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PubMed2005

Developing terminology for documenting perioperative nursing interventions.

OBJECTIVE: To develop terminology for documenting perioperative nursing interventions. METHOD: Nursing documentation of 250 patients was explored by content analysis. The study was conducted to validate further the Perioperative Nursing Data Set (PNDS) in Finland. The data included 3442 terms that were clustered into 104 nursing interventions. A Delphi-panel (N=5) evaluated the relevance of each term on a scale from 1 to 4. The structure of each nursing intervention was checked to meet the minimum requirements of the ISO reference terminology model for nursing action concepts. Finally, the nursing interventions were compared with the original PNDS-interventions. RESULTS: The Delphi-panel accepted 98 nursing interventions with Content Validity Index from 0.88 to 1.0. Of the 133 nursing interventions in the PNDS, 60% (n=80) were covered by nursing interventions identified in this study. A notable portion of the nursing interventions related to preventive aspects of perioperative care and the patients' coping with perioperative experience. CONCLUSION: The findings supported the need for cross-cultural validation of a nursing language prior to clinical implementation. The ISO reference terminology model is recommended as framework in constructing concepts for nursing interventions in a regular form.

Delphi Technique↗
PubMed2004

Impact of a school-based peer sexual health intervention on normative beliefs, risk perceptions, and sexual behavior of Zambian adolescents.

PURPOSE: To determine whether adolescents' normative beliefs about abstinence and condoms, their personal risk perception, and safer sex practices changed after the implementation of a peer sexual health education intervention implemented in Zambian secondary schools. METHODS: The peer intervention was implemented during the first week of September 2000 in Lusaka, Zambia. A quasi-experimental, longitudinal panel design was used to evaluate its impact. Three schools were randomly assigned to the intervention condition and two to the control condition. Three rounds of data from male and female adolescents in grades 10 and 11 were collected at baseline in July 2000, at first follow-up in the second half of September 2000, and at second follow-up in early April 2001. A total of 416 respondents aged 14-23 (at baseline) were interviewed in all three survey rounds. A mixed-effects logistic regression growth curve analysis was used to calculate adjusted odds ratios to compare intervention and control groups on the outcome variables. RESULTS: Student self-reports showed positive changes in normative beliefs about abstinence immediately after the intervention, and these improvements were largely sustained until 6 months after the intervention. Students became more likely to approve of condom use and to intend using condoms immediately after the intervention, but these positive outcomes could not be sustained during the 6 months that followed the intervention. Normative beliefs regarding condom use took longer to develop: these were only observed at 6 months follow-up. Students reported reductions in multiple regular partnerships. There was no change in condom use. CONCLUSIONS: A single session school-based peer sexual health intervention resulted in the development of normative beliefs about abstinence that were sustained over a 6-month period. Normative beliefs about condoms took longer to develop. More regular efforts may be required to sustain the approval of, and the intention to use, condoms. The intervention was successful in reducing multiple regular partnerships.

Adolescent↗
PubMed2005

Adolescent pregnancy prevention: An abstinence-centered randomized controlled intervention in a Chilean public high school.

PURPOSE: To evaluate the efficacy of an abstinence-centered sex education program in adolescent pregnancy prevention, the TeenSTAR Program was applied in a high school in Santiago, Chile. METHODS: A total of 1259 girls from a Santiago high school were divided into three cohorts depending on the year they started high school: the 1996 cohort of 425 students, which received no intervention; the 1997 cohort, in which 210 students received an intervention and 213 (control group) did not; and the 1998 cohort, in which 328 students received an intervention and 83 (control group) did not. Students were randomly assigned to control and intervention groups in these cohorts, before starting with the program. We conducted a prospective, randomized study using the application of the TeenSTAR sex education program during the first year of high school to the intervention groups in the 1997 and 1998 cohorts. All cohorts were followed up for 4 years; pregnancy rates were recorded and subsequently contrasted in the intervention and control groups. Pregnancy rates were measured and Risk Ratio with 95% confidence interval were calculated for intervention and control groups in each cohort. RESULTS: Pregnancy rates for the intervention and control groups in the 1997 cohort were 3.3% and 18.9%, respectively (RR: 0.176, CI: 0.076-0.408). Pregnancy rates for the intervention and control groups in the 1998 cohort were 4.4% and 22.6%, respectively (RR 0.195, CI: 0.099-0.384). CONCLUSIONS: The abstinence-centered TeenSTAR sex education intervention was effective in the prevention of unintended adolescent pregnancy.

