Category: Statistics

J Adv Nurs. 2021 Jun 12. doi: 10.1111/jan.14920. Online ahead of print.

ABSTRACT

AIM: This study aims to provide economic evidence of the cost-effectiveness of employing specialist Parkinson’s nurses in a regional community in Australia.

STUDY DESIGN: This retrospective study utilized hospital service usage data to compare outcomes for people with Parkinson’s disease before and after the employment of a specialist Parkinson’s nurse in a regional community.

METHODS: A representative sample was drawn from the target population of people with a diagnosis of Parkinson’s admitted to a regional hospital over a 4-year period (2013-2014 and 2016-2017). A multiple regression approach and cost-benefit analysis were used to examine hospital costs related to length of stay based on hospital records. All costs were attributed to resource allocation according to service category and the national funding system. Quantitative data were analysed using Strata Analytics.

RESULTS: Statistical findings demonstrated a reduction in hospital length of stay ranging from 0.37 (AUD$1924) to 0.755 day (AUD$3926) after the establishment of the specialist Parkinson’s nurse. The cost-benefit analysis showed a net dollar benefit, or savings in hospital costs, of up to $8600.00 per person over a 3-year period, as a result of the specialist Parkinson’s nurse intervention.

CONCLUSION: The statistical results show significant cost benefits associated with reduced length of hospital stay following introduction of the specialist Parkinson’s nurse. These findings support advocacy for sustainable specialist Parkinson’s nurse positions and have the potential to inform and influence policy and systemic changes within the health care system.

IMPACT: The benefits of embedding specialist nursing services for people with Parkinson’s disease in primary health settings include the direct impact on the potential to avoid hospital admissions due to worsening symptoms, improving quality of life for the person with Parkinson’s and slowing the trajectory of the disease. Additional benefits are increased access to specialist services and reduced family caregiver burden.

PMID:34118161 | DOI:10.1111/jan.14920

J Adv Nurs. 2021 Jun 12. doi: 10.1111/jan.14915. Online ahead of print.

ABSTRACT

AIMS: This study systematically reviews the literature regarding preoperative stoma site marking and discusses the effectiveness of the procedure on complication rates, self-care deficits and health-related quality of life (HRQOL).

DESIGN: Systematic review and meta-analysis.

DATA SOURCE: Our review was conducted following the PRISMA guidelines. PubMed, EMBASE, Cochrane and CINAHL databases were searched to obtain articles published in English. Articles were also retrieved from Korean databases as well. Our last search was conducted on 2 June 2019.

REVIEW METHODS: Two reviewers independently selected relevant studies, evaluated their methodological quality and extracted data. Experimental and observational studies were included. Our main focus was on complication rates, self-care deficits and HRQOL. We conducted meta-analysis using the statistical software spss 25.0 and Stata 13.0.

RESULTS: Of the 1,039 articles reviewed, 20 were included for review, and 19 were used for quantitative synthesis. Preoperative stoma site marking reduced complication rates (odds ratio [OR]: 0.47; 95% confidence interval [CI]: 0.36-0.62; I² : 70.6%), lowered self-care deficits (OR: 0.34; 95% CI: 0.18-0.64; I² : 0%), and increased HRQOL (standardized mean difference, 1.05; 95% CI: 0.70-1.40; I² : 0%). Quality appraisal results for both the individual studies and the studies overall were excellent. The possibility of publication bias was low.

CONCLUSIONS: Our findings indicate that preoperative stoma site marking improves patient outcomes: stoma-related complication rates and self-care deficits decrease and HRQOL rises. For this reason, preoperative stoma site marking should be a mandatory procedure in clinical settings. The practice should also be supported by policymakers and healthcare expert associations.

IMPACT: Preoperative stoma site marking reduces overall complication rates by 53% and skin problems by 59%. Preoperative stoma site marking also improves self-care and health-related quality of life. We recommend that preoperative stoma site marking should be a mandatory procedure in clinical settings.

