scholarly journals Patch augmentation surgery for rotator cuff repair: the PARCS mixed-methods feasibility study

2021 ◽  
Vol 25 (13) ◽  
pp. 1-138
Author(s):  
Jonathan A Cook ◽  
Mathew Baldwin ◽  
Cushla Cooper ◽  
Navraj S Nagra ◽  
Joanna C Crocker ◽  
...  
Keyword(s):  
Systematic Review ◽  
Rotator Cuff ◽  
Feasibility Study ◽  
Delphi Study ◽  
Clinical Evidence ◽  
Controlled Trial ◽  
Health Technology ◽  
Patch Use ◽  
Randomised Controlled ◽  
Rotator Cuff Surgery

Background A rotator cuff tear is a common, disabling shoulder problem. Symptoms may include pain, weakness, lack of shoulder mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a need to improve the outcome of rotator cuff surgery, and the use of patch augmentation (on-lay or bridging) to provide support to the healing process and improve patient outcomes holds promise. Patches have been made using different materials (e.g. human/animal skin or tissue and synthetic materials) and processes (e.g. woven or mesh). Objectives The aim of the Patch Augmented Rotator Cuff Surgery (PARCS) feasibility study was to determine the design of a definitive randomised controlled trial assessing the clinical effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. Design A mixed-methods feasibility study of a randomised controlled trial. Data sources MEDLINE, EMBASE and the Cochrane Library databases were searched between April 2006 and August 2018. Methods The project involved six stages: a systematic review of clinical evidence, a survey of the British Elbow and Shoulder Society’s surgical membership, a survey of surgeon triallists, focus groups and interviews with stakeholders, a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. The various stakeholders (including patients, surgeons and industry representatives) were involved in stages 2–6. Results The systematic review comprised 52 studies; only 15 were comparative and, of these, 11 were observational (search conducted in August 2018). These studies were typically small (median number of participants 26, range 5–152 participants). There was some evidence to support the use of patches, although most comparative studies were at a serious risk of bias. Little to no published clinical evidence was available for a number of patches in clinical use. The membership survey of British Elbow and Shoulder surgeons [105 (21%) responses received] identified a variety of patches in use. Twenty-four surgeons (77%) completed the triallist survey relating to trial design. Four focus groups were conducted, involving 24 stakeholders. Differing views were held on a number of aspects of trial design, including the appropriate patient population (e.g. patient age) to participate. Agreement on the key research questions and the outline of two potential randomised controlled trials were achieved through the Delphi study [29 (67%)] and the consensus meeting that 22 participants attended. Limitations The main limitation was that the findings were influenced by the participants, who are not necessarily representative of the views of the relevant stakeholder groups. Conclusion The need for further clinical studies was clear, particularly given the range and number of different patches available. Future work Randomised comparisons of on-lay patch use for completed rotator cuff repairs and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. These elements are included in the trial designs proposed in this study. Study registration The systematic review is registered as PROSPERO CRD42017057908. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 13. See the NIHR Journals Library website for further project information.

scholarly journals Findings from the Patch Augmented Rotator Cuff Surgery (PARCS) Feasibility Study

2021 ◽  
Author(s):  
Jonathan Alistair Cook ◽  
Mathew Baldwin ◽  
Cushla Cooper ◽  
Navraj S. Nagra ◽  
Joanna C. Crocker ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Focus Groups ◽  
Feasibility Study ◽  
Delphi Study ◽  
Clinical Evidence ◽  
Healing Process ◽  
Consensus Meeting ◽  
Trial Participation ◽  
Patch Use ◽  
Rotator Cuff Surgery

Abstract BackgroundA rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The Patch Augmented Rotator Cuff Surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible.MethodsA mixed methods feasibility study of a RCT. The project involved six stages: a systematic review of clinical evidence; a survey of the British Elbow and Shoulder (BESS) society’s surgical membership; a survey of surgeon trialists; focus groups and interviews with stakeholders; a two-round Delphi study administered via online questionnaires; and a two-day Consensus Meeting. ResultsThe BESS surgeons’ survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) individuals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting). ConclusionsRandomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.

