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Hence buy generic zenegra 100 mg on-line causes of erectile dysfunction in 40 year old, it is no wonder that what is described as ence a worsening of their symptoms cheap zenegra 100 mg line impotence legal definition. Similarly order zenegra 100mg without prescription erectile dysfunction is caused by, seven fami- the first episode of schizophrenia is dominated by the pres- lies of schizophrenic patients must go through the effort cheap 100 mg zenegra free shipping erectile dysfunction pump as seen on tv, ence of positive symptoms, mostly fully formed delusions expense, and potential adverse effects of intensive family and hallucinations. Almost 90% of first-episode patients therapy for 1 year, to prevent relapse on the part of one of treated with neuroleptics experience a rapid, albeit transient, seven recently discharged patients with schizophrenia (98). Despite the good The dilemma of preventive treatment is not limited to initial response to treatment, relapse with reoccurrence of psychiatry. For instance, approximately 70 elderly patients psychotic symptoms is common. Predominance of negative with moderate hypertension must be treated with antihyper- symptoms and hebephrenic, catatonic presentations are not tensive drugs for 5 years to save one life, and 100 men with part of the characteristic presentation of the first episode. In a onset are present on the first episode, and the response of study using the number needed to treat method, which is these symptoms to treatment is very limited. Cognitive defi- the number of persons who need to receive treatment to cits are common and relatively severe at the time of the first prevent one bad outcome, it was calculated that one must episode. Performance on most cognitive tests is approxi- administer antipsychotics to 35 adolescents with paranoid mately 1 SD below age- and education-adjusted expecta- or schizotypal personality disorder for 1 to 3 years to delay tions, with more that 50% of the first-episode patients per- hospitalization for schizophrenia by 6 months to 1 year in forming even worse (123). The impairment affects almost 646 Neuropsychopharmacology: The Fifth Generation of Progress all aspects of cognition; however, specific areas of impair- chotic episodes (116), and elderly patients with continuous ment are distributed unevenly. For example, deficits in psychosis (reviewed later), there is still marked heterogeneity memory, abstraction, and attention are more severe than of recovery of cognitive functioning immediately after the deficits in verbal or perceptual skills (124). In a cross-sectional persistent social and vocational decline in the first psychotic comparison of Raven Progressive Matrixes scores (a valid episode. For instance, in a study reported by Ho and col- measure of IQ), it was found that apparently healthy adoles- leagues (128), more than half of a sample of first-episode cents closer to their first hospitalization for psychosis per- patients with schizophrenia were found to be supported by formed more poorly than adolescents who were tested sev- public funds within 12months of their first episode of ill- eral years before their first exacerbation, but better than ness, and fewer than 25% of them had a job or went to patients whose disease had already exacerbated (125) (Fig. Furthermore, cognitive performance appears to be the part of some patients at the time of the first episode, slightly worse in patients with chronic disease (114) in com- continuing cognitive and functional deficit is the rule. In contrast to psychotic symptoms, including psychosis, are present many months to few years cognitive functions are less responsive to the neuroleptic before the formal diagnosis, and most, but not all, patients treatment administered for schizophrenia (126). Occupa- cognition with treatment, two separate studies demon- tional and cognitive deficits are clearly disproportionate strated modest longitudinal improvements in certain areas compared with the severity of psychotic symptoms in most of cognitive functioning (111,127). These findings suggest cases, despite evidence of improvement on the part of some diversity in the course of cognitive deficit even early in the patients. However, these results may be biased, because most illness, although they also indicate that there is no consistent first-episode studies enroll patients who (a) were sufficiently pattern of specific dimensions of improvement. Further- sick to need hospitalization, but (b) became sufficiently well more, even though an improvement in cognition was seen to be able and willing to consent to be followed-up after in these studies, no research to date has demonstrated that discharge, yet (c) are not sufficiently recovered to be com- many first-episode patients show evidence of normalization pletely out of the treatment network. More important, most in their cognitive functioning. Thus, although evidence of first-episode studies last less than 5 years because of attrition, worsening in cognitive functioning associated with duration funding, or other factors. Middle Course of Schizophrenia Until the early 1990s, the characteristics of schizophrenia in patients older than 55 years were largely the subject of speculation. As of 1993, it was estimated that less than 5% of all of the research ever performed on patients with schizo- phrenia had included any patients older than 55 years (129). It was 'common knowledge' that by age 55 to 60 years the illness has run its