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Presence of back pain prior total knee arthroplasty and its effects on short-term patient-reported outcome measures

Eur J Orthop Surg Traumatol. 2021 May 26. doi: 10.1007/s00590-021-03010-3. Online ahead of print.

ABSTRACT

PURPOSE: Back pain may both decrease patient satisfaction after TKA and confound outcome assessment in satisfied patients. Our primary objective was to determine whether preoperative back pain is associated with differences in postoperative patient-reported outcome measures (PROMs).

METHODS: We retrospectively reviewed 234 primary TKA patients who completed PROMs preoperatively and 12 weeks postoperatively, which included a back pain questionnaire, the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) and the Forgotten Joint Score-12 (FJS-12). Cohorts were defined based on the severity of preoperative back pain (none, mild, moderate and severe) and compared. Demographics were compared using ANOVA and Chi-square analysis. Univariate ANCOVA analysis was utilized to compare PROMs while accounting for significant demographic differences.

RESULTS: Both preoperative KOOS JR scores (none: 47.90, mild: 47.61, moderate: 44.61 and severe: 38.70; p = 0.013) and 12-week postoperative KOOS JR scores (none: 61.24, mild: 64.94, moderate: 57.48 and severe: 57.01; p = 0.012) had a statistically significant inverse relationship with regard to the intensity of preoperative back pain. Although FJS-12 scores at the 12-week postoperative period trended lower with increasing levels of preoperative back pain (p = 0.362), it did not reach statistical significance. Patients who reported severe back pain preoperatively achieved the largest delta improvement from baseline compared to those with lesser pain intensity (p = 0.003). Patients who had a 2-grade improvement in their back pain achieved significantly higher KOOS JR scores 12 weeks postoperatively compared to patients with either 1-grade or no improvement (63.53 vs. 55.98; p = 0.042). Both preoperative (47.99 vs. 41.11; p = 0.003) and 12-week postoperative (64.06 vs. 55.73; p < 0.001) KOOS JR scores were statistically higher for those who reported mild or no back pain pre-and postoperatively than those who reported moderate or severe back pain pre-and postoperatively.

CONCLUSION: Knee pain and back pain both exert negative effects on outcome instruments designed to measure pain and function. Although mean improvement from pre- to postoperative KOOS JR scores for patients with severe pre-existing back pain was higher than their counterparts, this statistical difference is likely not clinically significant. This implies that all patients may experience similar benefits from TKA despite the presence or absence of back pain. Attempts to measure TKA outcomes using PROMs should seek to control for lumbago and other sources of body pain. Level of Evidence IIIRetrospective Cohort Study.

PMID:34037858 | DOI:10.1007/s00590-021-03010-3

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The international Pediatric Oncology Exercise Guidelines (iPOEG)

Transl Behav Med. 2021 May 26:ibab028. doi: 10.1093/tbm/ibab028. Online ahead of print.

ABSTRACT

Physical activity (PA) and exercise are safe and beneficial for children and adolescents affected by cancer. Yet, this population is not active enough to receive benefits. PA guideline and recommendation statements can support individual behavior and practice change. The purpose of this project was to develop the international Pediatric Oncology Exercise Guidelines (iPOEG), comprised of guideline and recommendation statements, to promote PA among children and adolescents affected by cancer. Guideline development procedures, stakeholder engagement strategies, and the Delphi technique were used. Four online surveys were distributed to the iPOEG network (n = 9 core team members, n = 122 expert consensus committee members). Surveys included closed- and open-ended items informed by a literature synthesis and an in-person meeting. Responses were analyzed using descriptive statistics and content analysis. Consensus was defined as ≥ 80% agreement. Response rates to online surveys ranged from 82% to 91%. The iPOEG network agreed on four guideline and five recommendation statements, which highlight that movement is important for all children and adolescents affected by cancer. These statements are generic in nature as more research is still required to provide specific guidance on the frequency, intensity, time, and type of PA for this population. Nevertheless, the iPOEG statements represent available evidence and expert opinion, collectively suggesting that it is time for children and adolescents affected by cancer to move more.

PMID:34037786 | DOI:10.1093/tbm/ibab028

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Congenital Rubella: A Salient Cause of Congenital Heart Defects in Infants

J Trop Pediatr. 2021 May 17;67(2):fmab044. doi: 10.1093/tropej/fmab044.

