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1.

Objective

To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis (RA).

Methods

Non-adherent RA patients using disease-modifying anti-rheumatic drugs (DMARDs) were randomized to an intervention or control arm. The intervention consisted, amongst others, of two motivational interviewing-guided group sessions led by the same pharmacist. Control patients received brochures about their DMARDs. Questionnaires were completed up to 12 months follow-up.

Results

123 patients (mean age: 60 years, female: 69%) were randomized. No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm, except at 12 months’ follow-up: participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm (b: −1.0 (95% CI: −2.0, −0.1)).

Conclusion

This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time.

Practice implications

Absent intervention effects might have been due to, amongst others, selection bias and a suboptimal treatment integrity level. Hence, targeting beliefs about medication in clinical practice should not yet be ruled out.  相似文献   

2.

Objective

Test the efficacy of educational interventions to reduce literacy barriers and enhance health outcomes among patients with inflammatory arthritis.

Methods

The intervention consisted of plain language information materials and/or two individualized sessions with an arthritis educator. Randomization was stratified by education level. Principal outcomes included adherence to treatments, self-efficacy, satisfaction with care, and appointment keeping. Secondary outcomes included health status and mental health. Data were collected at baseline, six, and twelve months post.

Results

Of the 127 patients, half had education beyond high school and three quarters had disease duration greater than five years. There were no differences in the primary outcome measures between the groups. In mixed models controlling for baseline score and demographic factors, the intervention group showed improvement in mental health score at six and twelve months (3.0 and 3.7 points, respectively), while the control group showed diminished scores (−4.5 and −2.6 points, respectively) (p = 0.03 and 0.01).

Conclusion

While the intervention appears to have had no effect on primary outcomes, further studies with continued attention to literacy are warranted. Study site and disease duration must be considered as participants in this study had higher than average health literacy and had established diagnoses for years prior to this study.

Practice implications

The study offers insight into an application of many of the protocols currently recommended to ameliorate effects of limited literacy.  相似文献   

3.
Introduction: Within diabetes care, the majority of health decisions are in the hands of the patient. Therefore, the concepts of disease management and self-care represent inescapable challenges for both patient and healthcare professionals, entailing a considerable amount of learning. Thus, a computerised diabetes disease management systems (CDDM) is to be seen not merely as tools for the medical treatment, but also as pedagogical tools to enhance patient competence. Hypothesis: The unfortunate lack of success for most knowledge-based systems might be related to the problem of finding an adequate way of evaluating the systems from their development through the implementation phase to the daily clinical practice. The following presents the initial methodological considerations for evaluating the usefulness of a CDDM system called DiasNet, which is being implemented as a learning tool for patients. The evaluation of usefulness of a CDDM, we claim, entails clinical assessment taking into account the challenges and pitfalls in diabetes disease management. Results: Drawing on activity theory, we suggest the concept of copability as a supplement to ‘usability’ and ‘utility’ when determining ‘usefulness’. We maintain that it is necessary to ask how well the user copes with the new situation using the system. As ways to measure copability of DiasNet the concepts of coping and learning are discussed, as well as ways this methodology might inform systems development, implementation, and daily clinical practice.  相似文献   

4.
Bipolar disorder is known to be highly recurrent and people with bipolar illnesses often experience high degrees of interpersonal and social impairment. The emergence of prodromal symptoms not only causes distress but may also predispose patients to greater risk of a full relapse. Studies have found that patients can report prodromes reliably. Common mania prodromes include decreased need for sleep, increased activities, being more sociable and racing thoughts while common depression prodromes are loss of interest, not being able to put worries aside and interrupted sleep. Furthermore, patients' coping with prodromal symptoms predicted relapses in bipolar disorder. These findings have led to a handful of randomized controlled studies which aimed at teaching patients relevant and adaptive coping strategies in dealing with bipolar prodromes as part of the intervention strategies and the results are very encouraging. The packages in these studies are of different complexity. The mode of intervention also varied from individual work, group work to family work. This paper also examines the differential effects of these interventions.  相似文献   

5.

Objective

To test the effectiveness of an individualized educational intervention on knowledge, attitudes and beliefs about acute coronary syndrome (ACS).

