Effect of supervised exercise on physical function and balance in patients with intermittent claudication

Background The aim of the study was to identify whether a standard supervised exercise programme (SEP) for patients with intermittent claudication improved specific measures of functional performance including balance. Methods A prospective observational study was performed at a single tertiary vascular centre. Patients with symptomatic intermittent claudication (Rutherford grades 1–3) were recruited to the study. Participants were assessed at baseline (before SEP) and 3, 6 and 12 months afterwards for markers of lower-limb ischaemia (treadmill walking distance and ankle : brachial pressure index), physical function (6-min walk, Timed Up and Go test, and Short Physical Performance Battery (SPPB) score), balance impairment using computerized dynamic posturography with the Sensory Organization Test (SOT), and quality of life (VascuQoL and Short Form 36). Results Fifty-one participants underwent SEP, which significantly improved initial treadmill walking distance (P = 0·001). Enrolment in a SEP also resulted in improvements in physical function as determined by 6-min maximum walking distance (P = 0·006), SPPB score (P < 0·001), and some domains of both generic (bodily pain, P = 0·025) and disease-specific (social domain, P = 0·039) quality of life. Significant improvements were also noted in balance, as determined by the SOT (P < 0·001). Conclusion Supervised exercise improves both physical function and balance impairment

Embedding patient and public involvement: managing tacit and explicit expectations

Background: Evidencing well-planned and implemented patient and public involvement (PPI) in a research project is increasingly required in funding bids and dissemination activities. There is a tacit expectation that involving people with experience of the condition under study will improve the integrity and quality of the research. This expectation remains largely unproblematised and unchallenged. Objective: To critically evaluate the implementation of PPI activity, including co-research in a programme of research exploring ways to enhance the independence of people with dementia. Design: Using critical cases we make visible and explicate theoretical and moral challenges of PPI. Results: Case 1 explores the challenges of undertaking multiple PPI roles in the same study making explicit different responsibilities of being a co-applicant, PPI advisory member and a co-researcher. Case 2 explores tensions which arose when working with carer co-researchers during data collection; here the co-researcher’s wish to offer support and advice to research participants, a moral imperative, was in conflict with assumptions about the role of the objective interviewer. Case 3 defines and examines co-research data coding and interpretation activities undertaken with people with dementia; reporting the theoretical outputs of the activity and questioning whether this was co-researcher analysis or PPI validation. Conclusion: PPI activity can empower individual PPI volunteers and improve relevance and quality of research but it is a complex activity which is socially constructed in flexible ways with variable outcomes. It cannot be assumed to be simple or universal panacea for increasing the relevance and accessibility of research to the public

Reflections and Experiences of a Co-Researcher involved in a Renal Research Study

Background Patient and Public Involvement (PPI) is seen as a prerequisite for health research. However, current Patient and public involvement literature has noted a paucity of recording of patient and public involvement within research studies. There have been calls for more recordings and reflections, specifically on impact. Renal medicine has also had similar criticisms and any reflections on patient and public involvement has usually been from the viewpoint of the researcher. Roles of patient and public involvement can vary greatly from sitting on an Advisory Group to analysing data. Different PPI roles have been described within studies; one being a co-researcher. However, the role of the co-researcher is largely undefined and appears to vary from study to study. Methods The aims of this paper are to share one first time co-researcher's reflections on the impact of PPI within a mixed methods (non-clinical trial) renal research study. A retrospective, reflective approach was taken using data available to the co-researcher as part of the day-to-day research activity. Electronic correspondence and documents such as meeting notes, minutes, interview thematic analysis and comments on documents were re-examined. The co-researcher led on writing this paper. Results This paper offers a broad definition of the role of the co-researcher. The co-researcher reflects on undertaking and leading on the thematic analysis of interview transcripts, something she had not previously done before. The co-researcher identified a number of key themes; the differences in time and responsibility between being a coresearcher and an Advisory Group member; how the role evolved and involvement activities could match the co-researchers strengths (and the need for flexibility); the need for training and support and lastly, the time commitment. It was also noted that it is preferable that a co-researcher needs to be involved from the very beginning of the grant application. Conclusions The reflections, voices and views of those undertaking PPI has been largely underrepresented in the literature. The role of co-researcher was seen to be rewarding but demanding, requiring a large time commitment. It is hoped that the learning from sharing this experience will encourage others to undertake this role, and encourage researchers to reflect on the needs of those involved.Peer reviewedFinal Published versio

