Service implications of the revised 2022 National Institute for Health and Care Excellence (NICE) follow-up guidelines for stage IA–IIC melanoma
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PROVIDER: S-EPMC10810063 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundThere is international concern that conflicts of interest (COI) may bias clinical guideline development and render it untrustworthy. Guideline COI policies exist with the aim of reducing this bias but it is not known how such policies are interpreted and used by guideline producing organisations. This study sought to determine how conflicts of interest (COIs) are disclosed and managed by a national clinical guideline developer (NICE: the UK National Institute for Health and Care Excellence).MethodsQualitative study using semi-structured telephone interviews with 14 key informants: 8 senior staff of NICE's guideline development centres and 6 chairs of guideline development groups (GDGs). We conducted a thematic analysis.ResultsParticipants regard the NICE COI policy as comprehensive leading to transparent and independent guidance. The application of the NICE COI policy is, however, not straightforward and clarity could be improved. Disclosure of COI relies on self reporting and guideline developers have to take "on trust" the information they receive, certain types of COI (non-financial) are difficult to categorise and manage and disclosed COI can impact on the ability to recruit clinical experts to GDGs. Participants considered it both disruptive and stressful to exclude members from GDG meetings when required by the COI policy. Nonetheless the impact of this disruption can be minimised with good group chairing skills.ConclusionsWe consider that the successful implementation of a COI policy in clinical guideline development requires clear policies and procedures, appropriate training of GDG chairs and an evaluation of how the policy is used in practice.
| S-EPMC4374927 | biostudies-literature
Project description:Colonoscopic polypectomy is effective in decreasing the incidence and mortality of colorectal cancer (CRC). Premalignant polyps discovered during colonoscopy are associated with the risk of metachronous advanced neoplasia. Postpolypectomy surveillance is the most important method for the management of advanced metachronous neoplasia. A more efficient and evidence-based guideline for postpolypectomy surveillance is required because of limited medical resources and concerns regarding colonoscopy complications. In these consensus guidelines, an analytic approach was used to address all reliable evidence to interpret the predictors of CRC or advanced neoplasia during surveillance colonoscopy. The key recommendations state that the high-risk findings for metachronous CRC following polypectomy are as follows: (1) adenoma ≥10 mm in size; (2) 3 to 5 (or more) adenomas; (3) tubulovillous or villous adenoma; (4) adenoma containing high-grade dysplasia; (5) traditional serrated adenoma; (6) sessile serrated lesion (SSL) containing any grade of dysplasia; (7) serrated polyp of at least 10 mm in size; and (8) 3 to 5 (or more) SSLs. More studies are needed to fully comprehend the patients most likely to benefit from surveillance colonoscopy and the ideal surveillance interval to prevent metachronous CRC.
| S-EPMC9726446 | biostudies-literature
Project description:Colonoscopic polypectomy is effective in decreasing the incidence and mortality of colorectal cancer (CRC). Premalignant polyps discovered during colonoscopy are associated with the risk of metachronous advanced neoplasia. Postpolypectomy surveillance is the most important method for managing advanced metachronous neoplasia. A more efficient and evidence-based guideline for postpolypectomy surveillance is required because of the limited medical resources and concerns regarding colonoscopy complications. In these consensus guidelines, an analytic approach was used to address all reliable evidence to interpret the predictors of CRC or advanced neoplasia during surveillance colonoscopy. The key recommendations state that the high-risk findings for metachronous CRC following polypectomy are as follows: adenoma ≥10 mm in size; 3 to 5 (or more) adenomas; tubulovillous or villous adenoma; adenoma containing high-grade dysplasia; traditional serrated adenoma; sessile serrated lesion containing any grade of dysplasia; serrated polyp of at least 10 mm in size; and 3 to 5 (or more) sessile serrated lesions. More studies are needed to fully comprehend the patients who are most likely to benefit from surveillance colonoscopy and the ideal surveillance interval to prevent metachronous CRC.
| S-EPMC9911266 | biostudies-literature
Project description:The UK's National Institute for Health and Care Excellence (NICE) is responsible for conducting health technology assessment (HTA) on behalf of the National Health Service (NHS). In seeking to justify its recommendations to the NHS about which technologies to fund, NICE claims to adopt two complementary ethical frameworks, one procedural-accountability for reasonableness (AfR)-and one substantive-an 'ethics of opportunity costs' (EOC) that rests primarily on the notion of allocative efficiency. This study is the first to empirically examine normative changes to NICE's approach and to analyse whether these enhance or diminish the fairness of its decision-making, as judged against these frameworks. It finds that increasing formalisation of NICE's approach and a weakening of the burden of proof laid on technologies undergoing HTA have together undermined its commitment to EOC. This implies a loss of allocative efficiency and a shift in the balance of how the interests of different NHS users are served, in favour of those who benefit directly from NICE's recommendations. These changes also weaken NICE's commitment to AfR by diminishing the publicity of its decision-making and by encouraging the adoption of rationales that cannot easily be shown to meet the relevance condition. This signals a need for either substantial reform of NICE's approach, or more accurate communication of the ethical reasoning on which it is based. The study also highlights the need for further empirical work to explore the impact of these policy changes on NICE's practice of HTA and to better understand how and why they have come about.
| S-EPMC7387327 | biostudies-literature
Project description:In the past several years, the science of health care improvement has advanced considerably. In this article, we describe the development of SQUIRE 2.0 and its key components. We undertook the revision between 2012 and 2015 using (1) interviews and focus groups to evaluate SQUIRE 1.0 plus feedback from an international steering group, (2) face-to-face consensus meetings to develop interim drafts, and (3) pilot testing with authors and a public comment period. SQUIRE 2.0 emphasizes 3 key components of systematic efforts to improve the quality, value, and safety of health care: formal and informal theory in planning, implementing, and evaluating improvement work; the context in which the work is done; and the study of the intervention(s). SQUIRE 2.0 is intended for reporting the range of methods used to improve health care, recognizing that they can be complex and multidimensional. It provides common ground to share these discoveries in the scholarly literature (www.squire-statement.org).
