Clive Liles

Patient Reported Outcomes (PROs) in Clinical Trials: Is ‘In-Trial’ Guidance Lacking? A Systematic Review

Background Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on ‘in-trial’ activity (recruitment, data collection and data inputting) and the management of ‘concerning’ PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. Methods and Findings Systematic review of 1,362 articles identified 18 eligible papers containing ‘in-trial’ guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86–0.97), and validity (<2% residual category coding). The majority of guidelines present were concerned with ‘pre-trial’ activities (72%), for example, outcome measure selection and study design issues, or ‘post-trial’ activities (16%) such as data analysis, reporting and interpretation. ‘In-trial’ guidelines represented 9.2% of all guidance across the papers reviewed, with content primarily focused on compliance, quality control, proxy assessment and reporting of data collection. There were no guidelines surrounding the management of concerning PRO data. Conclusions The findings highlight there are minimal in-trial guidelines in publication regarding PRO data collection and management in clinical trials. No guidance appears to exist for researchers involved with the handling of concerning PRO data. Guidelines are needed, which support researchers to manage all PRO data appropriately and which facilitate unbiased data collection.

Linking reflective practice to evidence of competence: a workshop for allied health professionals

Under new regulation requirements for Allied Health Professionals in the UK, maintenance of professional registration is linked to evidence of competence through continuing professional development. This paper reports on the outcomes of a multi‐professional workshop for Allied Health Professionals working in one National Health Service Trust. The aim of the workshop was to help practitioners from different health professions understand and implement the process of reflective practice and link their learning to evidence of competence using a common framework. The workshop demonstrated that collectively, Allied Health Professionals in the Trust are taking advantage of a range of opportunities for informal practice‐based learning, and was helpful in enabling practitioners move from a factual to a more critical level of reflective thinking. The outcomes suggest that a common framework within which Allied Health Professionals can reflect on their practice and facilitate their own CPD, as well as demonstrate continuing competence to a variety of stakeholders, is realistic and workable.

Working Postures and Physiotherapy Students

Summary A direct observational study was undertaken of second- and third-year physiotherapy students from one physiotherapy school performing clinical work. The Ovako Working Posture Analysing System (OWAS) was used to collect the information about the students’ working postures. This allows the calculation of action categories which give an indication of the need for corrective measures to alleviate the postural load. Particular note was taken of postures assumed during patient transfers and the number of transfers observed. An immense variety of working postures was observed in the study. There were no significant differences between the working postures adopted by the two years of students. On certain clinical placements the students demonstrated significantly greater numbers of hazardous working postures. Only standing transfers were observed in sufficient numbers for analysis, and all of these achieved an OWAS action category rating of two or more (indicating potential for harm to the musculoskeletal system). There was no significant difference between the scores for the two years of students. OWAS provided a simple posture analysis but greater detail is needed about the number of static postures assumed. The similarities between the working postures of the two years of students suggest that more emphasis needs to be placed on safe working postures during clinical practice.

THE PROBLEMATIC WORLD OF FOLLOWING A RENAL DIET OUTSIDE THE HOME.

BACKGROUND Individuals on peritoneal dialysis are given dietary advice to help reduce disease morbidity and mortality. However, the experience of people who have been given this advice is not well researched. OBJECTIVE To understand the experiences of individuals on peritoneal dialysis when following dietary advice. METHOD A phenomenological approach, using semi-structured in-depth interviews was used to understand the experiences of ten service-users of the renal dietetic service. Data were analysed using Framework Analysis. FINDINGS One theme emerged around difficulty when eating outside the home. Individuals experienced negative emotions when following advice. Individuals ate foods reluctantly, offered excuses as to why meals could not be eaten, or in extreme cases did not attend certain social gatherings in order to avoid the perceived attention and judgement from fellow guests related to their food choices. CONCLUSION A renal diet for peritoneal dialysis may be difficult to follow outside the home. Further support around eating in social situations may need to be offered when giving dietary advice.

Integrating renal nutrition guidelines into daily family life: a qualitative exploration

BACKGROUND Renal dietary compliance is challenging for individuals with chronic renal disease. Advice may change depending on renal function and medical treatment. Although patients seek support from family members with these changes, no literature exists with respect to how family members experience the offering of this support. The present study aimed to describe and interpret this lived experience of family members. METHODOLOGY Phenomenological qualitative semi-structured interviews were conducted with 12 adult family members via telephone (transcribed verbatim). Framework analysis and the qualitative software nvivo, version 10 (QSR International Pty Ltd, Melbourne, VIC, Australia) were used. Participants commented on the themes for accuracy of experience representation. RESULTS Four major themes emerged: (i) intrusion of the renal diet; (ii) dealing with the recommendations of a renal diet; (iii) seeking a new identity; and (iv) transition of family dynamics. Perceived conflicting advice intruded into family life. Children in the family resulted in more complex nutritional decisions. Continuing a diet to avoid perceived family and wider social judgement was not an option. Balance between nurturing the family as a whole and the necessity of attending to the specific needs of one individual with renal disease was challenging. Transition to a new identity included family members being drawn to scientifically guided understandings of nutrition and a medicalisation of daily food requirements, which included low prioritisation of childrens nutritional needs. CONCLUSION Family members who cooked found the integration of renal nutrition guidelines challenging, with children presenting further challenges. The present study highlights the need to offer practical and psychological support to families who are coping with end-stage renal failure and renal nutritional guidelines.

Reply to Selfe (2014) letter to the editor on: Measurement properties of patient-reported outcome measures (PROMS) in patellofemoral pain syndrome: A systematic review

1: We acknowledge the incorrect use of the term ‘Modified Functional Index Questionnaire (MFIQ)’ in the paper. We agree the term ‘Functional Index Questionnaire (FIQ)’ should have been used in its place. This error has now been corrected. 2: The inclusion criteria for our review were: “studies had to include participants that presented with a main complaint of patellofemoral pain (defined as anterior peripatellar or retropatellar knee pain) with symptoms that were provoked by at least two of the following: prolonged sitting or kneeling, stair walking, running, squatting, hopping, a positive Clarkes sign or grind test, a positive patellar compression test and recognisable painful symptoms on palpation of the patellar facets”. These criteria have been employed by several low risk of bias randomised controlled trials (Collins et al., 2008; van Linschoten et al., 2009; Collins et al., 2010).

Acquiring Interpersonal Skills

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