WHO informal consultation on revision of guidelines on evaluation of similar biotherapeutic products, virtual meeting, 30 June - 2 July 2021.

The WHO informal consultation was held to promote the revision of WHO guidelines on evaluation of similar biotherapeutic products (SBPs) adopted by the Expert Committee on Biological Standardization (ECBS) in 2009. It was agreed in the past consultations that the evaluation principles in the guidelines are still valid, but a review was recommended to provide more clarity and case-by-case flexibility. The opportunity was therefore taken to review the experience and identify areas where the current guidance could be more permissive without compromising its basic principles, and where additional explanation could be provided regarding the possibility of reducing the amount of data needed for regulatory approval. The meeting participants applauded the leading role taken by the WHO in providing a much-needed streamlined approach for development and evaluation of SBPs which will provide efficient and cost-effective product development and increase patient access to treatments. It was recognized that the principles as currently described in the draft WHO guidelines are based on sound science and experience gained over the last fifteen years of biosimilar approvals. However, since these guidelines when finalised will constitute the global standard for biosimilar evaluation and assist national regulatory authorities in establishing revised guidance and regulatory practice in this complex area, it was felt that further revision and clarity on certain perspectives in specific areas was necessary to dispel uncertainties arising in the current revised version. This report describes the principles in the draft guidelines, including topics discussed and consensus reached.

What does caring mean to nursing and social work students?

AIM: The aim of this study in Lithuania was to discover how the meaning of caring is perceived by nursing and social work students. BACKGROUND: Nursing and social work are caring professions, which provide care in different ways. It is still unclear what features constitute the meaning of caring for nursing and social work students as future caring professionals. METHODS: Snowball sampling technique was applied in the study. The data were collected as reflective narratives. Data were analysed using qualitative content analysis. FINDINGS: For nursing and social work students, the meaning of caring comprises mission, proficiency, values and collaboration. These features overlap, but the implementation of caring is dependent on the particular profession. DISCUSSION: Nursing and social work students describe the meaning of caring as holistic assistance to patient/client: the work mission for both. However, the tasks, responsibilities and focus on providing care to a patient/client differ in both professions. LIMITATIONS: Reflective narratives were preferred to semi-structured interviews. The researchers did not contact the participants in person to ask them additional questions. CONCLUSION: The meaning of caring is perceived as a developmental phenomenon, which depends on professional philosophy, practice, continuing learning and experience. Nursing and social work students perceive it as a way of thinking about the individual's being in a profession and acting collaboratively for the wellbeing of others. IMPLICATIONS FOR HEALTH POLICY: Focus on the meaning of caring in nursing and social work (post)graduate education is a premise to shift the training from self- to other-centred, from mono- to multi-disciplinary approach. This is related to the shift of practices towards effective patient-centred team-working within the health system, with the spotlight on caring.

Associations between family characteristics and parental empowerment in the family, family service situations and the family service system.

BACKGROUND: Parental empowerment signifies parents' sense of confidence in managing their children, interacting with services that their children use and improving child care services. High empowerment is associated with parents' resilience to demands and their confidence to make decisions and take actions that positively affect their families. Most families with children access various healthcare and education services. Professionals working in these services are therefore ideally placed to reinforce parental empowerment. However, little is known about the characteristics associated with parental empowerment within a generic sample of parents or in the context of basic child care services. AIM: The aim of this study was to assess how family characteristics are associated with maternal and paternal empowerment in the family, in service situations and in the service system. METHOD: Parental empowerment was measured among 955 parents (mothers = 571; fathers = 384) of children aged 0-9 years using the Generic Family Empowerment Scale. Family characteristics were assessed through questions on children, parents and the life situation. Associations between empowerment and family characteristics were evaluated using one-way analysis of variance and t-test. Parental empowerment was predicted by multiple linear regression analysis. RESULTS: Parents' concerns related to their parenting, such as whether they possessed sufficient skills as a parent or losing their temper with children, as well as experiences of stress in everyday life, were negatively associated with all dimensions of maternal and paternal empowerment. Both determinants were more common and more significant in empowerment than child-related problems. CONCLUSION: Promoting parental self-confidence and providing appropriate emotional and concrete support for everyday functioning may reinforce parental empowerment, thereby enhancing families' well-being and coping, as well as improving their access to required services and timely support. Finally, it may facilitate the provision of better services to all families.

