Adverse drug reactions to antiretroviral therapy in AIDS patients at a tertiary care hospital in India: A prospective observational study

Objectives: To identify the adverse drug reactions (ADRs) to antiretroviral therapy (ART) and to assess their impact on treatment compliance in patients with HIV/AIDS. Materials and Methods: Two hundred and thirty-five (235) AIDS patients who received ART were monitored for ADRs over a period of 6 months. The incidence and nature of ADRs occurring with different ART regimens were recorded. We also assessed the severity, causality as well as the impact of ADRs on the patients' compliance. Results: Of 235 patients receiving ART, 90.6% patients experienced ADRs. A total of 618 ADRs involving various systems were observed. A majority were related to gastrointestinal (42.39%) and central nervous (25.57%) system. 23.1% ADRs were severe in intensity. Severe ADRs occurred in 41 out of 235 (17.4%) patients necessitating drug withdrawal. A majority of the patients (87.8%) who complained of severe ADRs received combination of stavudine, lamivudine and nevirapine. Causality assessment revealed 6.63% ADRs were probable and 93.3% ADRs were possible. Non-compliance due to ADRs was observed in 28.9% patients. Conclusions: Myriad ADRs are associated with ART which leads to poor patient compliance. With the increasing access to ART in India, it is prudent that antiretroviral drugs are used judicially with regular monitoring of ADRs.     

Physician reported patient response to immunotherapy: a retrospective study of factors affecting the response

This study assessed physician evaluation of immunotherapy derived from questionnaires completed at specified intervals during the course of each program in 901 randomly selected patients in the Allergy Clinic, Kingston General Hospital, (1975 to 1985). The objective was to determine safety and efficacy and factors contributing to these from this information. Approximately ninety-six percent of completed questionnaires and 97.5% of patients reported symptomatic improvement. The requirement for supplemental medication was reported in 21.6% of questionnaires and by 35.6% of patients. This requirement was greater in females, in patients with asthma, and in patients with greater numbers of antigens administered. Single antigen programs provided the best response. Systemic reactions were reported in 6.7% of patients treated. In 1% of patients these reactions were severe and required adrenalin for management. Severe reactions occurred when higher concentrations of antigens were injected and frequently developed without warning of prior milder episodes. It was concluded that immunotherapy programs are safe and effective given in appropriate circumstances and with proper safeguards. A monitoring system, however, would provide valuable information on patient progress and collectively may indicate trends in response.     

Implications of comorbidity for primary care costs in the UK: a retrospective observational study

Background

Comorbidity is increasingly common in primary care. The cost implications for patient care and budgetary management are unclear.

Aim

To investigate whether caring for patients with specific disease combinations increases or decreases primary care costs compared with treating separate patients with one condition each.

Design

Retrospective observational study using data on 86 100 patients in the General Practice Research Database.

Method

Annual primary care cost was estimated for each patient including consultations, medication, and investigations. Patients with comorbidity were defined as those with a current diagnosis of more than one chronic condition in the Quality and Outcomes Framework. Multiple regression modelling was used to identify, for three age groups, disease combinations that increase (cost-increasing) or decrease (cost-limiting) cost compared with treating each condition separately.

Results

Twenty per cent of patients had at least two chronic conditions. All conditions were found to be both cost-increasing and cost-limiting when co-occurring with other conditions except dementia, which is only cost-limiting. Depression is the most important cost-increasing condition when co-occurring with a range of conditions. Hypertension is cost-limiting, particularly when co-occurring with other cardiovascular conditions.

Conclusion

Three categories of comorbidity emerge, those that are: cost-increasing, mainly due to a combination of depression with physical comorbidity; cost-limiting because treatment for the conditions overlap; and cost-limiting for no apparent reason but possibly because of inadequate care. These results can contribute to efficient and effective management of chronic conditions in primary care.     

Nursing consultations and control of diabetes in general practice: a retrospective observational study

Background

Diabetes affects around 3.6 million people in the UK. Previous research found that general practices employing more nurses delivered better diabetes care, but did not include data on individual patient characteristics or consultations received.

