Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials.

BACKGROUND: Clinical research coordinators play a pivotal role in phase I cancer clinical trials. PURPOSE: We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators' perspective on patients' expectations and understanding of these trials. METHOD: Fifteen clinical research coordinators participated in semi-structured interviews regarding clinical practices; perceptions of patients' expectations; and the challenges that occur before, during, and after phase I cancer clinical trials. DISCUSSION: Qualitative content analysis showed that most clinical research coordinators observed that patients have high expectations from the trials. Most listened to patients to confirm patients' understanding and reflected on responses to maintain hope, but to avoid excessive expectations; clinical research coordinators considered avoiding unplanned endings; and they aimed to establish good relationships between patients, medical staff, and among the professional team. CONCLUSIONS: Clinical research coordinators were insightful about the needs of patients and took a meticulous approach to the phase I cancer clinical trial process, allowing time to connect with patients and to coordinate the inter-professional research team. Additionally, education in advanced oncology care was valuable for comforting participants in cancer clinical trials.

Reliability and validity of revised and short form versions of diabetes diet-related quality of life scale.

OBJECTIVE: To develop both a revised version of the Diabetes Diet-Related Quality of Life (DDRQOL-R) scale that can be applied to patients with nephropathy and a short form of the DDRQOL-R. METHOD: A total of 184 outpatients with type 2 diabetes were asked to complete the self-administered DDRQOL-R scale to confirm its psychometric properties. A short-form version was developed, based on two methods: the result of the developed DDRQOL-R scale and consensus using the Delphi method among medical experts. RESULTS: Correlations were generally strong between the DDRQOL-R factors extracted by factor analysis and each SF-36 subscale. Cronbach's α coefficients were at least 0.7, and intraclass correlation coefficients were between 0.59 and 0.78. The nine items that showed high factor loadings were also assessed as important by the medical experts and were selected for the short form of the scale. The reliability and validity of the short form were found to be similar to those of the DDRQOL-R scale. DISCUSSION: Our findings indicate that the DDRQOL-R scale and its short form have acceptable reliability and validity. The revised version is highly versatile, and the short form can be conveniently administered.

Difficulties in Performing Mesalazine Enemas and Factors Related to Discontinuation Among Patients With Ulcerative Colitis.

Current first-line treatment of ulcerative colitis consists of a combination of mesalazine enemas and oral mesalazine; however, many patients may discontinue mesalazine enemas. In this single-center, cross-sectional study, 165 outpatients with ulcerative colitis completed a self-administered questionnaire regarding the frequency of mesalazine enemas, difficulties in performing these enemas, and factors possibly associated with their discontinuation, as well as patient clinical and demographic characteristics. Of 165 patients, 34 (20.6%) discontinued mesalazine enemas because of a lack of efficacy. Five of the 13 items assessing difficulties were answered affirmatively by the majority of patients. Discontinuation of enema application was associated with a perceived lack of efficacy, four or more bowel movements per day, and lower scores on measurement of the doctor-patient relationship. Application of mesalazine enemas by patients with ulcerative colitis may be improved by discussions with peers and healthcare professionals and by adjusting the frequency of application or the time of starting the enema based on worsening of ulcerative colitis.

Evaluation of care for leukemia and lymphoma patients during their last hospitalization from the perspective of the bereaved family.

We aimed to evaluate care for leukemia and lymphoma patients during their last hospitalization from the perspective of the bereaved family. Questionnaires were sent to the bereaved family members of adult leukemia and lymphoma patients. We used the Care Evaluation Scale (CES) and asked the bereaved family members about care satisfaction and "good death" factors during the patient's last week of life or last admission period. We distributed 177 questionnaires and were able to analyze 103 (58.2%) responses. Compared with the results of a previous study of palliative care units in Japan, the CES scores were significantly lower in 9 out of 10 domains. Assessment of the "good death" components revealed that only 33% of respondents agreed that the patient had been relieved as far as possible of pain and physical distress during the last week of life. Only 21.4% of respondents agreed that the patient had been relieved as far as possible of psychological distress, and 57% of caregivers were not satisfied with the level of care. During the last hospitalizations of leukemia or lymphoma patients, their care was insufficient and a good death was not often achieved. Improvement of end-of-life care for leukemia and lymphoma patients is needed.

