Tag: statistics

BMJ Open. 2021 Nov 3;11(11):e054954. doi: 10.1136/bmjopen-2021-054954.

ABSTRACT

INTRODUCTION: Heavy drinkers in contact with alcohol services do not routinely have access to testing to establish the severity of potential liver disease. Transient elastography by FibroScan can provide this information. A recent systematic review suggested providing feedback to patients based on markers of liver injury can be an effective way to reduce harmful alcohol intake. This randomised control trial (RCT) aims to establish the feasibility of conducting a larger national trial to test the effectiveness of FibroScan advice and Alcohol Recovery Video Stories (ARVS) in changing high-risk drinking behaviour in community alcohol services common to UK practice.

METHODS AND ANALYSIS: This feasibility trial consists of three work packages (WP). WP1: To draft a standardised script for FibroScan operators to deliver liver disease-specific advice to eligible participants having FibroScan. WP2: To create a video library of ARVS for use in the feasibility RCT (WP3). WP3: To test the feasibility of the trial design, including the FibroScan script and video stories developed in WP1 and WP2 in a one-to-one individual randomised trial in community alcohol services. Semi-structured interviews will be conducted at 6 months follow-up for qualitative evaluation. Outcomes will be measures of the feasibility of conducting a larger RCT. These outcomes will relate to: participant recruitment and follow-up, intervention delivery, including the use of the Knowledge of LIver Fibrosis Affects Drinking trial FibroScan scripts and videos, clinical outcomes, and the acceptability and experience of the intervention and trial-related procedures. Data analysis will primarily be descriptive to address the feasibility aims of the trial. All proposed analyses will be documented in a Statistical Analysis Plan.

ETHICS AND DISSEMINATION: This trial received favourable ethical approval from the West of Scotland Research Ethics Service (WoSRES) on 20 January 2021, REC reference: 20/WS/0179. Results will be submitted for publication to a peer-reviewed journal.

TRIAL REGISTRATION NUMBER: ISRCTN16922410.

PMID:34732502 | DOI:10.1136/bmjopen-2021-054954

BMJ Open. 2021 Nov 3;11(11):e051866. doi: 10.1136/bmjopen-2021-051866.

ABSTRACT

OBJECTIVES: To evaluate the cost-effectiveness of custom-made insoles compared with general practitioner (GP)-led usual care after 26 weeks of follow-up in individuals with plantar heel pain (PHP) from a societal perspective.

DESIGN: Cost-effectiveness analysis of a double-blinded randomised controlled trial.

SETTING: General practice in the Netherlands.

PARTICIPANTS: 116 participants with PHP for at least 2 weeks, aged 18-65 years and presenting to the GP.

INTERVENTIONS: Participants were randomised to GP-led usual care (n=46) or referral to a podiatrist for treatment with a custom-made insole (n=70). Participant randomised to a sham insole (n=69) were excluded from this analysis.

PRIMARY AND SECONDARY OUTCOMES: Outcomes comprised pain during rest and activity, and quality of life. Costs included healthcare and lost productivity costs. Statistical uncertainty was estimated using bootstrapping and presented using cost-effectiveness acceptability curves.

RESULTS: Participants in the custom-made insole group experienced statistically significant more pain during activity at 26 weeks than participants in the usual care group (overall effect 1.06; 95% CI 0.36 to 1.75). There were no significant differences between groups in other outcomes. Total societal costs in the custom-made insole group were non-significantly higher than in the usual care group (mean difference €376; 95% CI -€1775 to €2038). The intervention with custom-made insoles was dominated by usual care by the GP (ie, more expensive and less effective) for pain during activity and quality of life outcomes. For the outcome pain at rest, the intervention was more expensive and more effective than usual care. However, the maximum probability of cost-effectiveness was only 0.59 at very high ceiling ratios.

