Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “interventions”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 523 records · Page 29Linked to original sources

Fidelity to a 12-week structured medication adherence intervention in patients with HIV.

BACKGROUND: Researchers have been conducting efficacy and effectiveness studies on interventions that address medication-taking behavior in patients with HIV infection. However, they also must examine the fidelity to the research protocol for the delivery of the intervention. OBJECTIVES: The aims of this study were to determine the level of fidelity to each of the specified end points (number of intervention sessions, session duration, number of telephone calls per session, the length of time between sessions, sessions with multiple interventions, and attrition from the intervention protocol) in the delivery of the 12-week, nurse-delivered, structured telephone intervention designed to improve medication adherence and to determine the factors (race, gender, and socioeconomic status) related to participation in the intervention. METHODS: This descriptive correlational study was a substudy of a larger randomized clinical trial (N = 200) testing the effectiveness of a 12-week nurse-delivered intervention designed to improve medication adherence to antiretroviral medications in persons with HIV infection. The Intervention Tracking Form was used to collect data on all intervention delivery end points during the delivery of the structured intervention. A sociodemographic questionnaire was used to collect the sociodemographic characteristics of the sample. RESULTS: Two thirds of the sample (n = 66) were male, and slightly more than half were White. The average age was 39.68 (SD = 7.98) years. The average number of intervention sessions delivered was 8.1 (SD = 4.07). Participants were more likely to receive the first five intervention sessions (n = 77, 77.8%), and 21 (21.2%) dropped out of treatment before it was completed. Nearly one quarter (n = 24, 24.2%) of the sample had doubled-up interventions. Intervention sessions lasted, on average, 11.3 min. Typically, more than one telephone call was needed before the participant was reached (M = 2.2). The mean number of days between sessions was 11.5 days. Women were more likely to have doubled-up interventions (p = .036). There was a marginally significant difference (p = .075) in the number of sessions received between the Whites and non-Whites: Whites (M = 8.8, SD = 3.9) received slightly more sessions compared with non-Whites (M = 7.24, SD = 4.2). When examining the interaction effects between the demographic factors considered, a race-by-income effect was observed for the mean number of attempts to contact the participant (p = .044). DISCUSSION: These results demonstrate a lack of fidelity to the research intervention protocol. Factors beyond the researchers' control may have influenced fidelity to the intervention protocol.

Adult↗

[The efficacy of early intervention for infants and toddlers with hearing loss].

OBJECTIVE: To investigate the efficacy of early intervention on language, pronunciation and cognitive developments of infants and toddlers with hearing loss and to build up an early intervention model. METHODS: Fifty-six children with moderate to profound sensorineural hearing loss aged 10 months to 2 years were divided into two groups. 20 children, aged 10 months to 2 years, received early intervention services after wearing hearing aids for 6 - 18 months, and 36 children, aged 11 months to 2 years, didn't receive any intervention. The type and degree of hearing loss were measured by a series of auditory tests. Language and cognitive developments of the children with hearing loss and 28 age, and sex-matched children with normal hearing, aged 10 to 23 months, were evaluated by the Gesell developmental schedules. The results were expressed as developmental quotient (DQ). Pronunciation test in mandarin Chinese was adopted to evaluate the speech development of the 56 children with hearing loss. RESULTS: (1) The language DQ according the Gesell developmental schedules of the children with hearing loss who received early intervention was (92.25 +/- 17.32), significantly higher than those children with hearing loss who didn't receive intervention (70.44 +/- 29.99, P = 0.00), whish was significantly lower than that of the normal hearing children (P = 0.00). However, there was no significant difference in language DQ between the children who received early intervention and the normal hearing children. There was no significant correlation between the degree of hearing loss and language DQ in the children who received early intervention (P = 0.27). (2) The personal-social developmental quotient (DQ) of the children who received intervention was (101.40 +/- 7.66), significantly higher than that of the children who didn't receive intervention (83.94 +/- 22.09, P = 0.00), that were significantly lower than that of the children with normal hearing (P = 0.00). However, there were no significant difference in the personal-social DQ between the children who received early intervention and the children with normal hearing. No significant differences in the gross motor ability, fine motor ability and adaptive ability were observed between the two groups of children with hearing loss and normal hearing children. (3) The consonant pronunciation of the children with moderate to severe hearing loss who received early intervention was normal. Among those children only one case with profound hearing loss had/d/error. The consonant pronunciation of the children with moderate hearing loss who didn't receive early intervention of those was normal. One case with moderate-severe hearing loss and one case with severe hearing loss had/d/errors. Six cases with profound hearing loss had/d, m/errors. The tone of the children with moderate to severe hearing loss who received early intervention was normal. Three cases with profound hearing loss exhibited tone errors. Among the children who didn't receive early intervention, tone errors were found in two cases with moderate hearing loss, one case with moderate-severe hearing loss, one case with severe hearing loss, and twelve cases with profound hearing loss showed. CONCLUSION: The language, pronunciation and cognitive developments of the children who don't receive early intervention are significantly lower than those of the children with normal hearing. Early intervention can significantly improve the language, speech and cognitive abilities of children with hearing loss.

Child, Preschool↗

Population-based interventions for reducing sexually transmitted infections, including HIV infection.