How effective is an in-hospital heart failure self-care program in a Japanese setting? Lessons from a randomized controlled pilot study.

BACKGROUND: Although the effectiveness of heart failure (HF) disease management programs has been established in Western countries, to date there have been no such programs in Japan. These programs may have different effectiveness due to differences in health care organization and possible cultural differences with regard to self-care. Therefore, the purpose of this study was to evaluate the effectiveness of a pilot HF program in a Japanese setting. METHODS: We developed an HF program focused on enhancing patient self-care before hospital discharge. Patients were randomized 1:1 to receive the new HF program or usual care. The primary outcome was self-care behavior as assessed by the European Heart Failure Self-Care Behavior Scale (EHFScBS). Secondary outcomes included HF knowledge and the 2-year rate of HF hospitalization and/or cardiac death. RESULTS: A total of 32 patients were enrolled (mean age, 63 years; 31% female). There was no difference in the total score of the EHFScBS between the two groups. One specific behavior score regarding a low-salt diet significantly improved compared with baseline in the intervention group. HF knowledge in the intervention group tended to improve more over 6 months than in the control group (a group-by-time effect, F=2.47, P=0.098). During a 2-year follow-up, the HF program was related to better outcomes regarding HF hospitalization and/or cardiac death (14% vs 48%, log-rank test P=0.04). In Cox regression analysis after adjustment for age, sex, and logarithmic of B-type natriuretic peptide, the program was associated with a reduction in HF hospitalization and/or cardiac death (hazard ratio, 0.17; 95% confidence interval, 0.03-0.90; P=0.04). CONCLUSION: The HF program was likely to increase patients' HF knowledge, change their behavior regarding a low-salt diet, and reduce HF hospitalization and/or cardiac events. Further improvement focused on the transition of knowledge to self-care behavior is necessary.

Computer-supported indirect-form lifestyle-modification support program using Lifestyle Intervention Support Software for Diabetes Prevention (LISS-DP) for people with a family history of type 2 diabetes in a medical checkup setting: a randomized controlled trial.

AIMS: To investigate the effect of a computer-supported indirect-form lifestyle-modification program using Lifestyle Intervention Support Software for Diabetes Prevention (LISS-DP), as a clinically feasible strategy for primary prevention, on diet and physical activity habits in adults with a family history of type 2 diabetes. METHODS: This was a two-arm, randomized controlled trial: (1) lifestyle intervention (LI) group (n=70); (2) control (n=71). Healthy adults aged 30-60 years with a history of type 2 diabetes among their first-degree relatives were recruited. LI group received three times of lifestyle intervention using LISS-DP during six-month intervention period via mail. RESULTS: Lifestyle intervention group showed significantly greater decrease in energy intake six months after baseline, compared to control (-118.31 and -24.79 kcal/day, respectively, p=0.0099, Cohen's d=0.22), though the difference disappeared 1 year after from baseline. No difference was found in physical activity energy expenditure. CONCLUSIONS: A computer-based, non-face-to-face lifestyle intervention was effective on dietary habits, only during the intervention period. Further examination of the long-term effects of such intervention and physical activity is required.

Relationship between non-adherence to aminosalicylate medication and the risk of clinical relapse among Japanese patients with ulcerative colitis in clinical remission: a prospective cohort study.

BACKGROUND: Thirty to forty-five percent of ulcerative colitis (UC) patients show non-adherence to aminosalicylates, and non-adherence has been reported to increase the risk of clinical relapse. Because Japan differs from Western countries in terms of health care and drugs administered, adherence to aminosalicylates in Japan may differ from that elsewhere. Therefore, we examined aminosalicylate adherence and its relationship to the risk of clinical relapse of UC in Japan. METHODS: A 1-year, prospective cohort study was conducted in 104 outpatients with UC in remission who had taken aminosalicylates >6 months. Aminosalicylate adherence was evaluated using data from a self-administered questionnaire and medical records. Non-adherence was defined as taking <80 % of the prescribed dose of aminosalicylates. The primary outcome was the record of clinical relapse in medical charts. RESULTS: Twenty-nine patients (27.9 %) were evaluated as showing non-adherence. Among all subjects, 24 patients (23.1 %) relapsed. The non-adherence group had a higher rate of 1-year relapse than did the adherence group (41.3 vs. 16.0 %). Multiple Cox regression analysis showed that non-adherence increased the risk of clinical relapse 2.3-fold (hazard ratio 2.3, 95 % confidence interval 1.004-5.24, p = 0.04). CONCLUSIONS: Although the adherence rate in this study was slightly higher than that in previous studies, Japanese patients with UC who were not adherent to their medications had a twofold greater risk of relapse than those who were. These results indicate the importance of early identification of patients with non-adherence. A program to support medication taking behavior is needed to prevent UC relapse.