Aim

To examine whether the proportion of consultations with patients with diabetes provided by nurses in GP practices is associated with control of diabetes measured by levels of glycated haemoglobin (HbA1c).

Design and setting

A retrospective observational study using consultation records from 319 649 patients with diabetes from 471 UK general practices from 2002 to 2011.

Method

Hierarchical multilevel models to examine associations between proportion of consultations undertaken by nurses and attaining HbA1c targets over time, controlling for case-mix and practice level factors.

Results

The proportion of consultations with nurses has increased by 20% since 2002 but patients with diabetes made fewer consultations per year in 2011 compared with 2002 (11.6 versus 16.0). Glycaemic control has improved and was more uniformly achieved in 2011 than 2002. Practices in which nurses provide a higher proportion of consultations perform no differently to those where nurse input is lower (lowest versus highest nurse contact tertile odds ratio [OR] [confidence interval {95% CI}]: HbA1c ≤53 mmol/mol (7%) 2002, 1.04 [95% CI = 0.87 to 1.25] and 2011, 0.95 [95% CI = 0.87 to 1.03]; HbA1c ≤86 mmol/mol (10%) 2002, 0.97 [95% CI = 0.73 to 1.29] and 2011, 0.95 [95% CI = 0.86 to 1.04]).

Conclusion

Practices that primarily use GPs to deliver diabetes care could release significant resources with no adverse effect by switching their services towards nurse-led care.     

Clinical and microbiological features of Actinotignum bacteremia: a retrospective observational study of 57 cases

The purpose of this study was to investigate the incidence, clinical presentation, and prognosis of Actinotignum bacteremia in southern Sweden. Actinotignum isolates in blood cultures were identified retrospectively between 1st January 2012 and 31st March 2016 through searches in the clinical microbiology laboratory database. The population covered by this laboratory is approximately 1.3 million. Matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) was used for species determination. Etests were used for minimum inhibitory concentration (MIC) determination. The patients’ medical charts were reviewed. Fifty-eight episodes in fifty-seven patients with Actinotignum bacteremia were identified (A. schaalii = 53, A. sanguinis = 1, A. urinale = 2, and Actinotignum species = 3), which corresponds to an incidence of 11 cases per million inhabitants. Fifty-one percent of the isolates were in pure culture. The MICs were low for β-lactam antibiotics, whereas high MICs were recorded for ciprofloxacin and trimethoprim. Patients had a median age of 82 years, 72% were male, and a majority had underlying urological conditions. Thirty-six of the patients were diagnosed with a focus from the urinary tract. Thirty-one patients developed severe sepsis and nine patients died during the hospital stay. Our study is the largest of Actinotignum bacteremia and demonstrates that it is a condition with a significant fatality that affects elderly persons with underlying conditions. β-Lactams represent a rational treatment option.

     

Evaluating the risk of hyperkalaemia and acute kidney injury with cotrimoxazole: a retrospective observational study

ObjectivesIncreasing antimicrobial resistance has renewed interest in older, less used antimicrobials. Cotrimoxazole shows promise; however, hyperkalaemia and acute kidney injury (AKI) are potential complications. Identifying risk factors for and quantification of these events is required for safe use. This study aimed to evaluate predictors of cotrimoxazole-associated AKI and hyperkalaemia in a clinical setting.MethodsPatients prescribed cotrimoxazole were identified using electronic healthcare records over 3 years (1 April 2016 to 31 March 2019). Individual risk factors were recognized. Serum creatinine and potassium trends were analysed over the subsequent 21 days. AKI and patients with hyperkalaemia were classified using Kidney Disease Improving Global Outcomes (KDIGO) and laboratory criteria. Univariate and multiple logistic regression analyses were performed.ResultsAmong 214 patients prescribed cotrimoxazole, 42 (19.6%, 95% confidence interval (CI) 14.6–25.7) met AKI criteria and 33 (15.4%, 95% CI 11.0–21.1) developed hyperkalaemia. Low baseline estimated glomerular filtration rate (<60 mL/min/1.73 m², odds ratio (OR) 7.78, 95% CI 3.57–16.13, p < 0.0001) and cardiac disorders (OR 2.40, 95% CI 1.17–4.82, p 0.011) predicted AKI, while low baseline estimated glomerular filtration rate (<60 mL/min/1.73 m², OR 6.80, 95% CI 3.09–15.06, p < 0.0001) and higher baseline serum potassium (p 0.001) predicted hyperkalaemia. Low-dose cotrimoxazole (<1920 mg/d) was associated with lower AKI and hyperkalaemia risk (p 0.007 and 0.019 respectively). Early (within the first 2–4 days of therapy) serum creatinine changes predicted AKI (OR 3.65, 95% CI 1.73–7.41, p 0.001), and early serum potassium changes predicted hyperkalaemia (>0.6 mmol/L, OR 2.47, 95% CI 1.14–5.27, p 0.0236).ConclusionsCotrimoxazole-associated AKI and hyperkalaemia is frequent and dose dependent. Renal function, serum potassium and preexisting cardiac disorders should be evaluated before prescribing cotrimoxazole. Serum creatinine and potassium monitoring within first 2 to 4 days of treatment to identify susceptible patients is recommended, and the lowest effective dose ought to be prescribed.     

