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L’évaluation des prises en charge non-médicamenteuses dans le cadre d’affections chroniques. Etudes interventionnelles basées sur des Protocoles Expérimentaux à Cas Unique.
Abstract
Les Interventions Non-Médicamenteuses (INM), et autres procédures qui peuvent leur être associées (Médecine Traditionnelle, Médecines Complémentaires et Alternatives), sont aujourd’hui d’une prépondérance à ne pas sous-estimer dans l’optique d’une santé intégrative. Une évaluation scientifique robuste est nécessaire afin de trier les pratiques néfastes ou inefficaces, de celles attestant de réels bénéfices. Dans ce domaine, les essais randomisés contrôlés (ERC) font loi, à un titre discutable du fait de leurs limites intrinsèques. Par le biais d’une revue systématique de littérature centrée sur les pratiques de manipulation corporelles comme soins de support proposés en oncologie, nous confirmons la difficulté qu’ont les ERCs de tirer des conclusions fermes et bien appuyées. Nous présentons alors une méthode interventionnelle différente et peu enseignée, les protocoles expérimentaux à cas unique, et proposons leur illustration à travers quatre études. Celles-ci portent sur l’évaluation de différentes interventions dans des contextes de maladies chroniques ou de problèmes de santé variables : 1) Jeu vidéo thérapeutique dans le cadre de la réadaptation physique de la maladie de Parkinson, 2) Intervention musicale en Soins Palliatifs, 3) Hypnose face aux restrictions hydriques de patients sous hémodialyse et 4) Séances de shiatsu face à la dysménorrhée primaire. Ces études rendent compte de résultats intéressants, et permettent de discuter des forces et faiblesses de cette méthode. Nous plaidons alors en sa faveur du fait de ses principes expérimentaux légitimes ainsi que son adéquation avec la pratique fondée sur la preuve. Nous profitons enfin de la faible qualité des études que nous avons menées pour dresser une liste de recommandations et d’écueils à considérer afin de les employer de façon optimale.
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Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.
This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.
The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.
The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits.
PurposeThis study aimed to investigate the use of non-conventional medicine (NCM) among long-term cancer survivors and its links with healthy behavior.Methods
This study used data from the VICAN survey, conducted in 2015–2016 on a representative sample of French cancer survivors 5 years after diagnosis.ResultsAmong the 4174 participants, 21.4% reported using NCM at the time of the survey, including 8.4% who reported uses not associated with cancer. The most frequently cited reasons for using NCM were to improve their physical well-being (83.0%), to strengthen their body (71.2%), to improve their emotional well-being (65.2%), and to relieve the side effects of treatment (50.7%). The NCM users who reported using NCM to cure cancer or prevent relapses (8.5% of the participants) also used NCM for other reasons. They had more often experienced cancer progression, feared a recurrence, and had a poorer quality of life because of sequelae, pain, and fatigue. They also consulted their general practitioners more frequently and had changed their lifestyle by adopting more healthy practices.Conclusion
The use of NCM is not an alternative but a complementary means of coping with impaired health. Further research is now required to determine whether the use of NCM reflects a lifestyle change or whether it assists survivors rather to make behavioral changes.Implications for Cancer SurvivorsThe use of NCM should alert physicians to survivors’ impaired quality of life. It might be useful to provide patients with NCM guidelines in order to inform their decision and to prevent unrealistic expectations.
Despite a major increase in the range and number of software offerings now available to help researchers produce evidence syntheses, there is currently no generic tool for producing figures to display and explore the risk‐of‐bias assessments that routinely take place as part of systematic review. However, tools such as the R programming environment and Shiny (an R package for building interactive web apps) have made it straightforward to produce new tools to help in producing evidence syntheses. We present a new tool, robvis (Risk‐Of‐Bias VISualization), available as an R package and web app, which facilitates rapid production of publication‐quality risk‐of‐bias assessment figures. We present a timeline of the tool’s development and its key functionality.
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A key component of treatment for all people with advanced kidney disease is supportive care, which aims to improve quality of life and can be provided alongside therapies intended to prolong life, such as dialysis. This article addresses the key considerations of supportive care as part of integrated end-stage kidney disease care, with particular attention paid to programs in low- and middle-income countries. Supportive care should be an integrated component of care for patients with advanced chronic kidney disease, patients receiving kidney replacement therapy (KRT), and patients receiving non-KRT conservative care. Five themes are identified: improving information on prognosis and support, developing context-specific evidence, establishing appropriate metrics for monitoring care, clearly communicating the role of supportive care, and integrating supportive care into existing health care infrastructures. This report explores some general aspects of these 5 domains, before exploring their consequences in 4 health care situations/settings: in people approaching end-stage kidney disease in high-income countries and in low- and middle-income countries, and in people discontinuing KRT in high-income countries and in low- and middle-income countries.
Methodological quality (risk of bias) assessment is an important step before study initiation usage. Therefore, accurately judging study type is the first priority, and the choosing proper tool is also important. In this review, we introduced methodological quality assessment tools for randomized controlled trial (including individual and cluster), animal study, non-randomized interventional studies (including follow-up study, controlled before-and-after study, before-after/ pre-post study, uncontrolled longitudinal study, interrupted time series study), cohort study, case-control study, cross-sectional study (including analytical and descriptive), observational case series and case reports, comparative effectiveness research, diagnostic study, health economic evaluation, prediction study (including predictor finding study, prediction model impact study, prognostic prediction model study), qualitative study, outcome measurement instruments (including patient - reported outcome measure development, content validity, structural validity, internal consistency, cross-cultural validity/ measurement invariance, reliability, measurement error, criterion validity, hypotheses testing for construct validity, and responsiveness), systematic review and meta-analysis, and clinical practice guideline. The readers of our review can distinguish the types of medical studies and choose appropriate tools. In one word, comprehensively mastering relevant knowledge and implementing more practices are basic requirements for correctly assessing the methodological quality.
Complementary medicines and therapies are popular forms of healthcare with a long history of traditional use. Yet, despite increasing consumer demand, there is an ongoing exclusion of complementary medicines from mainstream healthcare systems. A lack of evidence is often cited as justification. Until recently, high-quality evidence of treatment efficacy was defined as findings from well-conducted systematic reviews and meta-analyses of randomized controlled trials. In a recent and welcome move by the Oxford Centre for Evidence-Based Practice, however, the N-of-1 trial design has also been elevated to the highest level of evidence for treatment efficacy of an individual, placing this research design on par with the meta-analysis. N-of-1 trial designs are experimental research methods that can be implemented in clinical practice. They incorporate much of the rigor of group clinical trials, but are designed for individual patients. Individualizing treatment interventions and outcomes in research designs is consistent with the movement towards patient-centered care and aligns well with the principles of holism as practiced by naturopaths and many other complementary medicine practitioners. This paper explores whether rigorously designed and conducted N-of-1 trials could become a new ‘gold standard’ for demonstrating treatment efficacy for complementary medicine interventions in individual patients in clinical practice.
