Drug adherence and multidisciplinary care in patients with multiple sclerosis: Protocol of a prospective, web-based, patient-centred, nation-wide, Dutch cohort study in glatiramer acetate treated patients (CAIR study)

Background: Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system, for which no definitive treatment is available. Most patients start with a relapsing-remitting course (RRMS). Disease-modifying drugs (DMDs) reduce relapses and disability progression. First line DMDs include glatiramer acetate (GA), interferon-beta (INFb)-1a and INFb-1b, which are all administered via injections. Effectiveness of DMD treatment depends on adequate adherence, meaning year-long continuation of injections with a minimum of missed doses. In real-life practice DMD-treated patients miss 30% of doses. The 6-month discontinuation rate is up to 27% and most patients who discontinue do so in the first 12 months.Treatment adherence is influenced by the socio-economic situation, health care and caregivers, disease, treatment and patient characteristics. Only a few studies have dealt with adherence-related factors in DMD-treated patients. Self-efficacy expectations were found to be related to GA adherence. Patient education and optimal support improve adherence in general. Knowledge of the aspects of care that significantly relate to adherence could lead to adherence-improving measures. Moreover, identification of patients at risk of inadequate adherence could lead to more efficient care.In the near future new drugs will become available for RRMS. Detailed knowledge on factors prognostic of adherence and on care aspects that are associated with adequate adherence will improve the chances of these drugs becoming effective treatments. We investigate in RRMS patients the relationship between drug adherence and multidisciplinary care, as well as factors associated with adherence. Given the differences in the frequency of administration and in the side effects between the DMDs we decided to study patients treated with the same DMD, GA.Methods/design: The Correlative analyses of Adherence In Relapsing remitting MS (CAIR) study is an investigator-initiated, prospective, web-based, patient-centred, nation-wide cohort study in the Netherlands.The primary objective is to investigate whether GA adherence is associated with specific disciplines of care or quantities of specific care. The secondary objective is to investigate whether GA adherence is associated with specific aspects of the socio-economic situation, health care and caregivers, disease, treatment or patient characteristics.All data are acquired on-line via a study website. All RRMS patients in the Netherlands starting GA treatment are eligible. Patients are informed by neurologists, nurses, and websites from national MS patient organisations. All data, except on disability, are obtained by patient self-reports on pre-defined and random time points. The number of missed doses and the number of patients having discontinued GA treatment at 6 and 12 months are measures of adherence. Per care discipline the number of sessions and the total duration of care are measures of received care. The full spectrum of non-experimental care that is available in the Netherlands is assessed. Care includes 'physical' contacts, contacts by telephone or internet, health-promoting activities and community care activities. Care received over the preceding 14 days is assessed by patients at baseline and every other week thereafter up to month 12. Every 3 months neurologists and nurses record care disciplines to which patients have been referred.The Dutch Adherence Questionnaire-90 (DAQ-90) is a 90-item questionnaire based on the World Health Organisation (WHO) 2003 report on adherence and comprehensively assesses five domains of evidence-based determinants of adherence: socio-economic, health care and caregivers, disease, treatment, and patient-related factors. In addition, self-efficacy is assessed by the MS Self-Efficacy Scale (MSSES), and mood and health-related quality of life (HRQoL) by the Multiple Sclerosis Quality of Life-54 questionnaire (MSQoL-54). Relapses and adverse events probably or definitively related to GA are also reported.Discussion: In this study data is mainly acquired by patients' self-reporting via the internet. On-line data acquisition by patients does not require study visits to the hospital and can easily be integrated into daily life. The web-based nature of the study is believed to prevent missing data and study drop-outs. Moreover, the automated process of filling in questionnaires ensures completeness and consistency, thus improving data quality. The combination of patient-reported outcomes, fully web-based data capture and nation-wide information to all eligible patients are distinguishing features of the study and contribute to its scientific potential.Trial registration: Netherlands Trial Register (NTR): NTR2432

Health care professionals’ views of the factors influencing the decision to refer patients to a stroke rehabilitation trial

