Prokop, Larry J.

Background The objective is to examine and synthesise the best available experimental evidence about the effect of ambulatory consultation duration on quality of healthcare. Methods We included experimental studies manipulating the length of outpatient clinical encounters between adult patients and clinicians (ie, therapists, pharmacists, nurses, physicians) to determine their effect on quality of care (ie, effectiveness, efficiency, timeliness, safety, equity, patient-centredness and patient satisfaction). Information sources Using controlled vocabulary and keywords, without restriction by language or year of publication, we searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Database of Systematic Reviews and Scopus from inception until 15 May 2023. Risk of bias Cochrane Risk of Bias instrument. Data synthesis Narrative synthesis. Results 11 publications of 10 studies explored the relationship between encounter duration and quality. Most took place in the UK’s general practice over two decades ago. Study findings based on very sparse and outdated evidence—which suggested that longer consultations improved indicators of patient-centred care, education about prevention and clinical referrals; and that consultation duration was inconsistently related to patient satisfaction and clinical outcomes—warrant low confidence due to limited protections against bias and indirect applicability to current practice. Conclusion Experimental evidence for a minimal or optimal duration of an outpatient consultation is sparse and outdated. To develop evidence-based policies and practices about encounter length, randomised trials of different consultation lengths—in person and virtually, and with electronic health records—are needed. Trial registration number OSF Registration DOI:10.17605/OSF.IO/EUDK8.

AbstractCeliac disease is a global disease requiring genetic susceptibility and gluten exposure to trigger immune‐mediated enteropathy. The effect of the degree of gluten‐containing grain availability on celiac disease prevalence is unknown. Our objective was to compare country‐based gluten availability to celiac prevalence using a systematic literature review. We searched MEDLINE, Embase, Cochrane, and Scopus until May 2021. We included population‐based serum screening with confirmatory testing (second serological study or small intestine biopsy) and excluded specific, high‐risk, or referral populations. We determined country‐specific gluten availability using the United Nations food balance for wheat, barley, and rye. Human leukocyte antigen (HLA) frequencies were obtained from allelefrequencies.net. The primary outcome was association between gluten‐containing grain availability and celiac disease prevalence. Generalized linear mixed models method with Poisson's link was used for analysis. We identified 5641 articles and included 120 studies on 427 146 subjects from 41 countries. Celiac disease prevalence was 0–3.1%, median 0.75% (interquartile range 0.35, 1.22). Median wheat supply was 246 g/capita/day (interquartile range 214.8, 360.7). The risk ratio (RR) for wheat availability on celiac disease was 1.002 (95% confidence interval [CI]: 1.0001, 1.004, P = 0.036). A protective association was seen with barley, RR 0.973 (95% CI: 0.956, 0.99, P = 0.003), and rye, RR 0.989 (95% CI: 0.982, 0.997, P = 0.006). The RR for gross domestic product on celiac disease prevalence was 1.009 (95% CI: 1.005, 1.014, P < 0.001). The RR for HLA‐DQ2 was 0.982 (95% CI: 0.979, 0.986, P < 0.001), and that for HLA‐DQ8 was 0.957 (95% CI: 0.950, 0.964, P < 0.001). In this geo‐epidemiologic study, gluten‐containing grain availability showed mixed associations with celiac disease prevalence.

Introduction: Wearable cardiac defibrillators (WCD) have been shown to be effective for detection and treatment of ventricular tachyarrhythmias. However, their efficacy in improving survival or decreasing mortality in patients with newly diagnosed cardiomyopathy (CM) is uncertain. This study reviews the current available evidence. Method: We searched databases since inception to April 2022, without language and year of publication restriction for randomized trials and cohort studies that examined the difference between WCD use and non-use in mortality and survival among patients with ischemic and non-ischemic CM. Two independent investigators screened the abstracts and full texts and extracted the data. Data was analyzed using random effect model. Results: From 603 records identified by a librarian, only 4 randomized trials on WCD use in ischemic CM met the inclusion criteria. One of them was an abstract without any full text published. The total participants were 18,779 of which 2,408 were in the WCD group (mean age 65.12±11.5, 20.7% female) and the rest in control group (mean age 65.45±11.36, 28% female). The adjusted all-cause mortality at 3 months follow up was significantly lower in WCD group (RR 0.32, CI [0.11-0.97], including three studies, 2,360 patients in WCD group and 4,954 in control group) (heterogeneity score I 2 =86%)(figure). Adjusted all-cause mortality at 12 months was also significantly lower in WCD group (RR 0.43, CI [0.25-0.71], two studies, 857 patients in WCD group and 15,566 in control group) (heterogeneity score, I 2 =49%). Only one study reported adjusted risk for arrhythmic death, myocardial infarction, arrhythmia (atrial or ventricular), stroke and hospitalization. In addition, one study reported the difference in cost and healthcare use between the two groups. Conclusion: Our meta-analysis confirms significant reduction in all-cause mortality associated with WCD use in patients with newly diagnosed ischemic cardiomyopathy.