ABSTRACT

BACKGROUND: Structural congenital heart defects (CHD) take a huge toll of congenital defects in children in India. Limited information is available regarding modifiable risk factors for its causation. This study was planned with an aim to determine the prevalence of congenital rubella infection in Indian infants with structural CHD’s.

METHODOLOGY: This cross-sectional, observational study was conducted at a tertiary care hospital in Northern India over 1 year period (1 July 2016 to 30 June 2017). Infants <6 months with structural CHD were enrolled after taking informed consent from their mothers. Blood samples were collected from mother-child binomials and tested for rubella IgM and IgG antibodies.

RESULTS: A total of 80 infants (M : F = 56 : 24), having mean age 69.4 (±56.5) days; were enrolled. In these infants, prevalence of congenital rubella infection (either infant’s IgM rubella positive or infant’s IgG rubella titers higher than mother’s) was 8.75% (7/80). A total of 12.5% of studied mothers were seronegative for rubella IgG antibodies. Statistically significant association was found between the occurrence of congenital rubella and cataract (p = 0.0039), splenomegaly (p = 0.007) and microcephaly (p = 0.0084) in infants having structural CHD.

CONCLUSIONS: Congenital rubella syndrome still remains an important modifiable cause for structural CHD in India. Sincere efforts for rubella elimination via further strengthening current vaccination strategy would help in decreasing burden of structural CHD in India.

PMID:34037788 | DOI:10.1093/tropej/fmab044

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Adherence to treatment by initial antihypertensive mono and combination therapies

Am J Hypertens. 2021 May 26:hpab083. doi: 10.1093/ajh/hpab083. Online ahead of print.

ABSTRACT

BACKGROUND: Aim of our study was to compare adherence to antihypertensive drug therapy between newly treated patients in whom monotherapy or a two-drug single-pill combination (SPC) was initially dispensed.

METHODS: The 63,448 residents of Lombardy Region (Italy), aged 40-80 years, who were newly treated with antihypertensive drugs during 2016, were identified and followed for 1 year after the first prescription. The outcome of interest was adherence to drug therapy that was measured according to the “proportion of days covered” (PDC) criterion, i.e. the ratio between the number of days in which the drug was available and the days of follow-up. Patients who had a PDC>75% and <25% were defined as highly and poorly adherent to drug therapy, respectively. Log-binomial regression models were fitted to compare the propensity to treatment adherence between the initial therapeutic strategies, after adjusting for baseline demographic and clinical covariates.

RESULTS: About 46% and 17% of patients showed high and poor adherence, respectively. Compared to patients under initial monotherapy (85%), those who were initially treated with a SPC (15%) had higher propensity to be highly adherent and a lower propensity to be poorly adherent to antihypertensive treatment (Risk Ratio: 1.18, 95% confidence interval 1.16-1.21; 0.42, 0.39-0.45, respectively). This was the case regardless the sex, the age, the patient clinical status, and with almost any type of SPC.

CONCLUSIONS: In a real-life setting, patients who were initially prescribed a two-drug SPC exhibited more frequently a good adherence to antihypertensive treatment than those starting with a single drug.

PMID:34037713 | DOI:10.1093/ajh/hpab083

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Home-Based vs Supervised Inpatient and/or Outpatient Rehabilitation Following Knee Meniscectomy: A Systematic Review and Meta-analysis

JAMA Netw Open. 2021 May 3;4(5):e2111582. doi: 10.1001/jamanetworkopen.2021.11582.

ABSTRACT

IMPORTANCE: Arthroscopic meniscectomy is one of the most common orthopedic procedures. The optimal postoperative approach remains debated.

OBJECTIVE: To compare outcomes associated with home-based rehabilitation programs (HBP) vs standard inpatient and/or outpatient supervised physical therapy (IOP) following arthroscopic isolated meniscectomy (AM).

DATA SOURCES: A systematic literature search was conducted on PubMed, Web of Science, Cochrane Library, and Scopus databases on March 15, 2021. The included studies were published from 1982 to 2019.

STUDY SELECTION: Randomized clinical trials of patients treated with HBP vs IOP after AM were included.

DATA EXTRACTION AND SYNTHESIS: Data were independently screened and extracted by 2 authors according to the Preferred Reporting Items for Systematic Reviews (PRISMA) reporting guideline. The meta-analysis was performed using a random-effect model; when an I2 < 25% was observed, the fixed-effect model was used. The Hartung-Knapp correction was applied.