Validation of the Japanese version of the EORTC hepatocellular carcinoma-specific quality of life questionnaire module (QLQ-HCC18).

BACKGROUND: This Study Examined The Measurement Properties Of The Japanese Version Of The European Organisation for Research and Treatment of Cancer (EORTC) Hepatocellular Carcinoma-Specific Quality of Life Questionnaire (QLQ-HCC18). METHODS: EORTC quality of life (QOL) translation guidelines were followed to create a Japanese version of the EORTC QLQ-HCC18. This was then administered to 192 patients with hepatocellular carcinoma along with the EORTC QLQ-C30 and FACT-Hep questionnaires. Tests for reliability and validity were conducted including comparison of scores between the EORTC and FACT questionnaire and detailed assessment of the new scales and items in clinically distinct groups of patients. RESULTS: Multi-trait scaling analysis confirmed three putative scales in the QLQ-HCC18, fatigue, fever and nutrition. Cronbach's alpha for these scales were between 0.68 and 0.78. The QLQ-HCC18 scales correlated with scales measuring similar items in the FACT-Hep and the questionnaire was stable over time with an intra-class correlation score of 0.70 for almost all scales. The questionnaire had the ability to distinguish between patients with different Karnofsky Performance Status, and Child-Pugh liver function class. CONCLUSIONS: The Japanese version of EORTC QLQ-HCC18 is a reliable supplementary measure to use with EORTC QLQ-C30 to measure QOL in Japanese patients with hepatocellular carcinoma.

Depressive symptoms are common and associated with adverse clinical outcomes in heart failure with reduced and preserved ejection fraction.

BACKGROUND: Little is known about depressive symptoms in heart failure with preserved ejection fraction (HFpEF, EF ≥50%). We aimed to assess the prevalence of depression, to clarify the impact of depressive symptoms upon clinical outcomes, and to identify factors associated with these symptoms in HF with reduced EF (HFrEF, EF <50%) and HFpEF. METHODS AND RESULTS: A total of 106 HF outpatients were enrolled. Of them, 61 (58%) had HFpEF. Most patients were male (HFrEF 80%, HFpEF 70%) and the mean of plasma B-type natriuretic peptide (BNP) level in the HFrEF group was similar to that in the HFpEF group (164.8 ± 232.8 vs. 98.7 ± 94.8 pg/mL). HFrEF patients were treated more frequently with beta-blockers compared with HFpEF patients (71% vs. 43%, p=0.004). Depressive symptoms were assessed using the Center for Epidemiologic Studies Depression Scale (CES-D). The prevalence of depression (CES-D score ≥16), and CES-D score did not significantly differ between HFrEF and HFpEF (24% vs. 25%, 14.1 ± 8.3 vs. 12.1 ± 8.3, respectively). During the 2-year follow-up, depressed patients had more cardiac death or HF hospitalization in HFrEF (55% vs. 12%, p=0.002) and HFpEF (35% vs. 11%, p=0.031). Cox proportional hazard analysis revealed that a higher CES-D score, indicating increased depressive symptoms, predicted cardiac events independent of BNP in HFrEF [hazard ratio (HR) 1.07, 95% confidence interval (CI) 1.01-1.13] and HFpEF (HR 1.09, 95% CI 1.04-1.15). Multiple regression analyses adjusted for BNP showed that independent predictors of depressive symptoms were non-usage of beta-blockers and being widowed or divorced in HFrEF. On the other hand, usage of warfarin was the only independent risk factor for depressive symptoms in HFpEF (all, p<0.05). CONCLUSIONS: Depressive symptoms are common and independently predict adverse events in HFrEF/HFpEF patients. This study suggests that beta-blockers reduce depressive symptoms in HFrEF. In contrast, treatment for depression remains to be elucidated in HFpEF.

Development of self-care educational material for patients with heart failure in Japan: a pilot study.