Abstract Background Early-stage breast cancer is among the most common cancer diagnoses. Adjuvant radiotherapy is an essential component of breast-conserving therapy, and several options exist for tailoring its extent and duration. This study assesses the comparative effectiveness of partial-breast irradiation (PBI) compared with whole-breast irradiation (WBI). Methods A systematic review was completed to identify relevant randomized clinical trials and comparative observational studies. Independent reviewers working in pairs selected studies and extracted data. Randomized trial results were pooled using a random effects model. Prespecified main outcomes were ipsilateral breast recurrence (IBR), cosmesis, and adverse events (AEs). Results Fourteen randomized clinical trials and 6 comparative observational studies with 17 234 patients evaluated the comparative effectiveness of PBI. PBI was not statistically significantly different from WBI for IBR at 5 years (RR = 1.34, 95% CI = 0.83 to 2.18; high strength of evidence [SOE]) and 10 years (RR = 1.29, 95% CI = 0.87 to 1.91; high SOE). Evidence for cosmetic outcomes was insufficient. Statistically significantly fewer acute AEs were reported with PBI compared with WBI, with no statistically significant difference in late AEs. Data from subgroups according to patient, tumor, and treatment characteristics were insufficient. Intraoperative radiotherapy was associated with higher IBR at 5, 10, and over than 10 years (high SOE) compared with WBI. Conclusions Ipsilateral breast recurrence was not statistically significantly different between PBI and WBI. Acute AEs were less frequent with PBI. This evidence supports the effectiveness of PBI among selected patients with early-stage, favorable-risk breast cancer who are similar to those represented in the included studies.

AbstractIntroductionFor too many people, their care plans are designed without fully accounting for who they are, the lives they live, what matters to them or what they aspire to achieve. We aimed to summarize instruments capable of measuring dimensions of patient–clinician collaboration to make care fit.MethodsWe systematically searched several databases (Medline, Embase, Cochrane, Scopus and Web of Science) from inception to September 2021 for studies using quantitative measures to assess, evaluate or rate the work of making care fit by any participant in real‐life clinical encounters. Eligibility was assessed in duplicate. After extracting all items from relevant instruments, we coded them deductively on dimensions relevant to making care fit (as presented in a recent Making Care Fit Manifesto), and inductively on the main action described.ResultsWe included 189 papers, mostly from North America (N = 83, 44%) and in the context of primary care (N = 54, 29%). Half of the papers (N = 88, 47%) were published in the last 5 years. We found 1243 relevant items to assess efforts of making care fit, included within 151 instruments. Most items related to the dimensions ‘Patient‐clinician collaboration: content’ (N = 396, 32%) and ‘Patient‐clinician collaboration: manner’ (N = 382, 31%) and the least related to ‘Ongoing and iterative process’ (N = 22, 2%) and in ‘Minimally disruptive of patient lives’ (N = 29, 2%). The items referred to 27 specific actions. Most items referred to ‘Informing’ (N = 308, 25%) and ‘Exploring’ (N = 93, 8%), the fewest items referred to ‘Following up’, ‘Comforting’ and ‘Praising’ (each N = 3, 0.2%).DiscussionMeasures of the work that patients and clinicians do together to make care fit focus heavily on the content of their collaborations, particularly on exchanging information. Other dimensions and actions previously identified as crucial to making care fit are assessed infrequently or not at all. The breadth of extant measures of making care fit and the lack of appropriate measures of this key construct limit both the assessment and the successful implementation of efforts to improve patient care.Patient ContributionPatients and caregivers from the ‘Making care fit Collaborative’ were involved in drafting the dimensions relevant to patient–clinician collaboration.