Methods

This multi-site, randomized controlled trial was conducted on 1947 patients with a diagnosis of ACS. Both groups received usual in-hospital education. Participants randomized to the intervention group received a 40-min one to one individualized education session, delivered using motivational interviewing techniques. The intervention was reinforced 1 month and 6 months later. Knowledge, attitudes and beliefs were measured using the ACS Response Index. A total of 1136 patients (control, n = 551; intervention, n = 585) completed the questionnaire at baseline, 3 and 12 months. Data were analyzed using repeated measures analysis of variance. Ethical approval was obtained.

Results

There was a significant effect of the intervention on mean knowledge (p < 0.001), attitude (p = 0.003) and belief (p < 0.001) scores at 3 and 12 months.

Conclusion

Ensuring patients retain information post education has always been difficult to attain. This study demonstrated that patient education using motivational interviewing techniques and an individualized approach has the potential to alter knowledge, attitudes and beliefs about ACS among a high risk population.

Practice implications

This relatively short, simple and effective educational intervention could be delivered by nurses in multiple settings.  相似文献   

6.
ObjectiveTo evaluate whether online resources developed to educate people about the risks associated with experimental stem cell (SC) treatments influence stroke survivors’ attitudes about the safety and effectiveness of these treatments.MethodsAdult stroke survivors who had not previously received SC treatments (N = 112) were recruited from international stroke advocacy/support groups for a prospective, parallel-group randomized controlled trial. Participants indicated whether they were considering SC treatments (yes/no) prior to, immediately following, and 30-days after reading/viewing the International Society for Stem Cell Research booklet or Stem Cell Network video. Participant attitudes regarding the safety, effectiveness, accessibility and affordability of SC treatments were examined on each occasion, and compared to those of a waitlist control group.ResultsSignificantly fewer participants were considering SC treatments immediately after reading the SC research booklet (p =.031), although neither intervention had any impact after 30-days (p >.05). Waitlist and intervention groups reported positive attitudes toward SC treatments at each assessment.ConclusionsStroke survivor attitudes toward SC treatments were initially influenced by the patient booklet, however these changes were not maintained.Practical ImplicationsClinicians are encouraged to initiate discussions about experimental SC treatments during inpatient rehabilitation and to reinforce the risks throughout subsequent care.  相似文献   

7.
ObjectiveProfessional appearance is easily modifiable, and might alter the effects of a clinical encounter. We aimed to determine whether professional attire influences a patient’s perception of treatment credibility.MethodsWe performed a single-blind randomized controlled study on 128 patients with acute non-specific low back pain who were about to receive treatment in primary care. The treating clinician was randomly allocated to wear formal attire (experimental condition) or casual attire (control condition) to the consultation. Clinicians provided a standardized briefing on the rationale behind the patient’s forthcoming treatment. Treatment credibility (Credibility and Expectancy Questionnaire) was assessed immediately after this briefing.ResultsAll patients received the experimental or control condition as allocated and provided complete primary outcome data. Formal attire had no effect on perceived treatment credibility (Mean difference between groups 1.2 [95%CI-1.1 to 3.5]). Age was the only significant predictor of treatment credibility; older patients rated treatment credibility higher (Beta = 0.16 [95%CI 0.08 to 0.24]).ConclusionIn a trial setting, whether or not a clinician is formally dressed has no effect on perceptions of treatment credibility in patients with acute low back pain.Practice implicationClinicians should dress comfortably without fear of losing credibility.  相似文献   

8.

Objectives

Cardiac rehabilitation (CR) is an effective treatment for cardiovascular disease, yet many referred patients do not participate. Motivational interviewing could be beneficial in this context, but efficacy with prospective CR patients has not been examined. This study investigated the impact of motivational interviewing on intention to participate in CR.

Methods

Individuals recovering from acute coronary syndrome (n?=?96) were randomized to motivational interviewing or usual care, following CR referral but before CR enrollment. The primary outcome was intention to attend CR. Secondary outcomes included CR beliefs, barriers, self-efficacy, illness perception, social support, intervention acceptability, and CR participation.

Results

Compared to those in usual care, patients who received the motivational intervention reported higher intention to attend CR (p?=?.001), viewed CR as more necessary (p?=?.036), had fewer concerns about exercise (p?=?.011), and attended more exercise sessions (p?=?.008). There was an indirect effect of the intervention on CR enrollment (b?=?0.45, 95% CI 0.04–1.18) and CR adherence (b?=?2.59, 95% CI 0.95–5.03) via higher levels of intention. Overall, patients reported high intention to attend CR (M?=?6.20/7.00, SD?=?1.67), most (85%) enrolled, and they attended an average of 65% of scheduled CR sessions.