This study assessed the need for information regarding heart failure and self-care, developed self-care educational material, and investigated the feasibility of the material. A total of 22 hospitalized heart failure patients (mean age: 63 years) completed a self-administered questionnaire. We found that more than 90% of patients desired information, particularly about heart failure symptoms, time to notify healthcare providers, prognosis, and exercise/physical activity. After examining the eight existing brochures for Japanese heart failure patients, we developed self-care educational material. This was based on heart failure guidelines and on the results of our inquiry regarding information needs. Finally, a pilot study was conducted in nine hospitalized heart failure patients (mean age: 57 years). None of the patients had difficulty reading or understanding the educational material. The self-administrated questionnaire survey revealed that comprehension of the following improved after the educational sessions with the material: heart failure symptoms, medication, weighing, sodium intake, and fluid intake (P < 0.05). In conclusion, heart failure patients have a great need for information about heart failure. Our pilot study suggests that the material was readable and had a beneficial effect on heart failure comprehension.

Difficulties in taking aminosalicylates for patients with ulcerative colitis.

Aminosalicylates are effective in inducing remission and are also useful in preventing relapse of ulcerative colitis (UC); however, previous studies have reported a 30%-45% rate of nonadherence to prescribed medication among UC patients. Enumerating and conceptualizing the difficulties in taking aminosalicylates enable us to assess and support patients more effectively. The aim of this study was to investigate the difficulties in taking aminosalicylates among Japanese UC patients and explore factors related to these difficulties. Outpatients with UC (n = 242) completed a questionnaire supported by a semistructured interview on the basis of a literature review. Twelve items about difficulties in taking aminosalicylates were processed by factor analysis and the related factors regarding difficulties were analyzed. The following three independent domains were identified: Domain 1: diminished sense of priority for medication; Domain 2: concern about side effects; and Domain 3: burden of taking the prescribed drug. Factors related to the difficulties in taking aminosalicylates included the disease state, psychosocial factors, and demographic characteristic variables. On the basis of the results, we recommend the creation and validation of a program aimed at decreasing the difficulties in taking aminosalicylates.

Development of a support skill scale in insulin therapy: a nationwide study in Japan.

The aim of this cross-sectional, nationwide study in Japan was to develop a support skill scale for insulin therapy (IT-SSS) and to evaluate its validity and reliability. The sample consisted of 1604 nurses at 123 hospitals throughout the country. The factor validity, known-group validity, convergent validity, discriminant validity and internal consistency of IT-SSS were assessed. IT-SSS consisted of 26 minimum and 25 standard support skills. They included 4 subscales for minimum skills: management strategy for hypoglycemia, education about insulin injection technique, individual assessment and support about insulin rejection, and collaboration with medical professionals and patient/family. Three subscales for standard skills: apprehensions concerning the will and emotion of the patient, management for blood glucose control, and coordination in insulin management. Cronbach's alpha coefficient was between 0.75 and 0.90, suggesting strong internal consistency. Multitrait analysis showed that convergent validity was complete, and discriminant validity was found to be almost complete in both minimum and standard skill scales (scaling success rates of 97.6% and 98.7% across all subgroups, respectively). Known group analysis clearly showed that specialist nurses have significantly higher skills than general nurses. These findings indicate that IT-SSS has a reasonable factor validity, convergent validity, discriminant validity, known group validity, and internal consistency.

Knowledge and Demand for Information about Islet Transplantation in Patients with Type 1 Diabetes.

This cross-sectional study based on self-administrated questionnaire was conducted to investigate knowledge, related factors, and sources of information regarding islet transplantation in patients with type 1 diabetes in Japan. Among 137 patients who provided valid responses, 67 (48.9%) knew about islet transplantation. Their main source of information was newspapers or magazines (56.7%) and television or radio (46.3%). However, 85.8% of patients preferred the attending physician as their source of information. Although more than half of the patients were correctly aware of issues related to islet transplantation, the following specific issues for islet transplantation were not understood or considered, and there was little knowledge of them: need for immunosuppressants, lifestyle and dietary adaptations, fewer bodily burdens, and complications. The experience of hypoglycaemia, a high level of academic background, frequent self-monitoring of blood glucose, and the use of continuous subcutaneous insulin infusion were related to higher knowledge about islet transplantation.

