Change In Overall Health Status Research Articles

Enhancement of Preventive Vaccination Approaches for Children with Health Problems: Prospective Cohort Study Results

Background. Modern preventive vaccination is intended to protect and enhance the health of every person considering age and health issues. Vaccination of children with chronic diseases in our country remains extremely topical and arguable problem that associated with many pending issues for doctors of various specialties, including those working as primary care specialists.Objective. The aim of the study is to develop major approaches and to prove scientifically the efficacy and safety of preventive vaccination for children with various chronic diseases.Methods. We have conducted comprehensive study of 100 children aged from 1 month to 17 years 11 months. Children were divided into 4 groups according to the specific disease. Vaccinal and infectious history was analyzed. The post-vaccination period was estimated due to the results of the questionnaire completed by parents. Vaccination immunogenicity was estimated based on the results of the level of specific antibodies to various controlled infections (measles, rubella, parotitis, hepatitis B, pertussis, haemophilus influenza type b).Results. Protective titers of antibodies against haemophilus influenza type b were revealed in 96.2% of all examined patients, tetanus and hepatitis B — in 95.2%, against pertussis — in 92.5%, rubella — in 91%, measles — in 87.5%, parotitis — in 71.9%, chickenpox — in 69% children a month after the completed vaccination. The postvaccinal period was characterized as favorable in most patients. Major changes in overall health status occurred after vaccination in 42% of children was the following: subfebrile fever, capriciousness, or fatigue. Local reactions have developed only in 15% of cases.Conclusion. The results of this study have demonstrated the preventive vaccination efficacy and safety in children with various chronic diseases

Comparative efficacy and safety of preventive treatment with cytovir-3 and arbidol in children during seasonal outbreak of respiratory viral infection (an open-label randomized clinical study)

Aim: To compare the safety and prophylactic efficacy of Cytovir-3 and Arbidol in an open-label randomized clinical trial in children at seasonal risk of infectious respiratory disease.Methods: This study was performed in the period preceding a seasonal outbreak of acute respiratory viral infections (ARVI) and influenza. The study enrolled apparently healthy children aged 6 to 18 years without contra-indications to either Cytovir-3 or Arbidol. Cytovir-3 was given as 1 capsule per day, each day in a fasted state for 12 days. Arbidol was taken as a 100 mg capsule twice a week for three weeks. Following dosing, subjects were followed-up for a further three weeks. Overall health and presence of symptoms of either ARVI or influenza were monitored daily in all subjects. The level of sIgA in saliva was baselined before treatment and measured at the end of the follow-up period.Results: Most subjects did not exhibit any change in overall health status during the dosing and follow-up periods. The first two cases of illness in subjects receiving Cytovir-3 were diagnosed at the end of the third week after completion of dosing. In those subjects receiving Arbidol the first cases of illness were reported at the end of the second week following the end of prophylactic dosing. All patients displayed a significant increase in sIgA level at the end of the dosing period, but this was more pronounced in the Cytovir-3 group. Conclusion: The results of this comparative randomized clinical trial confirmed the safety and tolerability of both medications, and that the prophylactic efficacy of Cytovir-3 is equal to that of Arbidol.

Determinants of Perceived Health Nonimprovement in Early Rheumatoid Arthritis Patients With Favorable Treatment Outcomes.