Background: Effective recruitment is an essential element of successful research but notoriously difficult to achieve. This article examines health care professionals' views on the factors influencing decision-making regarding referral to a stroke rehabilitation trial. Methods: Semi-structured interviews and a card-sorting task were undertaken with stroke service staff in acute and community hospital trusts. Data analysis used a thematic framework approach. Results: Twenty-seven qualified health care professionals from 12 (6 acute and 6 community) hospital trusts and one charity participated. Four main factors emerged: patient-related, professional views, the organisation and research logistics, which all contributed to staff's decision about whether to refer patients to a trial. Clinicians identified patient-related factors as the most frequent influence and considered themselves the patients' advocate. They used their knowledge of the patient to anticipate the patients' reaction to possible participation and tended to only refer those whom they perceived would respond positively. Participants also identified experience of research, a sense of ownership of the project and a positive view of the intervention being evaluated as factors influencing referral. The need to prioritise clinical matters, meet managerial demands and cope with constant change were organisational factors impacting negatively on referral. Staff often simply forgot about recruitment in the face of other higher priorities. Quick, simple, flexible research processes that were closely aligned with existing ways of working were felt to facilitate recruitment. Conclusions: Patient- and professional-related factors were the most frequent influence on clinicians' recruitment decisions, which often had a 'gate-keeping' effect. Managerial and clinical responsibility to juggle multiple (often higher) priorities was also an important factor. To facilitate recruitment, researchers need to develop strategies to approach potential participants as directly as possible to enable them to make their own decisions about participation; ensure that research processes are as quick and simple as possible; align with existing clinical pathways and systems; and give regular reminders and ongoing support to promote recruitment

A modest start, but a steady rise in research use: a longitudinal study of nurses during the first five years in professional life

<p>Abstract</p> <p>Background</p> <p>Newly graduated nurses are faced with a challenging work environment that may impede their ability to provide evidence-based practice. However, little is known about the trajectory of registered nurses' use of research during the first years of professional life. Thus, the aim of the current study was to prospectively examine the extent of nurses' use of research during the first five years after undergraduate education and specifically assess changes over time.</p> <p>Method</p> <p>Survey data from a prospective cohort of 1,501 Swedish newly graduated nurses within the national LANE study (Longitudinal Analyses of Nursing Education and Entry in Worklife) were used to investigate perceived use of research over the first five years as a nurse. The dependent variables consisted of three single items assessing instrumental, conceptual, and persuasive research use, where the nurses rated their use on a five-point scale, from 'never' (1) to 'on almost every shift' (5). These data were collected annually and analyzed both descriptively and by longitudinal growth curve analysis.</p> <p>Results</p> <p>Instrumental use of research was most frequently reported, closely followed by conceptual use, with persuasive use occurring to a considerably lower extent. The development over time showed a substantial general upward trend, which was most apparent for conceptual use, increasing from a mean of 2.6 at year one to 3.6 at year five (unstandardized slope +0.25). However, the descriptive findings indicated that the increase started only after the second year. Instrumental use had a year one mean of 2.8 and a year five mean of 3.5 (unstandardized slope +0.19), and persuasive use showed a year one mean of 1.7 and a year five mean of 2.0 (unstandardized slope +0.09).</p> <p>Conclusion</p> <p>There was a clear trend of increasing research use by nurses during their first five years of practice. The level of the initial ratings also indicated the level of research use in subsequent years. However, it took more than two years of professional development before this increase 'kicked in.' These findings support previous research claiming that newly graduated nurses go through a 'transition shock,' reducing their ability to use research findings in clinical work.</p

Risk of persistent high-grade squamous intraepithelial lesion after electrosurgical excisional treatment with positive margins: a meta-analysis

CONTEXT AND OBJECTIVE: Even if precursor lesions of cervical cancer are properly treated, there is a risk of persistence or recurrence. The aim here was to quantify the risks of persistence of high-grade intraepithelial squamous lesions, one and two years after cervical electrosurgical excisional treatment with positive margins. DESIGN AND SETTING: Systematic review of the literature and meta-analysis at Instituto Fernandes Figueira. METHODS: This meta-analysis was on studies published between January 1989 and July 2009 that were identified in Medline, Scopus, Embase, Cochrane, SciELO, Lilacs, Adolec, Medcarib, Paho, Wholis, Popline, ISI Web of Science and Sigle. Articles were selected if they were cohort studies on electrosurgical excisional treatment of high-grade squamous intraepithelial lesions with a minimum follow-up of one year, a histopathological outcome of persistence of these lesions and a small risk of bias. RESULTS: The search identified 7,066 articles and another 21 in the reference lists of these papers. After applying the selection and exclusion criteria, only four articles were found to have extractable data. The risk of persistence of high-grade intraepithelial lesions after one year was 11.36 times greater (95% confidence interval, CI: 5.529-23.379, P < 0.0001) in patients with positive margins and after two years, was four times greater (95% CI: 0.996-16.164), although without statistical significance. CONCLUSION: This meta-analysis confirms the importance of positive margins as an indicator of incomplete treatment after the first year of follow-up and highlights the need for appropriately chosen electrosurgical techniques based on disease location and extent, with close surveillance of these patients

