95.5%). Multiple-procedure success was 94.6% (95% CI 92.4% to 96.9). Postablation arrhythmia was noted in 5.6% patients (95% CI 4.1% to 7.2%). Repeat ablation occurred in 6.5% (95% CI 4.7% to 8.3%). For AFL studies, all-cause mortality was 0.6%, and adverse events were reported in 0.5% of patients. For SVT studies, all-cause mortality was 0.1%, and adverse events were reported in 2.9% of patients. In conclusion, studies of RFA for the treatment of patients with AFL and SVT report high efficacy rates and low rates of complications.

Weight and type 2 diabetes after bariatric surgery: systematic review and meta-analysis.

BACKGROUND: The prevalence of obesity-induced type 2 diabetes mellitus is increasing worldwide. The objective of this review and meta-analysis is to determine the impact of bariatric surgery on type 2 diabetes in association with the procedure performed and the weight reduction achieved. METHODS: The review includes all articles published in English from January 1, 1990, to April 30, 2006. RESULTS: The dataset includes 621 studies with 888 treatment arms and 135,246 patients; 103 treatment arms with 3188 patients reported on resolution of diabetes, that is, the resolution of the clinical and laboratory manifestations of type 2 diabetes. Nineteen studies with 43 treatment arms and 11,175 patients reported both weight loss and diabetes resolution separately for the 4070 diabetic patients in these studies. At baseline, the mean age was 40.2 years, body mass index was 47.9 kg/m2, 80% were female, and 10.5% had previous bariatric procedures. Meta-analysis of weight loss overall was 38.5 kg or 55.9% excess body weight loss. Overall, 78.1% of diabetic patients had complete resolution, and diabetes was improved or resolved in 86.6% of patients. Weight loss and diabetes resolution were greatest for patients undergoing biliopancreatic diversion/duodenal switch, followed by gastric bypass, and least for banding procedures. Insulin levels declined significantly postoperatively, as did hemoglobin A1c and fasting glucose values. Weight and diabetes parameters showed little difference at less than 2 years and at 2 years or more. CONCLUSION: The clinical and laboratory manifestations of type 2 diabetes are resolved or improved in the greater majority of patients after bariatric surgery; these responses are more pronounced in procedures associated with a greater percentage of excess body weight loss and is maintained for 2 years or more.

Studies of Swedish adjustable gastric band and Lap-Band: systematic review and meta-analysis.

BACKGROUND: This is the first systematic review and meta-analysis of the large body of data describing the Swedish adjustable gastric band (SAGB) and Lap-Band (LB). METHODS: A systematic review was performed that included screening of studies published in any language (January 1, 1998 through April 30, 2006) identified through MEDLINE, Current Contents, or the Cochrane Library. Studies with > or =10 SAGB or LB patients reporting > or =30-day efficacy or safety outcomes were eligible for review; the data were extracted from the accepted studies. A weighted means analysis and random-effects meta-analysis of efficacy outcomes of interest were conducted. RESULTS: A total of 4592 bariatric surgery studies met the initial criteria. Of these studies, 129 (28,980 patients) were accepted (33 SAGB and 104 LB studies); most had a retrospective single-center design. For 4273 patients (36 treatment groups) in 33 SAGB studies and 24,707 patients (111 groups) in 104 LB studies, the mean baseline age (39.1-40.2 yr), body mass index (43.8-45.3 kg/m2), and gender (women 79.2-82.5%) were similar. A laparoscopic technique was used in > or =88% and a pars flaccida technique in > or =41% of both groups. Early mortality was equivalent for SAGB/LB (< or =.1%). The 3-year mean SAGB and LB excess weight loss (56.36% and 50.20%, respectively) and body mass index reduction (-11.99 and -11.81 kg/m2, respectively) from baseline were statistically significant (P <.05), as was the resolution of diabetes (61.45% and 60.29%, respectively) and hypertension (62.95% and 43.58%, respectively). Although scant and inconsistently reported data precluded direct statistical comparisons, the complication rates for the 2 devices appeared comparable. In 8 directly comparative studies, meta-analysis found a significantly greater absolute weight loss (P <.05) with the SAGB at 2 years (48.4 versus 41.9 kg, mean difference -4.84, 95% confidence interval -9.47 to -0.22), although no difference was found in the percentage of excess weight loss or change in body mass index. CONCLUSION: In a systematic review of the published world SAGB and LB data, at 1, 2, and 3 years, the weight loss, resolution of diabetes and hypertension, and complications appeared comparable.

The natural history and prognosis of neovascular age-related macular degeneration: a systematic review of the literature and meta-analysis.