course, psychotic symptoms had burned out, and most patients did not need or did not benefit from medications. Since the early 1990s, however, Time until first admission a substantial amount of research on this topic has been completed, with this area one of the fastest developing as- FIGURE 47. Scores on the Ravens Progressive Matrices as a pects of research on schizophrenia. This research has consid- function of time until first admission for schizophrenia. One of the sources of the common knowledge that the Many of these questions are being addressed by a longitu- course of schizophrenia was established into old age was the dinal cohort study carried out by the Mt. Sinai School of consistent findings of symptomatic, cognitive, and func- Medicine group since the late 1980s, as well as other investi- tional stability on the part of patients after their first few gators who have become increasingly interested in this pop- episodes. Although many patients experience multiple psy- ulation. Most research on the course of func- in younger institutionalized patients (133). Many of these tional status suggests that the impairments noted at the time patients had cognitive and social performance compatible of the first episode are rarely reduced. Estimates of the pro- with dementia (136) that could not be accounted for by portion of patients with schizophrenia who are employed somatic treatment, lengthy institutionalization, poor moti- are in the range of about 40%, with most patients employed vation and education, or comorbidity. For example, in the in noncompetitive, sheltered settings (130). Likewise, inde- original publication on this population (133), it was demon- pendent living is the exception for patients with schizophre- strated that psychosurgery, insulin coma, electroconvulsive nia. There is also no significant evidence that functional therapy, and the severity of negative symptoms were not status in patients with schizophrenia changes markedly over the factors accounting for cognitive deficits. Relevant to the time or is altered by treatment with older antipsychotic issue of motivational deficits, in a subsample of the patients medications (131). This large body of data raises issues of from that study (137), the average level of education was importance when older patients are studied, including found to be more than 11 years, and their reading perfor- whether changes seen in later life are part of the natural mance was higher than the tenth grade level. In contrast course of the illness or whether they are the result of addi- to these indicators of educational achievement, the current tional comorbidities. Thus, some elderly institutionalized patients with schizophrenia appear Cognitive and Functional Deficits in to manifest decline in their functioning relative to premor- Older Patients bid functioning. It has been consistently reported, however, that many pa- Studies of the cognitive performance of elderly schizo- tients older than 65 years who have a lifelong course of phrenic patients have identified 'double dissociation' per- schizophrenia, especially those with a history of long-term formance profiles that discriminate them from patients with institutional care, have marked deficits in cognitive and clearly identified dementia (138–139), and a profile of dif- functional status (132–134). Similar findings have been re- ferential deficits has been identified. Differential deficits ported at different research sites in the United States and cannot be caused by a single constant factor, such as failing in the United Kingdom (135). Because of the lack of data to provide adequate effort when assessed. These data suggest regarding the lifetime course of functional and cognitive that studies of very poor-outcome long-stay patients, al- deficits in schizophrenia, it is not clear whether the presence though clearly reflecting the most seriously ill subset of the of severe deficits in functioning seen in these elderly institu- population, are not hugely biased by the obvious factors tionalized patients with schizophrenia is the result of deteri- associated with long institutional stay. There are multiple Longitudinal Course of Cognition and potential methodologic issues associated with the study of Functional Status in Late-Life older patients, particularly patients with a history of long- Schizophrenia: Patients with Chronic term institutional stay. The time course, prevalence, and correlates expected from studies of younger patients, that chronically of this decline are as yet undiscovered. There is surprisingly institutionalized patients have low levels of premorbid func- little longitudinal research on cognitive functioning and tioning, in domains of educational, social, occupational, and functional skill deficits in schizophrenia.
