Efficacy of a systematic depression management program in high utilizers of primary care: a randomized trial

ABSTRACT: BACKGROUND: Approximately 25% of so-called high utilizers of medical care are estimated to suffer from depression. A large proportion of these individuals remain undiagnosed and untreated. This study aims to examine the effects of a systematic screening and collaborative treatment program on depression severity in small primary care practices of the German outpatient health care system. METHOD: High utilizers of primary care who screened positive for depressive symptoms on the Brief Psychiatric Health Questionnaire (B-PHQ) were further diagnosed using the DIA-X, a standardized diagnostic interview, performed by trained and supervised interviewers. Patients with major depression were randomized (cluster randomization by practice) to (a) a six-month treatment program of pharmacotherapy, standardized patient and provider education, and physician and patient counseling or (b) six months of usual medical care. All subjects were followed for a 12-month observation period using the 17-item Hamilton Depression Rating scale (HAMD-17) rated by the treating physicians and the B-PHQ-9 rated by the patients. RESULTS: A total of 63 high utilizer patients were included in the trial (17 male, 46 female), 19 randomized to intervention, 44 to usual care. The mean age was 49.7 (SD 13.8). Most patients had one or more somatic co-morbidities. There was no significant difference in response (defined as a decrease in the HAMD-17 sum score of at least 50%) after six months of treatment (50% vs. 42%, p = 0.961, all analyses adjusted for age) and after 12 months of treatment (83% vs. 54%, p = 0.282) between groups. Using patient self-rating assessments with the B-PHQ-9 questionnaire the intervention was superior to treatment as usual at six months (83% vs. 16%, p = 0.000).There was no significant difference in HAMD-17 depression severity at six months between the groups (10.5 (SD 7.6) vs. 12.3 (SD 7.8), p = 0.718), but a trend at 12 months (4.7 (SD 8.0) vs. 11.2 (SD 7.4), p = 0.083). Again, using B-PHQ-9 sum scores depression severity was significantly lower in the intervention group than in the treatment as usual group after six months (6.4 (SD 5.2) vs. 11.5 (SD 5.8), p = 0.020), but not at 12 months (7.9 (SD 8.7) vs. 9.0 (SD 5.2), p = 0.858). CONCLUSION: A systematic collaborating treatment program for depression in high utilizers in primary care showed superiority to treatment as usual only in terms of patients[ACUTE ACCENT] self-assessment but not according to physicians[ACUTE ACCENT] assessment. The advance of the intervention group at 6 months was lost after 12 months of follow-up. Overall, positive results from similar trials in the US health care systems could not be confirmed in a German primary care setting.     

Selection bias from requiring patients to give consent to examine data for health services research

BACKGROUND: New rulings nationwide require health services researchers to obtain patient consent before examining personally identifiable data. A selection bias may result if consenting patients differ from those who do not give consent. OBJECTIVE: To compare patients who consent, refuse, and do not answer. DESIGN: Patients completing an in-office survey were asked for permission to be surveyed at home and for their records to be reviewed. Survey responses and practice billing data were used to compare patients by consent status. SETTING: Urban family practice center. PATIENTS: Of 2046 eligible patients, 1106 were randomly selected for the survey, were approached by staff, and agreed to participate. Approximately 87% of the nonparticipants were eliminated through a randomization process. MAIN OUTCOME MEASURE: Consent status. RESULTS: A total of 33% of patients did not give consent: 25% actively refused, and 8% did not answer. Consenting patients were older, included fewer women and African Americans, and reported poorer physical function than those who did not give consent (P<.05). Patients who did not answer the question were older, included more women and African Americans, and were less educated than those who answered (P<.02). Visits for certain reasons (eg, pelvic infections) were associated with lower consent rates. On multivariate analysis, older age, male sex, and lower functional status were significant predictors of consent. CONCLUSIONS: Patients who release personal information for health services research differ in important characteristics from those who do not. In this study, older patients and those in poorer health were more likely to grant consent. Quality and health services research restricted to patients who give consent may misrepresent outcomes for the general population. Arch Fam Med. 2000;9:1111-1118     

A randomized controlled trial of information-giving to patients referred for coronary angiography: effects on outcomes of care

