Treatment In Intervention Group Research Articles

Effect evaluation of intervene on healthy behavior of soldiers on platesu area to prevent hemorrhoids based on transtheoretical model

Objective To explore the effect of trans theoretical model in changing on healthy behavior of soldiers on plateau area to prevent hemorrhoids. Methods Fifty-four soldiers respectively from the artillery troops and air defenses force troops were selected and divided into control group that received normal healthy education and treatment group that received the healthy behavior intervene based on transtheoretical model and the changes of the behavior at each stage of intervention were observed and contrasted between two groups. Results There was no statistically significant difference in the number of each stage between two groups at 1 and 3 months after intervention (χ2=1.514, 6.554, P> 0.05). The number of former intention stage, intention stage, preparation stage, action stage, maintain stage at 6 months after intervention in treatment group were respectively 0, 0, 0, 15, 39 cases, and 2, 3, 6, 20, 23 cases in control group respectively, the difference was statistically significant (χ2=15.843, P 0.05). The number of daily training of the levator ani less than 5, 6-15, 16-25, 26-35, >35 times at 3, 6 months after intervention respectively was 5, 6, 6, 17 cases and 20, 0, 0, 0, 14, 40 cases in treatment group respectively, 9, 13, 14, 10, 8 cases, and 3, 4, 6, 22, 19 cases in control group,the differences were statistically significant (χ2=13.459, 22.252, P < 0.01). The incidence of bloody at 6 months after intervention was 3.70% (2/54) in treatment group and 16.67% (9/54) in control group, the difference was statistically significant (χ2 = 4.960, P < 0.05). Conclusions The intervene based on transtheoretical model can effectively promote the healthy behavior to prevent hemorrhoids and reduce the recurrence rate of hemorrhoids. Key words: Hemorrhoids; Trans theoretical model; Healthy behavior intervene; Soldiers on plateau area

Curative effect of benidipine hydrochloride on patients with coronary slow flow angina pectoris

Objective To investigate the curative effect of benidipine hydrochloride on patients with coronary slow flow angina pectoris(CSFA). Methods Sixty cases patients with CSFA were randomly divided into two groups of 30 patients each.In the control group patients were received aspirin(100 mg, 1 times/d) and atorvastatin(20 mg, 1 times/d) as basic treatment; in the treatment group patients were received basic treatment plus benidipine hydrochloride(4 mg, 1 times/d). Follow up for 6 mouths, the effectiveness rate of treatment(relief of angina and electrocardiogram of myocardial ischemia), the correction of thrombolysis in myocardial infarction(TIMI) frame count(CTFC) before and after the different intervention, and the incidence of adverse cardiovascular events were compared between the treatment group and the control group. Results The effectiveness rate of treatment in the treatment group(86.7%, 26/30) was significantly higher than that in the control group(63.3%(19/30); χ2=4.356, P=0.037). There were significant reductions of CTFC in both groups after the different intervention(treatment group: (28.43±3.95) frames vs.(18.40±3.73) frames, t=10.254, P=0.000; control group: (27.87±4.14) frames vs.(21.87±4.17) frames, t=5.580, P=0.000). There was more significant reductions of CTFC in the treatment group as compared to the control group(t=2.138, P=0.037). The incidence of adverse cardiovascular events in the treatment group(10.0%(3/30)) was significantly lower than that in the control group(33.3%(10/30), P=0.028). Conclusion Benidipine hydrochloride is effective in the treatment of CSFA. Key words: Benidipine hydrochloride; Coronary slow flow; Angina pectoris; Curative effect

CHRONIC LOW BACK PAIN;

