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The value of patient-reported adherence to antiretroviral therapy in predicting virologic and immunologic response. California Collaborative Treatment Group.

OBJECTIVE: To correlate self-reported antiretroviral adherence with virologic suppression. DESIGN: Prospective observational study of adherence to therapy nested in a randomized comparative trial of frequent versus infrequent monitoring of plasma HIV RNA. SETTING: Five university-affiliated HIV clinics. PATIENTS: A group of 173 HIV-infected patients with a mean baseline CD4 count of 142 x 10(6) cells/l (range 3-515) of whom 164 and 119 completed adherence questionnaires at 2 and 6 months, respectively. INTERVENTION: Individualized, unrestricted antiretroviral therapy. MEASUREMENTS: Patients were classified into four groups by adherence to therapy in the previous 4 weeks (< 80%, 80-95%, 95-99%, 100%). Plasma HIV RNA levels and CD4 lymphocyte counts were measured bimonthly. RESULTS: Recreational drug or alcohol use was associated with decreased adherence, whereas frequency of HIV RNA monitoring, demographic variables, (age, gender, education, and risk group) and stage of disease had no effect. Greater HIV suppression at 6 months was seen across four categories of increasing adherence (P = 0.009 for linear trend). Patients reporting < 80% adherence at 6 months had a 0.2 log10 copies/ml increase in HIV RNA and a loss of 19 x 10(6) CD4 cells/l compared with a 1.1 log10 copies/ml decrease in HIV RNA and an increase of 72 x 10(6) CD4 cells/l in those reporting 100% adherence (P = 0.02). CONCLUSION: Self-reported poor adherence (< 80%) and drug or alcohol use predicted non-response of HIV RNA at 6 months of antiretroviral therapy.

Adult↗

Improving adherence to a mechanical ventilation weaning protocol for critically ill adults: outcomes after an implementation program.

BACKGROUND: Despite multiple reminders, education sessions, and multidisciplinary team involvement, adherence to an evidence-based mechanical ventilation weaning protocol had been less than 1% in a general systems intensive care unit since implementation. OBJECTIVE: To assess the effectiveness of using an implementation program, the Model for Accelerating Improvement, to improve adherence and clinical outcomes after restarting a mechanical ventilation weaning protocol in an adult general systems intensive care unit. METHODS: A prospective comparative design, before and after implementation of the Model for Accelerating Improvement, was used with a consecutive sample of 129 patients and 112 multidisciplinary team members. Clinical outcomes were rate of unsuccessful extubations, rate of ventilator-associated pneumonia, and duration of mechanical ventilation; practice outcomes were staff's understanding of the mechanical ventilation weaning protocol, perceptions of the practice safety climate, and adherence to the weaning protocol. RESULTS: After the intervention, the rate of unsuccessful extubations decreased, and staff's understanding of and adherence to the weaning protocol increased significantly. The rate of ventilator-associated pneumonia, duration of mechanical ventilation, and staff's perceptions of the practice safety climate did not change significantly. CONCLUSION: Implementing the Model for Accelerating Improvement improved understanding of and adherence to protocol-directed weaning and reduced the rate of unsuccessful extubations.

Adolescent↗

Psychosocial impact of end-stage renal disease.

Renal dysfunction has a profound physical, psychological, social and sexual impact. The impact of end-stage renal disease can be interpreted in terms of crisis theory and interventions planned. Factors predicting non-adherence to therapy can be isolated and managed in order to promote adherence. The challenge of renal disease can be met by a collaborative multidisciplinary approach.

Body Image↗

Integrating non-drug treatments in early schizophrenia.

There is a range of psychological interventions for established schizophrenia. These include family interventions, motivational interventions for substance misuse and for non-adherence to medication, cognitive remediation for neurocognitive deficits and cognitive-behavioural therapy for symptoms. Psychological interventions may explicitly target risk factors for poor outcome, such as substance use, or protective factors, such as adherence to medication, or be directed at specific symptoms or deficits. There is emerging evidence for efficacy of psychological treatments during, following and even prior to the first episode. Important areas for further study are how different treatment modalities can interact productively, and patient and carer preferences for treatment. Many trials of psychological treatments have design flaws and this tends to overestimate the treatment effect.

Antipsychotic Agents↗

Intentional and unintentional nonadherence to antihypertensive medication.