Health problems are often idiosyncratic in nature and therefore require individualized diagnosis and treatment. In this paper, we show how single-case experimental designs (SCEDs) can meet the requirement to find and evaluate individually tailored treatments. We give a basic introduction to the methodology of SCEDs and provide an overview of the available design options. For each design, we show how an element of randomization can be incorporated to increase the internal and statistical conclusion validity and how the obtained data can be analyzed using visual tools, effect size measures, and randomization inference. We illustrate each design and data analysis technique using applied data sets from the healthcare literature.
Background
Complementary and Alternative Medicines (CAM) are widely used by cancer patients, despite limited evidence of efficacy. Manipulative and body-based practices are some of the most commonly used CAM. This systematic review evaluates their benefits in oncology.
Method
A systematic literature review was carried out with no restriction of language, time, cancer location or type. PubMed, CENTRAL, PsycArticle, PsychInfo, Psychology and Behavioral Sciences Collection and SOCindex were queried. Inclusion criteria were adult cancer patients and randomized controlled trials (RCT) assessing manipulative and body-based complementary practices on psychological and symptom outcomes. Effect size was calculated when applicable.
Results
Of 1624 articles retrieved, 41 articles were included: massage (24), reflexology (11), acupressure (6). Overall, 25 studies showed positive and significant effects on symptom outcomes (versus 9 that did not), especially pain and fatigue. Mixed outcomes were found for quality of life (8 papers finding a significant effect vs. 10 which did not) and mood (14 papers vs. 13). In most studies, there was a high risk of bias with a mean Jadad score of 2, making interpretation of results difficult.
Conclusion
These results seem to indicate that manipulative CAM may be effective on symptom management in cancer. However, more robust methodologies are needed. The methodological requirements of randomized controlled trials are challenging, and more informative results may be provided by more pragmatic study design.
Quality standards for single-case experimental designs (SCEDs) recommend inspecting six data aspects: level, trend, variability, overlap, immediacy, and consistency of data patterns. The data aspect consistency has long been neglected by visual and statistical analysts of SCEDs despite its importance for inferring a causal relationship. However, recently a first quantification has been proposed in the context of A-B-A-B designs, called CONsistency of DAta Patterns (CONDAP). In the current paper, we extend the existing CONDAP measure for assessing consistency in designs with more than two successive A-B elements (e.g., A-B-A-B-A-B), multiple baseline designs, and changing criterion designs. We illustrate each quantification with published research.
The revised edition of the Handbook offers the only guide on how to conduct, report and maintain a Cochrane Review.
The second edition of The Cochrane Handbook for Systematic Reviews of Interventions contains essential guidance for preparing and maintaining Cochrane Reviews of the effects of health interventions. Designed to be an accessible resource, the Handbook will also be of interest to anyone undertaking systematic reviews of interventions outside Cochrane, and many of the principles and methods presented are appropriate for systematic reviews addressing research questions other than effects of interventions.
This fully updated edition contains extensive new material on systematic review methods addressing a wide-range of topics including network meta-analysis, equity, complex interventions, narrative synthesis, and automation. Also new to this edition, integrated throughout the Handbook, is the set of standards Cochrane expects its reviews to meet.
Written for review authors, editors, trainers and others with an interest in Cochrane Reviews, the second edition of The Cochrane Handbook for Systematic Reviews of Interventions continues to offer an invaluable resource for understanding the role of systematic reviews, critically appraising health research studies and conducting reviews.
Background:
Acupuncture is widely used worldwide, and systematic reviews on acupuncture are increasingly being published. Although acupuncture systematic reviews share several essential elements with other systematic reviews, some essential information for the application of acupuncture is not covered by the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement. Considering this, we aimed to develop an extension of the PRISMA statement for acupuncture systematic reviews.
Methods:
We used the PRISMA statement as a starting point, and conducted this study referring to the development strategy recommended by the EQUATOR network. The initial items were collected through a wide survey among evidence users and a review of relevant studies. We conducted a three-round Delphi survey and one-day face-to-face meeting to select items and formulate the checklist. After the consensus meeting, we drafted the manuscript (including the checklist) and sent it to our advisory experts for comments, following which the checklist was refined and circulated to a group of acupuncture systematic review authors for pilot test. We also selected a sample of acupuncture systematic reviews published in 2017 to test the checklist.
Results:
A checklist of five new sub-items (including sub items) and six modified items was formulated, involving content related to title, rationale, eligibility criteria, literature search, data extraction, and study characteristics. We clarified the rationales of the items and provided examples for each item for additional guidance.
Conclusion:
The PRISMA for Acupuncture checklist is developed for improving the reporting of systematic reviews of acupuncture interventions.
Trial registration:
We have registered the study on the EQUATOR network ( http://www.equator-network.org/library/reporting-guidelines-under-development/#91 ).
Multilevel models (MLMs) have been proposed in single-case research, to synthesize data from a group of cases in a multiple-baseline design (MBD). A limitation of this approach is that MLMs require several statistical assumptions that are often violated in single-case research. In this article we propose a solution to this limitation by presenting a randomization test (RT) wrapper for MLMs that offers a nonparametric way to evaluate treatment effects, without making distributional assumptions or an assumption of random sampling. We present the rationale underlying the proposed technique and validate its performance (with respect to Type I error rate and power) as compared to parametric statistical inference in MLMs, in the context of evaluating the average treatment effect across cases in an MBD. We performed a simulation study that manipulated the numbers of cases and of observations per case in a dataset, the data variability between cases, the distributional characteristics of the data, the level of autocorrelation, and the size of the treatment effect in the data. The results showed that the power of the RT wrapper is superior to the power of parametric tests based on F distributions for MBDs with fewer than five cases, and that the Type I error rate of the RT wrapper is controlled for bimodal data, whereas this is not the case for traditional MLMs.
La méthodologie de l’étude de cas est une méthodologie de recherche très prisée en sciences sociales, utilisée pour étudier des phénomènes complexes nouveaux en situation réelle ou étendre les connaissances sur des phénomènes déjà investigués. Les études de cas apportent ainsi une analyse détaillée et en profondeur sur un nombre limité de sujets. L’objectif de ce chapitre est d’apporter un regard éclairé sur cette méthode pour les chercheurs-managers candidats au DBA qui envisagent d’utiliser l’étude de cas dans leur recherche, en expliquant pourquoi et comment utiliser cette méthodologie et en en exposant les avantages et inconvénients. Pour cela nous nous appuyons sur les travaux de chercheurs renommés comme Yin (2003, 2009) ou Stake (1995) pour leurs techniques et recommandations sur la méthodologie de l’étude de cas.
