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The Efficacy of Self-Management Strategies for Females with Endometriosis: a Systematic Review.
Mardon, AK, Leake, HB, Hayles, C, Henry, ML, Neumann, PB, Moseley, GL, Chalmers, KJ
Reproductive sciences (Thousand Oaks, Calif.). 2023;30(2):390-407
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Endometriosis is a gynaecological condition with symptoms of pelvic pain, fatigue, and stress. Decreased quality of life, impaired fertility and hinderances to carry out day to day tasks are all associated with endometriosis. Treatment options involve medications and surgery; however, both are associated with poorer outcomes than the initial disease itself. Self-management strategies that the individual can perform themselves, such as lifestyle changes, meditation, and rest have all been used to improve the quality of life of individuals with endometriosis, however their effectiveness has not been determined. This systematic review and meta-analysis aimed to determine the effectiveness of self-management strategies for the management of endometriosis. The study showed that many self-management strategies were no more effective than placebo or hormonal therapies for the management of endometriosis. It was concluded that many self-management strategies were no more effective than hormonal treatment at reducing endometriosis symptoms and the studies that did show a benefit were insufficient to base recommendations on due to poor design. This study could be used by healthcare professionals to understand that currently the research on self-management strategies of endometriosis is poor and whilst some may be of benefit to individuals who cannot or do not want to take hormone therapy, more research is warranted.
Expert Review
Conflicts of interest:
None
Take Home Message:
It is not possible to generalise the findings of this systematic review for the self-management of endometriosis due to the poor quality of evidence. Further studies of higher quality are needed.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
Endometriosis is an inflammatory condition where endometrial-like tissue is found outside of the uterus. Diagnosis of endometriosis is made in around 6-10% of females of reproductive age. Endometriosis can adversely affect fertility, psychological well being and quality of life (QoL). Conventional interventions can have side effects and limited effectiveness. The aim of this systematic review (SR) was to evaluate the efficacy of self-management interventions for pain-related symptoms and QoL.
Methods
Fifteen experimental studies were included in this SR. Ten evaluated dietary supplements, three evaluated dietary modifications, one evaluated over-the-counter (OTC) medication, and one evaluated exercise. Outcome measures were self-reported for dysmenorrhoea, dyspareunia, overall pain, non-menstrual pelvic pain, use of medications and QoL.
Results
- Most dietary supplements were no more effective than placebo or frequently recommended medical interventions, at reducing pain-related outcomes.
- Melatonin (one RCT n=30) performed better than placebo for managing dysmenorrhoea and overall pain but not for non-menstrual pelvic pain. PEA-transploydatin (one RCT n=20) performed better than placebo for dysmenorrhoea and non-menstrual pelvic pain but not better than medical intervention.
- Resveratrol (one RCT n=22 & one intervention study n=12) plus the oral contraceptive pill (OCP) was more effective than the OCP alone for managing dysmenorrhoea.
- In one observational study, 75% of participants (n=295) reported a reduction in ‘high’ intensity pain scores following a 12-month gluten-free diet (p- value =<0.005). Similarly, a full dietary modification (one non randomised controlled trial , n=30) found less participants reporting pain at ‘high intensity’ (18%) compared to linseed and calcium oil supplements (41%) and placebo (62%).
- A metal trace element supplement was more effective than placebo for managing overall pain (one RCT p- value<0.001).
- Naproxen (one cross over trial, n=11) performed better than placebo at managing dysmenorrhoea (83% vs 41%, p- value 0.008).
- Hatha yoga (one RCT n=12) was found to be effective at reducing overall pain and improving QoL compared to no yoga (p-value <0.05).
Conclusion
Due to limited, low-quality evidence, high risk of bias and high levels of heterogeneity between studies, it was not possible to generalise the findings of the studies included in this systematic review. Further research of high-quality is needed in order to make self-management recommendations for females with endometriosis.
Notes: The authors reported no conflicts of interest.
Clinical practice applications:
Evidence-based self-management interventions are considered critical for the management of endometriosis. However, the quality of evidence in this SR was considered of poor quality. Further high-quality research is needed in order to be able to make recommendations. Strategies that showed potential benefits included:
- Dietary modifications and a gluten-free diet may be effective for reducing the intensity of pain associated with endometriosis.
- Hatha yoga may be effective at reducing overall pain and supporting psychological wellbeing and QoL.
