JRSM OpenPub Date : 2023-06-07eCollection Date: 2023-06-01DOI: 10.1177/20542704231166621
Rebecca Dobra, Gemma Wilson, Jessie Matthews, Marco Boeri, Stuart Elborn, Frank Kee, Jane C Davies, Susan Madge
{"title":"A systematic review to identify and collate factors influencing patient journeys through clinical trials.","authors":"Rebecca Dobra, Gemma Wilson, Jessie Matthews, Marco Boeri, Stuart Elborn, Frank Kee, Jane C Davies, Susan Madge","doi":"10.1177/20542704231166621","DOIUrl":"10.1177/20542704231166621","url":null,"abstract":"<p><p>Patient-centred trial design and delivery; improves recruitment and retention; increases participant satisfaction; encourages participation by a more representative cohort; and allows researchers to better meet participants' needs. Research in this area mostly focusses on narrow facets of trial participation. We aimed to systematically identify the breadth of patient-centred factors influencing participation and engagement in trials, and collate them into a framework. Through this we hoped to assist researchers to identify factors that could improve patient-centred trial design and delivery. Robust qualitative and mixed methods systematic reviews are becoming increasingly common in health research. The protocol for this review was prospectively registered on PROSPERO, CRD42020184886. We used the SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research Type) framework as a standardised systematic search strategy tool. 3 databases were searched as well as references checking, and thematic synthesis was conducted. Screening agreement was performed and code and theme checking were conducted by 2 independent researchers. Data were drawn from 285 peer-reviewed articles. 300 discrete factors were identified, and sorted into 13 themes and subthemes. The full catalogue of factors is included in the Supplementary Material. A summary framework is included in the body of the article. This paper focusses on outlining common ground that themes share, highlighting critical features, and exploring interesting points from the data. Through this, we hope researchers from multiple specialities may be better able to meet patients' needs, protect patients' psychosocial wellbeing, and optimise trial recruitment and retention, with direct positive impact on research time and cost efficiency.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 6","pages":"20542704231166621"},"PeriodicalIF":0.0,"publicationDate":"2023-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/48/bc/10.1177_20542704231166621.PMC10262634.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10301156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JRSM OpenPub Date : 2023-06-01DOI: 10.1177/20542704231183266
Ida Ringsing Nielsen, Patricia Almine Skat-Rørdam, Ivan Werner Jensen
{"title":"Diabetic ketoacidosis in a patient known with Gitelman syndrome.","authors":"Ida Ringsing Nielsen, Patricia Almine Skat-Rørdam, Ivan Werner Jensen","doi":"10.1177/20542704231183266","DOIUrl":"https://doi.org/10.1177/20542704231183266","url":null,"abstract":"<p><p>Gitelman syndrome is a rare hereditary nephropathy, which causes chronic metabolic alkalosis with low potassium and magnesium levels. There is no known coherence between Gitelman syndrome and Type-1 diabetes but patients with both diseases that develop diabetic ketoacidosis might present with normal acid status and receive incorrect treatment. In our case report the patient was known with both diseases and quickly diagnosed and treated but the condition is rare and previously only described in two other case reports.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 6","pages":"20542704231183266"},"PeriodicalIF":0.0,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/63/a7/10.1177_20542704231183266.PMC10280783.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10298518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JRSM OpenPub Date : 2023-05-01DOI: 10.1177/20542704231166620
Joel Lexchin
{"title":"Prediction of therapeutic value of new drugs approved by health Canada from 2011-2020: A cross-sectional study.","authors":"Joel Lexchin","doi":"10.1177/20542704231166620","DOIUrl":"https://doi.org/10.1177/20542704231166620","url":null,"abstract":"<p><strong>Objectives: </strong>To examine whether a combination of three characteristics of new drugs - review type, outcome of premarket trials (surrogate or clinical) and first-in-class is associated with significant therapeutic value.</p><p><strong>Design: </strong>Cross-sectional analysis of new drugs approved by Health Canada from January 1, 2011 to December 31, 2020.</p><p><strong>Setting: </strong>Canada.</p><p><strong>Participants: </strong>New drugs approved by Health Canada for which therapeutic evaluations, trial outcomes and first-in-class status was available.