Nevin Manimala

Reg Anesth Pain Med. 2021 Aug 18:rapm-2021-102583. doi: 10.1136/rapm-2021-102583. Online ahead of print.

ABSTRACT

BACKGROUND: Acute and persistent pain after surgery is well described. However, no large-scale studies on immediate postoperative pain in the operating room (OR) exist, hindering potential areas of research to improve clinical outcomes. Thus, we aimed to describe the occurrence and severity of immediate postoperative pain in a large, unselected cohort.

METHODS: This was a prospective cohort study, encompassing all procedures in 31 public hospitals in the Danish Realm, during a 5-day period including the weekend. Data on procedures and anesthesia were collected and the main outcome was occurrence of moderate or severe pain in the OR. Secondary outcomes included pain, sedation and nausea in the OR or during the first 15 min in the postanesthesia care unit (PACU) including relevant risk factors. Descriptive and logistic regression statistics were used.

RESULTS: A total of 3675 procedures were included for analysis (87% inclusion rate). Moderate or severe pain occurred in 7.4% (95% CI 6.5% to 8.3%) of cases in the OR immediately after awakening, rising to 20.2% in the OR and/or PACU. Large intraprocedure and interprocedure variations occurred (0.0%-37.5%), and in 20% of cases with epidural-general anesthesia patients experienced moderate or severe pain. Independent risk factors were female sex, younger age, preoperative pain, daily opioid use and major surgical procedures.

CONCLUSION: Moderate or severe pain in the immediate postoperative phase occurred in 20% of all cases with procedure and anesthesiological technique variations, suggesting a need for identification of relevant procedure-specific risk factors and development of preventive treatments.

TRIAL REGISTRATION NUMBER: RoPR ID 43191.

PMID:34408068 | DOI:10.1136/rapm-2021-102583

BMJ Open. 2021 Aug 18;11(8):e054055. doi: 10.1136/bmjopen-2021-054055.

ABSTRACT

INTRODUCTION: Breast reconstruction (BR) is offered to improve quality of life for women with breast cancer undergoing mastectomy. As most women will be long-term breast cancer survivors, high-quality information regarding the long-term outcomes of different BR procedures is essential to support informed decision-making. As different techniques vary considerably in cost, policymakers also require high-quality cost-effectiveness evidence to inform care. The Brighter study aims to explore the long-term clinical and patient-reported outcomes (PROs) of implant-based and autologous BR and use health economic modelling to compare the long-term cost-effectiveness of different reconstructive techniques.

METHODS AND ANALYSIS: Women undergoing mastectomy and/or BR following a diagnosis of breast cancer between 1 January 2008 and 31 March 2009 will be identified from hospital episode statistics (HES). Surviving women will be contacted and invited to complete validated PRO measures including the BREAST-Q, EQ-5D-5L and ICECAP-A, or opt out of having their data included in the HES analysis. Long-term clinical outcomes will be explored using HES data. The primary outcome will be rates of revisional surgery between implant-based and autologous procedures. Secondary outcomes will include rates of secondary reconstruction and reconstruction failure. The long-term PROs of implant-based and autologous reconstruction will be compared using BREAST-Q, EQ-5D-5L and ICECAP-A scores. Multivariable regression will be used to examine the relationship between long-term outcomes, patient comorbidities, sociodemographic and treatment factors. A Markov model will be developed using HES and PRO data and published literature to compare the relative long-term cost-effectiveness of implant-based and autologous BR.

ETHICS AND DISSEMINATION: The Brighter study has been approved by the South-West -Central Bristol Research Ethics Committee (20/SW/0020), and the Confidentiality Advisory Group (20/CAG/0021). Results will be published in peer-reviewed journals and presented at national meetings. We will work with the professional associations, charities and patient groups to disseminate the results.

PMID:34408062 | DOI:10.1136/bmjopen-2021-054055

BMJ Open. 2021 Aug 18;11(8):e052212. doi: 10.1136/bmjopen-2021-052212.

ABSTRACT

INTRODUCTION: Tuberculosis (TB) continues to be a significant health burden, most commonly affecting the lungs and referred to as pulmonary TB (PTB). Diagnostic techniques of PTB primarily rely on expectorated sputum samples. However, the diagnostic yields are often hindered due to insufficient volume and quality of the sputum specimens. Moreover, some individuals are unable to provide sputum samples due to scanty sputum production or difficulty in coughing up and require an invasive procedure to obtain a respiratory sample, such as bronchoscopic or gastric aspiration. Thus, challenges in the acquisition of respiratory specimens warrant an alternate specimen. Therefore, this systematic review aims to evaluate the diagnostic accuracy of a stool specimen for the diagnosis of PTB in adults.

