Depression in internal medicine inpatients at the time of hospital discharge and referral to primary care

Background and objectives. This is the first multi-center study intended to document the prevalence, characteristics, and associations of depression in Medicine patients at the time of hospital discharge and their referral to Primary Care (PC). Methods. Adult patients randomly selected among consecutive admissions to Medicine wards in 8 hospitals in Spain, covering health districts, were examined in a two-phase 'case-finding' procedure. Standardized, Spanish versions of instruments were used, including the Standardized Polyvalent Psychiatric Interview (SPPI) and Cumulative Illness Rating Scale (CIRS). Cases of depression were diagnosed according to ICD-10 general hospital research criteria. Results. Three hundred and twelve patients with treatable depression and 777 non-depressed controls were identified. In a conservative estimate, the global prevalence of major depression was 7.1%, dysthymia 4.2% and adjustment depression 7.1%, and 51.9% of cases were of moderate/ severe intensity. Depression was more frequent in women, the differences being significant in all categories of depression. The prevalence of depression was lower in individuals aged 85 or more years, the differences being significant in cases of both dysthymia and adjustment depression. A clear pattern of decreasing prevalence with age was observed in women. The depressed had as an average five medical systems affected, and higher CIRS scores compared with the controls, the differences being significant in cases of both major depression and dysthymia. Conclusions. This is the first report showing a considerable prevalence of treatable cases of depression in Medicine patients at the time of hospital discharge and referral to PC. Depression is associated with the severity of the medical condition, and differences observed by age and sex have clinical implications. Paper read at the 3rd Annual Meeting of the European Association of Psychosomatic Medicine, Nuremberg 2015.

Planning and managing a complex multisite study in the age of technology.

A 2-year long, multisite research study that evaluated cardiopulmonary resuscitation skill decay among nursing students was conducted at 10 schools of nursing across the United States. The study was conducted in two phases and required carefully timed sessions for skill performance. Multisite studies in nursing education need to be carefully planned. Time delays should be anticipated with processes and Institutional Review Board protocols across sites. All team members were trained and consistently supported during the entire study. While challenges and obstacles were identified, innovative solutions were implemented that assisted the research team to successfully complete the study. The use of new and existing technology allowed the team to surmount many of the challenges encountered in this study. The purpose of this article is to describe the logistics, processes, challenges, and lessons learned related to conducting a complex multisite study.

Enrollment challenges in multicenter, international studies: The example of the GAS trial.

INTRODUCTION: Randomized trials are important for generating high-quality evidence, but are perceived as difficult to perform in the pediatric population. Thus far there has been poor characterization of the barriers to conducting trials involving children, and the variation in these barriers between countries remains undescribed. The General Anesthesia compared to Spinal anesthesia (GAS) trial, conducted in seven countries between 2007 and 2013, provides an opportunity to explore these issues. METHODS: We undertook a descriptive analysis to evaluate the reasons for variation in enrollment between countries in the GAS trial, looking specifically at the number of potential subjects screened, and the subsequent application of four exclusion criteria that were applied in a hierarchical order. RESULTS: A total of 4023 patients were screened by 28 centers in seven countries. Australia and the USA screened the most subjects, accounting for 84% of all potential trial participants. The percentage of subjects eliminated from the screened pool by each exclusion criterion varied between countries. Exclusion due to a predefined condition (H1) eliminated only 5% of potential subjects in Italy and the UK, but 37% in Canada. Exclusions due to a contraindication or a physician's refusal most impacted enrollment in Australia and the USA. The patient being "too large for spinal anesthesia" was the most commonly cited by anesthetists who refused to enroll a patient (64% of anesthetist refusals). The majority of surgeon refusals came from the USA, where surgeons preferred the patient to receive a general anesthetic. The percentage of approached parents refusing to consent ranged from a low of 3% in Italy to a high of 70% in the USA and Netherlands. The most frequently cited reason for parent refusal in all countries was a preference for general anesthesia (median: 43%, range: 32%-67%). However, a sizeable proportion of parents in all countries had a contrasting preference for spinal anesthesia (median: 25%, range: 13%-31%), and 23% of U.S. parents expressed concern about randomization. CONCLUSION: The GAS trial highlights enrollment challenges that can occur when conducting multicenter, international, pediatric studies. Investigators planning future trials should be aware of potential differences in screening processes across countries, and that exclusions by anesthetists and surgeons may vary in reason, in frequency, and by country. Furthermore, investigators should be aware that the U.S. centers encountered particularly high surgeon and parental refusal rates and that U.S. parents were uniquely concerned about randomization. Planning trials that address these difficulties should increase the likelihood of successfully recruiting subjects in pediatric trials.

