A cluster randomised trial of a Needs Assessment Tool for adult Cancer patients and their carers (NAT-C) in primary care: A feasibility study.

BackgroundPeople with cancer often have unidentified symptoms and social care needs. The Needs Assessment Tool-Cancer (NAT-C) is a validated, structured method of assessing patient/carer concerns and prompting action, to address unmet need.AimsAssess feasibility and acceptability of a definitive two-armed cluster randomised trial of NAT-C in primary care by evaluating: recruitment of GP practices, patients and carers; most effective approach of ensuring NAT-C appointments, acceptability of study measures and follow-up.MethodsNon-blinded, feasibility study in four General Practices, with cluster randomisation to method of NAT-C appointment delivery, and process evaluation. Adults with active cancer were invited to participate with or without carer. Practices cluster randomised (1:1) to Arm I: promotion and use of NAT-C with a NAT-C trained clinician or Arm II: clinician of choice irrespective of training status. Participants completed study questionnaires at: baseline, 1, 3 and 6 months. Patients booked a 20 minute needs-assessment appointment post-baseline. Patients, carers and GP practice staff views regarding the study sought through interviews/focus groups. Quantitative data were analysed descriptively. Qualitative data were analysed thematically, informed by Normalisation Process Theory. Progression to a definitive trial was assessed against feasibility outcomes, relating to: recruitment rate, uptake and delivery of the NAT-C, data collection and quality.ResultsFive GP practices approached, four recruited and trained to use the NAT-C. Forty-seven participants and 17 carers recruited. At baseline, 34/47 (72%) participants reported at least one moderate-severe unmet need, confirming study rationale. 32/47 (68%) participants received a NAT-C-guided consultation, 19 of which on Arm I. Study attrition at one month (n = 44 (94%), n = 16 (94%)), three months (n = 38 (81%), n = 14 (82%)) and six months (n = 32 (68%), n = 10 (59%)). Fifteen patient interviews conducted across the whole study and one focus group at each GP practice. Participants supported a definitive study and found measures acceptable.ConclusionThe feasibility trial indicated that recruitment rate, intervention uptake and data collection were appropriate, with refinements, for a definitive multi-centre cluster randomised controlled trial. Feasibility outcomes informed the design of a 2-armed cluster randomised controlled trial to test the effectiveness and cost-effectiveness of the NAT-C compared with usual care

Activity Increase Despite Arthritis (AÏDA): design of a Phase II randomised controlled trial evaluating an active management booklet for hip and knee osteoarthritis [ISRCTN24554946]

<p>Abstract</p> <p>Background</p> <p>Hip and knee osteoarthritis is a common cause of pain and disability, which can be improved by exercise interventions. However, regular exercise is uncommon in this group because the low physical activity level in the general population is probably reduced even further by pain related fear of movement. The best method of encouraging increased activity in this patient group is not known. A booklet has been developed for patients with hip or knee osteoarthritis. It focuses on changing disadvantageous beliefs and encouraging increased physical activity.</p> <p>Methods/Design</p> <p>This paper describes the design of a Phase II randomised controlled trial (RCT) to test the effectiveness of this new booklet for patients with hip and knee osteoarthritis in influencing illness and treatment beliefs, and to assess the feasibility of conducting a larger definitive RCT in terms of health status and exercise behaviour. A computerised search of four general medical practice patients' record databases will identify patients older than 50 years of age who have consulted with hip or knee pain in the previous twelve months. A random sample of 120 will be invited to participate in the RCT comparing the new booklet with a control booklet, and we expect 100 to return final questionnaires. This trial will assess the feasibility of recruitment and randomisation, the suitability of the control intervention and outcome measurement tools, and will provide an estimate of effect size. Outcomes will include beliefs about hip and knee pain, beliefs about exercise, fear avoidance, level of physical activity, health status and health service costs. They will be measured at baseline, one month and three months.</p> <p>Discussion</p> <p>We discuss the merits of testing effectiveness in a phase II trial, in terms of intermediate outcome measures, whilst testing the processes for a larger definitive trial. We also discuss the advantages and disadvantages of testing the psychometric properties of the primary outcome measures concurrently with the trial.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN24554946</p

Professional Disrespect between Doctors and Nurses:Implications for Voicing Concerns about Threats to Patient Safety

