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Reliability and validity of the self-efficacy and outcome expectations for osteoporosis medication adherence scales.

PURPOSE: The purpose of this study was to test the reliability and validity of the self-efficacy and outcome expectations for osteoporosis medication adherence measures (SEOMA and OEOMA). DESIGN: This was a descriptive study involving a single face-to-face interview. SAMPLE: The study included 152 older adults with a mean age of 85.7 (+) 5.5 years, the majority of whom were Caucasian (99%), female (74%), and unmarried (75%). METHODS: In addition to the SEOMA and OEOMA measures, demographic information (age, gender, and marital status) and other health behaviors (exercise and osteoporosis medication use) were explored. RESULTS: There was evidence of reliability of the SEOMA and OEOMA based on internal consistency and R values. Evidence of the validity of the SEOMA and OEOMA measures was based on confirmatory factor analysis and hypothesis testing. CONCLUSION: This study is an important first step to developing reliable and valid measures of self-efficacy and outcome expectations for adherence to osteoporosis medications. IMPLICATIONS FOR NURSING PRACTICE: The SEOMA and OEOMA can be used to evaluate self-efficacy and outcome expectancy beliefs related to osteoporosis medication use in older adults and interventions developed to strengthen those beliefs and improve medication adherence.

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Randomized controlled trials of socially complex nursing interventions: creating bias and unreliability?

BACKGROUND: The randomized controlled trial is viewed by many researchers as the 'gold standard' research design. It is used increasingly to evaluate the effectiveness of socially complex activities such as nursing interventions. This use is seen by many commentators as problematic, while others are concerned about the quality of many published trial reports. One area of concern is that of intervention bias: the impact that a sentient intervention, such as a nursing one, may have consciously or unconsciously on study outcomes. This paper reports on an analysis of intervention definitions and possible intervention bias in 47 reports of randomized controlled trials of nursing interventions published in 2000 or 2001. AIMS: This study evaluates four characteristics of the included reports: intervention sample size, intervention definition, involvement of intervention nurses in other aspects of the trial, and the claimed generalizability of results. METHODS: Reports of randomized controlled trials published in 2000 or 2001 were identified. Full-text versions of 47 papers were obtained and information about the four characteristics was extracted and analysed. RESULTS: Problems relating to possible intervention bias were identified in each of the papers. Inadequate intervention definition was the commonest problem, leading to difficulties in calculating the 'intervention dose' and in replicating or generalizing from the studies. DISCUSSION: None of the included studies met the requirements of the Consolidated Standards of Reporting Trials. Four types of intervention bias were identified, and their possible implications for the reporting of trials of nursing interventions are discussed. This was a small-scale study, limited by time and resources. Its results are suggestive of a major problem of intervention bias but larger-scale investigations are necessary to quantify its extent. CONCLUSIONS: Intervention bias is potentially a problem in randomized controlled trials. Lack of detail about interventions in published papers could be corrected by stricter adherence to guidelines such as the Consolidated Standards of Reporting Trials, but this will not correct the underlying problem of inadequate study design that appears to be widespread in randomized controlled trials of nursing interventions.

Bias↗

Effects of future writing and optimism on health behaviors in HIV-infected women.

Optimists (people who have positive expectations about the future) have been shown to perform more health-promoting behaviors than pessimists. This study attempts to alter individuals' levels of optimism, and thereby their health behaviors, by having them write about a positive future. HIV-infected women (N = 40) on combination therapies were randomly assigned to write about a positive future or assigned to a no-writing control group. Among participants who were low in optimism, the writing intervention led to increased optimism, a trend toward increased self-reported adherence to medications, and decreased distress from medication side effects, compared to controls who did not write. Participants who were high in optimism showed the opposite effects after writing about the future. Results suggest that a future-oriented writing intervention may be apromising technique to increase medication adherence and decrease symptom distress in pessimistic individuals.

Adolescent↗

The role of patient participation in the doctor visit. Implications for adherence to diabetes care.

For patients, treatment of diabetes involves complex changes in basic behaviors and adherence to complicated regimens. Understanding the factors that enable patients to adhere to diabetes treatment is the first step to designing effective interventions. Researchers of diabetes care have postulated that increasing diabetic patients' participation in medical decision making during the doctor visit is likely to improve their adherence to self-care. However, a critical review of the impact of patient participation on diabetic patients adherence to self-care is absent from the literature. We review the subject of patient participation in medical decision making and its effect on adherence to self-care for patients with diabetes. We introduce a model of the determinants of adherence to diabetes self-care that incorporates the effects of patient participation in medical decision making. In this model, we suggest three ways that patient participation can affect adherence to self-care: 1) it may have a direct effect; 2) it may affect adherence to self-care indirectly by affecting patients' understanding of their treatment regimen or the fit of their regimen with their lifestyle; and 3) perceived omissions of participation can affect adherence to self-care indirectly through an effect on patient satisfaction. Research is needed to identify more clearly which components of patient participation affect adherence to self-care and in what ways. Distinguishing patient and physician behaviors that contribute to the process of patient participation would provide a means to develop specific behavioral interventions.

