Cancer patients' perceptions of factors influencing their decisions on participation in clinical drug trials: A qualitative meta-synthesis.

AIMS AND OBJECTIVES: To examine cancer patients' perceptions of factors that may influence their decisions on participating in phase I-III clinical drug trials. BACKGROUND: The number of cancer participants in clinical drug trials has increased rapidly in Denmark in recent years. The rights, safety and well-being of patients considering participation are protected by the international, ethical and scientific principles. A meta-synthesis was conducted to enable health professionals to support cancer patients who are considering trial participation in accordance with the above principles. DESIGN: Meta-synthesis. METHODS: A qualitative meta-synthesis, as described by Sandelowski and Barroso, was conducted based on a literature search in PubMed, CINAHL, EMBASE and PsycINFO. Nine reports were found eligible and were included. The PRISMA checklist was used. RESULTS: A framework was developed, and patients' perceptions of the factors influencing their decisions were identified, namely patients' perceptions of their relatives, the physician, the hope of therapeutic benefit, altruism, having other options and living with cancer. CONCLUSIONS: This study shows that cancer patients' decisions on participation in clinical drug trials are influenced by their perceptions of trust towards the physician, their relatives' attitudes and the consequences participation might have for their families. Patients are motivated to participate due to the hope of therapeutic benefit and for altruistic reasons. The factors influencing their decisions to participate include a cost-benefit consideration, which in turn may be subject to the patient's perception of having other options available besides participation. This may be related to the patient's attitude towards living with cancer, and the decision can be a way of trying to cope with the psychological aspects of living with cancer. RELEVANCE TO CLINICAL PRACTICE: The results of this meta-synthesis offer insight into patients' perceptions of what may influence their decisions, and they enable health professionals to support patients making such decisions.

Caught between a rock and a hard place: An intrinsic single case study of nurse researchers' experiences of the presence of a nursing research culture in clinical practice.

AIMS AND OBJECTIVES: To explore how nurse researchers in clinical positions experience the presence of a nursing research culture in clinical practice. BACKGROUND: Higher demands in the hospitals for increasing the quality of patient care engender a higher demand for the skills of health professionals and evidence-based practice. However, the utilisation of nursing research in clinical practice is still limited. DESIGN: Intrinsic single case study design underlined by a constructivist perspective. METHODS: Data were produced through a focus group interview with seven nurse researchers employed in clinical practice in two university hospitals in Zealand, Denmark, to capture the intrinsic aspects of the concept of nursing research culture in the context of clinical practice. A thematic analysis was conducted based on Braun and Clarke's theoretical guideline. RESULTS: "Caught between a rock and a hard place" was constructed as the main theme describing how nurse researchers in clinical positions experience the presence of a nursing research culture in clinical practice. The main theme was supported by three subthemes: Minimal academic tradition affects nursing research; Minimal recognition from physicians affects nursing research; and Moving towards a research culture. CONCLUSIONS: The nurse researchers in this study did not experience the presence of a nursing research culture in clinical practice, however; they called for more attention on removing barriers against research utilisation, promotion of applied research and interdisciplinary research collaboration, and passionate management support. RELEVANCE TO CLINICAL PRACTICE: The results of this case study show the pressure which nurse researchers employed in clinical practice are exposed to, and give examples on how to accommodate the further development of a nursing research culture in clinical practice.

The SICAM-trial: evaluating the effect of spouses' involvement through case management in older patients' fast-track programmes during and after total hip replacement.