CONCLUSIONS: These findings show that that custom-made insoles are not cost-effective in comparison with GP-led usual care. Clinicians should be reserved in prescribing custom-made insoles for PHP as a primary intervention.

TRIAL REGISTRATION NUMBER: NTR5346.

PMID:34732484 | DOI:10.1136/bmjopen-2021-051866

BMJ Open. 2021 Nov 3;11(11):e047190. doi: 10.1136/bmjopen-2020-047190.

ABSTRACT

INTRODUCTION: One of the known risk factors for fall incidents is the use of specific medications, fall-risk-increasing drugs (FRIDs). However, to date, there is uncertainty related to the effectiveness of deprescribing as a single intervention in falls prevention. Thus, a comprehensive update of the literature focusing on all settings in which older people receive healthcare and all deprescribing interventions is warranted to enhance the current knowledge.

METHODS AND ANALYSIS: This systematic review protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A systematic search was performed in Cochrane Central Register of Controlled Trials, MEDLINE, Embase and PsycINFO (2 November 2020). We will also search in trial registers. We will include randomised controlled trials, in which any deprescribing intervention is compared with usual care and reports falls as an outcome. Both title and abstract screening and full-text screening will be done by two reviewers. The Cochrane Collaboration revised tool of Risk of Bias will be applied to perform risk of bias assessment. We will categorise the results separately for every setting. If a group of sufficiently comparable studies will be identified, we will perform a meta-analysis applying random effects model. We will investigate heterogeneity using a combination of visual inspection of the forest plot along with consideration of the χ² test and the I² statistic results. We have prespecified several subgroup and sensitivity analyses.

ETHICS AND DISSEMINATION: Ethics approval is not applicable for this study since no original data will be collected. The results will be disseminated through peer-reviewed publication and conference presentations. Furthermore, this systematic review will inform the recommendations of working group of polypharmacy and FRIDs of the anticipated World’s Falls Guidelines.

PROSPERO REGISTRATION NUMBER: CRD42020218231.

PMID:34732476 | DOI:10.1136/bmjopen-2020-047190

BMJ Open. 2021 Nov 3;11(11):e049568. doi: 10.1136/bmjopen-2021-049568.

ABSTRACT

INTRODUCTION: Robust randomised trial data have shown that routine preoperative (pre-op) testing for cataract surgery patients is inappropriate. While guidelines have discouraged testing since 2002, cataract pre-op testing rates have remained unchanged since the 1990s. Given the challenges of reducing low-value care despite strong consensus around the evidence, innovative approaches are needed to promote high-value care. This trial evaluates the impact of an interdisciplinary electronic health record (EHR) intervention that is informed by behavioural economic theory.

METHODS AND ANALYSIS: This pragmatic randomised trial is being conducted at UCLA Health between June 2021 and June 2022 with a 12-month follow-up period. We are randomising all UCLA Health physicians who perform pre-op visits during the study period to one of the three nudge arms or usual care. These three nudge alerts address (1) patient harm, (2) increased out-of-pocket costs for patients and (3) psychological harm to the patients related to pre-op testing. The nudges are triggered when a physician starts to order a pre-op test. We hypothesise that receipt of a nudge will be associated with reduced pre-op testing. The primary outcome will be the change in the percentage of patients undergoing pre-op testing at 12 months. Secondary outcomes will include the percentage of patients undergoing specific categories of pre-op tests (labs, EKGs, chest X-rays (CXRs)), the efficacy of each nudge, same-day surgery cancellations and cost savings.

ETHICS AND DISSEMINATION: The study protocol was approved by the institutional review board of the University of California, Los Angeles as well as a nominated Data Safety Monitoring Board. If successful, we will have created a tool that can be disseminated rapidly to EHR vendors across the nation to reduce inappropriate testing for the most common low-risk surgical procedures in the country.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT04104256.

PMID:34732478 | DOI:10.1136/bmjopen-2021-049568

BMJ Open. 2021 Nov 3;11(11):e046271. doi: 10.1136/bmjopen-2020-046271.