Previous research has introduced several effect size measures (ESMs) to quantify data aspects of single-case experimental designs (SCEDs): level, trend, variability, overlap, and immediacy. In the current article, we extend the existing literature by introducing two methods for quantifying consistency in single-case A-B-A-B phase designs. The first method assesses the consistency of data patterns across phases implementing the same condition, called CONsistency of DAta Patterns (CONDAP). The second measure assesses the consistency of the five other data aspects when changing from baseline to experimental phase, called CONsistency of the EFFects (CONEFF). We illustrate the calculation of both measures for four A-B-A-B phase designs from published literature and demonstrate how CONDAP and CONEFF can supplement visual analysis of SCED data. Finally, we discuss directions for future research.
Background: Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use
of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality
case reports are more likely when authors follow reporting guidelines. During 2011e2012, a group of clinicians, researchers, and journal
editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport)
Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been
endorsed by multiple medical journals, and translated into nine languages.
Objectives: This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist
in writing and publishing case reports.
Objective: To examine the effectiveness of hypnodialysis on anxiety levels and adherence to medication, kidney diet and fluid intake in patients with chronic kidney disease.Methods: This was a randomized controlled trial study conducted from November to December 2016. Thirty respondents recruited using simple random sampling, which 17 respondents assigned randomly in the experiment and control group. The Hamilton Anxiety Rating Scale (HARS), Morisky scale, adherence to kidney diet questionnaire, adherence to fluid intake questionnaire were used as instruments for this study. Paired t-test and repeated ANOVA were used for data analysis.Results: Findings showed that there was a statistically significant effect of hypnodialysis in reducing anxiety levels and improving adherence to medication, kidney diet, and fluid intake in patients with chronic kidney disease with p-value 0.000 (<0.05), which its effect started from day 7 (posttest 1).Conclusion: Hypnodialysis may decrease anxiety levels and improve medication adherence, kidney diet and fluid intake. Therefore, hypnodialyis can be anlternative treatment for patients with chronic kidney disease.
Dysmenorrhea is one of the most common gynecological disorders, affects more than half of the reproductive aged women. Women experience periodic repeated discomforts associated with menstruation can affect their daily activities. A Quasi experimental study was conducted to evaluate the efficacy of using shiatsu therapy at "Sea of Energy" point on relieving primary dysmenorrhea. The study was conducted at College of Applied Medical Science, Shaqra University in the academic year 2015-2016. Eighty-two of nursing students at different academic levels was recruited for the study, allocated into two groups 'shiatsu group (46) and non-shiatsu group (36).Three tools for data collection were used; a structured interviewing questionnaire, visual-analogue scale and follow up chart. The results of the current study revealed that, the severity of pain and the associated symptoms was decreased in the shiatsu group compared to non-shiatsu group, with a highly statistically significant difference was found between groups after using the shiatsu massage therapy at "sea of energy" point. In conclusion, the present study concluded that using of shiatsu therapy at "Sea of Energy" point was effective for relieving primary dysmenorrhea pain and the associated symptoms for women. The study recommended that considering the shiatsu therapy as one of the effective therapeutic options for women suffering primary dysmenorrhea. Further studies are needed to investigate the effect of shiatsu points in a large population and on other health problems.
Background
Menstrual pain is very common amongst young women. Despite the significant impact that menstrual pain has on academic attendance and performance, social activities and quality of life, most young women do not seek medical treatment but prefer to use self-care; commonly OTC analgesic medications and rest. Many women do not get significant pain relief from these methods, therefore other low cost, easy to learn self-care methods may be a valuable approach to management.
This review and meta-analysis examines the evidence for participant lead self-care techniques.
Methods
A search of Medline, PsychINFO, Google Scholar and CINAHL was carried out in September 2017.
Results
Twenty-three trials including 2302 women were eligible and included in the meta-analysis. Studies examined self-delivered acupressure, exercise and heat as interventions. Risk of bias was unclear for many domains. All interventions showed a reduction in menstrual pain symptoms; exercise (g = 2.16, 95% CI 0.97 to 3.35) showed the largest effect size, with heat (g = 0.73, 95% CI 0.06 to 1.40) and acupressure (g = 0.56, 95% CI 0.10 to 1.03) showing more moderate effect sizes. Exercise (g = 0.48, 95% CI 0.12 to 0.83) and heat (g = 0.48, 95% CI 0.10 to 0.87), were more effective than analgesics in reducing pain intensity, whereas acupressure was significantly less effective (g = − 0.76, 95% CI -1.37 to − 0.15).
Conclusion
Exercise showed large effects, while acupressure and heat showed moderate effects in reducing menstrual pain compared to no treatment. Both exercise and heat are potential alternatives to analgesic medication. However, difficulties in controlling for non-specific effects, along with potential for bias, may influence study findings.
Background
The preparation of a randomized controlled trial (RCT) requires substantial resources and the administrative processes can be burdensome. To facilitate the conduct of RCTs it is important to better understand cost drivers. In January 2014 the enactment of the new Swiss Legislation on Human Research (LHR) considerably changed the regulatory framework in Switzerland. We assess if the new LHR was associated with change in (i) resource use and costs to prepare an RCT, and (ii) approval times with research ethics committees (RECs) and the regulatory authority Swissmedic.
Methods
We surveyed investigators of RCTs which were approved by RECs in 2012 or in 2016 and asked for RCT preparation costs using a pre-specified item list. Additionally, we collected approval times from RECs and Swissmedic.
Results
The response rates of the investigator survey were 8.3% (19/228) for 2012 and 16.5% (47/285) in 2016. The median preparation cost of an RCT was USD 72,400 (interquartile range [IQR]: USD 59,500–87,700; n = 18) in 2012 and USD 72,600 (IQR: USD 42,800–169,600; n = 35) in 2016. For single centre RCTs a median REC approval time of 82 (IQR: 49–107; n = 38) days in 2012 and 92 (IQR: 65–131; n = 63) days in 2016 was observed. The median Swissmedic approval time for any clinical trial was 27 (IQR: 19–51; n = 213) days in 2012 and 49 (IQR: 36–67; n = 179) days in 2016. The total duration for achieving RCT approval from both authorities (REC and Swissmedic) in the parallel submission procedure applied in 2016 could not be assessed.
Conclusion
Based on limited data the costs to plan and prepare RCTs in Switzerland were approximately USD 72,000 in 2012 and 2016. For effective and valid research on costs and approval times of RCTs a greater willingness to share cost information among investigators and more collaboration between stakeholders with data linkage is necessary.
