Cohort Study In Clinical Practice Research Articles

10-year Historical Prospective Cohort Study of Calcium Phosphate-Blasted Acid-Etched Titanium Implants Placed in Different Ridges.

Purpose: To evaluate the survival rate and marginal bone level (MBL) of calcium phosphate-blasted acid-etched titanium implants placed in a cohort of patients with different ridges after a follow-up period of at least 10 years. Materials and Methods: A total of 61 patients with a minimum implant follow-up of 10 years were selected for this historical prospective, best clinical practice cohort study. Between 2009 and 2012, 121 titanium implants were placed using a flap, flapless, or postextractive technique. The implant placement timing was performed according to pre-extractive diagnosis and divided into immediate (immediately after tooth extraction with an absence of infection), early (within 2 to 3 months with an acute periapical lesion), delayed (6 to 12 months from extraction with a large periapical infection), or late (> 12 months from extraction with healed edentulous ridges). All implants were loaded after 3 months with provisional and definitive cemented restorations. Periapical radiographs were taken before implant insertion and at 3, 6, 12, 24, 36, 48, 96, and 120 months (T3, T6, T12, T24, T36, T48, T96, and T120, respectively). The MBL was calculated in single blind by an additional examiner. Linear logistic regression was performed to analyze statistically significant differences in relation to different operative variables at all evaluation times. Multilevel mixed logistic regression was made to evaluate the factors associated to MBL at 10 years (T120). Results: After 10 years, 47 patients and 92 implant restorations were analyzed, showing that 88 implants (95.6%) survived and 4 implants (4.4%) failed. The cumulative drop-out rate was 22.1%. Loosening and/or mobility was observed in a total of 9 abutments (9.7%) during the observational time. No other complications were reported. Implants placed with a flapless technique revealed a similar MBL to those placed with a flap technique. No significant differences were observed between the surgical techniques at T96 and T120. Immediate and early implants revealed a more stable MBL than both delayed and late implants up to T48. At longer evaluation times (T96 and T120), the MBL values were not statistically significant (P > .05). Narrower diameter implants (3.5 mm) revealed a higher bone loss when compared to the 4.1-mm- and 5.0-mm-diameters, especially in the first year from implant insertion (from T3 to T12) and at longer follow-up (T36 and T48). After that, the difference was reduced. Multilevel analysis showed that none of these variables appear to significantly influence MBL at 120 months. Conclusions: MBL was not influenced by surgical technique or implant placement timing after 10 years. Maintaining a strict occlusal and hygiene control created the conditions to preserve bone integrity and achieve a high implant survival rate.

