Tag: statistics

Clin Spine Surg. 2022 Aug 3. doi: 10.1097/BSD.0000000000001365. Online ahead of print.

ABSTRACT

STUDY DESIGN: Prospective randomized Food and Drug Administration investigational device exemption clinical trial.

OBJECTIVE: The purpose of the present study is to report the 1-year clinical and radiographic outcomes and safety profile of patients who underwent lumbar facet arthroplasty through implantation of the Total Posterior Spine System (TOPS) device.

SUMMARY OF BACKGROUND DATA: Lumbar facet arthroplasty is one proposed method of dynamic stabilization to treat grade-1 spondylolisthesis with stenosis; however, there are currently no Food and Drug Administration-approved devices for facet arthroplasty.

METHODS: Standard demographic information was collected for each patient. Radiographic parameters and patient-reported outcome measures were assessed preoperatively and at regular postoperative intervals. Complication and reoperation data were also collected for each patient.

RESULTS: At the time of this study, 153 patients had undergone implantation of the TOPS device. The mean surgical time was 187.8 minutes and the mean estimated blood loss was 205.7cc. The mean length of hospital stay was 3.0 days. Mean Oswestry Disability Index, Visual Analog Score leg and back, and Zurich Claudication Questionnaire scores improved significantly at all postoperative time points (P>0.001). There were no clinically significant changes in radiographic parameters, and all operative segments remained mobile at 1-year follow-up. Postoperative complications occurred in 11 patients out of the 153 patients (7.2%) who underwent implantation of the TOPS device. Nine patients (5.9%) underwent a total of 13 reoperations, 1 (0.6%) of which was for device-related failure owing to bilateral L5 pedicle screw loosening.

CONCLUSIONS: Lumbar facet arthroplasty with the TOPS device demonstrated a statistically significant improvement in all patient-reported outcome measures and the ability to maintain motion at the index level while limiting sagittal translation with a low complication rate.

PMID:36191093 | DOI:10.1097/BSD.0000000000001365

Hum Reprod Update. 2022 Oct 3:dmac034. doi: 10.1093/humupd/dmac034. Online ahead of print.

ABSTRACT

BACKGROUND: Depression and anxiety are highly prevalent among individuals struggling with infertility. Thus, numerous psychological interventions have been adapted to infertility, with the aim of relieving distress as well as increasing pregnancy rates.

OBJECTIVE AND RATIONALE: This systematic review and meta-analysis aimed to identify all randomized controlled trials (RCTs) evaluating the effect of psychological interventions on infertility-related distress and pregnancy rates among individuals and/or couples with infertility and to analyse their overall effect. It also sought to examine potential treatment moderators, including intervention length, format and therapeutic approach.

SEARCH METHODS: An electronic search of 11 databases, including MEDLINE, EMBASE, PsycINFO and Cochrane Central Register of Controlled Trials, was performed for studies published until January 2022. The inclusion criteria were RCTs conducted on humans and published in English. Psychological outcomes of interest included anxiety, depression, infertility-related distress, wellbeing and marital satisfaction. The Cochrane Risk of Bias tool was used to assess study quality, and the Grading of Recommendations Assessment, Development and Evaluation was used to assess the overall quality of the research evidence.

OUTCOMES: There were 58 RCTs in total, including 54 which included psychological outcomes and 21 which assessed pregnancy rates. Studies originated from all regions of the world, but nearly half of the studies were from the Middle East. Although a beneficial effect on combined psychological outcomes was found (Hedge’s g = 0.82, P < 0.0001), it was moderated by region (P < 0.00001) such that studies from the Middle East exhibited large effects (g = 1.40, P < 0.0001), while the effects were small among studies conducted elsewhere (g = 0.23, P < 0.0001). Statistically adjusting for study region in a meta-regression, neither intervention length, therapeutic approach, therapy format, nor participant gender (P > 0.05) moderated the effect of treatment. A beneficial treatment effect on pregnancy (RR (95% CI) = 1.25 (1.07-1.47), P = 0.005) was not moderated by region, treatment length, approach or format (P > 0.05). Largely due to the lack of high quality RCTs, the quality of the available evidence was rated as low to moderate.

WIDER IMPLICATIONS: This is the first meta-analysis of RCTs testing the effect of psychological interventions on infertility-related distress and pregnancy rates. These findings suggest that in most regions of the world, psychological interventions are associated with small reductions in distress and modest effects on conception, suggesting the need for more effective interventions. These findings must be considered in light of the fact that the majority of the included RCTs were deemed to be at high risk of bias. Rigorously conducted trials are needed.

