Category: Statistics

Pol Przegl Chir. 2021 Jun 23;93(5):1-5. doi: 10.5604/01.3001.0014.9658.

ABSTRACT

Objectives The diagnosis of deep venous thrombosis (DVT) is hampered in patients with primary varicose veins due to similarity of symptoms of DVT and PVV and elevated levels of D-dimers. The purpose of this study was to analyze factors that influence the D-dimer concentration in patients with PVV in order to redefine its diagnostic value. Methods Forty- one patients with non-complicated PVV were enrolled in the study, in whom D-dimer level was determined by immunoturbidimetric assay. The influence of selected clinical factors on the concentration of D-dimers was determined with univariate and bivariate analysis. Besides descriptive statistics the D-dimers levels were compared to the age -adjusted cutoff values. Results The median concentration of D-dimer was 630.0 ng/ml (440.0-1140.0 ng/ml) and was above the age-adjusted level in 21 (52%) of patients. There was a positive correlation between the patient’s age and and D-dimer concentration (p = 0.035, Spearman correlation coefficient rs=0,33. The bivariate analysis showed a significant interaction between age and weight p=0,02. Conclusions In patients with PVV the diagnostic value of D-dimers is limited especially in older and overweight subjects.

PMID:34552026 | DOI:10.5604/01.3001.0014.9658

BMJ Open. 2021 Sep 22;11(9):e052871. doi: 10.1136/bmjopen-2021-052871.

ABSTRACT

A wave of new treatments and treatment combinations are becoming available for solid tumours. Trials performed to obtain registration establish a positive benefit-risk but unavoidably leave many questions unanswered on place-in-therapy and the relative efficacy of different treatment sequences. Such limitations create problems in terms of strength of treatment guidelines and reimbursement (in countries where a public payer exists). Data on new drugs arriving during the last 10 years for the treatment of hepatocellular carcinoma and renal cancer are reported as an example of how the fortunate condition of having new effective treatments may translate into uncertainty regarding the optimal treatment plan. We suggest that academic research should react to such limitations and propose a model of patient-journey study (PJS), where patients are followed from the initial diagnosis across subsequent lines of treatment. A PJS master protocol might include at each node of clinical decision either the possibility of choosing treatment according to guidelines (generating prospective real-world evidence) or the possibility to randomise where uncertainty exists (generating comparative effectiveness data). PJS protocols might be adaptively modified every time a new drug arrives on the market. Overall, methodologically sound analyses of PJS will produce knowledge on the efficacy and the effectiveness of different treatment pathways and might significantly optimise treatment of patients in clinical practice. PJS would represent a jump from a few snapshots (trials performed to get regulatory approval) to a full movie (evidence on the relative value of treatment pathways).

PMID:34551954 | DOI:10.1136/bmjopen-2021-052871

Otolaryngol Pol. 2021 May 12;75(5):1-8. doi: 10.5604/01.3001.0014.8759.

ABSTRACT

Radiotherapy (RT) for patients with head and neck squamous cell carcinoma (HNSCC) affects vital functions related to the irradiation volume of the head and neck region and, in addition, has a negative impact on social functioning, thereby significantly impairing patients’ quality of life (QoL). The aim of this study was to assess changes in the quality of life in patients with head and neck cancer treated with curative RT at 12 months after completion of RT. The aim of this study was to assess the differences between the baseline QoL of patients with early clinical stage HNSCC and at 12 months after curative/radical RT. The prospective clinical study included 92 patients in good general condition (ECOG 0-1 – Eastern Cooperative Oncology Group performance status), without regional or distant metastases, diagnosed with pathomorphologically confirmed early-stage head and neck squamous cell carcinoma treated with definitive RT. All patients participating in the study signed an informed consent form. QoL was assessed using the standard EORTC QLQ-C30 and QLQH&N35 questionnaires. In addition, information on clinical aspects and data relating to socio-demographic factors were obtained from each patient. Statistical analysis was performed using a statistical package (SPSS 17.0). T-test was used for dependent and independent samples. A general linear model was used for repeated measures. Patients’ QoL deteriorated significantly after definitive RT. Worse QoL Core-30 scores in patients 12 months after the end of RT, compared with baseline QoL, before the start of RT, were observed in domains such as physical performance, fulfillment of life roles, cognitive functioning, loss of appetite, fatigue and constipation. For the QLQ-H&N35 questionnaires, patients 12 months after the end of RT reported problems in relation to aspects of life such as senses, mouth opening, dry mouth, thick saliva, pain, and weight loss. RT, even in early clinical stage head and neck cancer, has a negative impact on QoL, despite modern treatment techniques.