BACKGROUND: Sexually transmitted infections (STI) are common in developing countries. The World Health Organisation (WHO) estimates that in 1999, 340 million new cases of syphilis, gonorrhoea, chlamydial infection and trichomoniasis occurred. Human immunodeficiency virus (HIV) infection is also common in developing countries. UNAIDS estimates that over 95% of the 40 million people infected with HIV by December 1999 live in developing countries (UNAIDS 2003). The STI and HIV epidemics are interdependent. Similar behaviours, such as frequent unprotected intercourse with different partners, place people at high risk of both infections, and there is clear evidence that conventional STIs increase the likelihood of HIV transmission. Several studies have demonstrated a strong association between both ulcerative and non-ulcerative STIs and HIV infection (Cameron 1989, Laga 1993). There is biological evidence, too, that the presence of an STI increases shedding of HIV, and that STI treatment reduces HIV shedding (Cohen 1997, Robinson 1997). Therefore, STI control may have the potential to contribute substantially to HIV prevention. OBJECTIVES: To determine the impact of population-based STI interventions on the frequency of HIV infection, frequency of STIs and quality of STI management. SEARCH STRATEGY: The following electronic databases were searched for relevant randomised trials or reviews:1) MEDLINE for the years 1966 to 2003 using the search terms "sexually transmitted diseases" and "human immunodeficiency virus infection"2) The Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effectiveness and the Cochrane Clinical Trials Register, in the most recent issue of the Cochrane Library3) The specialist registry of trials maintained by the Cochrane Infectious Diseases Group.4) EMBASE The abstracts of relevant conferences were searched, and reference lists of all review articles and primary studies were scanned. Finally, authors of included trials and other experts in the field were contacted as appropriate. SELECTION CRITERIA: Randomised controlled trials in which the unit of randomisation is either a community or a treatment facility. Studies where individuals are randomised were excluded. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied the inclusion criteria to potential studies, with any disagreements resolved by discussion. Trials were examined for completeness of reporting. The methodological quality of each trial was assessed by the same two reviewers, with details recorded of randomisation method, blinding, use of intention-to-treat analysis and the number of patients lost to follow-up, using standard guidelines of the Cochrane Infectious Diseases Group. MAIN RESULTS: Five trials were included. Frequency of HIV infection: In Rakai, after 3 rounds of treatment of all community members for STIs, the rate ratio of incident HIV infection was 0.97 (95%CI 0.81 to 1.16), indicating no effect of the intervention. In Mwanza, the incidence of HIV infection in the intervention groups (strengthened syndromic management of STIs in primary care clinics) was 1.2% compared with 1.9% in the control groups (OR=0.58, 95% CI 0.42-0.70), corresponding to a 38% reduction (95%CI 15% to 55%) in HIV incidence in the intervention group. In the newest trial by Kamali et al, the rate ratio of behavioral intervention & STI management compared to control on HIV incidence was 1.00 (0.63-1.58, p=.98). These are consistent with Rakai data showing no effect of intervention. Frequency of STIs: In both Mwanza and Rakai, there was no significant reduction in gonorrhoea, chlamydia, urethritis, or reported STI symptoms among intervention communities. The prevalence ratio of syphilis between intervention and control groups in Rakai was 0.8 (95%CI 0.71-0.89), of trichmoniasis was 0.59 (0.38-0.91), and of bacterial vaginosis was 0.87 (0.74-1.02). In Mwanza, the prevalence of serologically diagnosed syphilis in the intervention community was 5% compared with 7% in the control community at the end of the trial (adjusted re7% in the control community at the end of the trial (adjusted relative risk 0.71 (95%CI 0.54-0.93). In Kamali et al, there was a significant decrease in gonorrhoea and active syphilis cases. Rate ratio for gonorrhoea was 0.29(0.12-0.71, p=0.016), active syphilis was 0.53(0.33-0.84,p=0.016). There was a trend towards significance with intervention on the use of condoms with the last casual partner; the rate ratio was 1.27(1.02-1.56,p=0.036). Quality of treatment: In Lima, following training of pharmacy assistants in STI syndromic management, symptoms were recognised as being due to an STI in 65% of standardised simulated patients (SSPs) visiting intervention and 60% of SSPs visiting control pharmacies (p=0.35). Medication was offered without referral to a doctor in most cases (83% intervention and 78% control, p=0.61). Of those SSPs offered medication, only 1.4% that visited intervention pharmacies and only 0.7% of those that visited control pharmacies (p=0.57) were offered a recommended regimen. Similarly in only 15% and 16% of SSP visits respectively was any recommended drug offered. However, education and counseling were more likely to be given to SSPs visiting intervention pharmacies (40% vs 27%, p=0.01). No SSPs were given partner cards or condoms. In Hlabisa, following the intervention targeting primary care clinic nurses (strengthened STI syndromic management and provision of STI syndrome packets containing recommended drugs, condom, partner cards and patient information leaflets), SSPs were more likely to be given recommended drugs in intervention clinics (83% vs 12%, p<0.005) and more likely to be correctly case managed [given correct drugs, partner cards and condoms] (88% vs 50%, p<0.005). There were no significant differences in the proportions adequately counseled (68% vs 46%, p=0.06), experiencing good staff attitude (84% vs 58%, p=0.07), and being consulted in privacy (92% vs 86%, p=0.4). There was no strong evidence of any impact on treatment-seeking behaviour, utilisation of services, or sexual behaviour in any of the four trials. REVIEWERS' CONCLUSIONS: There is limited evidence from randomised controlled trials for STI control as an effective HIV prevention strategy. Improved STI treatment services have been shown to reduce HIV incidence in an environment characterised by an emerging HIV epidemic (low and slowly rising prevalence), where STI treatment services are poor and where STIs are highly prevalent. There is no evidence for substantial benefit from treatment of all community members. The addition of the Kamali trial to the existing evidence supports the data from the Rakai trial of no effect. There are, however, other compelling reasons why STI treatment services should be strengthened, and the available evidence suggests that when an intervention is accepted it can substantially improve quality of services provided. The Kamali trial shows an increase in the use of condoms, a marker for improved risk behaviors. Further community-based randomised controlled trials that test a range of alternative STI control strategies are needed in a variety of different settings. Such trials should aim to measure a range of factors that include health seeking behaviour and quality of treatment, as well as HIV, STI and other biological endpoints.