Objective To assess the impact of providing an educational videotape, ` Treatment Choices for Ischaemic Heart Disease: a Shared Decision-Making Program Videotape ,' to patients referred for coronary angiography compared with standard patient-physician decision making (usual care).
Study design Randomized controlled clinical trial.
Setting University Hospital and Veterans Affairs Hospital.
Patients A consecutive sample of 217 patients referred for coronary angiography were randomized to receive `usual care' or to receive the videotape in addition to standard patient physician decision making (videotape): 109 completed the study (50% completion rate).
Main outcome measures Knowledge of coronary artery disease, satisfaction, self-reported physical and mental health functioning, and the proportion of patients who were referred for coronary revascularization.
Results Compared with patients who received `usual care,' those who received the videotape were more knowledgeable (mean score 83 vs. 58%; P  < 0.0001) but less satisfied with their treatment (79 vs. 88%; P  = 0.038). There were no significant differences between the videotape and `usual care' groups with respect to satisfaction with the decision making process (mean score 73 vs. 77%; P  = 0.37), satisfaction with the decision made (mean score 73 vs. 78%; P  = 0.28), physical functioning (38 vs. 38%; P  = 0.76), mental health functioning (49 vs. 49%; P  = 0.94), or in referral for coronary revascularization (OR 0.60; 95% CI 0.22–1.65; P  = 0.33).
Conclusion Although the educational videotape increased patients' knowledge level, it was associated with a decrease in their level of satisfaction with treatment. Before there is wide-spread dissemination of this technology, advocates should demonstrate its effectiveness in everyday practice.     

Impact of Peer Health Coaching on Glycemic Control in Low-Income Patients With Diabetes: A Randomized Controlled Trial

PURPOSE

Peer health coaches offer a potential model for extending the capacity of primary care practices to provide self-management support for patients with diabetes. We conducted a randomized controlled trial to test whether clinic-based peer health coaching, compared with usual care, improves glycemic control for low-income patients who have poorly controlled diabetes.

METHOD

We undertook a randomized controlled trial enrolling patients from 6 public health clinics in San Francisco. Twenty-three patients with a glycated hemoglobin (HbA_1C) level of less than 8.5%, who completed a 36-hour health coach training class, acted as peer coaches. Patients from the same clinics with HbA_1C levels of 8.0% or more were recruited and randomized to receive health coaching (n = 148) or usual care (n = 151). The primary outcome was the difference in change in HbA_1C levels at 6 months. Secondary outcomes were proportion of patients with a decrease in HbA_1C level of 1.0% or more and proportion of patients with an HbA_1C level of less than 7.5% at 6 months. Data were analyzed using a linear mixed model with and without adjustment for differences in baseline variables.

RESULTS

At 6 months, HbA_1C levels had decreased by 1.07% in the coached group and 0.3% in the usual care group, a difference of 0.77% in favor of coaching (P = .01, adjusted). HbA_1C levels decreased 1.0% or more in 49.6% of coached patients vs 31.5% of usual care patients (P = .001, adjusted), and levels at 6 months were less than 7.5% for 22.0% of coached vs 14.9% of usual care patients (P = .04, adjusted).

CONCLUSIONS

Peer health coaching significantly improved diabetes control in this group of low-income primary care patients.Key words: peer coach, diabetes mellitus type 2, self care, primary health care, self-management support     

Patient navigation and case management following an abnormal mammogram: a randomized clinical trial

BACKGROUND: A high rate of low-income, ethnic minority women delay or fail to keep appointments following abnormal mammograms. This study was designed to test the effectiveness of a structured counseling and patient navigation intervention for improving follow-up rates at a large public sector medical center. METHODS: This randomized clinical trial, conducted in Los Angeles 2001-2002, included 204 women with abnormal mammograms referred for follow-up who were then assigned to intervention or usual care. The primary outcome was the rate of follow-up through diagnostic resolution within eight months. RESULTS: The intervention resulted in a significant increase in the rate of adherence to follow-up through diagnostic resolution. The intervention group was much more likely to be adherent through diagnostic resolution than the control group (90% vs. 66%, OR=4.48, p<0.001) and were more likely to experience timely adherence than UC patients (77% vs. 57%, OR=2.5, p=0.01). Intervention effectiveness was not significantly different for women assigned to different levels of service intensity. CONCLUSIONS: Patient navigation and counseling driven by a structured clinical algorithm are highly effective strategies to improve diagnostic resolution follow-up among low-income, ethnic minority women with abnormal mammograms. The intervention algorithm and available training materials can be adapted for diverse care systems serving high-risk women to decrease loss to follow-up.     