PMID:34552020 | DOI:10.5604/01.3001.0014.8759

Int J Spine Surg. 2021 Sep 22:8123. doi: 10.14444/8123. Online ahead of print.

ABSTRACT

BACKGROUND: The frequency and complexity of spinal surgery performed in an ambulatory surgery center (ASC) is increasing. However, safety and efficacy data of most spinal procedures adapted to the ASC are sparse and have focused on anterior cervical surgery. The purpose of this study was to compare the 90-day complication and readmission rates of anterior lumbar spine surgery performed in an ASC or inpatient setting.

METHODS: We performed a retrospective comparative analysis of 226 consecutive anterior lumbar surgeries (283 levels treated) completed in an ASC (n = 124) or in an inpatient tertiary care hospital (n = 102) over a 3-year period. These included anterior lumbar interbody fusion (ALIF), artificial disc replacement (ADR), and hybrids. Patients undergoing simultaneous or staged posterior procedures within 3 months were excluded. Patient demographics and surgical parameters between the two surgical settings were compared. Ninety-day medical complications and readmission rates were assessed. One-way analysis of variance and Chi-square analysis were used. A P value of less than .05 was considered statistically significant.

RESULTS: The two study groups had similar baseline characteristics. While there was a trend toward fewer complications, reoperations, and readmissions for the ASC cohort, the differences were not statistically significant. There were 7 intraoperative complications (5.6% minor vascular injury) in the inpatient cohort and 0 in the ASC cohort. The overall 90-day postoperative complication rate was 5.6% for the inpatient cohort and 0.9% for the ASC cohort. The 90-day readmission rate was 1.9% in the ASC cohort and 1.6% in the inpatient cohort. The 90-day reoperation rate was 0.8% for the inpatient cohort and 0% in the ASC cohort. The average hospital stay was 2.3 ± 1.5 days for the inpatient cohort.

CONCLUSION: The 90-day readmission rates were lower for outpatients than for inpatients, while the complication and reoperation rates were similar. Our results demonstrate that anterior lumbar procedures, including single-level and multilevel ALIF, ADR, and hybrid procedures, can be performed safely in an ASC. This has significant cost savings implications for the ASC setting.

PMID:34551930 | DOI:10.14444/8123

BMJ Open. 2021 Sep 22;11(9):e049452. doi: 10.1136/bmjopen-2021-049452.

ABSTRACT

INTRODUCTION: Adolescents represent one of the most underserved population groups among people living with HIV. With successes in the elimination of mother to child transmission initiatives and advances in paediatric HIV treatment programmes, a large population of HIV-infected children are surviving into adolescence. Adolescence presents unique challenges that increase the risk of non-suppressed viral loads in adolescents living with HIV (ALHIV). There is a need to develop, implement and test interventions to improve viral suppression among ALHIV. Systematic reviews of recent studies present scarce and inconclusive evidence of effectiveness of current interventions, especially for adolescents. This protocol provides a description of a planned review of interventions to improve treatment outcomes among unsuppressed ALHIV.

METHODS AND ANALYSIS: A comprehensive search string will be used to search six bibliographic databases: PubMed/MEDLINE, Sabinet, EBSCOhost, CINAHL, Scopus and ScienceDirect, for relevant studies published between 2010 and 2020 globally, and grey literature. Identified articles will be exported into Mendeley Reference Management software and two independent reviewers will screen the titles, abstracts and full texts for eligibility. A third reviewer will resolve any discrepancies between the two initial reviewers. Studies reporting on interventions to improve viral suppression, retention and adherence for adolescents will be considered for inclusion. The systematic review will be performed and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols. Where feasible, a meta-analysis will be conducted using Stata Statistical Software: Release V.16. The quality of the studies and risk of bias will be assessed using the Critical Appraisal Skills Programme checklists and Risk of Bias in Non-randomised Studies of Interventions tool, respectively.

ETHICS AND DISSEMINATION: The systematic review entails abstracting and reviewing already publicly available data rather than any involvement of participants, therefore, no ethical clearance will be required. Results will be shared with relevant policy-makers, programme managers and service providers, and published and share through conferences and webinars.

PROSPERO REGISTRATION NUMBER: CRD42021232440.

PMID:34551946 | DOI:10.1136/bmjopen-2021-049452

Int J Spine Surg. 2021 Sep 22:8126. doi: 10.14444/8126. Online ahead of print.

ABSTRACT

PURPOSE: The objective of this study was to compare clinical and radiologic parameters between minimally invasive surgery-transforaminal lumbar interbody fusion (MIS-TLIF) and open TLIF.