MAIN OUTCOMES AND MEASURES: The primary outcome was the Lysholm score (scale of 0-100 with higher scores indicating better knee function) and secondary outcomes were subjective International Knee Documentation Committee (IKDC) score, knee extension and flexion, thigh girth, horizontal and vertical hop test, and days to return to work, as indicated in the PROSPERO registration. Outcomes were measured in the short-term (ranging from 28 to 50 days) and the midterm (6 months).

RESULTS: In this meta-analysis of 8 RCTs including 434 patients, IOP was associated with a greater short-term improvement in Lysholm score compared with HBP, with a mean difference of -8.64 points (95% CI, -15.14 to -2.13 points; P = .02) between the 2 approached, but the sensitivity analysis showed no difference. Similarly, no statistically significant difference was detected at midterm for Lysholm score, with a mean difference between groups of -4.78 points (95% CI, -9.98 to 0.42 points; P = .07). HBP was associated with a greater short-term improvement in thigh girth, with a mean difference between groups of 1.38 cm (95% CI, 0.27 to 2.48 cm; P = .01), whereas IOP was associated with a better short-term vertical hop score, with a mean difference between groups of -3.25 cm (95% CI, -6.20 to -0.29 cm; P = .03). No differences were found for all the other secondary outcomes.

CONCLUSIONS AND RELEVANCE: No intervention was found to be superior in terms of physical and functional outcomes as well as work-related and patient-reported outcomes, both at short-term and midterm follow-up. Overall, these results suggest that HBP may be an effective management approach after AM in the general population.

PMID:34037730 | DOI:10.1001/jamanetworkopen.2021.11582

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In patients undergoing coronary artery bypass grafting is semi-skeletonization superior to pedicled harvesting of the left internal mammary artery?

Interact Cardiovasc Thorac Surg. 2021 May 25:ivab103. doi: 10.1093/icvts/ivab103. Online ahead of print.

ABSTRACT

A best evidence topic in cardiac surgery was written according to a structured protocol. The question addressed was, ‘in patients undergoing coronary artery bypass grafting is semi-skeletonized harvesting superior to pedicled harvesting of the left internal mammary artery (LIMA) in terms of conduit length, flow, rate of sternal wound infections and post-operative bleeding?’. Altogether, 235 papers were found using the reported search, of which 5 represented the best evidence to answer the clinical question. Three studies were cohort studies and 2 were randomized controlled trials. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. One randomized controlled trial showed superiority with semi-skeletonized harvesting in terms of conduit length (P < 0.001), flow (P = 0.004) and diastolic filling (P = 0.005). Three studies included data on surgical wound infections/mediastinitis, all of which reported n = 0. One randomized controlled trial and 3 cohort studies reported that semi-skeletonized harvesting reduced postoperative bleeding. No studies reported a statistically significant difference in operative time. This review suggests that semi-skeletonized harvesting could possibly be associated with favourable outcomes when compared to pedicled harvesting with respect to graft length and flow, and lower postoperative bleeding, without increasing operative time; although there is insufficient data to compare sternal wound infections or long-term outcomes. In conclusion, the limited evidence base prevents robust informed decision-making when comparing both techniques.

PMID:34037772 | DOI:10.1093/icvts/ivab103

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Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial

JAMA. 2021 May 26. doi: 10.1001/jama.2021.8565. Online ahead of print.

ABSTRACT

IMPORTANCE: Although effective vaccines against COVID-19 have been developed, additional vaccines are still needed.

OBJECTIVE: To evaluate the efficacy and adverse events of 2 inactivated COVID-19 vaccines.

DESIGN, SETTING, AND PARTICIPANTS: Prespecified interim analysis of an ongoing randomized, double-blind, phase 3 trial in the United Arab Emirates and Bahrain among adults 18 years and older without known history of COVID-19. Study enrollment began on July 16, 2020. Data sets used for the interim analysis of efficacy and adverse events were locked on December 20, 2020, and December 31, 2020, respectively.

INTERVENTIONS: Participants were randomized to receive 1 of 2 inactivated vaccines developed from SARS-CoV-2 WIV04 (5 µg/dose; n = 13 459) and HB02 (4 µg/dose; n = 13 465) strains or an aluminum hydroxide (alum)-only control (n = 13 458); they received 2 intramuscular injections 21 days apart.

MAIN OUTCOMES AND MEASURES: The primary outcome was efficacy against laboratory-confirmed symptomatic COVID-19 14 days following a second vaccine dose among participants who had no virologic evidence of SARS-CoV-2 infection at randomization. The secondary outcome was efficacy against severe COVID-19. Incidence of adverse events and reactions was collected among participants who received at least 1 dose.