Adolescent↗
PubMed2005

Selecting, implementing, and evaluating teen pregnancy prevention interventions: lessons from the CDC's Community Coalition Partnership Programs for the Prevention of Teen Pregnancy.

PURPOSE: To summarize 13 communities' experiences with selecting, implementing, and evaluating teen pregnancy prevention interventions within the CDC Community Coalition Partnership Programs for the Prevention of Teen Pregnancy. The study focuses on decision-making processes and barriers encountered in five categories of interventions: reproductive health services, reproductive health education, parent-child communication, male involvement, and programs for pregnant and parenting teens. METHODS: Telephone interviews were conducted with program directors, lead evaluators, and community coalition chairpersons in each of the 13 communities. The descriptive analysis explored factors that influenced community decisions to develop or not to develop interventions. These factors were analyzed by type of intervention. RESULTS: Each community implemented an average of six interventions and operated them with a variety of funding sources. Interventions were selected on the basis of need, and the community needs and assets assessment process was "very important" for most reported interventions. Decision-making was influenced most often by project staff, the coalition, or related work groups. Teens were infrequently viewed as primary decision-makers in the selection of interventions. Communities with family planning services as hub agencies were more likely to address reproductive services and reproductive health education. Communities with child advocacy or youth-serving agencies were more likely to focus on other intervention categories. About two-thirds of the interventions were evaluated by either process or outcome measures, or by both. CONCLUSIONS: This study highlights important lessons learned that should be considered in examinations of the overall effectiveness of this community coalition approach to the prevention of teen pregnancy.

Adolescent↗
PubMed2005

A naturalistic inquiry on the impact of interventions aiming to improve health and the quality of life in the community.

The goal of this study is to identify and describe variables contributing to the efficiency of health promotion interventions, and to assess whether these variables can serve as reliable and early indicators of the success of such interventions. The study sample includes 44 interventions selected through a network of key informants from five cities--Liverpool, Sandwell, Vienna, Pula, and Rijeka--by using a chain technique. Data on each intervention are collected through an in-depth interview with a program leader, the collection of project-related documents, and on-site observation. Qualitative analysis of data performed with content analysis and computer-assisted free-text analysis reveals different characteristics of interventions depending on whether they are initiated by the city government sector, health-care system, or citizens sector (independent of the city or country). The assessment of the efficiency of these three groups of interventions also differs because of varying features, scope (activity potentials) and impact they are able to accomplish. We have identified ways in which the efficiency of all three groups of interventions can be improved. The efficiency of the interventions within the city sector can be increased through an improved process of delegation to other sectors, higher involvement of user groups, and higher receptivity and organizational flexibility. The efficiency of the interventions within the citizens sector can be improved through professional, organizational, and financial support. Support from the professional community is important for citizens sector interventions in confirming the importance of the problem they address and legitimizing the actions they propose and undertake.

Adolescent↗
PubMed2006

Targeted intervention for the ultra poor in rural Bangladesh: Does it make any difference in their health-seeking behaviour?