Decision Making↗

A personalized snack-based intervention for hip fracture patients: development, feasibility and acceptability.

INTRODUCTION: Undernutrition is common in older people admitted to hospital with hip fracture. Oral supplementation with sip feeds may be provided but compliance is a major problem. OBJECTIVE: To develop a personalized snack-based intervention for practical implementation in hip fracture patients and to assess feasibility, adherence, acceptability and cost. PARTICIPANTS AND METHODS: Twenty-three older hip fracture patients with a mean age (SD) 84.1 (6.3) were provided with three between-meal snacks daily for 4 weeks following surgery. Dietary counselling, assessment of acceptability and feasibility were undertaken and costs of intervention calculated. RESULTS: Sixteen of the 23 participants recruited completed the study. Mean estimated energy derived from the snacks provided 26% of daily energy requirements. Monitoring adherence proved problematic and stocktakes highlighted discrepancies. Although several participants reported that they did not usually eat between meals, overall the intervention was acceptable to participants. The cost of implementation was 21.29 UK pounds per participant per week. CONCLUSIONS: Although it proved feasible, practical difficulties were encountered with implementation and adherence due to timing. A more appropriate time to deliver such an intervention may be after the acute phase is over and patients are back home. The costs compared favourably with the alternative of providing sip feeds.

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Challenges and innovations in enhancing adherence.

Adherence is a complex phenomenon involving interactions among the individual, the environment and the community. In an adherence workshop, a small group of investigators discussed their experiences with challenges and innovations regarding adherence gleaned from clinical research. This article summarizes the information and outcomes of that meeting. Guided by theoretical frameworks for understanding and promoting adherence, challenges in the areas of measurement, community-based research, and interventions were explored and innovations for meeting these challenges suggested. The article concludes with recommendations for enhancing the adherence agenda: (1) adherence research must have a well-defined conceptual and theoretical basis; (2) individual perceptions and social context of behavior must be incorporated; (3) research must be undertaken as a collaborative process involving participants and the community. Looking ahead, it is clear that if we hope to develop a new and integrated model of adherence, we must continue to advance theory through theory testing, with particular attention given to mediators and diverse samples. Moreover, an interdisciplinary agenda is necessary to set the stage for bringing together researchers from various disciplines and backgrounds with both participants and community representatives.

Clinical Trials as Topic↗

Alcoholism treatment adherence: older age predicts better adherence and drinking outcomes.

OBJECTIVE: Adherence to treatment has been demonstrated to be an important factor for remission from alcohol dependence. The authors compared therapy and medication adherence for treatment of alcohol dependence in older adults with adherence in younger adults. METHODS: All subjects were participants in a randomized, double-blind, placebo-controlled efficacy trial of naltrexone for the treatment of alcohol dependence. All subjects received a medically-based psychosocial intervention focused on motivating patients to change and on adherence to treatment. The therapy is nonconfrontational and is delivered by a nurse-practitioner. RESULTS: Compared with younger adults, older adults had greater attendance at therapy sessions and greater adherence to the medication. Age-group was the only pretreatment factor associated with adherence. The greater adherence in older adults translated to less relapse than in younger adults. CONCLUSION: Treatment for alcohol dependence can be effective for older adults. Older adults appear to respond well to a medically-oriented program that is supportive and individualized. In fact, findings from this study suggest that older adults can be treated in mixed-age treatment settings when psychotherapeutic strategies are used that are age-appropriate and delivered on an individual basis.

Adult↗

Enhancing compliance with screening mammography recommendations: a clinical trial in a primary care office.

BACKGROUND AND OBJECTIVES: Despite consensus that screening mammography is an appropriate preventive tool, many women do not receive this examination. This study was undertaken to evaluate the relative efficacy and cost-effectiveness of three interventions designed to increase mammography rates. METHODS: A total of 151 women, aged 50-59, were randomized into four groups: control, physician telephone call, medical assistant telephone call, and physician letter. RESULTS: The women in the medical assistant telephone call group (16 of 37 = 43%) and the physician telephone call group (11 of 38 = 29%) responded significantly better than those in the control group (4 of 38 = 11%) (P < .05). None of the 10 widows in the entire study obtained a mammogram, compared with 38 of 141 (27%) women in all other marital groups (P < .05). The cost per intervention and cost per mammogram obtained were, respectively, physician telephone call: $15, $51.82; physician letter: $2.50, $13.57; medical assistant call: $1.30, $3. CONCLUSIONS: Medical assistant telephone callers are a cost-effective strategy to encourage mammography adherence. Widows appear particularly resistant to all screening mammography interventions.