Over the past years, there has been a growing interest in the association between lifestyle psychosocial interventions, severe mental illness, and suicide risk. Patients with severe mental disorders have higher mortality rates, poor health states, and higher suicide risk compared to the general population. Lifestyle behaviors are amenable to change through the adoption of specific psychosocial interventions, and several approaches have been promoted. The current article provides a comprehensive review of the literature on lifestyle interventions, mental health, and suicide risk in the general population and in patients with psychiatric disorders. For this purpose, we investigated lifestyle behaviors and lifestyle interventions in three different age groups: adolescents, young adults, and the elderly. Several lifestyle behaviors including cigarette smoking, alcohol use, and sedentary lifestyle are associated with suicide risk in all age groups. In adolescents, growing attention has emerged on the association between suicide risk and internet addiction, cyberbullying and scholastic and family difficulties. In adults, psychiatric symptoms, substance and alcohol abuse, weight, and occupational difficulties seems to have a significant role in suicide risk. Finally, in the elderly, the presence of an organic disease and poor social support are associated with an increased risk of suicide attempt. Several factors may explain the association between lifestyle behaviors and suicide. First, many studies have reported that some lifestyle behaviors and its consequences (sedentary lifestyle, cigarette smoking underweight, obesity) are associated with cardiometabolic risk factors and with poor mental health. Second, several lifestyle behaviors may encourage social isolation, limiting the development of social networks, and remove individuals from social interactions; increasing their risk of mental health problems and suicide.
Introduction:
This study evaluated the effects of geranium aromatherapy massage on premenstrual syndrome (PMS).
Methods:
A total of 120 female students with diagnosed PMS were randomly divided into three groups as control group, aromatherapy massage group, and massage group. Essential oil of geranium 2% in almond oil and sweet almond oil were used in aromatherapy massage group and massage group, respectively. Aromatherapy massage protocol was run for 8 weeks.
Results:
The study revealed that aromatherapy massage decreased the PMS physical and mental symptoms and massage therapy decreased the PMS physical and mental symptoms too (P < 0.001); however, this decrease was more in aromatherapy massage group (P < 0.001).
Conclusions:
This study recommends aromatherapy massage, as a complementary treatment, to improve PMS.
Tau (τ), a nonparametric rank order correlation statistic, has been applied to single-case experimental designs with promising results. Tau-U, a family of related coefficients, partitions variance associated with changes in trend and level. By examining within-phase trend and across-phase differences separately with Tau-U, single-case investigators may gain useful descriptive and inferential insights about their data. Heuristic data sets were used to explore Tau-U’s conceptual foundation, and 115 published single-case data sets were analyzed to demonstrate that Tau-U coefficients perform predictably when they are well understood. An understanding of Tau-U’s theoretical basis and unique limitations will help investigators select the appropriate statistical method to test their hypotheses and interpret their results appropriately. Limitations of Tau-U include as follows: vague or inconsistent Tau-U terminology in published single-case research; arithmetic problems that lead to unexpected and difficult-to-interpret results, especially when controlling for baseline trend; Tau-U methods are difficult to graph visually, and a comparison with visual raters found that several Tau-U effect size statistics are weakly correlated with visual analysis.
Background:
Chronic localized pain and decreased upper extremity mobility commonly occur following breast cancer surgery and may persist despite use of pain medication and physical therapy.
Purpose:
We sought to determine the value of myofascial massage to address these pain and mobility limitations.
Setting:
The study took place at a clinical massage spa in the U.S. Midwest. The research was overseen by MetroHealth Medical Center's Institutional Review Board and Case Center for Reducing Health Disparities research staff.
Participants:
21 women with persistent pain and mobility limitations 3-18 months following breast surgery.
Research design:
We conducted a pilot randomized controlled trial where intervention patients received myofascial massages and control patients received relaxation massages.
Intervention:
Intervention participants received 16 myofascial massage sessions over eight weeks that focused on the affected breast, chest, and shoulder areas. Control participants received 16 relaxation massage sessions over eight weeks that avoided the affected breast, chest, and shoulder areas. Participants completed a validated questionnaire at the beginning and end of the study that asked about pain, mobility, and quality of life.
Main outcome measures:
Outcome measures include change in self-reported pain, self-reported mobility, and three quality-of-life questions.
Results:
At baseline, intervention and control participants were similar in demographic and medical characteristics, pain and mobility ratings, and quality of life. Compared to control participants, intervention participants had more favorable changes in pain (-10.7 vs. +0.4, p < .001), mobility (-14.5 vs. -0.8, p < .001), and general health (+29.5 vs. -2.5, p = .002) after eight weeks. All intervention and control participants reported that receiving massage treatments was a positive experience.
Conclusions:
Myofascial massage is a promising treatment to address chronic pain and mobility limitations following breast cancer surgery. Further work in several areas is needed to confirm and expand on our study findings.
Background: The elderly are said to be more prone to depression as they become more isolated from their communities. Living alone, stressful life events, lack of social support systems, the recent loss of a loved one, lower socioeconomic status and presence of co-morbid medical illnesses are some of the risk factors for depression in the elderly which needs more than medical management. So, to demonstrate the scope, feasibility and possible outcome of the psychosocial intervention, a case of elderly person with depressive disorder and associated psychosocial problems formed the background of this case report. The positive outcome of this case also gave us an opportunity to critically assess the feasibility of psychosocial intervention in a facility named “Psychosocial Intervention Clinic” which has started functioning recently in the Department of Psychiatry, Government Medical College and Hospital, Chandigarh. Assessment & Management: The case presented here is that of a 78 years old, married, male, retired professor hailing from an upper-middle-class nuclear Hindu family with multiple psychosocial problems. Through an in-depth case study using face to face interview with the client and his family members, a psychosocial formulation was made and a plan for psychosocial intervention was made. As the sessions progressed, further associated issues were discussed. Consent was taken from the patient and family members for future possible reporting of this case in any journal. Outcome: After psychosocial intervention, understanding and awareness about the illness and psychosocial problem related to that in the family was enhanced, there was better involvement and interactions among the family members, self-esteem of the client improved, unwanted behaviour of the clientdecreased, family decided to resolve the inter-personal issues and family conflicts were significantly minimized, The client was contended and satisfied with the outcome of the intervention. Conclusion: The case study illustrates the nature and extent of psychosocial problems in a case of elderly person with depression and enhanced the understanding on some psychosocial issues associated with depression in elderly. It also demonstrated that psychosocial intervention plays a key role in the treatment of depression especially in the elderly.
