Development of Provisional Acupuncture Guidelines for Pelvic Pain in Endometriosis Using an e-Delphi Consensus Process.

Introduction: Growing evidence suggests that acupuncture can improve pelvic pain in women with endometriosis. The treatments used in research vary considerably. It remains unclear which treatment could be recommended for clinical practice. This research project aimed at clarifying how acupuncture could be used when treating this condition. Methods: This research comprised two phases: a systematized literature review to extract acupuncture treatment details from published research, and an e-Delphi study to gain knowledge about details as used by expert acupuncturists. Review: Four databases were searched using predefined eligibility criteria. Data were extracted based on the STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) criteria. e-Delphi: Purposeful sampling from colleagues and international experts. An open first round gathered qualitative data, analyzed with the Framework method. In rounds 2 and 3, experts rated statements to build group consensus, defined as a rating of ≥5 on a 7-point Likert scale by ≥70% of the experts. The strength of agreement was graded using the median score and interquartile range. Results from the literature review and the e-Delphi were compared using the STRICTA items. Results: The literature review (n = 29 unique studies) found a wide range of treatment details with little agreement. The e-Delphi of international experts (n = 20) resulted in agreement on 94 statements (such as key factors for effectiveness); disagreement on a further 29 (such as acupressure); and absence of consensus on 55 statements (such as the number of needle insertions). A comparison of the review and e-Delphi results found little agreement. Conclusions: Details of acupuncture treatment for endometriosis-related pelvic pain were presented. In the absence of acupuncture guidelines for this condition, the researchers of this e-Delphi recommend using the treatment details on which experts agreed as guidance for good practice. The effectiveness of these guidelines should be evaluated in future research. Study registration: Deutsches Register Klinischer Studien, DRKS00022215, June 30, 2020, retrospectively registered.

Defining Terms Used for Animals Working in Support Roles for People with Support Needs.

The nomenclature used to describe animals working in roles supporting people can be confusing. The same term may be used to describe different roles, or two terms may mean the same thing. This confusion is evident among researchers, practitioners, and end users. Because certain animal roles are provided with legal protections and/or government-funding support in some jurisdictions, it is necessary to clearly define the existing terms to avoid confusion. The aim of this paper is to provide operationalized definitions for nine terms, which would be useful in many world regions: "assistance animal", "companion animal", "educational/school support animal", "emotional support animal", "facility animal", "service animal", "skilled companion animal", "therapy animal", and "visiting/visitation animal". At the International Society for Anthrozoology (ISAZ) conferences in 2018 and 2020, over 100 delegates participated in workshops to define these terms, many of whom co-authored this paper. Through an iterative process, we have defined the nine terms and explained how they differ from each other. We recommend phasing out two terms (i.e., "skilled companion animal" and "service animal") due to overlap with other terms that could potentially exacerbate confusion. The implications for several regions of the world are discussed.

A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic treatment, compared with 10 children receiving usual care.

20 consecutively enrolled children age 5-16 with Attention Deficit Hyperactivity Disorder (ADHD) received treatment by a homeopath (8 consultations and individualized remedies) for one year. Ten subsequently enrolled children received similar time and attention for 4 months. The study explored optimum treatment protocols; the effectiveness, deliverability and acceptability of treatment; and the feasibility of outcome measurement and recruitment. Parents completed Conners' Parent Rating Scale, Revised Long Version ( CPRS-R: L) every 4 months, from which DSMIV total scores were extracted; and Measure Your Own Medical Outcome Profile (MYMOP) every consultation. An interaction between time (baseline/4 months) and group (treatment/non-treatment) was found .756 F (1,28)=9.06, p=0.005. The intervention was associated with statistically significant improvements in treated children over the year: CPRS-R: L (t (18)=4.529, p≤0.000); MYMOP (t (18)=6.938, p≤0.000). Mean DSMIV total t scores decreased at each time point: baseline: 85 (SD 5.1); 4 months 76.2 (SD 10.9); and 12 months 71.5 (SD 12.77). Recruitment of control participants was problematic. Recruitment to treatment was feasible via ADHD support groups, charities, police support agencies and social services, not schools or NHS services. Attending appointments was problematic for some participants, but home visits did not improve uptake. The best venue was a familiar clinic. Some participants took medicines inappropriately, but generally taking homeopathic remedies was acceptable and well implemented. CPRS-R: L (80 items) was problematic for some parents. MYMOP was preferred by parents but not acceptable to stakeholders. In this small consecutive sample the intervention was associated with improvements in criminality, anger and children with a concomitant diagnosis of Autism Spectrum Disorder ASD. Treatment by a homeopath was associated with sustained, increasing improvements and the intervention was acceptable to participants. More methodically rigorous research is warranted. "We recommend that future research in this area uses comparative effectiveness randomised controlled trial designs. We also recommend that these trials measure outcomes of relevance to stakeholder needs - the people and services who care for those with ADHD - parents, teachers and social workers and the criminal justice system".