Written Informed Consent for Participation in a Study and Reduction in Consent Rate

Background

The association between the method of obtaining informed consent and the consent rate in a cohort study, as well as the differences between consenters and non-consenters with regard to blood-sample donation are unclear.

Methods

We measured the consent rates among 64-year-old residents who underwent medical checkups in a city for a cohort study consisting of a questionnaire survey and blood-sample donation and determined the influence of different approaches to informed consent and the participants’ characteristics on the consent rates.

Results

Of 3,098 residents who underwent medical checkups over 10 years, 99.2% responded to the questionnaire survey, and 92.5% agreed to blood-sample donation. The consent rate for blood-sample donation after obtaining individual written informed consent was lower than that observed with the general-announcement approach. Differences in the consent rates for participation in the questionnaire study were, however, negligible. A higher percentage of men than women consented to donate blood samples. After adjustments for gender, it was observed that individuals with a history of hypertension and those without depression consented to blood-sample donation significantly more frequently.

Conclusion

The consent rate for blood-sample donation to the study decreased when the opt-in approach with written consent was used. This decrease may introduce consent bias, and the method of obtaining informed consent should be revised.Key words: Informed Consent, Consent Rate, Medical Check-up     

A Tailored Discharge Program Improves Frailty and Mood in Patients Undergoing Usual Rehabilitative Care: A Randomized Controlled Trial

ObjectiveTo investigate whether a tailored intersectoral discharge program (TIDP) impacts on multidimensional frailty, rehospitalization days, and patient-related outcome measures in older in-patients undergoing acute care and usual rehabilitative care.DesignRandomized controlled trial of TIDP vs usual rehabilitative care with a 6-month follow-up, 2019–2020, and historical control with a 6-month follow-up, 2016–2019.Setting and ParticipantsGeriatric co-managed internal medicine ward of a metropolitan university hospital. One hundred-twelve multimorbid patients older than age 60 years were consecutively assessed for eligibility and inclusion (age ≥60 years, multimorbidity, admitted for treatment of acute disease, at least 2 geriatric syndromes requiring usual rehabilitative care, and able to consent) and signed informed consent, with 110 recruited and randomized to either TIDP or usual rehabilitative care. At discharge, 104 patients were alive in the intention-to-treat group, the 6-month follow-up was completed for 91 patients. A historical control group of 468 patients was included for comparison.InterventionTIDP as intervention included contact with treating general practitioner to discuss the further treatment plan, a structured medical and lifestyle counseling to patients and caregivers at admission as well as a discharge program with internist, geriatrician, and general practitioner in shared decision making with patients.MethodsFifty-four patients underwent TIDP, 53 patients underwent usual rehabilitative care only. Rehospitalization days at follow-up as primary endpoint; multidimensional frailty and prognosis (Multidimensional Prognostic Index, Geriatric Depression Scale, Rosenberg Self-Esteem Scale, quality of life, falls, mortality, home care service need, and need of long-term care at 1-, 3- and 6-month follow-up as secondary endpoints.ResultsTIDP (median age 76.0 years, 56% female) showed significantly improved Multidimensional Prognostic Index scores at discharge compared with usual rehabilitative care (median age 78.5 years, 58% female) (0.43 vs 0.49, P = .011). Compared with usual rehabilitative care, TIDP improved self-confidence (Rosenberg Self-Esteem Scale 13.9 vs 12.4, P = .009) and mood (Geriatric Depression Scale 4 vs 5, P = .027) at follow-up. Compared with historical control (median age 77.0 years, 39 % female), usual rehabilitative care patients showed significantly lower rehospitalization rates (53% vs 70%, P = .002) and lower mortality rates (13% vs 32%, P < .001).Conclusions and ImplicationsA feasible TIDP improves frailty and mood in advanced age. In older patients undergoing potentially disabling acute treatments, usual rehabilitative care significantly reduces rehospitalization rates. Therefore, implementing geriatric treatment in general is useful to improve outcomes in older in-patients and a tailored discharge program can further increase the benefit for this frail population.     