PMID:34118170 | DOI:10.1111/jan.14915

Liver Transpl. 2021 Jun 12. doi: 10.1002/lt.26209. Online ahead of print.

ABSTRACT

BACKGROUND AND AIMS: The Affordable Care Act (ACA) expanded Medicaid around the same time that direct-acting antivirals (DAAs) became widely available for the treatment of hepatitis C virus (HCV). However, there is significant variation in Medicaid HCV treatment eligibility criteria between states. We explored the combined effects of Medicaid expansion and leniency of HCV coverage under Medicaid on liver outcomes.

METHODS: We assessed state-level end-stage liver disease (ESLD) mortality, listings for liver transplant (LT), and listing-to-death ratio (LDR) for adults 25-64 years old using data from UNOS and CDC WONDER. States were divided into four nonoverlapping groups based on expansion status on January 1, 2014 (expansion versus non-expansion) and leniency of Medicaid HCV coverage (lenient versus restrictive coverage). Joinpoint regression analysis evaluated for significant changes in slope over time (joinpoints) during the pre-expansion (2009-2013) and post-expansion (2014-2018) time periods.

RESULTS: We found significant changes in annual percent change (APC) for population-adjusted ESLD deaths between 2014-2015 in all cohorts except for the non-expansion/restrictive cohort, in which deaths increased at the same APC from 2009-2018 (APC +2.5% [95% CI 1.8, 3.3]). In the expansion/lenient coverage cohort, deaths increased at an APC of +2.6% (95% CI 1.8, 3.5) until 2014 and then tended to decrease at an APC of -0.4% (95% CI -1.5, 0.8). LT listings tended to decrease over time for all cohorts. For LDR, only the expansion/lenient and expansion/restrictive cohorts had statistically significant joinpoints.

CONCLUSION: Improvements in ESLD mortality and LDR were associated with both Medicaid expansion and leniency of HCV coverage under Medicaid. These findings argue for the implementation of more lenient and widespread public health insurance to improve liver disease outcomes, including mortality.

PMID:34118120 | DOI:10.1002/lt.26209

J Int AIDS Soc. 2021 Jun;24(6):e25726. doi: 10.1002/jia2.25726.

ABSTRACT

INTRODUCTION: Since the beginning of the HIV epidemic in resource-rich countries, Pneumocystis jirovecii pneumonia (PjP) is one of the most frequent opportunistic AIDS-defining infections. The Collaboration of Observational HIV Epidemiological Research Europe (COHERE) has shown that primary Pneumocystis jirovecii Pneumonia (PjP) prophylaxis can be safely withdrawn in patients with CD4 counts of 100 to 200 cells/µL if plasma HIV-RNA is suppressed on combination antiretroviral therapy. Whether this holds true for secondary prophylaxis is not known, and this has proved difficult to determine due to the much lower population at risk.

METHODS: We estimated the incidence of secondary PjP by including patient data collected from 1998 to 2015 from the COHERE cohort collaboration according to time-updated CD4 counts, HIV-RNA and use of PjP prophylaxis in persons >16 years of age. We fitted a Poisson generalized additive model in which the smoothed effect of CD4 was modelled by a restricted cubic spline, and HIV-RNA was stratified as low (<400), medium (400 to 10,000) or high (>10,000copies/mL).

RESULTS: There were 373 recurrences of PjP during 74,295 person-years (py) in 10,476 patients. The PjP incidence in the different plasma HIV-RNA strata differed significantly and was lowest in the low stratum. For patients off prophylaxis with CD4 counts between 100 and 200 cells/µL and HIV-RNA below 400 copies/mL, the incidence of recurrent PjP was 3.9 (95% CI: 2.0 to 5.8) per 1000 py, not significantly different from patients on prophylaxis in the same stratum (1.9, 95% CI: 0.1 to 3.7).