The validity and reliability of the Finnish Family Empowerment Scale (FES): a survey of parents with small children.

BACKGROUND: The Family Empowerment Scale (FES) is a widely used instrument which measures the parents' own sense of their empowerment at the level of the family, service system and community. It was originally developed for parents of children with emotional disabilities. AIM: The aims of this study were to evaluate the validity and reliability of the Finnish FES and to examine its responsiveness in measuring the empowerment of parents with small children. METHODS AND PARTICIPANTS: The English FES was translated into Finnish using back translation and modified so as to be generic and convenient for all families. The construct, convergent, discriminant and concurrent validities, reliability and responsiveness of the Finnish FES were examined. Participants (n = 955) were the parents of children aged 0-9 years who had been selected using stratified random sampling. RESULTS: Confirmatory factor analysis proved that the Finnish FES had three subscales based on the original FES. Convergent and discriminant validities confirmed and supported the same construct. The relationship between parents' participation and empowerment was tested for concurrent validity. As in previous FES studies, the participating parents were more empowered, which supported the concurrent validity. The reliability of the Finnish FES proved acceptable for both parents. The Finnish FES could also discriminate the responses of the parents. Participation in the activities organized by the family service system influenced parents' perceptions of empowerment more than did their background characteristics. CONCLUSIONS: The Finnish FES is a valid and reliable instrument and it is suitable for measuring the empowerment of parents. However, it is necessary to consider how the FES would identify in the best way the parents who perhaps need some help.

Clinical decision making involved in secluding and restraining an adult psychiatric patient: an integrative literature review.

The purpose of this integrative literature review was to describe different factors involved in the decision-making process of using seclusion or restraint, and to discuss the process in practice. The data used in this review were systematically retrieved from the following databases: CINAHL, Medline and PsycINFO. Manual data retrieval was conducted from the reference lists of the papers that came up in the original database search. A total of 32 studies were selected. Results suggest that the situations that lead to the use of seclusion or restraint are always dynamic and circumstantial. During the decision-making process staff observe a patient's behaviour, assesses risk and chooses and uses interventions that aim to de-escalate the situation. This process is affected by the previous experiences and history of staff as well as the behaviour and previous experience of the patient.

Families' experiences of interaction with the public health nurse at the child health clinic in connection with mother's post-natal depression.

The birth of a new family member causes many changes in the way a family functions. Annually some 10% of mothers giving birth suffer from post-natal depression. This depression affects the mother herself, the baby and the functioning of the entire family. The healthcare personnel are faced with an important task in supporting the family in the course of changes occasioned by the birth of a baby. According to earlier studies, families with small children are fairly satisfied with the service provided by the child health clinics. The purpose of the present study was to form a theory of interaction with the public health nurse in the child health clinic when the mother is suffering from post-natal depression from the viewpoint of family. The data for the study were gathered by interviewing nine families (nine mothers and five fathers) where the mother had displayed symptoms of post-natal depression. The data were analysed using continuous comparative analysis of grounded theory. The concepts of the theory emerged as a lack of continuing relationship, a need to be equal partners, a lack of individuality and a lack of family care. The relationships between categories were lack of discussing, lack of being confidential and lack of getting help enough. The core category emerging was lack of holistic cooperation with unique family. In spite of the emphasis placed on family centeredness in the operating principles of the work in child health clinics, its implementation in practical work cannot be taken for granted. Because of the limited resources available to the clinics, it is the experience of depressed mother in particular that they are not treated sufficiently as individuals and that they are subjected to adjudication in the clinics. The parents felt that the personality of the public health nurse was crucial to how they felt about the service they obtained from the clinic.

Cooperation between Finnish primary school nurses and pupils' parents.