Conclusion

A single collaborative conversation about CR can increase both intention to attend CR and actual program adherence.

Practice Implications

The findings will inform future efforts to optimize behavioral interventions to enhance CR participation.  相似文献   

9.

Objective

The modern joint protection (JP) concept for people with rheumatoid arthritis (RA) is an active coping strategy to improve daily tasks and role performance by changing working methods and using assistive devices. Effective group JP education includes psycho-educational interventions. The Pictorial Representation of Illness and Self Measure (PRISM) is an interactive hands-on-tool, assessing (a) the individual's perceived burden of illness and (b) relevant individual resources. Both issues are important for intrinsic motivation to take action and change behaviour. This study compared individual conventional JP education (C-JP) with PRISM-based JP education (PRISM-JP).

Methods

An assessor-blinded multicentre randomized controlled trial, including four JP education sessions over 3 weeks, with assessments at baseline and 3 months.

Results

In total 53 RA patients participated. At 3 months, the PRISM-JP (n = 26) participants did significantly better compared to the C-JP participants (n = 27) in JP behaviour (p = 0.02 and p = 0.008 when corrected for baseline values), Arthritis Self-efficacy (ASES, p = 0.015) and JP self-efficacy (JP-SES, p = 0.047). Within-group analysis also showed less hand pain (p < 0.001) in PRISM-JP group.

Conclusion

PRISM-JP more effectively supported learning of JP methods, with meaningful occupations, resource activation and self-efficacy acting as important mediators.

Practice implications

PRISM improved patient-clinician communication and is feasible for occupational therapy.  相似文献   

10.

Objective

Motivational Interviewing (MI) is a counseling approach to support behavioural change. The objective of the present study was to examine the uptake of MI in daily practice by health care professionals in a care management initiative for patients with diabetes in the region of Maastricht, the Netherlands.

Methods

MI was implemented by means of a training. Directly and six months after the training, the application of MI was measured objectively (MITI) and subjectively (questionnaire). In focus interviews, MI-trained professionals (n = 10) and MI untrained professionals (n = 10) were asked about facilitators and barriers for implementation. Additionally, data on patient characteristics (n = 141) were collected.

Results

Spirit of MI was present among professionals directly after the training and increased during follow-up. Mostly uncomplicated techniques were applied. Professionals stated the need for training and practice to be able to apply more complicated techniques.

Conclusion

The applicability of MI in daily practice was found feasible, with various degrees of uptake. Relevant conditions to further improve the implementation of MI in daily practice were identified.

Practice implications

In daily practice, a phased training in MI is recommended, with sufficient time and support by colleagues as essential conditions to profit most from the training sessions.  相似文献   

11.

Objective

Randomized controlled trials in patient education often have difficulty enrolling vulnerable populations—specifically, older, poorer, and less educated individuals. We undertook a randomized controlled trial (RCT) of an educational intervention for arthritis management, which included strategies to remove literacy-related barriers to participation. This paper reports on the multi-stage recruitment process and assesses whether refusal to participate was related to education, age, gender, working status, or insurance status.

Methods

The recruitment protocol was designed to eliminate literacy-related barriers to participation. Patients were never asked to read or fill out forms. Interactions were oral, using everyday terms and short, clear sentences. Patients who declined during a screening call were considered Stage 1 Refusers. Patients who initially expressed interest but neither completed a baseline questionnaire nor provided consent were considered Stage 2 Refusers. Patients who consented were considered Enrollees. Age, gender, and insurance status were compared between Stage 1 Refusers and Enrollees. A second analysis compared these variables, plus educational attainment and working status, between Stage 2 Refusers, and Enrollees.

Results

Of 408 eligible patients, there were 193 (47.3%) Stage 1 Refusers, 81 (19.9%) Stage 2 Refusers and 134 (32.8%) Enrollees. A higher proportion of Stage 1 Refusers than Enrollees were ≥65 years old (58% vs. 37%, p = .0003). Multivariate analysis, adjusting for gender and insurance status, confirmed the effect of older age on refusal (OR = 2.3 (1.4, 3.6)). There were no significant differences between Stage 2 Refusers and Enrollees.