PMID:36191078 | DOI:10.1093/humupd/dmac034

J Am Assoc Nurse Pract. 2022 Oct 1;34(10):1174-1180. doi: 10.1097/JXX.0000000000000774.

ABSTRACT

BACKGROUND: Goals of care conversations (GoCCs) are essential discussions, for those with chronic diseases, to identify a health care surrogate, initiate and review advance directives, and refer for palliative care. Prognosis with pulmonary hypertension (PH) related to heart failure (HF) remains challenging due to variation in trajectory of disease progression. The Gagne Combined Comorbidity score, an electronic prognostication score (E-Gagne), can be used to identify patients with high (>10%) 1-year mortality.

LOCAL PROBLEM: Implementation of E-Gagne tool to identify HF patients with high 1-year mortality risk and trigger GoCCs.

METHODS: Plan-Do-Study-Act cycles were used throughout nine-week pre- and postintervention in an outpatient setting. Descriptive statistics and Chi-square analysis were used to compare GoCCs pre and post intervention.

INTERVENTION: Using the E-Gagne tool, PH patients with high mortality risk were identified, within 1 week of their scheduled appointments. GoCCs education was provided to all stakeholders. Medical records were reviewed for four aspects of GoCCs: presence and review of advanced directive, documented health care surrogates, and referral for palliative care.

RESULTS: Documentation of GoCCs was greater postintervention compared with preintervention (0%, n = 0/47 and 88%, n = 35/40 respectively, p < .001). Documentation of each of the four aspects of GoCCs was variable with the greatest improvement in documentation of health care surrogate and review of advance directives. There were no referrals for palliative care (0%, n = 0/47 and 0%, n = 0/40).

CONCLUSION: Implementation of the E-Gagne tool, an electronic prognostication tool, identified high-risk PH HF patients and was effective in increasing documentation of GoCCs.

PMID:36191076 | DOI:10.1097/JXX.0000000000000774

J Am Assoc Nurse Pract. 2022 Oct 1;34(10):1133-1138. doi: 10.1097/JXX.0000000000000775.

ABSTRACT

BACKGROUND: Anterior capsular contraction syndrome (ACCS) describes the progressive fibrotic phimosis of the anterior capsular bag that usually occurs a few months after cataract surgery. YAG laser anterior capsulotomy (YAGAC) is the most common treatment option due to the low-risk profile of this intervention.

PURPOSE: In this series, we evaluated the outcomes of an advanced nurse practitioner (ANP) in conducting this laser intervention, comparing the results with those of ophthalmologists.

METHODOLOGY: Our study represents a single-centre, retrospective, continuous case series of 108 eyes that underwent YAGAC due to ACCS between January 2017 and July 2020 at the Birmingham and Midland Eye Centre, the second largest tertiary referral centre in the United Kingdom.

RESULTS: The groups treated by ANPs and ophthalmologists were similar in respect to age, gender, and laterality of the laser procedure. Eyes treated by ophthalmologists had significantly more ocular comorbidities (p < .001), the most common of which was glaucoma. Although the complication rate was higher in the ophthalmologist group, it did not reach statistical significance. However, there was a trend toward significance in the retreatment rate, with 8.6% (7/81) of eyes lasered by ophthalmologists requiring further YAGAC, and no repeat procedure was needed in the ANP group.

CONCLUSIONS: YAGAC leads to good visual outcomes and a low complication rate in both ophthalmologist and ANP groups.

IMPLICATIONS: Advanced nurse practitioners can deliver results that are comparable with those of experienced ophthalmologists.

PMID:36191073 | DOI:10.1097/JXX.0000000000000775

Spine (Phila Pa 1976). 2022 Sep 30. doi: 10.1097/BRS.0000000000004489. Online ahead of print.

ABSTRACT

STUDY DESIGN: Retrospective cohort.

OBJECTIVE: To quantify any reduction in venous thromboembolic events (VTE) caused by chemoprophylaxis among lumbar surgery patients.

SUMMARY OF BACKGROUND DATA: Chemoprophylactic anticoagulation (chemoprophylaxis) is used to prevent VTE after lumbar surgery. However, the treatment effect of chemoprophylaxis has not been reported among spine surgery patients, as conventional statistical methods preclude such inferences.