To explore the association between achieving favorable clinical outcomes and patients' perceived change in overall health status after 12 months of treat-to-target in patients with early rheumatoid arthritis (RA) and to identify determinants of subjective nonimprovement. Baseline and 12-month data of patients included in the Dutch Rheumatoid Arthritis Monitoring remission induction cohort study with at least a moderate response (by European League Against Rheumatism criteria) after 1 year were selected for analysis. Logistic regression analysis was used to identify factors associated with nonimproved perceived overall health status at 12 months. At 12 months, 75 of 210 patients (35%) did not consider their health to have improved despite having achieved favorable clinical outcomes. Relative change from baseline in pain (Wald = 20.20; P < 0.01) and fatigue (Wald = 5.58; P = 0.02) was independently associated with nonimproved perceived overall health status. The results were similar when only patients with ≤1 swollen joint were analyzed. An improvement of 55% in pain measured on a visual analog scale was found to discriminate reasonably well between patients who considered their health to have improved versus patients who did not, with an area under the receiver operating characteristic curve of 0.70 (95% confidence interval 0.61-0.78). These results demonstrate that clinical improvements do not equate with improved subjective health for all patients. The association of nonimprovement with changes in pain and fatigue suggest that it might be worthwhile to monitor and address pain and fatigue in addition to and independently of disease activity in early RA.

Is circumferential urethral mobilisation an overdo? A prospective outcome analysis of dorsal onlay and dorso - lateral onlay BMGU for anterior urethral strictures.

ABSTRACTIntroductionFor dorsal onlay graft placement, unilateral urethral mobilization is less invasive than standard circumferential urethral mobilization. Apart from success in terms of patency of urethra, other issues like sexual function, overall quality of life and patient satisfaction remain important issues while comparing outcomes of urethroplasty.AimTo prospectively compare the objective as well as subjective outcomes of two approaches.Materials and MethodsBetween July 2011 and January 2015, 136 adult males having anterior urethral stricture with urethral lumen ≥ 6 Fr. were prospectively assigned between two groups by alternate randomization. Operative time, complications, success rate (no obstructive symptoms, no need of any postoperative intervention, Q max > 15mL/sec), sexual functions (using Brief Male Sexual Function Inventory) were compared.ResultsBaseline parameters were similar in both groups (68 in each group). Overall success rate was similar in both groups (89 % and 91 % respectively). Improvement in total LUTS scores was similar in groups. Changes in overall health status (VAS and EQ 5D) was equal in both groups. Erectile function score was significantly decreased in DO than DL group while ejaculatory function and sexual desire remained stable after urethroplasty in both groups.ConclusionsIn anterior urethral stricture buccal mucosa graft provides satisfactory results as onlay technique. No technique whether dorsolateral and dorsal techniques is superior to other. Dorsolateral technique needs minimal urethral mobilization and should be preferred whenever feasible.

Dupilumab Improves General Health-Related Quality-of-Life in Patients with Moderate-to-Severe Atopic Dermatitis: Pooled Results from Two Randomized, Controlled Phase 3 Clinical Trials.

IntroductionPatients with moderate-to-severe atopic dermatitis (AD) report a multidimensional disease burden that includes impaired health-related quality-of-life (HRQoL). Changes in overall health status and specific dimensions that contribute to HRQoL were evaluated in adults with moderate-to-severe AD who participated in phase 3 clinical trials of dupilumab, which is a fully human monoclonal antibody that inhibits signaling of cytokines IL-4 and IL-13.MethodsTwo dupilumab phase 3 clinical trials of identical design included the 5-dimension 3-level EuroQol (EQ-5D) as a measure of HRQoL. EQ-5D data from the two trials were pooled in an analysis that, using analysis of covariance, compared subcutaneous dupilumab 300 mg once weekly (qw) or every 2 weeks (q2w) versus placebo for EQ-5D utility score change from baseline overall and for clinical responders. The proportions of patients who reported different levels of problems on the individual dimension of the EQ-5D were also compared by treatment group.ResultsPatients (n = 1379) were 57.9% male with a mean (SD) age of 38.3 (14.3) years; baseline EQ-5D utility scores ranged from 0.611 to 0.629 across treatment groups. EQ-5D least squares mean change from baseline at week 16 was 0.031 with placebo, and was significantly greater with dupilumab qw (0.207) and q2w (0.210) (both P < 0.0001), which exceeded the minimal clinically important difference and resulted in scores that approached population norms. Changes from baseline among patients who achieved AD clinical response were greater than changes among the total population. Improvements were driven by the individual EQ-5D dimensions with the greatest burden at baseline (i.e., pain/discomfort, anxiety/depression and usual activities).ConclusionIn adults with moderate-to-severe AD, dupilumab resulted in improvements in HRQoL that were statistically significant relative to placebo and were clinically meaningful.FundingSanofi and Regeneron Pharmaceuticals, Inc.Trial registrationClinicalTrials.gov identifiers, NCT02277743 and NCT02277769, EudraCT Numbers 2014-001198-15 and 2014-002619-40.