Developing Countries↗

Interventions to modify sexual risk behaviors for preventing HIV infection in men who have sex with men.

BACKGROUND: MSM remain at great risk for HIV infection. Program planners and policy makers need descriptions of interventions and quantitative estimates of intervention effects to make informed decisions concerning prevention efforts. OBJECTIVES: 1. To locate and describe outcome studies evaluating the effects of behavioral and social interventions targeting MSM. 2. To summarize the effectiveness of these interventions among MSM. 3. To stratify results by characteristics of interventions and participants. 4. To identify gaps and indicate future research, policy, and practice needs. SEARCH STRATEGY: We searched electronic databases (MedLine, PsycInfo, etc.); several current journals (e.g., AIDS, AIDS and Behavior, AIDS Education and Prevention, American Journal of Public Health, Journal of Acquired Immune Deficiency Syndromes, etc.); manuscripts submitted by researchers; bibliographies of relevant articles; and other published reviews, for published and unpublished reports from 1988 through 1997. SELECTION CRITERIA: Studies were considered in scope if they examined the effects of behavioral interventions to reduce risk for HIV or STD transmission. We reviewed studies in scope for criteria of outcome relevance (measurement of at least one of a list of behavioral or biologic outcomes, e.g., unprotected sex or incidence of HIV infections) and methodologic rigor (randomized controlled trials or certain strong quasi-experimental designs with comparison groups). DATA COLLECTION AND ANALYSIS: As of June 1998 we had identified 13 eligible studies. Twelve studies (7 trials of small group interventions, 3 community-level interventions, and 2 individual level interventions) reported intervention effects on unprotected sex. Because few studies reported effects on condom use (3 studies), number of sex partners without regard to condom use (4 studies), or HIV or STD incidence (1 study in which no infections occurred) we do not address these outcomes at this time. We present those analyses which can be performed in the current Cochrane RevMan software, followed by more complete analyses that permit inclusion of community-level studies, adjustment for baseline conditions, calculation of effect sizes from a wider variety of statistics (e.g., an F-statistic from a one-way ANOVA), and simultaneous meta-analysis of continuous and dichotomous outcomes (Johnson 2002b). We translate the summary effect to reduction in risk behavior based on the background prevalence of unprotected sex. Finally we provide analyses stratified by intervention content (interpersonal skills addressed or not), intervention format (community vs small group or individual) and mean age of participants (23 to 31 vs. 32 to 36). MAIN RESULTS: A summary measure of intervention effects on reducing unprotected sex was favorable (odds ratio = 0.73) and statistically significant (CI, 0.60 to 0.88), corresponding to a 23% reduction in the proportion of men engaging in unprotected sex. Effects were homogeneous among studies, but were slightly more favorable among community-level interventions, those that served populations in their 20s rather than their 30s, and those that promoted interpersonal skills. REVIEWER'S CONCLUSIONS: These studies demonstrate that interventions can promote risk reduction among MSM. Yet given the epidemiology of HIV in Pattern I countries, the small number of rigorous controlled intervention trials for this population is striking. Many more rigorous evaluations of HIV prevention efforts with MSM are needed to ascertain with confidence the effects of specific intervention components, population characteristics, and methodologic features.

HIV Infections↗

Limb interventions in patients undergoing treatment with an unsupported bifurcated aortic endograft system: a review of the Phase II EVT Trial.

INTRODUCTION: Both supported and unsupported bifurcated endograft limbs develop flow-restricting lesions, including kinks, stenoses, and occlusions, which can be identified during or after surgery. Recognition and intervention are essential to achieve long-term graft patency and a satisfactory functional result. This report represents a comprehensive retrospective review of graft limb interventions from the Phase II EVT Trial with the Endovascular Grafting System unsupported bifurcated endograft (Guidant/EVT, Menlo Park, Calif). METHODS: The study population consists of 242 patients who underwent treatment with bifurcated endografts implanted during the EVT Phase II Trial. Graft limb interventions have been divided into two groups: those in whom the intervention occurred during surgery versus those in whom the intervention occurred after surgery. Parameters studied included type, incidence, and timing of graft limb intervention, indications for intervention, procedures performed, and overall patient outcome. RESULTS: The mean follow-up period was 31 months. Primary, primary assisted, and secondary limb patency rates were 61.6%, 93.7%, and 97.1%, respectively. Technical success rate at case completion was 97.5%. In 68 of the 242 cases, limb interventions were performed during surgery to assure patency (28.1%). In 28 cases, interventions were performed after surgery (11.6%). Of these postoperative limb problems, 82% occurred during the first 6 months. Repeat limb interventions were necessitated in three patients (1.2%). Within the intraoperative intervention group, perceived indications included kinks (15%), stenosis (57%), dissection (6%), graft redundancy (12%), and instances of twists, thrombosis, and pressure gradients (10%). These findings were successfully managed with percutaneous transluminal angioplasty only (41%), percutaneous transluminal angioplasty and stent (50%), and various combined interventions. Within the postoperative intervention group, symptomatic indications included stenosis (46%) and thrombosis/occlusion (54%). These postoperative limb events were successfully managed with stent (64%), thrombolysis (32%), and femoral-femoral bypass (21%). When limb dysfunction developed in the postoperative setting, it most often occurred within the first 6 months of implantation. Only one patient in this Phase II cohort had a lower extremity amputation unrelated to a graft limb abnormality. CONCLUSION: The unsupported bifurcated limbs of this endograft necessitated primary adjunctive intervention in 40% of cases. Primary intervention was two times more likely to be performed at the time of the implant rather than after surgery. Repeat limb interventions were not common. Endograft limb flow problems were successfully treated with standard endovascular or surgical interventions or both. These data may support prophylactic stenting of unsupported Ancure graft limbs. A strategy that includes both intraoperative and early postoperative graft limb surveillance is essential to detect reduced limb flow.