It is now well recognised that regular microcredit intervention is not enough to effectively reach the ultra poor in rural Bangladesh, in fact it actively excludes them for structural reasons. A grants-based integrated intervention was developed (with health inputs to mitigate the income-erosion effect of illness) to examine whether such a targeted intervention could change the health-seeking behaviour of the ultra-poor towards greater use of health services and "formal allopathic" providers during illness, besides improving their poverty status and capacity for health expenditure. The study was carried out in three northern districts of Bangladesh with high density of ultra poor households, using a pre-test/post-test control group design. A pre-intervention baseline (2189 interventions and 2134 controls) survey was undertaken in 2002 followed by an intervention (of 18 months duration) and a post-intervention follow-up survey of the same households in 2004. Structured interviews were conducted to elicit information on health-seeking behaviour of household members. Findings reveal an overall change in health-seeking behaviour in the study population, but the intervention reduced self-care by 7 percentage units and increased formal allopathic care by 9 percentage units. The intervention increased the proportion of non-deficit households by 43 percentage units, as well as the capacity to spend more than Tk. 25 for treatment of illness during the reference period by 11 percentage units. Higher health expenditure and time (pre- to -post-intervention period) was associated with increased use of health care from formal allopathic providers. However, gender differences in health-seeking and health-expenditure disfavouring women were also noted. The programmatic implications of these findings are discussed in the context of improving the ability of health systems to reach the ultra poor.

Bangladesh↗
PubMed2003

Feedback intervention to reduce routine electrocardiogram use in primary care.

BACKGROUND: Although physicians frequently order non-essential diagnostic tests, including screening tests such as electrocardiograms (ECGs), effective strategies for achieving evidence-based test-ordering are not proven. Our objective was to evaluate the impact of a feedback intervention designed to reduce the rate of screening ECG use and its variation. METHODS: A non-randomized pre-post intervention trial assessed the ordering of ECGs among primary care providers affiliated with Massachusetts General Hospital. Among outpatients visiting providers, those with cardiac diagnoses or symptoms were excluded, as were providers with <120 annual visits. Data were available on 117 providers, 105,682 patients, and 511,328 patient visits. During a 9-month intervention, providers received periodic case-mix-adjusted peer-comparisons of their screening ECG use. Two computerized billing systems tracked baseline (December 1996 to March 1998), intervention (April 1998 to December 1998), and post-intervention (January 1999 to September 1999) ECG use. Our outcome measures were: 1) the likelihood of ECG ordering at office visits and 2) provider practice variation, indicated by coefficient of variation and interquartile range. RESULTS: ECGs were ordered in 4.6% of visits before the intervention. Provider variation in case-mix adjusted ECG ordering was substantial (coefficient of variation, 101.6%; interquartile range, 3.2% [1.5%-4.7%]). ECG ordering averaged 3.5% during the intervention and 2.8% post-intervention (P <.001). Variation in ECG ordering narrowed considerably (coefficient of variation, 92.5%; interquartile range, 2.0% [1.0%-3.0%]) after the intervention. Multivariate analysis confirmed a persistent impact of the intervention. CONCLUSIONS: Feedback to primary care providers successfully reduced ECG use and its variation. This approach may be applicable to other physician behaviors that remain contrary to evidence, but are not questioned because peer comparisons are unavailable.

Diagnosis-Related Groups↗
PubMed2002

The Advanced Glaucoma Intervention Study (AGIS): 11. Risk factors for failure of trabeculectomy and argon laser trabeculoplasty.