ABSTRACT

OBJECTIVE: To assess the association between the physical activity level and the built environment by accessibility, microinfrastructure and security in Latin America (LA).

DESIGN: We conducted a multicentre cross-sectional study to collect physical activity and built environment data. The levels of physical activity were calculated through the International Physical Activity Questionnaire survey. Using the Neighbourhood Environment Walkability Scale-Abbreviated, characteristics of the built environment were measured through three domains: accessibility, microinfrastructure and security. To estimate the association of the built environment and physical activity, we used mixed effects logistic regression analysis. In addition, likelihood ratio test to account for clustered effect within countries and/or cities was used.

SETTING: Eight countries in LA.

PARTICIPANTS: Adults aged 15-65 years (n=9218) living in urban areas and consented to participate of the Latin American Study of Nutrition and Health.

RESULTS: Most of the population in LA had access to a grocery store (97.2%), public transport stop (91.5%) and children’s playground (81.6%). Metropolitan parks were more accessible in Ecuador (59.8%) and Colombia (59.2%) than in Venezuela (33.5%). Individuals located within 20 min of walking from sport facilities or children’s playground areas were more likely to perform moderate-to-high physical activity OR 1.20 (95% CI 1.06 to 1.36) and OR 1.25 (95% CI 1.02 to 1.53), respectively. Only 14.5% of the population from the region considered that their neighbourhood had an adequate design for walking or cycling. Likewise, among adults living in LA, only 39.75% had the perception of living in a safe neighbourhood.

CONCLUSIONS: This multicentre study shows that currently, LA built environment does not promote physical activity in the region. Our findings provide the rationale to push forward, at regional and national levels, policies and interventions that will help to achieve a safe, healthy and friendly built environment to encourage participation in active recreation and sports in leisure time.

TRIAL REGISTRATION NUMBER: NCT02226627.

PMID:34732475 | DOI:10.1136/bmjopen-2020-046271

Endocrinol Metab (Seoul). 2021 Oct;36(5):1069-1077. doi: 10.3803/EnM.2021.1119. Epub 2021 Oct 28.

ABSTRACT

BACKGROUND: Positive fecal immunochemical test (FIT) results have been recently suggested as a risk factor for systemic inflammation. Diabetes induces inflammation in the gastrointestinal tract via several ways. We investigated the association between FIT results and the incidence of diabetes.

METHODS: A total of 7,946,393 individuals aged ≥50 years from the National Cancer Screening Program database who underwent FIT for colorectal cancer (CRC) screening from 2009 to 2012 were enrolled. The primary outcome was newly diagnosed diabetes based on the International Classification of Disease 10th revision codes and administration of anti-diabetic medication during the follow-up period.

RESULTS: During a mean follow-up of 6.5 years, the incidence rates of diabetes were 11.97, 13.60, 14.53, and 16.82 per 1,000 personyears in the FIT negative, one-positive, two-positive, and three-positive groups, respectively. The hazard ratios (HRs) for the incidence of diabetes were 1.14 (95% confidence interval [CI], 1.12 to 1.16; HR, 1.21; 95% CI, 1.16 to 1.27; and HR, 1.40; 95% CI, 1.28 to 1.55) in the one-positive, two-positive, and three-positive FIT groups compared with the FIT negative group, respectively. The effect was consistent in individuals with normal fasting blood glucose (adjusted HR 1.55 vs. 1.14, P for interaction <0.001).

CONCLUSION: Positive FIT results were associated with a significantly higher risk of diabetes, suggesting that the FIT can play a role not only as a CRC screening tool, but also as a surrogate marker of systemic inflammation; thus, increasing the diabetes risk.

PMID:34731934 | DOI:10.3803/EnM.2021.1119

Acta Ortop Mex. 2021 Mar-Apr;35(2):132-136.