Considerations for future research:
High quality studies are needed as well as a ‘gold standard’ definition for self-management criteria. Understanding potential barriers to self-management interventions may also be beneficial.
Abstract
Self-management is critical for the care of endometriosis. Females with endometriosis frequently use self-management strategies to manage associated symptoms; however, the efficacy of such strategies is unknown. The aim of this review was to systematically appraise the evidence concerning efficacy of self-management strategies for endometriosis symptoms. Electronic databases, including Medline, Embase, Emcare, Web of Science Core Collection, Scopus, and the Cochrane Central Register of Controlled Trials, were searched from inception to March 2021. We included peer-reviewed experimental studies published in English evaluating the efficacy of self-management strategies in human females laparoscopically diagnosed with endometriosis. Studies underwent screening, data extraction, and risk of bias appraisal (randomised studies: Risk of Bias 2 tool; non-randomised studies: Risk Of Bias In Non-randomized Studies - of Interventions tool). Of the fifteen studies included, 10 evaluated dietary supplements, three evaluated dietary modifications, one evaluated over-the-counter medication, and one evaluated exercise. Most studies had a high-critical risk of bias. Many self-management strategies were not more effective at reducing endometriosis symptoms compared to placebo or hormonal therapies. Where studies suggest efficacy for self-management strategies, no recommendations can be made due to the poor quality and heterogeneity of evidence. High-quality empirical evidence is required to investigate the efficacy of self-management strategies for females with endometriosis.
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Systematic review and meta-analysis of candidate gene association studies of benign prostate hyperplasia.
Lin, L, Li, P, Liu, X, Xie, X, Liu, L, Singh, AK, Singh, HN
Systematic reviews. 2022;11(1):60
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Benign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate which can cause urinary dysfunction and may affect the quality of life of patients. Polymorphism in several genes has been linked to the high susceptibility of BPH. The aim of this study was to analyse genetic variations in important genes towards the susceptibility of BPH. This study is a systematic review and meta-analysis of twenty-three case-control studies (11 for CYP17 [gene], 10 for VDR - vitamin D receptor [a member of the steroid/ thyroid hormone receptor family] and 4 for ACE - angiotensin-converting enzyme [component of the renin–angiotensin system] polymorphisms). The sample size in each study ranged from 20 to 588 participants. Results show that genetic polymorphism in the ACE gene was significantly associated with the risk of BPH when compared with control subjects. Whereas there was a negative association for the polymorphism located in VDR and CYP17 genes with the risk of BPH. Authors conclude that larger studies with prospective data and larger sample sizes are required.
Abstract
BACKGROUND Benign prostate hyperplasia (BPH) is the most common urological problem in elderly males. Recent studies have reported polymorphism in various metabolic genes in BPH. However, their association with the susceptibility of BPH is still inconsistent. Here, we systematically reviewed and performed a meta-analysis of CYP17, VDR, and ACE genes to determine their precise association with the risk of BPH. METHODS A comprehensive literature search for published studies on candidate gene associations involving vitamin D receptor (VDR), angiotensin-converting enzyme (ACE), and CYP17 genes with the risk of BPH was done up to April 2020 in PubMed, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and Google Scholar databases. Fixed/random effects models were used to estimate the odd's ratio (OR) and 95% confidence intervals (CIs). Begg's funnel plot was used to assess the potential for publication bias. RESULTS We found a total of 23 studies containing 3461 cases and 3833 controls for these gene polymorphisms. A significant association of ACE gene polymorphism was observed under the recessive (II vs. ID + DD) model for BPH susceptibility compared to control subjects (overall OR = 1.67, 95% CI = 1.03-2.73). Similar trends were observed for ACE gene polymorphism in Caucasian (OR = 6.18, 95% CI = 1.38-27.68) and Asian (OR = 1.42, 95% CI = 0.99-2.03) populations under study. No significant association was observed in VDR and CYP17 gene polymorphisms in any dominant or recessive models. CONCLUSION Significant OR demonstrated the implication of ACE gene polymorphism in the proliferation of prostate tissue, which in turn is associated with BPH susceptibility. However, prospective studies at large scale and sample size are needed to confirm the current findings.
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Menopause experience in First Nations women and initiatives for menopause symptom awareness; a community-based participatory research approach.