Second generation direct-acting antiviral (DAAs) Treatment on HCV+ patients: Patient reported outcomes (PROs) and psychiatric symptoms in a real world setting sample

IntroductionAnti-HCV treatments are moving away from interferon-alpha towards DAAs, associated with fewer side effects, better tolerability, and better PROs.AimsTo describe neuropsychiatric symptoms and PROs during DAAs treatment in a group of HCV+ patients.MethodsForty outpatients, scheduled for DAAs treatment, were assessed at enrolment (T0), 4 weeks (T1), at the end of treatment (EOT) and after 12 weeks of follow up (F-UP), by means of MDRS, HAM-D, HAM-A, MRS, Y-BOCS and SF-36. Afterwards the sample was divided into two groups as a function of a positive psychiatric history (19) and compared with each other.ResultsTotal sample mean scores between W0 and F-UP were compared and an improving trend was observed in all administered scales. An SF-36 items analysis showed a statistically significant difference in emotional role functioning between W0 vs EOT and EOT vs F-UP, in change in overall health status between W0 vs EOT and W0 vs F-UP.A multivariate logistic regression analysis showed that a positive psychiatric history was not associated with an improvement in vitality of 4.3 (minimal clinically important difference). Comparing the two groups, no significant fluctuations in SF-36 scores were founded and major deviations score increases were recorded in patients with a psychiatric history in all scales.ConclusionsOur real world data shows that new regimens do not seem to be associated with psychiatric side effects and conversely a clinical improvement compared to baseline was found, suggesting an immediate gain in PROs over the treatment period, particularly the psychiatric subgroup.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Experiences of colorectal cancer patients in the 2-years post-diagnosis and patient factors predicting poor outcome.

There are few recent longitudinal studies investigating the quality of life of colorectal cancer patients in the early years following diagnosis. This study aimed to (i) compare the health status of people with colorectal cancer less than 1year from diagnosis with health status 1year later and (ii) determine the characteristics associated with a change in overall health status. The study was conducted as part of a larger trial. Participants (n = 539) were identified via the Victorian Cancer Registry in Australia, completed a computer-assisted baseline telephone interview (including the EQ-5D-3L) within 6-12months of diagnosis, and mailed a survey 12months later. At baseline, the majority of participants (55%) reported some problems, including difficulties in usual activities (26%), pain or discomfort (25%), anxiety or depression (23%) and mobility issues (15%). Sixty-nine percent had either an unchanged or increased health utility score from baseline to follow-up. The largest proportion reporting an increase in problems between baseline and follow-up related to pain or discomfort (18%). While visual analogue scale scores indicated a significantly improved health state over time overall, 32% reported a decreased health utility score from baseline to follow-up. Those aged over 80years were more likely to report a decreased health utility score compared to 60-80-year-olds. A sizeable minority of patients experience ongoing problems in their daily lives and should be offered assistance in overcoming disabilities and returning to best possible functioning, particularly older patients who appear to be vulnerable to poor outcomes.