METHODS AND ANALYSIS: We will search MEDLINE (Ovid), Embase (Ovid), Web of Science and Cochrane database from inception to April 2021 using a comprehensive search strategy. Two reviewers will independently perform screening, data extraction and quality assessment. The risk of bias assessment and applicability of results of eligible studies will be performed using the Quality of Diagnostic Accuracy Studies-2 tool. Bivariate random-effects models will be performed to calculate pooled sensitivity, specificity, positive likelihood ratio and negative likelihood ratio and diagnostic odds ratio along with 95% CI of stool specimen for each reported diagnostic method against any of the reference standard test (ie, mycobacterial culture or smear microscopy or Xpert assay using respiratory specimens). Heterogeneity between studies will be assessed by I² statistics and Q statistic of the χ² test.

ETHICS AND DISSEMINATION: The results will be disseminated through publishing in a peer-reviewed medical journal and public presentations in relevant national and international conferences. As this is a systematic review of publicly available data, ethics approval is not required.

PROSPERO REGISTRATION NUMBER: CRD42021245203.

PMID:34408058 | DOI:10.1136/bmjopen-2021-052212

BMJ Open. 2021 Aug 18;11(8):e049228. doi: 10.1136/bmjopen-2021-049228.

ABSTRACT

OBJECTIVES: To explore the impact of data-sharing initiatives on the intent to share data, on actual data sharing, on the use of shared data and on research output and impact of shared data.

ELIGIBILITY CRITERIA: All studies investigating data-sharing practices for individual participant data (IPD) from clinical trials.

SOURCES OF EVIDENCE: We searched the Medline database, the Cochrane Library, the Science Citation Index Expanded and the Social Sciences Citation Index via Web of Science, and preprints and proceedings of the International Congress on Peer Review and Scientific Publication. In addition, we inspected major clinical trial data-sharing platforms, contacted major journals/publishers, editorial groups and some funders.

CHARTING METHODS: Two reviewers independently extracted information on methods and results from resources identified using a standardised questionnaire. A map of the extracted data was constructed and accompanied by a narrative summary for each outcome domain.

RESULTS: 93 studies identified in the literature search (published between 2001 and 2020, median: 2018) and 5 from additional information sources were included in the scoping review. Most studies were descriptive and focused on early phases of the data-sharing process. While the willingness to share IPD from clinical trials is extremely high, actual data-sharing rates are suboptimal. A survey of journal data suggests poor to moderate enforcement of the policies by publishers. Metrics provided by platforms suggest that a large majority of data remains unrequested. When requested, the purpose of the reuse is more often secondary analyses and meta-analyses, rarely re-analyses. Finally, studies focused on the real impact of data-sharing were rare and used surrogates such as citation metrics.

CONCLUSIONS: There is currently a gap in the evidence base for the impact of IPD sharing, which entails uncertainties in the implementation of current data-sharing policies. High level evidence is needed to assess whether the value of medical research increases with data-sharing practices.

PMID:34408052 | DOI:10.1136/bmjopen-2021-049228

BMJ Open. 2021 Aug 18;11(8):e048451. doi: 10.1136/bmjopen-2020-048451.

ABSTRACT

INTRODUCTION: The thyroid cancer incidence has been increasing all over the world. However, the aetiology of thyroid cancer remains unclear. A growing body of evidence suggested exposure to persistent organic pollutants (POPs) may play a role in the initiation of thyroid cancer, but the results are generally inconsistent across studies. This review aims to synthesise the evidence for the health effects of POPs on the risk of thyroid cancer.

METHODS AND ANALYSIS: This protocol was reported in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA) statements. A comprehensive search, including electronic database search (eg, PubMed, Embase, ProQuest and CNKI), website search and manual search, will be performed to identify all eligible studies. The Population, Exposure, Comparator and Outcome framework was used to clarify the inclusion and exclusion criteria. The Newcastle-Ottawa Scale will be used to assess the quality of included studies. Maximally adjusted effect estimates from individual studies will be summarised with random-effect models in a conservative manner. I ² statistics and Q-tests will be used to test the heterogeneity across studies. We will perform extensive sensitivity analyses, such as confounding risk ratio (confounding), E-value, fixed-effect models, excluding the most relatively weighted study, including only the high-quality studies and many predesigned subgroup analyses, etc. The findings will be reported in accordance to the PRISMA guidelines.