Tonsillectomy in adults—to do or not to do

Recurrent acute tonsillitis describes the repeated occurrence of acute bacterial infections of palatine tonsils with symptom-free intervals. Acute tonsillitis accounts for around a third of respiratory tract infections in primary care among people of all ages, 1 Petersen I Johnson AM Islam A Duckworth G Livermore DM Hayward AC Protective effect of antibiotics against serious complications of common respiratory tract infections: retrospective cohort study with the UK General Practice Research Database. BMJ. 2007; 335: 982 Crossref PubMed Scopus (210) Google Scholar with an estimated 600 million symptomatic cases of group A streptococcus tonsillitis worldwide annually. 2 Carapetis JR Steer AC Mulholland EK Weber M The global burden of group A streptococcal diseases. Lancet Infect Dis. 2005; 5: 685-694 Summary Full Text Full Text PDF PubMed Scopus (1995) Google Scholar Recurrent episodes occur in 12% of patients with tonsillitis—ie, around 12 000 per 100 000 people. 3 Kvestad E Kværner KJ Røysamb E Tambs K Harris JR Magnus P Heritability of recurrent tonsillitis. Arch Otolaryngol Head Neck Surg. 2005; 131: 383-387 Crossref PubMed Scopus (26) Google Scholar Beyond the relation to group A streptococcus infections, little is known about risk factors for the development of recurrent acute tonsillitis. 4 Roberts AL Connolly KL Kirse DJ et al. Detection of group A Streptococcus in tonsils from pediatric patients reveals high rate of asymptomatic streptococcal carriage. BMC Pediatr. 2012; 12: 3 Crossref PubMed Scopus (97) Google Scholar Recurrent acute tonsillitis could be a genetic immunosusceptibility disease because patients younger than 12 years show some subclinical antibody deficiency and aberrant T-cell function 5 Dan JM Havenar-Daughton C Kendric K et al. Recurrent group A Streptococcus tonsillitis is an immunosusceptibility disease involving antibody deficiency and aberrant TFH cells. Sci Transl Med. 2019; 11eaau3776 Crossref PubMed Scopus (1) Google Scholar and many undergo tonsillectomy. More than 30 000 tonsillectomies are performed annually in the UK. 6 Keltie K Donne A Daniel M et al. Paediatric tonsillectomy in England: a cohort study of clinical practice and outcomes using Hospital Episode Statistics data (2008–2019). Clin Otolaryngol. 2021; 46: 552-561 Crossref PubMed Scopus (16) Google Scholar Tonsillectomy can produce severe postoperative pain, complicated by postoperative bleeding which can result in death in rare cases. Clearly, we need evidence-based policies to guide health-care professionals for the indication of tonsillectomy. 7 Mandavia R Schilder AGM Dimitriadis PA Mossialos E Addressing the challenges in tonsillectomy research to inform health care policy: a review. JAMA Otolaryngol Head Neck Surg. 2017; 143: 943-947 Crossref PubMed Scopus (10) Google Scholar Unfortunately, not much has changed in the past 40 years. National guidelines are still based on the Paradise criteria from 1984, 8 Paradise JL Bluestone CD Bachman RZ et al. Efficacy of tonsillectomy for recurrent throat infection in severely affected children—results of parallel randomized and nonrandomized clinical trials. N Engl J Med. 1984; 310: 674-683 Crossref PubMed Google Scholar stating that a tonsillectomy is indicated when around seven or more treated tonsillitis episodes occur in 1 year. The Paradise criteria were based on paediatrics clinical trials and later extrapolated for adult guidelines without any justifying research in the adult population. Thus, the 2014 Cochrane Review concluded that the effectiveness of tonsillectomy is low. 9 Burton MJ Glasziou PP Chong LY Venekamp RP Tonsillectomy or adenotonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis. Cochrane Database Syst Rev. 2014; 2014CD001802 PubMed Google Scholar Until now, there was no basis to make confident decisions using national guidelines. 7 Mandavia R Schilder AGM Dimitriadis PA Mossialos E Addressing the challenges in tonsillectomy research to inform health care policy: a review. JAMA Otolaryngol Head Neck Surg. 2017; 143: 943-947 Crossref PubMed Scopus (10) Google Scholar Conservative management versus tonsillectomy in adults with recurrent acute tonsillitis in the UK (NATTINA): a multicentre, open-label, randomised controlled trialCompared with conservative management, immediate tonsillectomy is clinically effective and cost-effective in adults with recurrent acute tonsillitis. Full-Text PDF Open Access

Paediatric tonsillectomy in England: A cohort study of clinical practice and outcomes using Hospital Episode Statistics data (2008-2019).