AIM: The aim of this study was to evaluate the effect of spouses' involvement in older patients' care trajectories, using case management as intervention in total hip replacement through fast-track programmes. BACKGROUND: Patients need their spouses to be involved in their fast-track programmes and this involvement is often associated with improvements in patient outcomes. However, the effect of spouses' involvement in older patients' fast-track programmes has not yet been investigated. DESIGN: A two-group quasi-experimental design with pre-test and repeated post-test measures was conducted in an orthopaedic ward of a Danish Regional Hospital from February 2014-June 2015. Spouse-patient dyads were initially recruited for the control group (n = 14), receiving usual care; dyads for the intervention group (n = 15) were recruited afterwards, receiving case management intervention elements before, during and after admission. METHODS: Face-to-face interviews on questionnaires were conducted with spouses and patients at baseline, 2 weeks and 3 months after discharge, measuring spouses' caregiver satisfaction, difficulties and level of anxiety and patients' functional and nutritional status, pain and level of depression. RESULTS: The results showed that there were no differences between the groups with regard to any of the outcome measures. However, statistically significant improvements were found in the patient groups on functional status, pain and depression and in the groups of spouses on caregiver satisfaction. CONCLUSION: The case management intervention seemed to have an effect in patient and spousal groups; however, this improvement could also have been caused by the effect of fast-track treatment.

'Nursing research culture' in the context of clinical nursing practice: addressing a conceptual problem.

AIM: To report an analysis of the concept of nursing research culture in the context of clinical nursing practice. BACKGROUND: Nursing research culture should be valued for its contribution to improving patient care and should be considered as a routine hospital activity. However, the demand for efficiency, nurses' barriers to research use and the lack of definition of the concept of nursing research culture make it difficult to establish. DESIGN: Concept analysis. DATA SOURCES: Data were collected through a literature review in PubMed, CINAHL and PsycINFO during March 2016. METHODS: Walker and Avant's eight-step framework for concept analysis. RESULTS: Five defining attributes of nursing research culture in the context of clinical nursing practice were identified: strong monodisciplinary nursing professionalism, academic thinking and socialization, research use as a part of daily nursing practice, acceptance by colleagues and management and facilitation of resources from management and organization. CONCLUSION: Although the method of concept analysis has been criticized and heavily debated, the development of nursing research cultures based on the defining attributes and antecedents of the concept will be important to emphasize evidence-based clinical nursing care. Further research should support the development and the implementation of nursing research culture in clinical nursing practice.

Systematic review describing the effect of early mobilisation after dysvascular major lower limb amputations.

AIMS AND OBJECTIVES: To assess the effect of early mobilisation of patients after dysvascular lower limb amputation and to compare the effectiveness of different mobilisation regimens. BACKGROUND: Patients who have undergone dysvascular major lower limb amputations are at high risk of postoperative complications, which include loss of basic functions, and early mobilisation interventions might prevent these complications. DESIGN: Systematic review. METHODS: Systematic searches were performed on PubMed (including MEDLINE), CINAHL and EMBASE databases to identify studies investigating the effects of (early) mobilisation interventions in dysvascular lower limb-amputated patients. Data collection and quality assessment were performed using the Cochrane Effective Practice and Organization of Care Review Group data collection checklist and the Cochrane Handbook for Systematic Reviews of Interventions, respectively. RESULTS: Five studies were included in the review: four pre- to post-case studies and one randomised controlled study. However, none of these studies were of high quality. Four studies investigated early mobilisation promoted by immediate postoperative prosthesis. One study investigated whether reorganizing care increases mobilisation and thereby functional outcome. CONCLUSIONS: This systematic review reveals a lack of evidence to determine whether early mobilisation interventions are beneficial to this vulnerable patient group. Nevertheless, ambulation from the first postoperative day with temporary prosthesis is possible among the heterogeneous population of dysvascular lower limb-amputated patients if the necessary interdisciplinary team is dedicated to the task. RELEVANCE TO CLINICAL PRACTICE: Mobilisation is a fundamental care task often missed for several reasons. Moreover, mobilisation of the newly amputated patient is complex, and knowledge of effective strategies to promote postoperative mobilisation in this vulnerable population is desired. Nurses are urged to take responsibility for this fundamental care task and to engage the necessary collaborative interdisciplinary team to develop, implement and evaluate ambitious early mobilisation interventions.

A discussion of differences in preparation, performance and postreflections in participant observations within two grounded theory approaches.