| S-EPMC4620592 | biostudies-literature
Project description:BackgroundReal world evidence (RWE) is becoming more frequently used in technology appraisals (TAs). This study sought to explore the use and acceptance of evidence from primary care databases, a key source of RWE in the UK, in National Institute for Health and Care Excellence (NICE) technology assessments and to provide recommendations regarding their use in future submissions.MethodsA keyword search was conducted relating to the main primary care databases in the UK on the NICE website. All NICE TAs identified through this search were screened, assessed for duplication and information on the data source and the way the data was used in the submission were extracted. Comments by the evidence review group (ERG) and the appraisal committee were also extracted and reviewed. All data extraction was performed by two independent reviewers and all decisions were reached by consensus with an additional third reviewer.ResultsA total of 52 NICE TAs were identified, 47 used the General Practice Research Database /Clinical Practice Research Datalink (GPRD/CPRD) database, 10 used The Health Improvement Network (THIN) database and 3 used the QResearch databases. Data from primary care databases were used to support arguments regarding clinical need and current treatment in 33 NICE TAs while 36 were used to inform input parameters for economic models. The databases were sometimes used for more than one purpose. The data from the three data sources were generally well received by the ERGs/committees. Criticisms of the data typically occurred where the results had been repurposed from a published study or had not been applied appropriately.ConclusionsThe potential of UK primary care databases in NICE submissions is increasingly being realised, particularly in informing the parameters of economic models. Purpose conducted studies are less likely to receive criticism from ERGs/committees, particularly when providing clinical input into cost effectiveness models.
| S-EPMC7374907 | biostudies-literature
Project description:IntroductionAneurysmal subarachnoid haemorrhage has a high incidence, and morbidity. It has been suggested that a negative non-contrast CT head can rule out SAH if performed within 6 h of symptom onset.Research questionWhat is the sensitivity of CT head at ruling out SAH stratified by time-point, and what is the potential impact of omitting Lumbar Puncture (LP) from the diagnostic pathway?Material and methodsSystematic review and meta-analysis (PROSPEROID CRD42022379929). Three databases were searched, and articles published between January 2000-May 2022 included (Search date 27th November 2022). Primary objective was diagnostic accuracy of CT scans for detecting SAH at <6 h from symptom onset, including reported sensitivity, and specificity values.Results63 articles were included (38,237 patients, 7673 with SAH). Pooled CT head sensitivity was 0.94 for excluding SAH (22 studies, 95% Confidence Interval [CI] 0.90-0.97). At <6 h, CT head sensitivity was 0.995 (6 studies, 95% CI 0.941-1.000). Most studies (57.1%, n = 36/63) were classified as high risk of bias. If LP was removed from the diagnostic pathway in the UK, assuming an incidence of 4800 SAH per-year, 336 SAH would be missed per-year, 24 per-year if LP was removed for negative CT < 6 h (95% CI 0-278) and 58 per-year if mean sensitivity is used (95% CI 0-240).Discussion and conclusionCT head appears to be highly sensitive at excluding SAH <6 h from symptom onset. High quality, prospective data is required to further established the utility of early (<6 h) negative CT head. We recommend that if there is strong clinical suspicion of SAH, yet CT head is reported negative <6 h of symptom onset, that a LP be performed.
| S-EPMC11872663 | biostudies-literature
Project description:More efficient and preferably more convenient and greener synthetic solutions in coumarin scaffold functionalization are in steady demand. The Duff ortho-formylation of unsubstituted umbelliferone was revised in this study. The reaction conditions were optimized based upon data from the literature analysis and resulted in unexpectedly rapid ortho-formylation of umbelliferone, yielding a mixture of ortho-formyl position isomers. Thorough studies on the separation of ortho-formylated umbelliferones using chromatographic and recrystallization methods as well as the evaluation of their solubility in common organic solvents led to complete resolution of 8-formyl- and 6-formylumbelliferones. The precise protocol for simultaneous preparation, extraction, and purification of 8-formyl- and 6-formylumbelliferones is provided, and the prospective studies of biological and pharmacological activities of these compounds are synopsized.
| S-EPMC8706561 | biostudies-literature
Project description: Not available
| S-EPMC10809909 | biostudies-literature
Project description:BackgroundThe National Institute for Health and Care Excellence (NICE) Technology Appraisal Guidance on spinal cord stimulation (SCS) was published in 2008 and updated in 2012 with no change. This guidance recommends SCS as a cost-effective treatment for patients with neuropathic pain.ObjectiveTo assess the impact of NICE guidance by comparing SCS uptake in England pre-NICE (2008-2009) and post-NICE (2009-2012) guidance. We also compared the English SCS uptake rate with that of Belgium, the Netherlands, France and Germany.DesignSCS implant data for England was obtained from the Hospital Episode Statistics (HES) database and compared with other European countries where comparable data were available.ResultsThe HES data showed small increases in SCS implantation and replacement/revision procedures, and a large increase in SCS trials between 2008 and 2012. The increase in the total number of SCS procedures per million of population in England is driven primarily by revision/replacements and increased trial activity. Marked variability in SCS uptake at both health regions and primary care trust level was observed.ConclusionsDespite the positive NICE recommendation for the routine use of SCS, we found no evidence of a significant impact on SCS uptake in England. Rates of SCS implantation in England are lower than many other European countries.
| S-EPMC3902463 | biostudies-literature