Treatment of cutaneous leishmaniasis with aminosidine (paromomycin) ointment: double-blind,randomized trial in the Islamic Republic of Iran

OBJECTIVE: To compare the parasitological and clinical efficacy of four weeks versus two weeks of treatment with aminosidine (paromomycin) ointment in patients with cutaneous leishmaniasis caused by Leishmania major in the Islamic Republic of Iran. METHODS: Double-blind, randomized trial of four weeks of aminosidine ointment (n = 108) vs two weeks of aminosidine ointment and two weeks of placebo (n = 108). Patients were assessed on days 15, 29, 45, and 105 for clinical cures and clinical and parasitological cures. FINDINGS: Four weeks' treatment gave significantly better cure rates than two weeks' treatment: on day 29, there were 80/108 (74%) vs 64/108 (59%) clinical cures (P = 0.05) and 47 (44%) vs 26 (24%) clinical and parasitological cures (P = 0.005). By day 45, fewer patients who received four weeks' treatment had required rescue treatment with antimonials than those who received two weeks' treatment: 20 (19%) vs 36 (33%) (P = 0.02). On day 105, the results still favoured those who had been allocated four weeks of active treatment, but the differences were no longer as clearly significant. No side-effects were observed or reported. CONCLUSION: Approximately two-thirds of patients given ointment for four weeks were cured clinically. Although about half of those cured might have recovered spontaneously even without treatment, four weeks of aminosidine ointment could become the first-line treatment for uncomplicated cutaneous leishmaniasis due to L. major, with antimonials needed in only the one-third of patients not cured by the end of treatment with aminosidine. This would considerably reduce the costs and side-effects associated with antimonial drugs.     

Telephone reminders increase re-screening in a county breast screening program

INTRODUCTION: Mammography can reduce breast cancer mortality through routine screening. We tested an intervention to increase re-screening in a county program. METHODS: The program requires enrollment before screening. We randomized women who had previously been screened by the program to a telephone call reminder for re-enrollment or usual care (postcard reminder). We followed re-enrollment and re-screening rates for both groups. RESULTS: Compared with the control group (n=610), women in the intervention group (n=599) had higher rates of initial re-enrollment at one month (10% vs. 24%, p<.001) and re-screening at two months (11% vs. 19%, p<.001). These effects persisted over time (five-month re-enrollment: 24% vs. 35%, p<.001; six-month re-screening: 23% vs. 31%, p=.004). The intervention did not alter the odds of a woman's being re-screened once re-enrolled. CONCLUSION: The increase in our re-screening rate after this simple intervention was as great or greater than the rates reported in other studies. A telephone reminder for women previously enrolled in a county breast screening program can increase re-enrollment and subsequent re-screening rates.     

Integrated management of type 2 diabetes mellitus and depression treatment to improve medication adherence: a randomized controlled trial

PURPOSE

Depression commonly accompanies diabetes, resulting in reduced adherence to medications and increased risk for morbidity and mortality. The objective of this study was to examine whether a simple, brief integrated approach to depression and type 2 diabetes mellitus (type 2 diabetes) treatment improved adherence to oral hypoglycemic agents and antidepressant medications, glycemic control, and depression among primary care patients.

METHODS

We undertook a randomized controlled trial conducted from April 2010 through April 2011 of 180 patients prescribed pharmacotherapy for type 2 diabetes and depression in primary care. Patients were randomly assigned to an integrated care intervention or usual care. Integrated care managers collaborated with physicians to offer education and guideline-based treatment recommendations and to monitor adherence and clinical status. Adherence was assessed using the Medication Event Monitoring System (MEMS). We used glycated hemoglobin (HbA_1c) assays to measure glycemic control and the 9-item Patient Health Questionnaire (PHQ-9) to assess depression.

RESULTS

Intervention and usual care groups did not differ statistically on baseline measures. Patients who received the intervention were more likely to achieve HbA_1c levels of less than 7% (intervention 60.9% vs usual care 35.7%; P <.001) and remission of depression (PHQ-9 score of less than 5: intervention 58.7% vs usual care 30.7%; P <.001) in comparison with patients in the usual care group at 12 weeks.

CONCLUSIONS

A randomized controlled trial of a simple, brief intervention integrating treatment of type 2 diabetes and depression was successful in improving outcomes in primary care. An integrated approach to depression and type 2 diabetes treatment may facilitate its deployment in real-world practices with competing demands for limited resources.     