</p><p><strong>Main outcome measures: </strong>Distribution of therapeutic value (major, moderate, little to no) depending on how many of the three characteristics were present for each drug.</p><p><strong>Results: </strong>Health Canada approved 340 drugs of which 243 had data available for analysis. If all three characteristics were present 10 out of the 20 drugs had a major therapeutic rating. Conversely if none were present only 2 drugs out of 37 had a major therapeutic rating.</p><p><strong>Conclusion: </strong>This study introduces a new evaluation method for determining whether new drugs will have major therapeutic value that appears to be more successful than relying only on the type of review that drugs receive.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 5","pages":"20542704231166620"},"PeriodicalIF":0.0,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/93/58/10.1177_20542704231166620.PMC10225954.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10301606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JRSM OpenPub Date : 2023-04-01DOI: 10.1177/20542704231166619
Ava Robertson, Sarah Steele
{"title":"A cross-sectional survey of English NHS Trusts on their uptake and provision of active bystander training including to address sexual harassment.","authors":"Ava Robertson, Sarah Steele","doi":"10.1177/20542704231166619","DOIUrl":"https://doi.org/10.1177/20542704231166619","url":null,"abstract":"<p><strong>Objective: </strong>Reports identify that sexual harassment is troublingly pervasive in the NHS. Active bystander training (ABT) has been promoted to address sexual harassment, alongside other forms of poor behaviour, discrimination, and harassment. We explore ABT across all English NHS Trusts and determine whether the programmes address sexual misconduct in the training content.</p><p><strong>Design: </strong>Freedom of Information requests asking whether Trusts offer ABT, and if so, about the programme content and delivery, and to NHS England on centrally commissioned ABT.</p><p><strong>Setting: </strong>213 NHS Trusts in England, and NHS England.</p><p><strong>Participants: </strong>Not applicable.</p><p><strong>Main outcome measure: </strong>Provision of ABT, and presence of sexual harassment content in the training.</p><p><strong>Results: </strong>199 Trusts responded by August 2022. Of these, 35 Trusts provide ABT, the majority of which deliver content that is not specific to sexual misconduct, are in London, outsource training using private providers, and only provide workshops on an opt-in basis. One Trust offers a standalone ABT module on sexual harassment. Private providers prohibit Trusts from sharing training material, inhibiting content analysis and evaluation. Among the 163 Trusts without ABT programmes, only 23 (13%) have plans to implement training.</p><p><strong>Conclusions: </strong>ABT is underutilised in the NHS, despite being identified as an effective intervention in other settings like the military, higher education, and government workplaces. Studies should explore whether wider NHS adoption is warranted. Robust monitoring and evaluation processes are critical to strengthening the available literature regarding the effectiveness of ABT in the healthcare context and engaging in global knowledge sharing across health systems.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 4","pages":"20542704231166619"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10164257/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10644901","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JRSM OpenPub Date : 2023-04-01DOI: 10.1177/20542704231155815
Leah Hawkins, Jack Gibbs, Connor MacMillan
{"title":"Secondary haemophagocytic lymphohistiocytosis vs methotrexate toxicity - a diagnostic conundrum.","authors":"Leah Hawkins, Jack Gibbs, Connor MacMillan","doi":"10.1177/20542704231155815","DOIUrl":"https://doi.org/10.1177/20542704231155815","url":null,"abstract":"<p><p>A 74-year-old female with a background of rheumatoid arthritis, managed with weekly methotrexate, was admitted with; oedema, dyspnoea, cachexia and jaundice. Bloods revealed pancytopenia, hyperferritinaemia, hyperbilirubinaemia, hypoalbuminaemia and hypofolataemia. Imaging showed a large right-sided pleural effusion, requiring therapeutic aspiration, and splenomegaly. Bone marrow aspirate revealed haemophagocytosis. Differential diagnoses included methotrexate toxicity (MTXT) and haemophagocytic lymphohistiocytosis (HLH). Management was initiated for MTXT whilst ongoing investigation for possible HLH continued.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 4","pages":"20542704231155815"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5c/db/10.1177_20542704231155815.PMC10084538.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9305146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JRSM OpenPub Date : 2023-04-01DOI: 10.1177/20542704231159601