Aorta↗

Reliability and validity of hospital pharmacists' clinical intervention data.

The reliability and validity of pharmacist intervention data documented at a hospital in England were studied. The study involved intervention data recorded from September 1 to December 31 in 1990 (a pilot study), 1991, and 1992 by a total of 23 pharmacists. The interventions in 1990 were coded by a single pharmacist manager and compared with coding by pharmacists of their own interventions during 1991 and 1992. To test for internal reliability of the intervention data, 25% (584) of the 2342 interventions recorded in 1991 and 1992 were randomly sampled after interventions by the 11 pharmacists no longer at the site were eliminated. In September 1993 the 12 remaining pharmacists were asked to recode the interventions they had previously entered. In March 1994 a panel of 12 pharmacists recoded 62 interventions randomly selected from the 684 recoded interventions. Each panel member also assigned financial values to interventions. Medical records corresponding to the 62 recoded interventions were inspected for evidence of the interventions. The distribution of interventions among the drug-use-process (DUP) indicators used in the coding differed significantly between 1990 (when a manager assigned all codes) and 1991 plus 1992 (when pharmacists coded their own interventions). There were similar differences between 1991 and 1992. Results from code-recode and panel testing showed the DUP indicators to be reliable. Clinical outcome indicators were unreliable, as were financial indicators. Medical records verified the occurrence of 50 (81%) of the 62 interventions selected, but in only one case was there evidence that the change in drug therapy was initiated by a pharmacist. The capacity of pharmacists at a British hospital to reliably code interventions was poor.

Chi-Square Distribution↗

A nonpharmacological intervention to improve sleep in nursing home patients: results of a controlled clinical trial.

OBJECTIVES: To improve nighttime sleep in nursing home patients. DESIGN: Controlled clinical trial. SETTING: Eight community nursing homes enrolled two at a time. PARTICIPANTS: Of 1,077 patients assessed in the eight nursing homes, 638 (59%) were eligible, and consent was obtained for 273 (43% of those eligible). Of the 230 who underwent baseline assessments, 173 completed the immediate-intervention phase of the trial (77 in the intervention group and 96 in the control group). A total of 160 subjects completed the intervention (77 in the immediate-intervention group and 83 in the delayed-intervention phase). INTERVENTION: Trained research staff provided the intervention, which included daytime physical activity and attempts to keep subjects out of bed, evening bright light exposure, a consistent bedtime routine, nighttime care routines designed to minimize sleep disruption, and strategies to reduce nighttime noise. Subjects from one nursing home received the intervention (Group 1), whereas subjects in the second nursing home served as a control group (Group 2); then Group 2 received the intervention. MEASUREMENTS: Primary outcomes included measures of sleep recorded using wrist actigraphy in all subjects and polysomnography in a subgroup of subjects. Secondary measures included assessments of mood and behavior using the Neuropsychiatric Inventory, the Geriatric Depression Scale, and behavioral observations. RESULTS: There were no significant differences in any of the primary actigraphic sleep outcome measures between the intervention and control group after the immediate-intervention phase of the trial. In the 160 subjects who completed the intervention, there were no significant changes in any actigraphic measure of nighttime sleep, nor were there any significant changes in measures of sleep in the 45 subjects who had baseline and intervention polysomnography. CONCLUSION: This multicomponent, nonpharmacological intervention conducted by trained research staff had no effect on nighttime sleep in this sample of nursing home patients. Enhanced nonpharmacological interventions should be developed and tested and combined with environmental interventions to mitigate noise when feasible. Adjunctive drug therapy may be needed to improve sleep in a substantial proportion of this population and should be tested in addition to nonpharmacological interventions in rigorous clinical trials.

Aged↗

Interventions to improve medication compliance in older patients living in the community: a systematic review of the literature.

Noncompliance affects all age groups, but older patients have specific barriers against effective medication use and can be more vulnerable to the incorrect use of medication. Some age-related barriers are vision loss and cognitive impairment. In people aged 60 years or older, noncompliance with medication regimens varies from 26-59%. In this article we review randomised controlled trials (RCTs) on interventions aimed to improve compliance with medication regimens in older patients living in the community. It is known from other reviews that multifaceted interventions, a combination of interventions, are more often effective than single-focus interventions, probably because these address a wider range of barriers. Also, an individual approach with specifically tailored interventions is effective at improving compliance. In this review the following two hypotheses are evaluated: i) multifaceted interventions improve compliance more successfully than single interventions; and ii) interventions that are tailored to patients improve compliance more successfully than generalised interventions. A systematic literature search in four databases produced 14 suitable RCTs with 23 interventions that we categorised as single or multifaceted, and generalised or tailored. Differences in medication compliance between the intervention group and the control group were in less than half of the comparisons in favour of the intervention group. Telephone-linked reminder systems achieved the most striking effect, looking at differences between the intervention and control group, and deserve further attention. Overall, multifaceted interventions and tailored interventions seemed to result more often in differences in compliance rates in older adults in favour of the intervention group compared with a control group than single and generalised interventions.

Aged↗

Effectiveness of interventions to increase Papanicolaou smear use.