Te potential beneft to the child of a reliable infection in a child buy zenegra 100mg with amex erectile dysfunction yoga youtube, if culture for the isolation of N order zenegra 100mg on line erectile dysfunction doctors in houston tx. Gram stains are inadequate to ers with experience in the evaluation of sexually abused and evaluate prepubertal children for gonorrhea and should assaulted children purchase zenegra 100 mg fast delivery erectile dysfunction treatment chennai. Specimens Te scheduling of an examination should depend on the from the vagina purchase genuine zenegra online being overweight causes erectile dysfunction, urethra, pharynx, or rectum should be history of assault or abuse. If the initial exposure was recent, streaked onto selective media for isolation of N. A follow-up visit approximately involve diferent principles (e. Isolates should be preserved to a repeat physical examination and collection of additional enable additional or repeated testing. To allow sufcient time for antibodies to develop, • Cultures for C. However, a meatal specimen should be obtained medical evaluation. Pharyngeal specimens Te following recommendations for scheduling examina- for C. Te exact timing and nature of either sex because the yield is low, perinatally acquired follow-up examinations should be determined on an individual infection might persist beyond infancy, and culture sys- basis and should be performed to minimize the possibility tems in some laboratories do not distinguish between for psychological trauma and social stigma. Only standard culture follow-up appointments might be improved when law enforce- systems for the isolation of C. Te clinical manifestations of used for detection of C. All specimens should be retained Recommendations for HIV-Related Postexposure for additional testing if necessary. No data are available Assessment of Children within 72 Hours of regarding the use of NAATs in boys or for extragenital Sexual Assault specimens (e. Culture remains the preferred method HIV infection in the assailant. Sera should from the assault, discuss PEP with the caregiver(s), be tested immediately for antibodies to sexually transmit- including its toxicity and unknown efcacy. Agents for which suitable tests are available • If caregivers choose for the child to receive antiretroviral include T. Decisions regarding PEP (78,142,489), provide enough medication to last the agents for which to perform serologic tests should be until the return visit at 3–7 days after the initial assess- made on a case-by-case basis. Consultation with an expert is necessary before • Perform HIV antibody test at original assessment, 6 using NAATs in this context to minimize the possibility of weeks, 3 months, and 6 months. Follow-Up Examination After Assault cinerea, and Moraxella catarrhalis). NAATs can be used as an In circumstances in which transmission of syphilis, HIV, alternative to culture with vaginal specimens or urine from or hepatitis B is a concern but baseline tests are negative, an girls, whereas culture remains the preferred method for urethral examination approximately 6 weeks, 3 months, and 6 months specimens or urine from boys and for extragenital specimens after the last suspected sexual exposure is recommended to (pharynx and rectum) from all children. All positive specimens allow time for antibodies to infectious agents to develop. Serologic testing for HIV regarding which tests should be performed must be made on infection should be considered for abused children. Although data are insufcient concerning the Te risk of a child acquiring an STD as a result of sexual efcacy and safety of PEP among both children and adults, abuse or assault has not been well studied. Presumptive treat- treatment is well tolerated by infants and children (with and ment for children who have been sexually assaulted or abused without HIV infection), and children have a minimal risk for is not recommended because 1) the incidence of most STDs in serious adverse reactions because of the short period recom- children is low after abuse/assault, 2) prepubertal girls appear mended for prohylaxis. In considering whether to to be at lower risk for ascending infection than adolescent or ofer antiretroviral PEP, health-care providers should consider adult women, and 3) regular follow-up of children usually whether the child can be treated soon after the sexual expo- can be ensured. However, some children or their parent(s) or sure (i. Te potential beneft of treating a health-care provider. Such concerns might be an appropriate sexually abused child should be weighed against the risk for indication for presumptive treatment in some settings and adverse reactions. If antiretroviral PEP is being considered, a might be considered after all specimens for diagnostic tests provider specializing in evaluating or treating HIV-infected relevant to the investigation have been collected. Sexually transmitted diseases treatment guidelines, 2006. MMWR recurrent pelvic infammatory disease, chronic pelvic pain, or infertility 2006;55(No. Prevention of hepatitis A through active or passive immuniza- 2004;94:1327–9. A comprehensive immunization strategy to eliminate transmission 2004;82:454–61. Te relationship between the Advisory Committee on Immunization Practices (ACIP) Part II: condom use and herpes simplex virus acquisition. A comprehensive immunization strategy to eliminate transmis- 22. A pooled analysis of the sion of hepatitis B virus infection in the United States: recommenda- efect of condoms in preventing HSV-2 acquisition. Arch Intern Med tions of the Advisory Committee on Immunization Practices (ACIP) 2009;169:1233–40. Part 1: immunization of infants, children, and adolescents. Behavioral counseling to pre-Behavioral counseling to pre- JAMA 2001;285:3100–6. A systematic review of epidemiologic Preventive Services Task Force. Condom use and the risk of geni- Med 2008;149:491–6. Project RESPECT promotes regression of cervical intraepithelial neoplasia and clearance Study Group. Efcacy of risk-reduction counseling to prevent human of human papillomavirus: a randomized clinical trial. Int J Cancer immunodefciency virus and sexually transmitted diseases: a randomized 2003;107:811–6. Incidence of herpes regression of human papillomavirus-associated penile lesions in male simplex virus type 2 infection in 5 sexually transmitted disease (STD) sexual partners of women with cervical intraepithelial neoplasia. Int J clinics and the efect of HIV/STD risk-reduction counseling. Workshop summary: scientifc evidence on condom efectiveness transmitted disease clinics. CDC, Health Resources and Services Administration, National Institutes www. Non-latex versus Recommendations for incorporating human immunodefciency virus latex male condoms for contraception. Cochrane Database Syst Rev (HIV) prevention into the medical care of persons living with HIV.