PURPOSE: To investigate the association of pre-intervention and post-intervention patient and eye characteristics with failure of argon laser trabeculoplasty (ALT) and trabeculectomy. DESIGN: Cohort study of participants in the Advanced Glaucoma Intervention Study. METHODS: This multicenter study took place between 1988 and 2001. Between 1988 and 1992, 789 eyes of 591 patients aged 35 to 80 years with advanced glaucoma were randomized into one of two surgical treatment sequences: argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy or trabeculectomy-ALT-trabeculectomy. Upon study-defined failure (based on maximum medications, sustained intraocular pressure (IOP) elevation, visual field defect, and disk rim deterioration) of each intervention, patients were offered the subsequent intervention. Potential follow-up was 8 to 13 years. This report is based on data from 779 eyes that had at least 3 months of follow-up. The main outcome measures are failure of ALT and trabeculectomy, whether as first or second interventions. Effect size is measured by the hazard ratio (HR) and its corresponding 95% confidence interval (CI) obtained from Cox multiple regression analysis, where HR corresponds to the coefficient of change in risk associated with a unit increase in a factor. For binary factors, this corresponds to the change in risk in eyes with the factor relative to the risk in eyes without the factor. RESULTS: Pre-intervention factors associated with failure of ALT are younger age (HR = 0.98, CI = 0.96-0.99, P =.009) and higher IOP (1.11, 1.08-1.15, P <.001). Pre-intervention factors associated with failure of trabeculectomy are younger age (HR = 0.97, CI = 0.95-0.99, P =.005) and higher IOP (1.04, 1.01-1.06, P =.002), as well as diabetes (2.86, 1.88-4.36, P <.001) and any postoperative complication (1.99, 1.35-2.93, P <.001). Individual postoperative complications significantly associated with increased risk of failure of trabeculectomy are elevated IOP (3.4, 1.9-6.1, P <.001) and marked inflammation (2.4, 1.3-4.6, P =.006). CONCLUSIONS: In this study, ALT failure was associated with younger age and higher pre-intervention IOP. Trabeculectomy failure was associated with younger age, higher pre-intervention IOP, diabetes, and one or more postoperative complications, particularly elevated IOP and marked inflammation.

Adult↗
PubMed1998

Nutrition intervention for weight gain in cystic fibrosis: a meta analysis.

OBJECTIVES: A meta analysis of the literature on treatment approaches to malnutrition in cystic fibrosis (CF) was conducted to evaluate the effectiveness of oral supplementation, enteral nutrition, parenteral nutrition, and behavioral intervention on weight gain before and after treatment. STUDY DESIGN: Eighteen studies were reviewed: four behavioral, six supplement, five enteral nutrition, and three parenteral nutrition. RESULTS: The weighted effect size for weight gain was large for each intervention: 1.51 behavioral, 1.62 oral, 1.78 enteral, and 2.20 parenteral intervention. All interventions produced a large effect for weight gain in patients with CF. A univariate analysis of variance indicated no significant difference among the four interventions, F(3, 17) = 0.87, p > 0.05. Effect size for calorie intake was also evaluated when data were available (N = 7 studies), yielding a sample size of three behavioral, two enteral, and two oral supplement studies. Analysis of variance indicated a significant effect for treatment, F(2,4) = 13.34, p < 0.05, with post hoc analysis indicating that the behavioral intervention had a greater effect size for calorie intake than oral supplement. CONCLUSIONS: All interventions were effective in producing weight gain in patients with CF. Behavioral intervention appeared to be as effective in improving weight gain in patients with CF as more invasive medical procedures. These findings support continued research on nutrition intervention with patients with CF including controlled clinical trials of the interventions and long-term follow-up on the impact of nutrition on disease progression.

Behavior Therapy↗
PubMed1998

Contemporary urological intervention for cystinuric patients: immediate and long-term impact and implications.

PURPOSE: We determined the immediate efficacy of contemporary urological intervention for cystine stones and the impact of such intervention on the subsequent rate of recurrent stone formation. MATERIALS AND METHODS: A total of 31 cystinuric patients underwent selected intervention for 61 stone events. Patients were subsequently followed at 6 to 12-month intervals while being treated with standard medical therapy. Logistic regression models were used to correlate potential risk factors with the efficacy of the intervention in achieving a stone-free status. Kaplan-Meier estimates of the probability of recurrence-free survivals at 1 and 5 years were generated, and risk factors for stone recurrence were analyzed using the log rank test. RESULTS: Overall stone-free rate was 86.9%, which was not significantly influenced by the initial stone burden or type of intervention selected. The probability of recurrence-free survival at 1 and 5 years was 0.73 and 0.27, respectively, and again this probability was independent of initial stone burden or type of intervention selected. Urinary cystine levels before intervention and post-procedure residual stone status also failed to impact significantly on the risk of recurrence. However, a stone-free result, in contrast to residual stones, prolonged the mean time to stone recurrence from 346 to 1,208 days. CONCLUSIONS: While cystine stones are not amenable to all currently available minimally invasive therapeutic modalities, high stone-free rates can be achieved without the need for open surgery and as such cystinuric patients clearly benefit from contemporary intervention. When such intervention is used selectively, with consideration given primarily to stone burden and location, rates of recurrence will relate primarily to the natural history of the medically treated cystinuric patient, and not the type of intervention applied.