BACKGROUND: Many women fail to adhere to Papanicolaou smear screening guidelines. Although many interventions have been developed to increase screening, the effectiveness of different types of interventions is unclear. METHODS: We performed a systematic review of interventions to increase Papanicolaou smear use published between 1980 and April 2001 and included concurrently or randomized controlled studies with defined outcomes. Interventions were classified as targeted to patients, providers, patients and providers, or health care systems and as behavioral, cognitive, sociologic, or a combination based on the expected action of the intervention. Effect sizes and 95% confidence intervals were calculated for each intervention. RESULTS: Forty-six studies with 63 separate interventions were included. Most interventions increased Papanicolaou smear use, although in many cases the increase was not statistically significant. Behavioral interventions targeted to patients (eg, mailed or telephone reminders) increased Papanicolaou smear use by up to 18.8%; cognitive and sociologic interventions were only marginally effective, although a single culturally specific, sociologic intervention using a lay health worker increased use by 18.0% (95% confidence interval [CI]: 7.6, 28.4). Provider-targeted interventions were heterogeneous. Interventions that targeted both patients and providers did not appear to be any more effective than interventions targeted to either patients or providers alone. One of the most effective interventions, which introduced a system change by integrating a nurse-practitioner and offered same-day screening, increased screening by 32.7% (95% CI: 20.5, 44.9). CONCLUSIONS: Overall, most interventions increased Papanicolaou smear use, although there was tremendous variability in their effectiveness. Selection of intervention strategies will depend on provider and patient population characteristics and feasibility of implementation.

Female↗

Pancreaticoduodenectomy: role of interventional radiologists in managing patients and complications.

Although the mortality rate after pancreaticoduodenectomy has decreased, the morbidity rate remains high. Major morbidity is often managed with the aid of interventional radiologists. The objective of this study was to evaluate the cooperative roles of interventional radiologists and pancreatic surgeons in complex pancreatic surgery, specifically pancreaticoduodenectomy. Our pancreaticoduodenectomy database was reviewed for all patients undergoing pancreaticoduodenectomy between January 1, 1995 and December 31, 2000. The interventional radiologic procedures for each patient were evaluated. A total of 1061 patients underwent pancreaticoduodenectomy. The overall mortality and morbidity rates were 2.3% and 35%, respectively. Five hundred ninety patients (56%) had no interventional radiologic procedures, whereas 471 patients (44%) had interventional radiologic procedures. Of those, 342 (32%) had preoperative biliary drainage (PBD) and 129 (12%) required postoperative interventional radiologic procedures. Percutaneous aspiration/catheter drainage was required in 84 patients for intra-abdominal abscess, biloma, or lymphocele, with 24 requiring two or more abscess drains. Thirty-nine patients underwent postoperative PBD for bile leaks due to anastomotic disruption, undrained biliary segments, or T-tube/bile stent dislodgment. Eighteen patients had hemobilia/gastrointestinal bleeding treated by angiography with embolization. The reoperation rate for the entire cohort of 1061 patients was 4.1% (n = 43). Nineteen of the 129 patients (15%) requiring postoperative radiologic intervention required reoperation. Although 4 of 18 patients who required embolization for bleeding subsequently required surgical intervention for the same reason, only 4 of 84 patients undergoing abscess drainage later required operation for anastomotic disruption or unsuccessful percutaneous drainage. As would be expected, the patients who required postoperative radiologic intervention (n = 129) had a higher incidence of postoperative complications including pancreatic fistula (20% vs. 6%, P < 0.01), bile leakage (22% vs. 1%, P < 0.01), and wound infection (16% vs. 8%, P < 0.01). With the complications in these 129 patients, the postoperative mortality rate was only 6.2% compared to 1.7% in patients who did not require radiologic intervention (n = 932, P < 0.01). The median postoperative length of stay was 15 days in those patients requiring postoperative radiologic intervention, 10 days in those not requiring intervention (P < 0.01; postoperative interventional radiology vs. no postoperative interventional radiology), and 29.5 days for patients needing reoperation. Interventional radiologists play a critical role in the management of some patients undergoing pancreaticoduodenectomy. Although complications such as anastomotic leaks, abscess formation, and bleeding can result in increased mortality and a longer hospital stay, the skills of the interventional radiology team provide expert management of some life-threatening complications, thus avoiding reoperation, speeding recovery times, and minimizing morbidity.

Adenocarcinoma↗

Integrated fellowship in vascular surgery and intervention radiology: a new paradigm in vascular training.