AbstractObjectiveTo analyze the association between preoperative electrodiagnostic (EDX) studies and postoperative pain and functional outcomes following ulnar nerve decompression and/or transposition for ulnar neuropathy at the elbow (UNE).Literature SurveyProtocol was submitted and database search was conducted by an experienced librarian of all available studies in the English language from 1990 to June 8, 2022. Databases included Ovid MEDLINE(R) and Epub Ahead of Print, In‐Process & Other Non‐Indexed Citations and Daily, Ovid EMBASE, Ovid Cochrane Central Register of Controlled Trials, and Scopus.MethodologyInclusion criteria consisted of randomized controlled trials, prospective and retrospective longitudinal studies, and studies involving adults ≥18 years of age who underwent ulnar nerve decompression and/or transposition for UNE. Study quality and risk of bias were assessed using the National Heart, Lung, and Blood Institute (NHLBI) Study Quality of Assessment Tool. Certainty in evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. A meta‐analysis was not performed.SynthesisA total of 289 studies were screened, and 8 retrospective cohort studies met inclusion criteria comprising 762 patients. A decreased or absent preoperative sensory nerve action potential amplitude (SNAP) showed significance with worse postoperative outcomes. The presence of preoperative conduction block showed significance in higher quality studies. There was limited evidence for slow preoperative motor conduction velocities or preoperative electromyography (EMG) abnormalities and postoperative outcomes. Overall quality assessment demonstrated that two studies had “good,” four “fair,” and two “poor” quality of evidence. Certainty in evidence was “low” due to risk of bias.ConclusionsA decreased or absent preoperative ulnar SNAP may predict worse postoperative outcomes. Per higher quality studies, preoperative conduction block at the elbow may also predict worse postoperative outcomes. Careful interpretation is required with a full understanding of the limited evidence, risk of bias, and low certainty in evidence to support the use of preoperative EDX to predict postoperative outcomes in UNE.

Abstract Background Peripherally inserted central catheters (PICCs) and midlines are commonly used devices for reliable vascular access. Infection and thrombosis are the main adverse effects of these catheters. We aimed to evaluate the relative risk of complications from midlines and PICCs. Methods We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies. The primary outcomes were catheter-related bloodstream infection (CRBSI) and thrombosis. Secondary outcomes evaluated included mortality, failure to complete therapy, catheter occlusion, phlebitis, and catheter fracture. The certainty of evidence was assessed using the GRADE approach. Results Of 8368 citations identified, 20 studies met the eligibility criteria, including 1 RCT and 19 observational studies. Midline use was associated with fewer patients with CRBSI compared with PICCs (odds ratio [OR], 0.24; 95% CI, 0.15–0.38). This association was not observed when we evaluated risk per catheter. No significant association was found between catheters when evaluating risk of localized thrombosis and pulmonary embolism. A subgroup analysis based on location of thrombosis showed higher rates of superficial venous thrombosis in patients using midlines (OR, 2.30; 95% CI, 1.48–3.57). We did not identify any significant difference between midlines and PICCs for the secondary outcomes. Conclusions Our findings suggest that patients who use midlines might experience fewer CRBSIs than those who use PICCs. However, the use of midline catheters was associated with greater risk of superficial vein thrombosis. These findings can help guide future cost-benefit analyses and direct comparative RCTs to further characterize the efficacy and risks of PICCs vs midline catheters.

AbstractContextHypercalcemia is a common complication of malignancy that is associated with high morbidity and mortality.ObjectiveTo support development of the Endocrine Society Clinical Practice Guideline for the treatment of hypercalcemia of malignancy in adults.MethodsWe searched multiple databases for studies that addressed 8 clinical questions prioritized by a guideline panel from the Endocrine Society. Quantitative and qualitative synthesis was performed. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to assess certainty of evidence.ResultsWe reviewed 1949 citations, from which we included 21 studies. The risk of bias for most of the included studies was moderate. A higher proportion of patients who received bisphosphonate achieved resolution of hypercalcemia when compared to placebo. The incidence rate of adverse events was significantly higher in the bisphosphonate group. Comparing denosumab to bisphosphonate, there was no significant difference in the rate of patients who achieved resolution of hypercalcemia. Two-thirds of patients with refractory/recurrent hypercalcemia of malignancy who received denosumab following bisphosphonate therapy achieved resolution of hypercalcemia. Addition of calcitonin to bisphosphonate therapy did not affect the resolution of hypercalcemia, time to normocalcemia, or hypocalcemia. Only indirect evidence was available to address questions on the management of hypercalcemia in tumors associated with high calcitriol levels, refractory/recurrent hypercalcemia of malignancy following the use of bisphosphonates, and the use of calcimimetics in the treatment of hypercalcemia associated with parathyroid carcinoma. The certainty of the evidence to address all 8 clinical questions was low to very low.ConclusionThe evidence summarized in this systematic review addresses the benefits and harms of treatments of hypercalcemia of malignancy. Additional information about patients’ values and preferences, and other important decisional and contextual factors is needed to facilitate the development of clinical recommendations.