Effect of Expectations on Treatment Outcome for Lumbar Intervertebral Disc Herniation.

STUDY DESIGN: Secondary analysis of randomized and nonrandomized prospective cohorts. OBJECTIVE: To examine the effect of patient treatment expectations on treatment outcomes for patients with intervertebral disc herniation. SUMMARY OF BACKGROUND DATA: Patient expectations about treatment effectiveness may have important relationships with clinical outcomes. METHODS: Subgroup and reanalysis of the Spine Patient Outcomes Research Trial, a randomized trial and comprehensive cohort study enrolling patients between March 2000 and November 2004 from 13 multidisciplinary spine clinics in 11 US states. Overall, 501 randomized and 744 observational patients (1244 total) who were surgical candidates with radiculopathy and imaging confirmed lumbar intervertebral disc herniation were enrolled. The primary study compared surgical discectomy to usual nonoperative care; this subgroup analysis reassessed outcomes on the basis of treatment expectations at baseline. Expectations about symptomatic and functional improvement for both surgery and nonoperative care were assessed on 5-point scales (1="No Chance (0%)" to 5="Certain (100%)"). Outcomes were assessed using longitudinal regression models analyzed by treatment received. RESULTS: Among 1244 IDH SPORT participants, 1168 provided data on both outcomes and baseline expectations and were included in the current analysis: 467 from the randomized and 701 from the observational cohort. Low expectations of outcomes with surgery predicted poorer outcome regardless of treatment. High expectations of outcomes with nonoperative care predicted better nonoperative outcomes but did not affect surgical results. These differences were of similar magnitude to the difference in outcomes between surgery and nonoperative care. CONCLUSION: High expectations of treatment benefit had clinically significant positive associations with outcomes. LEVEL OF EVIDENCE: 2.

Nivolumab plus ipilimumab in the treatment of advanced melanoma.

Advanced melanoma has historically been a difficult disease to treat due to few effective systemic treatment options. However, over the past few years, scientific advancements in immune checkpoint inhibition have resulted in several novel approaches that have changed front-line management of advanced melanoma. Despite these exciting developments, there remains room for improvement in treatment outcomes. Combination immunotherapy, in particular combined cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) and programmed death 1 (PD-1) blockade, represents an important first step in this direction.

Bullied children and psychosomatic problems: a meta-analysis.

BACKGROUND AND OBJECTIVE: A previous meta-analysis showed that being bullied during childhood is related to psychosomatic problems, but many other studies have been published since then, including some longitudinal studies. We performed a new meta-analysis to quantify the association between peer victimization and psychosomatic complaints in the school-aged population. METHODS: We searched online databases up to April 2012, and bibliographies of retrieved studies and of narrative reviews, for studies that examined the association between being bullied and psychosomatic complaints in children and adolescents. The original search identified 119 nonduplicated studies, of which 30 satisfied the prestated inclusion criteria. RESULTS: Two separate random effects meta-analyses were performed on 6 longitudinal studies (odds ratio = 2.39, 95% confidence interval, 1.76 to 3.24) and 24 cross-sectional studies (odds ratio = 2.17, 95% confidence interval, 1.91 to 2.46), respectively. Results showed that bullied children and adolescents have a significantly higher risk for psychosomatic problems than non-bullied agemates. In the cross-sectional studies, the magnitude of effect size significantly decreased with the increase of the proportion of female participants in the study sample. No other moderators were statistically significant. CONCLUSIONS: The association between being bullied and psychosomatic problems was confirmed. Given that school bullying is a widespread phenomenon in many countries around the world, the present results indicate that bullying should be considered a significant international public health problem.

What is the effect of surgery on the quality of life of the adolescent with adolescent idiopathic scoliosis? A review and statistical analysis of the literature.