CONCLUSIONS: HIV viraemia importantly affects the risk of recurrent PjP. In virologically suppressed patients on ART with CD4 counts of 100 to 200/µL, the incidence of PjP off prophylaxis is below 10/1000 py. Secondary PjP prophylaxis may be safely withheld in such patients. While European guidelines recommend discontinuing secondary PjP prophylaxis only if CD4 counts rise above 200 cells/mL, the latest US Guidelines consider secondary prophylaxis discontinuation even in patients with a CD4 count above 100 cells/µL and suppressed viral load. Our results strengthen and support this US recommendation.

PMID:34118121 | DOI:10.1002/jia2.25726

Andrologia. 2021 Jun 12:e14121. doi: 10.1111/and.14121. Online ahead of print.

ABSTRACT

Our study aimed to assess for predictors of varicocele-associated pain and whether it predicts semen parameters after microsurgical varicocelectomy. We assessed all men diagnosed with a varicocele by two surgeons from 2017 to 2020, excluding those who did not undergo surgical treatment. Patients were stratified based on the presence of pain at clinical assessment, and these groups were compared. Logistic regression models were utilised to assess for predictors of pain. A total of 313 men were included, with relatively similar proportions completed by both surgeons (48.2% and 51.8%). A total of 98 (31.3%) had typical varicocele-associated pain at the time of assessment. The pain group was younger than the no pain group (30.5 versus. 35.0, respectively, p < .01), and those with pain had greater varicocele grades (p = .008). Although not statistically different, there was a greater portion of left-sided only varicoceles in the pain group (p = .09). No significant differences were demonstrated between sperm concentration, motility, volume or morphology pre-operatively, or post-operatively between groups. Younger age and varicocele grade were predictive of varicocele-associated pain. In conclusion, almost 1/3 of men presented with varicocele-associated pain. Pain does not predict response to varicocelectomy, but these men tend to be younger, and have higher grade varicoceles.

PMID:34118088 | DOI:10.1111/and.14121

J Int AIDS Soc. 2021 Jun;24(6):e25747. doi: 10.1002/jia2.25747.

ABSTRACT

INTRODUCTION: Vaginal rings are a promising approach to provide a woman-centred, long-acting HIV prevention strategy. Prior trials of a 25 mg dapivirine (DPV) ring have shown a favourable safety profile and approximately 30% risk reduction of HIV-1 infection. Extended duration rings replaced every three months may encourage user adherence, improve health service efficiency and reduce cost overall. We evaluated safety, pharmacokinetics, adherence and acceptability of two three-month rings with different DPV dosages, compared with the monthly DPV ring.

METHODS: From December 2017 to October 2018, MTN-036/IPM-047 enrolled 49 HIV-negative participant in Birmingham, Alabama and San Francisco, California into a phase 1, randomized trial comparing two extended duration (three-month) rings (100 or 200 mg DPV) to a monthly 25 mg DPV ring, each used over 13 weeks, with follow-up completed in January 2019. Safety was assessed by recording adverse events (AEs). DPV concentrations were quantified in plasma, cervicovaginal fluid (CVF) and cervical tissue, at nominal timepoints. Geometric mean ratios (GMRs) relative to the comparator ring were estimated from a regression model.

RESULTS: There were no differences in the proportion of participants with grade ≥2 genitourinary AEs or grade ≥3 AEs in the extended duration versus monthly ring arms (p = 1.0). Plasma and CVF DPV concentrations were higher in the extended duration rings compared to the monthly ring. Plasma GMRs were 1.31 to 1.85 and 1.41 to 1.86 and CVF GMRs were 1.45 to 2.87 and 1.74 to 2.60 for the 100 and 200 mg ring respectively. Cervical tissue concentrations were consistently higher in the 200 mg ring (GMRs 2.36 to 3.97). The majority of participants (82%) were fully adherent (ring inserted at all times, with no product discontinuations/outages) with no differences between the monthly versus three-month rings. Most participants found the ring acceptable (median = 8 on 10-point Likert scale), with a greater proportion of participants reporting high acceptability (9 or 10) in the 25 mg arm (73%) compared with the 100 mg (25%) and 200 mg (44%) arms (p = 0.01 and p = 0.15 respectively).