New interferon-free therapies on HCV+ chronic hepatitis: Overcoming psychiatric side effects in a real world setting

IntroductionInterferon-alpha (IFNα) was the backbone therapy for HCV+ related chronic hepatitis (CH-C). However, it was associated with significant neuropsychiatric side effects and impaired health-related quality of life. Second Generation IFNα-free direct-acting antiviral agents (DAAs) seem to be associated with fewer side effects, better tolerability, high efficacy rates and better patient reported outcomes (PROs) [Younoussi, 2014].AimsTo describe the neuropsychiatric symptoms and PROs during Second Generation DAAs plus ribavirin oral treatment in a group of CH-C real world patients.MethodsNineteen CH-C outpatients, scheduled for IFNα-free treatment, were assessed at enrolment (T0), at 4 (T1) and at 12 (T2) weeks, the end of treatment, by means of MDRS, HAM-D, HAM-A, MRS, Y-BOCS and SF-36. A pharmacological therapy, based on clinical evidence, was provided at psychiatric symptoms onset.ResultsDuring the treatment, we didn’t report any worsening in the administred psychometric scales. Furthermore, we observed a general improvement at week 12 (T2), statistically significant only for MRS (P &lt; 0.05). Any statistically significant difference was found for SF-36 mean scores comparing T0, T1 and T2. However, SF-36 cluster analysis showed between T0 and T2 a meaningful and significant rise of global health clusters “General health perceptions” (P &lt; 0.05), “Change in overall health status” (P &lt; 0.001) and a significant impairment in cluster “Emotional role functioning” (P &lt; 0.05).ConclusionsOur real world data are consistent with trial setting results [Younoussi, 2014]. Contrary to previous IFNα-based therapy, new regimens don’t seem to be associated with psychiatric side effects and suggest an immediate gain in general health PROs over the treatment period.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Differences in health behaviours between immigrant and non-immigrant groups: a protocol for a systematic review.

BackgroundHealth behaviours are important determinants of health and adoption of unhealthy behaviour is considered as one of the mechanisms through which immigrants’ health changes over time in the host country. The change in health behaviours over time can contribute either to improving or worsening the overall health status of immigrants. Despite being the important mediators for the change in overall health status and chronic health conditions, no previous review (either general or systematic) has examined differences in key health behaviours simultaneously between immigrants and non-immigrants. This study aims to provide a systematic overview of the current global literature on differences in key health behaviours (that is, tobacco smoking, physical activity and alcohol drinking) between immigrant and non-immigrant groups.Methods/DesignEmpirical studies in English language reporting quantitative data simultaneously on both immigrant and non-immigrant groups will be considered for this systematic review. Electronic scientific searches will be conducted on seven databases to identify relevant studies of interests: MEDLINE, CINAHL, PsycINFO, EMBASE, Global Health, SocINDEX and ProQuest. In addition, Google/Google Scholar will be used to find the relevant studies and personal contact with experts will also be undertaken. Titles, abstracts and keywords of studies identified in the search strategies will be screened for inclusion criteria. The authors will select the studies following the PRISMA guidelines. The quality of included studies will be appraised using the Critical Appraisal Skills Programme (CASP) checklists. A descriptive summary statistics of included studies will describe the study designs, socio-demographic characteristics, and the exposure (immigrant and non-immigrant groups) and outcome (key health behaviours) measures. P-values and confidence intervals (CIs) for the associations between exposure and key health behaviours will also be reported.DiscussionThis systematic review will facilitate a better understanding of differences in key health behaviours between immigrant and non-immigrant counterparts. It will provide a rigorous and reliable research base for future research and advance information on key health behaviours for a range of immigrant groups compared to non-immigrants in the high-migrant-receiving countries.Systematic review registrationThis systematic review protocol has been registered with PROSPERO (registration number: CRD42014008688).

AB0398 Responsiveness of a generic and disease specific health related quality of life questionnaire in patients with systemic lupus erythematosus.

BackgroundLittle is published on comparative responsiveness of generic and disease specific Patients reported outcomes (PRO) tool in systemic lupus erythematosus (SLE).ObjectivesTo determine and compare the responsiveness and minimally clinical important...