Background: Worldwide prevalence of chronic low back pain is 19.6% in thoseaged between 20-59 years and more prevalent in women. Routine physiotherapy appears to beeffective in reducing pain and improving functional outcome in chronic low back pain patients.Lumbar stabilization exercises are trending in the management of chronic low back pain thoughit is not known whether addition of these exercises produce better results as compared to routinephysiotherapy alone. Objectives: The objective of this study was to determine the effect of thelumbar stabilization exercises on pain, ROM and functional disability in the management ofchronic low back pain. A randomized control trial. Period: February 2016 to July 2016. Setting:Rehab &amp; Research Center, Pakistan Railway General Hospital. Methodology: 42 chronic lowback pain patients (02 drop outs, one from each group). The participants were recruited throughpurposive sampling technique. Random allocation was done through coin toss method into twogroups Lumbar Stabilization Exercise (LSE) group (n=20) and Conventional Physiotherapy(CPT) group (n=20). Tools used to collect data were NPRS, Modified ODI, Goniometer (LumbarFlexion, Extension and Side bendings) and MMT (Trunk Flexors and Extensors). The data wasanalyzed (n=40) at baseline and later after 2 weeks of intervention (8 sessions) on IBM SPSS-20. Results: 28 females and 12 males participated in the study with mean age of 38.88 ±12.69.After 02 weeks of intervention both treatment groups showed improvement in decreasing painand improving functional status. LSE group had significant gains in NPRS p=0.001, ModifiedODI p=0.001, ROM Extension p= 0.027, ROM Right side bend p= 0.024 and MMT Flexion p=0.031 as compared to CPT group. Conclusion: Lumbar stabilization exercises in addition toconventional physiotherapy are found more effective in chronic low back pain managementas compared to conventional physiotherapy alone in terms of reducing pain and functionaldisability.

Effectiveness of Short-Course Meglumine Antimoniate (Glucantime®) for Treatment of Visceral Leishmaniasis: A 13-Year, Multistage, Non-Inferiority Study in Iran.

The World Health Organization's (WHO) recommendation is 28-day course of meglumine antimoniate (Glucantime®, Sanofi Aventis, France) for the treatment of visceral leishmaniasis (VL). The aim of this study was to evaluate the effectiveness of a shorter duration of treatment in regions with low level of resistance to Glucantime. During 13 years, this study was conducted in three phases on 392 patients. In the pilot first phase, we performed splenic punctures in seven patients to assess the correlation between the changes in the parasite load during treatment with Glucantime and defervescence. With defervescence, parasite density was dramatically dropped (P = 0.014), propounding defervescence as a marker of parasitological response. On the basis of the results, we conducted a randomized trial on 75 patients, comparing the efficacy of continuation of Glucantime therapy for 1, 2, or 3 weeks after defervescence. The treatment course of 1 week after defervescence (mean = 11.7 days) was non-inferior to that of 3 weeks (final cure rate, 96% versus 100%; P = 0.023). The third phase was a retrospective cohort study of 302 patients treated either with the WHO's regimen or for 7 days after defervescence (intervention group). Relapse was detected in 8.3% patients of the intervention group and in 5% patients following the WHO's regimen (P = 0.006 for non-inferiority). The final duration of treatment in intervention group was significantly shorter than standard course (13.3 ± 2.6 versus 28 days; P < 0.001). In summary, treatment of VL with Glucantime for 1 week after defervescence was non-inferior to and appears to be an acceptable alternative to the standard 28-day course for patients in Iran who show a response to antimonial therapy.

Improvement in Long‐term Household Food Security among Indiana Households with Children did not Differ between Rural and Urban Counties after a Supplemental Nutrition Assistance Program‐Education Intervention