(188)Re radiopharmaceuticals for radiosynovectomy: evaluation and comparison of tin colloid, hydroxyapatite and tin-ferric hydroxide macroaggregates

BACKGROUND: Radiosynovectomy is a therapy used to relieve pain and inflammation from rheumatoid arthritis and related diseases. In this study three (188)Re particulate compounds were characterized according to their physico-chemical properties and their biological behavior in rabbits. The results were compared in order to establish which was the radiopharmaceutical that better fits the requirements of this kind of radiotherapy. METHODS: Three radiopharmaceutical formulations, tin colloid, hydroxyapatite particles (HA) and ferric hydroxide macroaggregates coated with tin colloid (FHMA), were physically characterized (number, volume and surface of the particles). For this purpose laser diffraction methodology was used. To evaluate cavity leakage of activity the following studies in New Zealand rabbits were performed: scintigraphic images for 48 hr after intraarticular injection of each radiopharmaceutical, biodistribution at 48 hr and urine samples collection during the first 24 hr post-radiopharmaceutical administration. RESULTS: Labeling procedures for (188)Re-HA and (188)Re-Sn-FHMA were labour intensive while (188)Re-Sn was easily prepared. Furthermore, (188)Re-Sn colloid offered the greatest surface area in the 2–10 microm range and was obtained with a radiochemical purity over 95%, while percentage of bound activity for (188)Re-HA and (188)Re-Sn-FHMA were 55% and 92% respectively. Stability was verified for the three radiopharmaceuticals for 24 hr. Scintigraphic studies and biodistribution in rabbits after intraarticular administration of the radiopharmaceuticals showed relevant activity only in the knee, this being over 90% of the residual activity in the whole body at 48 hr in every case. Renal elimination of (188)Re-Sn colloid and (188)Re-Sn-FHMA was detected by activity measurements in urine samples, during the first 12 hr post-radiopharmaceutical injection. The percentage of activity retained in the knee was 69.1% for (188)Re-Sn colloid, 55.1% for (188)Re-Sn-FHMA and 33.6% for (188)Re-HA. CONCLUSION: The (188)Re-Sn colloid was easy to prepare, minimum facilities were required, was stable for 24 hr and showed minimal leakage from the joint after intraarticular injection into the rabbit's knee. Furthermore, (188)Re-Sn colloid has greater retention in the knee when it is compared with the other radiopharmaceuticals, so it could provide the best therapeutic effect/absorbed dose ratio for the patient

Factor structure and construct validity of the Adult Social Care Outcomes Toolkit for Carers (ASCOT-Carer)

Background: The ASCOT-Carer is a self-report instrument designed to measure social care-related quality of life (SCRQoL). This article presents the psychometric testing and validation of the ASCOT-Carer four response-level interview (INT4) in a sample of unpaid carers of adults who receive publicly-funded social care services in England. Methods: Unpaid carers were identified through a survey of users of publicly-funded social care services in England. 387 carers completed a face-to-face or telephone interview. Data on variables hypothesised to be related to SCRQoL (for example, characteristics of the carer, cared-for person and care situation) and measures of carer experience, strain, health-related quality of life and overall QoL were collected. Relationships between these variables and overall SCRQoL score were evaluated through correlation, ANOVA and regression analysis to test the construct validity of the scale. Internal reliability was assessed using Cronbach’s alpha and feasibility by the number of missing responses. Results: The construct validity was supported by statistically significant relationships between SCRQoL and scores on instruments of related constructs, as well as with characteristics of the carer and care recipient in univariate and multivariate analyses. A Cronbach’s alpha of 0.87 (7 items) indicates that the internal reliability of the instrument is satisfactory and a low number of missing responses (<1%) indicates a high level of acceptance. Conclusions: The results provide evidence to support the construct validity, factor structure, internal reliability and feasibility of the ASCOT-Carer INT4 as an instrument for measuring social care-related quality of life of unpaid carers who care for adults with a variety of long-term conditions, disability or problems related to old age