Purpose (limit 100 words) Previous research has demonstrated that social-relational factors are instrumental to employee voice. An essential aspect of this relates to notions of respect or disrespect. Although nurses commonly report experiencing professional disrespect in their interaction with doctors, earlier studies have focused on how the professional status hierarchy and power imbalance between doctors and nurses hinder speaking up without considering the role of professional disrespect. Addressing this gap, we explore how professional disrespect in the doctor-nurse relationship in surgical teams influences the willingness of nurses to voice legitimate concerns about threats to patient safety. Design/methodology/approach (limit 100 words) Fifty-seven (57) semi-structured interviews with nurses drawn from a range of specialities, ranks and surgical teams in three hospitals in a West African Country. In addition, two (2) interviews with senior representatives from the National Registered Nurses and Midwifery Association (NRNMA) of the country were undertaken and analysed thematically with the aid of NVivo 12. Findings (limit 100 words) Disrespect is expressed in doctors’ condescending attitude towards nurses and undervaluing their contribution to care. This leads to the safety concerns raised by nurses being ignored, downplayed, or dismissed, with deleterious consequences for patient safety. Feeling disrespected further motivates nurses to consciously disguise silence amidst speech and engage in punitive silence aimed at making clinical practice difficult for doctors. Originality/value (limit 100 words) We draw attention to the detrimental effect of professional disrespect on patient safety in surgical environments. We contribute to employee voice and silence by showing how professional disrespect affects voice independently of hierarchy and conceptualise the notion of punitive silence

Professional Disrespect between Doctors and Nurses: Implications for Voicing Concerns about Threats to Patient Safety

Previous research has demonstrated that social-relational factors are instrumental to employee voice. An essential aspect of this relates to notions of respect or disrespect. Although nurses commonly report experiencing professional disrespect in their interaction with doctors, earlier studies have focused on how the professional status hierarchy and power imbalance between doctors and nurses hinder speaking up without considering the role of professional disrespect. Addressing this gap, we explore how professional disrespect in the doctor-nurse relationship in surgical teams influences the willingness of nurses to voice legitimate concerns about threats to patient safety

The Hip and Knee Book: helping you cope with osteoarthritis

The Hip & Knee Book is a guide for people who have osteoarthritis affecting their hip or knee. It will help you understand what has happened and shows you that there is a lot you can do to get on with your life. The news is good – you can increase your activity despite arthritis. This booklet tells you why you should, and explains how to do it. The advice is based on the latest medical research, and has been developed with the help of people with osteoarthritis

Measuring illness and exercise beliefs in osteoarthritis of the hip or knee: psychometric properties of the ‘Hip and Knee Beliefs Questionnaire’ and the ‘Exercise Attitude Questionnaire’

Objectives: To adapt the Back Beliefs Questionnaire (BBQ) to measure illness beliefs in people with osteoarthritis of the hip or knee, and to measure the psychometric properties of this new ‘Hip and Knee Beliefs Questionnaire’ (HKBQ) together with the ‘Exercise Attitude Questionnaire-18’ (EAQ-18), which measures exercise-related treatment beliefs. Method: Cognitive debriefing through semi-structured interviews was used to assess the face validity of the HKBQ and the EAQ-18. Both questionnaires were tested on people with hip or knee osteoarthritis enrolled into a phase II randomized controlled trial examining the effectiveness of an evidence-based booklet in changing illness and treatment beliefs. Items in these outcome measures were accepted if they fulfilled a series of psychometric criteria including response frequency, item–total correlation, and factor analysis. The final questionnaires were tested for reliability, responsiveness, criterion, and construct validity. Results: No items were discarded from either of the final questionnaires, although one item in the EAQ-18 was borderline. Both questionnaires showed evidence of internal consistency, test–retest reliability, face validity, and criterion validity; there was less evidence for construct validity. The responsiveness of the HKBQ showed a medium-sized change; the EAQ-18 a small change. Conclusion: Both these outcome measures can be used in future trials and other studies which measure change in illness and exercise beliefs in people with osteoarthritis of the hip or the knee. Further testing of validity and responsiveness using interventions with larger effect sizes should be performed. Trial registration: Current Controlled Trials ISRCTN24554946

Activity Increase Despite Arthritis (AÏDA): phase II randomised controlled trial of an active management booklet for hip and knee osteoarthritis in primary care

Background The Hip & Knee Book: Helping you cope with osteoarthritis was developed to change disadvantageous beliefs and encourage physical activity in people with hip or knee osteoarthritis. Aim To assess the feasibility of conducting a definitive randomised controlled trial (RCT) of this evidence-based booklet in people with hip or knee osteoarthritis. Design Phase II feasibility randomised controlled trial (RCT). Method Computerised searches of patients’ record databases identified people with osteoarthritis of the hip or knee, who were invited to participate in the RCT comparing the new booklet with a control booklet. Outcomes were measured at baseline, 1month, and 3months, and included: beliefs about hip and knee pain, exercise, and fear avoidance; level of physical activity; and health service use. Results The trialmethods were feasible in terms of recruitment, randomisation, and follow-up, but most participants recruited had longstanding established symptoms. After one and 3months, there was a small relative improvement in illness, exercise, and fear-avoidance beliefs and physical activity level in The Hip & Knee Book group (n = 59) compared with the control group (n = 60), which provides some proof of principle for using these outcomes in future trials. Conclusion This feasibility study provided proof of principle for testing The Hip & Knee Book in a larger definitive RCT