Cost of bacteraemia caused by methicillin-resistant vs. methicillin-susceptible Staphylococcus aureus in Spain: a retrospective cohort study

The aim of this study was to determine the impact on healthcare resource utilization and associated costs of bacteraemia due to methicillin-resistant Staphylococcus aureus (MRSA) vs. methicillin-susceptible S. aureus (MSSA) strains in Spain. An observational, retrospective, cohort multicentre study was conducted during 2005. The target population comprised Spanish patients with S. aureus bacteraemia (five and ten cases per hospital for resistant and susceptible strains, respectively). The resources used were obtained from the hospital patient records. The unit costs were obtained from the participating hospitals and from Spanish databases; the costs of a bacteraemic episode were estimated from resource utilization results and expressed in euros (€). Univariate sensitivity analyses were performed. The clinical records of 366 valid patients with S. aureus bacteraemia (121 MRSA and 245 MSSA) from 27 Spanish hospitals were reviewed. Resource use per bacteraemic episode was higher for MRSA cases than for MSSA cases, with longer antibiotic treatment (3.1 additional days) and greater length of hospital stay (LOS) (2.2 additional days), more diagnostic tests, and higher rates of admission to the intensive-care unit (ICU) (7.6%). As a consequence, a higher cost per episode was incurred, with an additional €1205 in episodes of MRSA infections (1.12-fold increase). The main drivers of the cost difference were the higher rates of ICU admission and hospital re-admission and increased LOS. The analysis confirmed that there were additional costs due to resistant strains, ranging from €293 to €5188. Overall, MRSA was associated with higher costs in bacteraemic patients, and this was attributable mainly to the greater rate of ICU admissions and increased LOS.     

Reduced referral and case fatality rates for severe symptomatic hyperlactataemia in a South African public sector antiretroviral programme: a retrospective observational study

Background  

Interventions to promote prevention and earlier diagnosis of severe symptomatic hyperlactataemia (SHL) were implemented in the Western Cape provincial antiretroviral programme (South Africa) from 2004. Interventions included clinician education, point-of-care lactate meters, switch from stavudine to zidovudine in high risk patients and stavudine dose reduction. This study assessed trends in referral rate, severity at presentation and case fatality rate for severe SHL.     

Compliance and adverse drug reactions: a prospective study with ethinylestradiol using continuous compliance monitoring