STUDY DESIGN: Review and statistical analysis of studies evaluating the effect of surgery on the health-related quality of life of adolescents with adolescent idiopathic scoliosis, using Scoliosis Research Society (SRS) outcomes. OBJECTIVE: Apply published minimum clinical important differences (MCID) values for the SRS22r questionnaire to the literature to identify what areas of health-related quality of life are consistently affected by surgery and whether changes are clinically meaningful. SUMMARY OF BACKGROUND DATA: The interpretation of published studies using the SRS outcomes has been limited by the lack of MCID values for the questionnaire domains. The recent publication of these data allows the clinical importance of any changes in these studies to be examined for the first time. METHODS: A literature search was undertaken to locate suitable studies that were then analyzed. Statistically significant differences from baseline to 2 years postoperatively were ascertained by narratively reporting the analyses within included studies. When possible, clinically significant changes were assessed using 95% confidence intervals for the change in mean domain score. If the lower bound of the confidence intervals for the change exceeded the MCID for that domain, the change was considered clinically significant. RESULTS: The numbers of cohorts available for the different analyses varied (5-16). Eighty-one percent and 94% of included cohorts experienced statistically significant improvements in pain and self-image domains. In terms of clinical significance, it was only self-image that regularly improved by more than MCID, doing so in 4 of 5 included cohorts (80%) compared with 1 of 12 cohorts (8%) for pain. No clinically relevant changes occurred in mental health or activity domains. CONCLUSION: Evidence suggests that surgery can lead to clinically important improvement in patient self-image. Surgeons and patients should be aware of the limited evidence for improvements in domains other than self-image after surgery. Surgical decision-making will also be influenced by the natural history of adolescent idiopathic scoliosis.

Clinical physiotherapists had both positive and negative perceptions about delivering two different interventions in a clinical trial: a mixed methods study.

QUESTION: What are clinical physiotherapists' perceptions about delivering two interventions during a randomised trial: the MOBILISE trial? DESIGN: Mixed methods study using semi-structured interviews involving closed- and open-ended questions. PARTICIPANTS: Thirteen physiotherapists involved in delivering the intervention for the trial. RESULTS: All thirteen physiotherapists (100%) had a preference for their patients to get one of the interventions, mostly dependent on the individual patient. Most were frustrated if their patients were not allocated to their preferred intervention but 62% were satisfied with the intervention they delivered and 100% would be happy to be involved in future research. Two significant themes emerged from the open-ended data: that there were both positive and negative aspects of being involved in the trial. The positive aspects included the trial's value as a way of participating in research and as a way of providing evidence for practice. The negative aspects were that the design of the trial was not always reflective of usual clinical practice and the trial's impact on departments, therapists and patients. CONCLUSION: Clinical physiotherapists had both positive and negative perceptions about delivering two different interventions in a clinical trial. However, they were all interested in participating in future research, suggesting that the positive aspects outweighed the negative.

Deciding to join a perinatal randomised controlled trial: experiences and views of pregnant women enroled in the Magpie Trial.

OBJECTIVE: to provide insight into pregnant women's experiences of participating in a large multi-centre randomised trial. DESIGN: qualitative semi-structured interviews. SETTING: six UK maternity units. PARTICIPANTS: women recruited to the Magpie Trial. The Magpie Trial was a trial of prophylactic anticonvulsants for women with severe pre-eclampsia. MEASUREMENTS FINDINGS: a number of major but related themes emerged regarding influences on the women's decision-making: unpredictability of pre-eclampsia; quality of information received; role of others in the decision-making process; perceived personal benefit from trial participation; and perception of voluntariness of joining. KEY CONCLUSIONS: the data presented give valuable insights into the women's views and experiences of decision-making. Research into many of the other elements of care given during pregnancy and childbirth is still needed, and with this need comes the ethical responsibility of researchers to ensure trials are performed in the most scientifically robust ways, which are also acceptable to women. To examine the experiences of those involved in trial participation and their views about doing so is a crucial way of advancing this. The QUOTE Study increases understanding of the experiences of women participating in a randomised controlled trial. IMPLICATIONS FOR PRACTICE: the general implication for practice is that procedures are needed that can improve the design and conduct of randomised trials and therefore ultimately enhance the experience for future women. Recommendations include informed consent should be tailored, recognising individual differences in the desire for information. For instance the time individuals need to make consent decisions varies, as do their desires to consult with family before agreeing.