OBJECTIVE: To evaluate an integrated fellowship in vascular surgery and interventional radiology initiated to train vascular surgeons in endovascular techniques and to train radiology fellows in clinical aspects of vascular diseases. SUMMARY BACKGROUND DATA: The rapid evolution of endovascular techniques for the treatment of vascular diseases requires that vascular surgeons develop proficiency in these techniques and that interventional radiologists develop proficiency in the clinical evaluation and management of patients who are best treated with endovascular techniques. In response to this need the authors initiated an integrated fellowship in vascular surgery and interventional radiology and now report their interim results. METHODS: Since 1999 vascular fellows and radiology fellows performed an identical year-long fellowship in interventional radiology. During the fellowship, vascular surgery and radiology fellows perform both vascular and nonvascular interventional procedures. Both vascular surgery and radiology-based fellows spend one quarter of the year on the vascular service performing endovascular aortic aneurysm repairs and acquiring clinical experience in the vascular surgery inpatient and outpatient services. Vascular surgery fellows then complete an additional year-long fellowship in vascular surgery. To evaluate the type and number of interventional radiology procedures, the authors analyzed records of cases performed by all interventional radiology and vascular surgery fellows from a prospectively maintained database. The attitudes of vascular surgery and interventional radiology faculty and fellows toward the integrated fellowship were surveyed using a formal questionnaire. RESULTS: During the fellowship each fellow performed an average of 1,201 procedures, including 808 vascular procedures (236 diagnostic angiograms, 70 arterial interventions, 59 diagnostic venograms, 475 venous interventions, and 43 hemodialysis graft interventions) and 393 nonvascular procedures. On average fellows performed 20 endovascular aortic aneurysm repairs per year. There was no significant difference between the vascular surgery and radiology fellows in either the spectrum or number of cases performed. Eighty-eight percent (23/26) of the questionnaires were completed and returned. Both interventional radiologists and vascular surgeons strongly supported the integrated fellowship model and favored continuation of the integrated program. Vascular surgery and interventional radiology faculty members wanted additional training in clinical vascular surgery for the radiology-based fellows. With the exception of the radiology fellows there was uniform agreement that vascular surgery fellows benefit from training in nonvascular aspects of interventional radiology. CONCLUSIONS: Integration of vascular surgery and interventional radiology fellowships is feasible and is mutually beneficial to both disciplines. Furthermore, the integrated fellowship provides exceptional training for vascular surgery and interventional radiology fellows in all catheter-based techniques that far exceeds the minimum requirements for credentialing suggested by various professional societies. There is a clear need for cooperation and active involvement on the parts of the American Board of Radiology and the American Board of Surgery and its Vascular Board to create hybrid training programs that meet mutually agreed-on criteria that document sufficient acquisition of both the cognitive and technical skills required to manage patients undergoing endovascular procedures safely and effectively.

Attitude of Health Personnel↗

Smoke-Free Home Intervention in Permanent Supportive Housing: A Cluster Randomized Clinical Trial.

IMPORTANCE: Chronic diseases related to tobacco use and secondhand smoke exposure are the leading causes of death among formerly homeless adults living in permanent supportive housing (PSH) in the US. OBJECTIVE: To evaluate the efficacy of a brief, smoke-free home intervention in promoting voluntary smoke-free home adoption among PSH residents. DESIGN, SETTING, AND PARTICIPANTS: In this cluster randomized clinical trial, data collection occurred from January 11, 2022, to March 31, 2025. Participants were residents aged 18 years or older who smoked cigarettes at home in 40 multiunit PSH sites in the San Francisco Bay area, randomized to intervention or waiting list control clusters, and housing staff who worked at the study sites. INTERVENTION: Residents in intervention sites received one-on-one in-person coaching from research staff on adopting a smoke-free home; waiting list control site residents received no interventions during the study but were offered the intervention once the intervention group completed follow-up. Staff in both intervention and control sites received training on providing brief tobacco cessation coaching. MAIN OUTCOMES AND MEASURES: Primary outcomes were smoke-free home adoption for at least 90 days and 7-day carbon monoxide-verified point prevalence abstinence (PPA; expired carbon monoxide level &#x2264;5 ppm) at 6 months. Secondary outcomes were any adoption (&#x2265;1 day) of a smoke-free home in the past 90 days among residents and changes in Smoking Knowledge, Attitudes, and Practices (S-KAP) scores among staff. RESULTS: The trial enrolled 400 residents (mean [SD] age, 54.5 [10.7] years; 251 [63.1%] male), 191 in the intervention and 209 in the control cluster. At 6 months, 13 residents (6.8%) in the intervention and 10 (4.8%) in the control group adopted a smoke-free home for at least 90 days (odds ratio [OR], 1.45; 95% CI, 0.69-3.07). Few residents achieved 7-day PPA, though more intervention residents (12 [6.3%]) achieved it compared with controls (2 [1.0%]) (OR, 6.94; 95% CI, 1.69-28.45). Intervention residents had greater odds than control residents of any smoke-free home adoption of at least 1 day (121 [63.4%] vs 77 [36.8%]; adjusted OR, 3.83 [95% CI, 2.63-5.57]). Among staff, mean (SD) S-KAP scores increased at 6 months vs baseline for beliefs (by 0.21 [0.55] points) and practices (by 0.24 [0.61] points) pertaining to providing cessation treatment. CONCLUSIONS AND RELEVANCE: In this cluster randomized clinical trial, the brief intervention did not result in a significant increase in smoke-free home adoption for at least 90 days, though more residents in the intervention than the control group attempted adoption for at least 1 day. These findings support the scalability of this approach to reduce smoking in PSH, but more intensive interventions may be needed to sustain intervention effects. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04855357.

Humans↗

On design considerations and randomization-based inference for community intervention trials.

This paper discusses design considerations and the role of randomization-based inference in randomized community intervention trials. We stress that longitudinal follow-up of cohorts within communities often yields useful information on the effects of intervention on individuals, whereas cross-sectional surveys can usefully assess the impact of intervention on group indices of health. We also discuss briefly special design considerations, such as sampling cohorts from targeted subpopulations (for example, heavy smokers), matching the communities, calculating sample size, and other practical issues. We present randomization tests for matched and unmatched cohort designs. As is well known, these tests necessarily have proper size under the strong null hypothesis that treatment has no effect on any community response. It is less well known, however, that the size of randomization tests can exceed nominal levels under the 'weak' null hypothesis that intervention does not affect the average community response. Because this weak null hypothesis is of interest in community intervention trials, we study the size of randomization tests by simulation under conditions in which the weak null hypothesis holds but the strong null hypothesis does not. In unmatched studies, size may exceed nominal levels under the weak null hypothesis if there are more intervention than control communities and if the variance among community responses is larger among control communities than among intervention communities; size may also exceed nominal levels if there are more control than intervention communities and if the variance among community responses is larger among intervention communities. Otherwise, size is likely near nominal levels. To avoid such problems, we recommend use of the same numbers of control and intervention communities in unmatched designs. Pair-matched designs usually have size near nominal levels, even under the weak null hypothesis. We have identified some extreme cases, unlikely to arise in practice, in which even the size of pair-matched studies can exceed nominal levels. These simulations, however, tend to confirm the robustness of randomization tests for matched and unmatched community intervention trials, particularly if the latter designs have equal numbers of intervention and control communities. We also describe adaptations of randomization tests to allow for covariate adjustment, missing data, and application to cross-sectional surveys. We show that covariate adjustment can increase power, but such power gains diminish as the random component of variation among communities increases, which corresponds to increasing intraclass correlation of responses within communities. We briefly relate our results to model-based methods of inference for community intervention trials that include hierarchical models such as an analysis of variance model with random community effects and fixed intervention effects. Although we have tailored this paper to the design of community intervention trials, many of the ideas apply to other experiments in which one allocates groups or clusters of subjects at random to intervention or control treatments.