BACKGROUND: Hypertension is poorly controlled in the US due to medication nonadherence. Recent evidence suggests that nonadherence can be classified as intentional or unintentional and different patient characteristics, such as the experience of adverse effects, may be associated with each. OBJECTIVE: To examine associations between patient characteristics, including reported adverse effects, and both intentional and unintentional nonadherence among 588 hypertensive patients. METHODS: Baseline data from a clinical trial, the Veterans' Study To Improve the Control of Hypertension, were examined. Intentional and unintentional nonadherence were assessed using a self-report measure. Participants were presented with a list of adverse effects commonly associated with antihypertensive medication and asked to indicate which symptoms they had experienced. Logistic regression analyses were used to examine adjusted associations between patient characteristics and type of nonadherence. RESULTS: Approximately 31% of patients reported unintentional nonadherence and 9% reported intentional nonadherence. Non-white participants, individuals without diabetes mellitus, and individuals reporting > or = 5 adverse effects were more likely to report intentional nonadherence than their counterparts. Individuals with less than a 10th-grade education and non-white participants were more likely to report unintentional nonadherence than their counterparts. When symptoms of increased urination and wheezing/shortness of breath were reported, patients were more likely to report intentional and unintentional nonadherence compared with those who were adherent. Unintentional nonadherence was also associated with reports of dizziness and rapid pulse. CONCLUSIONS: Both intentional and unintentional nonadherence are common and related to perceived adverse effects. Furthermore, different interventions may be necessary to improve adherence in unintentionally and intentionally nonadherent patients.

Aged↗

Meniett clinical trial: long-term follow-up.

OBJECTIVE: To delineate 2-year efficacy of Meniett device therapy in people with classic, unilateral, Ménière's disease unresponsive to traditional medical treatment. DESIGN: A 2-year long-term unblinded follow-up after a prior randomized, placebo-controlled, multicenter clinical trial of the Meniett device for Ménière's disease. SETTING: Follow-up was performed remotely by using diaries and questionnaires mailed to the data coordinating center by the participants. Those who failed to mail their diaries were interviewed by telephone. PARTICIPANTS: Sixty-one study participants agreed to use the Meniett device and report their symptoms for 2 years. All had active, unilateral cochleovestibular disease. Outcomes are available for 58 participants; 2 were unavailable for follow-up and 1 was excluded because of a concurrent condition that precluded Meniett device use. INTERVENTIONS: Participants were advised to adhere to a low-sodium diet, use the Meniett device 3 times daily, and maintain a patent tympanostomy tube in the affected ear. Diuretic and vestibular suppressant medications were used as needed. MAIN OUTCOME MEASURES: Outcomes were based on the participants' daily diary, questionnaires, and telephone interviews. Three different analyses were prepared: tracking of vertigo frequency throughout the study, comparison of vertigo frequency before and at the end of Meniett device use (American Academy of Otolaryngology-Head and Neck Surgery Foundation reporting guideline), and Kaplan-Meier estimates of vertigo remission and recurrence. RESULTS: Vertigo levels gradually improved for most but not all participants. American Academy of Otolaryngology-Head and Neck Surgery Foundation class A (remission) or class B (greatly improved) results occurred in 67% (39/58) of participants, and class F (dropped out to receive surgical therapy) results occurred in 24%. Of the 44 nondropout participants, 39 (89%) had American Academy of Otolaryngology-Head and Neck Surgery Foundation group A or B outcomes. People who went into remission were highly likely (80%) to remain in remission long term; participants who achieved remission (20/43; 47%) did so within the first year of follow-up. CONCLUSIONS: Use of the Meniett device was associated with a significant reduction in vertigo frequency in about two thirds of the participants, and this improvement was maintained long term. Therapy with the Meniett device is a safe and effective option for people with substantial vertigo uncontrolled by medical therapy.

Adult↗

The Role of Therapeutic Drug Monitoring in the Management of HIV-infected Patients.

The concept of targeting drug therapy based on plasma concentrations, also called therapeutic drug monitoring (TDM), has been used in the treatment of infectious diseases and other illnesses for decades. A number of clinical trials have demonstrated that drug concentrations are an important factor in response to therapy for HIV, but whether TDM will become a tool for the routine management of HIV infection remains to be determined. The concept of the inhibitory quotient, which integrates drug concentrations and resistance testing, also shows promise in a number of retrospective analyses. Logistical problems still remain with regard to its feasibility, and theoretical issues such as protein binding, variability, and the appropriate time of sampling continue to be debated. A growing body of literature supports the concept of TDM in HIV, but it is important that it be used with other interventions such as resistance testing, adherence monitoring, and patient counseling to be an effective tool in patient management.

Journal Article↗

Nosocomial infections in neurocritical care.