scholarly journals Findings from the patch augmented rotator cuff surgery (PARCS) feasibility study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Jonathan A. Cook ◽  
Mathew Baldwin ◽  
Cushla Cooper ◽  
Navraj S. Nagra ◽  
Joanna C. Crocker ◽  
...  
Keyword(s):  
Rotator Cuff ◽  
Focus Groups ◽  
Feasibility Study ◽  
Delphi Study ◽  
Clinical Evidence ◽  
Healing Process ◽  
Consensus Meeting ◽  
Trial Participation ◽  
Patch Use ◽  
Rotator Cuff Surgery

Abstract Background A rotator cuff tear is a common disabling shoulder problem. Symptoms include pain, weakness, lack of mobility and sleep disturbance. Many patients require surgery to repair the tear; however, there is a high failure rate. There is a pressing need to improve the outcome of rotator cuff surgery. The use of patch augmentation to provide support to the healing process and improve patient outcomes holds new promise. Different materials (e.g. human/animal skin or intestine tissue, and completely synthetic materials) and processes (e.g. woven or a mesh) have been used to produce patches. However, clinical evidence on their use is limited. The patch augmented rotator cuff surgery (PARCS) feasibility study aimed to determine the design of a definitive randomised controlled trial (RCT) assessing the effectiveness and cost-effectiveness of a patch to augment surgical repair of the rotator cuff that is both acceptable to stakeholders and feasible. Methods A mixed methods feasibility study of conducing a subsequent RCT. The project involved six stages: a systematic review of clinical evidence; a survey of the British Elbow and Shoulder Society’s (BESS) surgical membership; a survey of surgeon trialists; focus groups and interviews with stakeholders; a two-round Delphi study administered via online questionnaires and a 2-day consensus meeting. Results The BESS surgeons’ survey identified a variety of patches in use (105 (21%) responses received). Twenty-four surgeons (77%) completed the trialist survey relating to trial design. Four focus groups were conducted involving 24 stakeholders. Twenty-nine (67% of invited) individuals took part in the Delphi. Differing views were held on a number of aspects including the appropriate patient population for trial participation. Agreement on the key research questions and the outline of two potential RCTs were achieved through the Delphi study and the consensus meeting. Conclusions Randomised comparisons of on-lay patch use for completed rotator cuff repairs, and bridging patch use for partial rotator cuff repairs were identified as areas for further research. The value of an observational study to assess safety concerns of patch use was also highlighted. The main limitation was that the findings were influenced by the participants, who might not necessarily reflect all stakeholders.

scholarly journals Saline in Acute Bronchiolitis RCT and Economic evaluation: hypertonic saline in acute bronchiolitis – randomised controlled trial and systematic review

2015 ◽  
Vol 19 (66) ◽  
pp. 1-130 ◽  
Author(s):  
Mark L Everard ◽  
Daniel Hind ◽  
Kelechi Ugonna ◽  
Jennifer Freeman ◽  
Mike Bradburn ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Supportive Care ◽  
Technology Assessment ◽  
Controlled Trial ◽  
Health Technology ◽  
Controlled Trials ◽  
Acute Bronchiolitis ◽  
Randomised Controlled