Bias: A 30‐Year Review of Randomized Controlled Trials Published in Three Prosthodontic Journals

Due to copyright restrictions and/or publisher's policy full text access from Treasures at UT Dallas is limited to current UTD affiliates (use the provided Link to Article).Purpose: Bias can occur in various phases of an investigation, and its control is an important measure of the validity of results for randomized controlled trials (RCTs). The purpose of this study is to determine if bias control in prosthodontic RCTs published from 2008 to 2017 improved over those published from 1988 to 1997. Materials and Methods: MEDLINE was searched for RCTs in The International Journal of Prosthodontics, The Journal of Prosthetic Dentistry, and The Journal of Prosthodontics published from 2008 to 2017. Citations retrieved were included if the trial involved human subjects, included at least 2 treatment groups, and group assignment was by random allocation. Pilot and follow-up studies were excluded. Included RCTs were evaluated on the basis of how control of potential sources of bias in trial methodology were reported. Three areas—control of bias at entry, control of bias in assessment of outcome, and control of bias after entry—were scored 1 or 0, based on whether method of randomization was explicitly reported, blinding was done, and all subjects were accounted for at the end of the study. Thus, the maximum quality score was 3 (good bias control) and the minimum 0 (poor bias control). Frequencies were calculated for each dimension of trial methodology, and overall scores were reported. Results were compared to those of RCTs published from 1988 to 1997 reported in a previous study. Results: Ninety-six RCTs published from 2008 to 2017 met the inclusion criteria and were reviewed. Method of randomization was explicit in 68% of RCTs, 50% reported blinding, and 85% accounted for all subjects; 32% scored the maximum 3 points for good bias control. In comparison, 62 RCTs published from 1988 to 1997 had frequencies of 47%, 40%, and 76% in the 3 areas examined, respectively; only 16% had maximum scores for good bias control. Conclusion: Control of bias and overall quality scores have improved for RCTs published in the 3 studied prosthodontic journals. © 2019 by the American College of ProsthodontistsSchool of Natural Sciences and Mathematic

Prescribing drugs in primary health care - Thoughts, information strategy and outcome

Aims: General aim; to investigate whether tailored evidence-based drug information provided to general practitioners can be implemented more effectively than evidence-based drug information provided as usual. Specific aims; to describe general practitioners’ (GPs) thoughts on prescribing medication and evidence-based drug information: to explore GPs’ attitudes on drug information: to investigate whether tailored evidence-based drug information can influence these attitudes differently or the prescribing behaviour more effectively than drug information provided as usual.Methods: Focus-group interviews with a descriptive qualitative approach (I), a cross sectional survey using an attitude questionnaire analysed in a multilevel mode and by multiple logistic regression (II), and a randomised controlled study (RCTs, III and IV) were used. In the two latter medical information officers (MIOs) providing drug information to GPs were matched pair-wise and randomised into intervention or control groups. The GPs were cluster randomised by their MIOs. The intervention MIOs were trained to provide evidence-based drug information tailored with motivational interviewing and to focus on the benefit aspect. The control MIOs provided evidence-based drug information as usual. Data was collected by an attitude questionnaire (III), analysed by the Mann-Whitney test and intention-to-treat. Prescriptions for antihypertensive drugs were collected (IV). The change in proportion of ACE inhibitor prescriptions relative to the sum of ACE inhibitors and Angiotensin II receptor blockers, during 0–3 and 4–6 months after the intervention, was analysed with multiple linear regression, by intention-to-treat and per protocol.Results: GPs thoughts on prescribing medication and on evidence-based medicine dealt much with benefit. The core category ‘prompt and pragmatic benefit’ was the utmost benefit (I). A majority of the GPs perceived the information from the industry as too excessive; that the main task of the industry was to promote sales. The quality of public information was regarded as high and useful. Female GPs valued public information to a much greater extent than did male GPs (II). The changes in attitudes to drug information did not differ between the two groups (III). Information was given to 29% of GPs in both groups (IV). The GPs’ average change in proportion of prescribed ACE inhibitors increased in both groups after the intervention. General conclusions and implications: GPs’ thoughts on evidence-based drug information and prescribing medication relates predominantly to ‘prompt and pragmatic benefit’; delivered immediately, useful and handy. Female GPs valued public drug information much more than male GPs did, which might be useful to know in future implementation. GPs’ attitudes on drug information did not differ between the groups after the intervention. Neither did the change in proportion of prescribed ACE inhibitors differ. This indicates no benefit in using tailored evidence-based drug information compared to drug information provided as usual