Kiran Prabhu, Marc Woodman
{"title":"Area postrema syndrome: Intractable hiccups and vomiting as a result of neuromyelitis Optica Spectrum disorder.","authors":"Kiran Prabhu, Marc Woodman","doi":"10.1177/20542704231159601","DOIUrl":"https://doi.org/10.1177/20542704231159601","url":null,"abstract":"<p><p>A 31 year old woman was referred to the medical team for further investigation of intractable hiccups and vomiting. Initial investigations including blood tests, endoscopy and CT imaging did not identify any cause of symptoms. Following multidisciplinary team review, serial MRI Head imaging was arranged, which revealed progressive posterior fossa signal abnormality with involvement of the area postrema. In combination with a positive serum Aquaporin-4 antibody result, this helped establish a diagnosis of Neuromyelitis Optica Spectrum Disorder (NMOSD). Treatment included high dose steroids, plasma exchange and immunomodulatory therapy, and led to a marked improvement in symptoms. This case highlights the importance of utilising specialty team input and broadening lines of investigation, when managing patients with intractable hiccups and vomiting in whom an initial workup has not established a clear diagnosis. While NMOSD is rare, early identification can inform treatment strategies that may lead to a significant improvement in clinical outcome.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 4","pages":"20542704231159601"},"PeriodicalIF":0.0,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/09/bf/10.1177_20542704231159601.PMC10084536.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9310156","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JRSM OpenPub Date : 2023-03-07eCollection Date: 2023-03-01DOI: 10.1177/20542704231153562
Ahmed Mohamed, Mark Yao, Sonia Saw, Amanda Clark, Sanjeev Madaan
{"title":"Collision metastasis from prostate adenocarcinoma and pancreatic ductal adenocarcinoma to a lung nodule.","authors":"Ahmed Mohamed, Mark Yao, Sonia Saw, Amanda Clark, Sanjeev Madaan","doi":"10.1177/20542704231153562","DOIUrl":"10.1177/20542704231153562","url":null,"abstract":"<p><strong>Introduction: </strong>Prostate cancer and pancreatic cancer are often complex pathologies that affect millions of patients worldwide. However, the incidence of a distant collision metastasis of both malignancies remains a rare and often poorly documented incidence.</p><p><strong>Case presentation: </strong>A 75-year-old male patient with past history of prostate cancer on maximal androgen blockade was recently diagnosed with pancreatic cancer for which he underwent radical surgical resection of pancreas with curative intent. A metastatic lung nodule was noted on surveillance CT imaging and, subsequently, biopsied. A diagnosis of collision metastasis from two distinct primary malignancies was histopathologically confirmed following immunohistochemical evaluation.</p><p><strong>Conclusion: </strong>We report the first case of collision metastasis of prostate and pancreatic adenocarcinomata to a lung nodule to the best of our knowledge.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 3","pages":"20542704231153562"},"PeriodicalIF":0.0,"publicationDate":"2023-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d4/0c/10.1177_20542704231153562.PMC9996729.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9471673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JRSM OpenPub Date : 2023-03-06eCollection Date: 2023-03-01DOI: 10.1177/20542704231153563
Rachel Davies, Alex F Martin, Louise E Smith, Fiona Mowbray, Lisa Woodland, Richard Amlôt, G James Rubin
{"title":"The impact of \"freedom day\" on COVID-19 health protective behaviour in England: An observational study of hand hygiene, face covering use and physical distancing in public spaces pre and post the relaxing of restrictions.","authors":"Rachel Davies, Alex F Martin, Louise E Smith, Fiona Mowbray, Lisa Woodland, Richard Amlôt, G James Rubin","doi":"10.1177/20542704231153563","DOIUrl":"10.1177/20542704231153563","url":null,"abstract":"<p><strong>Objectives: </strong>To study the prevalence of COVID-19 health protective behaviours before and after rules eased in England on the 19<sup>th</sup> July 2021.</p><p><strong>Design: </strong>Observational study pre (12<sup>th</sup>-18<sup>th</sup> July) and post (26<sup>th</sup> July-1<sup>st</sup> August) 19<sup>th</sup> July, and a cross-sectional online survey (26<sup>th</sup> to 27<sup>th</sup> July).</p><p><strong>Setting: </strong>Observations occurred in supermarkets (n = 10), train stations (n = 10), bus stops (n = 10), a coach station (n = 1) and a London Underground station (n = 1). The survey recruited a nationally representative sample.