BackgroundAcute bronchiolitis is the most common cause of hospitalisation in infancy. Supportive care and oxygen are the cornerstones of management. A Cochrane review concluded that the use of nebulised 3% hypertonic saline (HS) may significantly reduce the duration of hospitalisation.ObjectiveTo test the hypothesis that HS reduces the time to when infants were assessed as being fit for discharge, defined as in air with saturations of > 92% for 6 hours, by 25%.DesignParallel-group, pragmatic randomised controlled trial, cost–utility analysis and systematic review.SettingTen UK hospitals.ParticipantsInfants with acute bronchiolitis requiring oxygen therapy were allocated within 4 hours of admission.InterventionsSupportive care with oxygen as required, minimal handling and fluid administration as appropriate to the severity of the disease, 3% nebulised HS every ± 6 hours.Main outcome measuresThe trial primary outcome was time until the infant met objective discharge criteria. Secondary end points included time to discharge and adverse events. The costs analysed related to length of stay (LoS), readmissions, nebulised saline and other NHS resource use. Quality-adjusted life-years (QALYs) were estimated using an existing utility decrement derived for hospitalisation in children, together with the time spent in hospital in the trial.Data sourcesWe searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and other databases from inception or from 2010 onwards, searched ClinicalTrials.gov and other registries and hand-searchedChest,PaediatricsandJournal of Paediatricsto January 2015.Review methodsWe included randomised/quasi-randomised trials which compared HS versus saline (± adjunct treatment) or no treatment. We used a fixed-effects model to combine mean differences for LoS and assessed statistical heterogeneity using theI2statistic.ResultsThe trial randomised 158 infants to HS (n = 141 analysed) and 159 to standard care (n = 149 analysed). There was no difference between the two arms in the time to being declared fit for discharge [median 76.6 vs. 75.9 hours, hazard ratio (HR) 0.95, 95% confidence interval (CI) 0.75 to 1.20] or to actual discharge (median 88.5 vs. 88.7 hours, HR 0.97, 95% CI 0.76 to 1.23). There was no difference in adverse events. One infant developed bradycardia with desaturation associated with HS. Mean hospital costs were £2595 and £2727 for the control and intervention groups, respectively (p = 0.657). Incremental QALYs were 0.0000175 (p = 0.757). An incremental cost-effectiveness ratio of £7.6M per QALY gained was not appreciably altered by sensitivity analyses. The systematic review comprised 15 trials (n = 1922) including our own. HS reduced the mean LoS by –0.36 days (95% CI –0.50 to –0.22 days). High levels of heterogeneity (I2 = 78%) indicate that the result should be treated cautiously.ConclusionsIn this trial, HS had no clinical benefit on LoS or readiness for discharge and was not a cost-effective treatment for acute bronchiolitis. Claims that HS achieves small reductions in LoS must be treated with scepticism.Future workWell-powered randomised controlled trials of high-flow oxygen are needed.Study registrationThis study is registered as NCT01469845 and CRD42014007569.Funding detailsThis project was funded by the NIHR Health Technology Assessment (HTA) programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 66. See the HTA programme website for further project information.

scholarly journals The feasibility of determining the effectiveness and cost-effectiveness of medication organisation devices compared with usual care for older people in a community setting: systematic review, stakeholder focus groups and feasibility randomised controlled trial

2016 ◽  
Vol 20 (50) ◽  
pp. 1-250 ◽  
Author(s):  
Debi Bhattacharya ◽  
Clare F Aldus ◽  
Garry Barton ◽  
Christine M Bond ◽  
Sathon Boonyaprapa ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Care ◽  
Cost Effectiveness ◽  
Health Outcomes ◽  
Focus Groups ◽  
Health Care Professionals ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Health Technology ◽  
Randomised Controlled