This paper presents a discussion of the differences in using participant observation as a data collection method by comparing the classic grounded theory methodology of Barney Glaser with the constructivist grounded theory methodology by Kathy Charmaz. Participant observations allow nursing researchers to experience activities and interactions directly in situ. However, using participant observations as a data collection method can be done in many ways, depending on the chosen grounded theory methodology, and may produce different results. This discussion shows that how the differences between using participant observations in classic and constructivist grounded theory can be considerable and that grounded theory researchers should adhere to the method descriptions of performing participant observations according to the selected grounded theory methodology to enhance the quality of research.

An evaluation of orthopaedic nurses' participation in an educational intervention promoting research usage--a triangulation convergence model.

AIMS AND OBJECTIVES: To describe the orthopaedic nurses' experiences regarding the relevance of an educational intervention and their personal and contextual barriers to participation in the intervention. BACKGROUND: One of the largest barriers against nurses' research usage in clinical practice is the lack of participation. A previous survey identified 32 orthopaedic nurses as interested in participating in nursing research. An educational intervention was conducted to increase the orthopaedic nurses' research knowledge and competencies. However, only an average of six nurses participated. DESIGN: A triangulation convergence model was applied through a mixed methods design to combine quantitative results and qualitative findings for evaluation. METHODS: Data were collected from 2013-2014 from 32 orthopaedic nurses in a Danish regional hospital through a newly developed 21-item questionnaire and two focus group sessions. Data were first analysed using descriptive statistics (stata 12.0) and qualitative manifest content analysis. Second, the results were compared, contrasted and interpreted using international literature. RESULTS: The nurses experienced the intervention as a new way to focus on nursing research in practice. However, some nurses were not able to see the relevance of research usage in clinical practice. Nursing research was not a top priority for the nurses and their personal barriers for research usage during their working day were prioritising patients' and colleagues' well-being. Their colleagues' and head section nurses' lack of acceptance regarding participation in the teaching session was a contextual barrier for the nurses. CONCLUSION: The nurses were interested in participating in the intervention. However, some felt restricted by the research-practice gap and by diverse personal and contextual barriers. RELEVANCE TO CLINICAL PRACTICE: The knowledge derived from this study has high clinical and practical relevance and is currently used to facilitate the nurses' research usage in the orthopaedic department setting, by working around the perceived barriers.

Integrating nurse researchers in clinical practice - a challenging, but necessary task for nurse leaders.

AIM: To create awareness among nurse leaders, of what they may need to consider, when integrating nurse researchers as advanced nurse practitioners (ANP) at PhD-level among their staff. BACKGROUND: In a time of transition nurse leaders may be challenged by the change towards evidence-based clinical nursing, including integrating nurse researchers in ANP positions. METHODS: A collective case study including three ANPs took place at a large regional hospital in Denmark. The cases were first analysed by focusing on the generic features, functions and skills of ANPs, and second by focusing on the approaches to evidence-based practice seen in the cases. RESULTS: Regardless of same position, formal level of research expertise and overall responsibility, different approaches related to each ANPs professional profile, interest, academic ambitions and personality were seen. CONCLUSION: Nurse leaders must ensure a process where the content and expectations of the particular role are mutually clarified and adjusted to the individual ANP and to the specific context, in order to create a harmonious match. IMPLICATIONS FOR NURSING MANAGEMENT: In order to clarify expectations regarding the inclusion of nurse researchers as ANPs at PhD level, the paper provides firm recommendations that may guide the process.

Spouses' involvement in older patients' fast-track programmes during total hip replacement using case management intervention. A study protocol of the SICAM-trial.