Impact of a Booklet about Diabetes Genetic Susceptibility and Its Prevention on Attitudes towards Prevention and Perceived Behavioral Change in Patients with Type 2 Diabetes and Their Offspring.

Background. Offspring of type 2 diabetic patients are at a high risk of type 2 diabetes. Information on diabetes genetic susceptibility and prevention should be supplied to the offspring. Methods. A six-page booklet on diabetes genetic susceptibility and prevention was distributed to 173 patients who ere ordered to hand it to their offspring. The patients answered a self-administered questionnaire on booklet delivery and attitudinal and behavioral changes toward diabetes and its prevention in themselves and their offspring. Results. Valid responses were obtained from 130 patients. Forty-nine patients had actually handed the booklet. Booklet induces more relief than anxiety. From the patient's view, favorable attitudinal and/or behavioral changes occurred in more than half of the offspring who were delivered the booklet. Conclusion. The booklet worked effectively on attitudes and behaviors toward diabetes and its prevention both in patients and their offspring. However, the effectiveness of patients as information deliverers was limited.

Opinions of physicians regarding problems and tasks involved in the medical care system for patients with adult congenital heart disease in Japan.

BACKGROUND: The aim of this study is to summarize the opinions of physicians regarding problems and tasks involved in the medical care system for patients with adult congenital heart disease (ACHD) in Japan. METHODS AND RESULTS: We conducted a semistructured interview with 30 subjects consisting of 13 pediatric cardiologists, 11 cardiovascular surgeons, and six cardiologists who were selected from among the randomly sampled medical facilities meeting each of the following institutional criteria: (1) facilities with ≥50 ACHD outpatients; (2) facilities with ACHD-specialized outpatient clinic; (3) facilities that are members of the Japanese Association of Chirdren's Hospitals and Related Facilities. The interview time was 27-91 minutes (mean, 70.0). The age of the subjects ranged from 36 to 62 years (mean, 46.7), and they had 0.5-34 years (mean, 16.2) of experience in treating congenital heart disease. From an analysis of interview details, the following four themes were extracted (in descending order of the number of comments): "(1) Who should treat ACHD" (comments by 29 subjects), "(2) Centralization of medical care" (comments by 29 subjects), "(3) What is the role of children's hospitals in ACHD?" (comments by 24 subjects), and "(4) Psychosocial problems" (comments by 24 subjects). CONCLUSIONS: Regional ACHD centers need to be established to promote centralization of patients, physicians, and educational function. This will provide higher quality medical service to more patients in the near future.

Factors affecting encouragement of relatives among families with Lynch syndrome to seek medical assessment.

Lynch syndrome (HNPCC) is an autosomal dominant hereditary cancer syndrome, and members of affected families are at-risk for developing colorectal and other associated tumors. Such individuals should disseminate familial genetic information, so they can seek specific medical assessment or genetic testing to reduce mortality and morbidity rates by early detection. Since published results have been encouraging, we explored which factors influence the likelihood of good communication within families regarding medical assessment. We studied 40 individuals from 33 families who satisfied the Japanese clinical criteria for Lynch syndrome and their relatives at our hospital. We determined the status of relatives of the 40 individuals after genetic counseling and testing using questionnaires and semi-structured interviews based on pedigree charts. We also examined their knowledge or perception of colorectal cancer syndrome, levels of intimacy and whether or not they encouraged their relatives to have specific medical assessments. We found that 75% of the individuals advised their relatives to seek medical assessment, and any significant background factors that promoted such encouragement were observed. They tended to encourage first degree relatives and discuss the issue with other family members such as spouses before undertaking such attempts at encouragement. The reasons and methods of imparting encouragement were essentially identical. We also found that genetic testing for at-risk or more distant relatives was not encouraged so often. Therefore, providing individuals who have been tested for Lynch syndrome with opportunities for disseminating familial genetic information through appropriate genetic counseling is important.

Quality of life as an independent predictor for cardiac events and death in patients with heart failure.