RESULTS: Among 40 382 participants randomized to receive at least 1 dose of the 2 vaccines or alum-only control (mean age, 36.1 years; 32 261 [84.4%] men), 38 206 (94.6%) who received 2 doses, contributed at least 1 follow-up measure after day 14 following the second dose, and had negative reverse transcriptase-polymerase chain reaction test results at enrollment were included in the primary efficacy analysis. During a median (range) follow-up duration of 77 (1-121) days, symptomatic COVID-19 was identified in 26 participants in the WIV04 group (12.1 [95% CI, 8.3-17.8] per 1000 person-years), 21 in the HB02 group (9.8 [95% CI, 6.4-15.0] per 1000 person-years), and 95 in the alum-only group (44.7 [95% CI, 36.6-54.6] per 1000 person-years), resulting in a vaccine efficacy, compared with alum-only, of 72.8% (95% CI, 58.1%-82.4%) for WIV04 and 78.1% (95% CI, 64.8%-86.3%) for HB02 (P < .001 for both). Two severe cases of COVID-19 occurred in the alum-only group and none occurred in the vaccine groups. Adverse reactions 7 days after each injection occurred in 41.7% to 46.5% of participants in the 3 groups; serious adverse events were rare and similar in the 3 groups (WIV04: 64 [0.5%]; HB02: 59 [0.4%]; alum-only: 78 [0.6%]).

CONCLUSIONS AND RELEVANCE: In this prespecified interim analysis of a randomized clinical trial, treatment of adults with either of 2 inactivated SARS-CoV-2 vaccines significantly reduced the risk of symptomatic COVID-19, and serious adverse events were rare. Data collection for final analysis is pending.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04510207; Chinese Clinical Trial Registry: ChiCTR2000034780.

PMID:34037666 | DOI:10.1001/jama.2021.8565

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Genetically Proxied Diurnal Preference, Sleep Timing, and Risk of Major Depressive Disorder

JAMA Psychiatry. 2021 May 26. doi: 10.1001/jamapsychiatry.2021.0959. Online ahead of print.

ABSTRACT

IMPORTANCE: Morning diurnal preference is associated with reduced risk of major depressive disorder (MDD); however, causality in this association is uncertain.

OBJECTIVE: To examine the association of genetically proxied morning diurnal preference with depression risk using mendelian randomization.

DESIGN, SETTING, AND PARTICIPANTS: This 2-sample mendelian randomization study used summary-level genetic associations with diurnal preference and MDD. Up to 340 genetic loci associated with diurnal preference in a meta-analysis of the UK Biobank and 23andMe cohorts were considered as genetic proxies for diurnal preference. The effect size of these variants was scaled using genetic associations with accelerometer-based measurement of sleep midpoint. Genetic associations with MDD were obtained from a meta-analysis of genome-wide association studies data from the Psychiatric Genomics Consortium and UK Biobank. The inverse-variance weighted method was used to estimate the association of genetically proxied morning diurnal preference, corresponding to a 1-hour earlier sleep midpoint, with MDD risk.

EXPOSURES: Morning diurnal preference scaled to a 1-hour earlier, objectively measured sleep midpoint.

MAIN OUTCOMES AND MEASURES: Risk of MDD, including self-reported and clinically diagnosed cases, as ascertained in meta-analyses of genome-wide association studies.

RESULTS: A total of 697 828 individuals (all of European ancestry) were in the UK Biobank and 23andMe cohorts; 85 502 in the UK Biobank had measurements of the sleep midpoint. A further 170 756 individuals with MDD and 329 443 control participants (all of European ancestry) were in the Psychiatric Genomics Consortium and UK Biobank data. Genetically proxied earlier diurnal preference was associated with a 23% lower risk of depression (odds ratio [OR] per 1-hour earlier sleep midpoint, 0.77 [95% CI, 0.63-0.94]; P = .01). This association was similar when restricting analysis to individuals with MDD as stringently defined by the Psychiatric Genomics Consortium (OR, 0.73 [95% CI, 0.54-1.00]; P = .05) but not statistically significant when defined by hospital-based billing codes in the UK Biobank (OR, 0.64 [95% CI, 0.39-1.06]; P = .08). Sensitivity analyses examining potential bias due to pleiotropy or reverse causality showed similar findings (eg, intercept [SE], 0.00 [0.001]; P = .66 by Egger intercept test).