Sydora, BC, Graham, B, Oster, RT, Ross, S
BMC women's health. 2021;21(1):179
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Little research has been conducted about menopause in First Nations women. In response to the wishes of Cree women living in Maskwacis, Alberta, a community-based participatory research (CBPR) project was conducted to explore menopause experience and raise awareness of menopause symptoms in the community. Local women between the ages of 40–65 years were invited to participate in workshops, they also completed questionnaires. The five workshops included a total of 37, mostly post-menopausal women. The main discussion themes were: ‘experiences of menopause symptoms’ including their impact on quality of life; ‘menopause knowledge prior to their own experience’ with most women feeling that they had insufficient information before menopause; ‘menopause symptom management’ which mainly included practical strategies; ‘impact of menopause on family members’ which was of prime concern with uncontrollable mood changes affecting the whole family and sometimes causing matrimonial disharmony. These workshops identified a need for increasing menopause awareness, particularly for partners and other family members.
Abstract
BACKGROUND Little research has been conducted about menopause in First Nations women. In response to the wishes of Cree women living in Maskwacis, Alberta, to start a dialogue on menopause, we undertook community-based participatory research (CBPR) to explore menopause experience and raise awareness of menopause symptoms in the community. METHODS The research adhered to the principles of Ownership, Control, Access and Possession (OCAP™) and was guided by the interest of the participating women. Local women (target age 40-65 years) were invited to participate in workshops using word-of-mouth and community posters in health centers. Five research workshops were held in community settings, attended by experienced women's health researchers and consenting women. The participants guided the informal discussions. They also completed questionnaires which included menopause-related quality of life. The researchers used extensive hand-written field notes to record data; qualitative content analysis was applied to identify themes. Simple descriptive analysis was used for the questionnaire results. The findings were discussed at a community feedback session and laid the basis for further knowledge translation initiatives. RESULTS The five workshops included a total of 37, mostly post-menopausal women with 6-11 women/workshop. The main discussion themes were: "experiences of menopause symptoms" including their impact on quality of life; "menopause knowledge prior to their own experience" with most women feeling that they had insufficient information before menopause; "menopause symptom management" which mainly included practical strategies; "impact of menopause on family members" which was of prime concern with uncontrollable mood changes affecting the whole family and sometimes causing matrimonial disharmony. Questionnaire responses corroborated the workshop discussions. Knowledge translation of the research findings produced two information pamphlets specifically for the Maskwacis community: one for husband/partner, the other for women and family members. These pamphlets have been distributed in all areas of the community. CONCLUSION This CBPR project addressed a topic identified by the community as being important. Community members developed informative pamphlets in response to the women's concern of lack of understanding for menopause symptoms among families. This simple solution has been widely accepted by community members, opening the possibility of wider discussion about menopause.
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Total estimated usual nutrient intake and nutrient status biomarkers in women of childbearing age and women of menopausal age.
Devarshi, PP, Legette, LL, Grant, RW, Mitmesser, SH
The American journal of clinical nutrition. 2021;113(4):1042-1052
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Nutritional needs vary depending on the stage in a woman’s lifecycle. Women of child-bearing age (WCBA) and women of menopausal age (WMENO) are at high risk of not meeting required nutrient amounts, yet data is limited on nutrient intakes in these groups. This observational study of 4134 WCBA and 3438 WMENO aimed to determine any nutrient gaps and if associations exist between dietary intake and blood levels of key nutrients. The results showed that WCBA and WMENO had inadequate dietary intakes of calcium, magnesium, and vitamins A, C, D and E, which was allevaited by supplementation. Women who had lower levels of folate, vitamins D, B12 and essential fatty acids had lower dietary intakes of these nutrients, indicating a risk of deficiency. It was concluded that many women of WCBA and WMENO may have inadequate dietary nutrient intake and supplementation may improve this. This study could be used by healthcare professionals to understand that nutrient intakes may be inadequate in WCBA and WMENO. Dietary recommendations to increase nutrient intake would be advisable, however if individuals are still not meeting nutrient requirements, nutrient supplementation may be advisable.