Appointments and Schedules↗

Sex differences in obese children and siblings in family-based obesity treatment.

OBJECTIVE: The primary goal was to evaluate sex differences in child weight control programs that targeted increasing physical activity (increase) or the combination of reducing sedentary behavior and increasing physical activity (combined). A second goal was to evaluate the benefits of family-based interventions on nontargeted siblings. RESEARCH METHODS AND PROCEDURES: Sixty-seven families with obese children and 89 siblings were randomized to interventions that targeted increasing physical activity (increase) or the combination of reducing sedentary behavior and increasing physical activity (combined). Targeted participants and nontargeted siblings were followed for 1 year. RESULTS: At 12 months, boys showed significantly better percentages of overweight changes (-15.8%) for the combined treatment than girls (-1.0%), with no significant differences for the increase intervention for boys (-9.3%) or girls (-7.6%). Boys adhered to treatment better than girls (p < 0.01). Adherence and predilection for physical activity were significant predictors of targeted child weight loss at 1 year in multiple regression analysis. Predictors of sibling weight loss included age, number of siblings, targeted child percentage of overweight change, and the interaction of group assignment by same sex of treated sibling. DISCUSSION: Gender may influence response to programs that attempt to decrease sedentary behavior, and generalization of treatment effects to siblings may depend on the intervention and characteristics of the siblings.

Adolescent↗

The impact of pharmacogenetic-informed care on medication adherence and psychological factors associated with adherence: A narrative review.

Improvement in medication adherence is often proposed as a potential advantage of pharmacogenetic-guided prescribing over a traditional one-size-fits-all approach. This paper provides a review of the published literature and presents the findings of studies that measure adherence to medication as an outcome of pharmacogenetic-informed care, or that measure the impact of pharmacogenetic-informed care on psychological factors that are associated with medication adherence. Adherence-related psychological factors are mapped to the Theoretical Domains Framework (TDF) to provide insight into how participants interact with pharmacogenetic-informed care as an intervention and to consider this in the context of medication adherence. A total of 23 studies were included, with 10 quantitative studies measuring medication adherence outcomes associated with pharmacogenetic-informed care. Five of these studies found a statistically significant improvement in adherence in the pharmacogenetic-tested group, two reported a small but non-significant trend, and three showed no difference. Additionally, 13 studies examined the impact of pharmacogenetic-informed care on psychological factors related to adherence. These factors were mapped to 10 TDF domains: knowledge (8 studies); social/professional role and identity (1); beliefs about capabilities (2); optimism (4); beliefs about consequences (10); intentions (5); goals (1); memory, attention and decision processes (7); social influences (4); and emotion (8). The findings suggest that although the evidence for pharmacogenetic-informed care improving medication adherence is mixed and limited, pharmacogenetic-informed care appears to positively influence psychological factors that may support adherence. These include improving knowledge, supporting decision-making and generally being perceived as a positive experience by patients.

adherence↗

Group cohesion in older adult exercisers: prediction and intervention effects.

Two studies were conducted to examine the relationship between class cohesion and exercise adherence in older adult exercisers. Study 1 examined the predictive ability of four dimensions of cohesion on exercise participation at 1, 6, and 12 months following the initial assessment of cohesion. Study 2 examined the effectiveness of a team-building intervention, designed to enhance class cohesion (and based on Study 1 results), on improving exercise adherence and return rates. Participants were assigned to a team-building, placebo, or control condition. Study 1 showed that three measures of cohesion, Individual attractions to the group-social, Group integration-social, and Group integration-task, were all significantly related to exercise class attendance following a 1-month interval. Group integration-task was significantly related to class attendance following a 6- and a 12-month interval. Study 2 showed that participants in the team-building condition (a) attended more classes than the control and placebo conditions and (b) had a higher return rate following a 10-week hiatus than the control condition. It was concluded that (a) class cohesion plays a significant role in exercise class participation, both short- and long-term, and (b) samples of older adult exercisers are appropriate groups for interventions based on developing class cohesion.

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Hip protectors in aged-care facilities: a randomized trial of use by individual higher-risk residents.