Attitudes to randomized clinical trials amongst out-patients attending a medical oncology clinic

Objective  To assess the understanding of and attitudes towards randomized clinical trials amongst patients attending oncology out-patient clinics.
Design  Cross-sectional survey.
Subjects  Patients attending medical oncology out-patient clinics at a Sydney teaching hospital.
Main outcome  Patients' willingness to participate in a randomized clinical trial.
Results  Sixty consecutive patients were surveyed. The mean age was 55.2 (SD 14) years. Eighty-eight per cent of respondents thought that patients should be asked to participate in trials testing new treatments, however, only a third would consider participating in a randomized trial themselves. If a trial was endorsed by an independent cancer information service such as the NSW Cancer Council, 72% of respondents would be more likely to participate. Knowledge about randomized trials was not high. Respondents scored a median of 3 out of 7 (interquartile range, 2–4) correct answers to a series of questions about randomized trials. Patients willing to participate in a randomized trial were more likely to perceive the doctor favourably ( P  = 0.05), less likely to perceive trials as experimental ( P  = 0.05) and less likely to perceive trials as representing an inconvenience or loss of control ( P  = 0.09).
Conclusions  Understanding amongst patients of the need for and mechanisms of randomized clinical trials is not good. This may contribute to the difficulties investigators face in seeking consent for clinical trials. Evaluation of new strategies to educate the public and patients about randomized trials is needed. Involvement of consumers in the design and conduct of clinical trials and evaluation of strategies to improve doctors' communication of clinical trial information is also required.     

A randomized trial of the effect of moistening misoprostol before vaginal administration when used with methotrexate for abortion.

A prospective multicenter, randomized trial was performed to evaluate if moistened misoprostol results in a more rapid abortion and a higher rate of complete abortion compared with dry misoprostol when administered intravaginally for medical abortion after methotrexate. A total of 240 pregnant women < or = 49 days gestation seeking elective abortion received 50 mg/m2 methotrexate intramuscularly followed 5-6 days later by 800 micrograms misoprostol vaginally. The misoprostol dose was repeated in 1-2 days if the abortion did not occur. Group 1 moistened the misoprostol before administration and group 2 used dry tablets. There was no statistically significant difference in the cumulative rate of abortion after the first misoprostol dose (73.0% vs 71.3%, p = 0.87), second misoprostol dose (84.1% vs 81.1%, p = 0.65), or by 35 days after methotrexate administration (95.2% vs 91.8%, p = 0.40) between groups 1 and 2, respectively. The proportion of subjects with embryonic cardiac activity 2 weeks after methotrexate injection was greater in group 2 (5.7%, 95% confidence interval [CI] 1.0%, 9.9%) than in group 1 (2.4%, 95% CI 0%, 5.0%), although not statistically significant (p = 0.21). The immediate success rate in Pittsburgh was greater, albeit not statistically, for the women that moistened the misoprostol (87% vs 76%, p = 0.19); these rates were also not statistically different in Havana (82% vs 86%, p = 0.62). The rate of side effects after methotrexate was not different between groups but women in group 1 had significantly more diarrhea (36% vs 21%, p = 0.02) and fever/warmth/chills (44% vs 30%, p = 0.04). Moistening misoprostol before vaginal administration in a medical abortion regimen with methotrexate does not statistically improve efficacy. This trial demonstrates the importance of prospective, randomized studies to prove the relative efficacy of any medical abortion treatment regimen.     

A Randomized Controlled Trial of Heart Failure Disease Management in Skilled Nursing Facilities

ObjectivePatients discharged from the hospital to a skilled nursing facility (SNF) are not typically part of a heart failure disease management program (HF-DMP). The objective of this study is to determine if an HF-DMP in SNF improves outcomes for patients with HF.DesignCluster-randomized controlled trial.ParticipantsThe trial was conducted in 47 SNFs, and 671 patients were enrolled (329 HF-DMP; 342 to usual care).MethodsThe HF-DMP included documentation of ejection fraction, symptoms, weights, diet, medication optimization, education, and 7-day visit post SNF discharge. The composite outcome was all-cause hospitalization, emergency department visits, or mortality at 60 days. Secondary outcomes included the composite endpoint at 30 days, change in the Kansas City Cardiomyopathy Questionnaire and the Self-care of HF Index at 60 days. Rehospitalization and mortality rates were calculated as an exploratory outcome.ResultsMean age of the patients was 79 ± 10 years, 58% were women, and the mean ejection fraction was 51% ± 16%. At 30 and 60 days post SNF admission, the composite endpoint was not significant between DMP (29%) and usual care (32%) at 30 days and 60 days (43% vs 47%, respectively). The Kansas City Cardiomyopathy Questionnaire significantly improved in the HF-DMP vs usual care for the Physical Limitation (11.3 ± 2.9 vs 20.8 ± 3.6; P = .039) and Social Limitation subscales (6.0 ± 3.1 vs 17.9 ± 3.8; P = .016). Self-care of HF Index was not significant. The total number of events (composite endpoint) totaled 517 (231 in HF-DMP and 286 in usual care). Differences in the 60-day hospitalization rate [mean HF-DMP rate 0.43 (SE 0.03) vs usual care 0.54 (SE 0.05), P = .04] and mortality rate (HF-DMP 5.2% vs usual care 10.8%, P < .001) were significant.Conclusions and ImplicationsThe composite endpoint was high for patients with HF in SNF regardless of group. Rehospitalization and mortality rates were reduced by the HF-DMP. HF-DMPs in SNFs may be beneficial to the outcomes of patients with HF. SNFs should consider structured HF-DMPs for their patients.     