Adolescent↗
PubMed2003

An academic detailing intervention to disseminate physician-delivered smoking cessation counseling: smoking cessation outcomes of the Physicians Counseling Smokers Project.

BACKGROUND: Little is known about the effectiveness of interventions to disseminate smoking cessation interventions among a population of primary care physicians. This study's objective was to determine the effect of a community-based academic detailing intervention on the quit rates of a population-based sample of smokers. METHODS: This community-based, quasi-experimental study involved representative samples of 259 primary care physicians and 4295 adult smokers. An academic detailing intervention was delivered to physicians in intervention areas over a period of 15 months. Analyses were performed on the data from the 2346 subjects who reported at least one physician visit over 24 months. Multivariate regression analyses were conducted to determine the impact of the intervention on self-reported smoking quit rates, reported by adjusted odds ratios. RESULTS: Among smokers reporting a physician visit during the study period, there was a borderline significant effect for those residing in intervention areas versus control areas (OR = 1.35; 95% CI.99-1.83; P = 0.057). Among a subgroup of 819 smokers who reported a visit with an enrolled physician, we observed a significant effect for those residing in intervention areas (OR = 1.80; 95% CI 1.16-2.75; P = 0.008). CONCLUSION: An academic detailing intervention to enhance physician delivered smoking cessation counseling is an effective strategy for disseminating smoking cessation interventions among community-based practices.

Adult↗
PubMedDate not supplied

Effects of a behavioural intervention to reduce acquisition of HIV infection among men who have sex with men: the EXPLORE randomised controlled study.

BACKGROUND: Effective interventions are needed to prevent acquisition of HIV infection in men who have sex with men. To date, no behavioural interventions specifically for this risk group have been tested with HIV infection as the primary outcome. METHODS: This multisite two-group randomised controlled phase IIb trial tested the efficacy of a behavioural intervention in preventing HIV infection among 4295 men who have sex with men. The experimental intervention consisted of ten one-on-one counselling sessions followed by maintenance sessions every 3 months. The standard condition was twice-yearly Project RESPECT individual counselling. Twice-yearly follow-up visits included testing for HIV antibody and assessment of behavioural outcomes. FINDINGS: The rate of acquisition of HIV infection was 18.2% (95% CI -4.7 to 36.0) lower in the intervention group than the standard group. Adjustment for baseline covariates attenuated the intervention effect to 15.7% (-8.4 to 34.4). The effect was more favourable in the first 12-18 months of follow-up. The occurrence of unprotected receptive anal intercourse with HIV-positive and unknown-status partners was 20.5% (10.9 to 29.0) lower in the intervention than in the standard group. INTERPRETATION: The results from the primary analyses allow us to rule out that the experimental intervention is associated with a 35% lower rate of HIV acquisition than in the standard group. The overall estimate of a difference of 18.2%, more favourable estimates of effect in the first 12-18 months, and similar effects on risk behaviours suggest that prevention of HIV infection among men who have sex with men by a behavioural intervention is feasible. Further work should be done to develop more effective interventions.

Adolescent↗
PubMedDate not supplied

Co-coverage of preventive interventions and implications for child-survival strategies: evidence from national surveys.