Gender Disparities in Disease-specific Health Status in Postoperative Patients with Peripheral Arterial Disease

ObjectivesTo investigate gender disparities in disease-specific health status (HS), 3- and 5-year post-intervention in peripheral arterial disease (PAD) patients. DesignCohort study. MethodsData of 711 consecutively enrolled vascular surgery patients were collected in 11 hospitals in The Netherlands in 2004. HS was assessed with the Peripheral Artery Questionnaire (PAQ). Our sample included patients for whom it was possible to calculate a PAQ summary score at 3- and 5-year follow-up (n = 351). ResultsWomen experienced worse physical health (52.1 vs. 62.0, P = 0.012), greater disability (64.5 vs. 71.1, P = 0.026), and worse overall HS (58.1 vs. 66.7, P = 0.007) at 3-year follow-up than men. At 5-year follow-up, however, male and female patients reported similar levels of HS. Mean changes in overall HS from 3- to 5-year follow-up were significantly different for men and women (−4.12 vs. 1.69, P = 0.014). In male patients, overall HS was significantly lower at 5-year follow-up compared to the 3-year follow-up (66.7 vs. 62.6, P = 0.001). In female patients, there was no significant difference (58.1 vs. 59.8, P = 0.393). ConclusionsMen and women experience different levels of HS over time. Attention should be paid to gender disparities in postoperative PAD patients.

Medical Evaluations for Patients With Psychiatric Disorders

Back to table of contents Previous article Next article LetterFull AccessLetterGlenn D. Grace Ph.D., M.S.Richard C. Christensen M.D., M.A.Glenn D. Grace Ph.D., M.S.Search for more papers by this authorRichard C. Christensen M.D., M.A.Search for more papers by this authorPublished Online:1 Jun 2009https://doi.org/10.1176/ps.2009.60.6.849AboutSectionsPDF/EPUB ToolsAdd to favoritesDownload CitationsTrack Citations ShareShare onFacebookTwitterLinked InEmail Medical Evaluations for Patients With Psychiatric DisordersTo the Editor: We strongly agree with the conclusions and recommendations of Rothbard and colleagues' study ( 1 ) in the April issue that there are high rates of undiagnosed general medical illnesses among psychiatric inpatients and that routine testing for such illnesses is needed. However, implications of general medical screening of all psychiatric patients, especially outpatients with newly diagnosed mental disorders, were not explored. The onset of a mental disorder signals an important change in overall health status and may indicate an underlying general medical disorder that is causing or, at the very least, contributing to the patient's symptoms. Although Rothbard and colleagues examined inpatients, other studies that included outpatients found similar results—that comorbid general medical illnesses are often unrecognized and either directly cause or exacerbate psychological symptoms ( 2 , 3 ). In fact, conservative estimates suggest that up to 10% of all psychological symptoms may be driven by general medical causes ( 4 ). Together, these findings suggest that a significant percentage of persons with a recent diagnosis of a new-onset psychiatric disorder may benefit from screening for general medical illnesses. In our collective experience, mental health providers vary greatly in how often they refer patients for medical evaluation. Although many routinely refer patients for a comprehensive or focused medical evaluation, a large number rarely or never request that patients schedule a medical checkup. Perhaps the most widely accepted recommendation is that each patient be assessed individually for his or her risk of having a medical condition and, only then, be referred for a medical evaluation. However, this approach ignores the reality of our mental health system. Often the individual making the initial diagnosis and treatment plan is a behavioral health specialist with no medical training. Many of these clinicians are unable to recognize signs and symptoms of the most common medical illnesses that produce psychological symptoms ( 5 ). Because they lack training, they understandably do not possess the knowledge and skills necessary to assess whether their patients warrant a medical evaluation. All mental health providers, regardless of their professional background, can easily employ the straightforward recommendation of directing their patients to schedule a medical evaluation with a primary care provider. In some cases, a recent evaluation—within the past six to 12 months—may suffice.Medically trained mental health providers should consider the costs and benefits of recommending a medical evaluation for each patient with a newly diagnosed mental disorder and refer accordingly. However, to ensure patient safety, clinicians with no medical training would be well advised to refer for medical evaluation their adult patients with newly diagnosed mental disorders.All clinicians should consider the possibility that their patients may be experiencing the effects of a general medical disorder that is masquerading as a constellation of psychological symptoms. Increasing referrals for medical screenings would not only result in the diagnosis of previously unrecognized comorbid medical conditions but also lead to more effective, integrated, and comprehensive care. Indeed, persons who have comorbid illnesses would then stand a better chance of receiving the safe and effective treatment that they desperately need and so clearly deserve.Dr. Grace is affiliated with the North Florida/South Georgia Veterans Health System, Gainesville, Florida, and with the Department of Clinical and Health Psychology, University of Florida, Gainesville. Dr. Christensen is with the Division of Public Psychiatry, University of Florida College of Medicine, Gainesville, and with Behavioral Health Services, Sulzbacher Center, Jacksonville, Florida.