Development of nosocomial infections is a commonly encountered problem for critically ill patients. Approximately half of all nosocomial pneumonias in the neurointensive care unit (NICU) are associated with ventilator-associated pneumonia. Prompt diagnosis with appropriate specimen analysis is required in order to prevent increased morbidity. Catheter-related blood stream infection imposes financial as well as medical implications. Multifaceted interventions are helpful to ensure adherence with evidence-based infection control guidelines. Urosepsis occurs in approximately 16% of patients. Colonized patients without evidence of infection do not require treatment, but the indwelling catheter should be changed. NICU patients have increased risk of developing cerebrospinal fluid infection due to frequent placement of external ventricular drains. The incidence of ventriculostomy-related meningitis or ventriculitis is approximately 8%. It is unclear whether the duration of ventricular catheter has any relationship with the risk of infection. Patients often receive multiple antibiotics, leading to an increased risk of developing Clostridium difficile colitis, which needs prompt diagnosis and appropriate antimicrobial therapy.

Anti-Bacterial Agents↗

An update on the role of psychotherapy in the management of bipolar disorder.

Recent studies have examined the value of combining structured forms of psychotherapy with medication maintenance for patients with bipolar disorder. These studies have been influenced by the growing body of literature on stress in the elicitation of manic and depressive episodes. Randomized trials published within the past 5 years indicate positive benefits of cognitive-behavioral therapy, interpersonal and social rhythm therapy, family-focused therapy, and group psychoeducation as adjuncts to mood stabilizers in delaying recurrences, stabilizing symptoms, and improving medication adherence. Open trials of family interventions for pediatric-onset bipolar patients also have yielded promising results. Questions remain about the relative advantages of one psychosocial approach over the others, whether there are subgroups of patients who respond to each type of intervention, the impact of psychotherapy on role functioning, mediators of treatment effects, and the potential utility of early intervention as a means of delaying the onset and/or severity of the disorder.

Antimanic Agents↗

Comparison of hemostatic efficacy for epinephrine injection alone and injection combined with hemoclip therapy in treating high-risk bleeding ulcers.

BACKGROUND: Rebleeding occurs in 10% to 30% of bleeding ulcer patients receiving endoscopic epinephrine injection therapy. It remains unclear whether addition of a secondary clip therapy following epinephrine injection may reduce the rebleeding rate of high-risk bleeding ulcers. OBJECTIVE: To compare the efficacies of epinephrine injection alone and epinephrine injection combined with hemoclip therapy in treating high-risk bleeding ulcers. DESIGN: Prospective randomized controlled trial. SETTING: A medical center in Taiwan. PATIENTS: One hundred five bleeding ulcer patients with active spurting, oozing, nonbleeding visible vessels or adherent clots in ulcer bases. INTERVENTIONS: Endoscopic combination therapy (n = 52) or diluted epinephrine injection alone (n = 53). MAIN OUTCOME MEASUREMENTS: Initial hemostasis rates and recurrent bleeding rates. RESULTS: Initial hemostasis was achieved in 51 patients treated with combination therapy and 49 patients with epinephrine injection therapy (98% vs 92%, P = .18). Bleeding recurred in 2 patients in the combination therapy group and 11 patients in the epinephrine injection group (3.8% vs 21%, P = .008). Among the patients with rebleeding, repeated combination therapy was more effective than repeated injection therapy in achieving permanent hemostasis (100% vs 33%, P = .02). No patient required an emergency operation in the combination therapy group. However, 5 patients in the epinephrine injection group underwent emergency surgery to arrest bleeding (0% vs 9%, P = .023). LIMITATIONS: Treatment outcome of endoscopic hemoclip therapy is related to the techniques of endoscopists. CONCLUSION: Endoscopic combination therapy is superior to epinephrine injection alone in the treatment of high-risk bleeding ulcers.

Aged↗

Adherence to treatment of depression in active injection drug users: the minerva study.

The impact of depression on drug users is extensive, serving as a trigger for high-risk injection practices and continued drug use. Yet the ability to retain active drug users in mental health treatment has never been tested clinically. We recruited injection drug users (IDU) for a randomized study of combined psychotherapy and pharmacotherapy for the treatment of depression. Among the 53 SCID-diagnosed depressed subjects assigned to the combined treatment group, 43.4% were "fully adherent" to treatment (75% or greater attendance at cognitive-behavioral therapy (CBT) sessions or 75% or greater adherence to the pharmacotherapy regimen). The correlation of CBT attendance and pharmacotherapy use was high (r(s) =.74). Persons with double depression (major depression plus dysthymia) were most likely to be fully adherent (p =.01); frequency of heroin use was inversely associated with adherence. Developing public health treatment interventions to engage out-of-treatment, dually-diagnosed IDUs is possible.

Adolescent↗

Using a collaborative approach to reduce postoperative complications for hip-fracture patients: a three-year follow-up.