BackgroundMedication organisation devices (MODs) provide compartments for a patient’s medication to be organised into the days of the week and the recommended times the medication should be taken.AimTo define the optimal trial design for testing the clinical effectiveness and cost-effectiveness of MODs.DesignThe feasibility study comprised a systematic review and focus groups to inform a randomised controlled trial (RCT) design. The resulting features were tested on a small scale, using a 2 × 2 factorial design to compare MODs with usual packaging and to compare weekly with monthly supply. The study design was then evaluated.SettingPotential participants were identified by medical practices.ParticipantsAged over 75 years, prescribed at least three solid oral dosage form medications, unintentionally non-adherent and self-medicating. Participants were excluded if deemed by their health-care team to be unsuitable.InterventionsOne of three MODs widely used in routine clinical practice supplied either weekly or monthly.ObjectivesTo identify the most effective method of participant recruitment, to estimate the prevalence of intentional and unintentional non-adherence in an older population, to provide a point estimate of the effect size of MODs relative to usual care and to determine the feasibility and acceptability of trial participation.MethodsThe systematic review included MOD studies of any design reporting medication adherence, health and social outcomes, resource utilisation or dispensing or administration errors. Focus groups with patients, carers and health-care professionals supplemented the systematic review to inform the RCT design. The resulting design was implemented and then evaluated through questionnaires and group discussions with participants and health-care professionals involved in trial delivery.ResultsStudies on MODs are largely of poor quality. The relationship between adherence and health outcomes is unclear. Of the limited studies reporting health outcomes, some reported a positive relationship while some reported increased hospitalisations associated with MODs. The pre-trial focus groups endorsed the planned study design, but suggested a minimum recruitment age of 50–60 years. A total of 35.4% of patients completing the baseline questionnaire were excluded because they already used a MOD. Active recruitment yielded a higher consent rate, but passive recruitment was more cost-effective. The prevalence of intentional non-adherence was 24.7% [n = 71, 95% confidence interval (CI) 19.7% to 29.6%] of participants. Of the remaining 76 participants, 46.1% (95% CI 34.8% to 57.3%) were unintentionally non-adherent. There was no indication of a difference in adherence between the study arms. Participants reported a high level of satisfaction with the design. Five adverse/serious adverse events were identified in the MOD study arms and none was identified in the control arms. There was no discernible difference in health economic outcomes between the four study arms; the mean intervention cost was £20 per month greater for MOD monthly relative to usual supply monthly.ConclusionsMOD provision to unintentionally non-adherent older people may cause medication-related adverse events. The primary outcome for a definitive MOD trial should be health outcomes. Such a trial should recruit patients by postal invitation and recruit younger patients.Future workA study examining the association between MOD initiation and adverse effects is necessary and a strategy to safely introduce MODs should be explored. A definitive study testing the clinical effectiveness and cost-effectiveness of MODs is also required.Study registrationCurrent Controlled Trials ISRCTN 30626972 and UKCRN 12739.FundingThis project was funded by National Institute for Health Research (NIHR) Health Technology Assessment Programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 50. See the NIHR Journals Library website for further project information.

scholarly journals An intervention to improve outcomes of falls in dementia: the DIFRID mixed-methods feasibility study

2019 ◽  
Vol 23 (59) ◽  
pp. 1-208
Author(s):  
Louise M Allan ◽  
Alison Wheatley ◽  
Amy Smith ◽  
Elizabeth Flynn ◽  
Tara Homer ◽  
...  
Keyword(s):  
Health Care ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Feasibility Study ◽  
Technology Assessment ◽  
Controlled Trial ◽  
Realist Review ◽  
Health Technology ◽  
People With Dementia ◽  
Randomised Controlled