Keywords: Elder person, depression, psychosocial intervention
Mixed methods single case research (MMSCR) is research in which single case experimental and qualitative case study methodologies, and their accompanying sets of methods and techniques, are integrated to answer research questions that concern a single case. This article discusses the historical roots and the distinct nature of MMSCR, the kinds of knowledge MMSCR produces, its philosophical underpinnings, examples of MMSCR, and the trustworthiness and validity of MMSCR. Methodological challenges relate to the development of a critical appraisal tool for MMSCR, to the team work that is involved in designing and conducting MMSCR studies, and to the application of mixed methods research synthesis for multiple case studies and single case experiments.
Interrupted time series analysis differs from most other intervention study designs in that it involves a before-after comparison within a single population, rather than a comparison with a control group. This has the advantage that selection bias and confounding due to between-group differences are limited. However, the basic interrupted time series design cannot exclude confounding due to co-interventions or other events occurring around the time of the intervention. One approach to minimizse potential confounding from such simultaneous events is to add a control series so that there is both a before-after comparison and an intervention-control group comparison. A range of different types of controls can be used with interrupted time series designs, each of which has associated strengths and limitations. Researchers undertaking controlled interrupted time series studies should carefully consider a priori what confounding events may exist and whether different controls can exclude these or if they could introduce new sources of bias to the study. A prudent approach to the design, analysis and interpretation of controlled interrupted time series studies is required to ensure that valid information on the effectiveness of health interventions can be ascertained.
Background:
This systematic review aimed to identify the unmet care needs and their associated variables in patients with advanced cancer and informal caregivers, alongside summarizing the tools used for needs assessment.
Methods:
Ten electronic databases were searched systematically from inception of each database to December 2016 to determine eligible studies. Studies that considered the unmet care needs of either adult patients with advanced cancer or informal caregivers, regardless of the study design, were included. The Mixed Methods Appraisal Tool was utilized for quality appraisal of the included studies. Content analysis was used to identify unmet needs, and descriptive analysis was adopted to synthesize other outcomes.
Results:
Fifty studies were included, and their methodological quality was generally robust. The prevalence of unmet needs varied across studies. Twelve unmet need domains were identified in patients with advanced cancer, and seven among informal caregivers. The three most commonly reported domains for patients were psychological, physical, and healthcare service and information. The most prominent unmet items of these domains were emotional support (10.1-84.4%), fatigue (18-76.3%), and "being informed about benefits and side-effects of treatment" (4-66.7%). The most commonly identified unmet needs for informal caregivers were information needs, including illness and treatment information (26-100%) and care-related information (21-100%). Unmet needs of patients with advanced cancer were associated with their physical symptoms, anxiety, and quality of life. The most commonly used instruments for needs assessment among patients with advanced cancer were the Supportive Care Needs Survey (N = 8) and Problems and Needs in Palliative Care questionnaire (N = 5). The majority of the included studies investigated unmet needs from the perspectives of either patients or caregivers with a cross-sectional study design using single time-point assessments. Moreover, significant heterogeneity, including differences in study contexts, assessment methods, instruments for measurement, need classifications, and reporting methods, were identified across studies.
Conclusion:
Both advanced cancer patients and informal caregivers reported a wide range of context-bound unmet needs. Examining their unmet needs on the basis of viewing patients and their informal caregivers as a whole unit will be highly optimal. Unmet care needs should be comprehensively evaluated from the perspectives of all stakeholders and interpreted by using rigorously designed mixed methods research and longitudinal studies within a given context.
Introduction : De plus en plus de thérapeutiques non pharmacologiques aussi appelées interventions non médicamenteuses (INM) sont prescrites par des médecins aux patients malades chroniques de manière complémentaire ou alternative aux traitements conventionnels. Leur usage est recommandé par d’autres professionnels de santé sans prescription. Leur offre s’étend chaque jour davantage notamment dans les domaines de la nutrition, de la e-santé et de l’ajustement psychologique à la maladie (ex. ETP). L’objectif de ce travail était de vérifier s’il existait un modèle consensuel de validation clinique et de surveillance de ces thérapeutiques comme c’est le cas pour le médicament et les dispositifs médicaux implantables. Méthode : Nous avons procédé à une revue de la littérature sur les modèles de validation et de surveillance des INM. Nous avons interrogé les bases de données scientifiques et médicales. Résultats : Nous avons identifié 17 modèles de la validation et de surveillance des INM. Des modèles s’inspirent du médicament. D’autres se fondent sur les interventions comportementales. D’autres se basent sur le design et l’implémentation. D’autres enfin, sont hybrides. Aucun modèle n’est consensuel ou dominant actuellement. Conclusion : L’usage croissant des INM encouragé par les médias et l’arrivée dans le secteur de la santé des industriels des nouvelles technologies et de la nutrition exige qu’un modèle consensuel de validation clinique et de surveillance soit adopté. A ce jour, force est de constater que ce n’est pas le cas. Leur nombre augmente même, nous en avons identifié 17. Cette diversité réduit la comparabilité des résultats des études et risque de multiplier les erreurs de prescription et les mésusages.
Objective. To compare the efficacy of a local anesthetic cream and music distraction in reducing or preventing pain from needle puncture (intravenous cannulation) in children. A secondary aim was to examine the influence of age on the pain report and behavior and on the therapeutic outcome.
Methodology. Children aged 4 to 16 years (N = 180) who were to undergo surgery under general anesthesia via intravenous cannulation were randomly allocated to one of three interventions. The comparison of lidocaine-prilocaine emulsion (EMLA, Astra) and a placebo emulsion was double-blind. Stratification by age group (4 to 6, 7 to 11, 12 to 16) ensured an equal number of children (20) in each intervention/age group category. A global assessment of the behavioral reaction to the procedure was made by the principal investigator, taking into account vocal, verbal, facial, and motor responses. The child was asked to assess pain severity on the Faces Pain Scale (FPS) and a visual analogue toy (VAT). The scales were applied conservatively as ordinal scales: FPS 0 to 6; VAT 0 to 10.
Results. Children who received lidocaine-prilocaine emulsion reported less pain (mean FF5 score = 1.42) compared with placebo emulsion (mean FPS score = 2.58) and with music distraction (mean FPS = 2.62). There was a highly significant therapeutic effect (P < .001) on the self-report and behavioral scores. Younger children, regardless of intervention, reported significantly more pain than the older children (mean FPS scores: 2.85, 2.33, 1.43 for age groups 4 to 6, 7 to 11, and 12 to 16 respectively; P < .001). The superiority of the local anesthetic emulsion was maximal in the youngest age group (4 to 6) almost eliminating pain-related behavior, and multiple regression analysis confirmed significant age and treatment effects and revealed interaction between therapeutic effect and age. Although a trend favoring the active emulsion was evident in the older children (7 to 11, 12 to 16) the differences were not significant. The pain scores were influenced by the type (gauge) of cannula, but this did not affect the conclusion regarding therapeutic and age effects. There was no influence of sex, experience with venipuncture, or whether the child was anxious on arrival in the operating room.