ObjectivesTo assess the safety of paediatric tonsillectomy procedures conducted in NHS hospitals in England between 2008 and 2019.DesignRetrospective observational cohort study using Hospital Episode Statistics (HES) data.SettingAcute NHS trusts in England conducting paediatric tonsillectomy procedures.ParticipantsChildren (≤16 years old) undergoing bilateral tonsillectomy.Main outcome measuresNumber of tonsillectomies performed per year by procedural method. In‐hospital complications including return to theatre for arrest of haemorrhage. Readmission within 28 days, including those for pain, haemorrhage and surgical arrest of haemorrhage. Long‐term outcomes: all‐cause mortality, revision tonsillectomy.ResultsA total of 318 453 paediatric tonsillectomies were performed from 2008 to 2019:278,772 dissection (87.5%) and 39 681 coblation (12.5%). The proportion of tonsillectomy performed using coblation increased from 7% in 2008/9 to 27% in 2018/9. Five patients died in hospital (including 4 due to respiratory complications). In‐hospital complications occurred in 4202 children (1.3%), with the most frequent being haemorrhage. Within 28 days of tonsillectomy, 28 170 patients (8.8%) were readmitted and 7 deaths occurred. Readmission rates for haemorrhage and pain have increased since 2008. The proportion of children undergoing revision tonsillectomy procedures within 5 years following coblation tonsillectomy (1.4%) was approximately double that of dissection (0.6%).ConclusionsClinical practice of paediatric tonsillectomy has changed in England over the past 11 years. The overall mortality rate associated with the procedure is 0.0037%. Differences in outcomes have been identified for different procedural methods. However, routine administrative data are limited in differentiating procedural detail (eg we are unable to differentiate intra or extra‐capsular techniques from current clinical coding of tonsillectomy procedures). Therefore, prospective national data collection or more granular clinical coding is essential to capture relative outcomes of the different tonsillectomy methods and techniques being used in the NHS.

Association between rheumatic diseases and cancer: results from a clinical practice cohort study

The association between cancer and immune-mediated rheumatic conditions is controversial, especially as far as polymyalgia rheumatica (PMR) is concerned. Furthermore, no clinical feature has been shown to be suggestive of a paraneoplastic rheumatic syndrome. With the present study, we aim to address both these issues. The study population comprised N=1750 patients, including N=100 with PMR, who attended our tertiary immuno-rheumatology clinic between January 1, 2005 and November 30, 2012. A rheumatic disease was deemed paraneoplastic if cancer had been diagnosed in the 2years preceding or following its onset. The probability of a significant association between a specific rheumatic disease and cancer was evaluated by computing the odds ratio (OR): N=702 patients with osteoarthritis serving as controls. Furthermore, clinical features distinguishing paraneoplastic rheumatic diseases were searched for by univariate and multivariate analysis. Sjogren's syndrome (SS) [OR 3.6 (CI 95% 1.7-7.5)], PMR (OR 5.1 CI 95% 2.9-8.9), dermatomyositis/polymyositis [OR 12.09 (CI 95% 2.6-55.8)] and vasculitis [OR 3.70 (CI 95% 1.81-7.52)] are associated with cancer. At multivariate analysis, older age is associated with cancer among SS patients (p=0.03), while in the PMR group, older age, male gender, and ≥6 tender joints are independent predictors of paraneoplastic PMR (p<0.0004). Cancer frequently either heralds or follows rheumatic manifestations, including PMR. Older age, male gender and a more extensive joint involvement should be considered red flags for paraneoplastic PMR.

Endoscopic Severity Predicts Long-Term Prognosis in Crohn's Disease Patients with Clinical Remission

Introduction: Mucosal healing has emerged as a desirable treatment goal in clinical practice for patients with Crohn's disease (CD). The aim of this study was to assess the relationship between endoscopic activity and the long-term prognosis of CD using simple endoscopic score for Crohn's disease (SESCD) and Rutgeerts' score. Methods: We conducted a cohort study in clinical practice at a single center. Among CD patients who underwent colonoscopy between July 2008 and June 2011 at our hospital, 131 patients with clinical remission were selected, and the patients were divided into 2 groups: a non-surgical group (n = 84) and a surgical group (n = 47). The primary endpoint of this study was to assess the associations between variables and clinical relapse after endoscopic procedures. The cut-off levels of SESCD or Rutgeerts' score for the prediction of relapse were also assessed in patients with clinical remission. Results: In the non-surgical group, SESCD and C-reactive protein at baseline were significantly higher in patients who had clinical recurrence than in patients who maintained remission. A factor of SESCD ≤2 was independently associated with sustained remission, even in patients with clinical remission. In the surgical group, patients with Rutgeerts' scores ≤1 had significantly prolonged clinical remission compared to patients with Rutgeerts' scores ≥3. Conclusion: A cut-off value of SESCD ≤2 and a Rutgeerts' score ≤1 enabled the prediction of long-term prognosis. These cut-off values could be used in clinical trials of endoscopic remission from the point of view of the clinical outcomes of CD.