AIM: To present the protocol of a two-group quasi-experimental study of spouses' involvement through case management (The SICAM-trial) in older patients' fast-track programmes during total hip replacement. BACKGROUND: Patients in fast-track programmes are required to take an active part in their treatment and rehabilitation. Spouses of older patients can often provide valued practical and emotional support, reducing stress, pain and length of stay - yet they are seldom invited to participate in a supporting role. DESIGN: A two-group quasi-experimental design with pre-test and repeated post-test measures (protocol approved in November 2012). METHODS: A total of 120 patients aged 65 years or older going through a fast-track programme for a total hip replacement and their spouses will be recruited from one Danish orthopaedic ward. We will initially include the control group for data collection and subsequently include the intervention group to avoid contamination of the control group. A case manager will be recruited to perform the case management intervention. Data will be collected from both groups at baseline, 2 weeks and 3 months after surgery. Outcome measures for patients include: functional status, nutrition, pain, depression and healthcare consumptions; and for spouses: caregiver satisfaction and difficulties and anxiety. CONCLUSION: The intervention will give further evidence on the need for relatives' participation in the patients' fast-track programmes and the results will contribute to education of the health professionals in their need to include relatives in fast-track programmes. The study was funded by the Novo Nordisk Foundation and the Regional Health Scientific Foundation of Sealand.

Maintaining Unity - relatives in older patients' fast-track treatment programmes. A grounded theory study.

AIM: To generate a substantive grounded theory of relatives' pattern of behaviour in older patients' fast-track treatment programmes during total hip or knee replacement. BACKGROUND: Fast-track treatment programmes are designed to make total hip and knee replacements more efficient through recovery improvements. The support of relatives during older patients' trajectory is important. However, knowledge is needed on the relatives' pattern of behaviour to strengthen their involvement in fast-track treatment programmes. DESIGN: We used a Glaserian grounded theory approach based on a systematic generation of theory from data to explain the latent pattern of behaviour of relatives. METHODS: Data were collected from 2010-2011 in orthopaedic wards at two Danish university hospitals and consisted of 14 non-participant observations, 14 postobservational interviews and five interviews. Seven relatives of patients over 70 years of age participated. The constant comparative method was the guiding principle for simultaneous data collection, data analysis and coding, while theoretically sampling and writing memos. FINDINGS: Maintaining Unity emerged as the relatives' pattern of behaviour through which they resolved their main concern: preventing the patients from feeling alone. The relatives resolved their main concern through three interchangeable behavioural modes: Protecting Mode, by providing loving and respectful support; Substituting Mode, with practical and cognitive support; and an Adapting Mode, by trying to fit in with the patients' and health professionals' requirements. CONCLUSION: The substantive theory of Maintaining Unity offers knowledge of relatives' strong desire to provide compassionate and loving support for the older patients during fast-track treatment programmes.

Inhibiting Interference--a grounded theory of health professionals' pattern of behaviour related to the relatives of older patients in fast-track treatment programmes.

AIM: To generate a grounded theory explaining health professionals' pattern of behaviour and experience related to the relatives of older patients in fast-track treatment programmes during total joint replacement. BACKGROUND: Health professionals uphold standardised care for patients, and effect on quality is seen when relatives support patients during total joint replacement. Since health professionals often have problematic relationships with relatives, knowledge is needed of the health professionals' pattern of behaviour in relation to relatives of older patients in fast-track treatment programme. DESIGN: Grounded theory according to Glaser's methodology was used to generate substantive theory of health professionals' pattern of behaviour. METHODS: Data were collected from 2010 to 2011 by 44 health professionals in orthopaedic wards at two Danish hospitals. Data from nonparticipant observations, formal interviews, group interviews, informal interviews and written information material were collected, coded and analysed through the constant comparative method. FINDINGS: Inhibiting Interference emerged as health professionals' pattern of behaviour through which they resolved their main concern, striving for maintenance of the fast-track treatment programme and principles. Their main concern was resolved by a main strategy: Focusing on Principles, by striving for patients' full compliance during the trajectory, followed by two strategies of social control: Accepting Compliant Motivators, by involving well-informed relatives, and Avoiding Disobedient Doubters, by excluding relatives who do not comply with programme principles. CONCLUSION: In the health professionals' strive to maintain programme principles, relatives were perceived as interferences, if noncompliant with trajectory rules, resulting in exclusion with consequences for their potential of being resources for patients.