Conclusions. The results show that lidocaine-prilocaine emulsion is highly effective in preventing pain from venipunctures in young children the group in most need of prevention.
Objectives
To examine changes in psychological and occupational wellbeing in education professionals that attended a brief yoga and mindfulness-based program.
Design
Pragmatic controlled trial comparing education professionals that attended a yoga mindfulness-based program (n = 9) to a waitlist control group (n = 22).
Setting
The 3-day program was delivered at the Kripalu Center for Yoga & Health in Massachusetts. Intervention: The 3-day yoga mindfulness program included 5 hours per day of yoga, mindfulness exercises, formal meditation, didactic, and experiential activities.
Main Outcome Measures: Measures of psychological and occupational wellbeing were completed before (baseline), immediately after (post-program), and two months after the program (follow-up). Results: Relative to controls (n = 21), the RISE group (n = 9) showed significant improvements in positive affect (p = .033), negative affect (p = .044), mindfulness (p = .001), empowerment (p = .022), self-compassion (p = .001), and work engagement from baseline to post-program. From baseline to follow-up, the RISE group showed significant improvements in stress (p = .008), negative affect (p = .013), mindfulness (p = .001), empowerment (p = .007), and self-compassion (p = .001) compared to the control group.
Conclusions
The yoga mindfulness program was associated with improvements in educators’ psychological and occupational wellbeing immediately following and 2-months following the program. Future research with a larger sample size is needed to confirm these results.
With the objective of increasing the magnitude of treatment effects in behavioral health, there is a steadily growing interest in tailoring assessments and interventions to better match individual needs. This aligns with the central idea that behaviors can be adequately understood by considering the unique characteristics of the individual and context. Thus, data collected at an individual-level provides critical evidence that can be used to inform health care decisions, improve treatment or refine theories. Yet, the majority of research in behavioral health is based on group-level analyses. Recent developments in the field of single case experimental design (SCED) has provided new opportunities to utilize individual data. The present paper provides a state-of-the art overview regarding key aspects of SCED, including a historical background to why and how SCED emerged, declined, and recently re-emerged as well as methodological aspects such as design issues, challenges related to reliability and validity of repeated observations, innovations in visual and statistical analyses of individual data, strategies to deal with missing values, methodology to examine effect size, and approaches to summarize data from a large number of SCEDs using multilevel models and meta-analyses of replication data. Finally, the paper discusses key concerns and actions needed to move the field forward.
This chapter addresses the decision to use permutation tests as opposed to parametric analyses in the context of between-group analysis in randomized clinical trials designed to evaluate a medical intervention. It is important to understand at the outset that permutation tests represent a means to an end, rather than an end unto themselves. It is not so much that one seeks to use permutation tests just for the sake of doing so but, rather, that one recognizes the severe deficiencies of parametric analyses and wishes to use some other type of analysis that does not similarly suffer from these drawbacks. When viewed in this context, properly conducted permutation tests are the solution to the problem of how to compare treatments without having to rely on assumptions that cannot possibly be true. We argue that the default position would clearly be the use of exact analyses and that the burden of proof would fall to those who would argue that the approximate analyses are just as good or, as is sometimes argued, even better.
Single-case experiments have become increasingly popular in psychological and educational research. However, the analysis of single-case data is often complicated by the frequent occurrence of missing or incomplete data. If missingness or incompleteness cannot be avoided, it becomes important to know which strategies are optimal, because the presence of missing data or inadequate data handling strategies may lead to experiments no longer "meeting standards" set by, for example, the What Works Clearinghouse. For the examination and comparison of strategies to handle missing data, we simulated complete datasets for ABAB phase designs, randomized block designs, and multiple-baseline designs. We introduced different levels of missingness in the simulated datasets by randomly deleting 10%, 30%, and 50% of the data. We evaluated the type I error rate and statistical power of a randomization test for the null hypothesis that there was no treatment effect under these different levels of missingness, using different strategies for handling missing data: (1) randomizing a missing-data marker and calculating all reference statistics only for the available data points, (2) estimating the missing data points by single imputation using the state space representation of a time series model, and (3) multiple imputation based on regressing the available data points on preceding and succeeding data points. The results are conclusive for the conditions simulated: The randomized-marker method outperforms the other two methods in terms of statistical power in a randomization test, while keeping the type I error rate under control.
Les échelles dimensionnelles de mesure de la détresse psychologique sont généralement construites à partir d’une liste de symptômes associés à des cas cliniques de dépression, d’anxiété et d’autres désordres psychologiques. Leur validité de construit et concomitante est fragilisée par une faible validité de contenu. Cet article présente les résultats des validations de contenu, de construit et concomitante d’une nouvelle Échelle de Mesure des Manifestations de la Détresse Psychologique (ÉMMDP). Son originalité est de reposer sur une liste initiale de manifestations de la détresse rapportées par une population non clinique. L’ÉMMDP comprend, dans sa version courte, 23 items regroupés en quatre facteurs non orthogonaux d’auto-dévalorisation, d’irritabilité, d’anxiété/dépression et de désengagement social (alpha de Cronbach variant entre 0,81 et 0,89). Des scores élevés de détresse psychologique sont associés avec une augmentation de la consommation d’alcool, de médicaments psychotropes, le recours aux professionnels de la santé et des mesures d’auto-évaluation de l’état de santé psychologique.
Assessment of risk of bias is regarded as an essential component of a systematic review on the effects of an intervention. The most commonly used tool for randomised trials is the Cochrane risk-of-bias tool. We updated the tool to respond to developments in understanding how bias arises in randomised trials, and to address user feedback on and limitations of the original tool.
Cet article présente les principes fondamentaux des protocoles individuels expérimentaux et quasi-expérimentaux, tels qu’ils peuvent être utilisés en psychologie, notamment pour évaluer de façon expérimentale l’efficacité d’une intervention auprès d’un seul individu. Après avoir introduit les fondements théoriques des plans de recherche à cas uniques, les caractéristiques méthodologiques des protocoles quasi-expérimentaux et expérimentaux sont décrites. Les particularités de chaque plan expérimental sont détaillées et illustrées par une étude. Enfin, les différentes méthodes d’évaluation des données issues de protocoles individuels sont présentées et discutées.This paper presents the basic principles of experimental and quasi-experimental single-case designs, as they can be used in psychology, in particular to evaluate experimentally the effectiveness of an intervention with a single individual. After reviewing the theoretical foundations of single-case research designs, the methodological requirements of quasi-experimental and experimental single-case designs are described. The primary features of each experimental design are detailed and illustrated by a study. Finally, different methods of evaluating data from single-case designs are presented and discussed.