AIM: To generate information on how school nurses in Finnish primary schools describe cooperation with the school-aged (7-12 years) children's parents. BACKGROUND: Cooperation between the school nurse and parents is essential for health promotion with primary school children. The topic has not been widely investigated in international research. METHODS: The data consist of descriptions written by 20 Finnish primary school nurses in 2003 and 2005. The data were analysed by the method of grounded theory. FINDINGS: Cooperation with parents aims at outlining the child's life situation, ascertaining the family's health situation and helping when the child has difficulties. The school nurses described meetings with parents, providing health information and bolstering parental resources as the forms of cooperation. Cooperation is professionally rewarding and school nurse-centred. Confidentiality and familiarity are perceived as facilitating factors while difficulties in communication, factors connected with family and structural factors of work were perceived as barriers. CONCLUSIONS: It is necessary to develop cooperation between school nurses and parents in primary schools. Cooperation and communication skills should be emphasized more in school nurses' training. The findings enable an understanding of the phenomenon of cooperation in school health services and they add valuable point of views to the discussion and the development of children's health services.

Intimate partner violence as experienced by men.

The purpose of this qualitative, phenomenological study is to describe intimate partner violence as experienced by men and to formulate the common structure of meanings of experiences of men exposed to intimate partner violence. The data were gathered by open-ended interviews with 10 (n = 10) men. The participants had experiences in intimate partner violence. All the 10 men were interviewed twice and they were allowed to tell their experiences as they liked. The data were analysed by applying the method developed by Colaizzi. The experiences of men formulated three main themes describing the factors leading to intimate partner violence, being a victim of intimate partner violence and own violent behavior. The main themes are named as follows: (1) a burden on the pair relationship; (2) face to face with violence; and (3) from denying violence to striving towards the truth. The research results enhance the understanding of the experiences of men. The information may be useful in promoting women's, men's and families' health, developing work on violence and in the education of professionals in social and health care. The results may also help women to understand men's experiences in a pair relationship.

Family dynamics and postnatal depression.

Research has shown that postnatal depression (PND) affects 10-15% of mothers in Western societies. PND is not easily identified and therefore it often remains undetected. Untreated depression has a detrimental effect on the mother and child and the entire family. The purpose of this study was to ascertain the state of family dynamics after delivery and whether the mother's PND was associated with family dynamics. The study used a survey covering the catchment area of one Finnish university hospital. Both primi- and multiparas took part and data were collected using the Edinburgh Postnatal Depression Scale (EPDS) for mothers and the Family Dynamics Measure II (FDM II) for both mothers and fathers. The data were analysed using SPSS statistical programme and frequency and percentage distributions, means and standard deviations were examined. Correlations were analysed using Spearman's correlation coefficients. The significance of any differences between mothers' and fathers' scores was determined with a paired t-test. Of the families participating in the study (373 mothers and 314 partners), 13% of the mothers suffered from PND symptoms (EPDS score of 13 or more). As a whole, family dynamics in the families participating in the study were reported to be rather good. However, mothers having depressive symptoms reported more negative family dynamics compared with other families. With the exception of individuation, mothers having depressive symptoms reported more negative family dynamics than their partners. With the exception of role reciprocity, non-depressed mothers reported more positive family dynamics than their partners. Knowledge of the association of mothers' PND with family dynamics could help to develop nursing care at maternity and child welfare clinics and maternity hospitals. Depressed mothers and their families need support to be able to make family dynamics as good as possible.

Long term efficacy and safety of cyclosporin versus parenteral gold in early rheumatoid arthritis: a three year study of radiographic progression, renal function, and arterial hypertension.