BACKGROUND: In most low-income countries, several child-survival interventions are being implemented. We assessed how these interventions are clustered at the level of the individual child. METHODS: We analysed data from Bangladesh, Benin, Brazil, Cambodia, Eritrea, Haiti, Malawi, Nepal, and Nicaragua. A co-coverage score was obtained by adding the number of interventions received by each child (including BCG, diphtheria-pertussis-tetanus, and measles vaccines), tetanus toxoid for the mother, vitamin A supplementation, antenatal care, skilled delivery, and safe water. Socioeconomic status was assessed through principal components analysis of household assets, and concentration indices were calculated. FINDINGS: The percentage of children who did not receive a single intervention ranged from 0.3% (14/5495) in Nicaragua to 18.8% (1154/6144) in Cambodia. The proportions receiving all available interventions varied from 0.8% (48/6144) in Cambodia to 13.3% (733/5495) in Nicaragua. There were substantial inequities within all countries. In the poorest wealth quintile, 31% of Cambodian children received no interventions and 17% only one intervention; in Haiti, these figures were 15% and 17%, respectively. Inequities were inversely related to coverage levels. Countries with higher coverage rates tended to show bottom inequity patterns, with the poorest lagging behind all other groups, whereas low-coverage countries showed top inequities with the rich substantially above the rest. INTERPRETATION: The inequitable clustering of interventions at the level of the child raises the possibility that the introduction of new technologies might primarily benefit children who are already covered by existing interventions. Packaging several interventions through a single delivery strategy, while making economic sense, could contribute to increased inequities unless population coverage is very high. Co-coverage analyses of child-health surveys provide a way to assess these issues.

Adult↗
PubMed2006

Comparison of primary and facilitated percutaneous coronary interventions for ST-elevation myocardial infarction: quantitative review of randomised trials.

BACKGROUND: Facilitated percutaneous coronary intervention for ST-segment-elevation myocardial infarction (STEMI) is defined as the use of pharmacological substances before a planned immediate intervention, to improve coronary patency. We undertook a meta-analysis of randomised controlled trials (published and unpublished) to compare facilitated and primary percutaneous coronary intervention. METHODS: We identified 17 trials of patients with STEMI assigned to facilitated (n=2237) or primary (n=2267) percutaneous coronary intervention. We identified short-term outcomes (up to 42 days) of death, stroke, non-fatal reinfarction, urgent target vessel revascularisation, and major bleeding. Grade 3 flow rates for prethrombolysis and post-thrombolysis in myocardial infarction (TIMI) were also analysed. FINDINGS: The facilitated approach resulted in a greater than two-fold increase in the number of patients with initial TIMI grade 3 flow, compared with the primary approach (832 patients [37%] vs 342 [15%], odds ratio 3.18, 95% CI 2.22-4.55); however, final rates did not differ (1706 [89%] vs 1803 [88%]; 1.19, 0.86-1.64). Significantly more patients assigned to the facilitated approach than those assigned to the primary approach died (106 [5%] vs 78 [3%]; 1.38, 1.01-1.87), had higher non-fatal reinfarction rates (74 [3%] vs 41 [2%]; 1.71, 1.16-2.51), and had higher urgent target vessel revascularisation rates (66 [4%] vs 21 [1%]; 2.39, 1.23-4.66); the increased rates of adverse events seen with the facilitated approach were mainly seen in thrombolytic-therapy-based regimens. Facilitated intervention was associated with higher rates of major bleeding than primary intervention (159 [7%] vs 108 [5%]; 1.51, 1.10-2.08). Haemorrhagic stroke and total stroke rates were higher in thrombolytic-therapy-containing facilitated regimens than in primary intervention (haemorrhagic stroke 15 [0.7%] vs two [0.1%], p=0.0014; total stroke 24 [1.1%] vs six [0.3%], p=0.0008). INTERPRETATION: Facilitated percutaneous coronary intervention offers no benefit over primary percutaneous coronary intervention in STEMI treatment and should not be used outside the context of randomised controlled trials. Furthermore, facilitated interventions with thrombolytic-based regimens should be avoided.