Renal function improvement in liver transplant recipients after early everolimus conversion: A clinical practice cohort study in Spain.

A national, multicenter, retrospective study was conducted to assess the results obtained for liver transplant recipients with conversion to everolimus in daily practice. The study included 477 recipients (481 transplantations). Indications for conversion to everolimus were renal dysfunction (32.6% of cases), hepatocellular carcinoma (HCC; 30.2%; prophylactic treatment for 68.9%), and de novo malignancy (29.7%). The median time from transplantation to conversion to everolimus was 68.7 months for de novo malignancy, 23.8 months for renal dysfunction, and 7.1 months for HCC and other indications. During the first year of treatment, mean everolimus trough levels were 5.4 (standard deviation [SD], 2.7) ng/mL and doses remained stable (1.5 mg/day) from the first month after conversion. An everolimus monotherapy regimen was followed by 28.5% of patients at 12 months. Patients with renal dysfunction showed a glomerular filtration rate (4-variable Modification of Diet in Renal Disease) increase of 10.9 mL (baseline mean, 45.8 [SD, 25.3] versus 57.6 [SD, 27.6] mL/minute/1.73 m(2) ) at 3 months after everolimus initiation (P < 0.001), and 6.8 mL at 12 months. Improvement in renal function was higher in patients with early conversion (<1 year). Adverse events were the primary reason for discontinuation in 11.2% of cases. The probability of survival at 3 years after conversion to everolimus was 83.0%, 71.1%, and 59.5% for the renal dysfunction, de novo malignancy, and HCC groups, respectively. Everolimus is a viable option for the treatment of renal dysfunction, and earlier conversion is associated with better recovery of renal function. Prospective studies are needed to confirm advantages in patients with malignancy.

Efficacy and Safety of Intravenous Ferric Carboxymaltose in Geriatric Inpatients at a German Tertiary University Teaching Hospital: A Retrospective Observational Cohort Study of Clinical Practice.

Current iron supplementation practice in geriatric patients is erratic and lacks evidence-based recommendations. Despite potential benefits in this population, intravenous iron supplementation is often withheld due to concerns regarding pharmacy expense, perceived safety issues, and doubts regarding efficacy in elderly patients. This retrospective, observational cohort study aimed to evaluate the safety and efficacy of intravenous ferric carboxymaltose (FCM, Ferinject) in patients aged >75 years with iron deficiency anaemia (IDA). Within a twelve-month data extraction period, the charts of 405 hospitalised patients aged 65–101 years were retrospectively analysed for IDA, defined according to WHO criteria for anaemia (haemoglobin: <13.0 g/dL (m)/<12.0 g/dL (f)) in conjunction with transferrin saturation <20%. Of 128 IDA patients screened, 51 (39.8%) received intravenous iron. 38 patient charts were analysed. Mean cumulative dose of intravenous FCM was 784.4 ± 271.7 mg iron (1–3 infusions). 18 patients (47%) fulfilled treatment response criteria (≥1.0 g/dL increase in haemoglobin between baseline and hospital discharge). AEs were mild/moderate, most commonly transient increases of liver enzymes (n = 5/13.2%). AE incidence was comparable with that observed in patients <75 years. No serious AEs were observed. Ferric carboxymaltose was well tolerated and effective for correction of Hb levels and iron stores in this cohort of IDA patients aged over 75 years.

SAT0065 Effectiveness and Drug Adherence of Biologic Monotherapy in Danish Rheumatoid Arthritis Patients: A Cohort Study of Clinical Practice in the Danbio Registry

BackgroundConcurrent use of methotrexate (MTX) and a biologic is generally the standard-of-care in patients with RA who have disease activity despite MTX. It has been estimated that between 10 and...