OBJECTIVE: To compare the three year safety and efficacy of cyclosporin and parenteral gold in the treatment of early, active, severe rheumatoid arthritis (RA), and to study the reversibility of cyclosporin associated renal dysfunction in patients who discontinued cyclosporin treatment. METHODS: The patients continued to receive cyclosporin or parenteral gold in an 18 month open extension to an 18 month randomised, parallel group study. The main efficacy variable was blinded evaluation of radiographic progression of joint damage. Safety variables included serum creatinine, calculated creatinine clearance, and blood pressure. RESULTS: Radiographic progression during follow up was similar in both groups. About 60% of the patients in the intention to treat groups (n=272) and about half of the patients in the completer groups (n=114) had definite radiographic progression in joint damage (increases >6 in the Larsen-Dale score), and about one in three also had substantial progression (>18 increase in Larsen-Dale score). Both systolic and diastolic blood pressure were significantly increased in the cyclosporin group compared with the gold group, and 12/139 (9%) versus 3/139 (2%) (p=0.03) had notably raised blood pressure. The mean serum creatinine increased by 28% at the treatment end point in the cyclosporin group as compared with 7% in the gold group. The mean calculated creatinine clearance was reduced by 16% and increased by 1% in the cyclosporin and gold groups, respectively, at the end of the study. At the final follow up visit after discontinuation of cyclosporin (at least three months after treatment was stopped) the mean serum creatinine was increased by 15% and creatinine clearance reduced by 16%. Sustained increases in serum creatinine at this post-treatment end point were mostly seen in patients with a raised serum creatinine during treatment of at least 50%. CONCLUSION: Three year changes in radiographic damage during cyclosporin and parenteral gold were similar in patients with early, active RA. Abnormal renal function and raised blood pressure were often seen in the cyclosporin treated patients.

Humour between nurse and patient, and among staff: analysis of nurses' diaries.

AIM OF THE STUDY: The aim of this study was to investigate the occurrence of humour both between nurses and patients and among nursing staff. BACKGROUND: Humour has positive effects on both a person's physiology and the psyche. Laughter signifies positive things to people; it may add to feelings of togetherness, closeness and friendliness. The use of humour is an indication of mental well-being and it minimizes the effect of negative factors and protects from difficulties. METHODS: The data consisted of diaries written by nurses (n=16), which were analysed inductively using content analysis. FINDINGS: The main categories of humour between nurse and patient were nurse-based humour, co-operation-orientated humour and patient-orientated humour. Humour among staff consisted of the main category of resource-orientated humour. CONCLUSION: The consequences of humour between nurse and patient enabled them both to cope with various unpleasant procedures. It helped them to manage difficult situations and led to an improvement in the working climate. Humour among staff helped nurses to cope with their work and created a better atmosphere on the ward.

Methodological issues in interviewing families in family nursing research.

AIM OF THE STUDY: The aim of this study is to discuss what methodological problems can be met in family research with one family member as an interviewee speaking on behalf of the whole family and, vice versa, what is the meaning of having multiple family members or the whole family unit as informants. BACKGROUND: Family nursing research is part of multidisciplinary research with families. It is a basis for family nursing and contributes to research, especially from the perspective of family welfare and its promotion. Family nursing research generates knowledge concerning families' and family members' wellbeing and experiences and expectations of nursing and health care. METHODS: The examination of methodological problems while pursuing family research is based on two studies conducted in Finland. FINDINGS: Quantitative methods add to the general knowledge of families. Qualitative methods are well suited to the study of family experiences. Family interviews performed for research purposes differ from interviews aiming at caring for families. They aim at obtaining knowledge of families on a general level so as to improve family nursing. Family research has to be looked at as a whole. It faces many challenges such as the definition of the family, gaining access, methods of data collection and data management. CONCLUSIONS: A family is a complex system and research with families need flexible, sensitive and practical methods. Family research should also aim at developing new methods for data collection and analysis.

Treatment strategy, disease activity, and outcome in four cohorts of patients with early rheumatoid arthritis.