Abstract
BACKGROUND Women of childbearing age (WCBA) and women of menopausal age (WMENO) have distinct nutritional needs. Understanding nutrient intake and status in these life stages is critical for tailoring dietary recommendations. OBJECTIVES The objectives of this study were to evaluate total estimated usual nutrient intakes from food and food plus supplements and to compare these to established recommendations for WCBA and WMENO life stages and examine associations between self-reported estimated usual intakes and nutrient status biomarkers. METHODS Twenty-four-hour dietary recall data from 2011-2016 NHANES were used to estimate usual intake of nutrients from food and food plus supplements for WCBA (aged 15-44 y, n = 4,134) and WMENO (aged 40-65 y, n = 3,438). Estimates of mean usual intake were derived and compared across clinically defined nutrient biomarker categories. RESULTS Both young (aged 15-30 y) and older (aged 31-44 y) WCBA had intakes from food below the Estimated Average Requirement (EAR) for calcium (49% and 44%, respectively), magnesium (62%, 44%), and vitamins A (50%, 44%), C (47%, 46%), D (>97%, >97%), and E (92%, 88%). Similarly, perimenopausal (aged 40-50 y) and menopausal (aged 51-65 y) women had intakes from food below the EAR for calcium (48% and 74%, respectively), magnesium (50%, 49%), and vitamins A (44%, 37%), C (44%, 41%), D (>97%, >97%), and E (88%, 86%). Nutrient gaps decreased with supplement usage. For folate, vitamins D and B-12, and DHA, women in the lowest biomarker category (indicating increased risk of deficiency) had significantly lower intake from food (315.2 ± 25.9 compared with 463.8 ± 5.2 µg dietary folate equivalents, 3.5 ± 0.1 compared with 4.2 ± 0.1 µg, 3.6 ± 0.2 compared with 4.3 ± 0.1 µg, and 0.037 ± 0.005 compared with 0.070 ± 0.006 g, respectively; P < 0.01) of the corresponding nutrient compared with the highest biomarker category. CONCLUSIONS Substantial percentages of WCBA and WMENO are not meeting recommendations for multiple nutrients, whereas supplement usage partially fills nutrient gaps. Dietary intake was positively associated with most nutrient status biomarkers. Specific guidance is needed to ensure adequate nutrient intakes and nutrient status during these critical life stages.
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Does weight-related stigmatisation and discrimination depend on educational attainment and level of income? A systematic review.
Bernard, M, Fankhänel, T, Riedel-Heller, SG, Luck-Sikorski, C
BMJ open. 2019;9(11):e027673
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Obesity is a global health issue due to its association with many chronic diseases, including type 2 diabetes, cardiovascular disease and certain cancers. Stigmatisation and discrimination against people with obesity has increased over the past few decades. According to the “Theory of class” a person’s “habitus”, that is their general attitude, lifestyle and even body shape, can be seen as a metaphor for social status. The aim of this systematic review of 17 studies was to investigate whether socioeconomic status is associated with “weight bias”, that is stigmatising and discriminating attitudes towards people with obesity. 11 of the 17 studies found a significant association between educational attainment and/or income with stigmatising and/or discriminatory attitudes, but results were mixed, with some studies showing that people with higher education and/or income level were more likely to display stigmatising and/or discriminating attitudes, whilst other studies showed the opposite. The authors conclude that the findings have to be discussed in the cultural context, including cultural and governmental differences.
Abstract
OBJECTIVES Obesity is considered a global health issue, because of its health-related consequences and also because of its impact on social status as a result of stigma. This study aims to review the quantitative state of research regarding socioeconomic characteristics' influence on weight-related stigmatisation and discrimination. Based on Bourdieu's Theory of Class and his concept of 'habitus', it is assumed that people with a higher level of education and income show stronger negative attitudes towards people with obesity. METHOD A narrative systematic literature review was conducted in 2017 using PubMed, PsychINFO, Web of Science and the Cochrane Library. Seventeen studies that measured weight bias and either educational attainment or level of income were included in the analysis. RESULTS The results of the studies included were inconsistent: six of these studies were found to support the hypothesis, whereas two of the studies contradicted it. The remaining seven studies did not show any significant correlation between weight bias and either education or income. CONCLUSION In light of the inconsistent and heterogeneous results of the studies that report a significant association between weight bias and socioeconomic variables, the findings must be discussed concerning their cultural context, that is, cultural and governmental differences. Furthermore, educational attainment seems to be more likely to predict weight bias than income. The review revealed a lack of research when it came to examining the impact of socioeconomic capital on weight bias.
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Patient understanding of two commonly used patient reported outcome measures for primary care: a cognitive interview study.