Can depression treatment in primary care reduce disability? A stepped care approach

OBJECTIVE: To assess effects of stepped collaborative care depression intervention on disability. DESIGN: Randomized controlled trial. SETTING: Four primary care clinics of a large health maintenance organization. PATIENTS: Two hundred twenty-eight patients with either 4 or more persistent major depressive symptoms or a score of 1.5 or greater on the Hopkins Symptom Checklist. Depression items were randomized to stepped care intervention or usual care 6 to 8 weeks after initiating antidepressant medication. INTERVENTION: Augmented treatment of persistently depressed patients by an on-site psychiatrist collaborating with primary care physicians. Treatment included patient education, adjustment of pharmacotherapy, and proactive monitoring of outcomes. MAIN OUTCOME MEASURES: Baseline, 1-, 3-, and 6-month assessments of the Sheehan Disability Scale and the social function and role limitation subscales of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). RESULTS: Patients who received the depression intervention experienced less interference in their family, work, and social activities than patients receiving usual primary care (Sheehan Disability Scale, z = 2.23; P =.025). Patients receiving intervention also reported a trend toward more improvement in SF-36-defined social functioning than patients receiving usual care (z = 1.63, P =.10), but there was no significant difference in role performance (z = 0.07, P =.94). CONCLUSIONS: Significant disability accompanied depression in this persistently depressed group. The stepped care intervention resulted in small to moderate functional improvements for these primary care patients. Arch Fam Med. 2000;9:1052-1058     

Staff training and ambulatory tuberculosis treatment outcomes: a cluster randomized controlled trial in South Africa

OBJECTIVE: To assess whether adding a training intervention for clinic staff to the usual DOTS strategy (the internationally recommended control strategy for tuberculosis (TB)) would affect the outcomes of TB treatment in primary care clinics with treatment success rates below 70%. METHODS: A cluster randomized controlled trial was conducted from July 1996 to July 2000 in nurse-managed ambulatory primary care clinics in Cape Town, South Africa. Clinics with successful TB treatment completion rates of less than 70% and annual adult pulmonary TB loads of more than 40 patients per year were randomly assigned to either the intervention (n = 12) or control (n = 12) groups. All clinics completed follow-up. Treatment outcomes were measured in cohorts of adult, pulmonary TB patients before the intervention (n = 1200) and 9 months following the training (n = 1177). The intervention comprised an 18-hour experiential, participatory in-service training programme for clinic staff delivered by nurse facilitators and focusing on patient centredness, critical reflection on practice, and quality improvement. The main outcome measure was successful treatment, defined as patients who were cured and those who had completed tuberculosis treatment. FINDINGS: The estimated effect of the intervention was an increase in successful treatment rates of 4.8% (95% confidence interval (CI): -5.5% to 15.2%) and in bacteriological cure rates of 10.4% (CI: -1.2% to 22%). A treatment effect of 10% was envisaged, based on the views of policy-makers on the minimum effect size for large-scale implementation. CONCLUSION: This is the first evidence from a randomized controlled trial on the effects of experiential, participatory training on TB outcomes in primary care facilities in a developing country. Such training did not appear to improve TB outcomes. However, the results were inconclusive and further studies are required.     