OBJECTIVE: To compare four different inception cohorts of patients with early rheumatoid arthritis (RA) with respect to treatment strategies, disease activity, and outcome during a five year follow up period. METHOD: Data from cohorts of patients with early RA, with a standardised assessment at least every six months for five years from four different centres, were included in one database. Owing to slight differences in the individual study designs, linearly interpolated values were calculated to complete the standard follow up schedule. RESULTS: Despite similar inclusion criteria, significant differences in demographic factors and baseline disease activity were found between the different cohorts. During the follow up an aggressive treatment strategy was followed in the Dutch and Finnish cohort, an intermediate strategy in the British cohort, and a conservative strategy in the Swedish cohort. A significant improvement in disease activity was seen in all cohorts, though the most rapid and striking improvement was seen in those receiving aggressive treatment. This resulted in less radiographic destruction in the long run. CONCLUSION: This observational study of cohorts of patients with early RA confirms that early aggressive treatment results not only in a more rapid reduction of disease activity but also in less radiographic progression in the long term.

Risk factors of child maltreatment within the family: towards a knowledgeable base of family nursing.

The purpose of this study was to compare family dynamics in child maltreating families (n=42) with that in ordinary families with children (n=77), and to ascertain risk factors of child maltreatment within the family. Child maltreatment was defined as physical, psychological or sexual abuse or neglect of a child by a parent. Data were collected using questionnaires (Family Dynamics Measure 2, FMD 2) (N=119) basing on Barnhill's conceptual framework of healthy family systems and analysed by forming sum variables and logistic regression. The study results indicate that family functioning in child maltreating families is lower on all dimensions of family dynamics (individuation, mutuality, flexibility, stability, communication and roles) than that in ordinary families with children. Furthermore, it seems that specific risk factors, detected with logistic regression analysis, are related to whether child maltreatment occurs in the family or not. These include the parent's low educational background, many children in the family, unemployment of a parent, low individuation of the family members, and poor stability and security within the family. The results of this study provide guidelines for detecting and preventing child maltreatment as well as for recognising its existence, although no generalizations can be made due to the small sample size and complexity of the phenomenon under study.

Assessment of strategies in families tested by Finnish families.

The aim of this paper was to describe testing a Finnish version of the assessment of strategies in families (ASF) instrument and its construct validity and reliability in Finnish families. The ASF instrument is based on Friedemann's framework of systemic organization and the version used in this study consists of 25 items, each containing three statements. The instrument was developed to estimate family functioning in reaching the four targets of the framework of systemic organization. It provides sub-scores for the targets, family stability (system maintenance and coherence), family growth (system change and individuation), control (system maintenance and system change) and spirituality (individuation and coherence). Data were collected from patients attending the outpatient clinics of pulmonary and rheumatic diseases (N=196). Questionnaires were given to patients capable of understanding the questions and they returned questionnaires by mail directly to researchers. Construct validity was tested with exploratory factor analysis. Factor analysis was done with 22 items. The four factor solution was best suited. Two items were eliminated because of low factor loadings and crossloading. The total of 20 items were left in the instrument. Crohnbach's alpha was used to measure internal consistency. It was computed for each target separately and the total tool. There were discrepancies in the assignment of process dimensions which were expected because of cultural perceptions. The total instrument had a reliability of 0.85. The result of the analyses was a pretested tool with subscales for stability, growth, control and spirituality that have acceptable reliability and concept validity. Less satisfactory was the small number of items representing individuation. Another weakness is the lack of statistical distinction between system maintenance and coherence. The instrument is also usable in these subscales, but it needs further development and retesting. Items need to be added to express individuation, possibly some others. The new items will be formulated freely, paying attention to culture. However, the tool appears good enough to be used as measurement in various research studies.

Association of autoantibodies to filaggrin with an active disease in early rheumatoid arthritis.

OBJECTIVE: To evaluate the clinical significance of antifilaggrin antibodies (AFA) measured by an enzyme linked immunosorbent assay (ELISA) in serial specimens from patients with recent onset rheumatoid arthritis (RA). METHODS: Filaggrin was purified from human skin and used as an antigen in ELISA. The AFA test was applied to five serial specimens from 78 patients with recent onset RA followed up for three years. Rheumatoid factor (RF) had been measured earlier from the same samples by quantitative immunoturbidimetry. RESULTS: The mean AFA level was highest at entry (54% positive), followed by a statistically significant decline at six months and a slight increase at three years. AFA were persistently positive in 23 patients and persistently negative in 28 patients. Eleven of the latter patients were persistently negative for RF. At study entry AFA levels correlated to some degree with RF levels. In general, raised AFA levels at entry were associated with an active and treatment resistant disease, but they did not predict radiological progression. CONCLUSIONS: The test for AFA has potential for an additional immunological test for RA.