ObjectiveTo determine the relationship of rural and urban county household status to long‐term food security among households with children in Indiana after a Supplemental Nutrition Assistance Program‐Education (SNAP‐Ed) intervention.MethodsA randomized, controlled parallel nutrition education intervention study using SNAP‐Ed as the intervention was implemented across 38 Indiana counties from August 2013 to March 2015. Study participants (n=575) were low‐income SNAP‐Ed eligible adults ≥ 18 years with ≥ 1 child living in the household. SNAP‐Ed paraprofessionals recruited and randomized participants to either the control or intervention treatment group. Intervention group participants received at least the first 4 SNAP‐Ed lessons over an intervention period of 4–10 weeks. All participants completed a baseline, post‐intervention, and 1 year follow‐up assessment. Food security score was assigned using the 18‐item United States Household Food Security Survey Module. Urban or rural county status was assigned using the classifications provided by the United States Office of Management and Budget. A linear mixed regression model adjusted for household characteristics and urban or rural county status was included as an independent variable to compare study treatment group and urban or rural county status effects over time on food security.ResultsRural or urban county status was not significantly associated with improvement in household food security score from baseline to 1 year follow‐up assessment (p=0.6).ConclusionSNAP‐Ed was consistently effective at improving long‐term food security between rural and urban county Indiana households with children.Support or Funding InformationFunding: This project was supported with a grant from the University of Kentucky Center for Poverty Research through funding by the U.S. Department of Agriculture, Food and Nutrition Service, contract number AG‐3198‐S‐12‐0044.

Effects of WeChat group in teaching of standardized training among Operating Room nurses

Objective To explore the effects of WeChat group in teaching of standardized training among Operating Room nurses. Methods A total of 28 nurses accepting standardized training in Operating Room were selected as control group (standardized training) from July 2011 to December 2012. A total of 28 nurses accepting standardized training in Operating Room were selected as intervention group (standardized training & WeChat group teaching ) from January 2013 to July 2014. What was compared after intervention among nurses between two groups included theoretical knowledge, the score of operation skill, nurses′ satisfaction with training, the satisfaction degree of patients and family members and surgeons′ satisfaction with nurses. Results After the intervention with WeChat group teaching, scores of theoretical knowledge and technical knowledge were (96.3±3.6) and (94.5±4.6) in intervention group which were higher than those in control group with significant differences (t=-8.652, -7.254; P 0.05). Scores of suture needle, aseptic technique, transferring equipment in operation, arranging surgical position, surgery cooperation were (92.1±6.2), (91.6±5.2), (95.6±3.3), (96.2±3.6), (97.1±2.6) in intervention group which were higher than those in control group with significant differences (t=-4.125, -4.526, -3.856, -5.846, -9.032; P<0.01). Satisfaction degrees of nurses with training, surgeons with nurses, patients′ family members with treatment in intervention group were obviously better than those in control group with significant differences (P<0.01). Conclusions Training with WeChat group in nurses can visibly improve nurses′ study enthusiasm, theoretical knowledge, operation skill, satisfaction degrees of nurses with training, surgeons with nurses, patients and their family members with treatment and improve the quality of care in operating room at the same time. Key words: Operating Room; Standardized training; WeChat group

Differences in Effectiveness among Devices for Endovascular Thrombectomy in Patients with Acute Ischemic Stroke.

Differences in Effectiveness among Devices for Endovascular Thrombectomy in Patients with Acute Ischemic Stroke.

Comprehensive treatments for hepatocellular carcinoma with tumor thrombus in major portal vein

To evaluate the efficacy of transcatheter arterial chemoembolisation (TACE) compared with surgical intervention and sorafenib for treatment of hepatocellular carcinoma (HCC) in patients with tumor thrombus extending to the main portal vein. From 2009 to 2013, a total of 418 HCC patients with tumor thrombus extending to the main portal vein were enrolled in this study and divided into four groups. These groups underwent different treatments as follows: TACE (n = 307), surgical intervention (n = 54), sorafenib (n = 15) and palliative treatment (n = 42). Overall survival rates were determined by Kaplan-Meier method, and differences between the groups were identified through log-rank analysis. Cox's proportional hazard model was used to identify the risk factors for survival. The mean survival periods for patients in the TACE, surgical intervention, sorafenib and palliative treatment groups were 10.39, 4.13, 5.54 and 2.82 mo, respectively. For the TACE group, the 3-, 6-, 12- and 24-mo survival rates were 94.1%, 85.9%, 51.5% and 0.0%, respectively. The corresponding rates were 60.3%, 22.2%, 0.0% and 0.0% for the surgical intervention group and 50.9%, 29.5%, 0.0% and 0.0% for the sorafenib group. Evidently, the results in the TACE group were significantly higher than those in the other groups (P < 0.0001). Furthermore, no significant difference among survival rates was observed between TACE with/without sorafenib (10.22 mo vs 10.52 mo, P = 0.615). No significant difference in survival rates was also found among the surgical intervention, sorafenib and palliative treatment groups (P > 0.05). These values significantly increased after TACE with/without sorafenib compared with other treatments (P < 0.05). For HCC patients with tumor thrombus extending to the main portal vein, TACE can yield a higher survival rate than surgical intervention or sorafenib treatment.