Murphy, M, Hollinghurst, S, Salisbury, C
BMC family practice. 2018;19(1):162
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Assessing the effectiveness of healthcare interventions from a patient perspective involves the use of patient-reported outcome measures (PROMs). The objective of this study was to test qualitatively, through cognitive interviews, two PROMs designed specifically for primary care: a PROM which uses a transitional scale and an individualised PROM. The study was conducted alongside a larger qualitative study. Patients were purposefully sampled to include both men and women, and a range of ages, conditions and ethnicities. The patients who were interviewed for the qualitative study were asked to complete two existing questionnaires designed to measure outcomes in primary care and the process of completion was assessed using cognitive interviews. The study results are in line with previous research findings that transitional instruments like the PEI are more difficult than status questionnaires for respondents to complete, because they require a greater number of internal calculations. Authors conclude that cognitive interviews should be an essential part of new measure development, to ensure the questions are understood consistently and are measuring the desired concept.
Abstract
BACKGROUND Standardised generic patient-reported outcome measures (PROMs) which measure health status are often unresponsive to change in primary care. Alternative formats, which have been used to increase responsiveness, include individualised PROMs (in which respondents specify the outcomes of interest in their own words) and transitional PROMs (in which respondents directly rate change over a period). The objective of this study was to test qualitatively, through cognitive interviews, two PROMs, one using each respective format. METHODS The individualised PROM selected was the Measure Yourself Medical Outcomes Profile (MYMOP). The transitional PROM was the Patient Enablement Instrument (PEI). Twenty patients who had recently attended the GP were interviewed while completing the questionnaires. Interview data was analysed using a modification of Tourangeau's model of cognitive processing: comprehension, response, recall and face validity. RESULTS Patients found the PEI simple to complete, but for some it lacked face validity. The transitional scale was sometimes confused with a status scale and was problematic in situations when the relevant GP appointment was part of a longer episode of care. Some patients reported a high enablement score despite verbally reporting low enablement but high regard for their GP, which suggested hypothesis-guessing. The interpretation of the PEI items was inconsistent between patients. MYMOP was more difficult for patients to complete, but had greater face validity than the PEI. The scale used was open to response-shift: some patients suggested they would recalibrate their definition of the scale endpoints as their illness and expectations changed. CONCLUSIONS The study provides information for both users of PEI/MYMOP and developers of individualised and transitional questionnaires. Users should heed the recommendation that MYMOP should be interview-administered, and this is likely to apply to other individualised scales. The PEI is open to hypothesis-guessing and may lack face-validity for a longer episode of care (e.g. in patients with chronic conditions). Developers should be cognisant that transitional scales can be inconsistently completed: some patients forget during completion that they are measuring change from baseline. Although generic questionnaires require the content to be more general than do disease-specific questionnaires, developers should avoid questions which allow broad and varied interpretations.
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Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.
Calvert, M, Kyte, D, Mercieca-Bebber, R, Slade, A, Chan, AW, King, MT, Hunn, A, Bottomley, A, Regnault, A, Chan, AW, et al
JAMA. 2018;319(5):483-494
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Clinical trial protocols are essential documents that describe the study design and conduct. The importance of patient-reported outcomes (PRO) has been recognized by major international health policy and regulatory authorities and patients. The aim of this study was to develop an evidence-based extension of the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 statement, identifying additional PRO items recommended for inclusion in clinical trial protocols (extensions), and to elaborate on the existing SPIRIT 2013 statement specifically as applied to PROs (elaborations). The study is a systematic review of existing PRO-specific protocol guidance. It also included a stake holder survey of a group of international experts, and a Delphi exercise and consensus meeting, followed by consultation on the final SPIRIT-PRO Extension. The final SPIRIT-PRO Extension recommends that, in conjunction with existing SPIRIT 2013 items, 16 items (11 extensions and 5 elaborations) should be routinely addressed in all clinical trial protocols in which PROs are a primary or key secondary outcome. Authors conclude that improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centred care.
Abstract
Importance: Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. Objective: To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). Design, Setting, and Participants: The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. Results: The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. Conclusions and Relevance: The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.
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Acceptability of a very-low-energy diet in Type 2 diabetes: patient experiences and behaviour regulation.