Background Fall-related injuries are a significant cause of morbidity and mortality in people with dementia. There is presently little evidence to guide the management of such injuries, and yet there are potentially substantial benefits to be gained if the outcomes of these injuries could be improved. This study aimed to design an appropriate new health-care intervention for people with dementia following a fall and to assess the feasibility of its delivery in the UK NHS. Objectives To determine whether or not it is possible to design an intervention to improve outcomes of falls in dementia, to investigate the feasibility and acceptability of the DIFRID (Developing an Intervention for Fall related Injuries in Dementia) intervention and to investigate the feasibility of a future randomised controlled trial and the data collection tools needed to evaluate both the effectiveness and the cost-effectiveness of the DIFRID intervention. Design This was a mixed-methods feasibility study. A systematic review (using Cochrane methodology) and realist review [using Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) methodology] explored the existing evidence base and developed programme theories. Searches were carried out in November 2015 (updated in January 2018) for effectiveness studies and in August 2016 for economic studies. A prospective observational study identified service use via participant diary completion. Qualitative methods (semistructured interviews, focus groups and observation) were used to explore current practice, stakeholder perspectives of the health and social care needs of people with dementia following a fall, ideas for intervention and barriers to and facilitators of change. Each of the resulting data sets informed intervention development via Delphi consensus methods. Finally, a single-arm feasibility study with embedded process evaluation was conducted. Setting This study was set in the community. Participants The participants were (1) people with dementia presenting with falls necessitating health-care attention in each setting (primary care, the community and secondary care) at three sites and their carers, (2) professionals delivering the intervention, who were responsible for training and supervision and who were members of the intervention team, (3) professionals responsible for approaching and recruiting participants and (4) carers of participants with dementia. Interventions This was a complex multidisciplinary therapy intervention. Physiotherapists, occupational therapists and support workers delivered up to 22 sessions of tailored activities in the home or local area of the person with dementia over a period of 12 weeks. Main outcome measures (1) Assessment of feasibility of study procedures; (2) assessment of the acceptability, feasibility and fidelity of intervention components; and (3) assessment of the suitability and acceptability of outcome measures for people with dementia and their carers (number of falls, quality of life, fear of falling, activities of daily living, goal-setting, health-care utilisation and carer burden). Results A multidisciplinary intervention delivered in the homes of people with dementia was designed based on qualitative work, realist review and recommendations of the consensus panel. The intervention was delivered to 11 people with dementia. The study suggested that the intervention is both feasible and acceptable to stakeholders. A number of modifications were recommended to address some of the issues arising during feasibility testing. The measurement of outcome measures was successful. Conclusions The study has highlighted the feasibility of delivering a creative, tailored, individual approach to intervention for people with dementia following a fall. Although the intervention required greater investment of time than usual practice, many staff valued the opportunity to work more closely with people with dementia and their carers. We conclude that further research is now needed to refine this intervention in the context of a pilot randomised controlled trial. Trial registration Current Controlled Trials ISRCTN41760734 and PROSPERO CRD42016029565. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 59. See the NIHR Journals Library website for further project information.

scholarly journals Is End-Stage Ankle Arthrosis Best Managed with Total Ankle Replacement or Arthrodesis? A Systematic Review

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Robert W. Jordan ◽  
Gurdip S. Chahal ◽  
Anna Chapman
Keyword(s):  
Systematic Review ◽  
Functional Outcome ◽  
Controlled Trial ◽  
Ankle Arthrodesis ◽  
Total Ankle Replacement ◽  
Online Databases ◽  
Ankle Replacement ◽  
Comparative Group ◽  
Randomised Controlled ◽  
End Stage

Introduction. End-stage ankle osteoarthritis is a debilitating condition. Traditionally, ankle arthrodesis (AA) has been the surgical intervention of choice but the emergence of total ankle replacement (TAR) has challenged this concept. This systematic review aims to address whether TAR or AA is optimal in terms of functional outcomes.Methods. We conducted a systematic review according to PRISMA checklist using the online databases Medline and EMBASE after January 1, 2005. Participants must be skeletally mature and suffering from ankle arthrosis of any cause. The intervention had to be an uncemented TAR comprising two or three modular components. The comparative group could include any type of ankle arthrodesis, either open or arthroscopic, using any implant for fixation. The study must have reported at least one functional outcome measure.Results. Of the four studies included, two reported some significant improvement in functional outcome in favour of TAR. The complication rate was higher in the TAR group. However, the quality of studies reviewed was poor and the methodological weaknesses limited any definitive conclusions being drawn.Conclusion. The available literature is insufficient to conclude which treatment is superior. Further research is indicated and should be in the form of an adequately powered randomised controlled trial.

scholarly journals Feasibility study of an integrated stroke self-management programme: a cluster-randomised controlled trial

BMJ Open ◽  
2016 ◽  
Vol 6 (1) ◽  
pp. e008900 ◽  
Author(s):  
Fiona Jones ◽  
Heather Gage ◽  
Avril Drummond ◽  
Ajay Bhalla ◽  
Robert Grant ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Management Programme ◽  
Self Management ◽  
Cluster Randomised ◽  
Randomised Controlled
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