FIRE (facilitating implementation of research evidence) : a study protocol

Research evidence underpins best practice, but is not always used in healthcare. The Promoting Action on Research Implementation in Health Services (PARIHS) framework suggests that the nature of evidence, the context in which it is used, and whether those trying to use evidence are helped (or facilitated) affect the use of evidence. Urinary incontinence has a major effect on quality of life of older people, has a high prevalence, and is a key priority within European health and social care policy. Improving continence care has the potential to improve the quality of life for older people and reduce the costs associated with providing incontinence aids

Utilisation of an operative difficulty grading scale for laparoscopic cholecystectomy

Background A reliable system for grading operative difficulty of laparoscopic cholecystectomy would standardise description of findings and reporting of outcomes. The aim of this study was to validate a difficulty grading system (Nassar scale), testing its applicability and consistency in two large prospective datasets. Methods Patient and disease-related variables and 30-day outcomes were identified in two prospective cholecystectomy databases: the multi-centre prospective cohort of 8820 patients from the recent CholeS Study and the single-surgeon series containing 4089 patients. Operative data and patient outcomes were correlated with Nassar operative difficultly scale, using Kendall’s tau for dichotomous variables, or Jonckheere–Terpstra tests for continuous variables. A ROC curve analysis was performed, to quantify the predictive accuracy of the scale for each outcome, with continuous outcomes dichotomised, prior to analysis. Results A higher operative difficulty grade was consistently associated with worse outcomes for the patients in both the reference and CholeS cohorts. The median length of stay increased from 0 to 4 days, and the 30-day complication rate from 7.6 to 24.4% as the difficulty grade increased from 1 to 4/5 (both p < 0.001). In the CholeS cohort, a higher difficulty grade was found to be most strongly associated with conversion to open and 30-day mortality (AUROC = 0.903, 0.822, respectively). On multivariable analysis, the Nassar operative difficultly scale was found to be a significant independent predictor of operative duration, conversion to open surgery, 30-day complications and 30-day reintervention (all p < 0.001). Conclusion We have shown that an operative difficulty scale can standardise the description of operative findings by multiple grades of surgeons to facilitate audit, training assessment and research. It provides a tool for reporting operative findings, disease severity and technical difficulty and can be utilised in future research to reliably compare outcomes according to case mix and intra-operative difficulty

The GRIPP 2 reporting checklists: tools to improve reporting of patient and public involvement in research

Background: While the PPI evidence base has expanded over the last decade, the quality of reporting within papers is often inconsistent, limiting our understanding of how it works, in what context, for whom and why. Objective: To develop international consensus on the key items to report to enhance the quality, transparency and consistency of the PPI evidence base. To collaboratively involve patients as research partners at all stages in the development of GRIPP 2. Methods: The EQUATOR method for developing reporting guidelines was utilised. The original GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklist was revised, based on updated systematic review evidence. A three round Delphi survey was used to develop consensus on items to be included in the guideline. A subsequent face-to-face meeting produced agreement on items not reaching consensus during the Delphi process. Results: 143 participants agreed to participate in round 1, with an 86% (123/143) response for round 2 and a 78% (112/143) response for round 3. The Delphi survey identified the need for long-form (LF) and short-form (SF) versions. GRIPP2-LF includes 34 items on aims, definitions, concepts and theory, methods, stages and nature of involvement, context, capture or measurement of impact, outcomes, economic assessment and reflections, and is suitable for studies where the main focus is PPI. GRIPP2-SF includes 5 items on aims, methods, results, outcomes and critical perspective and is suitable for studies where PPI is a secondary focus. Conclusions: GRIPP2-LF and GRIPP2-SF represent the first international evidence-based, consensus-informed guidance for reporting patient and public involvement in research. Both versions of GRIPP2 aim to improve the quality, transparency and consistency of the international PPI evidence base, to ensure PPI practice is based on the best evidence. GRIPP 2 is co-published with Research Involvement and Engagement