</p><p><strong>Participants: </strong>All adults entering the observed locations during a one-hour period (n = 3819 pre- and n = 2948 post-19<sup>th</sup> July). In the online survey, 1472 respondents reported having been shopping for groceries/visited a pharmacy and 566 reported having used public transport or having been in a taxi/minicab in the last week.</p><p><strong>Main outcome measures: </strong>We observed whether people wore a face covering, maintained distance from others and cleaned their hands. We investigated self-reports of wearing a face covering while in shops or using public transport.</p><p><strong>Results: </strong>In most locations observed, the proportion of people wearing face coverings, cleaning the hands and maintaining physical distance declined post 19th July. Pre 19<sup>th</sup> July, 70.2% (95% CI 68.7 to 71.7%) of people were observed to be wearing a face covering versus 55.8% (54.2 to 57.9%) post 19<sup>th</sup> July. Equivalent rates for physical distancing were 40.9% (39.0 to 42.8%) versus 29.5% (27.4 to 31.7%), and for hand hygiene were 4.4% (3.8 to 5.1%) versus 3.9% (3.2 to 4.6%). Self-reports of \"always\" wearing face coverings were broadly similar to observed rates.</p><p><strong>Conclusions: </strong>Adherence to protective behaviours was sub-optimal and declined during the relaxation of restrictions, despite appeals to exercise caution. Self-reports of \"always\" wearing a face covering in specific locations appear valid.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 3","pages":"20542704231153563"},"PeriodicalIF":0.0,"publicationDate":"2023-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/31/80/10.1177_20542704231153563.PMC9989406.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9087545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JRSM OpenPub Date : 2023-02-08eCollection Date: 2023-02-01DOI: 10.1177/20542704231153529
Matthew Dunckley, Frank Smedley, Brian Andrews
{"title":"Acute subcutaneous emphysema: A rare clinical presentation of large bowel perforation.","authors":"Matthew Dunckley, Frank Smedley, Brian Andrews","doi":"10.1177/20542704231153529","DOIUrl":"10.1177/20542704231153529","url":null,"abstract":"<p><p>These atypical presentations of colonic perforation illustrate the importance of considering acute intra-abdominal pathology when subcutaneous emphysema is identified.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 2","pages":"20542704231153529"},"PeriodicalIF":0.0,"publicationDate":"2023-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a8/ad/10.1177_20542704231153529.PMC9912557.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10707041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
JRSM OpenPub Date : 2023-02-06eCollection Date: 2023-02-01DOI: 10.1177/20542704221148059
Othmane Bourouail, Noureddine Njoumi, Youssef Elmahdaouy, Mohamed Fahssi, Mbarek Yaka, Abderrahmane Hejjouji, Abdelmounaim Ait Ali
{"title":"Long recurrence-free survival of localized rectal melanoma after abdominoperineal resection in comparison to partial excision and highlighting the place of immunotherapy: A case report.","authors":"Othmane Bourouail, Noureddine Njoumi, Youssef Elmahdaouy, Mohamed Fahssi, Mbarek Yaka, Abderrahmane Hejjouji, Abdelmounaim Ait Ali","doi":"10.1177/20542704221148059","DOIUrl":"10.1177/20542704221148059","url":null,"abstract":"<p><p>Rectal malignant melanomas (RMM) are remarkably uncommon, the rectal location represents less than one percent of all rectal cancer. Because of its low global survival rate, the surgical strategy is a subject of controversy for attaining a r0 resection. the palliative treatment is also debateable, but recently; radiotherapy and immunotherapy became the preferred treatment and offer the best outcome. to ensure r0 resection, abdominoperineal resection (apr) is considered the main surgical option, but because of its morbidity and functional limitations, local excision techniques such as endoscopic mucosal resection (emr) combined with chemoradiotherapy are being increasingly performed to preserve the quality of life and reduce local recurrence rate. In this report, we evaluate the place that apr still keeps as surgical procedure in comparison to partial excision. we report a case of a 72 years old patient, who presented rectal syndrome with rectorrhagia for 2 months, the diagnosis of localized rectal melanoma was confirmed by endoscopy, magnetic resonance imaging, histological analysis tissue with immunohistochemistry. the procedure strategy was a surgical treatment with apr. After a long recurrence-free survival period, the patient develops local recurrence and immunotherapy-resistant metastasis.</p>","PeriodicalId":17674,"journal":{"name":"JRSM Open","volume":"14 2","pages":"20542704221148059"},"PeriodicalIF":0.0,"publicationDate":"2023-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/e0/3f/10.1177_20542704221148059.PMC9905026.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9410360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}