Integration of depression and hypertension treatment: a pilot, randomized controlled trial

PURPOSE We wanted to examine whether integrating depression treatment into care for hypertension improved adherence to antidepressant and antihypertensive medications, depression outcomes, and blood pressure control among older primary care patients.METHODS Older adults prescribed pharmacotherapy for depression and hypertension from physicians at a large primary care practice in West Philadelphia were randomly assigned to an integrated care intervention or usual care. Outcomes were assessed at baseline, 2, 4, and 6 weeks using the Center for Epidemiologic Studies Depression Scale (CES-D) to assess depression, an electronic monitor to measure blood pressure, and the Medication Event Monitoring System to assess adherence.RESULTS In all, 64 participants aged 50 to 80 years participated. Participants in the integrated care intervention had fewer depressive symptoms (CES-D mean scores, intervention 9.9 vs usual care 19.3; P <.01), lower systolic blood pressure (intervention 127.3 mm Hg vs usual care 141.3 mm Hg; P <.01), and lower diastolic blood pressure (intervention 75.8 mm Hg vs usual care 85.0 mm Hg; P <.01) compared with participants in the usual care group at 6 weeks. Compared with the usual care group, the proportion of participants in the intervention group who had 80% or greater adherence to an antidepressant medication (intervention 71.9% vs usual care 31.3%; P <.01) and to an antihypertensive medication (intervention 78.1% vs usual care 31.3%; P <.001) was greater at 6 weeks.CONCLUSION A pilot, randomized controlled trial integrating depression and hypertension treatment was successful in improving patient outcomes. Integrated interventions may be more feasible and effective in real-world practices, where there are competing demands for limited resources.     

Consent to medical treatment: the mature minor

Can children and young people consent to their own medical treatment? Consent issues involving children and young people are complex. This article examines the legal obligations of general practitioners when obtaining consent to medical treatment from patients who are less than 18 years of age.     

Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS)

Background  Patients and clinicians report difficulties with the process of informed consent to clinical trials and audiotape audits show that critical information is often omitted or poorly presented. Decision aids (DAs) may assist in improving consent.
Aims  This study piloted a DA booklet for a high priority breast cancer prevention trial, IBIS-II DCIS, which compares the efficacy of an aromatase inhibitor (anastrozole) with tamoxifen in women who have had surgery for ductal carcinoma in situ (DCIS).
Method  Thirty-one Australian women participating in the IBIS-I breast cancer prevention trial and who are currently in follow-up agreed to read the IBIS-II DCIS participant information sheet and the DCIS DA booklet, complete a set of standardized questionnaires, and provide feedback on the DA via a semi-structured phone interview.
Results  Women found the DA helpful in deciding about trial participation, reporting that it aided their understanding over and above the approved IBIS-II DCIS participant information sheet and was not anxiety provoking. Women's understanding of the rationale and methods of clinical trials and the IBIS-II DCIS trial was very good; with more than 80% of items answered correctly. The only areas that were not understood well were the concepts of randomization and blinding.
Conclusions  This study suggests that the DA will be acceptable to and valued by potential participants in the IBIS-II DCIS study. The revised DA is currently being evaluated prospectively in a randomized controlled trial. If successful, such DAs could transform the consent process to large clinical trials and may also reduce dropout rates.     

Who can best recruit to randomized trials? Randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study)

BACKGROUND AND OBJECTIVE: Recruitment to randomized trials is often difficult, but few studies have investigated interventions to improve recruitment. In a randomized trial nested within a trial of treatments for localized prostate cancer, we investigated the comparative effectiveness and cost-effectiveness of nurses and surgeons in recruiting patients. METHODS: Men with localized prostate cancer were randomized to see a nurse or urologic surgeon for an "information appointment" in which they were asked to consent to the ProtecT treatment trial comparing surgery, radiotherapy, and active monitoring. Analysis was conducted by intention to treat using chi-square with 95% confidence intervals for proportions and differences between groups. An economic evaluation was performed using the duration of appointments and grade of recruitment staff. RESULTS: Case-finding identified 167 men with localized prostate cancer. One hundred fifty (90%) took part in the recruitment trial. There was a 4.0% difference between nurses and surgeons in recruitment rates (67% nurses, 71% urologists, 95% CI -10.8% to +18.8%, P=.60). Cost-minimization analysis showed that nurses spent longer times with patients but surgeon costs were higher and nurses often supported surgeon-led clinics. CONCLUSION: Nurses were as effective and more cost-effective recruiters than urologic surgeons. This suggests an increased role for nurses in recruiting patients to randomized trials.