Reasons for participating in randomised controlled trials: conditional altruism and considerations for self.

BACKGROUND: Randomised controlled trials of healthcare interventions depend on the participation of volunteers who might not derive any personal health benefit from their participation. The idea that altruistic-type motives are important for trial participation is understandably widespread, but recent studies suggest considerations of personal benefit can influence participation decisions in various ways. METHODS: Non-participant observation of recruitment consultations (n = 25) and in-depth interviews with people invited to participate in the UK REFLUX trial (n = 13). RESULTS: Willingness to help others and to contribute towards furthering medical knowledge featured strongly among the reasons people gave for being interested in participating in the trial. But decisions to attend recruitment appointments and take part were not based solely on consideration of others. Rather, they were presented as conditional on individuals additionally perceiving some benefit (and no significant disadvantage) for themselves. Potential for personal benefit or disadvantage could be seen in both the interventions being evaluated and trial processes. CONCLUSIONS: The term 'conditional altruism' concisely describes the willingness to help others that may initially incline people to participate in a trial, but that is unlikely to lead to trial participation in practice unless people also recognise that participation will benefit them personally. Recognition of conditional altruism has implications for planning trial recruitment communications to promote informed and voluntary trial participation. TRIAL REGISTRATION: ISRCTN15517081.

Estrategias de control y seguimiento orientado a la consecución de objetivos: la asignatura pendiente / Monitoring and follow-up strategies oriented towards achieving objectives: a pending issue

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Women's experiences of participating in the Magpie Trial: a postal survey in the United Kingdom.

BACKGROUND: The Magpie Trial compared magnesium sulfate with placebo for women with preeclampsia. The objective of this study was to explore women's views and experiences of participating in the Magpie Trial in the United Kingdom. METHODS: Postal questionnaires were sent to 771 women participants in the Magpie Trial to assess long-term health of UK women and children. The questionnaire included three questions exploring women's experience of participating in the trial: (a) If time suddenly went backward, and you had to do it all over again, would you agree to participate in the Magpie Trial? (b) Please tell us if there was anything about the Magpie Trial that you think could have been done better; and (c) Please tell us if there was anything about the Magpie Trial, or your experience of joining the trial, that you think was particularly good. RESULTS: Overall, 619 of the 771 women who were sent questionnaires returned them. In response to the three questions: (a) 58 percent (356) of women responded "definitely yes," 27 percent (169) "probably yes," 4 percent (23) "probably no," 5 percent (33) "definitely no," and 5 percent (34) "not sure." No clear evidence was shown of a relationship with allocated treatment, although women who responded "probably or definitely no" were more likely to have had side effects from trial treatment. (b) Although 44 percent of women stated that nothing could have been done better, free text suggestions related to content of recruitment information, and its timing, and wanting to know treatment allocation and trial results. c) Women were generally extremely positive about being followed up and receiving trial results. CONCLUSIONS: Women were largely positive about participation in the trial and its follow-up, but still reported ways they believed the study could have been improved, such as more information, given earlier, which also has implications for clinical care.

The role and potential contribution of clinical research nurses to clinical trials.

AIMS AND OBJECTIVES: This study explores the scope and potential contribution of the Clinical Research Nurse (CRN) role to clinical trials of a nursing-specific topic. BACKGROUND: Over the past two decades, there have been increases in the numbers of nurses working as CRNs because of the increasing global demand for clinical trials. CRNs can influence the quality of clinical trials but the scope and contribution of the role to clinical trials is not known. DESIGN: Qualitative focus group study. METHODS: A focus group interview was carried out with CRNs (n = 9) employed on a large, multi-centre (six NHS Trusts) randomized controlled trial of pressure area care. The focus group interview was recorded, alongside field notes of participant interactions and behaviours, and transcribed verbatim. Data were analysed for thematic content and process. FINDINGS: CRNs described their transition to a clinical research role. They reported a lack of confidence, role conflict as researcher and nurse, the challenges of gaining cooperation of clinical nursing staff to comply with trial protocols and difficulties maintaining their own motivation. CRNs provided their perceptions and observations of pressure area care and prevention. They identified areas of inadequate treatment, management and care, influenced by organizational and clinical aspects of care delivery. CONCLUSIONS: The study reveals challenges associated with training and management of CRNs. CRNs are usually associated with trial recruitment and data collection. This study highlights the additional contributions of CRNs for the study of topics specific to nursing as the result of their unique placement in the research centres as informal 'participant observers.' Such observations enhance understanding of the contexts being studied. RELEVANCE TO CLINICAL PRACTICE: These findings are relevant to the design and conduct of research studies of nursing care and practice and present ways for investigators to optimize the skills and knowledge of nurses working as CRNs.