A realist process evaluation within the Facilitating Implementation of Research Evidence (FIRE) cluster randomised controlled international trial: An exemplar

Trial Registration: Current Controlled Trials ISRCTN11598502Background Facilitation is a promising implementation intervention, which requires theory informed evaluation. This paper presents an exemplar of a multi-country realist process evaluation that was embedded in the first international randomised controlled trial evaluating two types of facilitation for implementing urinary continence care recommendations. We aimed to uncover what worked (and did not work), for whom, how, why and in what circumstances during the process of implementing the facilitation interventions in practice. Methods This realist process evaluation included theory formulation, theory testing and refining. Data were collected in 24 care home sites across four European countries. Data were collected over four time-points using multiple qualitative methods: observation (372 hours), interviews with staff (n=357), residents (n=152), next of kin (n=109) other stakeholders (n=128), supplemented by facilitator activity logs. A combined inductive and deductive data analysis process focused on realist theory refinement and testing. Results The content and approach of the two facilitation programmes prompted variable opportunities to align and realign support with the needs and expectations of facilitators and homes. This influenced their level of confidence in fulfilling the facilitator role, and ability to deliver the intervention as planned. The success of intervention implementation was largely dependent on whether sites prioritised their involvement in both the study and the facilitation programme. In contexts where the study was prioritised (including release of resources) and where managers and staff support was sustained, this prompted collective engagement (as an attitude and action). Internal facilitators’ (IF) personal characteristics and abilities, including personal and formal authority, in combination with a supportive environment prompted by managers triggered the potential for learning over time. Learning over time resulted in a sense of confidence and personal growth, and enactment of the facilitation role, which resulted in practice changes. Conclusion The scale and multi-country nature of this study provided a novel context to conduct one of the few trial embedded realist informed process evaluations. In addition to providing an explanatory account of implementation processes, a conceptual platform for future facilitation research is presented. Finally a realist informed process evaluation framework is outlined, which could inform future research of this nature.The research leading to these results has received funding from the European Union's Seventh Framework Programme (FP7/2007-2013) under grant agreement n° 223646. The funder had no role in designing, conducting, or interpreting study findings.https://implementationscience.biomedcentral.com/articles13pubpub13

The GRIPP 2 reporting checklists: tools to improve reporting of patient and public involvement in research

Background: While the PPI evidence base has expanded over the last decade, the quality of reporting within papers is often inconsistent, limiting our understanding of how it works, in what context, for whom and why. Objective: To develop international consensus on the key items to report to enhance the quality, transparency and consistency of the PPI evidence base. To collaboratively involve patients as research partners at all stages in the development of GRIPP 2. Methods: The EQUATOR method for developing reporting guidelines was utilised. The original GRIPP (Guidance for Reporting Involvement of Patients and the Public) checklist was revised, based on updated systematic review evidence. A three round Delphi survey was used to develop consensus on items to be included in the guideline. A subsequent face-to-face meeting produced agreement on items not reaching consensus during the Delphi process. Results: 143 participants agreed to participate in round 1, with an 86% (123/143) response for round 2 and a 78% (112/143) response for round 3. The Delphi survey identified the need for long-form (LF) and short-form (SF) versions. GRIPP2-LF includes 34 items on aims, definitions, concepts and theory, methods, stages and nature of involvement, context, capture or measurement of impact, outcomes, economic assessment and reflections, and is suitable for studies where the main focus is PPI. GRIPP2-SF includes 5 items on aims, methods, results, outcomes and critical perspective and is suitable for studies where PPI is a secondary focus. Conclusions: GRIPP2-LF and GRIPP2-SF represent the first international evidence-based, consensus-informed guidance for reporting patient and public involvement in research. Both versions of GRIPP2 aim to improve the quality, transparency and consistency of the international PPI evidence base, to ensure PPI practice is based on the best evidence. GRIPP 2 is co-published with Research Involvement and Engagement