CONCLUSIONS AND RELEVANCE: The results of this mendelian randomization study support a protective association of earlier diurnal preference with risk of MDD and provide estimates contextualized to an objective sleep timing measure. Further investigation in the form of randomized clinical trials may be warranted.

PMID:34037671 | DOI:10.1001/jamapsychiatry.2021.0959

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Prevalence of Hidradenitis Suppurativa: A Systematic Review and Meta-regression Analysis

JAMA Dermatol. 2021 May 26. doi: 10.1001/jamadermatol.2021.1677. Online ahead of print.

ABSTRACT

IMPORTANCE: Hidradenitis suppurativa/acne inversa (HS) is a chronic inflammatory skin disease characterized by occlusion of hair follicles as a primary pathogenic factor. There are scarce data regarding the prevalence of HS.

OBJECTIVE: To estimate overall HS prevalence.

DATA SOURCES: This review and meta-regression analysis was conducted using the Meta-analysis of Observational Studies in Epidemiology (MOOSE) reporting guideline. The academic search included PubMed, Cochrane registry, ClinicalTrials.gov, and evidence by NHS UK and Trip databases from inception through May 2020. To analyze HS prevalence, only cross-sectional studies or baseline assessments of longitudinal cohorts using census-based surveys or probabilistic and nonprobabilistic epidemiologic methods were considered. The search terms were (prevalence OR incidence OR epidemiology) AND (hidradenitis suppurativa OR acne inversa OR Verneuil’s disease). No language restriction was applied.

STUDY SELECTION: Original investigations that reported HS prevalence were included. After exclusion criteria were applied, 17 studies qualified for qualitative analysis, but only 16 studies were quantitatively assessed.

DATA EXTRACTION AND MEASURES: Two reviewers extracted data by age, diagnostic criteria, presence of any comorbidity, sample sizes, continent/location, sex, and other characteristics. Assessment of bias risk used the Joanna Briggs Institute Critical Appraisal Instrument for Studies Reporting Prevalence Data using random-effects models to synthesize available evidence.

MAIN OUTCOMES AND MEASURES: Hidradenitis suppurativa prevalence (with 95% CI) among the overall population and among subgroups. Between-study heterogeneity was assessed (Cochran Q statistic) and quantified (I2 statistic).

RESULTS: In 16 quantitatively assessed studies included, prevalence estimates were reported only from Western European and Scandinavian countries, the US, and Australia. Meta-analysis with random effects, after adjusting for publication bias in the prevalence estimates, revealed a 0.40% prevalence (95% CI, 0.26%-0.63%) for HS. Studies based on clinical samples revealed a higher pooled prevalence of HS (1.7%) than population-based studies (0.3%).

CONCLUSIONS AND RELEVANCE: The findings of this systematic review and meta-regression analysis may help facilitate policy formulation, channeling funding and guiding principles for better disease diagnosis using universal valid tools and management.

PMID:34037678 | DOI:10.1001/jamadermatol.2021.1677

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Frequency of use of household products containing VOCs and indoor atmospheric concentrations in homes

Environ Sci Process Impacts. 2021 May 26;23(5):699-713. doi: 10.1039/d0em00504e.

ABSTRACT

Volatile organic compounds (VOCs) are a key class of atmospheric emission released from highly complex petrochemical, transport and solvent sources both outdoors and indoors. This study established the concentrations and speciation of VOCs in 60 homes (204 individuals, 360 × 72 h samples, 40 species) in summer and winter, along with outdoor controls. Self-reported daily statistics were collected in each home on the use of cleaning, household and personal care products, all of which are known to release VOCs. Frequency of product use varied widely: deodorants: 2.9 uses home per day; sealant-mastics 0.02 uses home per day. The total concentration of VOCs indoors (range C2-C10) was highly variable between homes e.g. range 16.6-8150 μg m-3 in winter. Indoor concentrations of VOCs exceeded outdoor for 84% of households studied in summer and 100% of homes in winter. The most abundant VOCs found indoors in this study were n-butane (wintertime range: 1.5-4630 μg m-3), likely released as aerosol propellant, ethanol, acetone and propane. The cumulative use VOC-containing products over multiday timescales by occupants provided little predictive power to infer 72 hour averaged indoor concentrations. However, there was weak covariance between the cumulative usage of certain products and individual VOCs. From a domestic emissions perspective, reducing the use of hydrocarbon-based aerosol propellants indoors would likely have the largest impact.

PMID:34037627 | DOI:10.1039/d0em00504e