BACKGROUND: To reduce perioperative complications for hip fracture, (1) patients were assigned admitting service using a simple clinical algorithm, (2) evidence-based guidelines and order sets were implemented for perioperative care; (3) a nurse specialist facilitated adherence to evidence-based interventions and mobility goals; and (4) patients and families were given an educational brochure highlighting the daily hospital course. METHODS: A case series with pre/post intervention comparison was conducted for all patients with hip fracture (preintervention n = 97, postintervention n = 589) at 9 months before and 33 months after the intervention. RESULTS: The algorithm assigned approximately one-third of patients to each of the three general services, with few to subspecialty services. Miscellaneous complications were almost eliminated, and significant reductions were observed in the proportion of patients with iatrogenic complications and postprocedure hemorrhage and hematoma. The percentage of patients with any postoperative complication fell from almost 60% to less than 10% by the end of the study. CONCLUSIONS: This study provides preliminary data from which to investigate the effectiveness of collaborative approaches to management on the outcomes of care for medically complex and geriatric surgical patients.

Cooperative Behavior↗

Hope, attitudes, emotions, and expectations in healthcare providers of services to patients infected with HIV.

The results of this preliminary study of 94 healthcare providers show that they had high hope levels when working with patients infected with HIV. The providers named imparting hope during the counseling process as the most important intervention for increasing patients' treatment adherence. Although half of the respondents had uncertain expectations for the future of their patients, more than one third had hopeful expectations, with only a small minority having hopeless expectations. An overwhelming majority reported they did not have negative attitudes toward or uncomfortable feelings when working with patients who were infected with HIV, regardless of method of acquiring HIV, gender, or sexual orientation. Moreover, respondents seemed to have a balanced emotional state, with the majority reporting that they experienced more positive emotions than negative emotions when working with their patients over time. Implications for healthcare providers are discussed.

Adult↗

The potential impact on melanoma mortality of reducing rates of suboptimal excision margins.

We estimated the potential benefit of reducing rates of inadequate excision margins in the treatment of localized invasive melanoma. A computer-simulated Markov decision analytic model was created to follow until death a hypothetical cohort of 55 y old Caucasians, newly diagnosed in a community setting with localized invasive melanoma. We considered two scenarios: usual care, and a hypothetical intervention. Markov states included well without local recurrence, local recurrence, cured, and dead. Published population-based data were used for rates of optimal excision margins, local recurrence, and mortality. Two outcome measures were employed: melanoma-related mortality and life expectancy. Major assumptions included: local recurrence occurs within 10 y of diagnosis, and patients revert to general population mortality rates 10 y following melanoma excision or subsequent local recurrence. For usual care, the model estimated 8.17% melanoma-related mortality. Modeling intervention with 100% optimal excision margins reduced this rate to 6.15%, a 25% relative reduction in mortality. This increased average life expectancy by 0.437 y, which equates to approximately 11 additional years in the 4% who would not experience a local recurrence due to improved excision margins. Increasing the percentage of optimal excision margins to 80% would still yield substantial improvement, with 6.83% melanoma-related mortality, saving 0.29 life-years compared with baseline. Results were insensitive to moderate changes in the parameter values. Suboptimal excision margins may account for approximately one-fourth of all melanoma-related mortality for localized invasive melanoma. If intervention can achieve even modest adherence to optimal excision margins, it might substantially reduce mortality.

Cohort Studies↗

Retethering of sectioned fibrolipomatous filum terminales: report of two cases.

OBJECTIVE AND IMPORTANCE: The release of a tethered spinal cord by sectioning a thickened filum terminale is a straightforward surgical procedure that can prevent, arrest, or ameliorate neurological deficits. We recently recognized progressive neurological deterioration caused by filum retethering in two patients years after this procedure was performed. This sequela of a recurrent tethered cord after the sectioning of a filum terminale has not previously been described. CLINICAL PRESENTATION: Two female patients, each 13 years of age at presentation, had been previously operated on for tethered spinal cords secondary to fibrolipomatous (fatty) fila terminale. Both presented with bladder dysfunction and one with progressive paraparesis. Magnetic resonance images revealed a low-lying conus medullaris and a sectioned filum with the proximal stump adherent to the posterior dura. INTERVENTION: Each patient underwent neurosurgical exploration of the previous site of sectioning, with the recognition of a retethered proximal stump of the filum terminale. After rerelease of the fatty filum, the patient with only bladder dysfunction stabilized and a motor examination revealed normal results for the patient with progressive paraparesis. CONCLUSION: Retethering of the spinal cord is a rare sequela after the sectioning of a tight filum terminale. The clinical presentation is typical for recurrent cord tethering, and the radiographic findings are subtle. Careful surgical exploration should be offered for spinal cord untethering. Awareness of this rare and hitherto undescribed sequela is necessary for appropriate long-term management of tethered spinal cord caused by a fatty filum terminale.