Diagnosis and treatment of iron deficiency in medical inpatients at a Swiss tertiary university referral hospital: a retrospective observational cohort study of clinical practice

Iron deficiency anaemia is a common disease with a prevalence of up to 19.2% in populations at risk. However, the prevalence of iron deficiency (ID) in hospitalised patients is not well known. The aims of this retrospective, observational cohort study were to evaluate the current diagnostic procedures for, and treatment of, ID as well as to estimate the prevalence of undiagnosed ID in hospitalised patients at the division of internal medicine in a Swiss tertiary university referral centre. Within a study period of 6 months, data from all patients hospitalised at the division of internal medicine were analysed for the presence of anaemia (defined as haemoglobin levels for males <130 g/l and for females <120 g/l) and ID (ferritin <15 µg/l or ferritin <50 µg/l and transferrin saturation <20%). A total of 2,781 hospitalisation cases were analysed (2,251 unique patients, male 55.5%, mean age 66.4 years). In 2,267 cases (81.5%) results of a red blood cell count were available. In 329 cases (14.5%) iron parameters (IP) were determined and 45 (13.7%) cases / unique patients with ID were detected. Among the remaining 1,938 cases without IP determination, statistical estimation predicted 103 (56-329) undiagnosed ID cases. In ID patients, the most prevalent diagnosis was heart failure (24.4%). Of these patients, 72.7% had haemorrhage-facilitating drugs on hospital admission or discharge. Iron deficiency is common in internal medicine and up to two-thirds of cases may not be diagnosed. Every seventh patient who had iron parameters analysed was iron deficient and two-thirds of patients with ID were treated with intravenous iron.

LDL-C Goal Attainment in Patients who Remain on Atorvastatin or Switch to Equivalent or Non-equivalent Doses of Simvastatin: A Retrospective Matched Cohort Study in Clinical Practice

Background: As clinical trials have shown the benefits of more intensive cholesterol control, treatment targets for low-density lipoprotein cholesterol (LDL-C) have decreased progressively. At the same time, physicians have been encouraged to contain costs by prescribing cheaper, generic statins for cholesterol management. To determine how these possibly conflicting goals are managed in clinical practice, we examined LDL-C control in patients switched from a potent, branded statin (atorvastatin) to a less potent, generic statin (simvastatin). Methods: Patients who switched from atorvastatin to simvastatin between July 2006 and January 2008 were retrospectively identified from a US medical and pharmacy claims database, and matched with controls remaining on atorvastatin. Outcomes measured were the number of switched patients receiving a simvastatin milligram dose ≥ 2 times their previous atorvastatin dose, changes in LDL-C levels, and percentage of patients achieving recommended LDL-C targets. All study variables were analyzed descriptively. Results: After applying exclusion and inclusion criteria, 1048 patients who switched from atorvastatin to simvastatin and 1048 matched controls who remained on atorvastatin were included. Among the switchers, 379 (36%) received an inappropriately low dose of simvastatin (< 2 times atorvastatin dose). In patients remaining on atorvastatin, mean LDL-C decreased from 105.7 mg/dL to 102.3 mg/dL after 44 weeks, whereas in switched patients, LDL-C remained similar, at 105.9 mg/dL on atorvastatin and 105.8 mg/dL on simvastatin. Before switching, when all patients were receiving atorvastatin, 67.4% of switchers and 69.9% of controls achieved recommended LDL-C targets. After switching, significantly fewer switchers than controls met LDL-C targets (69.1% vs 74.6%; P = 0.005). However, among patients who switched to an equivalent dose of simvastatin (≥ 2 times prior atorvastatin dose), similar proportions met LDL-C targets (72.8% vs 74.6% of controls; P = 0.402), whereas among patients who switched to inappropriate non-equivalent dose of simvastatin, a significantly lower proportion met LDL-C targets (62.5% vs 74.6% of controls; P = 0.001). Conclusions: Continuing atorvastatin was associated with lower LDL-C levels and better LDL-C target attainment compared with switching to simvastatin. Patients switched to an equivalent simvastatin dose had lower LDL-C levels and were more likely to achieve LDL-C targets than patients switched to a non-equivalent dose, suggesting physicians must consider dosage equivalence when switching statins, and should measure LDL-C and titrate statins as necessary to achieve LDL-C control.