Self-monitoring of lower leg skin temperature: accuracy of self-reported data and adherence to a cooling protocol for the prevention of venous leg ulcers.

BackgroundFor intervention studies that require the use of participant self-reports, the quality and accuracy of recorded data and variability in participant adherence rates to the treatment can cause significant outcome bias.PurposeTo assess the quality and accuracy of participant documentation of daily self-monitoring of leg skin temperature, adherence to a graduated cooling treatment protocol to prevent venous leg ulcers, and the potential for bias in treatment effect in a randomized controlled trial that included a population with chronic venous disease.MethodsIndividuals were randomized to a leg cooling intervention or placebo treatment group to daily self-monitor and record lower leg skin temperature over a 9-month period on monthly paper study logs. Returned study logs for the first 100 completed participants (n=54 cooling intervention, n=46 control) were reviewed for quality and accuracy. Adherence was determined from evaluating the accuracy of participant documentation. To examine potential outcome bias in treatment effect, mean between group and within group comparisons of the before and after treatment differences were conducted using an intention-to-treat (ITT) versus a modified intention-to-treat (mITT) analysis approach with an 85% accuracy cut-off rate. Data were collected in 2011–2014.ResultsOf the expected 900 study logs, 91.8% (826/900) were returned and 8.2% (74/900) were not. Non-mutually exclusive main error types in returned documentation included: 59.2% (489/826) white-outs, cross-off and/or overwrites, 34.9% (288/826) entries omitted, 29.4% (243/826) no performance of daily self-monitoring, 28.7% (237/826) no performance of the treatment intervention per the prescribed protocol regime, 26.8% (221/826) extraneous data, 8.6% (71/826) suspected fabrication, and 7.6% (63/826) questionable validity. Under ITT analysis, 38.4% (346/900) of all returned logs were <85% accurate, 25.0% (225/900) were 85%–99% accurate, and 36.6% (329/900) were 100% accurate. Mean overall participant adherence rates were: 22.0% at <85% accuracy, 53.0% at 85%–99% accuracy, and 25.0% at 100% accuracy. Under the mITT analysis, 54.0% (483/900) of returned logs were deemed adherent with ≥85% accuracy.ConclusionThis study found good rates of adherence. Under ITT analysis, 78.0% of participants were deemed adherent to the study protocol with ≥85% accuracy in documenting daily self-monitoring of skin temperatures in response to a topically applied experimental cooling cuff intervention for the prevention of venous leg ulcers.

Does Long-Term Group Psychoeducation of Parents of Individuals with Schizophrenia Help the Family as a System? A Quasi-Experimental Study

:A chronic illness like schizophrenia seriously disrupts family functioning in various ways that can be addressed through family psychoeducational interventions in routine clinical services, an approach that has not received proper research attention. We pre- and post-tested four sets of parents of individuals with schizophrenia who participated in a long-term group psychoeducational intervention (treatment group) and four sets of parents of individuals with schizophrenia who received standard outpatient services (clinical control group), using three self-reported questionnaires to measure family functioning (Family Assessment Device), family atmosphere (Family Rituals Scale), and family burden (Family Burden Scale). At pre-test, there were no systematic differences between the two groups in any of the parameters assessed. At post-test, within and across groups, comparisons revealed significant improvements (under cut-off scores) in the mean scores of the treatment group (p < 0.05) in all three parameters under study. Our findings provide pilot evidence that intensive group parent psychoeducation is an efficient and efficacious treatment intervention for improvement of systemic properties of families, such as family functioning, family atmosphere, and family burden.

Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study.

Objectives:To evaluate the efficiency of occupational therapy relative to a home program in improving quality of life (QoL) among men who were treated for metastatic prostate cancer (MPC).Methods:Fifty-five men were assigned randomly to either the 12-week cognitive behavioral therapy based occupational therapy (OT-CBSM) intervention (treatment group) or a home program (control group) between March 2012 and August 2014 in the Department of Occupational Therapy, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey. The Canadian Occupational Performance Measure (COPM) was used to measure the occupational performance and identify difficulties in daily living activities. The QoL and symptom status were measured by The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 and its Prostate Cancer Module. A 12-week OT-CBSM intervention including client-centered training of daily living activities, recreational group activities, and cognitive behavioral stress management intervention were applied.Results:The COPM performance and satisfaction scores, which indicate occupational participation and QoL increased statistically in the treatment group in relation to men who were included in the home-program (p≤0.05).Conclusion:A 12-week OT-CBSM intervention was effective in improving QoL in men treated for MPC, and these changes were associated significantly with occupational performance.

A Randomized Trial of a Bereavement Intervention for Pregnancy Loss

To examine the effects of a secondary bereavement intervention on grieving in women who experienced a miscarriage (pregnancy loss) at 12-20 weeks gestation. Experimental, posttest only, control group design. Obstetric emergency center of a county hospital in a large city. Forty women who experienced complete spontaneous miscarriages in the first or second trimester (8-20 weeks gestation). Participants were randomly assigned to the grief intervention treatment group or usual standard care control group. The Medical Professional Guidelines for Health Care Professionals were used to construct the perinatal grief intervention. The Perinatal Grief Scale (PGS) was completed during a routine follow-up visit 2 weeks postloss. A one-way multiple ANOVA (MANOVA) was used to examine the difference in grieving between the control and experimental groups. Three dependent variables were used: despair, difficulty coping, and active grieving. Analysis revealed a significant difference on the combined dependent variables, F(3, 36) = 22.40, p < .000. When considering the three dependent variables separately, the treatment group displayed significantly lower levels of despair, F(1, 38) = 42.27, p < .001. Active grieving was high in both groups with the treatment group mean higher than the control group. Group means were similar for coping difficulty. A bereavement intervention administered immediately after the miscarriage promotes women's ability to cope with early pregnancy loss.

Feasibility and acceptability of a resilience training program for intensive care unit nurses.

The critical nursing shortage is particularly apparent in specialty areas such as intensive care units (ICUs). Some nurses develop resilient coping strategies and adapt to stressful work experiences, mitigating the development of common maladaptive psychological symptoms. To determine if a multimodal resilience training program for ICU nurses was feasible to perform and acceptable to the study participants. In a randomized and controlled 12-week intervention study, treatment and control groups completed demographic questions and measures of resilience, anxiety, depression, posttraumatic stress disorder (PTSD), and burnout syndrome before and after the intervention. The intervention included a 2-day educational workshop, written exposure sessions, event-triggered counseling sessions, mindfulness-based stress reduction exercises, and a protocolized aerobic exercise regimen. Nurses in the intervention arm also completed satisfaction surveys for each component of the intervention. This mulitmodal resilience training program was feasible to conduct and acceptable to ICU nurses. Both nurses randomized to the treatment group and nurses randomized to the control group showed a significant decrease in PTSD symptom score after the intervention. A multifaceted resilience training program for ICU nurses was both feasible and acceptable. A sufficiently powered, randomized clinical trial is needed to assess the effect of the intervention on improving individuals' level of resilience and improving psychological outcomes such as symptoms of anxiety, depression, burnout syndrome, and PTSD.