Rehackova, L, Araújo-Soares, V, Adamson, AJ, Steven, S, Taylor, R, Sniehotta, FF
Diabetic medicine : a journal of the British Diabetic Association. 2017;34(11):1554-1567
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Patients with type 2 diabetes can return to normal blood glucose levels through substantial weight loss. While many studies have addressed this, very few have assessed the effects of adherence to a very-low-energy diet (VLED) on patients’ quality of life. The aim of this study was to evaluate the experiences of adhering to VLED for patients in remission for type 2 diabetes. Fifteen participants were interviewed before and after the 8-week VLED intervention and narratives were analysed. This study identified common barriers, facilitators and strategies used by the participants. Overall, participants found adherence easier than anticipated, and found barriers to be offset by suggested behaviour-regulation strategies. Based on this study, the authors conclude dietary treatment for reversal of type 2 diabetes is acceptable and feasible in motivated patients, and suggest further controlled research be done to confirm the validity and applicability of these findings.
Abstract
AIMS: To evaluate the acceptability of an 8-week very-low-energy diet for remission of Type 2 diabetes, and to identify barriers and facilitators of adherence and behaviour-regulation strategies used by participants in the Counterbalance study. METHODS Eighteen of 30 participants in the Counterbalance study (ISRCTN88634530) took part in semi-structured interviews. Of these, 15 participants were interviewed before and after the 8-week very-low-energy diet intervention. Thematic analysis was used to analyse the narratives. RESULTS The prospect of diabetes remission, considerable weight loss, and long-term health improvement provided participants with substantial initial motivation. This motivation was sustained through the experience of rapid weight loss, improvements in blood glucose levels, social support and increased physical and psychological well-being. Overall, adherence to the very-low-energy diet for 8 weeks was perceived as much easier than anticipated, but required personal effort. Participants addressed challenges by removing food from the environment, planning, avoidance of tempting situations or places, and self-distraction. Weight loss and improvements in blood glucose levels lead to a sense of achievement and improvements in physical and psychological wellbeing. CONCLUSIONS Dietary treatment for reversal of Type 2 diabetes is acceptable and feasible in motivated participants, and the process is perceived as highly gratifying. Research outside of controlled trial settings is needed to gauge the generalisability of these findings.
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Therapist-supported Internet cognitive behavioural therapy for anxiety disorders in adults.
Olthuis, JV, Watt, MC, Bailey, K, Hayden, JA, Stewart, SH
The Cochrane database of systematic reviews. 2016;3:CD011565
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Previous research has supported the use of cognitive behavioural therapy (CBT) in the treatment of anxiety disorders, which is aimed at changing negative or unhealthy thinking patterns. Many individuals with anxiety find it challenging to get to CBT appointments and so an internet-based programme, with telephone and email support, has been developed. This systematic review of 38 randomised controlled trial studies aimed to assess the effects of internet CBT (ICBT) on anxiety symptoms and severity. The results showed that there was a clinically important improvement in anxiety alongside reductions in symptom severity and an increase in the patient’s quality of life (QoL) when following ICBT compared to no treatment or online support group discussions. When comparing supported ICBT and self-guided CBT there were no differences between anxiety symptom severity and QoL. When comparing ICBT and face to face therapist-supported CBT, no differences were reported in anxiety symptoms and QoL. It was concluded that ICBT is more beneficial than no treatment or online discussion groups and may be just as useful as face-to-face CBT. The number of studies that compared ICBT to self-guided CBT was limited and so specific conclusions were difficult to ascertain. This study could be used by healthcare professionals to understand that people suffering from anxiety may not be receiving the treatment they need for fears of new situations or leaving the house. In this instance ICBT is an alternative treatment that is just as beneficial as face-to-face therapy.