Summary This study examined the relationship between adverse reactions and patient compliance with ethinylestradiol at 40 g twice daily versus 20 g four times daily. In a randomized study 61 female patients with primary- infertility were prescribed the drug twice daily (n = 31) or four times daily (n = 30). Ethinylestradiol was administered for 7 days before the sperm cervical mucus penetration-test was performed for hormonal standardization of the cervical mucus quality. Drug compliance was measured by continuous monitoring using the Medication Event Monitoring System. Two parameters were evaluated: percentage of prescribed doses taken (administration compliance) and adherence to the prescribed dose schedule (regimen compliance, number of days with two or four dosing events recorded). Adverse drug reactions were assessed using a standardized questionnaire. Fourty-four women experienced side effects, of which 81% were rated by patients as being mild. Patient compliance was higher with the twice daily than with the four times daily regimen: 85% versus 65% prescribed doses taken (P<0.05). There was no significant difference in compliance comparing patients with and without adverse reactions (82% versus 72%, respectively), but compliance was lower and more irregular with at least 3 versus one or two adverse reactions reported: 54% versus 84% in administration compliance and 31% versus 58% in regimen compliance (P<0.05). Compliance was also lower in patients with nausea and vomiting than in those without these symptoms, 59% versus 91% and 34% versus 66% (P<0.005), respectively, and lower with moderate or severe compared to mild side effects; 48% versus 85% and 25% versus 59% (P<0.005). Thus the mere occurrence of side effects was not associated with low compliance. However, the number and nature of symptoms and their intensity as perceived by patients may have considerably influenced drug use behavior.Abbreviations ADR adverse drug reactions - SCMPT sperm cervical mucus penetration-test Prof. Dr. E. Weber died 7 December 1992     

Treatment duration for central line-associated infection caused by Enterococcus spp.: a retrospective evaluation of a multicenter cohort

European Journal of Clinical Microbiology & Infectious Diseases - Objective of this study was to assess the appropriate treatment duration for enterococcal central line-associated bloodstream...     

Disseminated microsporidiosis caused by Encephalitozoon cuniculi III (dog type) in an Italian AIDS patient: a retrospective study.

We report a case of disseminated microsporidiosis in an Italian woman with AIDS. This study was done retrospectively using formalin-fixed, paraffin-embedded tissue specimens obtained at autopsy. Microsporidia spores were found in the necrotic lesions of the liver, kidney, and adrenal gland and in ovary, brain, heart, spleen, lung, and lymph nodes. The infecting agent was identified as belonging to the genus Encephalitozoon based on transmission electron microscopy and indirect immunofluorescence. Additional molecular studies, including sequence of the rDNA internal transcribed spacer region, identified the agent as E. cuniculi, Genotype III. We believe that this is the first report of a human case of disseminated microsporidial infection involving the ovary.     

Natural supplements for H1N1 influenza: retrospective observational infodemiology study of information and search activity on the Internet

Background

As the incidence of H1N1 increases, the lay public may turn to the Internet for information about natural supplements for prevention and treatment.

Objective

Our objective was to identify and characterize websites that provide information about herbal and natural supplements with information about H1N1 and to examine trends in the public’s behavior in searching for information about supplement use in preventing or treating H1N1.

Methods

This was a retrospective observational infodemiology study of indexed websites and Internet search activity over the period January 1, 2009, through November 15, 2009. The setting is the Internet as indexed by Google with aggregated Internet user data. The main outcome measures were the frequency of “hits” or webpages containing terms relating to natural supplements co-occurring with H1N1/swine flu, terms relating to natural supplements co-occurring with H1N1/swine flu proportional to all terms relating to natural supplements, webpage rank, webpage entropy, and temporal trend in search activity.

Results

A large number of websites support information about supplements and H1N1. The supplement with the highest proportion of H1N1/swine flu information was a homeopathic remedy known as Oscillococcinum that has no known side effects; supplements with the next highest proportions have known side effects and interactions. Webpages with both supplement and H1N1/swine flu information were less likely to be medically curated or authoritative. Search activity for supplements was temporally related to H1N1/swine flu-related news reports and events.

Conclusions

The prevalence of nonauthoritative webpages with information about supplements in the context of H1N1/swine flu and the increasing number of searches for these pages suggest that the public is interested in alternatives to traditional prevention and treatment of H1N1. The quality of this information is often questionable and clinicians should be cognizant that patients may be at risk of adverse events associated with the use of supplements for H1N1.     

The impact of consent on observational research: a comparison of outcomes from consenters and non consenters to an observational study

Background  

Public health benefits from research often rely on the use of data from personal medical records. When neither patient consent nor anonymisation is possible, the case for accessing such records for research purposes depends on an assessment of the probabilities of public benefit and individual harm.