ETHICS AND DISSEMINATION: Ethical approval is not required in this systematic review of published literatures. The results will be published in a peer-reviewed journal and presented at relevant conferences.

PROSPERO REGISTRATION NUMBER: CRD42020181343.

PMID:34408050 | DOI:10.1136/bmjopen-2020-048451

BMJ Open. 2021 Aug 18;11(8):e041091. doi: 10.1136/bmjopen-2020-041091.

ABSTRACT

OBJECTIVES: The aim of this study was to explore the extent of implementation of the General Medical Services 2018/2019 ‘frailty identification and management’ contract in general practitioner (GP) practices in England, and link implementation outcomes to a range of practice and Clinical Commissioning Group (CCG) factors.

DESIGN: A cross-sectional study design using publicly available datasets relating to the year 2018 for all GP practices in England.

SETTINGS: English general practices.

DATA: The analysis was conducted across 6632 practices in 193 CCGs with 9 995 558 patients aged 65 years or older.

OUTCOMES: Frailty assessment rates, frailty coding rates and frailty prevalence rates, plus rates of medication reviews, falls assessments and enriched Summary Care Records (SCRs).

ANALYSIS: Summary statistics were calculated and multilevel negative binomial regression analysis was used to investigate relationships of the six outcomes with explanatory factors.

RESULTS: 14.3% of people aged 65 years or older were assessed for frailty, with 35.4% of these-totalling 5% of the eligible population-coded moderately or severely frail. 59.2% received a medications review, but rates of falls assessments (3.7%) and enriched SCRs (21%) were low. However, percentages varied widely across practices and CCGs. Practice differences in contract implementation were most strongly accounted for by their grouping within CCGs, with weaker but still important associations with some practice and CCG factors, particularly healthcare demand-related factors of chronic caseload and (negatively) % of patients aged 65 years or older.

CONCLUSION: CCG appears the strongest determinant of practice engagement with the frailty contract, and fuller implementation may depend on greater engagement of CCGs themselves, particularly in commissioning suitable interventions. Practices understandably targeted frailty assessments at patients more likely to be found severely frail, resulting in probable underidentification of moderately frail individuals who might benefit most from early interventions. Frailty prevalence estimates based on the contract data may not reflect actual rates.

PMID:34408025 | DOI:10.1136/bmjopen-2020-041091

BMJ. 2021 Aug 18;374:n1868. doi: 10.1136/bmj.n1868.

ABSTRACT

OBJECTIVE: To determine associations of BNT162b2 vaccination with SARS-CoV-2 infection and hospital admission and death with covid-19 among nursing home residents, nursing home staff, and healthcare workers.

DESIGN: Prospective cohort study.

SETTING: Nursing homes and linked electronic medical record, test, and mortality data in Catalonia on 27 December 2020.

PARTICIPANTS: 28 456 nursing home residents, 26 170 nursing home staff, and 61 791 healthcare workers.

MAIN OUTCOME MEASURES: Participants were followed until the earliest outcome (confirmed SARS-CoV-2 infection, hospital admission or death with covid-19) or 26 May 2021. Vaccination status was introduced as a time varying exposure, with a 14 day run-in after the first dose. Mixed effects Cox models were fitted to estimate hazard ratios with index month as a fixed effect and adjusted for confounders including sociodemographics, comorbidity, and previous medicine use.

RESULTS: Among the nursing home residents, SARS-CoV-2 infection was found in 2482, 411 were admitted to hospital with covid-19, and 450 died with covid-19 during the study period. In parallel, 1828 nursing home staff and 2968 healthcare workers were found to have SARS-CoV-2 infection, but fewer than five were admitted or died with covid-19. The adjusted hazard ratio for SARS-CoV-2 infection after two doses of vaccine was 0.09 (95% confidence interval 0.08 to 0.11) for nursing home residents, 0.20 (0.17 to 0.24) for nursing home staff, and 0.13 (0.11 to 0.16) for healthcare workers. Adjusted hazard ratios for hospital admission and mortality after two doses of vaccine were 0.05 (0.04 to 0.07) and 0.03 (0.02 to 0.04), respectively, for nursing home residents. Nursing home staff and healthcare workers recorded insufficient events for mortality analysis.

CONCLUSIONS: Vaccination was associated with 80-91% reduction in SARS-CoV-2 infection in all three cohorts and greater reductions in hospital admissions and mortality among nursing home residents for up to five months. More data are needed on longer term effects of covid-19 vaccines.