Abstract
BACKGROUND Cognitive behavioural therapy (CBT) is an evidence-based treatment for anxiety disorders. Many people have difficulty accessing treatment, due to a variety of obstacles. Researchers have therefore explored the possibility of using the Internet to deliver CBT; it is important to ensure the decision to promote such treatment is grounded in high quality evidence. OBJECTIVES To assess the effects of therapist-supported Internet CBT (ICBT) on remission of anxiety disorder diagnosis and reduction of anxiety symptoms in adults as compared to waiting list control, unguided CBT, or face-to-face CBT. Effects of treatment on quality of life and patient satisfaction with the intervention were also assessed. SEARCH METHODS We searched the Cochrane Depression, Anxiety and Neurosis Review Group Specialised Register (CCDANCTR) to 16 March 2015. The CCDANCTR includes relevant randomised controlled trials from MEDLINE, EMBASE, PsycINFO and CENTRAL. We also searched online clinical trial registries and reference lists of included studies. We contacted authors to locate additional trials. SELECTION CRITERIA Each identified study was independently assessed for inclusion by two authors. To be included, studies had to be randomised controlled trials of therapist-supported ICBT compared to a waiting list, attention, information, or online discussion group; unguided CBT (that is, self-help); or face-to-face CBT. We included studies that treated adults with an anxiety disorder (panic disorder, agoraphobia, social phobia, post-traumatic stress disorder, acute stress disorder, generalized anxiety disorder, obsessive compulsive disorder, and specific phobia) defined according to the Diagnostic and Statistical Manual of Mental Disorders III, III-R, IV, IV-TR or the International Classification of Disesases 9 or 10. DATA COLLECTION AND ANALYSIS Two authors independently assessed the risk of bias of included studies and judged overall study quality. We used data from intention-to-treat analyses wherever possible. We assessed treatment effect for the dichotomous outcome of clinically important improvement in anxiety using a risk ratio (RR) with 95% confidence interval (CI). For disorder-specific and general anxiety symptom measures and quality of life we assessed continuous scores using standardized mean differences (SMD). We examined statistical heterogeneity using the I(2) statistic. MAIN RESULTS We screened 1736 citations and selected 38 studies (3214 participants) for inclusion. The studies examined social phobia (11 trials), panic disorder with or without agoraphobia (8 trials), generalized anxiety disorder (5 trials), post-traumatic stress disorder (2 trials), obsessive compulsive disorder (2 trials), and specific phobia (2 trials). Eight remaining studies included a range of anxiety disorder diagnoses. Studies were conducted in Sweden (18 trials), Australia (14 trials), Switzerland (3 trials), the Netherlands (2 trials), and the USA (1 trial) and investigated a variety of ICBT protocols. Three primary comparisons were identified, therapist-supported ICBT versus waiting list control, therapist-supported versus unguided ICBT, and therapist-supported ICBT versus face-to-face CBT.Low quality evidence from 11 studies (866 participants) contributed to a pooled risk ratio (RR) of 3.75 (95% CI 2.51 to 5.60; I(2) = 50%) for clinically important improvement in anxiety at post-treatment, favouring therapist-supported ICBT over a waiting list, attention, information, or online discussion group only. The SMD for disorder-specific symptoms at post-treatment (28 studies, 2147 participants; SMD -1.06, 95% CI -1.29 to -0.82; I(2) = 83%) and general anxiety symptoms at post-treatment (19 studies, 1496 participants; SMD -0.75, 95% CI -0.98 to -0.52; I(2) = 78%) favoured therapist-supported ICBT; the quality of the evidence for both outcomes was low.One study compared unguided CBT to therapist-supported ICBT for clinically important improvement in anxiety at post-treatment, showing no difference in outcome between treatments (54 participants; very low quality evidence). At post-treatment there were no clear differences between unguided CBT and therapist-supported ICBT for disorder-specific anxiety symptoms (5 studies, 312 participants; SMD -0.22, 95% CI -0.56 to 0.13; I(2) = 58%; very low quality evidence) or general anxiety symptoms (2 studies, 138 participants; SMD 0.28, 95% CI -2.21 to 2.78; I(2) = 0%; very low quality evidence).Compared to face-to-face CBT, therapist-supported ICBT showed no significant differences in clinically important improvement in anxiety at post-treatment (4 studies, 365 participants; RR 1.09, 95% CI 0.89 to 1.34; I(2) = 0%; low quality evidence). There were also no clear differences between face-to-face and therapist supported ICBT for disorder-specific anxiety symptoms at post-treatment (7 studies, 450 participants; SMD 0.06, 95% CI -0.25 to 0.37; I(2) = 60%; low quality evidence) or general anxiety symptoms at post-treatment (5 studies, 317 participants; SMD 0.17, 95% CI -0.35 to 0.69; I(2) = 78%; low quality evidence).Overall, risk of bias in included studies was low or unclear for most domains. However, due to the nature of psychosocial intervention trials, blinding of participants and personnel, and outcome assessment tended to have a high risk of bias. Heterogeneity across a number of the meta-analyses was substantial, some was explained by type of anxiety disorder or may be meta-analytic measurement artefact due to combining many assessment measures. Adverse events were rarely reported. AUTHORS' CONCLUSIONS Therapist-supported ICBT appears to be an efficacious treatment for anxiety in adults. The evidence comparing therapist-supported ICBT to waiting list, attention, information, or online discussion group only control was low to moderate quality, the evidence comparing therapist-supported ICBT to unguided ICBT was very low quality, and comparisons of therapist-supported ICBT to face-to-face CBT were low quality. Further research is needed to better define and measure any potential harms resulting from treatment. These findings suggest that therapist-supported ICBT is more efficacious than a waiting list, attention, information, or online discussion group only control, and that there may not be a significant difference in outcome between unguided CBT and therapist-supported ICBT; however, this latter finding must be interpreted with caution due to imprecision. The evidence suggests that therapist-supported ICBT may not be significantly different from face-to-face CBT in reducing anxiety. Future research should explore heterogeneity among studies which is reducing the quality of the evidence body, involve equivalence trials comparing ICBT and face-to-face CBT, examine the importance of the role of the therapist in ICBT, and include effectiveness trials of ICBT in real-world settings. A timely update to this review is needed given the fast pace of this area of research.