BACKGROUND: Little is known about health-related quality of life (QOL) in Japanese patients with heart failure. The purpose of this study was to identify factors related to QOL using a disease-specific QOL instrument, and to clarify whether QOL independently predicts clinical outcomes among Japanese patients with heart failure. METHODS AND RESULTS: A total of 114 outpatients with heart failure were enrolled (mean age 64.7 ± 15.8 years; 73.7% males). The Minnesota Living with Heart Failure Questionnaire (MLHFQ) to assess patient's QOL was used. At baseline, depressive symptoms and chronic kidney disease were significantly associated with worse QOL in multiple regression analysis. During a 2-year follow up, patients with a MLHFQ score ≥ 26, indicating worse QOL, had a higher incidence of the combined endpoint of cardiac death or hospitalization for heart failure, and a higher all-cause mortality than those with a score < 26 (25.3% vs. 7.5%, P = 0.011; 18.5% vs. 6.4%, P = 0.018; respectively). Multivariate Cox proportional hazard models demonstrated that a higher MLHFQ score was significantly associated with increased risks of cardiac events (hazard ratio, 1.02, 95% confidential interval, 1.001-1.05, P = 0.038) and of all-cause death (hazard ratio, 1.04, 95% confidential interval, 1.02-1.07, P = 0.001). CONCLUSIONS: Depressive symptoms and chronic kidney disease are major determinants of impaired QOL, and the MLHFQ score is an independent predictor of both cardiac events and death among Japanese patients with heart failure.

Influence of dietary therapy appraisal on future perceived control of type 2 diabetes.

We sought to elucidate the causal effect of patients' self-appraisal of their dietary regimen on their control beliefs among adults with type 2 diabetes. Data from 176 outpatients were assessed using a two-wave cross-lagged panel model. We found that a cross-lagged path connecting dietary appraisal at baseline to perceived control at one year (ß = .30, p = .003) was larger than a path connecting perceived control at baseline to dietary appraisal at one year (ß = -.16, p = .07). We conclude that dietary appraisal has a feedback effect on the future perceived control of type 2 diabetes.

Translation and validation study of the Japanese versions of the Coronary Revascularisation Outcome Questionnaire (CROQ-J).

BACKGROUND AND AIMS: Assessing the health related quality of life (HRQOL) in patients with a disease specific scale is essential. The purpose of this study was to develop the Japanese version of the coronary revascularisation outcome questionnaire (CROQ), a disease-specific scale to measure HRQOL before and after coronary revascularisation. METHODS: The English version of the questionnaire was translated into Japanese; some terms were revised, and some items were eliminated to suit the Japanese medical environment. Eight patients filled out the questionnaire, which was then analyzed for face validity. In the field study, subjects were recruited from a university hospital in Tokyo, and questionnaires were given to fill out. In terms of statistical analysis, factor analysis, internal consistency, known-groups validity, concurrent validity with using Short-Form36 (SF-36) and Seattle Angina Questionnaire-Japanese version (SAQ-J), and test-retest reliability were assessed. RESULTS: Informed consents were obtained from 356 patients, and out of 325 patients responded in the field study (91.3%). The factor structure of CROQ-Japanese version (CROQ-J) was similar to that of the original version. Cronbach's α ranged from 0.78 to 0.92. The concurrent validity was mostly supported by the pattern of association between CROQ-J, SAQ-J, and SF-36. Patients without chest symptoms had significantly higher scores of CROQ-J than those with chest symptoms. On the basis of analysis of the test-retest reliability, intra-class correlation coefficients were close to 0.70. CONCLUSIONS: The Japanese translation of CROQ is a valid and reliable scale for assessing the patient's HRQOL in CAD.

Influences of Allocating HIV/AIDS Specialized Nurses on Clinical Outcomes in Japan.

PURPOSE: This retrospective cohort study was conducted to demonstrate how allocation of nurses specialized in HIV care influences clinical outcomes of antiretroviral therapy (ART) for people living with HIV (PLWH). METHODS: The medical records of 116 PLWH who started ART between January 2002 and December 2004 were analyzed. Occurrence of viral suppression and viral relapse after suppression achievement and their time from baseline were observed as clinical outcomes related to ART. Clinical outcomes were obtained from medical records between January 2002 and December 2006. PLWH were classified into two groups according to allocation (n = 95, nurse allocated group) or nonallocation (n =21, nurse nonallocated group) of nurses specialized in HIV. RESULTS: Survival analysis showed that HIV viral load was suppressed more rapidly and continuously in nurse allocated group than nonallocated group (p < .0001). Viral relapse after suppression achievement occurred easily in nurse nonallocated group than allocated group (p = .003). CONCLUSIONS: The present findings demonstrated that the role of specialized nurses is critically important from the viewpoint of clinical outcome.