PMID:34407952 | DOI:10.1136/bmj.n1868

Ann Rheum Dis. 2021 Aug 18:annrheumdis-2021-219931. doi: 10.1136/annrheumdis-2021-219931. Online ahead of print.

ABSTRACT

OBJECTIVES: This study aimed to determine the prevalence of ultrasound-detected tendon abnormalities in healthy subjects (HS) across the age range.

METHODS: Adult HS (age 18-80 years) were recruited in 23 international Outcome Measures in Rheumatology ultrasound centres and were clinically assessed to exclude inflammatory diseases or overt osteoarthritis before undergoing a bilateral ultrasound examination of digit flexors (DFs) 1-5 and extensor carpi ulnaris (ECU) tendons to detect the presence of tenosynovial hypertrophy (TSH), tenosynovial power Doppler (TPD) and tenosynovial effusion (TEF), usually considered ultrasound signs of inflammatory diseases. A comparison cohort of patients with rheumatoid arthritis (RA) was taken from the Birmingham Early Arthritis early arthritis inception cohort.

RESULTS: 939 HS and 144 patients with RA were included. The majority of HS (85%) had grade 0 for TSH, TPD and TEF in all DF and ECU tendons examined. There was a statistically significant difference in the proportion of TSH and TPD involvement between HS and subjects with RA (HS vs RA p<0.001). In HS, there was no difference in the presence of ultrasound abnormalities between age groups.

CONCLUSIONS: Ultrasound-detected TSH and TPD abnormalities are rare in HS and can be regarded as markers of active inflammatory disease, especially in newly presenting RA.

PMID:34407928 | DOI:10.1136/annrheumdis-2021-219931

Int J Oral Maxillofac Surg. 2021 Aug 15:S0901-5027(21)00265-4. doi: 10.1016/j.ijom.2021.07.015. Online ahead of print.

ABSTRACT

The goal of this study was to determine whether a relationship exists between the amount of mandibular setback and the amount of airway dimensional changes. Records and cone beam computed tomography (CBCT) of patients who had undergone isolated bilateral sagittal split osteotomy setback between January 1, 2013 and March 16, 2020 at a single institution were reviewed retrospectively. The primary outcome variable was upper airway volume dimension change, and the predictor variable was the magnitude of mandibular setback as measured by six different methods. Thirty-one patients were included in the study, with a mean mandibular setback ranging from 1.41 mm to 6.11 mm. None of the predictor variables showed an association with oropharyngeal (P = 0.54) or hypopharyngeal (P = 0.33) volume. Stepwise regression analysis failed to show any significant relationships. Similarly, there was no statistically significant association between any of the predictor variables and oropharyngeal (P = 0.44) or hypopharyngeal (P = 0.74) minimum axial area. The results showed that no correlation exists between the magnitude of mandibular setback and the amount of static airway dimensional changes; therefore, it may not be possible to predict whether obstructive sleep apnea will develop following mild to moderate mandibular setback based upon CBCT measurements.

PMID:34407912 | DOI:10.1016/j.ijom.2021.07.015

Cardiol Young. 2021 Aug 19:1-27. doi: 10.1017/S1047951121003693. Online ahead of print.

ABSTRACT

OBJECTIVE: This study was conducted to evaluate the persisting Covid-19-related symptoms of the cases included in our study and to assess their cardiac findings in order to determine the impact of Covid-19 on children’s cardiovascular health.

METHODS: In this study, 121 children between the ages of 0-18 with Covid-19 were evaluated based on their history, blood pressure values, and electrocardiography and echocardiography results. These findings were compared with the findings of the control group which consisted of 95 healthy cases who were in the same age range as the study group and did not have Covid-19. The results were evaluated using the statistics program, SPSS 21.

RESULTS: There was no significant difference between the study group and the control group in terms of age, weight, and body mass index. The clinical symptoms (chest and back pain, dizziness, headache, palpitation, fatigue, shortness of breath, loss of balance, coughing) of 37.2% of the cases persisted at least 1 month after Covid-19 recovery. Statistically significant differences were found in systolic blood pressure, left ventricular ejection fraction, relative wall thickness, and tricuspid annular plane systolic excursion.

CONCLUSION: The continuation of some cases’ clinical symptoms post-recovery indicates that long Covid infection can be observed in children. The fact that statistically significant differences were observed between the echocardiographic parameters of the study and control groups suggests that Covid-19 may have effects on the cardiovascular system. To shed light on the long Covid cases among children and the infection’s cardiac impacts, it would be beneficial to conduct more comprehensive studies on this matter.

PMID:34407902 | DOI:10.1017/S1047951121003693