PURPOSE: To describe the natural history and progression of visual loss in eyes with untreated neovascular age-related macular degeneration (AMD). DESIGN: Systematic review and meta-analysis. PARTICIPANTS: Four thousand three hundred sixty-two untreated neovascular AMD patients from published interventional studies. METHODS: A systematic review of the literature from 1980 to August 2005 was performed. Studies reporting disease progression outcomes for untreated patients with neovascular AMD were included. Outcome measures were summarized using simple counts and means. Random effects meta-analyses were conducted and tests of heterogeneity were performed where appropriate. MAIN OUTCOME MEASURES: Changes in visual acuity (VA) loss, development of comorbidities, and fellow eye involvement. RESULTS: Fifty-three primary studies were included. Nearly half of the studies (28) were randomized clinical trials. The quality of the studies was high, with over 80% providing level I or II evidence. Mean baseline VA among study patients was 0.64 logarithm of the minimum angle of resolution (logMAR) (approximately 20/87 Snellen). The mean VA change in logMAR progressed from 0.1 (1 line lost) at 3 months to 0.3 (2.7 lines lost) after 12 months and 0.4 (4 lines lost) after 24 months. The proportion of patients who developed severe vision loss (>6 lines) from baseline increased from 21.3% at 6 months to 41.9% by 3 years. The proportion of patients with VA worse than logMAR 1.0 (20/200 Snellen) increased from 19.7% at baseline to 75.7% by 3 years. Neovascular AMD developed in the fellow eye in 12.2% of patients by 12 months and in 26.8% by 4 years. Meta-analyses of vision outcome by subtype of neovascular AMD were not possible. CONCLUSIONS: A doubling of the visual angle of presenting VA may be expected to occur in the year after initial presentation in eyes with untreated neovascular AMD. No conclusions can be drawn as to the differences in rates of disease progression by neovascular AMD subtype. The diversity of reporting formats, paucity of long-term natural history data, and heterogeneity among the reported clinical studies impose limits to the clear understanding of long-term prognosis for visual function in neovascular AMD.

Trends in mortality in bariatric surgery: a systematic review and meta-analysis.

BACKGROUND: This is the first systematic review and meta-analysis of published mortality data after bariatric surgery. METHODS: The review includes all papers published in English from January 1, 1990 to April 30, 2006, identified through electronic searches in MEDLINE, Current Contents, and the Cochrane Library, supplemented by manual reference checks. All accepted studies were assigned a level of evidence (Centre for Evidence-Based Medicine, Oxford, UK), and randomized controlled trials were rated for quality using the Jadad scoring method. Random effects meta-analyses were performed. Mortality was analyzed at either 30 days to 2 years was 0.35% (95% CI, 0.12-0.58) in 140 treatment arms (n = 19,928). Mortality at or=65 years). CONCLUSION: The early and late mortality rates after bariatric surgery are low and can be subjected to risk stratification for comparative analyses and prospective risk assessments.

A comparison of the accuracy of two minimally invasive breast biopsy methods: a systematic literature review and meta-analysis.

OBJECTIVE: The primary objective was to quantify and compare the accuracy and failure rates of directional vacuum assisted biopsy (DVAB) and core needle biopsy (CNB) when used under stereotactic (ST) guidance to biopsy suspicious breast lesions identified with screening mammography. METHODS: We performed a systematic review of the literature published from January 1996 to July 2004, reporting all-comers populations in Western-style health care systems (i.e., North America, Europe, Australia or New Zealand), referred after screening mammography for breast biopsy using DVAB or CNB under ST guidance. Meta-analyses were conducted for DVAB and CNB, using open surgical biopsy and/or long-term clinical and/or mammogram follow-up as the diagnostic reference standard. The main outcomes of interest were those of greatest clinical relevance, i.e., miss rates and underestimation rates for malignancy. Also, technical failure rate and non-diagnostic rate were assessed for each biopsy method. RESULTS: Thirty-five studies qualified for the review. There were 12 studies with a DVAB group (n=5,119 patients), and 25 studies with a CNB group (n=6,236). There were no studies including both a DVAB and a CNB group, thus precluding any direct, within-study comparisons of accuracy. Overall agreement rate between DVAB and the reference standard was 97.3%, and between CNB and the reference standard, 93.5%. The frequency of technical failures with CNB was slightly higher than DVAB (5.7 vs. 1.5%), as was the frequency of non-diagnostic samples (2.1 vs. 0%). Of the non-diagnostic CNB samples, 23% were subsequently found to be malignant on reference standard. In multivariate analyses using four covariates (procedure type, geographic location, reference standard, and patient position), there were no significant predictors of agreement rates, but some variables were significant predictors of miss rates. For benign to malignant upgrades, study location was a significant predictor, with more upgrades in non-NA locations. For atypia to malignant upgrades, the type of procedure was a significant predictor, with more underestimations in CNB studies. CONCLUSION: The best available evidence suggests that, in screening populations referred for minimally invasive breast biopsy biopsy requiring ST guidance, DVAB may provide lower miss and underestimation rates for clinically relevant diagnoses than does CNB.