Importance
The quality of reporting of randomized clinical trials is suboptimal. In an era in which the need for greater research transparency is paramount, inadequate reporting hinders assessment of the reliability and validity of trial findings. The Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement was developed to improve the reporting of randomized clinical trials, but the primary focus was on parallel-group trials with 2 groups. Multi-arm trials that use a parallel-group design (comparing treatments by concurrently randomizing participants to one of the treatment groups, usually with equal probability) but have 3 or more groups are relatively common. The quality of reporting of multi-arm trials varies substantially, making judgments and interpretation difficult. While the majority of the elements of the CONSORT 2010 Statement apply equally to multi-arm trials, some elements need adaptation, and, in some cases, additional issues need to be clarified.
Objective
To present an extension to the CONSORT 2010 Statement for reporting multi-arm trials to facilitate the reporting of such trials.
Design
A guideline writing group, which included all authors, formed following the CONSORT group meeting in 2014. The authors met in person and by teleconference bimonthly between 2014 and 2018 to develop and revise the checklist and the accompanying text, with additional discussions by email. A draft manuscript was circulated to the wider CONSORT group of 36 individuals, plus 5 other selected individuals known for their specialist knowledge in clinical trials, for review. Extensive feedback was received from 14 individuals and, after detailed consideration of their comments, a final revised version of the extension was prepared.
Findings
This CONSORT extension for multi-arm trials expands on 10 items of the CONSORT 2010 checklist and provides examples of good reporting and a rationale for the importance of each extension item. Key recommendations are that multi-arm trials should be identified as such and require clear objectives and hypotheses referring to all of the treatment groups. Primary treatment comparisons should be identified and authors should report the planned and unplanned comparisons resulting from multiple groups completely and transparently. If statistical adjustments for multiplicity are applied, the rationale and method used should be described.
Conclusions and Relevance
This extension of the CONSORT 2010 Statement provides specific guidance for the reporting of multi-arm parallel-group randomized clinical trials and should help provide greater transparency and accuracy in the reporting of such trials.
(Abstracted from JAMA Oncol 2018;4:1375–1381)
Complementary medicine (CM) refers to integration of unproven nonmedical methods with conventional therapies, whereas alternative medicine is use of unproven methods instead of conventional therapy. In the United States, complementary and alternative medicine is a multibillion-dollar industry.
The overarching purpose of this article is to provide an introduction to the use of rigorous single-case research designs (SCRDs) in special education and related fields. Authors first discuss basic design types and research questions that can be answered with SCRDs, examine threats to internal validity and potential ways to control for and detect common threats, and provide guidelines for selection of specific designs. Following, contemporary standards regarding rigor, measurement, description, and outcomes are presented. Then, authors discuss data analytic techniques, differentiating rigor, positive outcomes, functional relations, and magnitude of effects.
Although single-case design seems to be an appropriate method for practicing psychologists as it fits perfectly with the evidence-based practice framework, their use remains quasi-anecdotal in psychology. The aim of the present article is to present the advantages of single-case protocols and to demonstrate the ease of their implementation. It provides practitioners with a tutorial of a free open-source statistical program (SCDA) to analyze single-case data. The main results from a single-case protocol are presented and illustrated through an example. Strategies for integrating these protocols in the clinical practice are discussed. This tutorial could encourage the use of the single-case design in research and practice settings.
Single-case designs refer to a methodological approach that can be used to investigate the effectiveness of treatment with the individual client. The designs permit scientifically valid inferences to be drawn about the effects of treatment and hence offer advantages over alternative strategies such as the uncontrolled case study or open study that are used with the individual case. The present article discusses the key features of the methodology, illustrates specific designs and how inferences are drawn, and discusses critical issues (feasibility, generality of results, ethical issues) in the use of the designs. Essential features of the design, including ongoing assessment and drawing on the underlying thinking and logic of the designs can improve the clinical care for individual clients, even when the rigors of experimentation are not feasible or desirable. Lamentably, single-case methods are rarely trained among researchers or practitioners in psychology or related mental health professions. The designs could play a special role by improving individual care and therapeutic change, apart from the strength of the methodology as a purely research tool.
Perhaps no other topic in risk analysis is more difficult, more controversial, or more important to risk management policy analysts and decision-makers than how to draw valid, correctly qualified causal conclusions from observational data. Statistical methods can readily quantify associations between observed variables using measures such as relative risk (RR) ratios, odds ratios (OR), slope coefficients for exposure or treatment variables in regression models, and quantities derived from these measures. Textbooks of epidemiology explain how to calculate population attributable fractions, attributable risks, burden-of-disease estimates, and probabilities of causation from relative risk (RR) ratios. Despite their suggestive names, these association-based measures have no necessary connection to causation if the associations on which they are based arise from bias, confounding, p-hacking, coincident historical trends, or other noncausal sources. But policy analysts and decision makers need something more: trustworthy predictions - and, later, evaluations - of the changes in outcomes caused by changes in policy variables. This concept of manipulative causation differs from the more familiar concepts of associational and attributive causation most widely used in epidemiology. Drawing on modern literature on causal discovery and inference principles and algorithms for drawing limited but useful causal conclusions from observational data, we propose seven criteria for assessing consistency of data with a manipulative causal exposure-response relationship - mutual information, directed dependence, internal and external consistency, coherent causal explanation of biological plausibility, causal mediation confirmation, and refutation of non-causal explanations - and discuss to what extent it is now possible to automate discovery of manipulative causal dependencies and quantification of causal effects from observational data. We compare our proposed principles for causal discovery and inference to the traditional Bradford Hill considerations from 1965. Understanding how old and new principles are related can clarify and enrich both.
Objective:
To develop ROBIS, a new tool for assessing the risk of bias in systematic reviews (rather than in primary studies).
Study design and setting:
We used four-stage approach to develop ROBIS: define the scope, review the evidence base, hold a face-to-face meeting, and refine the tool through piloting.
Results:
ROBIS is currently aimed at four broad categories of reviews mainly within health care settings: interventions, diagnosis, prognosis, and etiology. The target audience of ROBIS is primarily guideline developers, authors of overviews of systematic reviews ("reviews of reviews"), and review authors who might want to assess or avoid risk of bias in their reviews. The tool is completed in three phases: 1) assess relevance (optional), 2) identify concerns with the review process, and 3) judge risk of bias. Phase 2 covers four domains through which bias may be introduced into a systematic review: 1) study eligibility criteria; 2) identification and selection of studies; 3) data collection and study appraisal; and 4) synthesis and findings. Phase 3 assesses the overall risk of bias in the interpretation of review findings and whether this considered limitations identified in any of the phase 2 domains. Signaling questions are included to help judge concerns with the review process (phase 2) and the overall risk of bias in the review (phase 3); these questions flag aspects of review design related to the potential for bias and aim to help assessors judge risk of bias in the review process, results, and conclusions.