METHODS: Data of 145 patients who underwent single- or double-level TLIF procedures with an open (n = 76) or a MIS (n = 69) technique were analyzed. Average operation time, estimated blood loss, and hospital stay were compared between open TLIF and MIS-TLIF. Improvement in clinical scores was analyzed using visual analog scale (VAS) and Oswestry Disability Index (ODI) scores in both groups and statistically compared using t tests. Radiologic parameters, such as lumbar lordosis, focal lordosis at the index level, and pelvic incidence (PI), were calculated at preoperative, postoperative, and final follow-up for comparison. The differences in improvement between open and MIS groups were analyzed using unpaired t tests.

RESULTS: Average follow-up was 35.8 ± 15.4 months in open TLIF and 37.9 ± 14.4 months in MIS-TLIF. The average blood loss and operation times were higher and hospital stay was less in MIS-TLIF compared to open TLIF. VAS scores were improved from preoperative (8.5 ± 0.6) to postoperative (2.1 ± 0.8) and preoperative (8.4 ± 0.8) to postoperative (2.0 ± 0.7) in open TLIF and MIS-TLIF, respectively (P < .0001), and ODI scores were improved from preoperative (55.2 ± 5.2) to postoperative (22.5 ± 4.3) and preoperative (56.7 ± 4.9) to postoperative (22.0 ± 5.0) in open TLIF and MIS-TLIF, respectively (P < .0001). Similarly, there were significant improvements in lumbar lordosis and focal lordosis at the index level with a difference of 3.9° and 2.5°, respectively, in open TLIF and 4.0° and 2.9°, respectively, in MIS-TLIF. However, there were no differences in PI in both groups. There were 9 (11.8%) and 9 (13%) complications encountered in open TLIF and MIS-TLIF, respectively. Two patients from open TLIF and 5 from MIS-TLIF had to undergo revision surgeries without any statistical difference.

CONCLUSIONS: Open TLIF and MIS-TLIF are equally efficient surgical techniques with similar clinical and radiologic outcomes. MIS-TLIF is associated with less intraoperative blood loss and hospital stay; however, it increases operation time significantly.

PMID:34551928 | DOI:10.14444/8126

Int J Spine Surg. 2021 Sep 22:8121. doi: 10.14444/8121. Online ahead of print.

ABSTRACT

BACKGROUND: Transforaminal lumbar interbody fusion (TLIF) with bilateral pedicle screw instrumentation is a well-accepted technique in lumbar degenerative disc disorder. Unilateral instrumentation in TLIF has been reported in the literature. This study aims to compare the clinical and radiological outcomes of unilateral and bilateral instrumented TLIF in a selected series of patients.

METHODS: We retrospectively analyzed patients operated with unilateral pedicle screw fixation in TLIF (UPSF TLIF) or with bilateral pedicle screw fixation in TLIF (BPSF TLIF) with a minimum of 2 years of follow-up. Patients were evaluated at regular intervals for functional and radiological outcomes. Functional outcome was assessed using the Oswestry disability index (ODI) and visual analog score (VAS) preoperatively and at 6 months, 1 year, and 2 years after surgery. Fusion rates were assessed using Bridwell interbody fusion grading.

RESULTS: Our study shows that there was a significant improvement in VAS and ODI in both groups at 2 years follow-up, and there was no significant difference in improvements between the groups. The complication rates between the groups were similar. The fusion rate in UPSF TLIF was 97.3% and was 98.34% in BPSF TLIF; this was not statistically significant between groups. There is a significant difference in terms of blood loss, duration of surgery, and average duration of hospital stay between the groups (P < .001), favoring UPSF TLIF.

CONCLUSIONS: Unilateral pedicle screw fixation in open TLIF is comparable with bilateral pedicle screw fixation in terms of patient-reported clinical outcomes, fusion rates, and complication rates with the additional benefits of less operative time, less blood loss, shorter hospitalization, and less cost in selective cases.

LEVEL OF EVIDENCE: 4.

PMID:34551929 | DOI:10.14444/8121

Arch Dis Child Fetal Neonatal Ed. 2021 Sep 22:fetalneonatal-2020-321489. doi: 10.1136/archdischild-2020-321489. Online ahead of print.

ABSTRACT

OBJECTIVE: Assess the impact of introducing a consensus guideline incorporating an adapted Sepsis Risk Calculator (SRC) algorithm, in the management of early onset neonatal sepsis (EONS), on antibiotic usage and patient safety.

DESIGN: Multicentre prospective study SETTING: Ten perinatal hospitals in Wales, UK.

PATIENTS: All live births ≥34 weeks’ gestation over a 12-month period (April 2019-March 2020) compared with infants in the preceding 15-month period (January 2018-March 2019) as a baseline.