CONCLUSIONS: The extended duration DPV rings were well-tolerated and achieved higher DPV concentrations compared with the monthly DPV ring. These findings support further evaluation of three-month DPV rings for HIV prevention.

PMID:34118115 | DOI:10.1002/jia2.25747

Diabetes Ther. 2021 Jun 12. doi: 10.1007/s13300-021-01092-0. Online ahead of print.

ABSTRACT

INTRODUCTION: Sodium-glucose co-transporter-2 (SGLT2) inhibitors moderately reduce glucose levels in type-2 diabetes mellitus (T2DM). Some cases of diabetic ketoacidosis (DKA) were reported with SGLT2 inhibitors. However, data on the long-term safety of dapagliflozin in Saudi Arabia are lacking. The present study aimed to monitor the safety of dapagliflozin in patients with T2DM and evaluate the change in HbA1c during the observation period compared to baseline.

METHODS: This was a local, prospective, single-arm, non-interventional, regulatory post-marketing study. The study was conducted in Saudi Arabia from May 2017 to September 2019. Patients received either 5 or 10 mg dapagliflozin in conjunction with diet and exercise modifications to treat T2DM. The occurrence of adverse events was observed over the treatment duration and for 3 days after administering the last dose of dapagliflozin.

RESULTS: A total of 527 patients were recruited in the study, 524 of which were eligible for the statistical analysis. About 62% were males. The median (IQR) age was 52.3 (14.8) years, while the median (IQR) body mass index was 31.6 (7.7) kg/m². The median (IQR) duration since the patients were first diagnosed with T2DM was 8.78 (6.73) years. The most common comorbidities were hyperlipidemia (51.1%) and hypertension (41.1%). Almost three-quarters of the study population (73.7%) received other antidiabetic medications in addition to dapagliflozin. Over a period of 12 months, a total of 106 adverse events were experienced by 65 (12.33%) patients. Vulvovaginal pruritus (3.1%), dysuria (2.7%), polyuria (1.3%), urinary tract infections (1%), fatigue (0.8%), and hypoglycemia (0.8%) were among the reported adverse events. One case of DKA (0.2%) was reported. The mean (SD) HbA1c% level significantly decreased from 8.6 (1.6) % at baseline to reach 7.2 (1.2) % after 12 months of treatment (p < 0.0001).

CONCLUSION: Dapagliflozin was found to be a well tolerated and effective treatment option for T2DM patients in Saudi Arabia. Vulvovaginal pruritus and dysuria were the most common adverse events.

PMID:34118010 | DOI:10.1007/s13300-021-01092-0

J Am Geriatr Soc. 2021 Jun 12. doi: 10.1111/jgs.17290. Online ahead of print.

ABSTRACT

BACKGROUND/OBJECTIVES: To assess whether vitamin D supplementation prevents specific fall subtypes and sequelae (e.g., fracture).

DESIGN: Secondary analyses of STURDY (Study to Understand Fall Reduction and Vitamin D in You)-a response-adaptive, randomized clinical trial.

SETTING: Two community-based research units.

PARTICIPANTS: Six hundred and eighty-eight participants ≥70 years old with elevated fall risk and baseline serum 25-hydroxyvitamin D levels of 10-29 ng/ml.

INTERVENTION: 200 IU/day (control), 1000 IU/day, 2000 IU/day, or 4000 IU/day of vitamin D3.

MEASUREMENTS: Outcomes included repeat falls and falls that were consequential, were injurious, resulted in emergency care, resulted in fracture, and occurred either indoors or outdoors.

RESULTS: After adjustment for multiple comparisons, the risk of fall-related fracture was greater in the pooled higher doses (≥1000 IU/day) group compared with the control (hazard ratio [HR] = 2.66; 95% confidence interval [CI]:1.18-6.00). Although not statistically significant after multiple comparisons adjustment, time to first outdoor fall appeared to differ between the four dose groups (unadjusted p for overall difference = 0.013; adjusted p = 0.222), with risk of a first-time outdoor fall 39% lower in the 1000 IU/day group (HR = 0.61; 95% CI: 0.38-0.97; unadjusted p = 0.036; adjusted p = 0.222) and 40% lower in the 2000 IU/day group (HR = 0.60; 95%CI 0.38-0.97; p = 0.037; adjusted p = 0.222), each versus control.