OBJECTIVES: To investigate the effect of use of external hip protectors on occurrence of hip fracture. DESIGN: Randomized controlled trial, with randomization at the individual level. SETTING: residential aged-care facilities in urban areas of New South Wales, Australia. PARTICIPANTS: 174 women, aged 75 years and older, who had had two or more falls or one fall requiring hospital admission in the previous 3 months, and who lived in hostels or nursing homes. Eighty-six subjects were in the intervention group and 88 in the control group. INTERVENTION: Use of external hip protectors and encouragement by nurses to use the protectors. MEASUREMENTS: Follow-up visits at approximately 2 weeks and 2, 10 and 18 months to determine falls and fall injury (including hip fracture); we also measured adherence to hip protector use. RESULTS: The mean age of participants was 85; they lived in 32 different aged-care facilities, two-thirds of which were nursing homes. Intervention and control groups had similar baseline characteristics, with a mean Barthel index of 58 at enrollment and a mean Short Portable Mental Status Questionnaire score of six errors, indicating severe disability and major cognitive impairment. During follow-up, a mean of 4.6 falls per person occurred. There was no difference in mortality, with 28 deaths in each group. Eight hip fractures occurred in the intervention group and seven in the control group (hazard ratio 1.46; 95% confidence interval 0.53-4.51). No hip fractures occurred when hip protectors were being worn as directed. Adherence was about 57% over the duration of the study and hip protectors were worn at the time of 54% of falls in the intervention group. Adherence varied markedly between institutions, but the greatest was about 80%. CONCLUSION: Hip protectors were not effective in reducing the incidence of hip fractures in this study, but because of low statistical power, a reduction in risk of hip fracture of up to 50% may not have been detected. There was limited adherence with their use, resulting in a large number of falls occurring without hip protectors in place. All hip fractures in the intervention group occurred when hip protectors were not being used.

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A case study in dissemination: lessons learned from a pilot study involving the National Cancer Institute's Cancer Information Service.

The Cancer Information Service Research Consortium (CISRC) was funded by the National Cancer Institute to disseminate as a pilot study a longitudinally tailored print intervention to promote the 5 A Day for Better Health program among callers to the National Cancer Institute's Cancer Information Service (CIS). Using a one-group (intervention-only) study design, 1,022 eligible CIS callers were enrolled to receive the intervention consisting of four mailings of tailored print materials over a 3-month period. Program evaluation focused on process and implementation evaluation, including adherence to the baseline interviews by CIS information specialists based on live-call monitoring (n = 55 eligible callers), and the timeliness of the intervention mailouts (4,088 scheduled mailouts). Adherence to the baseline interviews by CIS information specialists was extremely high, exceeding 90% for all indicators of quality control. Of the 4,088 intervention mailings, 75% occurred on or before the target date, while 95% occurred within 21 days of the target date. All delays in the scheduled mailouts occurred in the first mailing, due to changes made in the production process (batch printing of all tailored print materials at baseline). This change required additional system upgrades and more intensive and time-consuming quality control than originally anticipated, which was exacerbated by the faster-than-expected accrual of eligible participants. Based on this pilot study, the CIS is now positioned for widespread dissemination of the 5 A Day tailored print intervention. Several key lessons learned are also identified to facilitate the transition from research to dissemination.

Evaluation Studies as Topic↗

Retention, adherence and compliance: important considerations for home- and group-based resistance training programs for older adults.

Reports on the efficacy of physical activity intervention trials usually only include discussion of the primary outcomes. However, assessing factors such as participant retention, adherence and compliance can assist in the accurate interpretation of the overall impact of a program in terms of reach and appeal. A quasi-randomised trial was carried out to assess and compare retention and adherence rates, and compliance with, a twice weekly resistance training program provided either individually at home or in a group format. Retirement villages (n=6) were assigned to either 'Have A Try' (HAT, home-based) or 'Come Have A Try' (CHAT, group-based); both programs included nine strength and two balance exercises. The program involved a 20-week Intervention Phase a 24-week Maintenance Phase and a 20-week On-going Maintenance Phase. One hundred and nineteen participants (mean age 80+/-6 years) were recruited (HAT=38, CHAT=81). There was no difference in retention rates at the end of the Intervention Phase, but significantly more HAT than CHAT participants had dropped out of the study (p<0.01) after the Maintenance Phase and the On-going Maintenance Phase. During the Intervention Phase, over half the HAT and CHAT participants completed > or =75% of the prescribed activity sessions, but adherence was significantly greater in CHAT than HAT during the Maintenance Phase (p<0.01). Participants in CHAT were significantly more compliant than HAT participants (p<0.05). Both home- and group-based formats were successful over the short-term, but, in retirement villages, the group program had better adherence and compliance in the longer-term.