Participation in a clinical trial: views of children and young people with diabetes.

AIM: To investigate whether involvement in research can have a positive effect on the education and management of disease of children and young people with diabetes. METHOD: Children's and young people's experiences of exposure to intensified intervention during a clinical trial were examined by a questionnaire given to 44 young patients with type 1 diabetes from the UK and Ireland. The young people had participated in a trial comparing specific insulin regimes. Most patients were obliged to increase injection frequency, clinic attendance, glucose monitoring and diary entries. FINDINGS: Of the 44 patients, 36 completed the questionnaire. Most, including the younger children, did not regard basal-bolus therapy, additional injections or intensified self-monitoring as barriers to self-management. They also believed that the management of their diabetes was further supported as a result of increased contact and intensive insulin management. Many of the children participating in this study felt they had learned something about their diabetes, and, furthermore, almost all opted to remain on an intensive treatment regimen. CONCLUSION: These results suggest that trial involvement benefits the young person's approach to self-management of diabetes.

Factors affecting older african american women's decisions to join the PLCO Cancer Screening Trial.

PURPOSE: The purpose of this study is to describe the factors associated with the decisions of older African American women to join the PLCO (Prostate, Lung, Colorectal and Ovarian) Cancer Screening Trial when recruited. METHODS: African American women between ages 55 and 74 years who were never diagnosed with a PLCO cancer were eligible for our study. Two methods of recruitment were used. First, mailings were sent to a random sample of women describing the PLCO followed by a telephone call to determine interest in the PLCO. If women were not interested in PLCO but consented to participate in our study, they were interviewed immediately. Second, we followed up with African American women who responded to mass mailings sent out before the start of our study by the Pittsburgh PLCO office. Women completed an interview about their cancer and clinical trial knowledge, attitudes, beliefs, and behaviors. The responses of women who joined the PLCO Trial are contrasted with the responses of women who did not join. RESULTS: Numerous factors were associated with the decision of older African American women to join the PLCO, including perceptions of cancer prevention and detection, the experience of having a loved one with cancer, knowledge of and experience with clinical trials, and beliefs regarding the benefits and risks of clinical trial participation. CONCLUSION: Minority recruitment to cancer clinical trials could be increased by designing interventions focused on individual, organizational, and community needs.

Searching for treatment outcome measures for use across trials.

OBJECTIVE: Inconsistencies in outcome measures across studies of treatment efficacy have made comparisons among them difficult. As a result, there is interest in identifying one or more measures that might be recommended as universal indicators of outcome. The present article seeks to identify drinking, psychosocial and/or biological variables that could be candidates for use as universal indicators of change following alcoholism treatment. METHOD: The primary data set included 128 alcohol-dependent men and women who were randomly assigned to cognitive-behavioral or interactional group treatment for 26 weekly sessions. RESULTS: The greatest changes following treatment were seen in measures of drinking and drinking consequences. Correlational analyses indicated that changes from baseline in drinking consequences were significantly associated with changes in drinking. Psychosocial and biological indicators showed much smaller changes from baseline, and these were only weakly associated with changes in drinking, indicating that they are not sensitive measures of treatment-related change. The overall pattern of these findings was replicated in the Project MATCH data set. CONCLUSIONS: It was concluded that drinking frequency and intensity measures, as well as a measure of drinking consequences, may be useful as universal indicators of alcohol treatment outcome, but that the other psychosocial and biological measures studied in these two data sets are not strong candidates for this purpose.

Independent evaluator knowledge of treatment in a multicenter comparative treatment study of panic disorder.