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A brief patient-reported outcome instrument for primary care: German translation and validation of the Measure Yourself Medical Outcome Profile (MYMOP).
Hermann, K, Kraus, K, Herrmann, K, Joos, S
Health and quality of life outcomes. 2014;12:112
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Plain language summary
Patient-reported outcomes (PROs) are important tools for evaluating the effectiveness of patient-centred care. The Measure Yourself Medical Outcome Profile (MYMOP) is a short 4-item questionnaire which allows patients themselves to nominate up to two symptoms that are concerning them most, and to subjectively assess the change of these symptoms over time following a therapeutic intervention. The aim of this study was to translate the MYMOP from English into German and pilot its use in a primary care setting. 567 participants (476 patients from 34 general practices and 91 patients from 11 CAM practices) were included in this study and completed a MYMOP questionnaire as well as a quality of life questionnaire (called EQ-5D). Out of these, 341 patients (60.1%) completed follow-up questionnaires. 161 of the follow-up patients also rated the change of symptoms on direct questioning on a scale from “much better” to “much worse”. The validity of the German translation of the MYMOP was shown by a high correlation between MYMOP-D and EQ-5D and patient reported change of symptoms. Due to only a small number of patients reporting a worsening of symptoms, validity was only established for patients whose symptoms improved or stayed the same. The authors conclude that the MYMOP-D proved to be a valid tool for assessing patient-centred care and because of its brevity and simplicity, could easily be incorporated into primary health care settings.
Abstract
BACKGROUND Measure Yourself Medical Outcome Profile (MYMOP) is a patient-generated outcome instrument capable of measuring effects from a wide range of health care interventions. This paper reports the translation of this instrument into German (MYMOP-D) and the assessment of validity and sensitivity to change for the MYMOP-D. The instrument was piloted in a German primary care context. METHODS The translation process was conducted according to international guidelines. Recruited patients of both general practitioners and non-medical Complementary and Alternative Medicine (CAM) practitioners ("Heilpraktiker") in the German state of Baden-Wuerttemberg completed a questionnaire comprised of the MYMOP-D and the EQ-5D. Responses were analysed to assess construct validity. For assessing the instrument's sensitivity to change, patients received the MYMOP-D again after four weeks at which point they were also asked for their subjective views on change of symptoms. Correlation between MYMOP-D and EQ-5D and sensitivity to change as gradient in score change and as standardized response mean (SRM) were calculated. RESULTS 476 patients from general practices and 91 patients of CAM practitioners were included. Construct validity of the MYMOP-D was given with a correlation of r = .47 with the EQ-5D. Sensitivity to change for subjective change of symptoms could only be analysed for improvement or no change of symptoms, as only 12 patients reported deterioration of symptoms. Results showed the expected smooth gradient with 2.2, 1.3, and 0.5 points of change for large, little improvement and no change, respectively. SRM for MYMOP-D Profile Score was 0.88. CONCLUSIONS The MYMOP-D shows excellent construct validity. It is able to detect changes when symptoms in patients improve or remain unchanged. Deterioration of symptoms could not be evaluated due to too few data. With its brevity and simplicity, it might be an important tool for enhancing patient-centred care in the German health care context.