Evaluation on training effect of "The Guidelines for Prevention and Treatment of Hypertension in China" training in Shanghai General practitioners

Objective To evaluate the effect of Guidelines for Prevention and Treatment of Hypertension in China (the Guidelines) training in Shanghai General practitioners(GPs). Methods One hundred and forty seven GPs from 5 community health centers in Xuhui District of Shanghai were assigned into intervention group(n=78) and control group(n=69). GPs in intervention group received regular trainings of the Guideline for 8 months, the control group did not receive the training.A questionnaire survey was conducted in both groups before and after the training. Results Most of GPs in the study (92.5%) had received hypertension training courses before, and majority of them (87.7%) wished to receive the further training.The scores of knowledge about hypertension in intervention group increased significantly(P=0.025) after training, but there were no changes in the control group(P=0.078) before and after training. The correct rate of hypertension treatment in intervention group was lower than that of control group before training (50.1% vs. 59.3%, P=0.001); however, the correct rate in intervention group was significantly higher than that of control group (65.5% vs. 55.4%, P=0.000) after training. Conclusions Providing GPs with regular training course on the Guidelines would improve their clinical ability for treatment of hypertension in the community. Key words: Hypertension; General practitioner; Train

EPA-1373 – Clinical experience treating affective disorders among cancer patients using fluoxetine 20 mg

Cancer patients treating in the specialized Oncological hospital, and psychotherapy in any specialized form almost unavailable (no psychotherapist in the staff), and mental health care is possible through counseling, in the form of a transfer to a psychiatric hospital. A study was designed to assess the effectiveness of 20 mg fluoxetine monotherapy and in combination with psychotherapy. 27 patients with cancer of the urinary system were included. 10 patients were randomized to a fluoxetine-monotherapy treatment group (FT), 10 patients to a fluoxetine prescibing combined with psychotherapeutic intervention treatment group (FPT) and 7 patients to a psychotherapeutic treatment group (PT). The Montgomery and Asberg Depression Scale (MADRS), the Hamilton Anxiety Scale (HAS), the Hamilton Depression Scale (HDS), the Hospital Anxiety and Depression Scale (HADS), were used to assess the efficacy of fluoxetine. The response rate, defined by HADS lower than 8 after 4 weeks of treatment, was not significantly higher in the FT group (10%) compared to the PT group (8%), but lower than in the FPT group (13%). Patients in the FT and FTP groups showed a significantly greater decrease in HADS mean score after 4 weeks. No difference between the three groups was found in observer-reported assessments (MADRS, HAS and HDS). Use monotherapy Fluoxetine20 mg justified out the most acute affective reactions as a maintenance therapy. The most effective use of combination therapy (Fluoxetine + psychotherapy session).

Application of “Earl's Assessment as, Assessment for, and Assessment of Learning Model” with Orthopaedic Assessment Clinical Competence

Context In order to study the efficacy of assessment methods, a theoretical framework of Earl's model of assessment was introduced. Objective (1) Introduce the predictive learning assessment model (PLAM) as an application of Earl's model of learning; (2) test Earl's model of learning through the use of the Standardized Orthopedic Assessment Tool (SOAT); and (3) establish construct validity of the SOAT. Design Quasi-experimental. Setting Three Canadian universities Patients or Other Participants A convenience sample of 57 third-year undergraduate athletic therapy students from three universities were randomly assigned into three experimental groups. Intervention(s) Treatment group 1 gave the instructor access to the SOAT, but the instructor could not explicitly share it. Treatment group 2 gave both the instructor and students access to the SOAT throughout the semester to use formatively. Group three was the comparison. Main Outcome Measure(s) All students were tested using the SOAT at the end of the semester using expert raters. An analysis of variance (ANOVA) (P &amp;lt; .05) was used to determine whether there was a difference between groups in their final examination grades. Results The ANOVA demonstrated a significant difference between groups (F2,56 = 28.6, P &amp;lt; .01). The effect size, calculated using η2, was 0.51. Post hoc analysis revealed a significant difference between treatment group 2 and the other treatment group and comparison group. Conclusions Small sample size and the quasi-experimental design prevent definitive conclusions, but the SOAT was able to discriminate between various groups, supporting our construct validity objective. The SOAT was introduced as a predictive tool that may assist orthopaedic assessment skill development. The treatment group exposed to the SOAT demonstrated that formative assessment of students using the SOAT was an effective means of teaching relative to no exposure or where only the instructor was exposed to the SOAT.