Cutting down: insights from qualitative studies of smoking in pregnancy.

The adverse effects of smoking in pregnancy are minimised if the mother quits completely in early pregnancy. Smokers are therefore advised to quit abruptly; cutting down is not recommended either as a method of, or alternative to, quitting. However, most pregnant smokers do not quit and cutting down is widely reported. Evidence comes primarily from quantitative studies; qualitative research has contributed little to understandings of cigarette consumption in pregnancy. In consequence, little is known about the place and meaning of cutting down for pregnant smokers. The paper investigates this important dimension of maternal smoking. It explores perceptions and experiences of cutting down among pregnant smokers by examining data from a systematic review of qualitative studies of smoking in pregnancy. The studies were located in high-income countries and published between 1970 and 2012. Twenty-six studies, reported in 29 papers, were included, representing over 640 women. Meta-ethnography guided the analysis and synthesis. Data (participants' accounts and authors' interpretations) were extracted and coded; codes were progressively combined to identify overarching themes ('lines of argument'). Running through the lines of argument was evidence on cutting down; the paper presents and analyses this evidence. The analysis indicates that cutting down figured centrally as both a method of quitting and, for persistent smokers, a method of harm reduction. While pregnant women were aware that official advice was to quit abruptly, cutting down was seen as a positive behaviour change in often-difficult domestic circumstances, and one that health professionals condoned. Our findings suggest that cutting down in pregnancy, as an aid and an alternative to quitting, requires greater recognition if healthcare and tobacco control policies are to be sensitive to the perspectives and circumstances of pregnant smokers.

Reporting of industry funded study outcome data: comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion.

OBJECTIVE: To investigate whether published results of industry funded trials of recombinant human bone morphogenetic protein 2 (rhBMP-2) in spinal fusion match underlying trial data by comparing three different data sources: individual participant data, internal industry reports, and publicly available journal publications and conference abstracts. DATA COLLECTION AND SYNTHESIS: The manufacturer of rhBMP-2 products (Medtronic; Minneapolis, MN) provided complete individual participant data and internal reports for all its studies of rhMBP-2 in spinal fusion. We identified publications and conference abstracts through comprehensive literature searches. We compared outcomes provided in the individual participant data against outcomes reported in publications. For effectiveness outcomes, we compared meta-analyses of randomised controlled trials based on each of the three data sources. For adverse events, meta-analysis of the published aggregate data was not possible and we compared the number and type of adverse events reported between data sources. RESULTS: 32 publications reported outcomes from 11 of the 17 existing manufacturer sponsored studies. For individual randomised controlled trials, 56% (9/16) to 88% (15/17) of effectiveness outcomes known to have been collected were reported in the published literature. Meta-analyses of effectiveness data were almost identical for pain outcomes and similar for fusion across the three data sources. A minority of adverse event data known to have been collected were reported in the published literature. Several journal articles reported only "serious," "related," or "unanticipated" adverse events, without defining these terms. Others reported a small proportion of the collected adverse event categories. Around 23% (533/2302) of the total adverse events collected in published randomised controlled trials have been reported in the literature, with randomised controlled trials evaluating the licensed preparation (Infuse) reporting around 11% (122/1108) of collected adverse events. CONCLUSIONS: The published literature only partially represents the total data known to have been collected on the effects of rhBMP-2. This did not lead to substantially different results for meta-analysis of effectiveness outcomes. In contrast, reporting of adverse event data in trial publications was inadequate and inconsistent to the extent that any systematic review based solely on the publicly available data would not be able to properly evaluate the safety of rhBMP-2. Analysis of individual participant data enabled the most complete, detailed, and in-depth analysis and was not more resource intensive than extracting, collating, and analysing aggregate data from multiple trial publications and conference abstracts. Confidential internal reports presented considerably more adverse event data than publications, and in the absence of individual participant data access to these reports would support more accurate and reliable investigation, with less time and effort than relying on incomplete published data.

Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: a meta-analysis of individual-participant data.

BACKGROUND: Recombinant human bone morphogenetic protein-2 (rhBMP-2) is widely used to promote fusion in spinal surgery, but its safety has been questioned. PURPOSE: To evaluate the effectiveness and safety of rhBMP-2. DATA SOURCES: Individual-participant data obtained from the sponsor or investigators and data extracted from study publications identified by systematic bibliographic searches through June 2012. STUDY SELECTION: Randomized, controlled trials of rhBMP-2 versus iliac crest bone graft (ICBG) in spinal fusion surgery for degenerative disc disease and related conditions and observational studies in similar populations for investigation of adverse events. DATA EXTRACTION: Individual-participant data from 11 eligible of 17 provided trials sponsored by Medtronic (Minneapolis, Minnesota) (n = 1302) and 1 of 2 other eligible trials (n = 106) were included. Additional aggregate adverse event data were extracted from 35 published observational studies. DATA SYNTHESIS: Primary outcomes were pain (assessed with the Oswestry Disability Index [ODI] or Short Form-36), fusion, and adverse events. At 24 months, ODI scores were 3.5% lower (better) with rhBMP-2 than with ICBG (95% CI, 0.5% to 6.5%) and radiographic fusion was 12% higher (CI, 2% to 23%). At or shortly after surgery, pain was more common with rhBMP-2 (odds ratio, 1.78 [CI, 1.06 to 2.95]). Cancer was more common after rhBMP-2 (relative risk, 1.98 [CI, 0.86 to 4.54]), but the small number of events precluded definite conclusions. LIMITATION: The observational studies were diverse and at risk of bias. CONCLUSION: At 24 months, rhBMP-2 increases fusion rates, reduces pain by a clinically insignificant amount, and increases early postsurgical pain compared with ICBG. Evidence of increased cancer incidence is inconclusive. PRIMARY FUNDING SOURCE: Yale University Open Data Access Project.

Smoking in pregnancy: a systematic review of qualitative research of women who commence pregnancy as smokers.

AIM: To provide evidence on how women's circumstances and experiences influence their smoking behaviour in pregnancy, including their attempts to quit. BACKGROUND: Women in disadvantaged circumstances are more likely to smoke prior to pregnancy; they are also less likely to quit in pregnancy and, among those who quit, more likely to resume smoking after birth. Although there is a rich seam of qualitative research on their experiences, it has yet to be bought together and synthesized. DESIGN: The synthesis was conducted using meta-ethnography. DATA SOURCES: A comprehensive search of five electronic databases (inception to May 2012) was completed to identify qualitative research exploring pregnant women's experiences of smoking in pregnancy. REVIEW METHODS: Following critical appraisal, 26 studies reported in 29 papers were included in the review. Over 640 pregnant women were represented, the majority drawn from disadvantaged groups. We carried out the synthesis using meta-ethnography. RESULTS: Four dimensions of women's circumstances and experiences of smoking in pregnancy were highlighted: the embeddedness of smoking in women's lives, questioned only because of pregnancy; quitting for pregnancy rather than for good; quitting had significant costs for the woman and cutting down was a positive alternative; the role of partners and the broader dynamics of the couple's relationship in influencing women's smoking habits. CONCLUSION: Syntheses of qualitative research have an important role to play in producing the evidence base for midwifery, nursing, and public health policy and practice. The four dimensions identified in this review have implications for the design and delivery of interventions to support women to quit smoking in pregnancy.

A systematic review of models of care for the follow-up of childhood cancer survivors.

Follow-up care for survivors of childhood cancer is increasingly seen as a priority service as numbers of survivors increase. Despite this there are few published evaluations of the available options. We conducted a systematic review of published and unpublished literature. Seven uncontrolled studies, and one comparative study of a related intervention, were identified. Observational data suggest that follow-up care was useful even for patients who did not perceive this as a need. Suitably powered, well-conducted, controlled trials of adequate duration that directly compare follow-up models are required to provide robust evidence on the optimal care for these patients.