ABSTRACT

INTRODUCTION: Hallux valgus is a high frequency disorder, affecting the first ray. Operative correction techniques have grown popularity lately. One of them is the Reverdin-Isham technique (first metatarsal medial incomplete osteotomy). Recently, a protection and osteotomy cutting guide has been developed: the BARU system.

OBJECTIVE: To test the usefulness of the BARU system as a protective factor for soft structures adjacent to the surgical site and guidance for osteotomy.

MATERIAL AND METHODS: Experimental cadaveric study. Six cadaveric feet (two fresh-frozen and four in formaldehyde solution), unapproached. Feet were numbered and intervened with RI technique, three of them with BARU system and three without it. Afterwards, dissection by two dissectors who did not know whether the BARU system had been used or not, establishing a single-blinded model. 13 structures were evaluated in each foot. Data was recovered into Microsoft Office Excel and processed with SPSS. 2 test (significative if p value < 0.05) and relative risk were calculated.

RESULTS: Approach using BARU system was satisfactory, with usual-size operation-ports. BARU system colocation was simple and radiological control showed adequate spatial location. The device contributed as reference for cutting direction and depth. 65 out of the 78 searched structures were found (83.3%). Six injuries were found among the assessed structures: plantar medial nerve (one injury), plantar medial artery (one injury), flexor brevis muscle (three injuries), abductor muscle (one injury). Five of these injuries occurred in non-utilizing BARU system feet.

CONCLUSION: Promising results in terms of protection of nearby structures, cutting guide, and ease of intervention. Avoids X-rays exposure. Not significant statistical calculations, the sample should be enlarged.

PMID:34731912

J Am Acad Audiol. 2021 Jun;32(6):366-373. doi: 10.1055/s-0041-1728649. Epub 2021 Nov 3.

ABSTRACT

BACKGROUND: Understanding the functional differences between crossed and uncrossed medial olivocochlear (MOC) neurons has been of interest to researchers for decades. Previous reports revealed conflicting results about which MOC pathway, crossed or uncrossed, is stronger in humans. Both crossed and uncrossed MOC neurons synapse at the base of the outer hair cells (OHCs) in each ear. OHCs generate the cochlear microphonic, which is a major contributor to the cochlear response (CR) PURPOSE: The current study investigated the effects of eliciting the crossed and uncrossed MOC reflex (MOCR) on CR in humans with three levels of noise.

RESEARCH DESIGN: Normal-hearing, young adults (n = 16) participated in this study. The CR was recorded using 500 Hz tone-burst stimuli presented at 80 dB nHL. To examine the crossed and uncrossed MOCR, CR was recorded without and with continuous ipsilateral or contralateral broadband noise (BBN) at three levels (40, 50, and 60 dB SPL).

DATA ANALYSIS: Analysis of the CR was completed using the amplitude of the response extracted using fast Fourier transform. Statistical analysis was completed using repeated measures analysis of variance and post-hoc analysis.

RESULTS: Compared with baseline, the presentation of BBN, specifically contralaterally, resulted in CR enhancement with no significant difference as a function of the three BBN levels. Greater enhancement of the CR amplitude was observed with contralateral than ipsilateral BBN elicitor.

CONCLUSIONS: The current findings suggest that a contralateral elicitor of the uncrossed MOC pathway results in a larger CR amplitude enhancement compared with an ipsilateral elicitor of the crossed MOC pathway, regardless of the elicitor level. Eliciting the MOCR appears to modulate the OHCs function. Furthermore, assessing the MOCR with the 500 Hz CR with BBN elicitors at moderate levels should separate its effects (i.e., increase response amplitude) from those associated with the middle ear muscle reflex (i.e., reduce response amplitude).

PMID:34731904 | DOI:10.1055/s-0041-1728649

J Glaucoma. 2021 Nov 3. doi: 10.1097/IJG.0000000000001958. Online ahead of print.