Conclusion

We found no evidence of refusal to participate due to educational attainment, working status, insurance status, or gender. Older patients were more likely to refuse participation at the first stage of recruitment.

Practice implications

Researchers should continue efforts to increase participation among older patients, particularly when studies are designed to be generalized to an elderly population as is the case with arthritis research. Strategies used in this recruitment protocol designed to remove literacy-related barriers to recruitment may be responsible for the observation that subjects with lower education did not have a higher rate of refusal. Such strategies deserve further study.  相似文献   

12.

Objectives

To develop and validate the Osteoporosis Patient Satisfaction Questionnaire (OPSQ) and to assess the opinion of postmenopausal osteoporotic women towards pharmaceutical care.

Methods

A 16-item instrument was designed. Each response consists of a five-point Likert-like scale with higher scores indicating greater satisfaction. The face and content validity was established via consultation with an endocrinologist and three pharmacists as well as feedback from participants in a preliminary study. Postmenopausal osteoporotic women taking bisphosphonates were recruited and randomly allocated to the intervention (n = 90) and control groups (n = 90). Pharmaceutical care was provided at month 2 to the intervention group while the control group received standard pharmacy services. The OPSQ was administered at month 6 (end of the intervention period), to assess patients’ satisfaction. Factor analysis was performed using varimax rotation. Internal reliability was established using Cronbach's α. Construct validity was performed by using the Mann–Whitney U test.

Results

The internal reliability of the OPSQ produced a Cronbach's α of 0.86. Factor analysis identified one component in the OPSQ, which measured patient satisfaction. The intervention group showed significantly better overall OPSQ score than the control group (91.89 ± 7.22% versus 84.32 ± 7.48%, p < 0.001). This indicates that the OPSQ was able to differentiate between participants who received pharmaceutical care from those who did not.

Conclusions

The 16-item OPSQ developed in this study has high internal reliability and is a valid instrument for assessing osteoporotic women's satisfaction with pharmaceutical care service in Malaysia.  相似文献   

13.

Objectives

To compare the effectiveness of quitting immediately and cutting down to quit in promoting smoking abstinence among smokers in an outpatient clinic.

Methods

A total of 100 subjects were randomized into two groups, 50 in the quit immediately group, who received an intervention on abruptly quitting, and 50 in the cut down to quit group, who received an intervention on gradual reduction. All subjects were followed up at 6 and 12 months via telephone. The intention-to-treat principle was used.

Results

At the 6-month follow-up, the self-reported quit rate of subjects in the quit immediately group was significantly higher than in the cut down to quit group (18.0% vs. 4.0%, p?=?0.04). However, this difference was not significant at the 12-month follow-up (12.0% vs. 4.0%, p?=?0.16).

Conclusion

These data suggest that quitting immediately might be more effective than cutting down to quit at 6 months but not at 12 months.

Practice implications

It is crucial to allow smokers to select quitting immediately or reducing the number of cigarettes smoked. Further studies are warranted to compare the effectiveness of various approaches for achieving smoking abstinence.  相似文献   

14.

Background

Alcohol problems are a serious public health concern, and few problem drinkers ever seek treatment. The Internet is one means of promoting access to care, but more research is needed to test the best types of interventions to employ. Evaluation of Internet-based interventions that contain a variety of research-validated cognitive-behavioral tools, which have been shown to be helpful to those with more severe alcohol concerns, should be a priority.

Objective

To evaluate whether providing access to an extended Internet intervention for alcohol problems offers additional benefits in promoting reductions in alcohol consumption compared with a brief Internet intervention. The hypothesis for the current trial was that respondents who were provided with access to an extended Internet intervention (the Alcohol Help Center [AHC]) would display significantly improved drinking outcomes at 6-month follow-up, compared with respondents who were provided with access to a brief Internet intervention (the Check Your Drinking [CYD] screener).

Methods

A single-blinded randomized controlled trial with a 6-month follow-up. A general population sample of problem drinkers was recruited through newspaper advertisements in a large metropolitan city. Baseline and follow-up data were collected by postal mail.