METHODS: 1243 consecutive lumbar fusions and 1433 non-instrumented lumbar decompressions performed at our institution over a six-year period were identified, and clinical and demographic data were collected, including on VTE events within 30 days postoperatively. Instrumented lumbar fusions and non-instrumented lumbar surgeries were analyzed separately. Patients who were given chemoprophylaxis (treatment) and controls were matched according to known VTE risk factors, including age, body mass index, sex, diabetes, chronic kidney disease, history of VTE, estimated blood loss, length of surgery, transfusion, whether surgery was staged, and whether surgery used an anterior approach. K-nearest neighbor propensity score matching was performed, and the treatment effect of chemoprophylaxis was calculated.

RESULTS: Unadjusted, there was no difference in the rate of VTE between treatment and controls in either population. Baseline clinical and demographic characteristics differed significantly between treatment and control groups. 575 lumbar fusion patients and 435 non-instrumented lumbar decompression patients were successfully propensity score matched, yielding balanced models (Rubin’s B<25, 0.5<Rubin’s R<2.0) and >60% reduction in known bias for both populations. The treatment effect of chemoprophylaxis after lumbar fusion in our patient population was a reduction in VTE incidence from 9.4% to 4.2% (P<0.05), and propensity score adjusted regression confirmed a reduced odds of VTE with chemoprophylaxis (OR=0.37, P=0.035). The treatment effect was not significant for non-instrumented lumbar decompression patients.

CONCLUSION: Among patients undergoing instrumented lumbar fusions, chemoprophylactic anticoagulation causes a significant reduction in VTE, but causes no significant reduction among patients undergoing non-instrumented lumbar decompression.

PMID:36191060 | DOI:10.1097/BRS.0000000000004489

Spine (Phila Pa 1976). 2022 Oct 3. doi: 10.1097/BRS.0000000000004499. Online ahead of print.

ABSTRACT

STUDY DESIGN: A retrospective study.

OBJECTIVE: The purpose of this study is to identify the incidences, causes, and risk factors of 30-day unplanned reoperation of posterior surgery for thoracic spinal stenosis (TSS) based on 1948 patients in a single center.

SUMMARY OF BACKGROUND DATA: Unplanned reoperation is suggested to be a useful quality indicator for spine surgery. However, the incidences, causes, and risk factors of 30-day unplanned reoperation in patients who underwent posterior spinal surgery for TSS have not been well established.

METHODS: We retrospectively analyzed the clinical data of patients who underwent posterior spinal surgery for TSS from January 2011 to December 2021. Statistical methods including univariate and multivariate analyses were performed to assess the incidences, causes and risk factors.

RESULTS: A total of 1948 patients who underwent posterior spinal surgery for TSS in our institution were reviewed, and 77 (3.95%) required unplanned reoperations within 30 days because of epidural hematoma (1.64%), wound-related complications (1.02%), inadequate decompression (0.41%), and implant malposition or failure (0.36%), neurological deficit (0.26%), and other causes (0.26%). After univariate analysis, seven clinical factors were associated with unplanned reoperation (P<0.05). Multivariate logistic regression analysis showed that upper thoracic spine surgery (P=0.010), thoracic kyphosis ≥45° (P=0.039), and intraoperative dural injury (P=0.047) were independent risk factors for 30-day unplanned reoperation of posterior surgery for TSS.

CONCLUSION: The incidence of 30-day unplanned reoperations after posterior surgical treatment for TSS was 3.95%. The most common causes were epidural hematoma, wound-related complications, inadequate decompression, and implant malposition or failure. Upper thoracic spine durgery, thoracic kyphosis≥45°, and intraoperative dural injury led to an increased risk of unplanned reoperation within 30 days after posterior spinal surgery for TSS.

LEVEL OF EVIDENCE: 4.

PMID:36191058 | DOI:10.1097/BRS.0000000000004499

PLoS Comput Biol. 2022 Oct 3;18(10):e1010577. doi: 10.1371/journal.pcbi.1010577. Online ahead of print.