Conclusions:
ROBIS is the first rigorously developed tool designed specifically to assess the risk of bias in systematic reviews.
Background:
Acupuncture has a history of traditional use in China for women's health conditions including premenstrual syndrome (PMS), but its effectiveness for this condition remains unclear. This review examined the available evidence supporting the use of acupuncture or acupressure to treat PMS.
Objectives:
To evaluate the effectiveness and safety of acupuncture or acupressure for women with PMS or premenstrual dysphoric disorder (PMDD).
Search methods:
We searched the Cochrane Gynaecology and Fertility Specialised Register, Cochrane Central Register of Studies Online (CENTRAL CRSO), MEDLINE, Embase, AMED, PsycINFO, CINAHL (from inception to 21 September 2017), two clinical trial databases (from their inception to 21 September 2017), and four electronic databases in China (from their inception to 15 October 2017): Chinese Biomedical Literature database (CBM), China National Knowledge Infrastructure (CNKI), VIP information/ Chinese Scientific Journals database and WANFANG. Reference lists from included articles were handsearched.
Selection criteria:
We included studies if they randomised women with PMS and associated disorders (PMDD and late luteal phase dysphoric disorder/LPDD) to receive acupuncture or acupressure versus sham, usual care/waiting-list control or pharmaceutical interventions mentioned by the International Society for Premenstrual Disorders (ISPMD). If acupuncture or acupressure were combined with another therapy, these studies were also included where the additional therapy was the same in both groups. Cross-over studies were eligible for inclusion, but only data from the first phase could be used.
Data collection and analysis:
Two review authors independently selected the studies, assessed eligible studies for risk of bias, and extracted data from each study. Study authors were contacted for missing information. The quality of the evidence was assessed using GRADE. Our primary outcomes were overall premenstrual symptoms and adverse events. Secondary outcomes included specific PMS symptoms, response rate and quality of life.
Main results:
Five trials (277 women) were included in this review. No trials compared acupuncture or acupressure versus other active treatments. The number of treatment sessions ranged from seven to 28. The quality of the evidence ranged from low to very low quality, the main limitations being imprecision due to small sample sizes and risk of bias related to detection bias and selective reporting.Acupuncture versus sham acupunctureAcupuncture may provide a greater reduction in mood-related PMS symptoms (mean difference (MD) -9.03, 95% confidence interval (CI) -10.71 to -7.35, one randomised controlled trial (RCT), n = 67, low-quality evidence) and in physical PMS symptoms (MD -9.11, 95% CI -10.82 to -7.40, one RCT, n = 67, low-quality evidence) than sham acupuncture, as measured by the Daily Record of Severity of Problems scale (DRSP). The evidence suggests that if women have a mood score of 51.91 points with sham acupuncture, their score with acupuncture would be between 10.71 and 7.35 points lower and if women have a physical score of 46.11 points, their score with acupuncture would be between 10.82 and 7.4 points lower.There was insufficient evidence to determine whether there was any difference between the groups in the rate of adverse events (risk ratio (RR) 1.74, 95% CI 0.39 to 7.76, three RCTs, n = 167, I2 = 0%, very low-quality evidence).Specific PMS symptoms were not reportedThere may be little or no difference between the groups in response rates. Use of a fixed-effect model suggested a higher response rate in the acupuncture group than in the sham group (RR 2.59, 95% CI 1.71 to 3.92; participants = 100; studies = 2; I2 = 82%), but owing to the high heterogeneity we tested the effect of using a random-effects model, which provided no clear evidence of benefit for acupuncture (RR 4.22, 95% CI 0.45 to 39.88, two RCTs, n = 100, I2 = 82%, very low-quality evidence).Acupuncture may improve quality of life (measured by the WHOQOL-BREF) compared to sham (MD 2.85, 95% CI 1.47 to 4.23, one RCT, n = 67, low-quality evidence).Acupuncture versus no treatmentDue to the very low quality of the evidence, we are uncertain whether acupuncture reduces PMS symptoms compared to a no treatment control (MD -13.60, 95% CI -15.70 to -11.50, one RCT, n = 14).No adverse events were reported in either group.No data were available on specific PMS symptoms, response rate or quality of life outcomes.Acupressure versus sham acupressureWe found low-quality evidence that acupressure may reduce the number of women with moderate to severe PMS symptoms at the end of the trial compared to sham acupressure (RR 0.64 95% CI 0.52 to 0.79, one RCT, n = 90, low-quality evidence). The evidence suggests that if 97 women out of 100 in the sham acupressure group had moderate to severe PMS symptoms, the number of women in the acupressure group with moderate to severe symptoms would be 50 to 76 women.Acupressure may improve both physical (MD 24.3, 95% CI 17.18 to 31.42, one RCT, n = 90, low-quality evidence) and mental (MD 17.17, 95% CI 13.08 to 21.26, one RCT, n = 90, low-quality evidence) quality of life.No data were available on adverse events, specific symptoms or response rates.
Authors' conclusions:
The limited evidence available suggests that acupuncture and acupressure may improve both physical and psychological symptoms of PMS when compared to a sham control. There was insufficient evidence to determine whether there was a difference between the groups in rates of adverse events.There is no evidence comparing acupuncture or acupressure versus current ISPMD recommended treatments for PMS such as selective serotonin reuptake inhibitors (SSRIs). Further research is required, using validated outcome measures for PMS, adequate blinding and suitable comparator groups reflecting current best practice.
Single Case Experimental Design is a discipline grounded in applied behavior analysis where the needs of individual clients and the application of scientific inquiry are fundamental tenets. These two principles remain tantamount in the conduct of research using this methodology and the expansion of the method into evidence-based practice determinations. Although recommendations for quality indicators are widespread, implementation is not. Concurrent to the rise of quality indicators is an increasing interest in analysis methodology. Visual analysis has a history of application and validity, newer forms of analysis less so. While some argue for concordance between the two, it may be the differences that are worth exploration in understanding characteristics of trend and variability in much of the published literature. Design choice and visual analysis decisions are rarely fully articulated. Statistical analyses are likewise inadequately justified or described. Recommendations for the explicit language of reporting as derived from prior meta-analysis and a current review of two leading journals provides a scaffold consistent with existing guidelines but additive in detail, exemplars, and justification. This is intended to improve reporting of results for individual studies and their potential use in future meta-analytic work.