Effectiveness of entecavir for the treatment of NUC-naïve chronic hepatitis B patients: A large multicenter cohort study in clinical practice

Background and aim. Registration trials showed entecavir (ETV) to be a safe and effective therapy for NUC-naïve patients with chronic hepatitis B, but its long-term effectiveness in field practice patients is unknown.

Sustained effects in hypercholesterolaemic patients on combined simvastatin/ezetimibe treatment: observational cohort study in clinical practice

ABSTRACTBackground: In order to reduce individual cardiovascular risk, many patients require life-long lipid-lowering therapy, often as a drug combination approach. We aimed to describe the usage pattern, effectiveness and tolerability of long-term treatment with lipid-lowering agents, with particular focus on an oral combination of simvastatin (SIM 10, 20, 40 or 80 mg) plus ezetimibe (EZ 10 mg).Methods: A prospective, observational study in 512 general practices throughout Germany. From a sample of patients at moderate or high cardiovascular risk who had previously taken part in a half-year study of an SIM/EZ combination, 5485 patients were documented after 1 year of treatment (mean 58 ± 16 weeks) with regard to lipid parameters, adverse drug reactions (ADRs) and adverse events.Results: At the start of follow-up, 78.6% of patients were still on the SIM/EZ combination. At the end of follow-up, mean low density lipoprotein cholesterol (LDL-C) in patients on the combination versus those on other lipid-lowering therapy was reduced by 29.3 vs. 17.6% compared with baseline, total cholesterol by 23.1 vs. 14.5%, mean high density lipoprotein cholesterol (HDL-C) was increased by 15.9 vs. 13.4%, and mean triglycerides were reduced by 16.1 vs. 7.9%. Individual LDL-C targets were achieved by 56.6% on the SIM/EZ combination versus 35.9% on other therapy. In the long term (but not the short term), low acceptance of nutrition counselling as rated by the physician was associated with poor lipid levels. ADRs during follow-up occurred in 18 patients (0.3%; all cases non-serious), with seven cases of myalgia, and three cases each of nausea or arthralgia.Conclusions: This observational study showed that long-term therapy with the SIM/EZ combination resulted in sustained beneficial effects on serum lipids and was well-tolerated. Compared to patients with therapy discontinuations or switches, those remaining on the combination had better outcomes regarding lipid status.

Intra-articular administration of hylan G-F 20 in patients with symptomatic hip osteoarthritis: tolerability and effectiveness in a large cohort study in clinical practice

ABSTRACTObjective: This prospective, observational, open study aimed to assess the efficacy and safety of hylan G-F 20 in a large cohort of patients with symptomatic hip osteoarthritis (OA), and identify predictors of clinical response.Research design and methods: Patients presenting with symptomatic hip OA received one 2 mL intra-articular (IA) injection of hylan G-F 20 under ultrasound guidance. Patients were followed-up every 3 months for a total of 12 months and were offered an optional, additional injection at each follow-up visit if symptomatically justified. At each visit, pain scores (100 mm visual analogue scale [VAS]), Lequesne index scores, NSAID intake, and physician and patient global assessments scores were recorded. Adverse events (AEs) were recorded throughout the study.Main outcome measures; results: 250 patients completed the 12 month follow-up and received a total of 734 injections. Statistically significant reductions in VAS pain scores, Lequesne index scores and NSAID usage were reported at all time-points ( p < 0.05). No systemic, serious or severe side effects were observed. Fifty-two local AEs were reported (7.08% per injection) all of which were mild and transient. One predictor of clinical response was identified, with patients < 75 years of age reporting better outcomes.Conclusions: This study supports the safety, tolerability and effectiveness of hylan G-F 20 in the treatment of symptomatic hip OA. Hylan G-F 20 may also offer economic benefits due to a reduction in NSAID usage and the resultant reduction in management costs of NSAID related side-effects. These data reflect those obtained in previous studies of hylan G-F 20 in patients with knee OA.