Aged↗
PubMed2006

Sustained reduction in the incidence of type 2 diabetes by lifestyle intervention: follow-up of the Finnish Diabetes Prevention Study.

BACKGROUND: Lifestyle interventions can prevent the deterioration of impaired glucose tolerance to manifest type 2 diabetes, at least as long as the intervention continues. In the extended follow-up of the Finnish Diabetes Prevention Study, we assessed the extent to which the originally-achieved lifestyle changes and risk reduction remain after discontinuation of active counselling. METHODS: Overweight, middle-aged men (n=172) and women (n=350) with impaired glucose tolerance were randomly assigned to intensive lifestyle intervention or control group. After a median of 4 years of active intervention period, participants who were still free of diabetes were further followed up for a median of 3 years, with median total follow-up of 7 years. Diabetes incidence, bodyweight, physical activity, and dietary intakes of fat, saturated fat, and fibre were measured. FINDINGS: During the total follow-up, the incidence of type 2 diabetes was 4.3 and 7.4 per 100 person-years in the intervention and control group, respectively (log-rank test p=0.0001), indicating 43% reduction in relative risk. The risk reduction was related to the success in achieving the intervention goals of weight loss, reduced intake of total and saturated fat and increased intake of dietary fibre, and increased physical activity. Beneficial lifestyle changes achieved by participants in the intervention group were maintained after the discontinuation of the intervention, and the corresponding incidence rates during the post-intervention follow-up were 4.6 and 7.2 (p=0.0401), indicating 36% reduction in relative risk. INTERPRETATION: Lifestyle intervention in people at high risk for type 2 diabetes resulted in sustained lifestyle changes and a reduction in diabetes incidence, which remained after the individual lifestyle counselling was stopped.

Blood Glucose↗
PubMed1996

Systematic review of randomised trials of interventions to assist patients to follow prescriptions for medications.

BACKGROUND: Low adherence of patients to prescribed, self-administered medical interventions is ubiquitous. Low adherence limits the benefits of current medical care. Efforts to assist patients to follow treatments might improve the efficiency of care and substantially enhance benefits. Our objective was to summarise the results of randomised controlled trials (RCTs) of interventions to help patients follow prescriptions for medications. METHODS: A previous systematic review was updated through computerised searches in Medline, International Pharmaceutical Abstracts, Psychinfo, and HSTAR online databases; bibliographies in articles on patient adherence; articles in the reviewers' personal collections; and contact with authors. Articles were judged of interest if they reported original data concerning an unconfounded RCT of an intervention to improve adherence with prescribed medications, with one or more measure of medication adherence, one or more measure of treatment outcome, at least 80% follow-up of each group studied, and, for long-term treatments, at least 6 months of follow-up for studies with positive initial findings. Information on study design features, interventions and controls, and findings were extracted by one reviewer (RK) and checked by the other two reviewers. FINDINGS: 1,553 relevant citations and abstracts were screened, 252 full text articles were reviewed in detail, and 13 RCTs met all criteria. The studies were too disparate in clinical problems, adherence interventions, measures and reporting of adherence, and the clinical outcomes studied to warrant meta-analysis. Seven of 15 interventions were associated with improvements in adherence and six interventions led to improvements in treatment outcomes. For short-term treatments, one study showed an effect on adherence and outcome of counselling and written information. The interventions that were effective for long-term care were complex, including various combinations of more convenient care, information, counselling, reminders, self-monitoring, reinforcement, family therapy, and other forms of additional supervision or attention. Even the most effective interventions did not lead to substantial improvements in adherence. INTERPRETATION: Although adherence and treatment outcomes can be improved by certain-usually complex-interventions, full benefits of medications cannot be realised at currently achievable levels of adherence. It is time that additional efforts be directed towards developing and testing innovative approaches to assist patients to follow treatment prescriptions.

Drug Therapy↗
PubMed2003

An international multicenter protocol to assess the single and combined benefits of antiemetic interventions in a controlled clinical trial of a 2x2x2x2x2x2 factorial design (IMPACT).