This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed 100 mg zenegra fast delivery erectile dysfunction treatment tablets, the full report) may be included in professional journals xv provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising purchase 100 mg zenegra with visa erectile dysfunction at the age of 18. Applications for commercial reproduction should be addressed to: NIHR Journals Library order zenegra 100mg with mastercard erectile dysfunction doctor in nj, National Institute for Health Research buy 100mg zenegra otc erectile dysfunction symptoms, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. The policy rationale was that layers of bureaucracy could be removed if GPs took responsibility for assessing local health needs and designing and commissioning services that met the needs of their patients. A number of important questions arise from this innovation. The first and most obvious is whether or not, and, if so, how, GPs would rise to this challenge and opportunity. As far as we are aware, despite a number of research reports about CCGs (e. The research found some novel examples of active clinical leadership in new forms of service design. These occurred at different levels and in different arenas, and the patterns are described and illustrated in this report. On the other hand, many CCGs struggled even to find GPs willing to serve on their governing bodies. In a significant number of cases, non-clinical managers exercised the most influence. Managers took their lead from the NHS England (NHSE) hierarchical structures, and thus the centre-led influence persisted. Moreover, within 3 years of their existence, other major nationally led initiatives and policy priorities took centre stage. Notably, sustainability and transformation plans, launched in 2016, handed strategic service redesign to larger institutional footprints than the CCGs. Likewise, the influential NHSE initiative, the Five Year Forward View (NHS England. London: NHS England; 2014), placed emphasis on integration and collaboration rather than on competition and commissioning. Many clinical leaders gravitated towards new provider organisations, such as the federations of general practices and other forms of large-scale general practice, rather than towards the commissioning bodies. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals xvii provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. The policy documents made clear that GPs, in particular, were invited to and expected to exercise clinical leadership. Our aim was not only to uncover whether or not they had risen to this challenge but, more importantly, where this had been achieved, what had been involved and what barriers had been surmounted. When the CCGs were set up in 2012/13 they were designed to devolve considerable responsibility and accountability to clinicians – especially GPs. In addition, crucially, the question arises as to what difference clinical leaders in and around CCGs have actually made. As far as we are aware, despite a number of research reports about CCGs (e. Objectives The overall aim was to assess and clarify the extent, nature and effectiveness of clinical engagement and leadership in the work of the CCGs. This was broken down into five main research questions. What is the range of clinical engagement and clinical leadership modes being used in CCGs? What is the extent, and nature, of the scope for clinical leadership and engagement in service redesign that is possible and facilitated by commissioning bodies, particularly the CCGs and the health and well-being boards (HWBs)? What is the range of benefits being targeted through different kinds of clinical engagement and leadership? What are the forces and factors that serve either to enable or to block the achievement of benefits in different contexts, and how appropriate are the different kinds of clinical engagement and leadership for achieving effective service design? What can be learned from international practices of clinical leadership in service redesign in complex systems that will be of theoretical and practical value to CCGs and HWBs? Theoretical perspective The theoretical perspective we used to investigate this activity was based on institutional theory. Health care takes place within, and through, institutions. These institutions include GP surgeries, outpatient appointments, mental health institutions, and primary, secondary and tertiary care institutions. Emergent health and well-being perspectives extend the institutional field to include local authorities, voluntary agencies, housing associations and so on. These institutions are built over time and become taken for granted. Sedimentation is a key concept in institutional theory. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals xix provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Institutions are maintained by established interests using devices (such as professional boundaries), bureaucratic mechanisms (such as job evaluations and job grades) and cultural mechanisms (such as beliefs and norms). Yet, as we show in this report, institutional work can involve modification of existing institutions and the creation of new ones. This interplay between defence routines, disruption and innovation is in many ways the story of the CCGs. The building of institutions is underpinned by logics. Thus, a market logic requires plural agents able to compete on price and other bases, such as quality. A bureaucratic logic uses plans, rules and division of labour. A network logic relies on collaboration and negotiation. The very creation of CCGs was itself an outcome of institutional work – in this case work done at the parliamentary level led by a particular Secretary of State. The institutions created had a bias towards a logic of efficiency driven through competition, but the details of how the new institutions should operate in practice were left somewhat open. Hence, much more institutional work was required at a local level. However, they were faced not with a blank sheet but with a set of existing institutions whose agents often sought to protect current arrangements. In addition, crucial to the account given in this report, other institutional work designed to drive other changes to the health-care system can be seen to overlay and compete with the focal initiatives. Research methods The project proceeded in five phases.
We ensured that all accompanying documentation sent to the NHS Ethics Committee was produced in partnership with the Health and Social Care Alliance Scotland (the ALLIANCE) generic zenegra 100mg without prescription erectile dysfunction doctor chicago, which represents nearly 400 bodies and individuals working to make the lives of people with LTCs and disabilities cheap zenegra 100mg with amex erectile dysfunction korean ginseng, and the lives of unpaid carers purchase zenegra 100mg with mastercard erectile dysfunction low testosterone treatment, better generic zenegra 100 mg fast delivery erectile dysfunction forum discussion. More than three-quarters of its member organisations are voluntary groups that support or represent disabled people, people living with LTCs and unpaid carers. We also recruited two PPI representatives early in this process to enable them to contribute to all study documentation prepared for the NHS Ethics Committee (letters of invitation, information and consent forms, etc. These PPI representatives also served on our project management group (PMG) throughout the study. Patient and public involvement Our aims for PPI were to conduct research with members of the public, taking on board their expert advice in the design and conduct of our study, especially in relation to the presentation of our study and its materials to our patient/public/carer audience (through commenting on, and developing, research materials); ensuring continued input to the conduct of the research as members of a project steering group; and ensuring that our dissemination strategy and our key messages were clear and targeted appropriately for patient/public/carer audiences. This would ensure that the language and content of information provided were appropriate and accessible (e. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals 11 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. OVERVIEW OF STUDY DESIGN, METHODOLOGY AND GENERAL MANAGEMENT methods proposed for the study were more acceptable and sensitive to the situations of potential research participants; and our research would capture outcomes that are important to the public, and we would ensure that the findings of our research were accessible to the public. This amounted to three levels of public involvement (out of a possible six) endorsed by the National Institute for Health Research (NIHR), namely as joint grant holders or co-applicants on a research project, as members of a project advisory or steering group and commenting on and developing patient information leaflets or other research materials. However, we also included a further level around enhancing dissemination activity and outputs, especially for public audiences. Patient and public involvement in preparing this application was provided via the ALLIANCE. The ALLIANCE is the national third-sector intermediary for a range of health and social care organisations. It has over 1700 members, including large, national support providers, as well as small, local volunteer-led groups and people who are disabled, living with LTCs or providing unpaid care. Our key contact within the ALLIANCE was a full partner on this project and also shared the protocol with ALLIANCE members. They commented on the proposal during its development and specifically on issues of recruitment of patients, and the feasibility of patient data collection processes. They also provided current experiences of members of their health assessments in primary care to inform the feasibility and applicability of the research. Three patient representatives were recruited to the study on a formal basis; two attended all PMG meetings and another commented on all documentation provided to the Study Steering Committee (SSC). One member of the PMG was already known to the project team from PPI in a previous study led by the RCGP. The second member of the PMG was recruited via an e-mail from NHS FV to its PPI advisors, and the PPI member recruited to the SSC was recruited in the same way. All PPI members were