3 results
Pilot study of a ketogenic diet in bipolar disorder
- Nicole Needham, Iain H. Campbell, Helen Grossi, Ivana Kamenska, Benjamin P. Rigby, Sharon A. Simpson, Emma McIntosh, Pankaj Bahuguna, Ben Meadowcroft, Frances Creasy, Maja Mitchell-Grigorjeva, John Norrie, Gerard Thompson, Melissa C. Gibbs, Ailsa McLellan, Cheryl Fisher, Tessa Moses, Karl Burgess, Rachel Brown, Michael J. Thrippleton, Harry Campbell, Daniel J. Smith
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- Journal:
- BJPsych Open / Volume 9 / Issue 6 / November 2023
- Published online by Cambridge University Press:
- 10 October 2023, e176
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Background
Recent evidence from case reports suggests that a ketogenic diet may be effective for bipolar disorder. However, no clinical trials have been conducted to date.
AimsTo assess the recruitment and feasibility of a ketogenic diet intervention in bipolar disorder.
MethodEuthymic individuals with bipolar disorder were recruited to a 6–8 week trial of a modified ketogenic diet, and a range of clinical, economic and functional outcome measures were assessed. Study registration number: ISRCTN61613198.
ResultsOf 27 recruited participants, 26 commenced and 20 completed the modified ketogenic diet for 6–8 weeks. The outcomes data-set was 95% complete for daily ketone measures, 95% complete for daily glucose measures and 95% complete for daily ecological momentary assessment of symptoms during the intervention period. Mean daily blood ketone readings were 1.3 mmol/L (s.d. = 0.77, median = 1.1) during the intervention period, and 91% of all readings indicated ketosis, suggesting a high degree of adherence to the diet. Over 91% of daily blood glucose readings were within normal range, with 9% indicating mild hypoglycaemia. Eleven minor adverse events were recorded, including fatigue, constipation, drowsiness and hunger. One serious adverse event was reported (euglycemic ketoacidosis in a participant taking SGLT2-inhibitor medication).
ConclusionsThe recruitment and retention of euthymic individuals with bipolar disorder to a 6–8 week ketogenic diet intervention was feasible, with high completion rates for outcome measures. The majority of participants reached and maintained ketosis, and adverse events were generally mild and modifiable. A future randomised controlled trial is now warranted.
VP75 Improving Access To Ultra-Orphan Medicines In NHS Scotland
- Noreen Downes, Jan Jones, Anne Lee, Ailsa Brown, Pauline McGuire, Helen Wright
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- Journal:
- International Journal of Technology Assessment in Health Care / Volume 35 / Issue S1 / 2019
- Published online by Cambridge University Press:
- 31 December 2019, p. 93
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Introduction
Medicines for very rare conditions present challenges for healthcare globally due to uncertain evidence and often extremely high costs. In 2014, SMC introduced an ultra-orphan framework placing less emphasis on the cost per quality adjusted life year (QALY). Despite this, many medicines continued to be not recommended. A new pathway aimed at improved patient access based on further evidence collection is now being implemented.
MethodsThe development of the new pathway has involved collaboration with key stakeholders including patient groups, the pharmaceutical industry, and clinicians. Medicines that meet a new definition (based on four criteria including the prevalence of the condition treated) will be appraised by the SMC committee and a data collection plan will then be agreed with the pharmaceutical company.
ResultsFrom April 2019, medicines validated as ultra-orphans will initially be appraised using the broader decision-making framework and the SMC committee will outline key uncertainties in the clinical effectiveness. The medicine will then be available for a period of at least three years while further data are gathered, potentially comprising ongoing clinical trials, registry data, and patient reported outcome measures. SMC will then re-assess the clinical and economic evidence to inform a final decision on routine use of the medicine in NHS Scotland.
ConclusionsThe new pathway for ultra-orphan medicines will allow further evidence on their longer-term clinical benefits to be collected before a final decision on routine use. This approach reflects the current direction of travel in medicines regulation, by making medicines that address an unmet need available to patients at an earlier stage of development.
Exit Polling in Canada: An Experiment
- Steven D. Brown, David Docherty, Ailsa Henderson, Barry Kay, Kimberly Ellis-Hale
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- Journal:
- Canadian Journal of Political Science/Revue canadienne de science politique / Volume 39 / Issue 4 / December 2006
- Published online by Cambridge University Press:
- 18 December 2006, pp. 919-933
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Abstract. Although exit polling has not been used to study Canadian elections before, such polls have methodological features that make them a potentially useful complement to data collected through more conventional designs. This paper reports on an experiment with exit polling in one constituency in the 2003 Ontario provincial election. Using student volunteers, a research team at Wilfrid Laurier University conducted an exit poll in the bellwether constituency of Kitchener Centre to assess the feasibility of mounting this kind of study on a broader scale. The experiment was successful in a number of respects. It produced a sample of 653 voters that broadly reflected the partisan character of the constituency, and which can hence be used to shed light on patterns of vote-switching and voter motivations in that constituency. It also yielded insights about best practices in mounting an exit poll in the Ontario context, as well as about the potential for using wireless communication devices to transmit respondent data from the field. The researchers conclude that exit polling on a limited basis (selected constituencies) is feasible, but the costs and logistics associated with this methodology make a province-wide or country-wide study unsupportable at present.
Résumé. Bien que les sondages “sortie des urnes” n'aient pas été utilisés jusqu'ici dans l'étude des élections au Canada, de tels sondages possèdent certaines caractéristiques qui en font un complément potentiellement très utile des méthodes plus traditionnelles de cueillette des données. Cet article rend compte d'un sondage “sortie des urnes” expérimental effectué dans une circonscription lors de l'élection provinciale de 2003 en Ontario. Utilisant des bénévoles étudiants, une équipe de recherche de l'Université Wilfrid Laurier a conduit un sondage “sortie des urnes” à Kitchener Centre, une circonscription indicatrice de tendance, afin de déterminer la faisabilité de ce type d'étude au niveau fédéral. L'expérience a réussi à plusieurs égards. Elle a fourni un échantillon de 653 électeurs qui reflétaient en gros le caractère partisan de la circonscription, ce qui a rendu possible l'étude des motivations des électeurs et des revirements de vote dans la région. L'expérience a aussi fourni des renseignements sur les pratiques exemplaires concernant l'utilisation des sondages “sortie des urnes” au niveau provincial, ainsi que sur la possibilité d'employer des techniques de communication sans fil pour transmettre les données recueillies des répondants. Les chercheurs ont conclu que les sondages “sortie des urnes” sont réalisables dans un cadre restreint, dans certaines circonscriptions sélectionnées, mais que les coûts et la logistique nécessités par cette méthodologie la rendent actuellement impraticable pour une étude à l'échelle provinciale ou nationale.