Interaction between adult patients' family members and nursing staff on a hospital ward.

The purpose of this study was to generate knowledge of the interaction between an adult patient's family members and nursing staff from the staff's perspective. Data were collected from nursing staff (n = 155) working on the wards and out-patient departments for pulmonary, rheumatic, neurological and gastroenterological diseases at a university hospital by using a new questionnaire based on earlier research and the literature. The questions explored the staff's views of interaction with the adult patient's family members. In this study, interaction is seen as an umbrella concept which encompasses giving information to relatives, discussion, contacts between staff and significant others and working together. The instrument included questions about personal and telephone discussions, the provision of written instructions and factors facilitating and complicating interaction. The response rate was 55%. The data were analysed using SPSS software and examined using frequency and percentage distributions and cross-tabulation. The open-ended questions were analysed using qualitative content analysis by reducing, grouping and abstracting the data inductively. Discussions with relatives while they visited the patient in hospital were the commonest form of interaction. The majority of respondents perceived the interaction with the patient and knowing his or her family members as important. Less than one-fourth of the respondents started discussion with family members, while the majority expected family members to initiate interaction. The majority of respondents perceived the patient's presence in discussion as important, but sometimes they thought it was necessary to discuss with family members without the patient. The staff discussed with family members mainly in the ward office or in patient rooms, which were, however, not perceived as peaceful. Discussions primarily pertained to the patient's condition, discharge from hospital and planning of continued treatment. The majority of respondents reported that the opportunity for discussion offered by staff, the patient's positive attitude towards discussion with the family and family members' own interest facilitated interaction. The staff's haste and shift-work, family members' shyness of approaching the staff and the absence of a peaceful place for discussion serve to complicate interaction. Family members are primarily seen as informants and recipients of information. The staff's ability to recognize the importance of family members to successful patient care is relatively adequate. However, insufficient attention is paid to family members and their need for support.

Importance of humour to client--nurse relationships and clients' well-being.

Humour is an important and integral part of everyday life, social integration and professional nursing care. However, there has been little systematic research into the use of humour in nursing contexts, from the clients' point of view. With a touch of humour, this article aims to describe the positive impact of humour on client-nurse relationship and on clients' well-being. The data consisted of focused interviews (n = 8) and letters (n = 5) received from nursing clients in response to an invitation published in a patient organization newsletter. The data were analysed using the method of content analysis. The results suggest that humour helped the client to cope with difficult situations by offering a moment of rest and a new perspective on an altered life situation. Humour also helped clients to show their emotions and to preserve their dignity. In the nurse-client relationship, humour enabled the client to communicate criticism or to express themselves. Nurses can alleviate clients' anxieties through humour, and humour can help nurses to cope.

Family involvement in perioperative nursing of adult patients undergoing emergency surgery.

The purpose of this study was to describe how adult patients undergoing emergency surgery experience family centredness in perioperative nursing practice. The central aim was to generate knowledge to be used while developing the practice, education and management of perioperative nursing. Data were collected using a questionnaire with emergency surgical patients in five regional hospitals in Southern Finland. The number of distributed questionnaires was 132. The response rate was 85% (n = 112). The results were mainly described as frequencies and percentages. The open-ended sections of the answers were analysed using qualitative content analysis. The findings from the open-ended questions were used for deepening and complementing the quantitative description of the results. In the preoperative phase, ascertaining the family situation and informing the family member chosen by the patient were not achieved systematically. Family situation was also rarely examined in the intraoperative and postoperative phases, although it is central to coping after surgery, especially in home care. The results support the view of earlier research about the importance of individuality of patients and their families during the perioperative care process and hence enhance the endeavour to develop nursing based on families' real needs.