Results

A volunteer sample of problem drinkers of legal drinking age with home access to the Internet were recruited for the trial. Of 239 potential respondents recruited in 2010, 170 met inclusion criteria (average age 45 years; 101/170, 59.4% male; average Alcohol Use Disorders Identification Test [AUDIT] score of 22). Follow-up rates were 90.0% (153/170) with no adverse effects of the interventions reported. A repeated-measures multivariate analysis of variance of the outcome measures using an intent-to-treat approach found a significantly greater reduction in amount of drinking among participants provided access to the AHC than among participants provided access to the CYD (P = .046).

Conclusions

The provision of the AHC gave additional benefit in the short term to problem drinkers over that seen from the research-validated CYD, indicating the benefits of promoting access to these interventions as one means of helping people with problem drinking concerns.

Trial Registration

ClinicalTrials.gov NCT01114919; http://clinicaltrials.gov/ct2/show/NCT01114919 (Archived by WebCite at http://www.webcitation.org/68t1dCkRZ)  相似文献   

15.
王建华 《医学信息》2019,(10):81-84
目的 以Meta分析的方法来评价利妥昔单抗联合CHOP方案治疗B细胞性非霍奇金淋巴瘤的疗效。方法 计算机检索维普数据库、中国知网、万方数据库、pubmed数据库等,检索利妥昔单抗联合化疗治疗B细胞性非霍奇金淋巴瘤的随机对照试验,并手工检索相关会议记录及纸质文献,应用国际Cochrane协作网的系统评价方法对所得数据进行质量评分,进行资料提取后,采用RevMan5.3软件进行Meta分析。结果 共检索到14个随机对照试验,共包括2433例患者,异质性检验P>0.1,基线具有可比性,选择固定效应模型分析所得结果显示R-CHOP方案化疗组的完全缓解率高于单纯CHOP化疗组(RR=1.3,95%CI为1.3~1.41),差异有统计学意义(P<0.05);R-CHOP方案总有效率高于CHOP组(RR=1.32,95%CI为1.22~1.42),差异有统计学意义(P<0.05);其不良反应与对照组比较,差异无统计学意义(P>0.05)。结论 R-CHOP方案相对CHOP方案治疗B细胞性非霍奇金淋巴瘤来说具有更高的完全缓解率和总有效率,进一步证明其治疗效果需开展更多的随机对照试验。  相似文献   

16.
This study aimed to assess the efficacy of a rural community-based integratedintervention for early prevention and management of chronic obstructive pulmonarydisease (COPD) in China. This 18-year cluster-randomized controlled trialencompassing 15 villages included 1008 patients (454 men and 40 women in theintervention group [mean age, 54 ± 10 years]; 482 men and 32 women in the controlgroup [mean age, 53 ± 10 years]) with confirmed COPD or at risk for COPD. Villageswere randomly assigned to the intervention or the control group, and studyparticipants residing within the villages received treatment accordingly.Intervention group patients took part in a program that included systematic healtheducation, smoking cessation counseling, and education on management of COPD. Controlgroup patients received usual care. The groups were compared after 18 years regardingthe incidence of COPD, decline in lung function, and mortality of COPD. COPDincidence was lower in the intervention group than in the control group (10%vs 16%, <0.05). A decline in lung function was alsosignificantly delayed in the intervention group compared to the control group of COPDand high-risk patients. The intervention group showed significant improvement insmoking cessation compared with the control group, and smokers in the interventiongroup had lower smoking indices than in the control group (350 vs450, <0.05). The intervention group also had a significantly lower cumulativeCOPD-related death rate than the control group (37% vs 47%,<0.05). A rural community-based integrated intervention is effective in reducingthe incidence of COPD among those at risk, delaying a decline in lung function inCOPD patients and those at risk, and reducing mortality of COPD.  相似文献   

17.
18.

Objective

To perform a meta-analysis assessing the effects of self-care management interventions in improving glycaemic control in type 2 diabetes by analysing the impact of different study characteristics on the effect size.

Methods

A literature search in eight scientific databases up to November 2007 included original studies of randomised controlled trials involving adult patients diagnosed with type 2 diabetes and evaluating a self-care management intervention.