Adult↗

Thrombolytic therapy for adhesion of percutaneous central venous catheters to vein intima associated with Malassezia furfur Infection.

OBJECTIVE: To report our experience with thrombolytic agents in the management of two infants with silicone central venous catheters that had adhered to the vein wall as a result of infection with Malassezia furfur. STUDY DESIGN: Case review of two very low birth weight infants with adherent central venous catheters. RESULTS: Treatment with urokinase and tissue plasminogen activator facilitated the removal of these catheters without breakage or surgical intervention. CONCLUSIONS: Thrombolytic agents should be considered as a treatment of adhered catheters, as well as of occluded catheters.

Catheters, Indwelling↗

Sodium reduction for hypertension prevention in overweight adults: further results from the Trials of Hypertension Prevention Phase II.

Sodium reduction is efficacious for primary prevention of hypertension, but the feasibility of achieving this effect is unclear. The objective of the paper is detailed analyses of adherence to and effects of the sodium reduction intervention among overweight adults in the Trials of Hypertension Prevention, Phase II. Sodium reduction (comprehensive education and counselling about how to reduce sodium intake) was tested vs no dietary intervention (usual care) for 36-48 months. A total of 956 white and 203 black adults, ages 30-54 years, with diastolic blood pressure 83-89 mmHg, systolic blood pressure (SBP) <140 mmHg, and body weight 110-165% of gender-specific standard weight were included in the study. At 36 months, urinary sodium excretion was 40.4 mmol/24 h (24.4%) lower in sodium reduction compared to usual care participants (P<0.0001), but only 21% of sodium reduction participants achieved the targeted level of sodium excretion below 80 mmol/24 h. Adherence was positively related to attendance at face-to-face contacts. Net decreases in SBP at 6, 18, and 36 months of 2.9 (P<0.001), 2.0 (P<0.001), and 1.3 (P=0.02) mmHg in sodium reduction vs usual care were associated with an overall 18% lower incidence of hypertension (P=0.048); were relatively unchanged by adjustment for ethnicity, gender, age, and baseline blood pressure, BMI, and sodium excretion; and were observed in both black and white men and women. From these beneficial but modest results with highly motivated and extensively counselled individuals, sodium reduction sufficient to favourably influence the population blood pressure distribution will be difficult to achieve without food supply changes.

Adult↗

Caring for poorly controlled diabetes mellitus: a randomized pharmacist intervention.

BACKGROUND: There is limited information from randomized controlled studies about the influence of pharmacist interventions on diabetes control. OBJECTIVE: To evaluate the effect of a pharmacist intervention on improving diabetes control; secondary endpoints were medication appropriateness and self-reported adherence. METHODS: A randomized, controlled, multi-clinic trial was conducted in the University of Washington Medicine Neighborhood Clinics. Seventy-seven subjects, > or =18 years old with a hemoglobin (Hb) A(1c) > or =9% at baseline and taking at least one oral diabetes medication, were randomized to receive a pharmacist intervention (n = 43) or usual care (n = 34) for 6 months followed by a 6-month usual-care observation period for both groups. Subjects met with a clinical pharmacist to establish and initiate a diabetes care plan followed by weekly visits or telephone calls to facilitate diabetes management and adherence. HbA(1c), medication appropriateness, and self-reported adherence were assessed at baseline, 6 months, and 12 months. RESULTS: The mean HbA(1c) did not differ between groups over the 12-month period (p = 0.61). A reduction in HbA(1c) was noted for both groups over time compared with baseline (p = 0.001); however, control subjects relied more heavily on provider visits. Medication appropriateness was not improved for diabetes medications (p = 0.65). Self-reported adherence was not significantly improved by the intervention. CONCLUSIONS: This pharmacist intervention did not significantly improve diabetes control, but did allow for similar HbA(1c) control with fewer physician visits. Medication appropriateness and self-reported adherence compared with usual care in individuals with poorly controlled diabetes were not changed.

Administration, Oral↗

Enhancing adherence in randomized controlled clinical trials.

This paper identifies individual and systematic primary, secondary, and tertiary prevention approaches that can be used to enhance adherence in randomized controlled trials. Specifically, strategies such as these are discussed: careful screening during enrollment, use of a run-in period, fully informing participants of the study burden, explaining randomization, determining the participant's prior history with treatment interventions, establishing and using a tracking system, clearly specifying adherence measures, and staff training in communication and negotiation. These strategies have been gathered over time from our experiences working in multiple randomized controlled trials. Research on factors that promote or detract from adherence should be a standard part of randomized controlled trials. Control Clin Trials 2000;21:226S-232S

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