A prospective study of short-term functional outcome after dysvascular major lower limb amputation.

This study investigates functional status on Day 21 after dysvascular major lower limb amputation compared with one month pre-amputation and evaluates factors potentially influencing outcome. METHODS: A prospective cohort study design was used. Data were collected via in-person interviews using structured instruments and covered functional level (Barthel index 100) one month pre-amputation and on Day 21. Out of a consecutive sample of patients having major lower limb amputation (tibia, knee or femoral) (n = 105), 51 participated on Day 21 follow-up. Clinical, demographic, body function and environmental data were analysed as factors potentially influencing outcome. RESULTS: From pre-amputation to Day 21, participants' functional level decreased significantly in all ten activities of daily living activities as measured by the Barthel Index. Almost 60% of participants were independent in bed-chair transfer on Day 21. Being independent in transfer on Day 21 was positively associated with younger age and attending physiotherapy after discharge. CONCLUSIONS: The findings indicate that short-term functional outcome is modifiable by quality of the postoperative care provided and thus highlights the need for increased focus on postoperative care to maintain basic function as well as establish and provide everyday rehabilitation in the general population of patients who have dysvascular lower limb amputations.

A sense of security: Spouses' experiences of participating in an orthopaedic case management intervention (the SICAM-trial).

The aim of the study was to explore and describe spouses' experiences of participating in a case management intervention during older patients' fast-track programme having total hip replacement as well as which intervention elements they found useful. Data were collected through qualitative interviews with 10 spouses from the intervention group of the SICAM-trial, directed by predetermined codes based on elements of the intervention. Data were analysed by both authors using directed content analysis. The results showed that the spouses were very pleased about being a part of the case management intervention. They enjoyed being active participants even though problems sometimes occurred such as coordination difficulties between the case manager and other healthcare professionals and their feeling of being burdened. The spouses experienced the contact with the case manager as the most meaningful part of their participation and the telephone contact with her as the most useful element of the intervention. The fact that not all spouses participated in all the available intervention elements could be explained by their feeling of being burdened and that they were not fully aware of what the intervention elements were.

Orchestrating care through the fast-track perspective: A qualitative content analysis of the provision of individualised nursing care in orthopaedic fast-track programmes.

The lack of individualised care in orthopaedic regimes is often explained by the extended use of patient pathways and clinical guidelines. The aim of this study was to illuminate orthopaedic nurses' perceptions and experiences of providing individual nursing care for older patients in standardised fast-track programmes after total hip or knee replacement. Ten semi-structured interviews were conducted with orthopaedic nurses in orthopaedic wards at three Danish hospitals between April and June of 2015. Data were analysed using manifest and latent content analysis according to Graneheim and Lundman. The main theme of the overall interpretation was Orchestrating care through the fast-track perspective, accompanied by three sub-themes: Identifying and legitimising relevant individual care in the fast-track programme, Struggling to fit all patients in the fast-track programme and Justifying individualised care-related actions in the fast-track programme. The study concluded that, even though the nurses struggled to comply with the programme, they still found themselves compromising their nursing care and ethics to follow the standardised regime. There is a need to establish more specific inclusion criteria to maintain the effective elements in the programme and to facilitate nurses' opportunities to offer individual care, thereby ensuring that fragile patients have access to other possibilities.

Pendulating-A grounded theory explaining patients' behavior shortly after having a leg amputated due to vascular disease.