Cost effectiveness of a manual based coping strategy programme in promoting the mental health of family carers of people with dementia (the START (STrAtegies for RelaTives) study): a pragmatic randomised controlled trial

Objective To assess whether the START (STrAtegies for RelatTives) intervention added to treatment as usual is cost effective compared with usual treatment alone.Design Cost effectiveness analysis nested within a pragmatic...

Religious Cognitive–Behavior Therapy (RCBT) on Marital Satisfaction OCD Patients

Religious themes commonly feature in religious with Obsessive-compulsive disorder (OCD).OCD which includes cognitive, emotional, and behavioral components, is a debilitating chronic disorder and can effects on patient's marital satisfaction. Marital satisfaction is very important for couples’ mental health and effects on marital status. The aim of this study was to evaluate efficacy of Religious Cognitive- Behavior therapy (RCBT) on marital satisfaction religious oriented Obsessive-Compulsive disorder. With randomized control clinical trial. This study conducted on 90 Religious OCD outpatients according to DSM IV, and divided into two groups, intervention (45) and control (45) groups with randomly. Intervention consisted of 10 weekly RCBT 90minute session. For asses’ marital satisfaction used Enrich scale before and after treatment. Data analyzed by ANCOVA repeated to measure test the using SPSS ver.15.The result showed significant difference in Enrich scores after treatment in intervention groups (p=0.001). At the end added Religious component in CBT can help religious OCD patients.

Planning for Study Design and Analysis for Point-of-Care Research Teams: Does Size Matter?

Planning for Study Design and Analysis for Point-of-Care Research Teams: Does Size Matter?

Cohort Profile: The Japan Diabetes Complications Study: a long-term follow-up of a randomised lifestyle intervention study of type 2 diabetes

The Japan Diabetes Complications Study, a randomised lifestyle intervention study of type 2 diabetes conducted at 59 institutes throughout Japan that enrolled 2033 eligible patients from January 1995 to March 1996, was directed at: (i) determining the incidence and progression rates of complications of diabetes; (ii) exploring clinical risk factors for complications of diabetes; and (iii) determining the association between lifestyle factors, including diet and physical activity, and complications of diabetes, in addition to comparing, in a randomised manner, the effects on type 2 diabetes of an extensive lifestyle intervention and conventional treatment. The protocol for the study originally specified four study populations according to primary outcomes, consisting of: (1) a macroangiopathy group (N = 1771); (ii) a nephropathy group (N = 1607); (iii) a retinopathy-incident group (N = 1221); and (iv) a retinopathy-progression group (N = 410). The primary outcomes were: (i) development of retinopathy; (ii) progression of retinopathy; (iii) development of overt nephropathy; and (iv) occurrence of macroangiopathic events including proven coronary heart disease and stroke. The study was originally planned to follow patients for 8 years, and an extended follow-up is ongoing. Information about primary outcomes, laboratory tests, and other clinical variables for each patient was collected at a central data centre through an annual report from each investigator. Additionally, extensive lifestyle surveys were conducted at baseline and 5 years after the beginning of the study intervention in both the intervention and conventional treatment groups. A description of the occurrence of complications of diabetes and of all-cause mortality, provided in this paper, demonstrated a clear gender-based difference in cardiovascular disease and all-cause mortality.