ABSTRACT

PRECIS: This retrospective study characterized the efficacy and safety of three different microinvasive glaucoma surgery (MIGS) procedures in a predominantly African-American population at the Philadelphia Veterans Affairs Hospital (Hydrus, Kahook, iStent), demonstrating no significant difference in IOP and medication reduction between the three at long term follow up.

PURPOSE: To compare the efficacy and safety of three different microinvasive glaucoma surgery (MIGS) procedures in a predominantly African-American population.

METHODS: Retrospective cohort study of patients undergoing cataract extraction combined with one of three MIGS procedures (Hydrus, iStent, Kahook) at the Philadelphia Veterans Affairs Medical Center between 1/1/2015 and 11/1/2020. Analysis of variance and regression models were used to compare reduction in intraocular pressure (IOP) and medication use among three MIGS types.

RESULTS: 123 eyes of 112 patients were included, including 56 (45.5%) eyes for Hydrus, 40 (32.5%) eyes for iStent , and 27 (22.0%) eyes for Kahook. Adjusted mean IOP reduction was greater for Hydrus at postoperative day 1 (-4.49 vs. -1.76 for iStent and -1.69 for Kahook, P=0.05 and greater for Kahook at postoperative week 1 (-2.53 vs. +0.70 for iStent vs. -1.41 for Hydrus, P=0.02), but did not differ significantly between MIGS types at subsequent postoperative visits (all P>0.05). In multivariable analysis, MIGS type was not significantly associated with reduction in IOP or medication use at 9-12 months postoperatively. There were no significant differences in complication rates across MIGS types.

CONCLUSION: In this study, the difference in IOP lowering and medication reduction postoperatively between the Hydrus, iStent, and Kahook was not statistically significant after postoperative day 1. More studies are needed to evaluate outcomes of MIGS surgeries in glaucoma populations of different disease severity.

PMID:34731870 | DOI:10.1097/IJG.0000000000001958

Klin Monbl Augenheilkd. 2021 Nov 3. doi: 10.1055/a-1553-4256. Online ahead of print.

ABSTRACT

BACKGROUND: Especially in rural areas, access of visually impaired people to ophthalmic care and counselling can be limited. The Eye Van is a project supported by the Ministry for Rural Affairs and Consumer Protection Baden-Württemberg which offers visually impaired people an on-the-spot ophthalmological examination and counselling on low-vision aids and social support services. The aim of this project was to evaluate the quality of care provided to visually impaired people in the rural areas of South Baden.

MATERIALS AND METHODS: Between 2016 and 2019, 45 villages in South Baden participated in this project. The visits were advertised in the local press. Appointments were assigned and participant eligibility was assessed over the telephone by the local Federation of the Blind and Partially Sighted in South Baden. During the on-site visits, a medical history was obtained from participants, who then received a comprehensive ophthalmological examination and counselling on low-vision aids and social support services. Interviews were conducted in order to determine the expectations of the participants and to assess their quality of life. A second interview, focused on the measures that had been implemented and changes in the participants’ quality of life, was carried out three months later.

RESULTS: In total, 264 participants were examined. Of these, 101 participants fulfilled the criteria of moderate/severe visual impairment or blindness defined by the WHO (World Health Organization). The mean age of the visually impaired participants was 85 years. The median decimal visual acuity was 0.08. The median length of time since the participants’ last ophthalmological examination was one year. Among the visually impaired participants, 13% did not have any low-vision aids. Their use was recommended to 62% of the visually impaired participants. The main expectation of participants was counselling on low-vision aids and support services. Among all the participants, 42 did one interview and 28 did two interviews. In the second interview, 72% of the participants claimed to have implemented the recommendations. There was no statistically significant change in their quality of life.

CONCLUSION: The access of visually impaired people to ophthalmic care does not seem to be limited in the rural areas of South Baden. Nevertheless, there was a high demand for counselling on low-vision aids and social support services.

PMID:34731897 | DOI:10.1055/a-1553-4256