The purpose of this study was to examine independent evaluators' (IEs) blindness to treatment condition during a Multicenter Comparative Treatment Study of Panic Disorder. IEs were 15 doctoral- and masters-level clinicians in psychology, social work, and medicine. They conducted three post-treatment assessments with each patient. Immediately after each assessment interview, IEs completed a form indicating which of the five possible treatments they believed the patient had received and any specific information that provided IEs with information about a patient's treatment condition. These forms were completed for 170 patients. Analyses were conducted to determine the accuracy of guesses about treatment condition by IEs during post-treatment assessments, the relationship between accuracy of IE guessing and actual treatment assignment, the relationship between accurate guessing and outcome ratings, and contributors to the breaking of the blind. A significant relationship was found between IE guesses and actual treatment at all three assessment points, across individual IEs, treatment sites, and IE professional affiliations. IEs were no more accurate in their guessing about patients taking medication than those receiving behavior therapy. Patients and project staff inadvertently provided information to IEs that enhanced the rates of accurate guessing. Implications of these findings on interpretation of the treatment study are discussed, and recommendations are made for improving blindness procedures.

Reasons for non-enrollment in a cohort study of ARF: the Program to Improve Care in Acute Renal Disease (PICARD) experience and implications for a clinical trials network.

BACKGROUND: Acute renal failure (ARF) is associated strongly with in-hospital mortality and morbidity. Previous clinical trials of ARF have been hampered by the heterogeneous population affected, difficulty defining ARF, delays in identification of ARF, and significant comorbid conditions, among other factors. METHODS: The Program to Improve Care in Acute Renal Disease (PICARD) phase I was a multicenter cohort study aimed to identify clinical characteristics and practice patterns associated with adverse and favorable outcomes in patients with ARF in intensive care units. Although PICARD used no interventions, signed informed consent was required of all study subjects or their proxies. RESULTS: Signed informed consent was obtained in 645 of 1,243 ARF episodes (52%). The fraction of patients not enrolled and reasons for non-enrollment varied widely across the 5 PICARD centers. Refusal by potential study subjects was infrequent, although the absence of family or proxy (15%) and refusal by family or proxy (18%) accounted for large fractions of non-enrolled subjects. Death (23%) and discharge (11%) before study personnel could evaluate patients were additional important reasons for non-enrollment. CONCLUSION: Understanding reasons for non-enrollment may help rationalize mortality and other outcome differences seen in clinical trials and cohort studies that require informed consent compared with historic reports of "all comers" with ARF.

Timing of quality of life (QoL) assessments as a source of error in oncological trials.

AIM OF THE STUDY: To produce an empirical estimate of the nature and magnitude of the error produced by incorrect timing quality of life (QoL) measurements in patients receiving chemotherapy. DESIGN: In a multicentre trial, 283 patients were randomized to receive either docetaxel (T) or sequential methotrexate and 5-fluorouracil (MF). The QoL was assessed at baseline and before each treatment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The study design was retrospective. Data were analysed using t-tests. RESULTS: Erroneous timing affected the QoL findings in both treatment arms. At baseline, there were statistically significant differences in the MF group on the nausea/vomiting scale, with ill-timed assessment showing more symptoms, and in the T group on the physical functioning scale with ill-timed assessments indicating better QoL. The mean scores of correct vs. incorrect timings over the first 14 cycles showed statistically significant differences on several scales. In the MF group, ill-timed assessments indicated significantly worse physical functioning and global QoL, and significantly more of the following symptoms: fatigue, nausea/vomiting, insomnia, appetite loss, and constipation. In the T group, ill-timed assessment showed better physical functioning, less dyspnoea and more insomnia than correctly timed assessments. The reasons for erroneous timing were not always detectable retrospectively. However, in some cases the MF group, being in standard treatment, seemed to have followed a clinical routine not involving the active participation of the study nurse responsible, whereas patients in the experimental T group were more consistently taken care of by the study nurses. CONCLUSIONS: Incorrect timing of QoL assessments in oncological trials jeopardises both the reliability of the QoL findings within treatment and the validity of QoL outcome comparisons between treatments. This issue should be emphasized in the planning of both the study design and clinical routines.