Clinical Trials as Topic↗

Psychosocial and psychological interventions for preventing postpartum depression.

BACKGROUND: The cause of postpartum depression remains unclear, with extensive research suggesting a multi-factorial aetiology. However, epidemiological studies and meta-analyses of predictive studies have consistently demonstrated the importance of psychosocial and psychological variables. While interventions based on these variables may be effective treatment strategies, theoretically they may also be used in pregnancy and the early postpartum period to prevent postpartum depression. OBJECTIVES: Primary: to assess the effect of diverse psychosocial and psychological interventions compared with usual antepartum, intrapartum, or postpartum care to reduce the risk of developing postpartum depression. Secondary: to examine (1) the effectiveness of specific types of psychosocial and psychological interventions, (2) the effectiveness of individual versus group-based interventions, (3) the effects of intervention onset and duration, and (4) whether interventions are more effective in women selected with specific risk factors. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (January 27 2004), the Cochrane Depression, Anxiety and Neurosis Group trials register (October 2003), the Cochrane Central Register of Controlled Trials (October 2003), MEDLINE (1966 to 2004), EMBASE (1980 to 2004) and CINAHL (1982 to 2004). We scanned secondary references and contacted experts in the field. SELECTION CRITERIA: All published and unpublished randomised controlled trials of acceptable quality comparing a psychosocial or psychological intervention with usual antenatal, intrapartum, or postpartum care. DATA COLLECTION AND ANALYSIS: Both reviewers participated in the evaluation of methodological quality and data extraction. Additional information was sought from several trial researchers. Results are presented using relative risk for categorical data and weighted mean difference for continuous data. MAIN RESULTS: Fifteen trials, involving over 7600 women, were included. Overall, women who received a psychosocial intervention were equally likely to develop postpartum depression as those receiving standard care (relative risk (RR) 0.81, 95% confidence interval (CI) 0.65 to 1.02). One promising intervention appears to be the provision of intensive postpartum support provided by public health nurses or midwives (RR 0.68, 95% CI 0.55 to 0.84). Identifying mothers 'at-risk' assisted the prevention of postpartum depression (RR 0.67, 95% CI 0.51 to 0.89). Interventions with only a postnatal component appeared to be more beneficial (RR 0.76, 95% CI 0.58 to 0.98) than interventions that also incorporated an antenatal component. While individually-based interventions may be more effective (RR 0.76, 95% CI 0.59 to 1.00) than those that are group-based, women who received multiple-contact intervention were just as likely to experience postpartum depression as those who received a single-contact intervention. REVIEWERS' CONCLUSIONS: Overall psychosocial interventions do not reduce the numbers of women who develop postpartum depression. However, a promising intervention is the provision of intensive, professionally-based postpartum support.

Depression, Postpartum↗

Communicating with children and adolescents about their cancer.

BACKGROUND: Communication with children and adolescents with cancer about their disease and treatment and the implications of these is an important aspect of good quality care. It is often poorly performed in practice. Various interventions have been developed that aim to enhance communication involving children or adolescents with cancer. OBJECTIVES: To examine the effects of interventions to enhance communication with children and/or adolescents about their cancer, its treatment and their implications. SEARCH STRATEGY: The following electronic databases were searched: Cochrane Library; Medline; PsycLit; Cinahl; Cancerlit; EMBASE; Sociofile; Health Management Information Consortium; ASSIA; LISA; ERIC; PAIS; Information Science Abstracts; Dissertation Abstracts; JICST; Pascal; Linguistics and Language Behavior Abstracts; Mental Health Abstracts; AMED; MANTIS. Bibliographies of identified studies were also checked and contact made with experts in the field. SELECTION CRITERIA: Randomised and non-randomised controlled trials and before and after studies that evaluated the effects of interventions to enhance communication with children and/or adolescents about their cancer, treatment and related issues. DATA COLLECTION AND ANALYSIS: Data relating to the interventions, populations and outcomes studied and the design and methodological quality of included studies were extracted by one reviewer and checked by another reviewer. A narrative summary of the results is presented. MAIN RESULTS: Six studies met the criteria for inclusion. They were diverse in terms of the interventions evaluated, study designs used, types of people who participated and the outcomes measured. One study of a computer-assisted education programme reported improvements in knowledge and understanding about blood counts and cancer symptoms. Two out of two studies of school reintegration programs reported improvements in some aspects of psychosocial wellbeing (one in anxiety and one in depression), social wellbeing (two in social competence and one in social support) and behavioural problems; and one reported improvements in physical competence. REVIEWER'S CONCLUSIONS: Interventions to enhance communication involving children and adolescents with cancer have not been widely or rigorously assessed. The weak evidence that exists suggests that some children and adolescents with cancer may derive some benefit from specific information-giving programs and from interventions that aim to facilitate their reintegration into school and social activities. More research is needed to investigate the effects of these and other related interventions.