Results

The 47 included studies yielded 7677 participants. The analysis showed a 0.36% (95% CI 0.21–0.51) improvement in glycaemic control in people who received self-care management treatment. In the univariate meta-regression sample size (effect size 0.42%, p = 0.007) and follow-up period (effect size 0.49%, p = 0.017) were identified to have significant effect on the effect size in favour of small studies and short follow-up. For type of intervention and duration of intervention there was a non-significant effect on effect size in favour of educational techniques and short interventions.

Conclusion

In type 2 diabetes, there are improvements in glycaemic control in people who receive self-care management treatment with a small advantage to intervention with an educational approach.

Practice implications

Further research on frequency and duration of intervention may provide useful information to identify the most effective regime.  相似文献   

19.

Objective

To examine the impact of Veterans’ coping strategies on mental health treatment engagement following a positive screen for depression.

Methods

A mixed-methods observational study using a mailed survey and semi-structured interviews. Sample included 271 Veterans who screened positive for depression during a primary care visit at one of three VA medical centers and had not received a diagnosis of depression or prescribed antidepressants 12 months prior to screening. A subsample of 23 Veterans was interviewed.

Results

Logistic regression models showed that Veterans who reported more instrumental support and active coping were more likely to receive depression or other mental health treatment within three months of their positive depression screen. Those who reported emotional support or self-distraction as coping strategies were less likely to receive any treatment in the same time frame. Qualitative analyses revealed that how Veterans use these and other coping strategies can impact treatment engagement in a variety of ways.

Conclusions

The relationship between Veterans’ use of coping strategies and treatment engagement for depression may not be readily apparent without in-depth exploration.

Practice implications

In VA primary care clinics, nurse care managers and behavioral health providers should explore how Veterans’ methods of coping may impact treatment engagement.  相似文献   

20.

Background

Recent studies have shown the potential of Web-based interventions for changing dietary and physical activity (PA) behavior. However, the pathways of these changes are not clear. In addition, nonusage poses a threat to these interventions. Little is known of characteristics of participants that predict usage.

Objective

In this study we investigated the users and effect of the Healthy Weight Assistant (HWA), a Web-based intervention aimed at healthy dietary and PA behavior. We investigated the value of a proposed framework (including social and economic factors, condition-related factors, patient-related factors, reasons for use, and satisfaction) to predict which participants are users and which participants are nonusers. Additionally, we investigated the effectiveness of the HWA on the primary outcomes, self-reported dietary and physical activity behavior.

Methods

Our design was a two-armed randomized controlled trial that compared the HWA with a waiting list control condition. A total of 150 participants were allocated to the waiting list group, and 147 participants were allocated to the intervention group. Online questionnaires were filled out before the intervention period started and after the intervention period of 12 weeks. After the intervention period, respondents in the waiting list group could use the intervention. Objective usage data was obtained from the application itself.

Results

In the intervention group, 64% (81/147) of respondents used the HWA at least once and were categorized as “users.” Of these, 49% (40/81) used the application only once. Increased age and not having a chronic condition increased the odds of having used the HWA (age: beta = 0.04, P = .02; chronic condition: beta = 2.24, P = .003). Within the intervention group, users scored better on dietary behavior and on knowledge about healthy behavior than nonusers (self-reported diet: χ2 2 = 8.4, P = .02; knowledge: F1,125 = 4.194, P = .04). Furthermore, users underestimated their behavior more often than nonusers, and nonusers overestimated their behavior more often than users (insight into dietary behavior: χ2 2 = 8.2, P = .02). Intention-to-treat analyses showed no meaningful significant effects of the intervention. Exploratory analyses of differences between pretest and posttest scores of users, nonusers, and the control group showed that on dietary behavior only the nonusers significantly improved (effect size r = −.23, P = .03), while on physical activity behavior only the users significantly improved (effect size r = −.17, P = .03).

Conclusions

Respondents did not use the application as intended. From the proposed framework, a social and economic factor (age) and a condition-related factor (chronic condition) predicted usage. Moreover, users were healthier and more knowledgeable about healthy behavior than nonusers. We found no apparent effects of the intervention, although exploratory analyses showed that choosing to use or not to use the intervention led to different outcomes. Combined with the differences between groups at baseline, this seems to imply that these groups are truly different and should be treated as separate entities.

Trial registration

Trial ID number: ISRCTN42687923; http://www.controlled-trials.com/ISRCTN42687923/ (Archived by WebCite at http://www.webcitation.org/5xnGmvQ9Y)  相似文献   

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