METHODS: The consensus guideline was introduced in clinical practice on 1 April 2019. It incorporated a modified SRC algorithm, enhanced in-hospital surveillance, ongoing quality assurance, standardised staff training and parent education. The main outcome measure was antibiotic usage/1000 live births, balancing this with analysis of harm from delayed diagnosis and treatment, disease severity and readmissions from true sepsis. Outcome measures were analysed using statistical process control charts.

MAIN OUTCOME MEASURES: Proportion of antibiotic use in infants ≥34 weeks’ gestation.

RESULTS: 4304 (14.3%) of the 30 105 live-born infants received antibiotics in the baseline period compared with 1917 (7.7%) of 24 749 infants in the intervention period (45.5% mean reduction). All 19 infants with culture-positive sepsis in the postimplementation phase were identified and treated appropriately. There were no increases in sepsis-related neonatal unit admissions, disease morbidity and late readmissions.

CONCLUSIONS: This multicentre study provides evidence that a judicious adaptation of the SRC incorporating enhanced surveillance can be safely introduced in the National Health Service and is effective in reducing antibiotic use for EONS without increasing morbidity and mortality.

PMID:34551917 | DOI:10.1136/archdischild-2020-321489

Int J Spine Surg. 2021 Sep 22:8119. doi: 10.14444/8119. Online ahead of print.

ABSTRACT

BACKGROUND: Clinical practice in postoperative bracing after posterior lumbar spine fusion (PLF) is inconsistent between providers. This paper attempts to assess the effect of bracing on short-term outcomes related to safety, quality of care, and direct costs.

METHODS: Retrospective cohort analysis of consecutive patients undergoing multilevel PLF with or without bracing (2013-2017) was undertaken (n = 980). Patient demographics and comorbidities were analyzed. Outcomes assessed included length of stay (LOS), discharge disposition, quality-adjusted life years (QALY), surgical-site infection (SSI), total cost, readmission within 30 days, and emergency department (ED) evaluation within 30 days.

RESULTS: Amongst the study population, 936 were braced and 44 were not braced. There was no difference between the braced and unbraced cohorts regarding LOS (P = .106), discharge disposition (P = .898), 30-day readmission (P = .434), and 30-day ED evaluation (P = 1.000). There was also no difference in total cost (P = .230) or QALY gain (P = .740). The results indicate a significantly lower likelihood of SSI in the braced population (1.50% versus 6.82%, odds ratio = 0.208, 95% confidence interval = 0.057-0.751, P = .037). There was no difference in relevant comorbidities (P = .259-1.000), although the braced cohort was older than the unbraced cohort (63 versus 56 y, P = .003).

CONCLUSION: Bracing following multilevel posterior lumbar fixation does not alter short-term postoperative course or reduce the risk for early adverse events. Cost analysis show no difference in direct costs between the 2 treatment approaches. Short-term data suggest that removal of bracing from the postoperative regimen for PLF will not result in increased adverse outcomes.

PMID:34551926 | DOI:10.14444/8119

Br J Sports Med. 2021 Sep 22:bjsports-2021-104028. doi: 10.1136/bjsports-2021-104028. Online ahead of print.

ABSTRACT

OBJECTIVES: To compare the success rates of arthroscopic Bankart and open Latarjet procedure in the treatment of traumatic shoulder instability in young males.

DESIGN: Multicentre randomised controlled trial.

SETTING: Orthopaedic departments in eight public hospitals in Finland.

PARTICIPANTS: 122 young males, mean age 21 years (range 16-25 years) with traumatic shoulder anteroinferior instability were randomised.

INTERVENTIONS: Arthroscopic Bankart (group B) or open Latarjet (group L) procedure.

MAIN OUTCOME MEASURES: The primary outcome measure was the reported recurrence of instability, that is, dislocation at 2-year follow-up. The secondary outcome measures included clinical apprehension, sports activity level, the Western Ontario Shoulder Instability Index, the pain Visual Analogue Scale, the Oxford Shoulder Instability Score, the Constant Score and the Subjective Shoulder Value scores and the progression of osteoarthritic changes in plain films and MRI.

RESULTS: 91 patients were available for analyses at 2-year follow-up (drop-out rate 25%). There were 10 (21%) patients with redislocations in group B and 1 (2%) in group L, p=0.006. One (9%) patient in group B and five (56%) patients in group L returned to their previous top level of competitive sports (p=0.004) at follow-up. There was no statistically significant between group differences in any of the other secondary outcome measures.

CONCLUSIONS: Arthroscopic Bankart operation carries a significant risk for short-term postoperative redislocations compared with open Latarjet operation, in the treatment of traumatic anteroinferior instability in young males. Patients should be counselled accordingly before deciding the surgical treatment.

TRIAL REGISTRATION NUMBER: NCT01998048.

PMID:34551902 | DOI:10.1136/bjsports-2021-104028