Adolescent↗

Designing effective nursing interventions.

The purpose of this article is to present issues scientists must consider to design effective experimental interventions. The efforts of nurse-researchers to test diverse interventions are consistent with the central role of interventions for the nursing discipline. Despite the importance of interventions, limited literature has addressed the actual design of these interventions. Many experimental interventions lack content validity, and others are inadequate to affect outcomes. Eight issues to consider in the development of interventions are discussed, including the conceptual basis of the intervention, descriptive research linking key concepts to the proposed outcome, previous intervention literature testing similar or related interventions, the intervention target, intervention specificity/generality, single or bundled interventions, intervention delivery, and intervention dose. Strategies are recommended for designing effective experimental interventions.

Clinical Trials as Topic↗

Small group intervention vs formal seminar for improving appropriate drug use.

In an attempt to evaluate the efficacy of different methods of interventions to improve the appropriate use of drugs for acute diarrhoea, a controlled study has been carried out in 6 districts in Yogyakarta and Central Java provinces, Indonesia. This study was designed to investigate the impacts of two different methods of educational intervention, i.e. a small group face-to-face intervention and a formal seminar for prescribers, on prescribing practice in acute diarrhoea. The districts were randomly assigned into 3 groups and 15 health centers were selected from each district. Prescribers in Group 1 underwent a small group face-to-face intervention conducted in the respective health center. Those in Group 2 attended a formal seminar conducted at the district level. Prescribers in Group 3 served as the control group. Both interventions were given on a single occasion without follow-up supervision or monitoring. Written information materials on the appropriate management of acute diarrhoea were developed and were provided to all prescribers in the intervention groups. Focus group discussions (FGDs) involving prescribers and consumers in the 6 districts were carried out to identify various underlying motivations of drug use in acute diarrhoea. The findings of the FGDs were used as part of the intervention materials. To evaluate the impacts of these interventions on prescribing practice, a prescribing survey for patients under five years old with acute diarrhoea was carried out in health centers covering 3-month periods before and after the intervention. The results showed that both interventions were equally effective in improving the levels of knowledge of prescribers about the appropriate management of acute diarrhoea. They were also partially effective in improving the appropriate use of drugs, reducing the use of non-rehydration medications. There was a highly significant reduction of antimicrobial usage either after small-group face-to-face intervention (77.4 +/- 2.7% to 60.4 +/- 2.9%; P < 0.001) or formal seminar (82.3 +/- 3.0% to 72.3 +/- 3.6%; P < 0.001), and the former caused significantly (P < 0.001) greater reduction than the latter. There was also a significant (P < 0.01) reduction in the usage of antidiarrhoeals after both interventions, i.e. from 20.3 +/- 3.7% to 12.5 +/- 3.3% (P < 0.01) after face-to-face intervention and from 48.5 +/- 4.1% to 27.0 +/- 4.3% (P < 0.01) after seminar. However, the formal seminar had a significantly (P < 0.01) greater impact than the small group face-to-face intervention. There was also a trend toward increased oral rehydration solution (ORS) usage after both interventions, but this did not achieve the level of statistical significance (P > 0.05). No changes were observed in the control group. Although the small group face-to-face intervention did not appear to offer greater impacts over large seminars in improving the appropriate use of drugs in acute diarrhoea, since the unit cost of training is far less costly than the seminar, it might be feasibly implemented in the existing supervisory structure of the health system.

Acute Disease↗

Coronary pressure measurement to identify the lesion requiring percutaneous coronary intervention in equivocal tandem lesions.

OBJECTIVES: No reliable methods are available for determining application of percutaneous coronary intervention for treatment of equivocal tandem lesions. We investigated whether coronary pressure measurement is useful for determining the lesion that requires percutaneous coronary intervention in tandem lesions. METHODS: We measured coronary pressure in 72 consecutive patients with tandem lesions. Myocardial fractional flow reserve (FFRmyo) was obtained as the ratio of coronary pressure distal to the lesion/aortic pressure under maximal hyperemia. If the FFRmyo across the tandem lesions was >or=0.75, we deferred percutaneous coronary intervention for the lesion. When the tandem lesions showed FFRmyo<0.75, percutaneous coronary intervention was performed on the lesion that showed angiographically higher stenosis. When FFRmyo was <0.75 after one-lesion percutaneous coronary intervention, this intervention was carried out on the remaining lesion. RESULTS: We deferred percutaneous coronary intervention for 26 patients (36.1%), and performed percutaneous coronary intervention in 46 patients (63.8%). We performed percutaneous coronary intervention for one lesion in 19 patients (26.4%) and for both lesions in 27 patients (37.5%). Among patients in whom percutaneous coronary intervention was deferred, only two patients (7.7%) required target lesion revascularization during the follow-up period. This rate was not higher than that in the 46 patients who underwent percutaneous coronary intervention for one or two lesions (six patients, 13.0%). Similarly, the target lesion revascularization in lesions with initially deferred percutaneous coronary intervention (5.6%, 4/71 lesions) was not higher than that in lesions with percutaneous coronary intervention (15.1%, 11/73 lesions). Major cardiac events, cardiac death and acute myocardial infarction, did not occur in patients with deferred percutaneous coronary intervention and in those with percutaneous coronary intervention during the follow-up period. CONCLUSION: Our results clearly showed that coronary pressure measurement was clinically useful for identifying equivocal tandem lesions requiring percutaneous coronary intervention.

Aged↗