offered support to participate by the ALLIANCE, but no PPI member requested such support, and most were experienced as PPI representatives or felt that they had sufficient life experience to confidently participate and contribute. In the event that there was any concern for the health and well-being of our PPI members, we also had a GP team member (SM) who could provide some initial advice, with the proviso that they then contact their own GP. Neither Christine Hoy nor Stewart Mercer was called on to act in these capacities. We used the NIHR cost calculator for public involvement, in conjunction with advice from the ALLIANCE about appropriate levels and methods of remuneration for patient/public involvement, to ensure that we had the funds to support this. Project management Margaret Maxwell was responsible for overall project delivery and worked on a day-to-day basis as required with the project manager (CH) and the two part-time research assistants (RAs). Carina Hibberd was project manager and supervised the two part-time RAs on a day-to-day basis and conducted fieldwork alongside the RAs as required, as well as being responsible for adapting and delivering the training to nurses. There were weekly meetings between Margaret Maxwell, Carina Hibberd and the RAs to report on study progress and timelines, and to deal with any immediate problems. Nadine Dougall and Rebekah Pratt also attended these meetings, as required, to ensure that preparation for data collection and subsequent data 12 NIHR Journals Library www. Video and telephone conferencing was available to minimise time and travel when attendance was required. Formal PMG meetings were held with all co-applicants and other members of our PMG, including our patient/carer representatives. These included a feedback report on study progress and discussion of any problems/issues arising. An independent SSC was established with four members: Professor Brian McKinstry (University of Edinburgh, Professor of Primary Care and practising GP) to chair the committee; Dr Ruth Jepson (University of Edinburgh, Senior Scientific Advisor, Scottish Collaboration for Public Health Research and Policy); Dr Dorothy Horsburgh (Edinburgh Napier University, Senior Lecturer, nurse and specialist in LTCs); and one PPI member. Dr Horsburgh retired during the study and was replaced by Dr Debbie Baldie of Queen Margaret University. Observers such as a sponsor representative, a representative of the Scottish Primary Care Research Network (SPCRN) and any members of the research team could be invited at the request of the chairperson. Formal SSC meetings (n = 4) were held in Edinburgh and consisted of a feedback presentation and supporting documentation, including any ethics amendments and their outcomes, interim reports to the funder (NIHR) and minutes of the PMG. Analytical framework Quantitative analysis The primary outcome of the pilot trial was to determine recruitment and retention rates of PNs, and the recruitment of patients and data completion for a future cluster RCT. We also wanted to establish which nurse- and patient-level measures should constitute primary and secondary outcomes for a future cluster RCT and, hopefully, use this knowledge to determine sample size for a future trial. The study combined data collection for nurses and patients as two separate units of analysis. One of the criteria for continuation to a full-scale trial would be to determine if the number of nurses required for a cluster RCT was feasible and within reasonable cost boundaries. Such a design would also need to be sufficiently powered at the patient level, thereby testing the impact of the PCAM tool on both nurse behaviour and patient outcomes. The characteristics of the nurses and patient groups and their related outcome measures were summarised using descriptive analysis. The related outcome measures were summarised using descriptive analysis together with estimates of precision, and any relevant change scores. Some modifications were made to the statistical analysis plan that was created at the time of requesting funding for the study. Since then, there has been a shift in expert guidance advising against all formal significance testing for pilot and feasibility study outcome measures, as these are not powered to detect statistical significance. Therefore, formal significance testing was omitted, as was the use of the multiple regression modelling approach. The focus of the analysis centred on the recruitment, data completion and attrition rates, and making use of descriptive analysis to summarise the data. The PEI and CARE measures were analysed at the nurse level and the 12-item General Health Questionnaire (GHQ-12), SF-12 and WEMWBS were analysed at the patient level. Both units of analysis were summarised between randomisation groups, using means and standard deviations, or medians and interquartile ranges, together with change scores estimated with their 95% confidence intervals (CIs). The number of practices recruited and the number of nurses recruited were less than planned, and this also ruled against the use of formal regression models to explore the influence of covariates on outcome measures. In addition, as the number of clusters was so low, and as some of the follow-up data were missing, the estimation of the ICC for the outcome measures was not appropriate. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals 13 provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising.
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