INTRODUCTION: Although the group of vascular leg amputated patients constitutes some of the most vulnerable and frail on the orthopedic wards, previous research of amputated patients has focused on patients attending gait training in rehabilitation facilities leaving the patient experience shortly after surgery unexplored. Understanding patients' behavior shortly after amputation could inform health professionals in regard to how these vulnerable patients' needs at hospital can be met as well as how to plan for care post-discharge. AIM: To construct a grounded theory (GT) explaining patients' behavior shortly after having a leg amputated as a result of vascular disease. METHOD: In line with constructivist GT methodology, data from ethnographic observations and interviews were simultaneously collected and analyzed using the constant comparative method covering the patients' experiences during the first 4 weeks post-surgery. Data collection was guided by theoretical sampling and comprised 11 patients. A GT was constructed. RESULTS: Patients went through a three-phased process as they realized they were experiencing a life-changing event. The first phase was "Losing control" and comprised the sub-categories "Being overwhelmed" and "Facing dependency." The second phase was "Digesting the shock" and comprised the sub-categories "Swallowing the life-changing decision," "Detecting the amputated body" and "Struggling dualism." The third phase was "Regaining control" and comprised the sub-categories "Managing consequences" and "Building-up hope and self-motivation." "Pendulating" was identified as the core category describing the general pattern of behavior and illustrated how patients were swinging both cognitively and emotionally throughout the process. CONCLUSION: The theory of "Pendulating" offers a tool to understand the amputated patients' behavior and underlying concerns and to recognize where they are in the process. Concepts from the theory could be used by health professionals who support patients coping with the situation by offering terms to express and recognize patients' reactions.

The content, dissemination and effects of case management interventions for informal caregivers of older adults: a systematic review.

OBJECTIVES: To investigate and describe the content, dissemination and effects of case management interventions for informal caregivers of older adults, focusing on outcomes related to patients' activities of daily living, nutrition assessment, pain measurement, depression, length of stay and to caregivers' satisfaction and difficulties. DESIGN: This systematic review was based on the Preferred Reporting Items for Systematic. Reviews and Meta-Analysis of studies that evaluate healthcare interventions (PRISMA) statement. DATA SOURCES: PubMed, CINAHL, and EMBASE were searched in September 2013 using a two-step search strategy combining an electronic search with a search in the reference lists. The search strategy was structured using the study inclusion criteria built on PICOS. REVIEW METHODS: Studies were reviewed by title, abstract and full-text by both authors. Duplicates and studies not meeting the inclusion criteria were excluded. Data was extracted from the eligible studies using narrative synthesis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was employed to rate the quality of the evidence. RESULTS: Seven studies (5 RCTs) including a total of 6956 patients over the age of 65 and their informal caregivers (spouses, family members, and close relatives) all in community-care settings were found eligible and included in the review. The assessment for risk of bias in the seven studies indicated variations in the study quality from very low (n=4), to low (n=1) and moderate (n=2) due to lack of randomisation, blinding, transparency and not following intention to treat. A case management approach was claimed in four studies and the remaining three studies used a psycho-educational intervention with core components of case management consistent with the literature. Significant effects of case management interventions were seen on patients' time to institutionalisation, municipal care costs and emotional health when informal caregivers were involved. A significant effect was also found on informal caregivers' decrease in depressive symptoms over time. CONCLUSION: Research of case management interventions for informal caregivers is very limited. This review identifies knowledge about case management as an intervention for informal caregivers to older patients, suggesting strengths and weaknesses for future interventions when informal caregivers are involved. PROSPERO registration: CRD42014007462.

Orthopaedic nurses' attitudes towards clinical nursing research - A cross-sectional survey.

The call for evidence-based knowledge in clinical nursing practice has increased during recent decades and research in orthopaedic nursing is needed to improve patients' conditions, care and treatment. A descriptive cross-sectional survey was conducted to determine the self-perceived theoretical knowledge and practical research competencies among orthopaedic nurses and their interest and motivation to increase these in everyday practice. A newly developed questionnaire was given to a convenience sample of 87 orthopaedic nurses. Forty three orthopaedic nurses (49.4%) completed the questionnaire. The results indicated that despite the majority of orthopaedic nurses having low self-perceived theoretical knowledge and practical research competencies, their interest and motivation to improve these were high, especially their inner motivation. However, the nurses' inner motivation was inhibited by a lack of acceptance from colleagues and section head nurses and a shortage of time. This study forms a baseline as a part of a larger study and contributes knowledge useful to other orthopaedic departments with an interest in optimizing nursing research to improve orthopaedic nursing care quality.