For various diseases clinicians have to combine different drugs or interventions when a single drug or intervention does not lead to satisfactory results. However, quantifying the relative benefit of certain drugs or interventions when given alone and in combination under controlled conditions requires a complex factorial design. This paper describes such a method applied to a large multicenter trial for the prevention of postoperative nausea and vomiting (PONV), which may be of great interest for other specialties. Approximately 28 million operations are performed annually in the United States, mainly under general anesthesia with volatile anesthetics. Unfortunately, one-third of these patients suffer from PONV. This prompted extensive research of antiemetic and anesthetic drugs, but none of the interventions appeared to satisfactorily prevent PONV. Scuderi et al. were the first to almost eliminate PONV by combining various antiemetic interventions; however, the relative benefit of each intervention remained unclear. Accordingly, we have designed a large randomized controlled trial studying six different antiemetic interventions-three involving use of various antiemetic drugs and three involving choice of anesthetic drugs-to answer the following main questions: (1) What is the relative benefit of each of the antiemetic intervention? (2) Are certain combinations of antiemetic interventions more effective than others? Using a complete factorial design this leads to 2(3)=8 antiemetic combinations, which multiply with the 2(3)=8 combinations of anesthetic drugs, leading to a total of 2(6)=64 possible combinations. The six factors are the antiemetics ondansetron (versus control), dexamethasone (versus control), droperidol (versus control), and the intravenous anesthetic propofol (versus volatile anesthetics), air (versus nitrous oxide), and remifentanil (versus fentanyl). The primary outcome is freedom from PONV within the first 24 hours after anesthesia. Eligible patients are adults scheduled for elective surgery under general anesthesia with an increased risk for PONV so that the expected incidence in the control group (with none of the six antiemetic interventions) is approximately 60%. In order to allow analyses for up to three factor interactions, a sample size was estimated to be in the range of approximately 5000 patients. To the best of our knowledge this is the first randomized controlled trial of a six-way factorial design that may serve as an example for numerous other medical specialties.

Anesthesia, Inhalation↗
PubMed2004

[Effectiveness of an intervention to provide information to patients with hypertension as short text messages and reminders sent to their mobile phone (HTA-Alert)].

OBJECTIVE: To analyze the effect of an intervention to provide information with mobile phone text messages to patients with hypertension on compliance with therapy for hypertension. DESIGN: Comparative, controlled, multicenter, randomized cluster study. SETTING: 26 primary care health centers in Spain. PARTICIPANTS: 26 researchers were randomized to a control group or an intervention group (52 patients each, for a total of 104 patients). All patients were receiving monotherapy for uncontrolled hypertension. INTERVENTION: Patients in the control group received their physician's usual interventions. Patients in the intervention group received messages and reminders sent to their mobile phones 2 days per week during 4 months. MAIN OUTCOME MEASURES: Tablets were counted and blood pressure was measured at the start of the study and 1, 3, and 6 months later. The percentage of compliers, mean percentage of compliance and degree of control of hypertension were compared. The reduction in absolute and relative risk was calculated, as was the number of individuals needed to treat to avoid noncompliance. RESULTS: The results were evaluated for a total of 67 individuals (34 in the intervention group and 33 in the control group). The rate of compliance was 85.1% (CI, 74.9%-95.3%) overall, 85.7% (CI, 70.5%-100.9%) in the control group and 84.4% in the intervention group (CI, 70.7%-95.3%) (P=NS). Mean percentage compliance was 90.2%+/-16.3% overall, 88.1%+/-20.8% in the control group and 91.9%+/-11.6% in the intervention group (P=NS). The percentage of patients whose hypertension was controlled at the end of the study was 51.5% (CI, 34.4%-68.6%) in the control group and 64.7% (CI, 48.6%-80.8%) in the intervention group (P=NS). CONCLUSIONS: The telephone messaging intervention with alerts and reminders sent to mobile phones did not improve compliance with therapy in patients with hypertension.

Aged↗