Adolescent↗

Indinavir plasma concentration and adherence score are codeterminant of early virologic response in HIV-infected patients of the APROCO cohort.

To study the respective roles of indinavir concentrations and treatment adherence as predictors of early virologic response, we analyzed the patients of the APROCO cohort treated by indinavir 800 mg TID during the first 4 months. Minimum (Cmin), maximum (Cmax), and the ratio of the measured to expected concentrations (CR) were estimated for each patient at M4, from a population pharmacokinetic analysis of all data. The relationship among virologic success at M4 [plasma HIV RNA (VL) <500 copies/mL], baseline characteristics, estimated indinavir concentrations, and adherence score measured by a self-administered questionnaire, was analyzed by multivariate logistic regression. In the 216 studied patients, baseline median HIV RNA was 4.4 log10 copies/mL, and CD4 cell count was 309/mm. Virologic success was achieved in 195 (90%) patients; it was independently related to baseline viral load (OR = 0.524, CI 0.29-0.93; P = 0.03), antiretroviral treatment naive status (OR = 3.89, CI 1.29-11.76; P = 0.01), and indinavir Cmin (OR = 1.06, CI 1.02-1.10; P = 0.004) when adherence score was not included in the model, whereas full adherence was the only independent related factor when included in the model (OR = 8.8, 95% CI 2.85-27.3; P < 10). In the 168 fully adherent patients, virologic success was more frequent in patients with shorter duration of antiretrovirals at baseline (P = 0.03), lower baseline HIV RNA (P = 0.03), and higher indinavir CR (P < 10); the most discriminating Cmin cut-off was 194 ng/mL. Data on the relationship between indinavir plasma concentration and virologic success are therefore misleading without a concomitant assessment of adherence. These data suggest that any strategy of therapeutic drug monitoring must imply first a combined evaluation of plasma concentrations and adherence level and second an intervention target based on the results of both assessments.

Adult↗

Adherence to treatment in Swedish HIV-infected patients.

OBJECTIVES: The objectives were to assess the prevalence of adherence to antiretroviral treatment in Swedish human immunodeficiency virus (HIV)-infected patients and to evaluate factors associated with adherence. METHODS: All HIV-treated patients, who attended one of 30 (of a total of 32) Swedish infectious diseases clinics, during 7 months, were asked to complete an anonymous questionnaire containing the 9-item Morisky Medication Adherence Scale (MMAS) and questions about other factors potentially affecting adherence. The summary score of MMAS ranges from 1 to 13, where 13 indicates perfect adherence; patients scoring 11 or above (corresponding to 95% adherence level) were classified as 'adherent'. RESULTS AND DISCUSSION: In total 946 patients participated (response rate 97.5%). The proportion of patients who reported not missing a dose during the day prior to the completion of the questionnaire was 97% and the proportion classified as 'adherent' was 63%. 'Adherent' patients were more likely to have a good relationship with their health care professionals (P < 0.05) and not have problems with drugs or alcohol (P < 0.01). Being older (P < 0.01) and having a shorter time on current treatment (P < 0.01) and on treatment in total (P < 0.05) were factors also associated with good adherence. CONCLUSION: Factors modifiable for interventions by health care professionals are patient-provider relationship, drug or alcohol problems and patients with long treatment periods.

Adult↗

Treating first episode psychosis--the service users' perspective: a focus group evaluation.

UK national guidance has prioritized developing specialist services for first episode psychosis. Such services are in the early stages of development and a definitive treatment model has yet to be established. The aim of this study was to explore service users' experiences of a first episode intervention designed along evidence-based 'best practice' guidelines and to establish specific elements seen as effective to help inform future service planning and provision. Twelve users of a specialist first episode service participated in focus groups. These were then analyzed using Interpretative Phenomenological Analysis, a specialized form of content analysis. Key elements identified by the service users included the 'human' approach as a key to the recovery process, being involved in treatment decisions, flexibility of appointments, high nurse to patient ratio, reduction in psychotic symptoms, increased confidence and independence and the provision of daily structure. To our knowledge, this is the first systematic qualitative evaluation of users' experience of a specialist first episode treatment intervention. Our findings indicate that adherence to best practice guidelines was appreciated. Regular focus groups provide a continuous audit cycle incorporating service improvements in line with government recommendations, centrally informed by the service users' and caregivers' perspective.

Adult↗