CONCLUSION: Vitamin D supplementation doses ≥1000 IU/day might have differential effects on fall risk based on fall location and fracture risk, with the most robust finding that vitamin D doses between 1000 and 4000 IU/day might increase the risk of first time falls with fractures. Replication is warranted, given the possibility of type 1 error.

PMID:34118059 | DOI:10.1111/jgs.17290

Equine Vet J. 2021 Jun 12. doi: 10.1111/evj.13488. Online ahead of print.

ABSTRACT

BACKGROUND: There is a lack of understanding of the pathological and/or physiological nature of lumbosacral region pain.

OBJECTIVES: To describe the gross variations of the osseous and soft tissues of the lumbosacral region and report the histological findings of sections of nerve tissue in affected and control horses.

STUDY DESIGN: Descriptive post-mortem case series.

METHODS: All horses had undergone full clinical and gait assessment, including ridden exercise. Horses with a substantial response to infiltration of local anaesthetic solution around the sacroiliac joint regions were included in the affected group (n=27). Horses for which the source(s) of pain was confirmed by diagnostic anaesthesia to be distant to the lumbosacral region were included in the control group (n=5). The pelvic regions were isolated and the soft tissues were assessed grossly. Sections of the lumbosacral plexus and cranial gluteal, sciatic and obturator nerves were examined histologically. The osseous specimens were evaluated for anatomical variants and abnormalities. Data were analysed using descriptive statistics.

RESULTS: Gross discolouration of the sciatic or obturator nerves was observed in 7 (26%) affected and no control horses. Grade 3/3 histological abnormality scores were assigned in 22% of nerve sections from affected horses compared with 3% from control horses. Several osseous variants (bifid sacral spinous processes, straight-shaped sacroiliac joint surface, short arrow-shaped sacral alae, left-right asymmetry of sacral alae, sacral curvature, absence of the 4^th -5^th and ankylosis of the 5^th -6^th lumbar articular process joints, left-right asymmetry of caudocranial position of the 4^th -5^th and lumbar-sacral articular process joints) and abnormalities (sacroiliac enthesopathy, extra ventral sacroiliac joint surface, lumbosacral symphyseal periarticular modelling, lumbosacral intertransverse joint pitting-lesions) were more frequently observed in affected horses.

MAIN LIMITATIONS: Both control and affected horses may have had pre-clinical abnormalities.

CONCLUSIONS: Lumbosacral region pain may reflect the presence of a number of pathological changes. Neural pain may play an important role in some horses.

PMID:34118082 | DOI:10.1111/evj.13488

Prev Sci. 2021 Jun 12. doi: 10.1007/s11121-021-01261-4. Online ahead of print.

ABSTRACT

Adolescent drinking remains a prominent public health and socioeconomic issue in the USA with costly consequences. While numerous drinking intervention programs have been developed, there is little guidance whether certain strategies of participant recruitment are more effective than others. The current study aims at addressing this gap in the literature using a computer simulation approach, a more cost-effective method than employing actual interventions. We first estimate stochastic actor-oriented models for two schools from the National Longitudinal Study of Adolescent to Adult Health (Add Health). We then employ different strategies for selecting adolescents for the intervention (either based on their drinking levels or their positions in the school network) and simulate the estimated model forward in time to assess the aggregated level of drinking in the school at a later time point. The results suggest that selecting moderate or heavy drinkers for the intervention produces better results compared to selecting casual or light drinkers. The intervention results are improved further if network position information is taken into account, as selecting drinking adolescents with higher in-degree or higher eigenvector centrality values for intervention yields the best results. Results from this study help elucidate participant selection criteria and targeted network intervention strategies for drinking intervention programs in the USA.

PMID:34117976 | DOI:10.1007/s11121-021-01261-4