Development and validation of a scale to measure symptoms of chronic graft-versus-host disease.

Chronic GVHD (cGVHD) affects 30% to 90% of surviving allogeneic transplant recipients. Thus far, no quality-of-life instruments have been developed to measure the effect of this common complication of allogeneic transplantation on patients' functioning and well-being. Using a prospective cohort of 107 patients with active cGVHD who completed the symptom scale at enrollment and at intervals of 3 and 6 months, we developed a 30-item symptom scale with 7 subscales to capture the cGVHD-specific symptom burden. The symptom scale correlated highly with patients' self-assessed mild, moderate, and severe cGVHD manifestations in cross-sectional analysis. Reliability (Cronbach's alpha = 0.79-0.90), test-retest (r2 = 0.28-0.93), and convergent and discriminant validity compared to the Medical Outcomes Study Short Form 36 (SF-36) and Functional Assessment of Chronic Illness Therapy with BMT subscale (FACT-BMT) were assessed and found to be adequate. Longitudinal assessments showed that changes in overall health status correlated best with changes in quality of life as measured by the SF-36 and FACT-BMT. In contrast, changes in cGVHD severity were best detected by changes in the symptom scale. We recommend that either the SF-36 or the FACT-BMT be combined with a cGVHD-specific symptom scale to measure the impact of cGVHD on patients' quality of life and that this endpoint be included in clinical trials testing cGVHD interventions. The cGVHD symptom scale is a short, simple, and valid measure of cGVHD manifestations and can be used to follow complication-specific symptoms using patient self-administered questionnaires.

Assessing health status and outcomes in a geriatric day hospital

The study objective was to assess the feasibility and usefulness of recommended outcome measures in older people attending a geriatric day hospital for multidisciplinary assessment and rehabilitation. We used the ‘Short Form 36’ (SF36) questionnaire which had been proposed as a suitable outcome tool for the elderly, as well as standard assessment scales (eg Barthel index). These were administered by interviewers at the start of day hospital attendance and repeated by postal survey three and six months later. Change in overall health status was rated by the clinical team. The study took place in a geriatric day unit based in a support hospital, specialising in assessment and rehabilitation of older people. Participants were older people referred directly from the community, or following an inpatient day, whose assessment indicated a need for multidisciplinary rehabilitation. Stroke and musculo-skeletal disorders were the commonest underlying conditions. There was a high incidence of non-completion on SF36 questions relating to physical and mental function. Subsequent interviews showed that patients found some questions irrelevant. Floor effects were common. In contrast, the standard scales were invariably fully completed. Compared with local population survey data, respondents had low baseline scores on all SF36 dimensions. Differences over time were probably explained by varying methods of administration. In spite of a clinical perception of improved health status during day hospital attendance, both standard and SF36 scores showed overall deterioration. Two conclusions could be drawn from this study. 1. Measures of physical and mental disability and quality of life gave lower results than expected and continued declining over a six month period, even when the clinical team felt that the patient had improved. 2. Administration of SF36 by an interviewer is essential to obtain meaningful results in older people with poor physical health, which should be interpreted with caution. Goal-specific measures may be more useful in this group of patients. Public Health (2000) 114, 440–445.