ABSTRACT

Consensus clustering has been widely used in bioinformatics and other applications to improve the accuracy, stability and reliability of clustering results. This approach ensembles cluster co-occurrences from multiple clustering runs on subsampled observations. For application to large-scale bioinformatics data, such as to discover cell types from single-cell sequencing data, for example, consensus clustering has two significant drawbacks: (i) computational inefficiency due to repeatedly applying clustering algorithms, and (ii) lack of interpretability into the important features for differentiating clusters. In this paper, we address these two challenges by developing IMPACC: Interpretable MiniPatch Adaptive Consensus Clustering. Our approach adopts three major innovations. We ensemble cluster co-occurrences from tiny subsets of both observations and features, termed minipatches, thus dramatically reducing computation time. Additionally, we develop adaptive sampling schemes for observations, which result in both improved reliability and computational savings, as well as adaptive sampling schemes of features, which lead to interpretable solutions by quickly learning the most relevant features that differentiate clusters. We study our approach on synthetic data and a variety of real large-scale bioinformatics data sets; results show that our approach not only yields more accurate and interpretable cluster solutions, but it also substantially improves computational efficiency compared to standard consensus clustering approaches.

PMID:36191044 | DOI:10.1371/journal.pcbi.1010577

J Correct Health Care. 2022 Sep 28. doi: 10.1089/jchc.21.02.0018. Online ahead of print.

ABSTRACT

Data from the Bureau of Justice Statistics occasional jail inmate and state prisoner surveys reveal that behavioral health issues-mental health and substance use disorders-are consistently the most prevalent health issues among criminal justice-involved (CJ-I) persons. Although these surveys provide a national-level perspective, they do not provide a true public health surveillance approach to determining the prevalence and types of behavioral health issues that burden the populations who pass through the criminal justice process. The fact that there are no “reportable” behavioral health conditions is cited as a factor in the lack of agreement on what constitutes the case definition of behavioral health disorders. This article takes an organizational systems perspective to provide a “flow” analysis of CJ-I individuals and the organizational entities involved at each step of the criminal justice system decision-making process. Issues associated with questions of “screening,” “assessment,” and “diagnosis” and how such information is potentially stored and reported to a centralized surveillance agency are explored. Informatics and standardization and the role of accrediting bodies in the development of behavioral health surveillance data are canvassed. A series of “first steps” in the development of a state- and national-level behavioral health surveillance system for CJ-I populations is provided.

PMID:36191038 | DOI:10.1089/jchc.21.02.0018

JMIR Diabetes. 2022 Oct 3;7(4):e40377. doi: 10.2196/40377.

ABSTRACT

BACKGROUND: Diabetes is a major health care problem, reaching epidemic numbers worldwide. Reducing hemoglobin A_1c (HbA_1c) levels to recommended targets is associated with a marked decrease in the risk of type 2 diabetes mellitus (T2DM)-related complications. The implementation of new technologies, particularly telemedicine, may be helpful to facilitate self-care and empower people with T2DM, leading to improved metabolic control of the disease.

OBJECTIVE: This study aimed to analyze the effect of a home digital patient empowerment and communication tool (DeMpower App) on metabolic control in people with inadequately controlled T2DM.

METHODS: The DeMpower study was multicenter with a retrospective (observational: 52 weeks of follow-up) and prospective (interventional: 52 weeks of follow-up) design that included people with T2DM, aged ≥18 and ≤80 years, with HbA_1c levels ≥7.5% to ≤9.5%, receiving treatment with noninsulin antihyperglycemic agents, and able to use a smartphone app. Individuals were randomly assigned (2:1) to the DeMpower app-empowered group or control group. We describe the effect of empowerment on the proportion of patients achieving the study glycemic target, defined as HbA_1c≤7.5% with a ≥0.5% reduction in HbA_1c at week 24.

RESULTS: Due to the COVID-19 pandemic, the study was stopped prematurely, and 50 patients (33 in the DeMpower app-empowered group and 17 in the control group) were analyzed. There was a trend toward a higher proportion of patients achieving the study glycemic target (46% vs 18%; P=.07) in the DeMpower app group that was statistically significant when the target was HbA_1c≤7.5% (64% vs 24%; P=.02) or HbA_1c≤8% (85% vs 53%; P=.02). The mean HbA_1c was significantly reduced at week 24 (-0.81, SD 0.89 vs -0.15, SD 1.03; P=.03); trends for improvement in other cardiovascular risk factors, medication adherence, and satisfaction were observed.

CONCLUSIONS: The results suggest that patient empowerment through home digital tools has a potential effect on metabolic control, which might be even more relevant during the COVID-19 pandemic and in a digital health scenario.

PMID:36190763 | DOI:10.2196/40377